Leping

Grant Agreement number: 101035467 — TEHDAS — HP-JA-2020 / HP-JA-2020-1 Associated with documentCHAFEA MGA — Multi:-v2.1 Ref. Ares(2021)4548885 13/07/2021 EUROPEAN COMMISSION European Health and Digital Executive Agency The Director GRANT AGREEMENT NUMBER 101035467 — TEHDAS This Agreement (‘the Agreement’) is between the following parties: on the one part, the European Health and Digital Executive Agency (HaDEA) ('the Agency'), under the powers delegated by the European Commission ('the Commission'), represented for the purposes of signature of this Agreement by Nicolas KRIEGER, Acting Head of Unit, or his/her duly authorised representative, and on the other part, 1. ‘the coordinator’: SUOMEN ITSENAISYYDEN JUHLARAHASTO (Sitra), established in ITAMERENKATU 11-13, HELSINKI 00180, Finland, VAT number: FI02021323, represented for the purposes of signing the Agreement by Heidi Saario and the following other beneficiaries, if they sign their ‘Accession Form’ (see Annex 3 and Article 40): 2. BUNDESMINISTERIUM FUER SOZIALES, GESUNDHEIT, PFLEGE UND KONSUMENTENSCHUTZ (ATNA), established in Radetzkystrasse 2, WIEN 1030, Austria, 3. SCIENSANO (Sciensano), established in JULIETTE WYTSMANSTRAAT 14, ELSENE 1050, Belgium, VAT number: BE0693876830, 4. HRVATSKI ZAVOD ZA ZDRAVSTVENO OSIGURANJE (CHIF), established in MARGARETSKA 3, ZAGREB 10000, Croatia, VAT number: HR3580261, 5. Ministry of Health of the Republic of Cyprus (MoH-CY), established in 1 Prodromou Street & 17 Chilonos Street 1 & 17, Nicosia 1448, Cyprus, 6. MINISTERSTVO ZDRAVOTNICTVI CESKE REPUBLIKY (MZCR), established in PALACKEHO NAMESTI 375/4, PRAHA 12801, Czech Republic, 7. REGION MIDTJYLLAND (RM), established in Skottenborg 26, VIBORG 8800, Denmark, VAT number: DK29190925, 1 Grant Agreement number: 101035467 — TEHDAS — HP-JA-2020 / HP-JA-2020-1 Associated with documentCHAFEA MGA — Multi:-v2.1 Ref. Ares(2021)4548885 13/07/2021 8. SOTSIAALMINISTEERIUM (MoSA), established in Suur-Ameerika 1, TALLINN 10122, Estonia, 9. PLATEFORME DES DONNEES DE SANTE (FR-HDH), established in 9 RUE GEORGES PITARD, Paris 75015, France, VAT number: FR66130003783, 10. BUNDESMINISTERIUM FUER GESUNDHEIT (BMG), established in ROCHUSTRASSE 1, BONN 53123, Germany, 11. DIOIKISI 6IS YGEIONOMIKIS PERIFEREIAS PELOPONNISOU IONION NYSON IPEIROU KAI DYTIKIS ELLADAS (6th Y. PE.), established in IPATIS 1, PATRAS 26 441, Greece, VAT number: EL999100797, 12. ORSZAGOS KORHAZI FOIGAZGATOSAG (OKFŐ), established in DIOS AROK 3, BUDAPEST 1125, Hungary, VAT number: HU15845883, 13. DEPARTMENT OF HEALTH (DoH-IE), established in Block 1, Miesian Plaza, 50 – 58 Lower Baggot Street, Dublin D02 XW14, Ireland, 14. MINISTERO DELLA SALUTE (MINSAL), established in Via Giorgio Ribotta 5, ROMA 00144, Italy, VAT number: N/A, 15. LIETUVOS RESPUBLIKOS SVEIKATOS APSAUGOS MINISTERIJA (SAM-LT), established in VILNIAUS G 33, VILNIUS LT 01506, Lithuania, 16. Ministry for Health - Government of Malta (DHIR), established in Palazzo Castellania, Merchants Street 15, Valletta VLT 200, Malta, VAT number: MT12979127, 17. AGENTIA DE TRANSPLANT (ATRM), established in STRADA TESTEMITEANU 29, CHISINAU 2025, Moldova, 18. MINISTERIE VAN VOLKSGEZONDHEID, WELZIJN EN SPORT (VWS), established in PARNASSUSPLEIN 5, DEN HAAG 2500 EJ, Netherlands, 19. THE NORWEGIAN MINISTRY OF HEALTH AND CARE SERVICES (MoH-NO), established in R6 Teatergata 9, 0030 Oslo 8011, Norway, 20. SPMS - SERVICOS PARTILHADOS DO MINISTERIO DA SAUDE EPE (SPMS), established in AVENIDA DA REPUBLICA, 61, LISBOA 1050 189, Portugal, VAT number: PT509540716, 21. INSTITUT ZA ZASTITU ZDRAVLJA SRBIJEDR MILAN JOVANOVIC BATUT (IPHS "Batut"), established in DR SUBOTICA STREET 5, BEOGRAD 11000, Serbia, VAT number: RS102000930, 22. NACIONALNI INSTITUT ZA JAVNO ZDRAVJE (NIJZ), established in TRUBARJEVA CESTA 2, LJUBLJANA 1000, Slovenia, VAT number: SI44724535, 23. INSTITUTO ARAGONES DE CIENCIAS DE LA SALUD (IACS), established in AVENIDA SAN JUAN BOSCO 13, ZARAGOZA 50009, Spain, VAT number: ESQ5000654C, 24. E-HALSOMYNDIGHETEN (SEHA), established in SANK ERIKSGATAN 117, STOCKHOLM 118 60, Sweden, VAT number: SE202100655201, 2 Grant Agreement number: 101035467 — TEHDAS — HP-JA-2020 / HP-JA-2020-1 Associated with documentCHAFEA MGA — Multi:-v2.1 Ref. Ares(2021)4548885 13/07/2021 25. THE NHS CONFEDERATION (NHSC), established in 2ND FLOOR 18 SMITH SQUARE, LONDON SW1P 3HZ, United Kingdom, VAT number: GB788186860, Unless otherwise specified, references to ‘beneficiary’ or ‘beneficiaries’ include the coordinator. The parties referred to above have agreed to enter into the Agreement under the terms and conditions below. By signing the Agreement or the Accession Form, the beneficiaries accept the grant and agree to implement it under their own responsibility and in accordance with the Agreement, with all the obligations and conditions it sets out. The Agreement is composed of: Terms and Conditions Annex 1 Description of the action Annex 2 Estimated budget for the action Annex 2a Not applicable Annex 3 Accession Forms Annex 4 Model for the financial statements Annex 5 Model for the certificate on the financial statements (CFS) 3 Grant Agreement number: 101035467 — TEHDAS — HP-JA-2020 / HP-JA-2020-1 Associated with documentCHAFEA MGA — Multi:-v2.1 Ref. Ares(2021)4548885 13/07/2021 TERMS AND CONDITIONS TABLE OF CONTENTS CHAPTER 1 GENERAL................................................................................................................................................9 ARTICLE 1 — SUBJECT OF THE AGREEMENT.........................................................................................9 CHAPTER 2 ACTION................................................................................................................................................... 9 ARTICLE 2 — ACTION TO BE IMPLEMENTED.........................................................................................9 ARTICLE 3 — DURATION AND STARTING DATE OF THE ACTION......................................................9 ARTICLE 4 — ESTIMATED BUDGET AND BUDGET TRANSFERS........................................................ 9 4.1 Estimated budget.................................................................................................................................. 9 4.2 Budget transfers....................................................................................................................................9 CHAPTER 3 GRANT.....................................................................................................................................................9 ARTICLE 5 — GRANT AMOUNT, FORM OF GRANT, REIMBURSEMENT RATE AND FORMS OF COSTS..............................................................................................................................................9 5.1 Maximum grant amount....................................................................................................................... 9 5.2 Form of grant, reimbursement rate and forms of costs....................................................................... 9 5.3 Final grant amount — Calculation.....................................................................................................10 5.4 Revised final grant amount — Calculation....................................................................................... 11 ARTICLE 6 — ELIGIBLE AND INELIGIBLE COSTS................................................................................12 6.1 General conditions for costs to be eligible........................................................................................ 12 6.2 Specific conditions for costs to be eligible........................................................................................12 6.3 Conditions for costs of affiliated entities to be eligible.....................................................................15 6.4 Ineligible costs....................................................................................................................................15 6.5 Consequences of declaration of ineligible costs................................................................................ 16 CHAPTER 4 RIGHTS AND OBLIGATIONS OF THE PARTIES........................................................................ 16 SECTION 1 RIGHTS AND OBLIGATIONS RELATED TO IMPLEMENTING THE ACTION................ 16 ARTICLE 7 — GENERAL OBLIGATION TO PROPERLY IMPLEMENT THE ACTION.........................16 7.1 General obligation to properly implement the action........................................................................ 16 7.2 Consequences of non-compliance...................................................................................................... 16 ARTICLE 8 — RESOURCES TO IMPLEMENT THE ACTION — THIRD PARTIES INVOLVED IN THE ACTION.........................................................................................................................................17 ARTICLE 8a — IMPLEMENTATION OF ACTION TASKS BY BENEFICIARIES NOT RECEIVING EU FUNDING...................................................................................................................................... 17 ARTICLE 9 — PURCHASE OF GOODS, WORKS OR SERVICES............................................................17 9.1 Rules for purchasing goods, works or services................................................................................. 17 4 Grant Agreement number: 101035467 — TEHDAS — HP-JA-2020 / HP-JA-2020-1 Associated with documentCHAFEA MGA — Multi:-v2.1 Ref. Ares(2021)4548885 13/07/2021 9.2 Consequences of non-compliance...................................................................................................... 17 ARTICLE 10 — IMPLEMENTATION OF ACTION TASKS BY SUBCONTRACTORS............................18 10.1 Rules for subcontracting action tasks.............................................................................................. 18 10.2 Consequences of non-compliance.................................................................................................... 18 ARTICLE 11 — IMPLEMENTATION OF ACTION TASKS BY AFFILIATED ENTITIES........................18 11.1 Rules for calling upon affiliated entities to implement part of the action........................................19 11.2 Consequences of non-compliance.................................................................................................... 20 ARTICLE 11a — FINANCIAL SUPPORT TO THIRD PARTIES.................................................................20 SECTION 2 RIGHTS AND OBLIGATIONS RELATED TO THE GRANT ADMINISTRATION.............. 20 ARTICLE 12 — GENERAL OBLIGATION TO INFORM............................................................................20 12.1 General obligation to provide information upon request.................................................................20 12.2 Obligation to keep information up to date and to inform about events and circumstances likely to affect the Agreement........................................................................................................................20 12.3 Consequences of non-compliance.................................................................................................... 21 ARTICLE 13 — KEEPING RECORDS — SUPPORTING DOCUMENTATION.........................................21 13.1 Obligation to keep records and other supporting documentation.................................................... 21 13.2 Consequences of non-compliance.................................................................................................... 22 ARTICLE 14 — SUBMISSION OF DELIVERABLES................................................................................. 22 14.1 Obligation to submit deliverables.................................................................................................... 22 14.2 Consequences of non-compliance.................................................................................................... 22 ARTICLE 15 — REPORTING — PAYMENT REQUESTS.......................................................................... 22 15.1 Obligation to submit reports............................................................................................................ 22 15.2 Reporting periods............................................................................................................................. 23 15.2a Request(s) for further pre-financing payment(s)............................................................................23 15.3 Periodic reports — Requests for interim payments.........................................................................23 15.4 Final report — Request for payment of the balance....................................................................... 24 15.5 Information on cumulative expenditure incurred.............................................................................25 15.6 Currency for financial statements and conversion into euro........................................................... 25 15.7 Language of reports..........................................................................................................................25 15.8 Consequences of non-compliance.................................................................................................... 25 ARTICLE 16 — PAYMENTS AND PAYMENT ARRANGEMENTS...........................................................25 16.1 Payments to be made....................................................................................................................... 25 16.2 Pre-financing payment — Amount .................................................................................................25 16.3 Interim payments — Amount — Calculation..................................................................................26 16.4 Payment of the balance — Amount — Calculation........................................................................ 26 5 Grant Agreement number: 101035467 — TEHDAS — HP-JA-2020 / HP-JA-2020-1 Associated with documentCHAFEA MGA — Multi:-v2.1 Ref. Ares(2021)4548885 13/07/2021 16.5 Notification of amounts due.............................................................................................................27 16.6 Currency for payments..................................................................................................................... 27 16.7 Payments to the coordinator — Distribution to the beneficiaries....................................................27 16.8 Bank account for payments..............................................................................................................28 16.9 Costs of payment transfers...............................................................................................................28 16.10 Date of payment............................................................................................................................. 28 16.11 Consequences of non-compliance.................................................................................................. 28 ARTICLE 17 — CHECKS, REVIEWS, AUDITS AND INVESTIGATIONS — EXTENSION OF FINDINGS..................................................................................................................................... 29 17.1 Checks, reviews and audits by the Agency and the Commission....................................................29 17.2 Investigations by the European Anti-Fraud Office (OLAF)............................................................30 17.3 Checks and audits by the European Court of Auditors (ECA)........................................................31 17.4 Checks, reviews, audits and investigations for international organisations..................................... 31 17.5 Consequences of findings in checks, reviews, audits and investigations — Extension of findings............................................................................................................................................. 31 17.6 Consequences of non-compliance.................................................................................................... 33 ARTICLE 18 — EVALUATION OF THE IMPACT OF THE ACTION....................................................... 33 18.1 Right to evaluate the impact of the action.......................................................................................33 18.2 Consequences of non-compliance.................................................................................................... 33 SECTION 3 OTHER RIGHTS AND OBLIGATIONS.......................................................................................33 ARTICLE 19 — PRE-EXISTING RIGHTS AND OWNERSHIP OF THE RESULTS (INCLUDING INTELLECTUAL AND INDUSTRIAL PROPERTY RIGHTS)................................................. 33 19.1 Pre-existing rights and access rights to pre-existing rights............................................................. 33 19.2 Ownership of results and rights of use............................................................................................ 34 19.3 Consequences of non-compliance.................................................................................................... 34 ARTICLE 20 — CONFLICT OF INTERESTS.............................................................................................. 34 20.1 Obligation to avoid a conflict of interests....................................................................................... 34 20.2 Consequences of non-compliance.................................................................................................... 34 ARTICLE 21 — CONFIDENTIALITY...........................................................................................................34 21.1 General obligation to maintain confidentiality................................................................................ 34 21.2 Consequences of non-compliance.................................................................................................... 35 ARTICLE 22 — PROMOTING THE ACTION — VISIBILITY OF EU FUNDING....................................35 22.1 Communication activities by the beneficiaries................................................................................ 35 22.2 Communication activities by the Agency and the Commission...................................................... 35 22.3 Consequences of non-compliance.................................................................................................... 36 ARTICLE 23 — PROCESSING OF PERSONAL DATA...............................................................................37 6 Grant Agreement number: 101035467 — TEHDAS — HP-JA-2020 / HP-JA-2020-1 Associated with documentCHAFEA MGA — Multi:-v2.1 Ref. Ares(2021)4548885 13/07/2021 23.1 Processing of personal data by the Agency and the Commission................................................... 37 23.2 Processing of personal data by the beneficiaries............................................................................. 37 23.3 Consequences of non-compliance.................................................................................................... 37 ARTICLE 24 — ASSIGNMENTS OF CLAIMS FOR PAYMENT AGAINST THE AGENCY....................37 CHAPTER 5 DIVISION OF BENEFICIARIES’ ROLES AND RESPONSIBILITIES....................................... 38 ARTICLE 25 — DIVISION OF BENEFICIARIES’ ROLES AND RESPONSIBILITIES............................38 25.1 Roles and responsibilities towards the Agency............................................................................... 38 25.2 Internal division of roles and responsibilities.................................................................................. 38 25.3 Internal arrangements between beneficiaries — Consortium agreement.........................................39 CHAPTER 6 REJECTION OF COSTS — REDUCTION OF THE GRANT — RECOVERY — SANCTIONS — DAMAGES — SUSPENSION — TERMINATION — FORCE MAJEURE................................ 39 SECTION 1 REJECTION OF COSTS — REDUCTION OF THE GRANT — RECOVERY — SANCTIONS.............................................................................................................................................. 39 ARTICLE 26 — REJECTION OF INELIGIBLE COSTS.............................................................................. 39 26.1 Conditions......................................................................................................................................... 39 26.2 Ineligible costs to be rejected — Calculation — Procedure............................................................40 26.3 Effects............................................................................................................................................... 40 ARTICLE 27 — REDUCTION OF THE GRANT......................................................................................... 40 27.1 Conditions......................................................................................................................................... 40 27.2 Amount to be reduced — Calculation — Procedure.......................................................................41 27.3 Effects............................................................................................................................................... 41 ARTICLE 28 — RECOVERY OF UNDUE AMOUNTS............................................................................... 41 28.1 Amount to be recovered — Calculation — Procedure....................................................................41 ARTICLE 29 — ADMINISTRATIVE SANCTIONS..................................................................................... 43 SECTION 2 LIABILITY FOR DAMAGES.........................................................................................................43 ARTICLE 30 — LIABILITY FOR DAMAGES.............................................................................................43 30.1 Liability of the Agency.................................................................................................................... 43 30.2 Liability of the beneficiaries............................................................................................................ 44 SECTION 3 SUSPENSION AND TERMINATION............................................................................................44 ARTICLE 31 — SUSPENSION OF PAYMENT DEADLINE....................................................................... 44 31.1 Conditions......................................................................................................................................... 44 31.2 Procedure.......................................................................................................................................... 44 ARTICLE 32 — SUSPENSION OF PAYMENTS.......................................................................................... 44 32.1 Conditions......................................................................................................................................... 44 32.2 Procedure.......................................................................................................................................... 45 ARTICLE 33 — SUSPENSION OF THE ACTION IMPLEMENTATION................................................... 45 7 Grant Agreement number: 101035467 — TEHDAS — HP-JA-2020 / HP-JA-2020-1 Associated with documentCHAFEA MGA — Multi:-v2.1 Ref. Ares(2021)4548885 13/07/2021 33.1 Suspension of the action implementation, by the beneficiaries.......................................................45 33.2 Suspension of the action implementation, by the Agency...............................................................46 ARTICLE 34 — TERMINATION OF THE AGREEMENT OR OF THE PARTICIPATION OF ONE OR MORE BENEFICIARIES..............................................................................................................47 34.1 Termination of the Agreement, by the beneficiaries........................................................................47 34.2 Termination of the participation of one or more beneficiaries, by the beneficiaries........................48 34.3 Termination of the Agreement or of the participation of one or more beneficiaries, by the Agency..............................................................................................................................................49 SECTION 4 FORCE MAJEURE.......................................................................................................................... 51 ARTICLE 35 — FORCE MAJEURE.............................................................................................................. 52 CHAPTER 7 FINAL PROVISIONS...........................................................................................................................52 ARTICLE 36 — COMMUNICATION BETWEEN THE PARTIES...............................................................52 36.1 Form and means of communication.................................................................................................52 36.2 Date of communication.................................................................................................................... 53 36.3 Addresses for communication.......................................................................................................... 53 ARTICLE 37 — INTERPRETATION OF THE AGREEMENT.....................................................................53 37.1 Precedence of the Terms and Conditions over the Annexes............................................................53 37.2 Privileges and immunities................................................................................................................ 54 ARTICLE 38 — CALCULATION OF PERIODS, DATES AND DEADLINES........................................... 54 ARTICLE 39 — AMENDMENTS TO THE AGREEMENT......................................................................... 54 39.1 Conditions......................................................................................................................................... 54 39.2 Procedure.......................................................................................................................................... 54 ARTICLE 40 — ACCESSION TO THE AGREEMENT............................................................................... 55 40.1 Accession of the beneficiaries mentioned in the preamble..............................................................55 40.2 Addition of new beneficiaries.......................................................................................................... 55 ARTICLE 41 — APPLICABLE LAW AND SETTLEMENT OF DISPUTES.............................................. 55 41.1 Applicable law..................................................................................................................................55 41.2 Dispute settlement............................................................................................................................ 55 ARTICLE 42 — ENTRY INTO FORCE OF THE AGREEMENT................................................................ 56 8 Grant Agreement number: 101035467 — TEHDAS — HP-JA-2020 / HP-JA-2020-1 Associated with documentCHAFEA MGA — Multi:-v2.1 Ref. Ares(2021)4548885 13/07/2021 CHAPTER 1 GENERAL ARTICLE 1 — SUBJECT OF THE AGREEMENT This Agreement sets out the rights and obligations and the terms and conditions applicable to the grant awarded to the beneficiaries for implementing the action set out in Chapter 2. CHAPTER 2 ACTION ARTICLE 2 — ACTION TO BE IMPLEMENTED The grant is awarded for the action entitled ‘Towards the European Health DAta Space Joint Action — TEHDAS’ (‘action’), as described in Annex 1. ARTICLE 3 — DURATION AND STARTING DATE OF THE ACTION The duration of the action will be 30 months as of 01/02/2021 (‘starting date of the action’). ARTICLE 4 — ESTIMATED BUDGET AND BUDGET TRANSFERS 4.1 Estimated budget The ‘estimated budget’ for the action is set out in Annex 2. It contains the estimated eligible costs and the forms of costs, broken down by beneficiary (and affiliated entity) and budget category (see Articles 5, 6 and 11). 4.2 Budget transfers The estimated budget breakdown indicated in Annex 2 may be adjusted — without an amendment (see Article 39) — by transfers of amounts between beneficiaries, budget categories and/or forms of costs set out in Annex 2, if the action is implemented as described in Annex 1. However, the beneficiaries may not add costs relating to subcontracts not provided for in Annex 1, unless such additional subcontracts are approved by an amendment or in accordance with Article 10. CHAPTER 3 GRANT ARTICLE 5 — GRANT AMOUNT, FORM OF GRANT, REIMBURSEMENT RATE AND FORMS OF COSTS 5.1 Maximum grant amount The ‘maximum grant amount’ is EUR 2 500 000.00 (two million five hundred thousand EURO). 5.2 Form of grant, reimbursement rate and forms of costs 9 Grant Agreement number: 101035467 — TEHDAS — HP-JA-2020 / HP-JA-2020-1 Associated with documentCHAFEA MGA — Multi:-v2.1 Ref. Ares(2021)4548885 13/07/2021 The grant reimburses 60% of the action's eligible costs (see Article 6) (‘reimbursement of eligible costs grant’) (see Annex 2). The estimated eligible costs of the action are EUR 4 166 666.67 (four million one hundred and sixty six thousand six hundred and sixty six EURO and sixty seven eurocents). Eligible costs (see Article 6) must be declared under the following forms ('forms of costs' or 'costs forms'): (a) for direct personnel costs: as actually incurred costs (actual costs); (b) for direct costs of subcontracting: as actually incurred costs (actual costs); (c) for other direct costs: as actually incurred costs (actual costs); (d) for indirect costs: on the basis of a flat-rate applied as set out in Article 6.2.D (‘flat-rate costs’); 5.3 Final grant amount — Calculation The ‘final grant amount’ depends on the actual extent to which the action is implemented in accordance with the Agreement’s terms and conditions. This amount is calculated by the Agency — when the payment of the balance is made — in the following steps: Step 1 – Application of the reimbursement rate to the eligible costs Step 2 – Limit to the maximum grant amount Step 3 – Reduction due to the no-profit rule Step 4 – Reduction due to substantial errors, irregularities or fraud or serious breach of obligations 5.3.1 Step 1 — Application of the reimbursement rate to the eligible costs The reimbursement rate (see Article 5.2) is applied to the eligible costs (actual costs and flat-rate costs; see Article 6) declared by the beneficiaries and affiliated entities (see Article 15) and approved by the Agency (see Article 16). 5.3.2 Step 2 — Limit to the maximum grant amount If the amount obtained following Step 1 is higher than the maximum grant amount set out in Article 5.1, it will be limited to the latter. 5.3.3 Step 3 — Reduction due to the no-profit rule The grant must not produce a profit. ‘Profit’ means the surplus of the amount obtained following Steps 1 and 2 plus the action’s total receipts, over the action’s total eligible costs. The ‘action’s total eligible costs’ are the consolidated total eligible costs approved by the Agency. 10 Grant Agreement number: 101035467 — TEHDAS — HP-JA-2020 / HP-JA-2020-1 Associated with documentCHAFEA MGA — Multi:-v2.1 Ref. Ares(2021)4548885 13/07/2021 The ‘action’s total receipts’ are the consolidated total receipts generated during its duration (see Article 3). The following are considered receipts: (a) income generated by the action; (b) financial contributions given by third parties to the beneficiary or to an affiliated entity specifically to be used for costs that are eligible under the action. The following are however not considered receipts: (a) financial contributions by third parties, if they may be used to cover costs other than the eligible costs (see Article 6); (b) financial contributions by third parties with no obligation to repay any amount unused at the end of the period set out in Article 3. If there is a profit, it will be deducted in proportion to the final rate of reimbursement of the eligible actual costs approved by the Agency (as compared to the amount calculated following Steps 1 and 2). 5.3.4 Step 4 — Reduction due to substantial errors, irregularities or fraud or serious breach of obligations If the grant is reduced (see Article 27), the Agency will calculate the reduced grant amount by deducting the amount of the reduction (calculated in proportion to the seriousness of the errors, irregularities or fraud or breach of obligations, in accordance with Article 27.2) from the maximum grant amount set out in Article 5.1. The final grant amount will be the lower of the following two: - the amount obtained following Steps 1 to 3 or - the reduced grant amount following Step 4. 5.4 Revised final grant amount — Calculation If — after the payment of the balance (in particular, after checks, reviews, audits or investigations; see Article 17) — the Agency rejects costs (see Article 26) or reduces the grant (see Article 27), it will calculate the ‘revised final grant amount’ for the action or for the beneficiary concerned. This amount is calculated by the Agency on the basis of the findings, as follows: - in case of rejection of costs: by applying the reimbursement rate to the revised eligible costs approved by the Agency for the beneficiary concerned; - in case of reduction of the grant: by deducting the amount of the reduction (calculated in proportion to the seriousness of the errors, irregularities or fraud or breach of obligations, in accordance with Article 27.2) from the maximum grant amount set out in Article 5.1 or from the maximum EU contribution indicated for the beneficiary in the estimated budget (see Annex 2). In case of rejection of costs and reduction of the grant, the revised final grant amount will be the lower of the two amounts above. 11 Grant Agreement number: 101035467 — TEHDAS — HP-JA-2020 / HP-JA-2020-1 Associated with documentCHAFEA MGA — Multi:-v2.1 Ref. Ares(2021)4548885 13/07/2021 ARTICLE 6 — ELIGIBLE AND INELIGIBLE COSTS 6.1 General conditions for costs to be eligible ‘Eligible costs’ are costs that meet the following criteria: (a) for actual costs: (i) they must be actually incurred by the beneficiary; (ii) they must be incurred in the period set out in Article 3, with the exception of costs relating to the submission of the periodic report for the last reporting period and the final report (see Article 15); (iii) they must be indicated in the estimated budget set out in Annex 2; (iv) they must be incurred in connection with the action as described in Annex 1 and necessary for its implementation; (v) they must be identifiable and verifiable, in particular recorded in the beneficiary’s accounts in accordance with the accounting standards applicable in the country where the beneficiary is established and with the beneficiary’s usual cost accounting practices; (vi) they must comply with the applicable national law on taxes, labour and social security, and (vii) they must be reasonable, justified and must comply with the principle of sound financial management, in particular regarding economy and efficiency; (b) for unit costs: not applicable; (c) for flat-rate costs: (i) they must be calculated by applying the flat-rate set out in Annex 2, and (ii) the costs (actual costs) to which the flat-rate is applied must comply with the conditions for eligibility set out in this Article. (d) for lump sum costs: not applicable; 6.2 Specific conditions for costs to be eligible Costs are eligible if they comply with the general conditions (see above) and the specific conditions set out below, for each of the following budget categories: A. direct personnel costs; B. direct costs of subcontracting; C. other direct costs; D. indirect costs; ‘Direct costs’ are costs that are directly linked to the action implementation and can therefore be attributed to it directly. They must not include any indirect costs (see Point D below). 12 Grant Agreement number: 101035467 — TEHDAS — HP-JA-2020 / HP-JA-2020-1 Associated with documentCHAFEA MGA — Multi:-v2.1 Ref. Ares(2021)4548885 13/07/2021 ‘Indirect costs’ are costs that are not directly linked to the action implementation and therefore cannot be attributed directly to it. A. Direct personnel costs Types of eligible personnel costs A.1 Personnel costs are eligible if they are related to personnel working for the beneficiary under an employment contract (or equivalent appointing act) and assigned to the action (‘costs for employees (or equivalent)’). They must be limited to salaries, social security contributions, taxes and other costs included in the remuneration, if they arise from national law or the employment contract (or equivalent appointing act). They may also include additional remuneration for personnel assigned to the action (including payments on the basis of supplementary contracts regardless of their nature), if: (a) it is part of the beneficiary’s usual remuneration practices and is paid in a consistent manner whenever the same kind of work or expertise is required; (b) the criteria used to calculate the supplementary payments are objective and generally applied by the beneficiary, regardless of the source of funding used. A.2 The costs for natural persons working under a direct contract with the beneficiary other than an employment contract or seconded by a third party against payment are eligible personnel costs, if: (a) the person works under the beneficiary’s instructions and, unless otherwise agreed with the beneficiary, on the beneficiary’s premises; (b) the result of the work carried out belongs to the beneficiary, and (c) the costs are not significantly different from those for personnel performing similar tasks under an employment contract with the beneficiary. Calculation Personnel costs must be calculated by the beneficiaries as follows: - for persons working exclusively on the action: {monthly rate for the person multiplied by number of actual months worked on the action}. The months declared for these persons may not be declared for any other EU or Euratom grant. The ‘monthly rate’ is calculated as follows: {annual personnel costs for the person divided by 12} 13 Grant Agreement number: 101035467 — TEHDAS — HP-JA-2020 / HP-JA-2020-1 Associated with documentCHAFEA MGA — Multi:-v2.1 Ref. Ares(2021)4548885 13/07/2021 using the personnel costs for each full financial year covered by the reporting period concerned. If a financial year is not closed at the end of the reporting period, the beneficiaries must use the monthly rate of the last closed financial year available. - for all other persons: {daily rate for the person multiplied by number of actual days worked on the action (rounded up or down to the nearest half-day)}. The number of actual days declared for a person must be identifiable and verifiable (see Article 13). The total number of days declared in EU or Euratom grants, for a person for a year, cannot be higher than the annual productive days used for the calculations of the daily rate. Therefore, the maximum number of days that can be declared for the grant are: {number of annual productive days for the year (see below) minus total number of days declared by the beneficiary, for that person for that year, for other EU or Euratom grants}. The ‘daily rate’ is calculated as follows: {annual personnel costs for the person divided by number of individual annual productive days} using the personnel costs and the number of annual productive days for each full financial year covered by the reporting period concerned. If a financial year is not closed at the end of the reporting period, the beneficiaries must use the daily rate of the last closed financial year available. The ‘number of individual annual productive days’ is the total actual days worked by the person in the year. It may not include holidays and other absences (such as sick leave, maternity leave, special leave, etc). However, it may include overtime and time spent in meetings, trainings and other similar activities. B. Direct costs of subcontracting (including related duties, taxes and charges, such as non- deductible value added tax (VAT) paid by beneficiaries that are not public bodies acting as public authority) are eligible if the conditions in Article 10.1.1 are met. C. Other direct costs C.1 Travel costs and related subsistence allowances (including related duties, taxes and charges, such as non-deductible value added tax (VAT) paid by beneficiaries that are not public bodies acting as public authority) are eligible if they are in line with the beneficiary’s usual practices on travel. C.2 The depreciation costs of equipment, infrastructure or other assets (new or second-hand) as recorded in the beneficiary’s accounts are eligible, if they were purchased in accordance 14 Grant Agreement number: 101035467 — TEHDAS — HP-JA-2020 / HP-JA-2020-1 Associated with documentCHAFEA MGA — Multi:-v2.1 Ref. Ares(2021)4548885 13/07/2021 with Article 9.1.1 and written off in accordance with international accounting standards and the beneficiary’s usual accounting practices. The costs of renting or leasing equipment, infrastructure or other assets (including related duties, taxes and charges, such as non-deductible value added tax (VAT) paid by beneficiaries that are not public bodies acting as public authority) are also eligible, if they do not exceed the depreciation costs of similar equipment, infrastructure or assets and do not include any financing fees. The only portion of the costs that will be taken into account is that which corresponds to the duration of the action and rate of actual use for the purposes of the action. C.3 Costs of other goods and services (including related duties, taxes and charges, such as non- deductible value added tax (VAT) paid by beneficiaries that are not public bodies acting as public authority) are eligible, if they are purchased specifically for the action and in accordance with Article 9.1.1. Such goods and services include, for instance, consumables and supplies, dissemination, protection of results, certificates on the financial statements (if they are required by the Agreement), translations and publications. D. Indirect costs Indirect costs are eligible if they are declared on the basis of the flat-rate of 7% of the eligible direct costs (see Article 5.2 and Points A to C above). Beneficiaries receiving an operating grant1 financed by the EU or Euratom budget cannot declare indirect costs for the period covered by the operating grant. 6.3 Conditions for costs of affiliated entities to be eligible Costs incurred by affiliated entities are eligible if they fulfil — mutatis mutandis — the general and specific conditions for eligibility set out in this Article (Article 6.1 and 6.2) and Article 11.1.1. 6.4 Ineligible costs ‘Ineligible costs’ are: (a) costs that do not comply with the conditions set out above (Article 6.1 to 6.3), in particular: (i) costs related to return on capital; (ii) debt and debt service charges; (iii) provisions for future losses or debts; (iv) interest owed; 1 For the definition, see Article 121(1)(b) of Regulation (EU, Euratom) No 966/2012 of the European Parliament and of the Council of 25 October 2012 on the financial rules applicable to the general budget of the Union and repealing Council Regulation (EC, Euratom) No 1605/2002 (OJ L 218, 26.10.2012, p.1) (‘Financial Regulation No 966/2012’): ‘operating grant’ means direct financial contribution, by way of donation, from the budget in order to finance the functioning of a body which pursues an aim of general EU interest or has an objective forming part of and supporting an EU policy. 15 Grant Agreement number: 101035467 — TEHDAS — HP-JA-2020 / HP-JA-2020-1 Associated with documentCHAFEA MGA — Multi:-v2.1 Ref. Ares(2021)4548885 13/07/2021 (v) doubtful debts; (vi) currency exchange losses; (vii) bank costs charged by the beneficiary’s bank for transfers from the Agency; (viii) excessive or reckless expenditure; (ix) deductible VAT; (x) costs incurred during suspension of the implementation of the action (see Article 33); (xi) in-kind contributions provided by third parties; (b) costs declared under another EU or Euratom grant (including grants awarded by a Member State and financed by the EU or Euratom budget and grants awarded by bodies other than the Agency for the purpose of implementing the EU or Euratom budget); in particular, indirect costs if the beneficiary is already receiving an operating grant financed by the EU or Euratom budget in the same period; (c) costs for staff of a national (or local) administration, for activities that are part of the administration’s normal activities (i.e. not undertaken only because of the grant); (d) costs (especially travel and subsistence costs) for staff or representatives of EU institutions, bodies or agencies. 6.5 Consequences of declaration of ineligible costs Declared costs that are ineligible will be rejected (see Article 26). This may also lead to any of the other measures described in Chapter 6. CHAPTER 4 RIGHTS AND OBLIGATIONS OF THE PARTIES SECTION 1 RIGHTS AND OBLIGATIONS RELATED TO IMPLEMENTING THE ACTION ARTICLE 7 — GENERAL OBLIGATION TO PROPERLY IMPLEMENT THE ACTION 7.1 General obligation to properly implement the action The beneficiaries must implement the action as described in Annex 1 and in compliance with the provisions of the Agreement and all legal obligations under applicable EU, international and national law. 7.2 Consequences of non-compliance If a beneficiary breaches any of its obligations under this Article, the grant may be reduced (see Article 27). 16 Grant Agreement number: 101035467 — TEHDAS — HP-JA-2020 / HP-JA-2020-1 Associated with documentCHAFEA MGA — Multi:-v2.1 Ref. Ares(2021)4548885 13/07/2021 Such breaches may also lead to any of the other measures described in Chapter 6. ARTICLE 8 — RESOURCES TO IMPLEMENT THE ACTION — THIRD PARTIES INVOLVED IN THE ACTION The beneficiaries must have the appropriate resources to implement the action. If it is necessary to implement the action, the beneficiaries may: - purchase goods, works and services (see Article 9); - call upon subcontractors to implement action tasks described in Annex 1 (see Article 10); - call upon affiliated entities to implement action tasks described in Annex 1 (see Article 11). In these cases, the beneficiaries retain sole responsibility towards the Agency and the other beneficiaries for implementing the action. ARTICLE 8a — IMPLEMENTATION OF ACTION TASKS BY BENEFICIARIES NOT RECEIVING EU FUNDING Not applicable ARTICLE 9 — PURCHASE OF GOODS, WORKS OR SERVICES 9.1 Rules for purchasing goods, works or services 9.1.1 If necessary to implement the action, the beneficiaries may purchase goods, works or services. The beneficiaries must make such purchases ensuring the best value for money or, if appropriate, the lowest price. In doing so, they must avoid any conflict of interests (see Article 20). The beneficiaries must ensure that the Agency, the Commission, the European Court of Auditors (ECA) and the European Anti-fraud Office (OLAF) can exercise their rights under Articles 17 and 18 also towards their contractors. 9.1.2 Beneficiaries that are ‘contracting authorities’ within the meaning of Directive 2004/18/EC2 (or 2014/24/EU3) or ‘contracting entities’ within the meaning of Directive 2004/17/EC4 (or 2014/25/EU5) must comply with the applicable national law on public procurement. 9.2 Consequences of non-compliance 2 Directive 2004/18/EC of the European Parliament and of the Council of 31 March 2004 on the coordination of procedures for the award of public work contracts, public supply contracts and public service contracts (OJ L 134, 30.04.2004, p. 114). 3 Directive 2014/24/EU of the European Parliament and of the Council of 26 February 2014 on public procurement and repealing Directive 2004/18/EC (OJ L 94, 28.3.2014, p. 65). 4 Directive 2004/17/EC of the European Parliament and of the Council of 31 March 2004 coordinating the procurement procedures of entities operating in the water, energy, transport and postal services sectors (OJ L 134, 30.04.2004, p. 1). 5 Directive 2014/25/EU of the European Parliament and of the Council of 26 February 2014 on procurement by entities operating in the water, energy, transport and postal services sectors and repealing Directive 2004/17/EC (OJ L 94, 28.3.2014, p. 243). 17 Grant Agreement number: 101035467 — TEHDAS — HP-JA-2020 / HP-JA-2020-1 Associated with documentCHAFEA MGA — Multi:-v2.1 Ref. Ares(2021)4548885 13/07/2021 If a beneficiary breaches any of its obligations under Article 9.1.1, the costs related to the contract concerned will be ineligible (see Article 6) and will be rejected (see Article 26). If a beneficiary breaches any of its obligations under Article 9.1.2, the grant may be reduced (see Article 27). Such breaches may also lead to any of the other measures described in Chapter 6. ARTICLE 10 — IMPLEMENTATION OF ACTION TASKS BY SUBCONTRACTORS 10.1 Rules for subcontracting action tasks 10.1.1 If necessary to implement the action, the beneficiaries may award subcontracts covering the implementation of certain action tasks described in Annex 1. Subcontracting may cover only a limited part of the action. The beneficiaries must award the subcontracts ensuring the best value for money or, if appropriate, the lowest price. In doing so, they must avoid any conflict of interests (see Article 20). The tasks to be implemented and the estimated cost for each subcontract must be set out in Annex 1 and the total estimated costs of subcontracting per beneficiary must be set out in Annex 2. The Agency may however approve subcontracts not set out in Annex 1 and 2 without amendment (see Article 39), if: - they are specifically justified in the periodic technical report and - they do not entail changes to the Agreement which would call into question the decision awarding the grant or breach the principle of equal treatment of applicants. The beneficiaries must ensure that the Agency, the Commission, the European Court of Auditors (ECA) and the European Anti-Fraud Office (OLAF) can exercise their rights under Articles 17 and 18 also towards their subcontractors. 10.1.2 The beneficiaries must ensure that their obligations under Articles 20, 21, 22 and 30 also apply to the subcontractors. Beneficiaries that are ‘contracting authorities’ within the meaning of Directive 2004/18/EC (or 2014/24/EU) or ‘contracting entities’ within the meaning of Directive 2004/17/EC (or 2014/25/EU) must comply with the applicable national law on public procurement. 10.2 Consequences of non-compliance If a beneficiary breaches any of its obligations under Article 10.1.1, the costs related to the subcontract concerned will be ineligible (see Article 6) and will be rejected (see Article 26). If a beneficiary breaches any of its obligations under Article 10.1.2, the grant may be reduced (see Article 27). Such breaches may also lead to any of the other measures described in Chapter 6. ARTICLE 11 — IMPLEMENTATION OF ACTION TASKS BY AFFILIATED ENTITIES 18 Grant Agreement number: 101035467 — TEHDAS — HP-JA-2020 / HP-JA-2020-1 Associated with documentCHAFEA MGA — Multi:-v2.1 Ref. Ares(2021)4548885 13/07/2021 11.1 Rules for calling upon affiliated entities to implement part of the action 11.1.1 The following 'affiliated entities'6 may implement the action tasks attributed to them in Annex 1: - TEKNOLOGIAN TUTKIMUSKESKUS VTT OY (VTT), affiliated or linked to Sitra - TERVEYDEN JA HYVINVOINNIN LAITOS (THL), affiliated or linked to Sitra - CSC-TIETEEN TIETOTEKNIIKAN KESKUS OY (CSC), affiliated or linked to Sitra - HRVATSKI ZAVOD ZA JAVNO ZDRAVSTVO (CIPH), affiliated or linked to CHIF - MIDTJYLLANDS EU KONTOR FORENING (CDEU), affiliated or linked to RM - UNIVERSITE PAUL SABATIER TOULOUSE III (UT3), affiliated or linked to FR-HDH - UNIVERSITE D'AIX MARSEILLE (AMU), affiliated or linked to FR-HDH - INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (Inserm), affiliated or linked to FR-HDH - HOSPICES CIVILS DE LYON (HCL), affiliated or linked to FR-HDH - AGENCE DU NUMÉRIQUE EN SANTÉ (ANS), affiliated or linked to FR-HDH - BUNDESINSTITUT FUR ARZNEIMITTEL UND MEDIZINPRODUKTE (FDZ), affiliated or linked to BMG - GEMATIK GMBH (GEMATIK), affiliated or linked to BMG - SEMMELWEIS EGYETEM (SU), affiliated or linked to OKFŐ - THE HEALTH RESEARCH BOARD (HRB), affiliated or linked to DoH-IE - STICHTING NATIONAAL ICT INSTITUUT IN DE ZORG (Nictiz), affiliated or linked to VWS - DIREKTORAT FOR E-HELSE (E-helse), affiliated or linked to MoH-NO - FOLKEHELSEINSTITUTTET (FHI), affiliated or linked to MoH-NO - HELSEDIREKTORATET (Hdir), affiliated or linked to MoH-NO - FOLKHALSOMYNDIGHETEN (PHAS), affiliated or linked to SEHA 6 For the definition, see Article 122 of the Financial Regulation (EU, Euratom) No 966/2012: entities affiliated to the beneficiary are: (a) entities that form a ‘sole beneficiary’ (i.e. where an entity is formed of several entities that satisfy the criteria for being awarded a grant, including where the entity is specifically established for the purpose of implementing an action to be financed by a grant); (b) entities that satisfy the eligibility criteria and that do not fall within one of the situations referred to in Article 131(4) and that have a link with the beneficiary, in particular a legal or capital link, which is neither limited to the action nor established for the sole purpose of its implementation. 19 Grant Agreement number: 101035467 — TEHDAS — HP-JA-2020 / HP-JA-2020-1 Associated with documentCHAFEA MGA — Multi:-v2.1 Ref. Ares(2021)4548885 13/07/2021 - SOCIALSTYRELSEN (NBHW), affiliated or linked to SEHA - GENOME RESEARCH LIMITED (WSI ), affiliated or linked to NHSC The affiliated entities may declare as eligible the costs they incur for implementing the action tasks in accordance with Article 6.3. The beneficiaries must ensure that the Agency, the Commission, the European Court of Auditors (ECA) and the European Anti-Fraud Office (OLAF) can exercise their rights under Articles 17 and 18 also towards their affiliated entities. 11.1.2 The beneficiaries must ensure that their obligations under Articles 13, 15, 20, 21 and 22 also apply to their affiliated entities. 11.2 Consequences of non-compliance If any obligation under Article 11.1.1 is breached, the costs of the affiliated entity will be ineligible (see Article 6) and will be rejected (see Article 26). If any obligation under Article 11.1.2 is breached, the grant may be reduced (see Article 27). Such breaches may also lead to any of the other measures described in Chapter 6. ARTICLE 11a — FINANCIAL SUPPORT TO THIRD PARTIES Not applicable SECTION 2 RIGHTS AND OBLIGATIONS RELATED TO THE GRANT ADMINISTRATION ARTICLE 12 — GENERAL OBLIGATION TO INFORM 12.1 General obligation to provide information upon request The beneficiaries must provide — during implementation of the action or afterwards and in accordance with Article 25.2 — any information requested in order to verify eligibility of the costs, proper implementation of the action and compliance with any other obligation under the Agreement. 12.2 Obligation to keep information up to date and to inform about events and circumstances likely to affect the Agreement Each beneficiary must keep information stored in the Participant Portal Beneficiary Register (via the electronic exchange system; see Article 36) up to date, in particular, its name, address, legal representatives, legal form and organisation type. Each beneficiary must immediately inform the coordinator — which must immediately inform the Agency and the other beneficiaries — of any of the following: (a) events which are likely to affect significantly or delay the implementation of the action or the EU’s financial interests, in particular: 20 Grant Agreement number: 101035467 — TEHDAS — HP-JA-2020 / HP-JA-2020-1 Associated with documentCHAFEA MGA — Multi:-v2.1 Ref. Ares(2021)4548885 13/07/2021 (i) changes in its legal, financial, technical, organisational or ownership situation or those of its affiliated entities and (ii) changes in the name, address, legal form, organisation type of its affiliated entities; (b) circumstances affecting: (i) the decision to award the grant or (ii) compliance with requirements under the Agreement. 12.3 Consequences of non-compliance If a beneficiary breaches any of its obligations under this Article, the grant may be reduced (see Article 27). Such breaches may also lead to any of the other measures described in Chapter 6. ARTICLE 13 — KEEPING RECORDS — SUPPORTING DOCUMENTATION 13.1 Obligation to keep records and other supporting documentation The beneficiaries must — for a period of five years after the payment of the balance — keep records and other supporting documentation, in order to prove the proper implementation of the action and the costs they declare as eligible. They must make them available upon request (see Article 12) or in the context of checks, reviews, audits or investigations (see Article 17). If there are on-going checks, reviews, audits, investigations, litigation or other pursuits of claims under the Agreement (including the extension of findings; see Article 17), the beneficiaries must keep the records and other supporting documentation until the end of these procedures. The beneficiaries must keep the original documents. Digital and digitalised documents are considered originals if they are authorised by the applicable national law. The Agency may accept non-original documents if it considers that they offer a comparable level of assurance. 13.1.1 Records and other supporting documentation on the technical implementation The beneficiaries must keep records and other supporting documentation on the technical implementation of the action, in line with the accepted standards in the respective field. 13.1.2 Records and other documentation to support the costs declared The beneficiaries must keep the records and documentation supporting the costs declared, in particular the following: (a) for actual costs: adequate records and other supporting documentation to prove the costs declared, such as contracts, subcontracts, invoices and accounting records. In addition, the beneficiaries’ usual cost accounting practices and internal control procedures must enable direct 21 Grant Agreement number: 101035467 — TEHDAS — HP-JA-2020 / HP-JA-2020-1 Associated with documentCHAFEA MGA — Multi:-v2.1 Ref. Ares(2021)4548885 13/07/2021 reconciliation between the amounts declared, the amounts recorded in their accounts and the amounts stated in the supporting documentation; (b) for unit costs: not applicable; (c) for flat-rate costs: adequate records and other supporting documentation to prove the eligibility of the costs to which the flat-rate is applied. The beneficiaries do not need to identify the costs covered or provide supporting documentation (such as accounting statements) to prove the amount declared at a flat-rate; (d) for lump sum costs: not applicable; In addition, for personnel costs (declared as actual costs), the beneficiaries must keep time records for the number of days declared. The time records must be in writing and approved by the persons working on the action and their supervisors, at least monthly. In the absence of reliable time records of the days worked on the action, the Agency may accept alternative evidence supporting the number of days declared, if it considers that it offers an adequate level of assurance. As an exception, for persons working exclusively on the action, there is no need to keep time records, if the beneficiary signs a declaration confirming that the persons concerned have worked exclusively on the action. For costs declared by affiliated entities (see Article 11), it is the beneficiary that must keep the originals of the financial statements and the certificates on the financial statements of its affiliated entities. 13.2 Consequences of non-compliance If a beneficiary breaches any of its obligations under this Article, costs insufficiently substantiated will be ineligible (see Article 6) and will be rejected (see Article 26), and the grant may be reduced (see Article 27). Such breaches may also lead to any of the other measures described in Chapter 6. ARTICLE 14 — SUBMISSION OF DELIVERABLES 14.1 Obligation to submit deliverables The coordinator must submit the ‘deliverables’ identified in Annex 1, in accordance with the timing and conditions set out in it. 14.2 Consequences of non-compliance If the coordinator breaches any of its obligations under this Article, the Agency may apply any of the measures described in Chapter 6. ARTICLE 15 — REPORTING — PAYMENT REQUESTS 15.1 Obligation to submit reports The coordinator must submit to the Agency (see Article 36) the technical and financial report(s) set 22 Grant Agreement number: 101035467 — TEHDAS — HP-JA-2020 / HP-JA-2020-1 Associated with documentCHAFEA MGA — Multi:-v2.1 Ref. Ares(2021)4548885 13/07/2021 out in this Article. These reports include request(s) for payment and must be drawn up using the forms and templates provided in the electronic exchange system (see Article 36). 15.2 Reporting periods The action is divided into the following ‘reporting periods’: - RP1: from month 1 to month 15 - RP2: from month 16 to month 30 15.2a Request(s) for further pre-financing payment(s) Not applicable 15.3 Periodic reports — Requests for interim payments The coordinator must submit a periodic report within 60 days following the end of each reporting period. The periodic report must include the following: (a) a ‘periodic technical report’ containing: (i) an explanation of the work carried out by the beneficiaries; (ii) an overview of the progress towards the objectives of the action, including milestones and deliverables identified in Annex 1. This report must include explanations justifying the differences between work expected to be carried out in accordance with Annex 1 and that actually carried out; (iii) a summary for publication by the Agency; (iv) the answers to the ‘questionnaire’: covering issues related to the action implementation and its impact; (b) a ‘periodic financial report’ containing: (i) an ‘individual financial statement’ (see Annex 4) from each beneficiary and from each affiliated entity, for the reporting period concerned. The individual financial statement must detail the eligible costs (actual costs and flat-rate costs; see Article 6) for each budget category (see Annex 2). The beneficiaries and affiliated entities must declare all eligible costs, even if — for actual costs and flat-rate costs — they exceed the amounts indicated in the estimated budget (see Annex 2). Amounts which are not declared in the individual financial statement will not be taken into account by the Agency. If an individual financial statement is not submitted for a reporting period, it may be included in the periodic financial report for the next reporting period. 23 Grant Agreement number: 101035467 — TEHDAS — HP-JA-2020 / HP-JA-2020-1 Associated with documentCHAFEA MGA — Multi:-v2.1 Ref. Ares(2021)4548885 13/07/2021 The individual financial statements of the last reporting period must also detail the receipts of the action (see Article 5.3.3). Each beneficiary and each affiliated entity must certify that: - the information provided is full, reliable and true; - the costs declared are eligible (see Article 6); - the costs can be substantiated by adequate records and supporting documentation (see Article 13) that will be produced upon request (see Article 12) or in the context of checks, reviews, audits and investigations (see Article 17), and - for the last reporting period: that all the receipts have been declared (see Article 5.3.3); (ii) an explanation of the use of resources and the information on subcontracting (see Article 10) from each beneficiary and from each affiliated entity, for the reporting period concerned; (iii) not applicable; (iv) a ‘periodic summary financial statement’, created automatically by the electronic exchange system, consolidating the individual financial statements for the reporting period concerned and including — except for the last reporting period — the request for interim payment; (v) a ‘certificate on the financial statements’ (drawn up in accordance with Annex 5) for each beneficiary and for each affiliated entity, if: - the (cumulative) amount of EU contribution it requests as reimbursement of actual costs (and for which no certificate has yet been submitted) is EUR 150 000 or more and - the maximum EU contribution indicated, for that beneficiary or affiliated entity, in the estimated budget (see Annex 2) as reimbursement of actual costs is EUR 200 000 or more. 15.4 Final report — Request for payment of the balance In addition to the periodic report for the last reporting period, the coordinator must submit the final report within 60 days following the end of the last reporting period. The final report must include the following: (a) a ‘final technical report’ with a summary for publication containing: (i) an overview of the results and their dissemination; (ii) the conclusions on the action and (iii) the impact of the action; 24 Grant Agreement number: 101035467 — TEHDAS — HP-JA-2020 / HP-JA-2020-1 Associated with documentCHAFEA MGA — Multi:-v2.1 Ref. Ares(2021)4548885 13/07/2021 (b) a ‘final financial report’ containing a ‘final summary financial statement’, created automatically by the electronic exchange system, consolidating the individual financial statements for all reporting periods and including the request for payment of the balance. 15.5 Information on cumulative expenditure incurred Not applicable 15.6 Currency for financial statements and conversion into euro Financial statements must be drafted in euro. Beneficiaries and affiliated entities with accounting established in a currency other than the euro must convert the costs recorded in their accounts into euro at the average of the daily exchange rates published in the C series of the Official Journal of the European Union, calculated over the corresponding reporting period. If no daily euro exchange rate is published in the Official Journal of the European Union for the currency in question, they must be converted at the average of the monthly accounting rates published on the Commission’s website, calculated over the corresponding reporting period. Beneficiaries and affiliated entities with accounting established in euro must convert costs incurred in another currency into euro according to their usual accounting practices. 15.7 Language of reports All report(s) (including financial statements) must be submitted in the language of the Agreement. 15.8 Consequences of non-compliance If the report(s) submitted do not comply with this Article, the Agency may suspend the payment deadline (see Article 31) and apply any of the other measures described in Chapter 6. If the coordinator breaches its obligation to submit the report(s) and if it fails to comply with this obligation within 30 days following a written reminder, the Agency may terminate the Agreement (see Article 34) or apply any of the other measures described in Chapter 6. ARTICLE 16 — PAYMENTS AND PAYMENT ARRANGEMENTS 16.1 Payments to be made The following payments will be made to the coordinator: - a pre-financing payment; - one or more interim payments, on the basis of the request(s) for interim payment (see Article 15), and - one payment of the balance, on the basis of the request for payment of the balance (see Article 15). 16.2 Pre-financing payment — Amount 25 Grant Agreement number: 101035467 — TEHDAS — HP-JA-2020 / HP-JA-2020-1 Associated with documentCHAFEA MGA — Multi:-v2.1 Ref. Ares(2021)4548885 13/07/2021 The aim of the pre-financing is to provide the beneficiaries with a float. It remains the property of the EU until the payment of the balance. The amount of the pre-financing payment will be EUR 1 250 000.00 (one million two hundred and fifty thousand EURO). The Agency will — except if Article 32 applies — make the pre-financing payment to the coordinator within 30 days, either from the entry into force of the Agreement (see Article 42) or from 10 days before the starting date of the action (see Article 3) , whichever is the latest. 16.3 Interim payments — Amount — Calculation Interim payments reimburse the eligible costs incurred for the implementation of the action during the corresponding reporting periods. The Agency will pay to the coordinator the amount due as interim payment within 90 days from receiving the periodic report (see Article 15.3), except if Articles 31 or 32 apply. Payment is subject to the approval of the periodic report. Its approval does not imply recognition of compliance, authenticity, completeness or correctness of its content. The amount due as interim payment is calculated by the Agency in the following steps: Step 1 – Application of the reimbursement rate Step 2 – Limit to 90% of the maximum grant amount 16.3.1 Step 1 — Application of the reimbursement rate The reimbursement rate (see Article 5.2) is applied to the eligible costs (actual costs and flat-rate costs; see Article 6) declared by the beneficiaries and the affiliated entities (see Article 15) and approved by the Agency (see above) for the concerned reporting period. 16.3.2 Step 2 — Limit to 90% of the maximum grant amount The total amount of pre-financing and interim payments must not exceed 90% of the maximum grant amount set out in Article 5.1. The maximum amount for the interim payment will be calculated as follows: {90% of the maximum grant amount (see Article 5.1) minus {pre-financing and previous interim payments}}. 16.4 Payment of the balance — Amount — Calculation The payment of the balance reimburses the remaining part of the eligible costs incurred by the beneficiaries for the implementation of the action. If the total amount of earlier payments is greater than the final grant amount (see Article 5.3), the payment of the balance takes the form of a recovery (see Article 28). 26 Grant Agreement number: 101035467 — TEHDAS — HP-JA-2020 / HP-JA-2020-1 Associated with documentCHAFEA MGA — Multi:-v2.1 Ref. Ares(2021)4548885 13/07/2021 If the total amount of earlier payments is lower than the final grant amount, the Agency will pay the balance within 90 days from receiving the final report (see Article 15.4), except if Articles 31 or 32 apply. Payment is subject to the approval of the final report. Its approval does not imply recognition of compliance, authenticity, completeness or correctness of its content. The amount due as the balance is calculated by the Agency by deducting the total amount of pre- financing and interim payments (if any) already made, from the final grant amount determined in accordance with Article 5.3: {final grant amount (see Article 5.3) minus {pre-financing and interim payments (if any) made}}. If the balance is positive, it will be paid to the coordinator. The amount to be paid may however be offset — without the beneficiaries’ consent — against any other amount owed by a beneficiary to the Agency, the Commission or another executive agency (under the EU or Euratom budget), up to the maximum EU contribution indicated, for that beneficiary, in the estimated budget (see Annex 2). If the balance is negative, it will be recovered from the coordinator (see Article 28). 16.5 Notification of amounts due When making payments, the Agency will formally notify to the coordinator the amount due, specifying that it concerns an interim payment or the payment of the balance. For the payment of the balance, the notification will also specify the final grant amount. In the case of reduction of the grant or recovery of undue amounts, the notification will be preceded by the contradictory procedure set out in Articles 27 and 28. 16.6 Currency for payments The Agency will make all payments in euro. 16.7 Payments to the coordinator — Distribution to the beneficiaries Payments will be made to the coordinator. Payments to the coordinator will discharge the Agency from its payment obligation. The coordinator must distribute the payments between the beneficiaries without unjustified delay. Pre-financing may however be distributed only: (a) if 90% of the beneficiaries have acceded to the Agreement (see Article 40) and (b) to beneficiaries that have acceded to the Agreement (see Article 40). 27 Grant Agreement number: 101035467 — TEHDAS — HP-JA-2020 / HP-JA-2020-1 Associated with documentCHAFEA MGA — Multi:-v2.1 Ref. Ares(2021)4548885 13/07/2021 16.8 Bank account for payments All payments will be made to the following bank account: Name of bank: NORDEA BANK FINLAND PLC Full name of the account holder: SUOMEN ITSENAISYYDEN JUHLARAHA Full account number (including bank codes): IBAN code: FI2412793000513180 16.9 Costs of payment transfers The cost of the payment transfers is borne as follows: - the Agency bears the cost of transfers charged by its bank; - the beneficiary bears the cost of transfers charged by its bank; - the party causing a repetition of a transfer bears all costs of the repeated transfer. 16.10 Date of payment Payments by the Agency are considered to have been carried out on the date when they are debited to its account. 16.11 Consequences of non-compliance 16.11.1 If the Agency does not pay within the payment deadlines (see above), the beneficiaries are entitled to late-payment interest at the rate applied by the European Central Bank (ECB) for its main refinancing operations in euros (‘reference rate’), plus three and a half points. The reference rate is the rate in force on the first day of the month in which the payment deadline expires, as published in the C series of the Official Journal of the European Union. If the late-payment interest is lower than or equal to EUR 200, it will be paid to the coordinator only upon request submitted within two months of receiving the late payment. Late-payment interest is not due if all beneficiaries are EU Member States (including regional and local government authorities or other public bodies acting on behalf of a Member State for the purpose of this Agreement). Suspension of the payment deadline or payments (see Articles 31 and 32) will not be considered as late payment. Late-payment interest covers the period running from the day following the due date for payment (see above), up to and including the date of payment. Late-payment interest is not considered for the purposes of calculating the final grant amount. 16.11.2 If the coordinator breaches any of its obligations under this Article, the grant may be reduced (see Article 27) and the Agreement or the participation of the coordinator may be terminated (see Article 34). Such breaches may also lead to any of the other measures described in Chapter 6. 28 Grant Agreement number: 101035467 — TEHDAS — HP-JA-2020 / HP-JA-2020-1 Associated with documentCHAFEA MGA — Multi:-v2.1 Ref. Ares(2021)4548885 13/07/2021 ARTICLE 17 — CHECKS, REVIEWS, AUDITS AND INVESTIGATIONS — EXTENSION OF FINDINGS 17.1 Checks, reviews and audits by the Agency and the Commission 17.1.1 Right to carry out checks The Agency or the Commission will — during the implementation of the action or afterwards — check the proper implementation of the action and compliance with the obligations under the Agreement, including assessing deliverables and reports. For this purpose, the Agency or the Commission may be assisted by external persons or bodies. The Agency or the Commission may also request additional information in accordance with Article 12. The Agency or the Commission may request beneficiaries to provide such information to it directly. Information provided must be accurate, precise and complete and in the format requested, including electronic format. 17.1.2 Right to carry out reviews The Agency or the Commission may — during the implementation of the action or afterwards — carry out reviews on the proper implementation of the action (including assessment of deliverables and reports) and compliance with the obligations under the Agreement. Reviews may be started up to five years after the payment of the balance. They will be formally notified to the coordinator or beneficiary concerned and will be considered to have started on the date of the formal notification. If the review is carried out on a third party (see Articles 9 to 11a), the beneficiary concerned must inform the third party. The Agency or the Commission may carry out reviews directly (using its own staff) or indirectly (using external persons or bodies appointed to do so). It will inform the coordinator or beneficiary concerned of the identity of the external persons or bodies. They have the right to object to the appointment on grounds of commercial confidentiality. The coordinator or beneficiary concerned must provide — within the deadline requested — any information and data in addition to deliverables and reports already submitted (including information on the use of resources). The Agency or the Commission may request beneficiaries to provide such information to it directly. The coordinator or beneficiary concerned may be requested to participate in meetings, including with external experts. For on-the-spot reviews, the beneficiaries must allow access to their sites and premises, including to external persons or bodies, and must ensure that information requested is readily available. Information provided must be accurate, precise and complete and in the format requested, including electronic format. On the basis of the review findings, a ‘review report’ will be drawn up. 29 Grant Agreement number: 101035467 — TEHDAS — HP-JA-2020 / HP-JA-2020-1 Associated with documentCHAFEA MGA — Multi:-v2.1 Ref. Ares(2021)4548885 13/07/2021 The Agency or the Commission will formally notify the review report to the coordinator or beneficiary concerned, which has 30 days to formally notify observations (‘contradictory review procedure’). Reviews (including review reports) are in the language of the Agreement. 17.1.3 Right to carry out audits The Agency or the Commission may — during the implementation of the action or afterwards — carry out audits on the proper implementation of the action and compliance with the obligations under the Agreement. Audits may be started up to five years after the payment of the balance. They will be formally notified to the coordinator or beneficiary concerned and will be considered to have started on the date of the formal notification. If the audit is carried out on a third party (see Articles 9 to 11a), the beneficiary concerned must inform the third party. The Agency or the Commission may carry out audits directly (using its own staff) or indirectly (using external persons or bodies appointed to do so). It will inform the coordinator or beneficiary concerned of the identity of the external persons or bodies. They have the right to object to the appointment on grounds of commercial confidentiality. The coordinator or beneficiary concerned must provide — within the deadline requested — any information (including complete accounts, individual salary statements or other personal data) to verify compliance with the Agreement. The Agency or the Commission may request beneficiaries to provide such information to it directly. For on-the-spot audits, the beneficiaries must allow access to their sites and premises, including to external persons or bodies, and must ensure that information requested is readily available. Information provided must be accurate, precise and complete and in the format requested, including electronic format. On the basis of the audit findings, a ‘draft audit report’ will be drawn up. The Agency or the Commission will formally notify the draft audit report to the coordinator or beneficiary concerned, which has 30 days to formally notify observations (‘contradictory audit procedure’). This period may be extended by the Agency or the Commission in justified cases. The ‘final audit report’ will take into account observations by the coordinator or beneficiary concerned. The report will be formally notified to it. Audits (including audit reports) are in the language of the Agreement. The Agency or the Commission may also access the beneficiaries’ statutory records for the periodical assessment of flat-rate amounts. 17.2 Investigations by the European Anti-Fraud Office (OLAF) 30 Grant Agreement number: 101035467 — TEHDAS — HP-JA-2020 / HP-JA-2020-1 Associated with documentCHAFEA MGA — Multi:-v2.1 Ref. Ares(2021)4548885 13/07/2021 Under Regulations No 883/20137 and No 2185/968 (and in accordance with their provisions and procedures), the European Anti-Fraud Office (OLAF) may — at any moment during implementation of the action or afterwards — carry out investigations, including on-the-spot checks and inspections, to establish whether there has been fraud, corruption or any other illegal activity affecting the financial interests of the EU. 17.3 Checks and audits by the European Court of Auditors (ECA) Under Article 287 of the Treaty on the Functioning of the European Union (TFEU) and Article 161 of the Financial Regulation No 966/20129, the European Court of Auditors (ECA) may — at any moment during implementation of the action or afterwards — carry out audits. The ECA has the right of access for the purpose of checks and audits. 17.4 Checks, reviews, audits and investigations for international organisations Not applicable 17.5 Consequences of findings in checks, reviews, audits and investigations — Extension of findings 17.5.1 Findings in this grant Findings in checks, reviews, audits or investigations carried out in the context of this grant may lead to the rejection of ineligible costs (see Article 26), reduction of the grant (see Article 27), recovery of undue amounts (see Article 28) or to any of the other measures described in Chapter 6. Rejection of costs or reduction of the grant after the payment of the balance will lead to a revised final grant amount (see Article 5.4). Findings in checks, reviews, audits or investigations may lead to a request for amendment for the modification of Annex 1 (see Article 39). Checks, reviews, audits or investigations that find systemic or recurrent errors, irregularities, fraud or breach of obligations may also lead to consequences in other EU or Euratom grants awarded under similar conditions (‘extension of findings from this grant to other grants’). Moreover, findings arising from an OLAF investigation may lead to criminal prosecution under national law. 17.5.2 Findings in other grants 7 Regulation (EU, Euratom) No 883/2013 of the European Parliament and of the Council of 11 September 2013 concerning investigations conducted by the European Anti-Fraud Office (OLAF) and repealing Regulation (EC) No 1073/1999 of the European Parliament and of the Council and Council Regulation (Euratom) No 1074/1999 (OJ L 232, 18.09.2013, p. 1). 8 Council Regulation (Euratom, EC) No 2185/1996 of 11 November 1996 concerning on-the-spot checks and inspections carried out by the Commission in order to protect the European Communities' financial interests against fraud and other irregularities (OJ L 292, 15.11.1996, p. 2). 9 Regulation (EU, Euratom) No 966/2012 of the European Parliament and of the Council of 25 October 2012 on the financial rules applicable to the general budget of the Union and repealing Council Regulation (EC, Euratom) No 1605/2002 (OJ L 298, 26.10.2012, p. 1). 31 Grant Agreement number: 101035467 — TEHDAS — HP-JA-2020 / HP-JA-2020-1 Associated with documentCHAFEA MGA — Multi:-v2.1 Ref. Ares(2021)4548885 13/07/2021 The Agency or the Commission may extend findings from other grants to this grant (‘extension of findings from other grants to this grant’), if: (a) the beneficiary concerned is found, in other EU or Euratom grants awarded under similar conditions, to have committed systemic or recurrent errors, irregularities, fraud or breach of obligations that have a material impact on this grant and (b) those findings are formally notified to the beneficiary concerned — together with the list of grants affected by the findings — no later than five years after the payment of the balance of this grant. The extension of findings may lead to the rejection of costs (see Article 26), reduction of the grant (see Article 27), recovery of undue amounts (see Article 28), suspension of payments (see Article 32), suspension of the action implementation (see Article 33) or termination (see Article 34). 17.5.3 Procedure The Agency or the Commission will formally notify the beneficiary concerned the systemic or recurrent errors and its intention to extend these audit findings, together with the list of grants affected. 17.5.3.1 If the findings concern eligibility of costs: the formal notification will include: (a) an invitation to submit observations on the list of grants affected by the findings; (b) the request to submit revised financial statements for all grants affected; (c) the correction rate for extrapolation established by the Agency or the Commission on the basis of the systemic or recurrent errors, to calculate the amounts to be rejected, if the beneficiary concerned: (i) considers that the submission of revised financial statements is not possible or practicable or (ii) does not submit revised financial statements. The beneficiary concerned has 90 days from receiving notification to submit observations, revised financial statements or to propose a duly substantiated alternative correction method. This period may be extended by the Agency or the Commission in justified cases. The Agency or the Commission may then start a rejection procedure in accordance with Article 26, either on the basis of the revised financial statements, the alternative method or the correction rate announced. 17.5.3.2 If the findings concern substantial errors, irregularities or fraud or serious breach of obligations: the formal notification will include: (a) an invitation to submit observations on the list of grants affected by the findings and (b) the flat-rate the Agency or the Commission intends to apply according to the principle of proportionality. The beneficiary concerned has 90 days from receiving notification to submit observations or to propose a duly substantiated alternative flat-rate. 32 Grant Agreement number: 101035467 — TEHDAS — HP-JA-2020 / HP-JA-2020-1 Associated with documentCHAFEA MGA — Multi:-v2.1 Ref. Ares(2021)4548885 13/07/2021 The Agency or the Commission may then start a reduction procedure in accordance with Article 27, either on the basis of the alternative flat-rate or the flat-rate announced. 17.6 Consequences of non-compliance If a beneficiary breaches any of its obligations under this Article, any insufficiently substantiated costs will be ineligible (see Article 6) and will be rejected (see Article 26). Such breaches may also lead to any of the other measures described in Chapter 6. ARTICLE 18 — EVALUATION OF THE IMPACT OF THE ACTION 18.1 Right to evaluate the impact of the action The Agency or the Commission may carry out interim and final evaluations of the impact of the action measured against the objective of the EU programme. Evaluations may be started during implementation of the action and up to five years after the payment of the balance. The evaluation is considered to start on the date of the formal notification to the coordinator or beneficiaries. The Agency or the Commission may make these evaluations directly (using its own staff) or indirectly (using external bodies or persons it has authorised to do so). The coordinator or beneficiaries must provide any information relevant to evaluate the impact of the action, including information in electronic format. 18.2 Consequences of non-compliance If a beneficiary breaches any of its obligations under this Article, the Agency may apply the measures described in Chapter 6. SECTION 3 OTHER RIGHTS AND OBLIGATIONS ARTICLE 19 — PRE-EXISTING RIGHTS AND OWNERSHIP OF THE RESULTS (INCLUDING INTELLECTUAL AND INDUSTRIAL PROPERTY RIGHTS) 19.1 Pre-existing rights and access rights to pre-existing rights Where industrial and intellectual property rights (including rights of third parties) exist prior to the Agreement, the beneficiaries must establish a list of these pre-existing industrial and intellectual property rights, specifying the owner and any persons that have a right of use. The coordinator must — before starting the action — submit this list to the Agency. Each beneficiary must give the other beneficiaries and their affiliated entities access to any pre-existing industrial and intellectual property rights needed for the implementation of the action and compliance with the obligations under the Agreement. 33 Grant Agreement number: 101035467 — TEHDAS — HP-JA-2020 / HP-JA-2020-1 Associated with documentCHAFEA MGA — Multi:-v2.1 Ref. Ares(2021)4548885 13/07/2021 19.2 Ownership of results and rights of use The results of the action (including the reports and other documents relating to it) are owned by the beneficiaries. The beneficiaries must give the Agency and the Commission the right to use the results for their communication activities under Article 22. 19.3 Consequences of non-compliance If a beneficiary breaches any of its obligations under this Article, the grant may be reduced (see Article 27). Such a breach may also lead to any of the other measures described in Chapter 6. ARTICLE 20 — CONFLICT OF INTERESTS 20.1 Obligation to avoid a conflict of interests The beneficiaries must take all measures to prevent any situation where the impartial and objective implementation of the action is compromised for reasons involving economic interest, political or national affinity, family or emotional ties or any other shared interest (‘conflict of interests’). They must formally notify to the Agency without delay any situation constituting or likely to lead to a conflict of interests and immediately take all the necessary steps to rectify this situation. The Agency may verify that the measures taken are appropriate and may require additional measures to be taken by a specified deadline. 20.2 Consequences of non-compliance If a beneficiary breaches any of its obligations under this Article, the grant may be reduced (see Article 27) and the Agreement or participation of the beneficiary may be terminated (see Article 34). Such breaches may also lead to any of the other measures described in Chapter 6. ARTICLE 21 — CONFIDENTIALITY 21.1 General obligation to maintain confidentiality During implementation of the action and for five years after the payment of the balance, the parties must keep confidential any data, documents or other material (in any form) that is identified as confidential at the time it is disclosed (‘confidential information’). They may use confidential information to implement the Agreement. The confidentiality obligations no longer apply if: (a) the disclosing party agrees to release the other party; (b) the information becomes generally and publicly available, without breaching any confidentiality obligation; 34 Grant Agreement number: 101035467 — TEHDAS — HP-JA-2020 / HP-JA-2020-1 Associated with documentCHAFEA MGA — Multi:-v2.1 Ref. Ares(2021)4548885 13/07/2021 (c) the disclosure of the confidential information is required by EU or national law. 21.2 Consequences of non-compliance If a beneficiary breaches any of its obligations under this Article, the grant may be reduced (see Article 27). Such breaches may also lead to any of the other measures described in Chapter 6. ARTICLE 22 — PROMOTING THE ACTION — VISIBILITY OF EU FUNDING 22.1 Communication activities by the beneficiaries 22.1.1 General obligation to promote the action and its results The beneficiaries must promote the action and its results. 22.1.2 Information on EU funding — Obligation and right to use the EU emblem Unless the Agency requests or agrees otherwise, any communication activity related to the action (including at conferences, seminars, in information material, such as brochures, leaflets, posters, presentations, etc., in electronic form, via social media, etc.) and any infrastructure, equipment or major results funded by the grant must: - display the EU emblem and - include the following text: “This [insert appropriate description, e.g. report, publication, conference, infrastructure, equipment, insert type of result, etc.] was funded by the European Union’s Health Programme (2014-2020).” When displayed in association with another logo, the EU emblem must have appropriate prominence. For the purposes of their obligations under this Article, the beneficiaries may use the EU emblem without first obtaining approval from the Agency. This does not, however, give them the right to exclusive use. Moreover, they may not appropriate the EU emblem or any similar trademark or logo, either by registration or by any other means. 22.1.3 Disclaimer excluding Agency and Commission responsibility Any communication activity related to the action must indicate the following disclaimer: "The content of this [insert appropriate description, e.g. report, publication, conference, etc.] represents the views of the author only and is his/her sole responsibility; it cannot be considered to reflect the views of the European Commission and/or the Consumers, Health, Agriculture and Food Executive Agency (CHAFEA) or any other body of the European Union. The European Commission and the Agency do not accept any responsibility for use that may be made of the information it contains.” 22.2 Communication activities by the Agency and the Commission 22.2.1 Right to use the beneficiaries’ materials, documents or information 35 Grant Agreement number: 101035467 — TEHDAS — HP-JA-2020 / HP-JA-2020-1 Associated with documentCHAFEA MGA — Multi:-v2.1 Ref. Ares(2021)4548885 13/07/2021 The Agency and the Commission may use information relating to the action, documents notably summaries for publication and public deliverables as well as any other material, such as pictures or audio-visual material received from any beneficiary (including in electronic form). This does not change the confidentiality obligations in Article 21, which still apply. The right to use the beneficiary’s materials, documents and information includes: (a) use for its own purposes (in particular, making them available to persons working for the Agency, the Commission or any other EU institution, body, office or agency or body or institutions in EU Member States; and copying or reproducing them in whole or in part, in unlimited numbers); (b) distribution to the public (in particular, publication as hard copies and in electronic or digital format, publication on the internet, as a downloadable or non-downloadable file, broadcasting by any channel, public display or presentation, communicating through press information services, or inclusion in widely accessible databases or indexes); (c) editing or redrafting for communication and publicising activities (including shortening, summarising, inserting other elements (such as meta-data, legends, other graphic, visual, audio or text elements), extracting parts (e.g. audio or video files), dividing into parts, use in a compilation); (d) translation; (e) giving access in response to individual requests under Regulation No 1049/200110, without the right to reproduce or exploit; (f) storage in paper, electronic or other form; (g) archiving, in line with applicable document-management rules, and (h) the right to authorise third parties to act on its behalf or sub-license the modes of use set out in Points (b), (c), (d) and (f) to third parties if needed for the communication and publicising activities of the Agency or the Commission. If the right of use is subject to rights of a third party (including personnel of the beneficiary), the beneficiary must ensure that it complies with its obligations under this Agreement (in particular, by obtaining the necessary approval from the third parties concerned). Where applicable (and if provided by the beneficiaries), the Agency or the Commission will insert the following information: “© – [year] – [name of the copyright owner]. All rights reserved. Licensed to the Consumers, Health, Agriculture and Food Executive Agency (CHAFEA) and the European Union (EU) under conditions.” 22.3 Consequences of non-compliance If the beneficiary breaches any of its obligations under this Article, the grant may be reduced (see Article 27). 10 Regulation (EC) No 1049/2001 of the European Parliament and of the Council of 30 May 2001 regarding public access to European Parliament, Council and Commission documents, OJ L 145, 31.5.2001, p. 43. 36 Grant Agreement number: 101035467 — TEHDAS — HP-JA-2020 / HP-JA-2020-1 Associated with documentCHAFEA MGA — Multi:-v2.1 Ref. Ares(2021)4548885 13/07/2021 Such breaches may also lead to any of the other measures described in Chapter 6. ARTICLE 23 — PROCESSING OF PERSONAL DATA 23.1 Processing of personal data by the Agency and the Commission Any personal data under the Agreement will be processed by the Agency or the Commission under Regulation No 23/200111 and according to the ‘notifications of the processing operations’ to the Data Protection Officer (DPO) of the Agency or the Commission (publicly accessible in the DPO register). Such data will be processed by the ‘data controller’ of the Agency or the Commission, for the purposes of implementing, managing and monitoring the Agreement or protecting the financial interests of the EU or Euratom (including checks, reviews, audits and investigations; see Article 17). The persons whose personal data are processed have the right to access and correct their own personal data. For this purpose, they must send any queries about the processing of their personal data to the data controller, via the contact point indicated in the privacy statement(s) on the Agency and Commission websites. They also have the right to have recourse at any time to the European Data Protection Supervisor (EDPS). 23.2 Processing of personal data by the beneficiaries The beneficiaries must process personal data under the Agreement in compliance with applicable EU and national law on data protection (including authorisations or notification requirements). The beneficiaries may grant their personnel access only to data that is strictly necessary for implementing, managing and monitoring the Agreement. The beneficiaries must inform the personnel whose personal data are collected and processed by the Agency or the Commission. For this purpose, they must provide them with the privacy statement(s) (see above), before transmitting their data to the Agency or the Commission. 23.3 Consequences of non-compliance If a beneficiary breaches any of its obligations under Article 23.2, the Agency may apply any of the measures described in Chapter 6. ARTICLE 24 — ASSIGNMENTS OF CLAIMS FOR PAYMENT AGAINST THE AGENCY The beneficiaries may not assign any of their claims for payment against the Agency to any third party, except if approved by the Agency on the basis of a reasoned, written request by the coordinator (on behalf of the beneficiary concerned). If the Agency has not accepted the assignment or the terms of it are not observed, the assignment will have no effect on it. 11 Regulation (EC) No 45/2001 of the European Parliament and of the Council of 18 December 2000 on the protection of individuals with regard to the processing of personal data by the Community institutions and bodies and on the free movement of such data (OJ L 8, 12.01.2001, p. 1). 37 Grant Agreement number: 101035467 — TEHDAS — HP-JA-2020 / HP-JA-2020-1 Associated with documentCHAFEA MGA — Multi:-v2.1 Ref. Ares(2021)4548885 13/07/2021 In no circumstances will an assignment release the beneficiaries from their obligations towards the Agency. CHAPTER 5 DIVISION OF BENEFICIARIES’ ROLES AND RESPONSIBILITIES ARTICLE 25 — DIVISION OF BENEFICIARIES’ ROLES AND RESPONSIBILITIES 25.1 Roles and responsibilities towards the Agency The beneficiaries have full responsibility for implementing the action and complying with the Agreement. The beneficiaries are jointly and severally liable for the technical implementation of the action as described in Annex 1. If a beneficiary fails to implement its part of the action, the other beneficiaries become responsible for implementing this part (without being entitled to any additional EU funding for doing so), unless the Agency expressly relieves them of this obligation. The financial responsibility of each beneficiary is governed by Articles 28, 29 and 30. 25.2 Internal division of roles and responsibilities The internal roles and responsibilities of the beneficiaries are divided as follows: (a) Each beneficiary must: (i) keep information stored in the Participant Portal Beneficiary Register (via the electronic exchange system) up to date (see Article 12); (ii) inform the coordinator immediately of any events or circumstances likely to affect significantly or delay the implementation of the action (see Article 12); (iii) submit to the coordinator in good time: - individual financial statements for itself and its affiliated entities and, if required, certificates on the financial statements (see Article 15); - the data needed to draw up the technical reports (see Article 15); - any other documents or information required by the Agency or the Commission under the Agreement, unless the Agreement requires the beneficiary to submit this information directly. (b) The coordinator must: (i) monitor that the action is implemented properly (see Article 7); (ii) act as the intermediary for all communications between the beneficiaries and the Agency (in particular, providing the Agency with the information described in Article 12), unless the Agreement specifies otherwise; (iii) provide a pre-financing guarantee if requested by the Agency (see Article 16.2); 38 Grant Agreement number: 101035467 — TEHDAS — HP-JA-2020 / HP-JA-2020-1 Associated with documentCHAFEA MGA — Multi:-v2.1 Ref. Ares(2021)4548885 13/07/2021 (iv) request and review any documents or information required by the Agency and verify their completeness and correctness before passing them on to the Agency; (v) submit the deliverables and reports to the Agency (see Articles 14 and 15); (vi) ensure that all payments are made to the other beneficiaries without unjustified delay (see Article 16). The coordinator may not subcontract the above-mentioned tasks. 25.3 Internal arrangements between beneficiaries — Consortium agreement The beneficiaries must have internal arrangements regarding their operation and co-ordination to ensure that the action is implemented properly. These internal arrangements must be set out in a written ‘consortium agreement’ between the beneficiaries, which may cover: - internal organisation of the consortium; - management of access to the electronic exchange system; - distribution of EU funding; - additional rules on rights and obligations related to pre-existing rights and results (see Article 19); - settlement of internal disputes; - liability, indemnification and confidentiality arrangements between the beneficiaries. The consortium agreement must not contain any provision contrary to the Agreement. CHAPTER 6 REJECTION OF COSTS — REDUCTION OF THE GRANT — RECOVERY — SANCTIONS — DAMAGES — SUSPENSION — TERMINATION — FORCE MAJEURE SECTION 1 REJECTION OF COSTS — REDUCTION OF THE GRANT — RECOVERY — SANCTIONS ARTICLE 26 — REJECTION OF INELIGIBLE COSTS 26.1 Conditions The Agency will — at the time of an interim payment, at the payment of the balance or afterwards — reject any costs which are ineligible (see Article 6), in particular following checks, reviews, audits or investigations (see Article 17). The rejection may also be based on the extension of findings from other grants to this grant (see Article 17.5.2). 39 Grant Agreement number: 101035467 — TEHDAS — HP-JA-2020 / HP-JA-2020-1 Associated with documentCHAFEA MGA — Multi:-v2.1 Ref. Ares(2021)4548885 13/07/2021 26.2 Ineligible costs to be rejected — Calculation — Procedure Ineligible costs will be rejected in full. If the rejection of costs does not lead to a recovery (see Article 28), the Agency will formally notify the coordinator or beneficiary concerned of the rejection of costs, the amounts and the reasons why (if applicable, together with the notification of amounts due; see Article 16.5). The coordinator or beneficiary concerned may — within 30 days of receiving notification — formally notify the Agency of its disagreement and the reasons why. If the rejection of costs leads to a recovery, the Agency will follow the contradictory procedure with pre-information letter set out in Article 28. 26.3 Effects If the Agency rejects costs at the time of an interim payment or the payment of the balance, it will deduct them from the total eligible costs declared, for the action, in the periodic or final summary financial statement (see Article 15.3 and 15.4). It will then calculate the interim payment or payment of the balance as set out in Article 16.3 or 16.4. If the Agency — after an interim payment but before the payment of the balance — rejects costs declared in a periodic summary financial statement, it will deduct them from the costs declared in the next periodic summary financial statement or final summary financial statement. It will then calculate the interim payment or payment of the balance as set out in Article 16.3 or 16.4. If the Agency rejects costs after the payment of the balance, it will deduct the amount rejected from the total eligible costs declared, by the beneficiary, in the final summary financial statement. It will then calculate the revised final grant amount as set out in Article 5.4. If the revised final grant amount is lower than the final grant amount, the Agency will recover the difference (see Article 28). ARTICLE 27 — REDUCTION OF THE GRANT 27.1 Conditions The Agency may — at the payment of the balance or afterwards — reduce the grant, if: (a) a beneficiary (or a natural person who has the power to represent or take decisions on its behalf) has committed: (i) substantial errors, irregularities or fraud or (ii) serious breach of obligations under the Agreement or during the award procedure (including improper implementation of the action, submission of false information, failure to provide required information, breach of ethical principles) or (b) a beneficiary (or a natural person who has the power to represent or take decisions on its behalf) has committed — in other EU or Euratom grants awarded to it under similar conditions — systemic or recurrent errors, irregularities, fraud or serious breach of obligations that have a material impact on this grant (extension of findings from other grants to this grant; see Article 17.5.2). 40 Grant Agreement number: 101035467 — TEHDAS — HP-JA-2020 / HP-JA-2020-1 Associated with documentCHAFEA MGA — Multi:-v2.1 Ref. Ares(2021)4548885 13/07/2021 27.2 Amount to be reduced — Calculation — Procedure The amount of the reduction will be proportionate to the seriousness of the errors, irregularities or fraud or breach of obligations. Before reduction of the grant, the Agency will formally notify a ‘pre-information letter’ to the coordinator or beneficiary concerned: - informing it of its intention to reduce the grant, the amount it intends to reduce and the reasons why and - inviting it to submit observations within 30 days of receiving notification. If the Agency does not receive any observations or decides to pursue reduction despite the observations it has received, it will formally notify confirmation of the reduction (if applicable, together with the notification of amounts due; see Article 16). 27.3 Effects If the Agency reduces the grant at the time of the payment of the balance, it will calculate the reduced grant amount for the action and then determine the amount due as payment of the balance (see Article 5.3.4 and 16.4). If the Agency reduces the grant after the payment of the balance, it will calculate the revised final grant amount for the action or for the beneficiary concerned (see Article 5.4). If the revised final grant amount is lower than the final grant amount, the Agency will recover the difference (see Article 28). ARTICLE 28 — RECOVERY OF UNDUE AMOUNTS 28.1 Amount to be recovered — Calculation — Procedure The Agency will — at the payment of the balance or afterwards — claim back any amount that was paid but is not due under the Agreement. The coordinator is fully liable for repaying debts of the consortium (under the Agreement) even if it has not been the final recipient of those amounts. In addition, the beneficiaries (including the coordinator) are jointly and severally liable for repaying any unpaid debts under the Agreement (due by the consortium or any beneficiary, including late- payment interest) — up to the maximum EU contribution indicated, for each beneficiary, in the estimated budget (as last amended; see Annex 2). Undue amounts paid by the Agency for costs declared by an affiliated entity will be considered as amounts unduly paid to the beneficiary. 28.1.1 Recovery at payment of the balance If the payment of the balance takes the form of a recovery (see Article 16.4), the Agency will formally notify a ‘pre-information letter’ to the coordinator: - informing it of its intention to recover, the amount due as the balance and the reasons why and 41 Grant Agreement number: 101035467 — TEHDAS — HP-JA-2020 / HP-JA-2020-1 Associated with documentCHAFEA MGA — Multi:-v2.1 Ref. Ares(2021)4548885 13/07/2021 - inviting the coordinator to submit observations within 30 days of receiving notification. If no observations are submitted or the Agency decides to pursue recovery despite the observations it has received, it will confirm the amount to be recovered and formally notify to the coordinator a debit note with the terms and the date for payment (together with the notification of amounts due; see Article 16.5). If payment is not made by the date specified in the debit note, the Agency or the Commission will recover the amount: (a) by ‘offsetting’ it — without the coordinator’s consent — against any amounts owed to the coordinator by the Agency, Commission or another executive agency (from the EU or Euratom budget). In exceptional circumstances, to safeguard the EU’s financial interests, the Agency may offset before the payment date specified in the debit note; (b) not applicable; (c) by holding the other beneficiaries jointly and severally liable — up to the maximum EU contribution indicated, for each beneficiary, in the estimated budget (as last amended; see Annex 2) (d) by taking legal action (see Article 41) or by adopting an enforceable decision under Article 299 of the Treaty on the Functioning of the EU (TFEU) and Article 79(2) of the Financial Regulation No 966/2012. If payment is not made by the date in the debit note, the amount to be recovered (see above) will be increased by late-payment interest at the rate set out in Article 16.11, from the day following the payment date in the debit note, up to and including the date the Agency or the Commission receives full payment of the amount. Partial payments will be first credited against expenses, charges and late-payment interest and then against the principal. Bank charges incurred in the recovery process will be borne by the beneficiary, unless Directive 2007/64/EC applies. 28.1.2 Recovery of amounts after payment of the balance If — after the payment of the balance — the Agency revised the final grant amount for the action or for the beneficiary concerned (see Article 5.4), due to a rejection of costs or reduction of the grant, and the revised final grant amount is lower than the final grant amount (see Article 5.3), the Agency will: - if the rejection or reduction does not concern a specific beneficiary or its affiliated entities: claim back the difference from the coordinator (even if it has not been the final recipient of the amount in question) or - otherwise: claim back the difference from the beneficiary concerned. The Agency will formally notify a pre-information letter to the coordinator or beneficiary concerned: 42 Grant Agreement number: 101035467 — TEHDAS — HP-JA-2020 / HP-JA-2020-1 Associated with documentCHAFEA MGA — Multi:-v2.1 Ref. Ares(2021)4548885 13/07/2021 - informing it of its intention to recover, the amount to be repaid and the reasons why and - inviting it to submit observations within 30 days of receiving notification. If no observations are submitted or the Agency decides to pursue recovery despite the observations it has received, it will confirm the amount to be recovered and formally notify to the coordinator or beneficiary concerned a debit note. This note will also specify the terms and the date for payment. If payment is not made by the date specified in the debit note, the Agency or the Commission will recover the amount: (a) by ‘offsetting’ it — without the coordinator’s or beneficiary’s consent — against any amounts owed to the coordinator or beneficiary by the Agency, Commission or another executive agency (from the EU or Euratom budget). In exceptional circumstances, to safeguard the EU’s financial interests, the Agency may offset before the payment date specified in the debit note; (b) by holding the other beneficiaries jointly and severally liable, up to the maximum EU contribution indicated, for each beneficiary, in the estimated budget (as last amended; see Annex 2) (c) by taking legal action (see Article 41) or by adopting an enforceable decision under Article 299 of the Treaty on the Functioning of the EU (TFEU) and Article 79(2) of the Financial Regulation No 966/2012. If payment is not made by the date in the debit note, the amount to be recovered (see above) will be increased by late-payment interest at the rate set out in Article 16.11, from the day following the date for payment in the debit note, up to and including the date the Agency or the Commission receives full payment of the amount. Partial payments will be first credited against expenses, charges and late-payment interest and then against the principal. Bank charges incurred in the recovery process will be borne by the beneficiary, unless Directive 2007/64/EC applies. ARTICLE 29 — ADMINISTRATIVE SANCTIONS In addition to contractual measures, the Agency or the Commission may also adopt administrative sanctions under Articles 106 and 131(4) of the Financial Regulation No 966/2012 (i.e. exclusion from future procurement contracts, grants and expert contracts and/or financial penalties). SECTION 2 LIABILITY FOR DAMAGES ARTICLE 30 — LIABILITY FOR DAMAGES 30.1 Liability of the Agency The Agency cannot be held liable for any damage caused to the beneficiaries or to third parties as a consequence of implementing the Agreement, including for gross negligence. 43 Grant Agreement number: 101035467 — TEHDAS — HP-JA-2020 / HP-JA-2020-1 Associated with documentCHAFEA MGA — Multi:-v2.1 Ref. Ares(2021)4548885 13/07/2021 The Agency cannot be held liable for any damage caused by any of the beneficiaries or third parties involved in the action, as a consequence of implementing the Agreement. 30.2 Liability of the beneficiaries Except in case of force majeure (see Article 35), the beneficiaries must compensate the Agency for any damage it sustains as a result of the implementation of the action or because the action was not implemented in full compliance with the Agreement. SECTION 3 SUSPENSION AND TERMINATION ARTICLE 31 — SUSPENSION OF PAYMENT DEADLINE 31.1 Conditions The Agency may — at any moment — suspend the payment deadline (see Article 16.2 to 16.4) if a request for payment (see Article 15) cannot be approved because: (a) it does not comply with the provisions of the Agreement (see Article 15); (b) the technical or financial report(s) have not been submitted or are not complete or additional information is needed, or (c) there is doubt about the eligibility of the costs declared in the financial statements and additional checks, reviews, audits or investigations are necessary. 31.2 Procedure The Agency will formally notify the coordinator of the suspension and the reasons why. The suspension will take effect the day notification is sent by the Agency (see Article 36). If the conditions for suspending the payment deadline are no longer met, the suspension will be lifted — and the remaining period will resume. If the suspension exceeds two months, the coordinator may request the Agency if the suspension will continue. If the payment deadline has been suspended due to the non-compliance of the technical or financial report(s) (see Article 15) and the revised report or statement is not submitted or was submitted but is also rejected, the Agency may also terminate the Agreement or the participation of the beneficiary (see Article 34.3.1(i)). ARTICLE 32 — SUSPENSION OF PAYMENTS 32.1 Conditions The Agency may — at any moment — suspend payments, in whole or in part for one or more beneficiaries, if: 44 Grant Agreement number: 101035467 — TEHDAS — HP-JA-2020 / HP-JA-2020-1 Associated with documentCHAFEA MGA — Multi:-v2.1 Ref. Ares(2021)4548885 13/07/2021 (a) a beneficiary (or a natural person who has the power to represent or take decision on its behalf) has committed or is suspected of having committed: (i) substantial errors, irregularities or fraud or (ii) serious breach of obligations under this Agreement or during the award procedure (including improper implementation of the action, submission of false information, failure to provide required information, breach of ethical principles) or (b) a beneficiary (or a natural person who has the power to represent or take decision on its behalf) has committed — in other EU or Euratom grants awarded to it under similar conditions — systemic or recurrent errors, irregularities, fraud or serious breach of obligations that have a material impact on this grant (extension of findings from other grants to this grant; see Article 17.5.2). If payments are suspended for one or more beneficiaries, the Agency will make partial payment(s) for the part(s) not suspended. If suspension concerns the payment of the balance, the payment (or recovery) of the amount(s) concerned after suspension is lifted will be considered to be the payment that closes the action. 32.2 Procedure Before suspending payments, the Agency will formally notify the coordinator or beneficiary concerned: - informing it of its intention to suspend payments and the reasons why and - inviting it to submit observations within 30 days of receiving notification. If the Agency does not receive observations or decides to pursue the procedure despite the observations it has received, it will formally notify confirmation of the suspension. Otherwise, it will formally notify that the suspension procedure is not continued. The suspension will take effect the day the confirmation notification is sent by the Agency. If the conditions for resuming payments are met, the suspension will be lifted. The Agency will formally notify the coordinator or beneficiary concerned. During the suspension, the periodic report(s) for all reporting periods except the last one (see Article 15.3) must not contain any individual financial statement(s) from the beneficiary concerned and its affiliated entities. The coordinator must include them in the next periodic report after the suspension is lifted or — if suspension is not lifted before the end of the action — in the last periodic report. The beneficiaries may suspend implementation of the action (see Article 33.1) or terminate the Agreement or the participation of the beneficiary concerned (see Article 34.1 and 34.2). ARTICLE 33 — SUSPENSION OF THE ACTION IMPLEMENTATION 33.1 Suspension of the action implementation, by the beneficiaries 33.1.1 Conditions 45 Grant Agreement number: 101035467 — TEHDAS — HP-JA-2020 / HP-JA-2020-1 Associated with documentCHAFEA MGA — Multi:-v2.1 Ref. Ares(2021)4548885 13/07/2021 The beneficiaries may suspend implementation of the action or any part of it, if exceptional circumstances — in particular force majeure (see Article 35) — make implementation impossible or excessively difficult. 33.1.2 Procedure The coordinator must immediately formally notify to the Agency the suspension (see Article 36), stating: - the reasons why and - the expected date of resumption. The suspension will take effect the day this notification is received by the Agency. Once circumstances allow for implementation to resume, the coordinator must immediately formally notify the Agency and request an amendment of the Agreement, to set the date on which the action will be resumed, extend the duration of the action and make other changes necessary to adapt the action to the new situation (see Article 39) — unless the Agreement or the participation of a beneficiary has been terminated (see Article 34). The suspension will be lifted with effect from the resumption date set out in the amendment. This date may be before the date on which the amendment enters into force. Costs incurred during suspension of the action implementation are not eligible (see Article 6). 33.2 Suspension of the action implementation, by the Agency 33.2.1 Conditions The Agency may suspend implementation of the action or any part of it, if: (a) a beneficiary (or a natural person who has the power to represent or take decisions on its behalf) has committed or is suspected of having committed: (i) substantial errors, irregularities or fraud or (ii) serious breach of obligations under this Agreement or during the award procedure (including improper implementation of the action, submission of false declaration, failure to provide required information, breach of ethical principles) or (b) a beneficiary (or a natural person who has the power to represent or take decisions on its behalf) has committed — in other EU or Euratom grants awarded to it under similar conditions — systemic or recurrent errors, irregularities, fraud or serious breach of obligations that have a material impact on this grant (extension of findings from other grants to this grant; see Article 17.5.2). 33.2.2 Procedure Before suspending implementation of the action, the Agency will formally notify the coordinator or beneficiary concerned: - informing it of its intention to suspend the implementation and the reasons why and 46 Grant Agreement number: 101035467 — TEHDAS — HP-JA-2020 / HP-JA-2020-1 Associated with documentCHAFEA MGA — Multi:-v2.1 Ref. Ares(2021)4548885 13/07/2021 - inviting it to submit observations within 30 days of receiving notification. If the Agency does not receive observations or decides to pursue the procedure despite the observations it has received, it will formally notify confirmation of the suspension. Otherwise, it will formally notify that the procedure is not continued. The suspension will take effect five days after confirmation notification is received (or on a later date specified in the notification). It will be lifted if the conditions for resuming implementation of the action are met. The coordinator or beneficiary concerned will be formally notified of the lifting and the Agreement will be amended, to set the date on which the action will be resumed, extend the duration of the action and make other changes necessary to adapt the action to the new situation (see Article 39) — unless the Agreement has already been terminated (see Article 34). The suspension will be lifted with effect from the resumption date set out in the amendment. This date may be before the date on which the amendment enters into force. Costs incurred during suspension are not eligible (see Article 6). The beneficiaries may not claim damages due to suspension by the Agency (see Article 30). Suspension of the action implementation does not affect the Agency’s right to terminate the Agreement or participation of a beneficiary (see Article 34), reduce the grant or recover amounts unduly paid (see Articles 27 and 28). ARTICLE 34 — TERMINATION OF THE AGREEMENT OR OF THE PARTICIPATION OF ONE OR MORE BENEFICIARIES 34.1 Termination of the Agreement, by the beneficiaries 34.1.1 Conditions and procedure The beneficiaries may terminate the Agreement. The coordinator must formally notify termination to the Agency (see Article 36), stating: - the reasons why and - the date the termination will take effect. This date must be after the notification. If no reasons are given or if the Agency considers the reasons do not justify termination, the Agreement will be considered to have been ‘terminated improperly’. The termination will take effect on the day specified in the notification. 34.1.2 Effects The coordinator must — within 60 days from when termination takes effect — submit a periodic report (for the open reporting period until termination; see Article 15.3) and the final report (see Article 15.4). 47 Grant Agreement number: 101035467 — TEHDAS — HP-JA-2020 / HP-JA-2020-1 Associated with documentCHAFEA MGA — Multi:-v2.1 Ref. Ares(2021)4548885 13/07/2021 If the Agency does not receive the report(s) within the deadline (see above), only costs which are included in an approved periodic report will be taken into account. The Agency will calculate the final grant amount (see Article 5.3) and the balance (see Article 16.4) on the basis of the report(s) submitted. Only costs incurred until termination are eligible (see Article 6). Costs relating to contracts due for execution only after termination are not eligible. Improper termination may lead to a reduction of the grant (see Article 27). After termination, the beneficiaries’ obligations (in particular, Articles 15, 17, 18, 19, 20, 21, 22, 24, 26, 27 and 28) continue to apply. 34.2 Termination of the participation of one or more beneficiaries, by the beneficiaries 34.2.1 Conditions and procedure The participation of one or more beneficiaries may be terminated by the coordinator, on request of the beneficiary concerned or on behalf of the other beneficiaries. The coordinator must formally notify termination to the Agency (see Article 36) and inform the beneficiary concerned. If the coordinator’s participation is terminated without its agreement, the formal notification must be done by another beneficiary (acting on behalf of the other beneficiaries). The notification must include: - the reasons why; - the opinion of the beneficiary concerned (or proof that this opinion has been requested in writing); - the date the termination takes effect. This date must be after the notification, and - a request for amendment (see Article 39), with a proposal for reallocation of the tasks and the estimated budget of the beneficiary concerned (see Annexes 1 and 2) and, if necessary, the addition of one or more new beneficiaries (see Article 40). If termination takes effect after the period set out in Article 3, no request for amendment must be included, unless the beneficiary concerned is the coordinator. In this case, the request for amendment must propose a new coordinator. If this information is not given or if the Agency considers that the reasons do not justify termination, the participation will be considered to have been terminated improperly. The termination will take effect on the day specified in the notification. 34.2.2 Effects The beneficiary concerned must submit to the coordinator: (i) a technical report and 48 Grant Agreement number: 101035467 — TEHDAS — HP-JA-2020 / HP-JA-2020-1 Associated with documentCHAFEA MGA — Multi:-v2.1 Ref. Ares(2021)4548885 13/07/2021 (ii) a financial statement covering the period from the end of the last reporting period to the date when termination takes effect. This information must be included by the coordinator in the periodic report for the next reporting period (see Article 15.3). If the request for amendment is rejected by the Agency (because it calls into question the decision awarding the grant or breaches the principle of equal treatment of applicants), the Agreement may be terminated according to Article 34.3.1(c). If the request for amendment is accepted by the Agency, the Agreement is amended to introduce the necessary changes (see Article 39). Improper termination may lead to a reduction of the grant (see Article 27) or termination of the Agreement (see Article 34). After termination, the concerned beneficiary’s obligations (in particular Articles 15, 17, 18, 19, 21, 22, 24, 26, 27 and 28) continue to apply. 34.3 Termination of the Agreement or of the participation of one or more beneficiaries, by the Agency 34.3.1 Conditions The Agency may terminate the Agreement or the participation of one or more beneficiaries, if: (a) one or more beneficiaries do not accede to the Agreement (see Article 40); (b) a change to their legal, financial, technical, organisational or ownership situation (or those of its affiliated entities) is likely to substantially affect or delay the implementation of the action or calls into question the decision to award the grant; (c) following termination of participation for one or more beneficiaries (see above), the necessary changes to the Agreement would call into question the decision awarding the grant or breach the principle of equal treatment of applicants (see Article 39); (d) implementation of the action is prevented by force majeure (see Article 35) or suspended by the coordinator (see Article 33.1) and either: (i) resumption is impossible, or (ii) the necessary changes to the Agreement would call into question the decision awarding the grant or breach the principle of equal treatment of applicants; (e) a beneficiary is declared bankrupt, being wound up, having its affairs administered by the courts, has entered into an arrangement with creditors, has suspended business activities, or is subject to any other similar proceedings or procedures under national law; (f) a beneficiary (or a natural person who has the power to represent or take decisions on its behalf) has been found guilty of professional misconduct, proven by any means; (g) a beneficiary does not comply with the applicable national law on taxes and social security; 49 Grant Agreement number: 101035467 — TEHDAS — HP-JA-2020 / HP-JA-2020-1 Associated with documentCHAFEA MGA — Multi:-v2.1 Ref. Ares(2021)4548885 13/07/2021 (h) a beneficiary (or a natural person who has the power to represent or take decisions on its behalf) has committed fraud, corruption, or is involved in a criminal organisation, money laundering or any other illegal activity; (i) a beneficiary (or a natural person who has the power to represent or take decisions on its behalf) has committed: (i) substantial errors, irregularities or fraud or (ii) serious breach of obligations under the Agreement or during the award procedure (including improper implementation of the action, submission of false information, failure to provide required information, breach of ethical principles); (j) a beneficiary (or a natural person who has the power to represent or take decisions on its behalf) has committed — in other EU or Euratom grants awarded to it under similar conditions — systemic or recurrent errors, irregularities, fraud or serious breach of obligations that have a material impact on this grant (extension of findings from other grants to this grant; see Article 17.5.2); (k) despite a specific request by the Agency, a beneficiary does not request — through the coordinator — an amendment to the Agreement to end the participation of one of its affiliated entities that is in one of the situations under points (e), (f), (g), (h), (i) or (j) and to reallocate its tasks 34.3.2 Procedure Before terminating the Agreement or participation of one or more beneficiaries, the Agency will formally notify the coordinator or beneficiary concerned: - informing it of its intention to terminate and the reasons why and - inviting it, within 30 days of receiving notification, to submit observations and — in case of Point (i.ii) above — to inform the Agency of the measures to ensure compliance with the obligations under the Agreement. If the Agency does not receive observations or decides to pursue the procedure despite the observations it has received, it will formally notify to the coordinator or beneficiary concerned confirmation of the termination and the date it will take effect. Otherwise, it will formally notify that the procedure is not continued. The termination will take effect: - for terminations under Points (b), (c), (e), (g), (i.ii) and (k) above: on the day specified in the notification of the confirmation (see above); - for terminations under Points (a), (d), (f), (h), (i.i) and (j) above: on the day after the notification of the confirmation is received. 34.3.3 Effects (a) for termination of the Agreement: The coordinator must — within 60 days from when termination takes effect — submit a periodic 50 Grant Agreement number: 101035467 — TEHDAS — HP-JA-2020 / HP-JA-2020-1 Associated with documentCHAFEA MGA — Multi:-v2.1 Ref. Ares(2021)4548885 13/07/2021 report (for the last open reporting period until termination; see Article 15.3) and a final report (see Article 15.4). If the Agreement is terminated for breach of the obligation to submit reports (see Articles 15.8 and 34.3.1(i)), the coordinator may not submit any reports after termination. If the Agency does not receive the report(s) within the deadline (see above), only costs which are included in an approved periodic report will be taken into account. The Agency will calculate the final grant amount (see Article 5.3) and the balance (see Article 16.4) on the basis of the report(s) submitted. Only costs incurred until termination takes effect are eligible (see Article 6). Costs relating to contracts due for execution only after termination are not eligible. This does not affect the Agency’s right to reduce the grant (see Article 27) or to impose administrative sanctions (Article 29). The beneficiaries may not claim damages due to termination by the Agency (see Article 30). After termination, the beneficiaries’ obligations (in particular Articles 15, 17, 18, 19, 21, 22, 24, 26, 27 and 28) continue to apply. (b) for termination of the participation of one or more beneficiaries: The coordinator must — within 60 days from when termination takes effect — submit a request for amendment (see Article 39), with a proposal for reallocation of the tasks and estimated budget of the beneficiary concerned (see Annexes 1 and 2) and, if necessary, the addition of one or more new beneficiaries (see Article 40). If termination is notified after the period set out in Article 3, no request for amendment must be submitted unless the beneficiary concerned is the coordinator. In this case the request for amendment must propose a new coordinator. The beneficiary concerned must submit to the coordinator: (i) a technical report and (ii) a financial statement covering the period from the end of the last reporting period to the date when termination takes effect. This information must be included by the coordinator in periodic report for the next reporting period (see Article 15.3). If the request for amendment is rejected by the Agency (because it calls into question the decision awarding the grant or breaches the principle of equal treatment of applicants), the Agreement may be terminated according to Article 34.3.1(c). If the request for amendment is accepted by the Agency, the Agreement is amended to introduce the necessary changes (see Article 39). After termination, the concerned beneficiary’s obligations (in particular Articles 15, 17, 18, 19, 20, 21, 22, 24, 26, 27 and 28) continue to apply. SECTION 4 FORCE MAJEURE 51 Grant Agreement number: 101035467 — TEHDAS — HP-JA-2020 / HP-JA-2020-1 Associated with documentCHAFEA MGA — Multi:-v2.1 Ref. Ares(2021)4548885 13/07/2021 ARTICLE 35 — FORCE MAJEURE ‘Force majeure’ means any situation or event that: - prevents either party from fulfilling their obligations under the Agreement, - was unforeseeable, exceptional situation and beyond the parties’ control, - was not due to error or negligence on their part (or on the part of third parties involved in the action), and - proves to be inevitable in spite of exercising all due diligence. The following cannot be invoked as force majeure: - any default of a service, defect in equipment or material or delays in making them available, unless they stem directly from a relevant case of force majeure, - labour disputes or strikes, or - financial difficulties. Any situation constituting force majeure must be formally notified to the other party without delay, stating the nature, likely duration and foreseeable effects. The parties must immediately take all the necessary steps to limit any damage due to force majeure and do their best to resume implementation of the action as soon as possible. The party prevented by force majeure from fulfilling its obligations under the Agreement cannot be considered in breach of them. CHAPTER 7 FINAL PROVISIONS ARTICLE 36 — COMMUNICATION BETWEEN THE PARTIES 36.1 Form and means of communication Communication under the Agreement (information, requests, submissions, 'formal notifications', etc.) must: - be made in writing and - bear the number of the Agreement. Until the payment of the balance: all communication must be made through the electronic exchange system and using the forms and templates provided there. After the payment of the balance: formal notifications must be made by registered post with proof of delivery (‘formal notification on paper’). Communications in the electronic exchange system must be made by persons authorised according to the Participant Portal Terms & Conditions. For naming the authorised persons, each beneficiary must 52 Grant Agreement number: 101035467 — TEHDAS — HP-JA-2020 / HP-JA-2020-1 Associated with documentCHAFEA MGA — Multi:-v2.1 Ref. Ares(2021)4548885 13/07/2021 have designated — before the signature of this Agreement — a ‘legal entity appointed representative (LEAR)’. The role and tasks of the LEAR are stipulated in his/her appointment letter (see Participant Portal Terms & Conditions). If the electronic exchange system is temporarily unavailable, instructions will be given on the Agency and Commission websites. 36.2 Date of communication Communications are considered to have been made when they are sent by the sending party (i.e. on the date and time they are sent through the electronic exchange system). Formal notifications through the electronic exchange system are considered to have been made when they are received by the receiving party (i.e. on the date and time of acceptance by the receiving party, as indicated by the time stamp). A formal notification that has not been accepted within 10 days after sending is considered to have been accepted. Formal notifications on paper sent by registered post with proof of delivery (only after the payment of the balance) are considered to have been made on either: - the delivery date registered by the postal service or - the deadline for collection at the post office. If the electronic exchange system is temporarily unavailable, the sending party cannot be considered in breach of its obligation to send a communication within a specified deadline. 36.3 Addresses for communication The electronic exchange system must be accessed via the following URL: https://ec.europa.eu/info/funding-tenders/opportunities/portal/screen/myarea/projects The Agency will formally notify the coordinator and beneficiaries in advance any changes to this URL. Formal notifications on paper (only after the payment of the balance) addressed to the Agency must be sent to the following address: European Health and Digital Executive Agency (HADEA) Health and Food EU4Health/SMP Food B-1049 Belgium Formal notifications on paper (only after the payment of the balance) addressed to the beneficiaries must be sent to their legal address as specified in the Participant Portal Beneficiary Register. ARTICLE 37 — INTERPRETATION OF THE AGREEMENT 37.1 Precedence of the Terms and Conditions over the Annexes The provisions in the Terms and Conditions of the Agreement take precedence over its Annexes. Annex 2 takes precedence over Annex 1. 53 Grant Agreement number: 101035467 — TEHDAS — HP-JA-2020 / HP-JA-2020-1 Associated with documentCHAFEA MGA — Multi:-v2.1 Ref. Ares(2021)4548885 13/07/2021 37.2 Privileges and immunities Not applicable ARTICLE 38 — CALCULATION OF PERIODS, DATES AND DEADLINES In accordance with Regulation No 1182/7112, periods expressed in days, months or years are calculated from the moment the triggering event occurs. The day during which that event occurs is not considered as falling within the period. ARTICLE 39 — AMENDMENTS TO THE AGREEMENT 39.1 Conditions The Agreement may be amended, unless the amendment entails changes to the Agreement which would call into question the decision awarding the grant or breach the principle of equal treatment of applicants. Amendments may be requested by any of the parties. 39.2 Procedure The party requesting an amendment must submit a request for amendment signed in the electronic exchange system (see Article 36). The coordinator submits and receives requests for amendment on behalf of the beneficiaries (see Annex 3). If a change of coordinator is requested without its agreement, the submission must be done by another beneficiary (acting on behalf of the other beneficiaries). The request for amendment must include: - the reasons why; - the appropriate supporting documents, and - for a change of coordinator without its agreement: the opinion of the coordinator (or proof that this opinion has been requested in writing). The Agency may request additional information. If the party receiving the request agrees, it must sign the amendment in the electronic exchange system within 45 days of receiving notification (or any additional information the Agency has requested). If it does not agree, it must formally notify its disagreement within the same deadline. The deadline may be extended, if necessary for the assessment of the request. If no notification is received within the deadline, the request is considered to have been rejected. 12 Regulation (EEC, Euratom) No 1182/71 of the Council of 3 June 1971 determining the rules applicable to periods, dates and time-limits (OJ L 124, 8/6/1971, p. 1). 54 Grant Agreement number: 101035467 — TEHDAS — HP-JA-2020 / HP-JA-2020-1 Associated with documentCHAFEA MGA — Multi:-v2.1 Ref. Ares(2021)4548885 13/07/2021 An amendment enters into force on the day of the signature of the receiving party. An amendment takes effect on the date agreed by the parties or, in the absence of such an agreement, on the date on which the amendment enters into force. ARTICLE 40 — ACCESSION TO THE AGREEMENT 40.1 Accession of the beneficiaries mentioned in the preamble The other beneficiaries must accede to the Agreement by signing the Accession Form (see Annex 3) in the electronic exchange system (see Article 36) within 30 days after its entry into force (see Article 42). They will assume the rights and obligations under the Agreement with effect from the date of its entry into force (see Article 42). If a beneficiary does not accede to the Agreement within the above deadline, the coordinator must — within 30 days — request an amendment to make any changes necessary to ensure proper implementation of the action. This does not affect the Agency's right to terminate the Agreement (see Article 34). 40.2 Addition of new beneficiaries In justified cases, the beneficiaries may request the addition of a new beneficiary. For this purpose, the coordinator must submit a request for amendment in accordance with Article 39. It must include an Accession Form (see Annex 3) signed by the new beneficiary in the electronic exchange system (see Article 36). New beneficiaries must assume the rights and obligations under the Agreement with effect from the date of their accession specified in the Accession Form (see Annex 3). ARTICLE 41 — APPLICABLE LAW AND SETTLEMENT OF DISPUTES 41.1 Applicable law The Agreement is governed by the applicable EU law, supplemented if necessary by the law of Belgium. 41.2 Dispute settlement If a dispute concerning the interpretation, application or validity of the Agreement cannot be settled amicably, the General Court — or, on appeal, the Court of Justice of the European Union — has sole jurisdiction. Such actions must be brought under Article 272 of the Treaty on the Functioning of the EU (TFEU). As an exception, if such a dispute is between the Agency and ‘AGENTIA DE TRANSPLANT’, ‘THE NORWEGIAN MINISTRY OF HEALTH AND CARE SERVICES’, ‘INSTITUT ZA ZASTITU ZDRAVLJA SRBIJEDR MILAN JOVANOVIC BATUT’, the competent Belgian courts have sole jurisdiction. If a dispute concerns administrative sanctions, offsetting or an enforceable decision under 55 Grant Agreement number: 101035467 — TEHDAS — HP-JA-2020 / HP-JA-2020-1 Associated with documentCHAFEA MGA — Multi:-v2.1 Ref. Ares(2021)4548885 13/07/2021 Article 79(2) of the Financial Regulation No 966/2012 and Article 299 TFEU (see Articles 28, 29 and 30), the beneficiaries must bring action before the General Court — or, on appeal, the Court of Justice of the European Union — under Article 263 TFEU. Actions against enforceable decisions must be brought against the Commission (not against the Agency). ARTICLE 42 — ENTRY INTO FORCE OF THE AGREEMENT The Agreement will enter into force on the day of signature by the Agency or the coordinator, depending on which is later. SIGNATURES For the coordinator For the Agency [--TGSMark#signature-906912365_75_210--] [--TGSMark#signature-service_75_210--] Heidi Saario with ECAS id n00430l4 signed in the Participant Signed by Nicolas KRIEGER with ECAS id kriegni as an authorised Portal on 14/07/2021 at 08:59:24 (transaction id SigId-65545-TfkfZ representative on 15-07-2021 18:30:55 (transaction id SigId-85875-8 FJROLRcwE7r7xjNiRcSeXwSntzMlpkzaXKlvppuWZxWTZqOaDsIDth rIN7OVPwf5avzwrMp9r65U5MQE6Hzlt3JutzMkGGYXM8IwFIQnxvfnU nn7rJYzt2pi5TzXNRwVkjnP6laoa-yntOf97TTHqL2QVETsEsmO-VwP P58xxGFzxdoKxgtHNHOazfdJKvtdg5zm-yntOf97TTHqL2QVETsEsmO- e3BiWtLBEMd4MtiLqEzZFZ87zjSItcC0xQF9Es8kiU3wgbRfWqzlXbf6 BmwSIoFCdPSKo8v1O8Ag9zpGR3J5qUbt9zocTNb0PbzyyVMmAOVE8 dlcNzV8gUYZZcQWcjEmpflm4dVJC). Timestamp by third party at HvbqY9p89qtvDawmb2zZkqNl7Dr750pJ6G) 2021.07.14 09:59:29 CEST 2021.07.15 18:30:59 CEST 56  Associated with document Ref. Ares(2021)4548885 - 13/07/2021 EUROPEAN HEALTH AND DIGITAL EXECUTIVE AGENCY (HADEA) HADEA.A – Health and Food A.02 – EU4Health/SMP Food ANNEX 1 (part A) Project NUMBER — 101035467 — TEHDAS  Associated with document Ref. Ares(2021)4548885 - 13/07/2021 Table of Contents 1.1. The project summary................................................................................................................................. 3 1.2. The list of beneficiaries..............................................................................................................................4 1.3. Workplan Tables - Detailed implementation..............................................................................................6 1.3.1. WT1 List of work packages........................................................................................................... 6 1.3.2. WT2 List of deliverables................................................................................................................ 7 1.3.3. WT3 Work package descriptions................................................................................................. 10 Work package 1......................................................................................................................... 10 Work package 2......................................................................................................................... 13 Work package 3......................................................................................................................... 17 Work package 4......................................................................................................................... 20 Work package 5......................................................................................................................... 23 Work package 6......................................................................................................................... 28 Work package 7......................................................................................................................... 31 Work package 8......................................................................................................................... 34 1.3.4. WT4 List of milestones................................................................................................................ 38 1.3.5. WT5 Critical Implementation risks and mitigation actions........................................................... 43 1.3.6 WT6 Summary of project effort in person-months........................................................................45 1.3.7. WT7 Tentative schedule of project reviews.................................................................................47  Associated with document Ref. Ares(2021)4548885 - 13/07/2021 1.1. The project summary Project Number 1 101035467 Project Acronym 2 TEHDAS One form per project General information Project title 3 Towards the European Health DAta Space Joint Action Starting date 4 01/02/2021 Duration in months 5 30 Call (part) identifier 6 HP-JA-2020-1 JA-04-2020 • Addressing differences in national General Data Protection Regulation (GDPR) Topic implementation in the health sector, including the European Health Data Space and the health data use Fixed EC Keywords data quality, eHealth, European Health Data Space, FAIR data, GDPR, governance, Free keywords health, health data, health systems, infrastructure, Joint Action, secodary use Abstract 7 The Joint Action Towards the European Health Data Space (TEHDAS) is a consortium of 26 EU MS and other countries that work to improve cross-border use of health data for the benefit of citizens’ health, for public health, research and innovation.TEHDAS builds on earlier EU actions fostering the digital transformation of European health systems. It contributes to responding to the Member States’ call at the October 2020 European Council to set up a European Health Data Space and proposed by the von der Leyen Commission.The Joint Action helps Members States and the Commission in developing and promoting concepts for sharing of data so that in the future Europe, citizens, communities and companies benefit from a protected and seamless access to health data regardless where it is stored.TEHDAS will suggest options for an operational framework and governance in order to overcome legal and technical differences between countries. TEHDAS is grounded on the principles of transparency, trust and citizen empowerment. It will work on technical and semantic challenges, propose services, architectural and infrastructural elements required in the European Health Data Space.Citizens increasingly manage their data which requires a better understanding and a European perspective. To maintain trust in fair and secure data sharing, TEHDAS will suggest strengthened governance mechanisms for cross-sector use of health data in common data spaces at the EU and Member State levels.TEHDAS will reach out and engage with many types of stakeholders to reflect their needs and expectations, explore views on economic issues, and suggest concrete ways to integrate results into the future the European Health Data Space. Page 3 of 47  Associated with document Ref. Ares(2021)4548885 - 13/07/2021 1.2. List of Beneficiaries Project Number 1 101035467 Project Acronym 2 TEHDAS List of Beneficiaries Project Project No Name Short name Country entry exit month8 month SUOMEN ITSENAISYYDEN 1 Sitra Finland 1 30 JUHLARAHASTO BUNDESMINISTERIUM FUER 2 SOZIALES, GESUNDHEIT, PFLEGE UND ATNA Austria 1 30 KONSUMENTENSCHUTZ 3 SCIENSANO Sciensano Belgium 1 30 HRVATSKI ZAVOD ZA ZDRAVSTVENO 4 CHIF Croatia 1 30 OSIGURANJE 5 Ministry of Health of the Republic of Cyprus MoH-CY Cyprus 1 30 MINISTERSTVO ZDRAVOTNICTVI 6 MZCR Czech Republic 1 30 CESKE REPUBLIKY 7 REGION MIDTJYLLAND RM Denmark 1 30 8 SOTSIAALMINISTEERIUM MoSA Estonia 1 30 9 PLATEFORME DES DONNEES DE SANTE FR-HDH France 1 30 BUNDESMINISTERIUM FUER 10 BMG Germany 1 30 GESUNDHEIT DIOIKISI 6IS YGEIONOMIKIS PERIFEREIAS PELOPONNISOU 11 6th Y. PE. Greece 1 30 IONION NYSON IPEIROU KAI DYTIKIS ELLADAS 12 ORSZAGOS KORHAZI FOIGAZGATOSAG OKFŐ Hungary 1 30 13 DEPARTMENT OF HEALTH DoH-IE Ireland 1 30 14 MINISTERO DELLA SALUTE MINSAL Italy 1 30 LIETUVOS RESPUBLIKOS SVEIKATOS 15 SAM-LT Lithuania 1 30 APSAUGOS MINISTERIJA 16 Ministry for Health - Government of Malta DHIR Malta 1 30 17 AGENTIA DE TRANSPLANT ATRM Moldova 1 30 MINISTERIE VAN VOLKSGEZONDHEID, 18 VWS Netherlands 1 30 WELZIJN EN SPORT THE NORWEGIAN MINISTRY OF 19 MoH-NO Norway 1 30 HEALTH AND CARE SERVICES SPMS - SERVICOS PARTILHADOS DO 20 SPMS Portugal 1 30 MINISTERIO DA SAUDE EPE INSTITUT ZA ZASTITU ZDRAVLJA 21 IPHS "Batut" Serbia 1 30 SRBIJEDR MILAN JOVANOVIC BATUT NACIONALNI INSTITUT ZA JAVNO 22 NIJZ Slovenia 1 30 ZDRAVJE Page 4 of 47  Associated with document Ref. Ares(2021)4548885 - 13/07/2021 1.2. List of Beneficiaries Project Project No Name Short name Country entry exit month8 month INSTITUTO ARAGONES DE CIENCIAS 23 IACS Spain 1 30 DE LA SALUD 24 E-HALSOMYNDIGHETEN SEHA Sweden 1 30 25 THE NHS CONFEDERATION NHSC United Kingdom 1 30 Page 5 of 47  Associated with document Ref. Ares(2021)4548885 - 13/07/2021 1.3. Workplan Tables - Detailed implementation 1.3.1. WT1 List of work packages WP Person- Start End WP Title Lead beneficiary10 Number9 months11 month12 month13 WP1 Coordination of the project 1 - Sitra 50.00 1 30 WP2 Dissemination of the project 1 - Sitra 23.00 1 30 WP3 Evaluation of the project 20 - SPMS 11.00 1 30 Outreach, engagement and WP4 3 - Sciensano 59.00 1 27 sustainability WP5 Sharing data for health 24 - SEHA 109.00 1 24 WP6 Excellence in data quality 23 - IACS 89.25 1 24 WP7 Connecting the dots 23 - IACS 100.50 1 24 WP8 Citizens 9 - FR-HDH 85.50 1 24 Total 527.25 Page 6 of 47  Associated with document Ref. Ares(2021)4548885 - 13/07/2021 1.3.2. WT2 list of deliverables Due Deliverable WP Dissemination Deliverable Title Lead beneficiary Type 15 Date (in Number14 number9 level16 months)17 Confidential, only for members D1.1 Project of the consortium D1.1 WP1 1 - Sitra Report 4 Management Plan (including the Commission Services) Confidential, only for members D1.2 Risk Management of the consortium D1.2 WP1 1 - Sitra Report 4 Plan (including the Commission Services) D1.3 D1.3 Interim report WP1 1 - Sitra Report Public 15 D1.4 D1.4 Final report WP1 1 - Sitra Report Public 30 Confidential, only for members MD2.1 Dissemination of the consortium D2.1 WP2 1 - Sitra Report 4 plan (including the Commission Services) D2.2 MD2.2 Leaflet WP2 1 - Sitra Report Public 4 Websites, D2.3 MD2.3 Website WP2 1 - Sitra patents Public 3 filing, etc. MD2.4 Layman D2.4 version final technical WP2 1 - Sitra Report Public 30 report Confidential, only for members of the consortium D3.1 MD3.1 Evaluation plan WP3 20 - SPMS Report 5 (including the Commission Services) MD3.2 Interim D3.2 WP3 20 - SPMS Report Public 16 evaluation report MD3.3 Final evaluation D3.3 WP3 20 - SPMS Report Public 30 report D4.1 D4.1 Country fact sheet WP4 3 - Sciensano Report Public 24 D4.2 Policy and Project D4.2 WP4 3 - Sciensano Report Public 27 Forum Report D4.3 D4.3 Sustainability plan WP4 1 - Sitra Report Public 24 D5.1 Report on D5.1 WP5 3 - Sciensano Report Public 13 secondary use of health Page 7 of 47  Associated with document Ref. Ares(2021)4548885 - 13/07/2021 Due Deliverable WP Dissemination Deliverable Title Lead beneficiary Type15 Date (in Number14 number9 level16 months)17 data through European case studies D5.2 Guidelines/ Recommendations for European countries D5.2 WP5 24 - SEHA Report Public 22 when planning national legislation on secondary use of health data D5.3 Recommendations for best practices for EU cross-border D5.3 exchange including data WP5 9 - FR-HDH Report Public 24 access and data permit processes in different national settings D5.4 Options for D5.4 governance models for WP5 18 - VWS Report Public 19 the EHDS D6.1 EHDS data D6.1 quality assurance WP6 7 - RM Report Public 12 framework D6.2 EHDS Semantic D6.2 WP6 23 - IACS Report Public 20 interoperability framework D7.1 Options for the minimum set of D7.1 services for secondary WP7 23 - IACS Report Public 12 use of health data in the EHDS D7.2 Options for the services’ and services architecture D7.2 WP7 23 - IACS Report Public 24 and infrastructure for secondary use of data in the EHDS D8.1 Qualitative study conducted amongst key stakeholders (public, private actors, D8.1 WP8 9 - FR-HDH Report Public 24 and patient / citizen groups) to assess citizen’s perception of health data D.8.2 Report on lessons learned to be applied and D8.2 recommendations for WP8 12 - OKFŐ Report Public 24 data altruism practices in the implementation of construction of Page 8 of 47  Associated with document Ref. Ares(2021)4548885 - 13/07/2021 Due Deliverable WP Dissemination Deliverable Title Lead beneficiary Type15 Date (in Number14 number9 level16 months)17 national and European health data spaces Page 9 of 47  Associated with document Ref. Ares(2021)4548885 - 13/07/2021 1.3.3. WT3 Work package descriptions Work package number 9 WP1 Lead beneficiary 10 1 - Sitra Work package title Coordination of the project Start month 1 End month 30 Objectives The objective of the WP is the high-quality overall management of the project and the consortium. This includes establishing of the management structure, procedures, and guidelines for the operations, providing systematic monitoring of the activities, establishing reporting guidelines, providing technical and financial reporting, and delivering all necessary reports, including the Interim report and the Final report, administration of the Grant Agreement and the Consortium Agreement, and general risk and ethics assessment. The specific objectives are: O1.1 High quality project management O1.2 Timely and robust financial management and payments to beneficiaries O1.3 Proactive control of contractual obligations according to the Grant agreement and Consortium agreements O1.4 Sound internal communications between WPs and overall, according to the project management structure to keep participants informed and up to date O1.5 Close interaction with the European Commission and other EU institutions, agencies, and health policy entities Description of work and role of partners WP1 - Coordination of the project [Months: 1-30] Sitra Lead: Sitra WP1 provides the overall project coordination, project management, financial management, and risks and ethics management. This includes arranging the online and face-to-face (hybrid) meetings, conflict solving, and how information will be exchanged among participants. Project leadership: The TEHDAS Joint Action Coordinator will work in close cooperation with the project management team and WP leaders to implement this project. Task 1.1 Project coordination Lead partner: Sitra; Duration: M1-M30 WP1 leader leads the Project Steering Group and coordinates the project. Deliverables and milestones are M1.1, M1.2, and M1.4. Task 1.2 Project management Lead partner: Sitra; Duration: M1-M30 This task includes all processes listed in chapter 9. WP1 is responsible of the monitoring and overall execution of the project. Deliverables and milestones are D1.1, D1.2, and M1.3. Task 1.3 Financial management and reporting Lead partner: Sitra; Duration: M1-M30 The project has specific and clear financial management and reporting rules specified by the operating agency of the grant. WP1 is responsible on behalf of the whole project to manage the budget, report to the agency on the actual costs and manage project finances. Deliverables and milestones are D1.3, and D1.4. Task 1.4 Stakeholder cooperation and representing TEHDAS externally Lead partner: Sitra, Duration: M1-M30 Where stakeholder engagement is distributed in thematic work packages in focus groups as well as to Work Package 4 with a policy forum and project forum, the TEHDAS joint action needs bilateral engagement with target policy entities listed in Chapter 3. The most evident relationship is with the European Commission and its’ operating agency Chafea. WP1 is responsible of those relationships as well as representing TEHDAS externally. A milestone is M1.5. Page 10 of 47  Associated with document Ref. Ares(2021)4548885 - 13/07/2021 Participation per Partner Partner number and short name WP1 effort 1 - Sitra 50.00 Total 50.00 List of deliverables Due Deliverable Deliverable Title Lead beneficiary Type15 Dissemination level16 Date (in Number14 months)17 Confidential, only for members of the D1.1 Project D1.1 1 - Sitra Report consortium (including 4 Management Plan the Commission Services) Confidential, only for members of the D1.2 Risk Management D1.2 1 - Sitra Report consortium (including 4 Plan the Commission Services) D1.3 D1.3 Interim report 1 - Sitra Report Public 15 D1.4 D1.4 Final report 1 - Sitra Report Public 30 Description of deliverables D1.1 Project Management Plan (M4) D1.2 Risk Management Plan (M4) D1.3 Interim report (M15) D1.4 Final report (M30) D1.1 : D1.1 Project Management Plan [4] Project Management Plan D1.2 : D1.2 Risk Management Plan [4] Risk Management Plan D1.3 : D1.3 Interim report [15] Interim Report D1.4 : D1.4 Final report [30] Final Report Schedule of relevant Milestones Due Milestone Milestone title Lead beneficiary Date (in Means of verification number18 months) MS1 M1.1 Grant Agreement 1 - Sitra 3 MS2 M1.2 Consortium Agreement 1 - Sitra 3 MS3 M1.3 PSO Agreement 1 - Sitra 3 Page 11 of 47  Associated with document Ref. Ares(2021)4548885 - 13/07/2021 Schedule of relevant Milestones Due Milestone Milestone title Lead beneficiary Date (in Means of verification number18 months) M1.4 Progress reports to M1.4 Progress reports to MS4 1 - Sitra 5 General Assembly (M5, M15, General Assembly M27) M1.5 Stakeholder Forums MS5 M1.5 Stakeholder Forums 1 - Sitra 9 (M9, M16, M28) Page 12 of 47  Associated with document Ref. Ares(2021)4548885 - 13/07/2021 Work package number 9 WP2 Lead beneficiary 10 1 - Sitra Work package title Dissemination of the project Start month 1 End month 30 Objectives The WP creates an identity for the project and provides the key messages to communicate about the project which are recognisable and deliver the purpose and importance of the work. The WP will make the deliverables and results of the project well-known among target groups during and beyond the lifetime of the project. The project will be a relevant stakeholder in the public dialogue regarding the European Health Data Space and especially the future of the secondary use of health data in Europe. The specific objectives are: O2.1 To guarantee well-coordinated and timely communication in each stage of the Joint Action and to maximize the effective dissemination of the JA’s efforts and results. O2.2 Create an identity for the project and a shared idea of the key messages (goals & relevance) as basis of communication. O2.3 Make the deliverables and results of the project well-known among target groups during and beyond the lifetime of the project. Description of work and role of partners WP2 - Dissemination of the project [Months: 1-30] Sitra Lead: Sitra The basis of the strategic communications plan is to identify the relevant stakeholders as explained in Chapter 3, target groups and networks and to engage (and build trust) accordingly in collaboration with WP4. For the communication and dissemination activities to succeed, measurable goals for these activities will be set in the Dissemination Plan (MD2.1). Effective communications and a shared view of the possibilities of health data is based on dialogue and engagement between the JA and different stakeholders. WP2 focuses on public dissemination. WP4 focuses on stakeholder involvement at operational level to share technical, scientific and political expertise within TEHDAS between policy makers and relevant European initiatives. To measure the effectiveness and the success of the dissemination activities and the success to reach the goals set in the beginning of the work, an on-going media analysis on the topic will be conducted as well as systematic social media monitoring. Also citizen polls can be a relevant tool. A more detailed stakeholder/target group analysis will be conducted in the beginning of the Joint Action but on a general level at least following groups and channels to reach them can be identified: Organisations and specialists working for/within TEHDAS Joint Action (Teams working space, webpage of the JA, quarterly newsletter, materials distributed via email, regular summits, General Assembly & online meetings, etc.) Stakeholders generating health data, i.a. individuals as citizens and patients, healthcare providers including primary care, hospitals, healthcare professionals, research organisations, registries, biobanks, companies involved in wellbeing, health, and health technology industries (main channels through which to reach them: dissemination of related deliverables via webpage and social media, newsletter, media coverage, final report of the JA) Stakeholders utilizing health data in the secondary use case, i.a. Health professionals, consulting and management organizations, health industry (meetings, briefings, webpage, social media, newsletter, media coverage, final report of the JA) Stakeholders guarding access to and protecting data, i.a. legislators, policy makers, data permit authorities and decision makers both on national and European level (meetings, briefings, webpage, newsletter, media coverage, final report of the JA) European citizens (identifying and understanding the on-going public debate on health data both on social media channels and in traditional media, surveys, possible online-seminars etc., in close relation to the work done in WP8) The Tasks of the WP2 are: Task 2.1 Plan dissemination activities Lead partner: Sitra; Duration: M1-M30 Page 13 of 47  Associated with document Ref. Ares(2021)4548885 - 13/07/2021 Strategic communication including timing of the communication activities with external events such as legal proposals from the European Commission, EU presidency events and other important external events. TEHDAS work is very much linked to other activities which take place planned or unplanned regardless of the timeline of our activities. Both proactive and reactive communications are needed to support TEHDAS and EHDS. A deliverable is MD2.1 Task 2.2 Create and maintain website for the JA Lead partner: Sitra; Duration:M1-M30 Website is of the first point of contact for stakeholders which are not in the inner circle of TEHDAS. They must serve wide range of stakeholders and provide up-to-date and accurate information of TEHDAS and EHDS and promote them and support the overall work. Deliverables are MD2.3 and MD2.4. Task 2.3 Maintain active presence and dialogue on social media and in other relevant channels Lead partner: Sitra, Duration: M1-M30 Social media presence is not a task of a single work package or an individual such as communication manager. However, TEHDAS will have an official social media accounts in selected social media channels as well as social media strategy. This task is responsible of the social media presence and dialogue and giving guidance to other project participants on how to engage stakeholders in a dialogue related to EHDS and its targets. Deliverables and milestones are MD2.2, M2.1 and M2.2. Task 2.4 Work packages related communications Lead partner: Sitra; Duration: M1-M30 Thematic WPs have communication needs especially when a deliverable or milestone is completed. This task supports all WPs in their communication and manages possible public consultation processes on their behalf. Milestones are M2.4 and M2.5. Task 2.5 Maintain contacts and direct communication Lead partner: Sitra, Duration: M1-M30 While social media has replaced newsletters as a main communicational mechanism, newsletters and other targeted communications still serve a purpose in summarizing the progress for stakeholders which do not follow the project closely. A contact list of interested stakeholders is also needed to activate stakeholders regarding events and consultations. Milestone are M2.3 and M2.6. Task 2.6 Communication reach and tracking Lead partner: Sitra, Duration: M1-M30 Media and social media coverage are great tools to understand both generic and specialists’ discourse over EHDS. Understanding how our project is covered and how much visibility targeted communications reach will enable more efficient communication and possibility to adapt key messages if necessary. A milestone is M2.7. Participation per Partner Partner number and short name WP2 effort 1 - Sitra 23.00 Total 23.00 List of deliverables Due Deliverable Deliverable Title Lead beneficiary Type15 Dissemination level16 Date (in Number14 months)17 Confidential, only for members of the MD2.1 Dissemination D2.1 1 - Sitra Report consortium (including 4 plan the Commission Services) Page 14 of 47  Associated with document Ref. Ares(2021)4548885 - 13/07/2021 List of deliverables Due Deliverable Deliverable Title Lead beneficiary Type 15 Dissemination level 16 Date (in Number14 months)17 D2.2 MD2.2 Leaflet 1 - Sitra Report Public 4 Websites, D2.3 MD2.3 Website 1 - Sitra patents filing, Public 3 etc. MD2.4 Layman D2.4 version final technical 1 - Sitra Report Public 30 report Description of deliverables MD2.1 Dissemination plan (M4) MD2.2 Leaflet (M4) MD2.3 Website (M3) MD2.4 Layman version final technical report (M30) D2.1 : MD2.1 Dissemination plan [4] The Dissemination Plan explains how the project plans to share outcomes with stakeholders, including public authorities. This dissemination plan includes what will be disseminated, to whom, why, how, and when. D2.2 : MD2.2 Leaflet [4] A summary leaflet promoting the project D2.3 : MD2.3 Website [3] The TEHDAS website is a dedicated website, summarising the project’s objectives and progress. There can be a public part and one accessible only to the participants. D2.4 : MD2.4 Layman version final technical report [30] The Layman version is the End of project booklet for the public. It is a summary of the outcomes, main results, achievements, benefits, written for the interested public as a target group. Schedule of relevant Milestones Due Milestone Milestone title Lead beneficiary Date (in Means of verification number18 months) M2.1 Open Call for MS6 1 - Sitra 2 Stakeholders M2.2 Quarterly newsletters MS7 M2.2 Quarterly newsletters 1 - Sitra 3 (M3, M5, M8, M11, M14, M17, M20, M23) M2.3 Stakeholder M2.3 Stakeholder MS8 1 - Sitra 12 consultations (M12, M16, consultations M18) M2.4 Dissemination reports MS9 M2.4 Dissemination reports 1 - Sitra 6 (M6, M12, M15, M18, M21, M24, M27) Page 15 of 47  Associated with document Ref. Ares(2021)4548885 - 13/07/2021 Schedule of relevant Milestones Due Milestone Milestone title Lead beneficiary Date (in Means of verification number18 months) M2.5 Dissemination activity M2.5 Dissemination activity MS10 1 - Sitra 3 checks with WPs (M3, M7, checks with WPs M11, M15, M19, M23) M2.6 Stakeholder contact list MS11 M2.6 Stakeholder contact list 1 - Sitra 3 (M3, M5, M8, M11, M14, M17, M20, M23, M29) M2.7 Coverage metrics and M2.7 Coverage metrics and MS12 1 - Sitra 3 follow-up (M2, M6, M10, follow-up M14, M18, M22, M26, M30) Page 16 of 47  Associated with document Ref. Ares(2021)4548885 - 13/07/2021 Work package number 9 WP3 Lead beneficiary 10 20 - SPMS Work package title Evaluation of the project Start month 1 End month 30 Objectives Objectives The success of this JA depends on the effectiveness in accomplishing defined goals and objectives. The overall aim of WP 3 is to assess the degree to which the TEHDAS JA achieves its defined objectives and has an impact in the target groups. The objectives are: O3.1 Develop a concise and structured internal evaluation plan with a focus on the general project objectives and the specific objectives of individual WPs. The evaluation plan will comprise three distinct components in the evaluation design: process evaluation, output evaluation, outcome evaluation. It will include a clear description of the methods for evaluation, indicators and measures of verification based on the specific objectives. This will ensure the adequate framework to assess if the Joint Action is being implemented as planned and reaches its foreseen objectives. The internal evaluation plan will describe the rational and design of evaluation activities so that quality assurance of deliverables is performed by partners that are not involved in the in the specific outputs/deliverables that are being assessed/evaluated. Also, to ensure consistency of deliverables and consistency of the quality review process (see Chapter 9.3), every deliverable to the target group should undergo a common, predefined, quality review checklist (to be provided to evaluators). The quality review will be incorporated as an integral part of the JA evaluation reports. Description of work and role of partners WP3 - Evaluation of the project [Months: 1-30] SPMS Lead: SPMS Task 3.1 Develop the evaluation strategy Lead partner: SPMS, Duration: M1-M5 The evaluation strategy will describe the rationale of project´s internal evaluation plan and will be developed at the beginning of the JA, in close collaboration with WP1. The evaluation strategy focus will be in defining a robust methodology to identify indicators that provide an insight into the extent to which processes, outputs and outcomes are being realized and meet user’s needs. The evaluation plan will outline evaluation objectives, systematic methods for collecting and measure evaluation data, what will be evaluated, responsibilities and roles for the evaluation and the timeline of evaluation activities. A deliverable is MD3.1. To ensure consistent quality of deliverables this WP will support, in collaboration with WP 1, a quality assurance framework to ensure every deliverable for the target group will undergo a predefined revision before approval by the Project Steering Group. To ensure quality in legal or technical aspects, this work may engage external matter experts in the revision panel. Deliverables and milestones are MD3.2, MD3.3, M3.2 and M3.3. Task 3.2 Conduct evaluation activities Lead partner: SPMS, Duration: M5-M24 WP3 will verify and assess how the delivered inputs (i.e. deliverables) of the Action have satisfied the needs and expectations of the target group and how the JA coordination has achieved MS involvement, dissemination, and sustainability of project results. The evaluation activities will focus on the main target group but also on the performance of the WPs delivering input. WP3 will further analyse the impact of the work done by WP4-WP8 on the main priority areas defined in the JA. Evaluation methods and tools will be defined for data to be collected from WPs, WP leaders and relevant participants (as applicable) as well as from target group representatives. A milestone is M3.1. Task 3.3. Analyse evaluation data Lead partner: SPMS, Duration: M5-M30 Page 17 of 47  Associated with document Ref. Ares(2021)4548885 - 13/07/2021 WP3 will collect and analyse data and perform evaluation of the JA at regular intervals. The key deliverables will be continuously monitored, and results presented in the interim evaluation report and the final evaluation report. The interim evaluation report will give special attention to deviation from the timeline of the project plan. The final evaluation report will focus on the registry of milestones and deliverables achievement by each WP, including the quality of outputs. It will engage stakeholders in the analysis of gathered evidence to justify conclusions and ensure use of lessons learned. Participation per Partner Partner number and short name WP3 effort 20 - SPMS 11.00 Total 11.00 List of deliverables Due Deliverable Deliverable Title Lead beneficiary Type 15 Dissemination level 16 Date (in Number14 months)17 Confidential, only for members of the D3.1 MD3.1 Evaluation plan 20 - SPMS Report consortium (including 5 the Commission Services) MD3.2 Interim D3.2 20 - SPMS Report Public 16 evaluation report MD3.3 Final evaluation D3.3 20 - SPMS Report Public 30 report Description of deliverables MD3.1 Evaluation plan (M5) The Evaluation Plan will define the design and timeline of project´s evaluation activities. MD3.2 Interim evaluation report (M16) The interim evaluation report will assess the intended outcomes, outputs, and the success indicators in the mid-term. MD3.3 Final evaluation report (M30) The final evaluation report will draw on the interim evaluation report to provide the results of the evaluation, with concluding remarks to the entire JA. D3.1 : MD3.1 Evaluation plan [5] The Evaluation Plan will define the design and timeline of project´s evaluation activities, including indicators, data sources, methods, and stakeholder analysis. D3.2 : MD3.2 Interim evaluation report [16] The interim evaluation report will assess the intended outcomes, outputs, and the success indicators in the mid-term. D3.3 : MD3.3 Final evaluation report [30] The final evaluation report will draw on the interim evaluation report to provide the results of the evaluation, with concluding remarks to the entire JA. Page 18 of 47  Associated with document Ref. Ares(2021)4548885 - 13/07/2021 Schedule of relevant Milestones Due Milestone Milestone title Lead beneficiary Date (in Means of verification number18 months) M3.1 Evaluation tools and MS13 20 - SPMS 9 templates M3.2 Draft interim evaluation MS14 20 - SPMS 12 report M3.3 Draft final evaluation MS15 20 - SPMS 28 report Page 19 of 47  Associated with document Ref. Ares(2021)4548885 - 13/07/2021 Work package number 9 WP4 Lead beneficiary 10 3 - Sciensano Work package title Outreach, engagement and sustainability Start month 1 End month 27 Objectives The aim of this Work Package is, in close collaboration with all Work Packages, to outreach and engage national and international players, for TEHDAS to reflect their needs and expectations, and to explore views on its economic sustainability as well as to suggest concrete ways to integrate the results into the future EHDS. The objectives are: O4.1 Provide an overview of national health data developments which include a reflection on needs and expectations at national and international level to allow alignment of TEHDAS’ activities, O4.2 Create a solid base for regular exchange and support for current and future EHDS activities, O4.3 Explore views of the value that could be created to share secondary data across Europe and EHDS O4.4 Propose a sustainability plan with a roadmap for further EHDS implementation. Description of work and role of partners WP4 - Outreach, engagement and sustainability [Months: 1-27] Sciensano, Sitra, MZCR, OKFŐ, DHIR, IPHS "Batut", NIJZ, SEHA Lead: Sciensano Task 4.1 Mapping countries expectations through country visits Lead partner: Sciensano; Partners: MZCR, OKFŐ, DHIR, RS, NIJZ, SEHA, DoH-IE (HRB), OKFŐ (SU) Duration: M1-M24 Through (virtual) country visits, a mapping is carried out to provide an overview of national health data developments and statuses, building on the Assessment of the EU Member States’ and other participating countries’ rules on health data in the light of GDPR report. Some countries have developed national health data hubs others have indicated interest in developing one. Making use of the diversity in Europe, a selection of countries in different stages of development and different health systems will be visited. The visits will allow to reflect on needs and expectations at national level and reflect on how TEHDAS and the EHDS can respond to them. MS/AC authorities and stakeholders will be mobilised and involved in the process providing an opportunity to exchange views. It will also provide an opportunity to familiarise TEHDAS to various stakeholders in the field. A subtask will respond to national needs put forward during the mapping exercise and respond by facilitating short targeted online training courses in collaboration with identified initiatives and projects in Task 4.2, which serves the capacity building needs in countries. WP leaders will be involved by providing an overview of what MS/AC authorities can expect from TEHDAS and will be engaged by providing input on what the mapping tool should include for their WP. Deliverables and milestones D4.1 and M4.1. Task 4.2 Policy and Project Forum to integrate in national and international landscape Lead partner: Sciensano; Partners: Sitra, MZCR, DHIR, NIJZ, SEHA, SEHA (PHAS), DoH-IE (HRB). Duration: M1- M27 To be integrated in the national and international landscape, it is key to engage with national and international stakeholders and initiatives. Two different levels of interaction are needed: policy level and project level. At policy level, MS/AC national authorities and international organisations will be engaged through a Political Forum. The progress of the different WPs will be presented and potential routes for sustainable interaction will be sought. At project level, connectivity with European initiatives and projects will be sought to build TEHDAS on previous projects. In preparation, a mapping exercise will be carried out to identify relevant initiatives TEHDAS. This includes, amongst others, BRIDGE Health, the Joint Action on Health Information (InfAct) PARENT, JASEHN, eHAction, eHDSI, the Health Research and Innovation Cloud, the European Open Science Cloud and the Population Health Information Research Infrastructure, the 1+ Million Genomes initiative, ELIXIR, Global Alliance for Genomics and Health GA4GH.org. These initiatives will be invited to participate to the Project Forum to share relevant outputs, to build on previous findings and to discuss potential synergies to avoid duplication. The Fora will bring key initiatives together, build on what has been done and strive towards making outcomes interoperable. Four Policy and Project Forum will be organised back to back in close collaboration with the WP leaders. As part of Task 4.2 and building on Task 4.1, this task will explore views on the value of sharing secondary data across Page 20 of 47  Associated with document Ref. Ares(2021)4548885 - 13/07/2021 Europe, potentially through an EHDS and ideas how to distribute the value (co-)created through EHDS. One of the Policy and Project Forum will be used to discuss this topic. The views and experience of MS/AC national authorities and international projects will be collected. Deliverables and milestones D4.2 and M4.2. Task 4.3 Sustainability plan Lead partner: Sitra; Partners: Sciensano, MZCR, OKFŐ, DHIR, OKFŐ (SU); Duration: M1-M24 In close collaboration with WP leaders, this task will develop a sustainability plan which considers also economic needs in setting up the EHDS; business models of designated agencies will be discussed in WP5. The sustainability plan will be a pragmatic approach to a roadmap providing recommendations on future implementation of EHDS. It will pay timely attention to policy proposals on EU data spaces and consider their evolving implementation, if necessary, an interim version of the plan will be provided. The sustainability plan will include outputs from each of the WPs including the results from the country visits. Task 4.3 will also map early on which existing data infrastructures can be leveraged on and could be building blocks of EHDS and assess how they could potentially be linked. Deliverables and milestones D4.3 and M4.3. Participation per Partner Partner number and short name WP4 effort 1 - Sitra 8.00 3 - Sciensano 29.00 6 - MZCR 3.00 12 - OKFŐ 2.00 SU 2.00 16 - DHIR 5.00 21 - IPHS "Batut" 1.00 22 - NIJZ 5.00 24 - SEHA 2.00 PHAS 2.00 Total 59.00 List of deliverables Due Deliverable Deliverable Title Lead beneficiary Type 15 Dissemination level 16 Date (in Number14 months)17 D4.1 D4.1 Country fact sheet 3 - Sciensano Report Public 24 D4.2 Policy and Project D4.2 3 - Sciensano Report Public 27 Forum Report D4.3 D4.3 Sustainability plan 1 - Sitra Report Public 24 Description of deliverables D4.1 Country fact sheet (M24) A fact sheet from each country visit will be provided providing an overview of the mapping exercise. D4.2 Policy and Project Forum Report (M27) The Policy and Project Forum Report provides the minutes and conclusions of the meetings. D4.3 Sustainability plan (M24) Page 21 of 47  Associated with document Ref. Ares(2021)4548885 - 13/07/2021 The sustainability plan will provide a pragmatic approach to a roadmap providing recommendations on future implementation of EHDS. It will provide the outputs of the different WPs and recommendations on how they can be taken up at national and international level. D4.1 : D4.1 Country fact sheet [24] A fact sheet from each country visit will be provided providing an overview of the mapping exercise. D4.2 : D4.2 Policy and Project Forum Report [27] The Policy and Project Forum Report provides the minutes and conclusions of the meetings. D4.3 : D4.3 Sustainability plan [24] The sustainability plan will provide a pragmatic approach to a roadmap providing recommendations on future implementation of EHDS. It will provide the outputs of the different WPs and recommendations on how they can be taken up at national and international level. Schedule of relevant Milestones Due Milestone Milestone title Lead beneficiary Date (in Means of verification number18 months) In close collaboration with all WPs leaders a template will be developed for the country visit mapping tool. It will provide the key topics M4.1 Template of mapping that will be mapped through MS16 tool and Expressions of 3 - Sciensano 6 the exercise and describe Interest the process for the country visits. A call for expression of interest will be launched to select countries for the mapping exercise based on the TEHDAS consortium. M4.2 Policy and Project M4.2 Policy and Project MS17 3 - Sciensano 4 Forum Forum (M4, M9, M16, M26) M4.3 Mapping of the existing MS18 1 - Sitra 8 infrastructures to build on Page 22 of 47  Associated with document Ref. Ares(2021)4548885 - 13/07/2021 Work package number 9 WP5 Lead beneficiary 10 24 - SEHA Work package title Sharing data for health Start month 1 End month 24 Objectives Overall objective is: Setting options for the operational framework and governance models for the exchange and secondary use of health data between European countries, respecting the principles of transparency, trust, FAIRness*, citizen empowerment and common good. Specific objectives are: O5.1 Define and develop the evidence base for the secondary use of health data in EHDS, user perspectives O5.2 Enable cross-border exchange and secondary use of health data through guidelines/recommendations for European countries when planning national legislation. O5.3 Create guidelines for an organizational framework for cross-border exchange of personal health data based on a single point of access model connecting centralized as well as decentralized systems in the EHDS and support national capacity building. O5.4 Develop options for governance models for the EHDS and support national capacity building. Description of work and role of partners WP5 - Sharing data for health [Months: 1-24] SEHA, Sitra, ATNA, Sciensano, CHIF, MZCR, RM, FR-HDH, 6th Y. PE., OKFŐ, MINSAL, SAM-LT, DHIR, VWS, MoH-NO, SPMS, IPHS "Batut", NIJZ, IACS , NHSC SEHA (Lead), VWS (Co-lead) Task 5.1 Define and develop the evidence base for the secondary use of health data in EHDS, user perspectives Task lead: Sciensano; Partners: MZCR, 6YPE, SAM-LT, MoH-NO (FHI), SPMS, IPHS “Batut”, NIJZ, IACS, SEHA, NHSC, DoH-IE (HRB), MoSA, NHSC (WSI), ATRM, MoH-CY; Duration: M1-M13 Task 5.1 aims to define and develop the evidence for secondary use of health data by identifying data sharing practices across Europe, to provide information to the European Health Data Space and the European Commission’s legislative proposals. Task 5.2 Enabling the secondary use of data by aligning the interpretation of GDPR Task lead: SEHA; Partners: CHIF, MZCR, RM, OKFŐ, MINSAL, SAM-LT, DHIR, VWS, NIJZ, DoH-IE (HRB), CHIF (CHIP), ATRM, MoSA, MoH-CY, OKFŐ (SU); Duration: M1-M22 This task initiates partially from the analysis of use cases in Task 5.1. to provide a multi-national and eventually Pan- European health data access permitters'/providers' perspective on the interpretation of GDPR in relation to secondary use (including cross-border data exchange). It provides permitters' and providers' perspective, and legal interoperability. Task 5.3 Best practises for EU-cross border sharing of personal health data Task lead: FR-HDH; Partners: Sitra (THL/Findata), VWS, IACS, FR-HDH (Inserm), FR-HDH (UT3); Duration: M1- M24 In order to identify best practices for EU-cross border sharing of personal health data (permitters' perspective and organisational interoperability), the four participating countries in this task offer a variety of solutions suitable for differing situations and the necessary level of maturity to be considered as a good practice. The subtasks will focus on the description of steps in accessing individual-level data for national and EU researchers in a selection of centralised (FIN, FR) and decentralised systems (NL, ES) and the establishment of a framework of a bi- or multilateral partnership agreement between structures responsible for the secondary use of health data. Task 5.4 Developing options for governance models for the EHDS Task lead: VWS; Partners: Sitra, ATNA, Sciensano, CHIF, RM, OKFŐ, MINSAL, MoH-NO, SPMS, IACS, SEHA, NHSC, CHIF (CHIP), RM (CDEU), BMG, NHSC (WSI), OKFŐ (SU); Duration: M1-M19 This task will provide a synthesis of the other tasks of WP5, resulting in preliminary elements for governance models at the end of the first iterative cycle. Page 23 of 47  Associated with document Ref. Ares(2021)4548885 - 13/07/2021 Participation per Partner Partner number and short name WP5 effort 1 - Sitra 1.00 THL 3.00 2 - ATNA 2.00 3 - Sciensano 8.00 4 - CHIF 1.20 CIPH 1.80 6 - MZCR 4.00 7 - RM 3.00 CDEU 1.00 9 - FR-HDH 4.75 UT3 2.00 Inserm 4.00 ANS 0.25 11 - 6th Y. PE. 2.00 12 - OKFŐ 2.00 SU 3.00 14 - MINSAL 3.00 15 - SAM-LT 4.00 16 - DHIR 2.00 18 - VWS 15.00 19 - MoH-NO 1.00 FHI 2.00 20 - SPMS 6.00 21 - IPHS "Batut" 1.00 22 - NIJZ 4.00 23 - IACS 8.00 24 - SEHA 16.00 25 - NHSC 3.00 WSI 1.00 Total 109.00 Page 24 of 47  Associated with document Ref. Ares(2021)4548885 - 13/07/2021 List of deliverables Due Deliverable Deliverable Title Lead beneficiary Type 15 Dissemination level 16 Date (in Number14 months)17 D5.1 Report on secondary use of health D5.1 3 - Sciensano Report Public 13 data through European case studies D5.2 Guidelines/ Recommendations for European countries D5.2 24 - SEHA Report Public 22 when planning national legislation on secondary use of health data D5.3 Recommendations for best practices for EU cross-border exchange D5.3 9 - FR-HDH Report Public 24 including data access and data permit processes in different national settings D5.4 Options for D5.4 governance models for 18 - VWS Report Public 19 the EHDS Description of deliverables D5.1 Report on secondary use of health data through European case studies (M13) This deliverable will present best practices identified in European case studies on the secondary use of data to inform the European Health Data Space. This document will summarise on a multinational level the conclusions the respective user categories included (scientific researcher and innovator, and policymaker respectively). The document will also consolidate the analysis results of the literature review, use cases and stakeholder consultation. The use cases will be presented in an annex to the document. Task 5.1 aims to define and develop the evidence for secondary use of health data by identifying data sharing practices across Europe, to provide information to the European Health Data Space and the European Commission’s legislative proposals. D5.2 Guidelines/Recommendations for European countries when planning national legislation on secondary use of health data (M22) This deliverable is a document presenting basic guidelines/recommendations intended to facilitate the planning (and implementation) of national legislation on secondary use of health data. These guidelines/recommendations are in turn based on a documented summary on a multinational level of the experiences and conclusions of pioneering European countries that already have a national legislation of this kind, in combination with the needs of other European countries in this respect. D5.3 Recommendations for best practices for EU cross-border exchange including data access and data permit processes in different national settings (M24) In order to identify best practises for EU-cross border sharing of personal health data this deliverable will focus on the description of steps in accessing individual-level data for national and EU researchers in a selection of centralized and decentralized systems and the establishment of a framework of a partnership agreement between structures responsible for the secondary use of health data. On this basis, use cases for cross-border collaborations for the secondary use of health data in centralized and decentralized systems will be identified. Recommendations for best practices for EU cross-border exchange including data access / data permit processes in different national settings will be elaborated and tested in an EU-wide workshop D5.4 Options for governance models for the EHDS (M19) Page 25 of 47  Associated with document Ref. Ares(2021)4548885 - 13/07/2021 This deliverable is a document presenting well-established options for governance models for the EHDS, taking into consideration a Pan-European perspective in combination with the best interest of the concerned stakeholders in general and the citizen. D5.1 : D5.1 Report on secondary use of health data through European case studies [13] This deliverable will present best practices identified in European case studies on the secondary use of data to inform the European Health Data Space. This document will summarise on a multinational level the conclusions the respective user categories included (scientific researcher and innovator, and policymaker respectively). The document will also consolidate the analysis results of the literature review, use cases and stakeholder consultation. The use cases will be presented in an annex to the document. D5.2 : D5.2 Guidelines/Recommendations for European countries when planning national legislation on secondary use of health data [22] This deliverable is a document presenting basic guidelines/recommendations intended to facilitate the planning (and implementation) of national legislation on secondary use of health data. These guidelines/recommendations are in turn based on a documented summary on a multinational level of the experiences and conclusions of pioneering European countries that already have a national legislation of this kind, in combination with the needs of other European countries in this respect. D5.3 : D5.3 Recommendations for best practices for EU cross-border exchange including data access and data permit processes in different national settings [24] In order to identify best practises for EU-cross border sharing of personal health data this deliverable will focus on the description of steps in accessing individual-level data for national and EU researchers in a selection of centralized and decentralized systems and the establishment of a framework of a partnership agreement between structures responsible for the secondary use of health data. On this basis, use cases for cross-border collaborations for the secondary use of health data in centralized and decentralized systems will be identified. Recommendations for best practices for EU cross-border exchange including data access / data permit processes in different national settings will be elaborated and tested in an EU-wide workshop. D5.4 : D5.4 Options for governance models for the EHDS [19] This deliverable is a document presenting well-established options for governance models for the EHDS, taking into consideration a Pan-European perspective in combination with the best interest of the concerned stakeholders in general and the citizen. Schedule of relevant Milestones Due Milestone Milestone title Lead beneficiary Date (in Means of verification number18 months) Identify and develop the use cases to represent the diversity of research user groups across Europe. The data collection will include and compile information M5.1 Use cases: Scientific regarding user purposes, MS19 3 - Sciensano 4 research and innovation requirements, type of data through an analysis of use cases, previous relevant studies, and stakeholder consultation. This milestone considers analysis of data on a spectrum of identifiability. Identify and develop the M5.2 Use cases: use cases to represent the MS20 Policymaking for public 3 - Sciensano 5 diversity of policy makers health purposes across Europe. The data Page 26 of 47  Associated with document Ref. Ares(2021)4548885 - 13/07/2021 Schedule of relevant Milestones Due Milestone Milestone title Lead beneficiary Date (in Means of verification number18 months) collection will include and compile information regarding purposes, requirements, type of data through an analysis of relevant case studies, previous relevant studies, and stakeholder consultation. This milestone considers analysis of data on a spectrum of identifiability. Data collection concluded and M5.3 GDPR interpretations compiled regarding health in the secondary use of health data access permitters and MS21 data in different member 9 - FR-HDH 6 providers in the different states and other participating MS regarding GDPR countries interpretations based on the use cases above. M5.4 Description of steps in accessing individual-level data for national and EU MS22 9 - FR-HDH 12 researchers in a selection of centralized systems and decentralized systems M5.5 Guideline document for a peer-to- peer and cross- MS23 9 - FR-HDH 12 border partnership for the secondary use of health data M5.6 Compilation of best practices for EU cross- border exchange including MS24 9 - FR-HDH 24 data access and data permit processes in different national settings M5.7 Analysis of health MS25 specific governance aspects 18 - VWS 5 for an EHDS M5.8 Analysis of the capacity of existing EU structures and options on how the MS26 governance aspects defined in 18 - VWS 7 M5.7 can be made within the current structures or with new structures Page 27 of 47  Associated with document Ref. Ares(2021)4548885 - 13/07/2021 Work package number 9 WP6 Lead beneficiary 10 23 - IACS Work package title Excellence in data quality Start month 1 End month 24 Objectives WP6 will be providing solutions for the trustworthy secondary use of health and health care data with a view to fostering the digital transformation of the European health systems. This overarching objective will be developed throughout two operational objectives: O6.1 Developing the EHDS data quality assurance framework for a secondary use of real-world health data. O6.2 Developing the EHDS Semantic Interoperability framework From the perspective of information users and data producers, data are deemed of quality if data faithfully depict the real-world construct that it aims at representing. For the TEHDAS JA, the real-world construct has to do with the digital transformation of the health systems in Europe, that must rely on the secondary use of massive data; thus, data routinely collected by multiple data holders and controllers in multiple sites throughout the European Union. The secondary use of health data, beyond the legal, governance and ethical questions, has as the main challenge to ensure that data collected and stored for different purposes is accurate to provide high-quality real-world evidence and by this means, inform national and European decision- making processes in a trustworthy and timely manner. In addition, the increasing use of sophisticated methodologies (for example, development of pragmatic trials, the use predictive machine learning or exploratory artificial intelligence approaches) creates also new demands on data quality. In that sense, the secondary use of real-world data (RWD) requires a quality assurance framework, but also guidance on what methods and techniques has been proved reliable to ensure the production of accurate evidence; thus, it will be needed to explore what methods and techniques allow the mitigation of data incompleteness and missingness, how to achieve semantic interoperability, how to reach over time data consistency, or conduct unbiased analyses. Notably, excellence in the secondary use of real-world data should fit-for-purpose; so, data quality must be responsive to the needs of the different information users. So, policy makers (e.g., in their role of planning and financing), regulators (e.g., in their legislative role), health technology assessment agencies (e.g., as regulators for the approval of high-value technologies), insurers (e.g., in the role of services purchasers), providers (e.g., pursuing the delivery of high-quality services), patients (e.g., as beneficiaries of the health system), citizens (e.g., as active agents for health promotion), the health industry in Europe (e.g., in their role of producers of high-value goods and services) and researchers (e.g., in their role of producers of real-world evidence). WP6 developments will have to be consistent with the architectural design in WP7 (i.e.., a peer-to-peer federated infrastructure whose nodes are of a different nature (member states, other participating countries, cross-national institutions, research infrastructures) and with the need of translating the data quality framework into a legal proposal. Description of work and role of partners WP6 - Excellence in data quality [Months: 1-24] IACS , Sitra, ATNA, Sciensano, MZCR, RM, FR-HDH, OKFŐ, MINSAL, VWS, MoH-NO, SPMS, SEHA WP6 IACS (Lead), RM (Co-lead) T6.1 Develop the EHDS Data quality assurance framework (DQAF) Task leader: RM, Partners: Sitra (THL), ATNA, Sciensano, FR-HDH, OKFŐ, MINSAL, SPMS, IACS, RM (CDEU), FR-HDH (Inserm), FR-HDH (AMU), DoH-IE (HRB), OKFŐ (SU); MoH-NO (Hdir) Duration: M1-M24 Subtask 6.1.1: Assessment of DQAF good practices. Partners involved: RM, Sitra (THL), ATNA, Sciensano, FR-HDH, OKFŐ, MINSAL, SPMS, IACS, RM (CDEU), FR- HDH (Inserm), FR-HDH (AMU), DoH-IE (HRB), OKFŐ (SU). Subtask 6.1.2 Assessment of existing European legislation. Partners involved: RM, Sitra (THL), ATNA, Sciensano, FR-HDH, OKFŐ, MINSAL, SPMS, IACS, RM (CDEU), FR- HDH (Inserm), FR-HDH (AMU), DoH-IE (HRB), OKFŐ (SU). T6.2 Develop the EHDS Semantic Interoperability Framework Page 28 of 47  Associated with document Ref. Ares(2021)4548885 - 13/07/2021 Task leader: IACS, Partners: Sitra (THL), ATNA, RM, FR-HDH, OKFŐ, MINSAL, MoH-NO (E-helse), SPMS, SEHA, FR-HDH (Inserm), FR-HDH (HCL), FR-HDH (ANS), BMG (Gematik), VWS(Nictiz), OKFŐ (SU), MZCR, E-helse- NO; Duration: M3-M20 Subtask 6.2.1: Assessment of existing Common Data Models for P2P federated infrastructures. Partners involved: IACS, Sitra (THL), ATNA, RM, FR-HDH, OKFŐ, MINSAL, MoH-NO (E-helse), SPMS, SEHA, FR-HDH (Inserm), FR-HDH (HCL), FR-HDH (ANS), BMG (Gematik), VWS(Nictiz), OKFŐ (SU), Subtask 6.2.2: Development of a EHDS semantic interoperability framework. Partners involved: IACS, Sitra (THL), ATNA, RM, FR-HDH, OKFŐ, MINSAL, VWS(Nictiz), MoH-NO (E-helse), SPMS, SEHA, FR-HDH (Inserm), FR-HDH (HCL), FR-HDH (ANS), BMG (Gematik), VWS(Nictiz), OKFŐ (SU), MZCR Participation per Partner Partner number and short name WP6 effort 1 - Sitra 0.00 THL 7.00 2 - ATNA 2.00 3 - Sciensano 2.00 6 - MZCR 1.00 7 - RM 12.00 CDEU 1.00 9 - FR-HDH 1.75 AMU 3.00 Inserm 4.00 HCL 1.50 ANS 0.25 12 - OKFŐ 2.00 SU 2.00 14 - MINSAL 4.00 18 - VWS 0.00 Nictiz 2.00 19 - MoH-NO 0.00 E-helse 2.00 Hdir 2.00 20 - SPMS 7.00 23 - IACS 30.75 24 - SEHA 2.00 Total 89.25 Page 29 of 47  Associated with document Ref. Ares(2021)4548885 - 13/07/2021 List of deliverables Due Deliverable Deliverable Title Lead beneficiary Type 15 Dissemination level 16 Date (in Number14 months)17 D6.1 EHDS data quality D6.1 7 - RM Report Public 12 assurance framework D6.2 EHDS Semantic D6.2 23 - IACS Report Public 20 interoperability framework Description of deliverables D6.1 EHDS data quality assurance framework (M12, M24). The deliverable will contain two types of contents: 1) the requisites for the inclusion of data in the EHDS, including semantic interoperability; among those, the document will identify those features that could be legally bound; and, 2) guidance on how to get data included in the EHDS, including requisites for data interoperability (i.e., data model and encoding systems) and recommendations for data quality governance. In Month 24, D6.1 will be upgraded with the EHDS sematic interoperability framework delivered in Month 20. D6.2 EHDS Semantic interoperability framework (M20) The deliverable will propose a semantic interoperability framework for the EHDS including the common data model for the EHDS. (NB T6.2 links with WP5 as the semantic interoperability framework is a key feature of the governance of a federated infrastructure. Its deliverable should also link with WP7 as the CDM is the underlying layer supporting part of the services envisaged). D6.1 : D6.1 EHDS data quality assurance framework [12] The deliverable will contain two types of contents: 1) the requisites for the inclusion of data in the EHDS, including semantic interoperability; among those, the document will identify those features that could be legally bound; and, 2) guidance on how to get data included in the EHDS, including requisites for data interoperability (i.e., data model and encoding systems) and recommendations for data quality governance. In Month 24, D6.1 will be upgraded with the EHDS sematic interoperability framework delivered in Month 20. D6.2 : D6.2 EHDS Semantic interoperability framework [20] The deliverable will propose a semantic interoperability framework for the EHDS including the common data model for the EHDS. (NB T6.2 links with WP5 as the semantic interoperability framework is a key feature of the governance of a federated infrastructure. Its deliverable should also link with WP7 as the CDM is the underlying layer supporting part of the services envisaged). Schedule of relevant Milestones Due Milestone Milestone title Lead beneficiary Date (in Means of verification number18 months) M6.1 Identification of those features that could be legally MS27 7 - RM 9 bound and provide advice to the European Commission M6.2 Identification of relevant encoding standards MS28 23 - IACS 12 and data models for semantic harmonization Page 30 of 47  Associated with document Ref. Ares(2021)4548885 - 13/07/2021 Work package number 9 WP7 Lead beneficiary 10 23 - IACS Work package title Connecting the dots Start month 1 End month 24 Objectives This work package will detail the technical options to provide an effective secondary use of health data through the EHDS. In this way, these solutions represent the technical interoperability elements of the EHDS, according to the European Interoperability Framework. The key concept for the envisaged EHDS is a federated peer-to-peer system, that interconnect node of different typologies (data permit authorities, European level health data providers, research infrastructures, data altruism bodies etc.). The EHDS nodes will operate regularly in an independent manner, providing services to their users, but as part of the federation they will be connected. The interconnection will be implemented through a series of specific EHDS services deployed on to provide federation-wide features, such as: announcement, authentication, data discovery, data retrieval, data analytics, etc. Work package deliverables will consist of the catalogue of required and advanced services to be implemented in the nodes aiming to join the EHDS and the options for the architecture and the infrastructure elements required for an effective deployment of the services. WP objectives are: O7.1 Study existing initiatives on secondary use of health data focusing on the requirements for their deployment O7.2 Foster the participation of future users of the EHDS and EHDS implementers on MSs, institutions or industry, to participate in the co-design of the services for secondary use of health data as well to provide architecture and infrastructure options. O7.3 Define the options for the EHDS services for secondary use of health data O7.4 Detail the architecture and infrastructure options of the EHDS services for secondary use of health data, fully compliant with legal frameworks and with total guarantee of privacy and security. Description of work and role of partners WP7 - Connecting the dots [Months: 1-24] IACS , Sitra, ATNA, Sciensano, MZCR, RM, FR-HDH, OKFŐ, MINSAL, SPMS, SEHA Lead: IACS Task 7.1 Technical and operational expertise of existing initiatives of data sharing and secondary use of health and biomedical data Task lead: Sitra (CSC) Partners: ATNA, SPMS, IACS, FR-HDH. Duration: M1-M10. Inquire and gather existing knowledge on public and/or private initiatives on data sharing and the secondary use of health and biomedical data. Task 7.2 WP7 Permanent Advisory Group Task lead: Sitra (VTT), Partners: MINSAL, SPMS, IACS, SEHA, DoH-IE (HRB), SEHA (NBHW), FR-HDH. Duration: M01-M24. Task 7.3 Definition of services for secondary use of data within the EHDS Task lead: IACS. Partners: Sitra (CSC), Sciensano, MZCR, FR-HDH, OKFŐ, MINSAL, OKFŐ (SU) Duration: M01- M18. Description of the services to be implemented in the federated nodes that will support the secondary use of health data within the EHDS, in an incremental manner. Task 7.4 Options for EHDS architecture and infrastructure of the EHDS services’ deployment Task lead: IACS. Partners: Sitra (VTT), ATNA, Sciensano, RM, OKFŐ, BMG (FDZ), RM (CDEU), OKFŐ (SU), FR- HDH. Duration: M09-M24. To provide specific options for the architecture and the infrastructure that will support the deployment of the EHDS services among participating nodes. Participation per Partner Page 31 of 47  Associated with document Ref. Ares(2021)4548885 - 13/07/2021 Partner number and short name WP7 effort 1 - Sitra 0.00 VTT 10.00 CSC 9.00 2 - ATNA 3.00 3 - Sciensano 5.00 6 - MZCR 2.00 7 - RM 2.00 CDEU 1.00 9 - FR-HDH 4.00 12 - OKFŐ 3.00 SU 2.00 14 - MINSAL 3.00 20 - SPMS 8.00 23 - IACS 45.50 24 - SEHA 1.00 NBHW 2.00 Total 100.50 List of deliverables Due Deliverable Deliverable Title Lead beneficiary Type15 Dissemination level16 Date (in Number14 months)17 D7.1 Options for the minimum set of services D7.1 23 - IACS Report Public 12 for secondary use of health data in the EHDS D7.2 Options for the services’ and services architecture D7.2 23 - IACS Report Public 24 and infrastructure for secondary use of data in the EHDS Description of deliverables D7.1 Options for the minimum set of services for secondary use of health data in the EHDS (M12) Document containing the API of services options required to be deployed in MS or other institutions wanting to join the EHDS federation for the basic operation of the EHDS. D7.2 Options for the services’ and services architecture and infrastructure for secondary use of data in the EHDS. (M24) Document containing the API of the service options for basic and advanced EHDS operation, as well as the options for the architecture and infrastructure that will sustain the actual deployment of the services in MS or other institutions wanting to join the EHDS. Page 32 of 47  Associated with document Ref. Ares(2021)4548885 - 13/07/2021 D7.1 : D7.1 Options for the minimum set of services for secondary use of health data in the EHDS [12] Document containing the API of services options required to be deployed in MS or other institutions wanting to join the EHDS federation for the basic operation of the EHDS. D7.2 : D7.2 Options for the services’ and services architecture and infrastructure for secondary use of data in the EHDS [24] Document containing the API of the service options for basic and advanced EHDS operation, as well as the options for the architecture and infrastructure that will sustain the actual deployment of the services in MS or other institutions wanting to join the EHDS. Schedule of relevant Milestones Due Milestone Milestone title Lead beneficiary Date (in Means of verification number18 months) M7.1 Technical and operational analysis report of existing data sharing and/ MS29 1 - Sitra 8 Task Lead: Sitra (CSC) or secondary use initiatives in health and biomedical sciences. M7.2 Report on EHDS MS30 1 - Sitra 9 Task Lead: Sitra (VTT) services users’ expectations. M7.3 Report on EHDS architecture and infrastructure MS31 1 - Sitra 16 Task Lead: Sitra (VTT) implementers’ expectations / experiences. M7.4 Validation report on the proposed services and MS32 1 - Sitra 22 Task lead: Sitra (VTT) architecture and infrastructure solutions. M7.5 Catalogue of the EHDS MS33 services for secondary use of 23 - IACS 10 health data. M7.6 Report on architecture and infrastructure options to MS34 23 - IACS 22 support EHDS services for secondary use of data. Page 33 of 47  Associated with document Ref. Ares(2021)4548885 - 13/07/2021 Work package number 9 WP8 Lead beneficiary 10 9 - FR-HDH Work package title Citizens Start month 1 End month 24 Objectives WP8 will provide evidence for decision-makers and healthcare professionals in the European Union so that they can more effectively promote the secondary use of health data and the acceptance thereof by citizens. Health data may indeed contribute to health promotion, disease prevention, fostering healthy lifestyles and development of innovative, efficient and sustainable health systems – as well as protecting EU citizens from serious cross-border health threats and facilitating access to high quality, safe healthcare for EU citizens. WP8 will do so by identifying citizen perceptions and attitudes on health data, ways of engaging citizens around their health data, defining data altruism practices in the EU, as well as identifying key features, conditions and determinants of integrating health related data captured and shared by individuals and data altruist organizations, in close alignment with the Data Governance Act. In order to achieve this goal, WP8 has the following specific objectives: O8.1 Obtain a better understanding of citizens' perception towards the sharing of their health data in a European perspective. O8.2 Improved citizen capacity to engage with data and improve citizen trust in data sharing: identify ways to better inform citizens better about the use of their health data including data portability and raise awareness, sensitize around innovation, and promote the role of citizens as actors of innovation. The design and implementation of this objective will be underpinned by equality and diversity principles. O8.3 Better understand tools of change management to empower citizens and enable them to become actors of health data. O8.4 Improve policymaking and facilitate decisions on which data generated and held by citizens can be used, how and by whom for the public good and interest (scientific research, public health, sustainable healthcare systems) purposes in a manner compliant with GDPR. O8.5 Strengthen the health data governance mechanisms at the EU level and in the Member States and other participating countries relevant for cross-sector data use and for data use in the common sectoral data spaces, by involving citizens, in line with the FAIR principles considering the developments and decisions of other health sector-specific stakeholders, authorities, agencies and care providers or researchers, as well as the input from other TEHDAS work packages (5,6 and 7). Description of work and role of partners WP8 - Citizens [Months: 1-24] FR-HDH, Sitra, Sciensano, CHIF, MZCR, OKFŐ, MoH-NO, NHSC Leads: FR-HDH, OKFŐ Task 8.1 Preparatory phase of online consultation in three pilot countries Task leader: FR-HDH, Partners: Sciensano, NHSC, FR-HDH (UT3), NHSC (WSI); Duration: M1-M10 Preparatory phase of online consultation in three pilot countries, including a pan-European qualitative assessment with literature review and interviews on stakeholders’ and citizens’ perceptions of health data. Task 8.2 Conduct online consultation to collect citizens’ perceptions Task leader: Sciensano; Partners: FR-HDH, FR-HDH (UT3), NHSC, NHSC (WSI) Duration: M1-M17 Conduct online consultation to collect citizens’ perceptions on a set of health-data related affirmations and questionnaires to be integrated with pedagogical material. Task 8.3 Develop recommendations for the EHDS to ensure citizen sensitization and engagement with health data Lead: FR-HDH, Partners: Sciensano, NHSC, NHSC (WSI), FR-HDH (UT3) Duration: M18 - M24 Conduct 1 workshop/ focus groups per country to discuss results and develop recommendations. T8.4 Overview of national data altruism definitions and systems Task leader: OKFŐ, Partners: Sitra, CHIF, MZCR, MoH-NO (Hdir), CHIF (CHIP), OKFŐ (SU); Duration M1-M7 Task 8.5 Recommend ways to foster GDPR-compliant data altruism mechanisms for the EHDS Page 34 of 47  Associated with document Ref. Ares(2021)4548885 - 13/07/2021 Task leader: OKFŐ; Partners: Sitra, CHIF, NHSC, NHSC (WSI), CHIF (CHIP), OKFŐ (SU), MoH-NO; Duration M8- M24 Participation per Partner Partner number and short name WP8 effort 1 - Sitra 5.00 3 - Sciensano 17.50 4 - CHIF 2.80 CIPH 1.20 6 - MZCR 1.00 9 - FR-HDH 17.00 UT3 2.00 12 - OKFŐ 13.00 SU 10.00 19 - MoH-NO 0.00 Hdir 2.00 25 - NHSC 12.00 WSI 2.00 Total 85.50 List of deliverables Due Deliverable Deliverable Title Lead beneficiary Type15 Dissemination level16 Date (in Number14 months)17 D8.1 Qualitative study conducted amongst key stakeholders (public, D8.1 private actors, and 9 - FR-HDH Report Public 24 patient / citizen groups) to assess citizen’s perception of health data D.8.2 Report on lessons learned to be applied and recommendations for data altruism practices D8.2 12 - OKFŐ Report Public 24 in the implementation of construction of national and European health data spaces Description of deliverables D8.1 Qualitative study conducted amongst key stakeholders (public, private actors, and patient / citizen groups) to assess citizen’s perception of health data (M24) Page 35 of 47  Associated with document Ref. Ares(2021)4548885 - 13/07/2021 D.8.2 Report on lessons learned to be applied and recommendations for data altruism practices in the implementation of construction of national and European health data spaces (M24) D8.1 : D8.1 Qualitative study conducted amongst key stakeholders (public, private actors, and patient / citizen groups) to assess citizen’s perception of health data [24] Qualitative study conducted amongst key stakeholders (public, private actors, and patient / citizen groups) to assess citizen’s perception of health data D8.2 : D.8.2 Report on lessons learned to be applied and recommendations for data altruism practices in the implementation of construction of national and European health data spaces [24] Report on lessons learned to be applied and recommendations for data altruism practices in the implementation of construction of national and European health data spaces Schedule of relevant Milestones Due Milestone Milestone title Lead beneficiary Date (in Means of verification number18 months) M8.1 Literature review of citizen’s perception of and MS35 9 - FR-HDH 10 engagement with health data in M8.2 Publication of results from comparative overview of citizen’s perception of MS36 3 - Sciensano 17 and engagement with health data in selected countries: Belgium, France, UK M8.3 Publication of recommendations the European Health Data Space MS37 9 - FR-HDH 24 to ensure citizen sensitization and engagement with health data M8.4 Presentation of a first set (catalogue) of data M8.4 Presentation of a altruism definitions, use first set (catalogue) of data cases and findings about MS38 altruism definitions, use cases 12 - OKFŐ 7 consent and accessibility and findings about consent issues (means of verification: and accessibility issues catalogue approved by stakeholders;) M8.5 Publication of an overview (prepared to launch a communication campaign) about the results of EU- M8.5 Publication of an wide multi stakeholder overview about the results of workshops, with a special MS39 EU-wide multi stakeholder 12 - OKFŐ 15 regard to updated definitions, workshops about data needs, solutions, experiences, altruism and good practices of data altruism (altruism structures and functions) for the future EHDS (means of verification: Page 36 of 47  Associated with document Ref. Ares(2021)4548885 - 13/07/2021 Schedule of relevant Milestones Due Milestone Milestone title Lead beneficiary Date (in Means of verification number18 months) published in TEHDAS webpage;) M8.6 Recommendations to M8.6 Recommendations to foster GDPR-compliant data foster GDPR-compliant data MS40 12 - OKFŐ 16 altruism mechanisms for the altruism mechanisms for the EHDS (means of verification: EHDS report;) Page 37 of 47  Associated with document Ref. Ares(2021)4548885 - 13/07/2021 1.3.4. WT4 List of milestones Due Milestone WP Milestone title Lead beneficiary Date (in Means of verification number18 number9 months)17 MS1 M1.1 Grant Agreement WP1 1 - Sitra 3 M1.2 Consortium MS2 WP1 1 - Sitra 3 Agreement MS3 M1.3 PSO Agreement WP1 1 - Sitra 3 M1.4 Progress reports to M1.4 Progress reports MS4 WP1 1 - Sitra 5 General Assembly (M5, M15, to General Assembly M27) M1.5 Stakeholder M1.5 Stakeholder Forums MS5 WP1 1 - Sitra 9 Forums (M9, M16, M28) M2.1 Open Call for MS6 WP2 1 - Sitra 2 Stakeholders M2.2 Quarterly newsletters M2.2 Quarterly MS7 WP2 1 - Sitra 3 (M3, M5, M8, M11, M14, newsletters M17, M20, M23) M2.3 Stakeholder M2.3 Stakeholder MS8 WP2 1 - Sitra 12 consultations (M12, M16, consultations M18) M2.4 Dissemination reports M2.4 Dissemination MS9 WP2 1 - Sitra 6 (M6, M12, M15, M18, M21, reports M24, M27) M2.5 Dissemination M2.5 Dissemination activity MS10 activity checks with WP2 1 - Sitra 3 checks with WPs (M3, M7, WPs M11, M15, M19, M23) M2.6 Stakeholder contact list M2.6 Stakeholder MS11 WP2 1 - Sitra 3 (M3, M5, M8, M11, M14, contact list M17, M20, M23, M29) M2.7 Coverage metrics and M2.7 Coverage metrics MS12 WP2 1 - Sitra 3 follow-up (M2, M6, M10, and follow-up M14, M18, M22, M26, M30) M3.1 Evaluation tools MS13 WP3 20 - SPMS 9 and templates M3.2 Draft interim MS14 WP3 20 - SPMS 12 evaluation report M3.3 Draft final MS15 WP3 20 - SPMS 28 evaluation report In close collaboration with all WPs leaders a template will be developed for the M4.1 Template of country visit mapping tool. MS16 mapping tool and WP4 3 - Sciensano 6 It will provide the key topics Expressions of Interest that will be mapped through the exercise and describe the process for the country visits. A call for expression Page 38 of 47  Associated with document Ref. Ares(2021)4548885 - 13/07/2021 Due Milestone WP Milestone title Lead beneficiary Date (in Means of verification number18 number9 months)17 of interest will be launched to select countries for the mapping exercise based on the TEHDAS consortium. M4.2 Policy and M4.2 Policy and Project MS17 WP4 3 - Sciensano 4 Project Forum Forum (M4, M9, M16, M26) M4.3 Mapping of the MS18 existing infrastructures WP4 1 - Sitra 8 to build on Identify and develop the use cases to represent the diversity of research user groups across Europe. The data collection will include and compile information M5.1 Use cases: regarding user purposes, MS19 Scientific research and WP5 3 - Sciensano 4 requirements, type of data innovation through an analysis of use cases, previous relevant studies, and stakeholder consultation. This milestone considers analysis of data on a spectrum of identifiability. Identify and develop the use cases to represent the diversity of policy makers across Europe. The data collection will include and compile information M5.2 Use cases: regarding purposes, MS20 Policymaking for WP5 3 - Sciensano 5 requirements, type of public health purposes data through an analysis of relevant case studies, previous relevant studies, and stakeholder consultation. This milestone considers analysis of data on a spectrum of identifiability. M5.3 GDPR Data collection concluded and interpretations in compiled regarding health the secondary use of data access permitters and MS21 health data in different WP5 9 - FR-HDH 6 providers in the different member states and MS regarding GDPR other participating interpretations based on the countries use cases above. M5.4 Description of steps in accessing individual-level MS22 WP5 9 - FR-HDH 12 data for national and EU researchers in a selection of Page 39 of 47  Associated with document Ref. Ares(2021)4548885 - 13/07/2021 Due Milestone WP Milestone title Lead beneficiary Date (in Means of verification number18 number9 months)17 centralized systems and decentralized systems M5.5 Guideline document for a peer-to- peer and cross-border MS23 WP5 9 - FR-HDH 12 partnership for the secondary use of health data M5.6 Compilation of best practices for EU cross-border exchange including MS24 WP5 9 - FR-HDH 24 data access and data permit processes in different national settings M5.7 Analysis of health specific MS25 WP5 18 - VWS 5 governance aspects for an EHDS M5.8 Analysis of the capacity of existing EU structures and options on how the governance MS26 WP5 18 - VWS 7 aspects defined in M5.7 can be made within the current structures or with new structures M6.1 Identification of those features that could be legally MS27 WP6 7 - RM 9 bound and provide advice to the European Commission M6.2 Identification of relevant encoding MS28 standards and data WP6 23 - IACS 12 models for semantic harmonization M7.1 Technical and operational analysis report of existing MS29 data sharing and/ WP7 1 - Sitra 8 Task Lead: Sitra (CSC) or secondary use initiatives in health and biomedical sciences. M7.2 Report on MS30 EHDS services users’ WP7 1 - Sitra 9 Task Lead: Sitra (VTT) expectations. Page 40 of 47  Associated with document Ref. Ares(2021)4548885 - 13/07/2021 Due Milestone WP Milestone title Lead beneficiary Date (in Means of verification number18 number9 months)17 M7.3 Report on EHDS architecture and infrastructure MS31 WP7 1 - Sitra 16 Task Lead: Sitra (VTT) implementers’ expectations / experiences. M7.4 Validation report on the MS32 proposed services WP7 1 - Sitra 22 Task lead: Sitra (VTT) and architecture and infrastructure solutions. M7.5 Catalogue of the EHDS services for MS33 WP7 23 - IACS 10 secondary use of health data. M7.6 Report on architecture and infrastructure options to MS34 WP7 23 - IACS 22 support EHDS services for secondary use of data. M8.1 Literature review of citizen’s perception MS35 WP8 9 - FR-HDH 10 of and engagement with health data in M8.2 Publication of results from comparative overview of citizen’s perception MS36 WP8 3 - Sciensano 17 of and engagement with health data in selected countries: Belgium, France, UK M8.3 Publication of recommendations the European Health MS37 Data Space to ensure WP8 9 - FR-HDH 24 citizen sensitization and engagement with health data M8.4 Presentation of a M8.4 Presentation of first set (catalogue) of data a first set (catalogue) altruism definitions, use of data altruism cases and findings about MS38 definitions, use WP8 12 - OKFŐ 7 consent and accessibility cases and findings issues (means of verification: about consent and catalogue approved by accessibility issues stakeholders;) M8.5 Publication of M8.5 Publication of an MS39 WP8 12 - OKFŐ 15 an overview about overview (prepared to launch Page 41 of 47  Associated with document Ref. Ares(2021)4548885 - 13/07/2021 Due Milestone WP Milestone title Lead beneficiary Date (in Means of verification number18 number9 months)17 a communication campaign) about the results of EU- wide multi stakeholder workshops, with a special the results of EU- regard to updated definitions, wide multi stakeholder needs, solutions, experiences, workshops about data and good practices of data altruism altruism (altruism structures and functions) for the future EHDS (means of verification: published in TEHDAS webpage;) M8.6 M8.6 Recommendations to Recommendations foster GDPR-compliant data to foster GDPR- MS40 WP8 12 - OKFŐ 16 altruism mechanisms for the compliant data altruism EHDS (means of verification: mechanisms for the report;) EHDS Page 42 of 47  Associated with document Ref. Ares(2021)4548885 - 13/07/2021 1.3.5. WT5 Critical Implementation risks and mitigation actions Risk Description of risk WP Number Proposed risk-mitigation measures number Effective coordination is ensured by the well- WP1, WP2, WP3, WP4, 1 Ineffective coordination thought managerial structure and transparent WP5, WP6, WP7, WP8 procedures. Ineffective overall Effective management is ensured through good 2 WP1 management PMO office services. All partners are experienced and motivated to reach the project objectives. The management structure is clear, the project deliverables include Project Management Plan, Risk Management WP1, WP2, WP3, WP4, 3 Conflicts in the Consortium Plan, and the Dissemination Plan.The Consortium WP5, WP6, WP7, WP8 Agreement will be comprehensive. Decreasing R1 and R2 decreases R3. Project partners are experienced with virtual collaboration and meetings, effective documenting and sharing. Ineffective collaboration WP1, WP2, WP3, WP4, Project Steering group meets regularly to mitigate 4 between WPs WP5, WP6, WP7, WP8 this risk. The coordinator, WP leaders and Task leaders will Coordination problems WP1, WP2, WP3, WP4, 5 monitor progress and flag problems early enough within an individual WP WP5, WP6, WP7, WP8 to enable fast mitigation. Planning within Work Packages has distributed WP1, WP2, WP3, WP4, 6 Delays with deliverables deliverables along the project lifecycle. Strong WP5, WP6, WP7, WP8 project management in place. Subcontracting is in a small role in this Problems with 7 WP2, WP5, WP8 project. Partners have extensive experience in subcontracting subcontracting. WP1, WP2, WP3, WP4, Reduce: Continuous monitoring of budgeted and 8 Budget overspending WP5, WP6, WP7, WP8 actual costs. Change of key staff in the Accept: With 8 WPs it is expected that some WP1, WP2, WP3, WP4, 9 coordination, WP, and Task exchange of persons will take place. Each CA is WP5, WP6, WP7, WP8 leaders. advised to make contingency plans for their staff Accept: New EU regulation is already in process Change of requirements for for data spaces. WPs are advices to make deliverables due external WP1, WP2, WP3, WP4, description of deliverables enough generic so that 10 events such as new EU laws, WP5, WP6, WP7, WP8 there is a room for change during the project. If budgets changes or similar the risk materializes severely changes in contracts might be needed. Reduce: One of the main target groups (EC) is consulted during the planning phase to mitigate The deliverables will not WP1, WP2, WP3, WP4, the risk. Participants and their experience are 11 meet the needs of the target WP5, WP6, WP7, WP8 expected to mitigate this risk towards other groups target groups that cannot be consulted during the planning phase. WP4 aims to include external parties early on into the project to assure their involvement, Lack of consensus with and WP1, WP2, WP3, WP4, 12 strengthening communication and collaboration between stakeholders WP5, WP6, WP7, WP8 which facilitates consensus. Further discussion and consensus building happens through the Page 43 of 47  Associated with document Ref. Ares(2021)4548885 - 13/07/2021 Risk Description of risk WP Number Proposed risk-mitigation measures number stakeholder forum and WPAGs. Adopting dialogue methods in communication. Active stakeholder engagement. Participatory meetings. Clear communication eg. not using abbreviations. Page 44 of 47  Associated with document Ref. Ares(2021)4548885 - 13/07/2021 1.3.6. WT6 Summary of project effort in person-months Total Person/Months WP1 WP2 WP3 WP4 WP5 WP6 WP7 WP8 per Participant 1 - Sitra 50 23 0 8 1 0 0 5 87 · VTT 0 0 0 0 0 0 10 0 10 · THL 0 0 0 0 3 7 0 0 10 · CSC 0 0 0 0 0 0 9 0 9 2 - ATNA 0 0 0 0 2 2 3 0 7 3 - Sciensano 0 0 0 29 8 2 5 17.50 61.50 4 - CHIF 0 0 0 0 1.20 0 0 2.80 4 · CIPH 0 0 0 0 1.80 0 0 1.20 3 5 - MoH-CY 0 0 0 0 0 0 0 0 0 6 - MZCR 0 0 0 3 4 1 2 1 11 7 - RM 0 0 0 0 3 12 2 0 17 · CDEU 0 0 0 0 1 1 1 0 3 8 - MoSA 0 0 0 0 0 0 0 0 0 9 - FR-HDH 0 0 0 0 4.75 1.75 4 17 27.50 · UT3 0 0 0 0 2 0 0 2 4 · AMU 0 0 0 0 0 3 0 0 3 · Inserm 0 0 0 0 4 4 0 0 8 · HCL 0 0 0 0 0 1.50 0 0 1.50 · ANS 0 0 0 0 0.25 0.25 0 0 0.50 10 - BMG 0 0 0 0 0 0 0 0 0 · FDZ 0 0 0 0 0 0 0 0 0 · GEMATIK 0 0 0 0 0 0 0 0 0 11 - 6th Y. PE. 0 0 0 0 2 0 0 0 2 Page 45 of 47  Associated with document Ref. Ares(2021)4548885 - 13/07/2021 Total Person/Months WP1 WP2 WP3 WP4 WP5 WP6 WP7 WP8 per Participant 12 - OKFŐ 0 0 0 2 2 2 3 13 22 · SU 0 0 0 2 3 2 2 10 19 13 - DoH-IE 0 0 0 0 0 0 0 0 0 · HRB 0 0 0 0 0 0 0 0 0 14 - MINSAL 0 0 0 0 3 4 3 0 10 15 - SAM-LT 0 0 0 0 4 0 0 0 4 16 - DHIR 0 0 0 5 2 0 0 0 7 17 - ATRM 0 0 0 0 0 0 0 0 0 18 - VWS 0 0 0 0 15 0 0 0 15 · Nictiz 0 0 0 0 0 2 0 0 2 19 - MoH-NO 0 0 0 0 1 0 0 0 1 · E-helse 0 0 0 0 0 2 0 0 2 · FHI 0 0 0 0 2 0 0 0 2 · Hdir 0 0 0 0 0 2 0 2 4 20 - SPMS 0 0 11 0 6 7 8 0 32 21 - IPHS "Batut" 0 0 0 1 1 0 0 0 2 22 - NIJZ 0 0 0 5 4 0 0 0 9 23 - IACS 0 0 0 0 8 30.75 45.50 0 84.25 24 - SEHA 0 0 0 2 16 2 1 0 21 · PHAS 0 0 0 2 0 0 0 0 2 · NBHW 0 0 0 0 0 0 2 0 2 25 - NHSC 0 0 0 0 3 0 0 12 15 · WSI 0 0 0 0 1 0 0 2 3 Total Person/Months 50 23 11 59 109 89.25 100.50 85.50 527.25 Page 46 of 47  Associated with document Ref. Ares(2021)4548885 - 13/07/2021 1.3.7. WT7 Tentative schedule of project reviews Review Tentative Planned venue Comments, if any number 19 timing of review RV1 15 RV2 30 Page 47 of 47  Associated with document Ref. Ares(2021)4548885 - 13/07/2021 1. Project number The project number has been assigned by the Commission as the unique identifier for your project. It cannot be changed. The project number should appear on each page of the grant agreement preparation documents (part A and part B) to prevent errors during its handling. 2. Project acronym Use the project acronym as given in the submitted proposal. It can generally not be changed. The same acronym should appear on each page of the grant agreement preparation documents (part A and part B) to prevent errors during its handling. 3. Project title Use the title (preferably no longer than 200 characters) as indicated in the submitted proposal. Minor corrections are possible if agreed during the preparation of the grant agreement. 4. Starting date Unless a specific (fixed) starting date is duly justified and agreed upon during the preparation of the Grant Agreement, the project will start on the first day of the month following the entry into force of the Grant Agreement (NB : entry into force = signature by the Agency). Please note that if a fixed starting date is used, you will be required to provide a written justification. 5. Duration Insert the duration of the project in full months. 6. Call (part) identifier The Call (part) identifier is the reference number given in the call or part of the call you were addressing, as indicated in the publication of the call in the Official Journal of the European Union. You have to use the identifier given by the Commission in the letter inviting to prepare the grant agreement. 7. Abstract 8. Project Entry Month The month at which the participant joined the consortium, month 1 marking the start date of the project, and all other start dates being relative to this start date. 9. Work Package number Work package number: WP1, WP2, WP3, ..., WPn 10. Lead beneficiary This must be one of the beneficiaries in the grant (not a third party) - Number of the beneficiary leading the work in this work package 11. Person-months per work package The total number of person-months allocated to each work package. 12. Start month Relative start date for the work in the specific work packages, month 1 marking the start date of the project, and all other start dates being relative to this start date. 13. End month Relative end date, month 1 marking the start date of the project, and all end dates being relative to this start date. 14. Deliverable number Deliverable numbers: D1 - Dn 15. Type Please indicate the type of the deliverable using one of the following codes: R Document, report DEM Demonstrator, pilot, prototype DEC Websites, patent fillings, videos, etc. OTHER ETHICS Ethics requirement ORDP Open Research Data Pilot DATA data sets, microdata, etc.  Associated with document Ref. Ares(2021)4548885 - 13/07/2021 16. Dissemination level Please indicate the dissemination level using one of the following codes: PU Public CO Confidential, only for members of the consortium (including the Commission Services) EU-RES Classified Information: RESTREINT UE (Commission Decision 2005/444/EC) EU-CON Classified Information: CONFIDENTIEL UE (Commission Decision 2005/444/EC) EU-SEC Classified Information: SECRET UE (Commission Decision 2005/444/EC) 17. Delivery date for Deliverable Month in which the deliverables will be available, month 1 marking the start date of the project, and all delivery dates being relative to this start date. 18. Milestone number Milestone number:MS1, MS2, ..., MSn 19. Review number Review number: RV1, RV2, ..., RVn 20. Installation Number Number progressively the installations of a same infrastructure. An installation is a part of an infrastructure that could be used independently from the rest. 21. Installation country Code of the country where the installation is located or IO if the access provider (the beneficiary or linked third party) is an international organization, an ERIC or a similar legal entity. 22. Type of access TA-uc if trans-national access with access costs declared on the basis of unit cost, TA-ac if trans-national access with access costs declared as actual costs, and TA-cb if trans-national access with access costs declared as a combination of actual costs and costs on the basis of unit cost, VA-uc if virtual access with access costs declared on the basis of unit cost, VA-ac if virtual access with access costs declared as actual costs, and VA-cb if virtual access with access costs declared as a combination of actual costs and costs on the basis of unit cost. 23. Access costs Cost of the access provided under the project. For virtual access fill only the second column. For trans-national access fill one of the two columns or both according to the way access costs are declared. Trans-national access costs on the basis of unit cost will result from the unit cost by the quantity of access to be provided.  Ref. Ares(2021)3802411 - 10/06/2021 Associated with document Ref. Ares(2021)4548885 - 13/07/2021 Joint Action Towards the European Health Data Space TEHDAS Proposal ID 101035467 Project Plan Coordinated by: Finnish Innovation Fund Sitra 3rd EU Health Programme Date: 2021-06-09 1 / 82 Doc Version: 1.0  Associated with document Ref. Ares(2021)4548885 - 13/07/2021 This template is aligned with the Open PM² Methodology of the European Commission. TABLE OF CONTENTS List of Applicants .................................................................................................................................................... 3 1 PROBLEM ANALYSIS INCLUDING EVIDENCE BASE .............................................................................................. 4 2 GOALS AND OBJECTIVES OF THE PROJECT ......................................................................................................... 8 2.1 General Objectives of the Project .................................................................................................................... 8 2.2 Specific Objectives of the Project .................................................................................................................... 9 3 STAKEHOLDER - TARGET GROUPS ................................................................................................................... 14 4 POLITICAL RELEVANCE ..................................................................................................................................... 15 4.1 Contribution to the Annual Work Plan .......................................................................................................... 15 4.2 Added Value ................................................................................................................................................... 16 4.3 Pertinence of Geographic Coverage .............................................................................................................. 17 4.4 Context of the project work ........................................................................................................................... 18 5 METHODS AND MEANS ................................................................................................................................... 18 6 EXPECTED OUTCOMES ..................................................................................................................................... 19 7 WORK PACKAGES ............................................................................................................................................ 21 7.1 Overview of Work Packages (WPs) ................................................................................................................ 21 7.2 Work Packages (WP) Description ................................................................................................................... 21 7.3 Timetable and Milestones ............................................................................................................................. 51 8 DELIVERABLES ................................................................................................................................................. 54 9 PROJECT MANAGEMENT ................................................................................................................................. 56 9.1 Methods ......................................................................................................................................................... 56 9.2 Governance, Roles, Responsibilities .............................................................................................................. 57 9.3 Processes & Artefacts .................................................................................................................................... 59 9.4 Quality & Capacity of the Partnership ........................................................................................................... 60 9.5 Capacity of the staff to carry out the project................................................................................................. 61 9.6 Risk Analysis and Treatment .......................................................................................................................... 64 9.7 Financial management ................................................................................................................................... 65 10 BUDGET ......................................................................................................................................................... 66 10.1 Content description and justification .......................................................................................................... 66 10.2 Summary of Effort ........................................................................................................................................ 68 10.3 Third-Party Contributions ............................................................................................................................ 69 10.4 Detailed Budget ........................................................................................................................................... 69 11 PREVIOUS AND CURRENT GRANTS RELEVANT TO THE PROGRAMME ............................................................ 97 12 CURRENT APPLICATIONS RELEVANT TO THE PROGRAMME ........................................................................... 97 13 EXCEPTIONAL UTILITY.................................................................................................................................... 97 14 COLLABORATING STAKEHOLDERS ................................................................................................................. 97 Date: 2021-06-09 2 / 82 Doc Version: 1.0  List of Applicants Associated with document Ref. Ares(2021)4548885 - 13/07/2021 # Applicant Organisation Name Acronym Country 1 Suomen itsenäisyyden juhlarahasto / Finnish Innovation Fund Sitra Sitra Finland 2 Bundesministerium für Soziales, Gesundheit, Pflege und ATNA Austria Konsumentenschutz 3 Sciensano Sciensano Belgium 4 Hrvatski zavod za zdravstveno osiguranje / Croatian Health Insurance CHIF Croatia Fund 5 Ministry of Health of the Republic of Cyprus MoH-CY Cyprus 6 Ministerstvo zdravotnictvi Ceske republiky MZCR Czechia 7 Region Midtjylland RM Denmark 8 Sotsiaalministeerium / Ministry of Social Affairs MoSA Estonia 9 Plateforme des données de santé / Health Data Hub FR-HDH France 10 Bundesministerium für Gesundheit BMG Germany 11 Dioikisi 6is Ygeionomikis Perifereias Peloponnisou Ionion Nyson 6th Y. PE. Greece Ipeirou Kai Dytikis Ellades/ Regional 6th Health Administration of Peloponnese - Ionian Islands Epirus & Western Greece 12 Országos Kórházi Főigazgatóság / National Healthcare Service Center OKFŐ Hungary 13 Department of Health DoH-IE Ireland 14 Ministero della Salute MINSAL Italy 15 Lietuvos Resbublikos Sveikatos Apsaugos Ministerija / Ministry of SAM-LT Lithuania Health of the Republic of Lithuania 16 Ministry for Health – Government of Malta, Directorate Health DHIR Malta Information and Research 17 Agentia de Transplant / Transplant Agency of the Republic of ATRM Moldova Moldova 18 Ministerie van Volksgezondheid, Welzijn en Sport / Ministry of Health, VWS Netherlands Welfare and Sports, Directorate Information Policy 19 E-helseavdelningen / The Norwegian Ministry of Health and Care MoH-NO Norway Services 20 SPMS – Serviços Partilhados do Ministério da Saúde Epe / Shared SPMS Portugal Services of the Ministry of Health, EPE 21 Institute za Zastitu Zoravlja Srbijedr Milan Jovanovic Batut / Institute IPHS Serbia of Public Health of Republic of Serbia "Dr Milan Jovanovic Batut" “Batut” 22 Nacionalni Institut za Javno Zdravje / National Institute of Public NIJZ Slovenia Health 23 Instituto Aragonés de Ciencias de la Salud IACS Spain Date: 2021-06-09 3 / 82 Doc Version: 1.0  24 E-hälsomyndigheten / Swedish eHealth Agency SEHA Associated with document Ref. Ares(2021)4548885 Sweden - 13/07/2021 25 The NHS Confederation NHSC UK Date: 2021-06-09 4 / 82 Doc Version: 1.0 Joint Action Towards the European Health Data Space (TEHDAS) Associated with document Ref. Ares(2021)4548885 - 13/07/2021 Responses to the comments of the European Commission, 9th June 2021 Comment of the European Commission TEHDAS Response Reference to Chapter in the proposal Please request affiliated entity WSI to submit a high quality copy/scan of its A better-quality copy of the signed DoH of WSI received from WSI and sent to signed DoH – the one which has been submitted is incomplete and illegible. HaDEA. Since the consortium composition changed as compared to the proposal BG withdrew because of lack of resources due to Covid pandemic. The budget was Chapter 10 (former beneficiary 4 Bulgarian Ministry of Health withdrew), please briefly reallocated to coordination (Sitra - FI): Other goods and services 3000,00 euros explain/outline the reasoning, and to which beneficiaries its budget was and communication subcontracting 3000,00 euros. Both budget lines support the reallocated. whole project. In Other goods and services the budget is used for General Assembly meeting and in Communication the additional budget is used for tehdas.eu website maintenance. Table 6 of Section 10.1 - please verify and correct the ‘total funding’ figure Corrected. Chapter 10. Table 6 of EUR 4 166 131.67, it should be EUR 4 166 666.67. of Section 10.1 Table 7 of Section 10.1 - the amount of PMs for WP4 that has been entered There was one PM missing for OKFÖ affiliated entity SU. The Project Plan Person Chapter 10. Table 7 in the system/Annex 1 Part A (58 PMs) does not correspond to the PM Months were correct. The correct PM total is 527.25. It was a typing error. of Section 10.1 figure stated in the table (59 PMs). Therefore, also the overall PM figure in the system (526.25 PMs) doesn’t correspond to the total PM figure stated in the table (527.25 PMs) – please verify and correct where appropriate. Table 9 of Section 10.2 - the PM figures in the table do not correspond to This is due to the same typing error in portal. This has been corrected. The correct Chapter 10. Table 9 those in the system (e.g. the total number of PMs in Annex 1 Part B is number is 527.25. of Section 10.2 527.25, while in the system/ the total number of PMs is 526.25). The total subcontracting amount mentioned on p.58 (EUR 180 000) does not This error was due to BG withdrawal from the project and the reallocation of their Chapter 10. correspond to the total subcontracting figure stated in Annex 2 (EUR 183 budget to the coordination team. The error has been corrected. 000) and in other parts of the project plan – please verify and correct where appropriate. On p.59 you state that ‘There are no known potential conflicts of interests No third-party contributions. Corrected to “N/A”. Chapter 10, Section Associated with document Ref. Ares(2021)4548885 - 13/07/2021 in case of third-party contributions’ – please clarify whether you will be 10.3. receiving any third-party contributions and clearly identify any such contributions. Please clarify which entities will provide in-kind contributions (we These countries and organisations have not requested Person Months in the Chapter 10 understand that MoSA, BMG, GEMATIK, FDZ, DoH-IE, HRB, ATRM are project. Their travel expenses have been included. None of their in-kind concerned), and please also confirm that none of the in-kind contributions contribution has been included in the budget. have been included in the estimated budget. Comments regarding the detailed budget – Section 10.4: In the chapter 10.1. in section Other costs we argue that due to Covid pandemic Chapter 10. Section • travel costs: the travelling budget has been limited. “At minimum, each participating 10.4 for each beneficiary/ affiliated entity budgeting travel costs, please make organization receives 6.000,00 euros travelling budget. That is calculated to sure to clarify the following: number of persons travelling, number of days, include three yearly general assembly meetings and additional face-to-face the type and number of events/meetings, and ideally also the destination workshop, altogether 6 meetings with 1.000,00 estimated costs each. Work (e.g. 2 persons travelling for 3 days to workshop XYZ in Brussels) - it is not Package leaders have additional travelling costs, and the coordinator is expected sufficient to state ‘additional travel from WP4 and country visits’/ ‘6 to have the most travelling during the project.” additional meetings as a WP leader’ / ‘3 face-to-face workshops’ / ‘Additional travelling added because of multiple persons involved without It is difficult to estimate travelling, but WP leaders are expected to have face-toface contribution budget’ etc. Project Steering Group meetings. So far, all such meetings has been virtual. Also workshops have all been virtual. We have estimated that also face-to-face workshop will be held, but at the moment it is unclear when and where due to the pandemic. Comments regarding the detailed budget – Section 10.4: We have added that the expertise is in health data. Chapter 10. Section • function descriptions: most beneficiaries/affiliated entities use function 10.4 names such as ‘expert’/ ‘junior expert’/ ‘senior expert’/ ‘senior lead expert’/ ‘expert level’ – in each case please provide a few more details on the function name/description (e.g. expert in the field of…/ expert on…). Comments regarding the detailed budget – Section 10.4: BG withdrew from the project in March at a time when Associated WP2 had started working with document Chapter 10. Section Ref. Ares(2021)4548885 - 13/07/2021 • Subcontracting: on the communication. All subcontracting from Sitra is planned for WP2. The 10.4 Sitra: please clarify why the subcontracting costs increased by EUR 3000 as creation of the website and further development of it throughout the project compared to the proposal; Sitra also states that ‘graphic design to create clearly benefitted from the additional 3000,00 euros left from BG. Also the budget leaflet as well as final report and media reach surveillance will be used for website and communication that serves all WPs was considered equal subcontracted’ – please bear in mind that the final report must be prepared distribution of the additional budget. We removed mention of final report from by the coordinator and the other beneficiaries together, since coordination here. It was not planned to subcontract coordination tasks. tasks cannot be subcontracted; therefore please adapt the text accordingly. Comments regarding the detailed budget – Section 10.4: This question was asked in the evaluation process and already answered at that Chapter 10. Section • Subcontracting: time. In WP5 T5.4. the current description is the following: “Task 5.4 is expected 10.4 FR-HDH, VWS, SEHA: these beneficiaries have included ‘legal services/ legal to involve external experts in the field of legal services for specific and focused EU expertise’ under subcontracting costs – since normally this type of expertise law problems for which in-house legal advice cannot be found.” during the spring should be found in-house, please clarify what exactly is covered under ‘legal subcontracting for legal advice was used to review a M5.7. document. The actual services/expertise’ in each case, and how it will be of added value to the document was written by experts in TEHDAS project. The subcontracting was used relevant tasks. to find potential problems from the text. Comments regarding the detailed budget – Section 10.4: We copied the description to the budget table. Chapter 10. Section • Other direct costs: 10.4 Sciensano: please briefly clarify what is covered under ‘Policy and project forums meetings’ – are these the costs of organising/conducting the meetings? What kind of meetings are these and how many will be organised? (it is mentioned in the project plan, but not clarified/specified in the budget section). Comments regarding the detailed budget – Section 10.4: Yes. They are costs from organising the workshops. FR-HDH is a task lead in Task Chapter 10. Section • Other direct costs: 5.3. which includes four partners. There is estimated one workshop between those 10.4 FR-HDH: please briefly clarify what is covered under ‘Workshops in Task 5.3 partners. In the WP8 FR-HDH is a WP leader and for 8.1. one workshop has been and in WP8, specifically 8.1’ – are these the costs of organising/conducting planned. Each workshop is estimated 2.500,00 euros. the workshops? What kind of workshops are these and how many will be organised? Comments regarding the detailed budget – Section 10.4: SU is an affiliated entity of OKFÖ which is the WP8 leader. Workshops are planned Chapter 10. Section • Other direct costs: to build deliverables for T8.4 and T8.5. Two workshops have been planned for both 10.4 SU: please briefly clarify what is covered under ‘WP8 Workshops’ – are these with 2.500,00 euros budget for each. the costs of organising/conducting the workshops? What kind of workshops are these and how many will be organised?  Associated with document Ref. Ares(2021)4548885 - 13/07/2021 Comments regarding the detailed budget – Section 10.4: Yes. The costs are for organising the workshops. IACS is leading WP7 and WP6. The Chapter 10. Section • Other direct costs: workshops build deliverables of both Work packages. Each WP has a budget of 10.4 IACS: please briefly clarify what is covered under ‘Workshops in WP6 and 7.500,00 euros and planned to have three workshops with a budget of 2.500,00 WP7’ – are these the costs of organising/conducting the workshops? What euros each. kind of workshops are these and how many will be organised? Comments regarding the detailed budget – Section 10.4: Yes. The costs are for organising the workshops. SEHA is leading WP5 and with their Chapter 10. Section • Other direct costs: budget two workshops of 2.500,00 euros each has been planned. 10.4 SEHA: please briefly clarify what is covered under ‘WP5 workshops’ – are these the costs of organising/conducting the workshops? What kind of workshops are these and how many will be organised? Comments regarding the detailed budget – Section 10.4: MoSA is the abbreviation for Estonia’s Competent Authority (CA) used in the Chapter 10. Section • various inconsistencies: TEHDAS project, its English acronyme. In the organisational profile of the Estonian 10.4 MoSA: please clarify who is is ‘EE’ CA in the EC portal its official name (i.e. from the registered organisational profile with PIC) is “Sotsiaalministeerium – MSAE” and EE is the country code. Extra acronyms are now taken away. Comments regarding the detailed budget – Section 10.4: Corrected. We removed the 0,50 PM from GEMATIK. Chapter 10. Section • various inconsistencies: 10.4 GEMATIK: the table states that it ‘GEMATIK will contribute to task 6.2 with 0.50 PM’ – however this 0,5 PM has not been recorded in the system, please verify and correct where appropriate. Comments regarding the detailed budget – Section 10.4: Corrected. We removed the 0,50 from FDZ. Chapter 10. Section Associated with document Ref. Ares(2021)4548885 - 13/07/2021 • various inconsistencies: 10.4 FDZ: the table states that it ‘FDZ will contribute to task 7.4 with 0,50 PM’ – however this 0.5 PM has not been recorded in the system, please verify and correct where appropriate. Comments regarding the detailed budget – Section 10.4: Corrected. 19 is correct. We have corrected the number in the system. Chapter 10. Section • various inconsistencies: 10.4 SU: the table mentions 19 PMs, but the system states 18 PMs – please verify and correct where appropriate. Comments regarding the detailed budget – Section 10.4: Corrected. We removed the 3,5 PMs from DoH-IE. Chapter 10. Section • various inconsistencies: 10.4 DoH-IE: the table mentions 3.5 PMs, but the system states zero PMs – please verify and correct where appropriate. Comments regarding the detailed budget – Section 10.4: Corrected. We removed the 3,5 PMs from HRB. Chapter 10. Section • various inconsistencies: 10.4 HRB: the table states 3.5 PMs, but the system states zero PMs – please verify and correct where appropriate. Comments regarding the detailed budget – Section 10.4: Corrected. We removed the 1,5 PMs from ATRM. Chapter 10. Section • various inconsistencies: 10.4 ATRM: the table states 1.5 PMs, but the system states zero PMs – please verify and correct where appropriate. Comments regarding the detailed budget – Section 10.4: Corrected to Director. Chapter 10. Section • various inconsistencies: 10.4 SPMS: please clarify what is meant by the ‘Directorate’ staff function Please verify whether beneficiaries Sitra, Sciensano, and IACS will need to Sitra, Sciensano and IACS need to submit CFS according to the Grant Agreement. Chapter 10. submit a certificate on financial statements (CFS) and if so, please make sure We have modified the Other goods and services of Sitra, Sciensano and IACS to they budget the CFS and mention it in the detailed budget under ‘Other include CFS costs. direct costs’. Comments regarding the detailed budget – Section 10.4: Corrected. Associated with document Ref. Ares(2021)4548885 - 13/07/2021 • various inconsistencies: Please refer to ‘HaDEA’ instead of ‘Chafea’ where appropriate. Any changes to names of partners could also be corrected now. Corrected. Please make sure to reflect all changes and the justifications in the History of This table. Done. Changes. Joint Action Towards the European Health Data Space (TEHDAS) Associated with document Ref. Ares(2021)4548885 - 13/07/2021 Responses to the comments in the Evaluation Summary Report and the explanation of changes made Comment in the Evaluation Summary Report ESR TEHDAS Response Reference to Chapter in the proposal Criterion 1 – Contribution to public health in Europe 1/ It does not provide sufficient details with regard to the specific public The General Objective in Chapter 2 has been edited to express that the Joint Chapter 2 health goals this use [of secondary data] would aim to achieve, and what Action addresses the secondary use of health data. The proposals will not limited level of secondary data will be the focus of the action. to specific use cases or types secondary use. Further, the text underlines that the secondary use benefits a wide range of public health goals. 2/ The proposal does not discuss in sufficient details the legislative, Chapter 1 describes the problematics to be solved on the European, Member Chapter 1 organizational, and semantic or ICT options despite evidence showing that States and regional level to share the data and to achieve added value with these can be used to generate, manage and share valuable data and sharing data. Longg-term impacts and outcomes are discussed in Chapter 6. information effectively and at reasonable cost. Effectivity and cost effects are hard to evaluate at this stage when the final legal, organisational and management solutions and models are open and can evaluated when these solutions are developed by the project. 3/ It also does not adequately highlight the key issues regarding different A short reference to key issues in secondary use of health data in countries in Chapter 1, 5, WP4 stages of development and disparities between health systems in different different stages of development and having health systems in different countries countries, whether or how these may affect the implementation of this JA is included in Chapter 1. A reference, which underlines the need to take the issue and how these differences will be mitigated to ensure the achievement of into account in TEHDAS, is added to Chapter 5 and WP4. the intended results. Criterion 2 – Technical quality 4/ The evidence on current trends in secondary data is limited and linkages Current status and trends for secondary use of data are described in Chapter 1. Chapter 1 between the state-of-the art in secondary data sharing models and the The project will develop and describe more the options for the future models of proposal are insufficiently developed. data-sharing in Europe and between the countries and regions, in particular in WP5, WP6 and WP7. 5/ There are limited details on whether and how this JA will build upon Most of these projects were already mentioned Chapter 5 andwith Associated 11.document For those Chapters 5 and 11, Ref. Ares(2021)4548885 - 13/07/2021 existing initiatives or complement them. In particular, links with very projects, their results relevant to TEHDAS will be described early on in WP4. The WP4 relevant actions such as Infact, BRIDGE, PARENT, JASEHN, eHAction, eHDSI, coordination work will continue in the technical project forum under WP4 and the have not been discussed in sufficient details. The lack of these linkages and TEHDAS consortium includes many partners, who have been involved in those discussion raises concerns on the risk of duplication of existing efforts. projects ensuring the knowledge transfer. 6/ It is not sufficiently clear how the JA will achieve the expected outcomes Chapter 6 is modified to show more clearly which outcomes flow directly from Chapter 6 listed in Chapter 6, particularly as it does not explicitly propose means to TEHDAS, and which outcomes may follow from the wider secondary data use if the measure progress towards such achievements. Joint Action’s proposals are adopted. 7/ Methods and means are described in a general manner, with limited The text is edited to include a specific reference to the relevant Work Packages. Chapter 5 specific references to the tasks and activities included in the WPs. 8a/ The WPs generally lack clear and detailed elaborations of activities, and Work Package descriptions have been checked and adjustments made, e.g., Chapter 7.2 the link between tasks and associated milestones/deliverables is often concerning T5.3, D5.2, M5.3 and WP7 (underlining sub-tasks and their division of insufficiently developed (e.g. missing link between task 5.2 and D5.2; lack of work). Further, all Work Packages will produce a more detailed work plan at the clear corresponding activities leading to M5.5, M5.7 and M5.8 etc.). beginning of the project (M01) as a part of the project management, to be endorsed by the PSG. 8b/ Methods, selection criteria and processes to achieve important results Task T5.4 has been revised to describe more clearly the process to arrive at D5.3 Chapter 7.2. such as the ‘recommendations for best practices’ (D5.3) or ‘ the and D5.4. wellestablished options for governance models’ (D 5.4) are not explicitly spelled out. 9/ Further, it is not sufficiently clear how the countries selected as sources The text has been clarified to show that the four countries represent different ways Chapter 7.2 WP5 of best practices (FIN, FR, NL, ES) will provide a realistic and representative of implementing the secondary use of health data. As the aim is to describe and status of health systems in the whole of Europe. test good practice, the participating countries must be moderately developed and willing to work on the topic. A sentence has been added to underline that the outcome recommendations need to realistic to implemented in different situations across Europe. 10a/ The logical sequence between process, outputs and outcomes indicators The background and a graph for the intervention logic has been added to Chapter Chapter 2.2 is not always fully consistent, 2.2. 10b/ the rationale for some indicators is not always clear and some outcome The rational and wording for indicators has been reviewed and with Associated adjusted when document Chapter 2.2 (and - 13/07/2021 Ref. Ares(2021)4548885 indicators needs restructuring as, in their current formulation, they do not necessary. The details of their practical follow-up will be elaborated in the internal 7.2 work packages) measure impact; e.g regarding consistency, for O5 the process indicator evaluation plan MD3.1. ’number of country visits ..’ sets a target value of 8, the corresponding output indicator ‘factsheets’ sets a target of 10; the outcome indicator 'number of stakeholders involved in country visits' sets a target of 4. Outcome indicators chosen for O1 do not appear to measure the achievement of ‘options for an operational framework and governance models‘. 11/ Details regarding the tailoring of interventions, e.g. hospital or Chapter 2.2 has been clarified to show that the main focus of the Joint Action is on Chapter 2.2 territorial/home/residential care are not clearly spelled out. cross-border use of data and any necessary national linkages, not data use at service provider level. 12/ Insufficient justification is provided as per why the partner tasked with The text for WP3 in Chapter 7.2 was modified to provide a clarification on the issue Chapter 7.2 WP3 evaluation is also involved in other project activities, including QA of raised by the ESR report. WP 3 deals with the project’s internal evaluation and, as deliverables (resulting in this partner evaluating some of its own work), The such, is coordinated by one of project partners; this ensures sufficient knowledge plan to deliver the end-of-project evaluation report six months before the of the JA to ensure an adequate evaluation plan. The evaluation rational and design end of the project is also not sufficiently justified. will describe how the evaluation activities will be carried out and how the selected indicators will be measured. The text in WP3 is updated to underline that technically sound evaluation must ensure that quality assurance is performed by partners that are not involved in the specific deliverables that are being evaluated. Also, to ensure consistency of deliverables and consistency of the quality review process every deliverable will undergo a predefined quality review checklist as described in Chapter 9.6. The dates of evaluation reports delivery have been reviewed. 13a/ The dissemination plan is lacking in details such as a clear identification These details will be included in the Dissemination Plan (due by M3) but the text Chapter 7.2 WP2, and breakdown of target groups and products, what will be disseminated to now provides more elements for future planning. The Joint Action does not use Chapter 9.5 who, and how the impact of dissemination activities will be measured. To term communication manager but Communications Lead, in Chapter 9.5. ensure consistency and efficiency, a dedicated communication manager should have been envisaged. 13b/ There are no clear provisions for translation, thus raising concerns on Translations are not foreseen as the primary target group is EU policy Associated withmakers. documentThe NA Ref. Ares(2021)4548885 - 13/07/2021 the capacity to effectively disseminate the results of the proposed activities. Consortium agreement will specify English as the working language. Partners are free to translate the output into their national languages. However, WP8 will translate the citizen engagement activities into local languages in participating countries EN, FR, BE 14/ The sustainability plan is also insufficiently detailed; e.g. it is not The text in Task 4.3 has been clarified to show that the sustainability aspects Chapter 7.2 WP4 sufficiently clear how the ‘option for Economics models focused on the included in the Joint Action's work are a business model for governance agencies sustainability of a EHDS’ as included in the Call’s expected results will be (WP5) and estimating financing needs of the EHDS, which are at the core of the developed. TEHDAS work. TEHDAS does not include work on economic modelling of the value of secondary use of data. Criterion 3 – Management quality 15/ As 43 partners – including affiliated partners - are envisaged to be We have identified this and therefore the coordination is also supported by Project Chapter 9.1, 9.2 involved in at least one activity and will receive some share of the budget, Support Office (PSO) which is described in Chapter 9.2. PSO is not withing the and 9.7 stronger and more elaborated discussion on the financial and management budget of the joint action, but the coordinator covers the costs outside of the plans would have been useful. The WP on coordination may be light vis-àvis project. With the addition of PSO the coordination efforts can be considered the share of coordination and management required by the project. sufficient. 16/ The Consortium is presented through the profile of WPs leaders rather The text is edited to show that the responsibility for Coordination and Work Package Chapter 9.5 than through their organization’s affiliation, which may bear the risk of the leadership is with an organisation, which is shortly described in the text. project's successful implementation be ‘person-dependent’. The description of key staff put at the disposal of TEHDAS is maintained. 17/ The division of work is not clearly explained, with four main partners The coordinator covers 22% of the total workload. While significant for one Chapter 10.1 envisaged to carry out the majority of the work (these 4 main project partner, the coordination is a major task (cf. comment 15) and the Coordinator is partners together have 334.25 PMs and the rest of the partners jointly have involved also in substance work. The second biggest partner by Person Months is 193 PMs). For a project which aims to consolidate diverging Member States’ ES because they carry the responsibility for two WPs for which they particularly opinions, this might present an obstacle in terms of satisfaction of the good experience project aims. The PM distribution follows the same logic as many other European projects where WP leads have significantly more work than the rest which is reflected in PMs. However, all partners regardless of their grant allocation have expressed their strong commitment to be involved in the processing and adoption of the final deliverables (see also the response to the next evaluation comment). 18/ With regards to the task distribution, the proposal provides insufficient The text on the zero-budget contribution has been clarified in Chapter Associated 10.4 Ref. with document to Ares(2021)4548885 Chapter 10.4 - 13/07/2021 justification of why six partners (Moldova, Bulgaria, Serbia, Estonia, Cyprus show that the partners are committing to full input to the adoption of the final and Ireland) will contribute 0 PM. deliverables. The term "generic participation" (meaning the same) has been deleted. 19/ The meaning of ‘generic participation’ to WPs by some partners is not See explanation for 18. Chapter 10.4 clearly explained. 20a/ Although a general risk analysis is included, the proposed risk The risk treatment and contingency plan are explained in more detail, including Chapter 9.6 treatment and contingency plan is insufficiently described, e.g. risks such as conflicts within the Consortium. potential conflicts within the Consortium are missing. 20b/ Additionally, as this project relies so heavily on interaction with This risk has been added to the list of risks. Chapter 9.6, stakeholders, significant efforts in terms of risk mitigation should have been included with regard to communication, reaching consensus etc. with all listed external parties. 21/ While the proposal has reduced to a minimum face-to-face meetings The application process has shown that this (digitally oriented) group can perform Chapter 9.2, and travel, references to alternative plans are not fully elaborated - for well also online, also in General Assembly type major meetings during the Chapter 10.1 Other example, the holding of the General Assembly may not be feasible in person planning. Naturally face-to-face meetings will be organised as soon as the COVID costs, WP1 and the possibility of organizing on-line events may be hampered by situation permits. While no major technical shortcomings appeared during the disparities in technical capacities. planning this will be secured. Textual addition in Chapter 9.2 and changes in 10.1 to show that hybrid and online meetings are a standard practice. Criterion 3 – Overall and detailed budget 22a/ The total budgetary allocations for dissemination accounts for 4.36% If communication towards stakeholders were done only in WP2 this would be the Chapter 10.1. of the total project budget. This seems a small amount considering that the case. WP4 is actually the main stakeholder engagement WP. All stakeholder project is geared towards communication with various stakeholders engagement activities of WP2 and other WPs added up to the total of 24% of the including health professionals and citizens. budget. It shows that the Joint Action takes stakeholder communication and engagement seriously. To clarify, this total calculation of 24% has been added to Chapter 10.1. 22b/ A large portion of external communication is allocated to WP4, but the As both WP2 and WP4 will be instrumental in stakeholder communication Associated (see with document Chapter 7.2 WP2 - 13/07/2021 Ref. Ares(2021)4548885 distinction between these two work packages is not sufficiently clear with above), the division of responsibilities has been clarified. The WP4 work focuses and WP4 consequent implications for the budget. on stakeholders as defined in Chapter 3, and WP2 on more general public communication. 23/ The rationale for the need to subcontract legal expertise is unclear The use of legal subcontracting has been made clearer in the relevant budget Chapter 10.4 (20.000 euros), as this seems to suggest the unlikely case that such expertise tables in Chapter 10.4. The reason for subcontracting is lack of the specific legal budget tables is unavailable within the consortium. knowledge available in the contracting partners (WP8), or the shortage of legal resources (WP5). 24/ The role of partner 19, is not fully clear, as some of its allocated work Partner 19 functions as the co-lead for WP5, and contributes to several tasks (T5.1, Chapter 10.4 will be subcontracted and yet, the budget allocated to this partner is one of T5.2 as the Task Lead and T5.4). The contribution is calculated using the same and budget table fo the highest (EUR 221490) for an involvement of a total of 17PM. equal principles as for all other partners as regards both the estimated volume and Partner 19 the cost level. The contribution of Partner 19 is similar in volume to the contribution of the other leading partner in WP5. 25/ Experts affiliated to partner 10 will contribute from a minimum of 0.5 The contributions and costs of the Affiliated Entities to Partner 10 are calculated Chapter 10.4 PM to a maximum of 8 PM with an allocated budget of 120.000 euro, which using the same and equal methodology as for all Partners. Those AEs represent budget tables seems excessive in the absence of appropriate justifications. highly qualified institutes and bring their specific knowledge to WP8. Their specific tasks have been listed in the budget tables. 26/ The description of events is insufficiently detailed (e.g. expected number A table describing scheduled meetings is added to 10.1. The basic events are Chapter 10.1 Other of participants; expected duration; envisaged translation etc.). General Assemblies, PSG meetings, various forums and workshops. Arranging costs. hybrid and virtual meetings is explicitly defined the Consortium Agreement. See also the response to Evaluation Comment 21. 27/ Role and tasks of affiliated partners are also lacking in details. All Work Packages have reviewed their AE roles and tasks and clarifications were Chapter 7.2 and made, including a more detailed division of work such as fine-tuning the Chapter 10.4 structuring of the activities by adding subtasks and added the specific activities to budget tables be performed by each partner on each subtask. For example, Affiliated Entities engaged in task 8.4, 8.5 and 8.5, based on their expertiseAssociated and experiences in public with document Ref. Ares(2021)4548885 - 13/07/2021 engagement and secondary use of data, will contribute to the literature review and assessment findings of the Study referred to in Chapter 5, and they will take part in preparing the initial and final set of recommendations to be delivered in D8.2. Further, in the more detailed work plan for each WP the exact task of each CA and AE will be detailed.  Associated with document Ref. Ares(2021)4548885 - 13/07/2021 1 PROBLEM ANALYSIS INCLUDING EVIDENCE BASE Data sharing and the use of data for research, development and innovations is not as widespread as it could be in the European Union, among its Member States and associated health and research structures. Health data is underused, especially for the purpose of secondary use. There are several reasons for underusing health data. Data is difficult to find and to access, with sometimes long-lasting bureaucratic permit processes. Data is also dispersed within the health systems, especially patient and health records. Data in many cases is not semantically interoperable. Concepts, classifications, and definitions vary from one health data system to another. Data may not be technically available, due to hermetic systems and undefined APIs. However, health data increases constantly in the ICT-systems of the health care providers, health professionals and health care systems. Regulation on the secondary use of health data differs strongly between the EU Member States and other participating countries, research project teams might obtain data from one national or local data source, but not in another country or hospital. The use of data may not be transparent to citizens. No systematic mechanisms are in place for citizens to either give consent to the use of their data or to “opt out.” In addition, there are many misconceptions and lack of trust in the use of health data, related to practices of misuse and failing cybersecurity and privacy issues. As a result, even in times of Covid-19, the practice of “data altruism” or data donation by citizens is still a rare practice and lacks an EU-wide regulatory framework. Data exchange between EU countries exists in cross-border social security and health services related to labour mobility between the EU Member States and other participating countries. It primarily focuses on the reimbursement of healthcare costs reimbursement. First EU countries (Croatia, Estonia, Finland, and Portugal) have recently started to exchange data on medications (electronic prescriptions) and electronic patients records in the form of so-called Patients Summaries (Croatia, Czech Republic, Luxembourg, Malta, and Portugal). This was made possible in 2018 when Members of the European Committee for Standardization (CEN)1 approved the European Standard for Patient Summaries for unplanned cross-border care. Nevertheless, data exchange and processing may follow various specific national laws making the collection and use of data non-transparent. After more than two years since the General Data Protection Regulation (GDPR) has been implemented, most of the EU Members States have adopted the new principles and adjusted their national legislation. Still, there is much to do in this matter. One of the concerns is the individual’s right to the transparency of the utilization of data, including their sharing – also cross-border – with third parties. The Commission Communication on European Strategy for Data and the European initiatives for data governance and services suggest a basis for common legal framework for Europe and Member States. One of the biggest challenges is to regulate data flow management and health data transfer between different service providers and re-use of data for secondary purposes. As a result, a lack of standard interfaces (data interoperability) and procedures (data portability) results in the fact that data cannot be used in large cross-disciplinary and cross-border research projects. This challenge occurs both when the data is used for primary purposes (treatment) or secondary purposes (not for treatment), e.g. knowledge-based management (training of medical staff, public health management). 1 Draft European standard 17269 ‘The Patient Summary for Unplanned, Cross-border Care’ approved, CEN, 2016. http://www.ehealth-standards.eu/draft-european-standard-17269-the-patientsummary-for- unplanned-cross-border-care-approved/ Retrieved 2020-10-14 Date: 2021-06-09 4 / 82 Doc Version: 1.0  Associated with document Ref. Ares(2021)4548885 - 13/07/2021 A baseline condition for the exchange and processing of data from different sources is their interoperability. To date, most attempts in the European Union to create a common framework for health data in this regard have been long lasting. During last years, the exchange of essential health data in cross-border healthcare has started. It was recently regulated in the eHealth Digital Service Infrastructure (eHDSI) and implemented by the Commission and the Member States through the Connecting Europe Facility (CEF) Programme. The eHDSI allows exchanging two sets of health data: patient summaries and ePrescriptions. Still, there is much work to be done to achieve pan-European data interoperability, including legislative (common interpretations of the GDPR) and technical interoperability (common data standards) between organisations. Although the eHealth Network, many EU Member States and other participating countries have recently undertaken initiatives to introduce interoperability standards, data classifications and definitions, the strategies and adapted solutions vary by country in Europe. It is essential to perceive the compatibility of data from the three2 angles of interoperability: foundational, structural (both technical), and semantic. The revised European eHealth interoperability framework adopted by the eHealth Network in 2015 defines four aspectsi, legal, organisational, technical and semantic. The implementation of standards such as HL7, FHIR (Fast Healthcare Interoperability Resources), ICD-11 or SNOMED CT (Systematized Nomenclature of Medicine Clinical Terms) is still ongoing. Many systems collecting and processing health data are developed in silos – they are unable to communicate with other systems. COVID-19 has stressed health systems capacities. We have learned that the basis for sustainable health systems is that they are flexible to adapt to changing conditions. Thanks to recent advances in digital health, citizens under lockdown conditions could use safe teleconsultation services, obtain electronic prescriptions, and be monitored remotely. Citizens have started using mobile applications for contact tracing to contribute to fight the COVID-19 pandemic. The difficulties of sharing data have been acknowledged in many international contexts, including by the World Health Organization and OECD, leading also to attempts to create regional solutions. The Nordic countries have sought to solve the lack of interoperability by developing a vision3 for their cooperation. Many problems of secondary use of health data remain similar in both advanced and less advanced European countries, such as ethical issues, consent, cyber security. Some problems are more pronounced in less advanced countries, such as lack of legal framework, digitalisation of information systems or shortage of skilled personnel. These problems also limit the ability to participate in European cross-border data sharing. However, the experience shows that countries at different economic levels can set up and run high-quality health information systems if the importance of the use of data is recognised. Promotion of primary and secondary of data in all countries must combine promoting recognition of the importance of data, creating a conducive legal environment (the focus of this Joint Action), as well as investments in infrastructure, methods, and skills. There exists a demand to develop more advanced methods and models to share the data from service providers, regional systems, and national systems. Efforts to enable data sharing in the EU Article 168 of the Treaty (TFEU) requires that the Union respects the responsibilities of the Member States for the definition of the health policy and organisation and delivery of national 2 https://innovatemedtec.com/digital-health/interoperability 3 A vision of a Nordic secure digital infrastructure for health data: The Nordic Commons. http://norden.diva-portal.org/smash/record.jsf?pid=diva2%3A1376735&dswid=3079 Retrieved 2020-10- 14. Date: 2021-06-09 5 / 82 Doc Version: 1.0  Associated with document Ref. Ares(2021)4548885 - 13/07/2021 health services and medical care. The EU health policy and interventions serve to complement national responses. They aim to protect and improve the health of EU citizens, support the modernization of health infrastructure, and improve the efficiency of Europe’s health systems (see for example a discussion on the COVID response 4). 2F In December 2017, health ministers agreed at the Council of the European Union on the broad lines of action for digital health. While the Council Conclusions 4 concentrated on the primary 3F use of health data, ministers urged the Member States and the Commission to implement citizens' right to have access to their health data, to enable its cross-border exchange and the availability of comparable and high-quality health data for research and innovation. In 2018, The European Commission published a Communication 5 enabling the digital 4F transformation of health and care in the Digital Single Market; empowering citizens and building a healthier society.6 It outlined three priorities: − Citizens' secure access to their health data, also across borders - enabling citizens to access their health data across the EU. − Better data to advance research, disease prevention and personalised health and care - allowing researchers and other professionals to pool resources (data, expertise, computing processing and storage capacities) through shared European data infrastructures across the EU. − Citizen empowerment with digital tools for user feedback and person-centric care - using digital tools to empower people to look after their health, stimulate prevention and enable feedback and interaction between users and healthcare providers. The Communication mentioned results of a public consultation 7 that was carried out in 5F preparation of a Communication, which recognised the need for further work on identifying important challenges that prevent digital health and care solutions from being adopted across the EU. The main findings showed that over 93% of over 1400 respondents to an online questionnaire believe that “Citizens should be able to manage their own health data”. Furthermore, 83% of all respondents either agreed or strongly agreed with the statement that “Sharing of health data could be beneficial to improve treatment, diagnosis and prevention of diseases across the EU". The overwhelming majority of all respondents (74%) identified improved possibilities for medical 4 Council Conclusions 2017 on digital health under the Estonian Presidency. https://eurlex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:C:2017:440:0003:0009:EN:PDF Retrieved 2020-1014. 5 Communications from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions on enabling the digital transformation of health and care in the Digital Single Market; empowering citizens and building a healthier society. Brussels, 25.4.2018 COM (2018) 233 final https://ec.europa.eu/newsroom/dae/document.cfm?doc_id=51628 Retrieved 2020-10-14. 6 Council Conclusions 2017 on digital health under the Estonian Presidency. European Union, 2017. https://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:C:2017:440:0003:0009:EN:PDF Retrieved 2020-10-14. 7 Synopsis Report on a Consultation on Transformation Health and Care in the Digital Single Market. European Union, Brussels, 2018. https://ec.europa.eu/health/sites/health/files/ehealth/docs/2018_consultation_dsm_en.pdf Retrieved 2020-10-14. Date: 2021-06-09 6 / 82 Doc Version: 1.0  Associated with document Ref. Ares(2021)4548885 - 13/07/2021 research as a reason for supporting cross-border transfer of medical data, which was higher than for their purpose of their own treatment (68%). Even more respondents (80%) 4 J. Hackenbroich et al. Health sovereignty: How to build a resilient European response to pandemics, June 2020. https://www.ecfr.eu/publications/summary/health_sovereignty_how_to_build_a_resilient_europe an_response_to_pandemics Retrieved 2020-10-14. agreed to share their health data if privacy and security were ensured. One key ambition which was raised was the shared health resources allowing targeted and faster research, diagnosis, and treatment. However, the 2018 Communication was not the starting point for the discussion of health data in Europe. Before that, Directive on Patients’ Rights in the Cross-Border Healthcare (2011/24/EU) can be considered a major milestone for cross-border healthcare in Europe. It defined patient rights in cross-border healthcare, set up the European reference networks (ERN) and the eHealth Network. These structures brought collaboration to a new level in Europe: The ERNs and cross- border exchange of ePrescriptions and Patient Summaries is operational. Recent developments in data analytics, AI, real-world data (RWD) and in general in the secondary use of health data have brought new requirements for European collaboration. In the mission letter to Commissioner Kyriakides 8 in September 2019, President of the European 6F Commission, Ursula von der Leyen reinforced these intentions by raising a European Health Data Space as one of the priorities in the EU health policy. She wrote that the Commissioner for Health should work on: The creation of a European Health Data Space to promote health-data exchange and support research on new preventive strategies, as well as on treatments, medicines, medical devices, and outcomes. As part of this, you should ensure citizens have control over their own personal data. The use of health data was further discussed at meeting of EU health ministers in December 2019 under the Finnish Presidency of the Council, which noted9 the importance of to make use of the potential of health and social data for advancing public health, research, and innovation, and in July 2020 during the German Presidency. The situation was thoroughly analysed in the Commission Communication on the European Strategy for Data10, underlining that the EU has everything to play as an important global player in the data economy of the future. The Communication lays out a vision that “health is an area where the EU can benefit from the data revolution, increasing the quality of healthcare, while decreasing costs.” Further, strengthening and extending the use and re-use of health data is critical for innovation in the healthcare sector. It underlines “a common European health data space, which is essential for advances in preventing, detecting and curing diseases as well as for informed, evidence-based decisions to improve the accessibility, effectiveness and sustainability of the healthcare systems.” 8 Commissioner-designate for Health to Stella Kyriakides, Brussels, 10 September 2019. Retrieved 202010-14. https://ec.europa.eu/commission/sites/beta-political/files/mission-letter-stella-kyriakides_en.pdf Retrieved 2020-10-14. 9 https://data.consilium.europa.eu/doc/document/ST-13171-2019-INIT/en/pdf Retrieved 2020-10-14 10 Commission Communication on a European strategy for data: https://eur- lex.europa.eu/legalcontent/EN/TXT/?qid=1593073685620&uri=CELEX%3A52020DC0066 Retrieved 2020-10-14 Date: 2021-06-09 7 / 82 Doc Version: 1.0  Associated with document Ref. Ares(2021)4548885 - 13/07/2021 This policy formulation process took a decisive step on 1-2 October 2020, when the European Council11 welcomed “the creation of common European data spaces in strategic sectors, and in particular invites the Commission to give priority to the health data space, which should be set up by the end of 2021.” 2 GOALS AND OBJECTIVES OF THE PROJECT 2.1 General Objectives of the Project While the Council Conclusions in 2017 set up a broad strategy for the European Union to promote digital transformation in health and care, the European Council adopted a specific call to set up the European Health Data Space by the end of 2021. Setting up the Joint Action under the 2020 Work Programme10F13 (Work Programme 2020) of the Third programme for EU action in the field of health (3rd Health Programme) is a logical step to implement the ideas in the Conclusions. The Work Programme 2020 sets the following objectives of the Joint Action: − Contribute to ensuring the protection and free flow of data in the health sector based on the examination how Member States and other participating countries have applied the GDPR rules on processing health data. − Draft options on the secondary use of health data, including the application of big data and artificial intelligence in health and long-term care. − To provide technical support for the development of guidelines on effective methods for enabling the use of medical information for public health and research. − Propose options for governance models for data-sharing at EU level, in particular networking for secondary use. As the expected result of the Joint Action, the Work Programme underlined the need for a data governance model for secondary use of health data. The other expected result, a Code of Conduct for health data processing under Article 40 of the GDPR to be developed by nongovernmental stakeholders, has been separated to another project. However, the Joint Action will need to encourage and support this separate process, where stakeholders produce a code of conduct for health data processing. The Joint Action will need to ensure the link to its interpretation and use as well as encourage stakeholders to adopt the code. The Member States, other participating countries and the EU institution have often underlined the need to ensure that citizens have control over their personal data12. The policy expectations were elaborated in the annex of the European Health and Digital Executive Agency HaDEA’s invitation to set up a Joint Action13. The invitation adds to and details the objectives and expected results. 11 Conclusions of the special meeting of the European Council 1 and 2 October 2020. https://www.consilium.europa.eu/media/45910/021020-euco-final-conclusions.pdf Retrieved 202010-14. 12 European Data Strategy, Making the EU a role model for a society empowered by data. European Commission, Brussels, 2019. https://ec.europa.eu/info/strategy/priorities-2019-2024/europe-fitdigital-age/european- data-strategy Retrieved 2020-10-14. 13 Third programme for EU action in the field of health 2020 work programme, ANNEX to the Commission Implementing Decision concerning the 2020 work programme in the framework of the third programme of Union action in the field of health (2014-2020) and the EU’s financial contribution Date: 2021-06-09 8 / 82 Doc Version: 1.0  Associated with document Ref. Ares(2021)4548885 - 13/07/2021 In particular, on the governance model, the Joint Action should develop proposals and options for data-sharing, including data governance structures and functions that ensure a fair, transparent, non-discriminatory, and balanced relationship between the involved parties, between different Member and other participating countries across Europe. The Joint Action should develop, explore, and analyse options on data governance, data quality and data infrastructure, as well as sustainability and ethical models. Further expectations include support to EU and national authorities as well as the medical community to agree on interoperability guidelines. These should deal with data quality and a technical backbone: − Semantic interoperability guidelines, ways of anonymization and re-use of health data by adhering to the FAIR principles of being Findable, Accessible, Interoperable and Reusable; and − Technical interoperability guidelines to provide a technical backbone for the European Health Data Space and take advantage of existing infrastructures. Based on these expectations expressed by the Member States, other participating countries, and the European Commission, the Joint Action has a broad, policy related General Objective. The General Objective expresses that a wider secondary use of health data would bring benefits at individual and community level, as well as for authorities and businesses and such use would apply to all aspects of public health, such as prevention, diagnostics, and treatment: “The Joint Action Towards the European Health Data Space (TEHDAS) helps the Members States and the Commission in developing and promoting concepts necessary for sharing of data in secondary use for purposes of citizens’ health, public health, as well as health research & innovation in Europe.” The goal relevant to the EU is that sharing can take place across national borders: “In the future Europe, citizens, communities and companies benefit from a protected and secure access to seamless health data available regardless of where it is stored.” These two statements form the mission statement of the Joint Action. The General Objective is translated into the Specific Objectives described in the next section. 2.2 Specific Objectives of the Project The Joint Action Towards the European Health Data Space has five Specific Objectives: 1. Produce elements and options for an operational framework and governance models for the exchange and secondary use of health data between European countries, respecting the principles of transparency, trust, FAIRness, citizen empowerment and a common good. 2. Provide solutions for the trustworthy secondary use of health and health care data with a view to fostering the digital transformation of the European health systems. to the WHO Framework Convention on Tobacco Control, European Commission, Brussels, 28.1.2020 C (2020) 368 final, Brussels, 2020. https://ec.europa.eu/health/sites/health/files/funding/docs/wp2020_annex_v1_en.pdf Retrieved 2020-10- 14. Date: 2021-06-09 9 / 82 Doc Version: 1.0  Associated with document Ref. Ares(2021)4548885 - 13/07/2021 3. Provide a catalogue of services to support the secondary use of health data through the European Health Data Space as well as the architecture and infrastructure options required for its deployment. 4. Obtain a better understanding of citizens’ relationships with health data and provide a European perspective to improve citizens’ engagement with data, and trust in, data sharing while strengthening the health data governance mechanisms for cross-sector data use and for data use in the common sectoral data spaces at EU level and in the Member States and other participating countries relevant. 5. Outreach and engage national and international players, to the TEHDAS Joint Action to reflect their needs and expectations, explore views on its economic sustainability as well as suggest concrete ways to integrate the results into the future EHDS. The following graph illustrates the relationships between the General Objective, Specific Objectives, and Work Packages. Figure 1 The General and specific objectives, and their relation to the Work Packages To support the development of a common European health data space, the Joint Action will propose concepts that apply to any secondary use of data, not limited to specific use cases. This also applies to types of secondary use, such as anonymous or pseudonymous data. However, the scope of proposals will focus on cross-border use of data; national linkages are only addressed when relevant. The Joint Action has analysed the intervention logic for this project aiming at policy development. Outcomes from the project will materialise through the implementation of the Joint Action’s proposals as described in Chapter 7. The intervention logic is presented below. Date: 2021-06-09 10 / 82 Doc Version: 1.0  Associated with document Ref. Ares(2021)4548885 - 13/07/2021 Figure 2 The intervention logic of the Joint Action Towards the European Health Data Space Based on this intervention logic, the following process, output, and impact/outcome indicators will be followed in the project (Table 1). Table 1 Objectives and indicators # Specific Objective Title and Description O1 Produce elements and options for an operational framework and governance models for the exchange and secondary use of health data between European countries, respecting the principles of transparency, trust, FAIRness*, citizen empowerment and a common good. FAIR = Findable, Accessible, Interoperable, Reusable Main responsibility: WP5 Process Indicator(s) Target value Relevant surveys conducted 4 (with 60% av. Response rate) Workshops conducted 4 Relevant major studies analysed 3 Output Indicator(s) Target value Number of countries included in the use cases for scientific research and policymaking 10 Number of countries that have described their national designated body as health data access 10 permitter/provider Number of partnership agreements designed 1 Outcome/Impact Indicator(s) Target value Number of countries contributing to recommendations on national legislation 10 Date: 2021-06-09 11 / 82 Doc Version: 1.0  Associated with document Ref. Ares(2021)4548885 - 13/07/2021 Number of stakeholder categories involved in entire proposal process (e.g., Patient 7 organizations, Citizen organizations, Healthcare professionals, Healthcare providers, Industry) Number of Member States and other participating countries contributing to recommendations 4 of best practices # Specific Objective Title and Description O2 Provide options for the trustworthy secondary use of health and health data with a view to fostering the digital transformation of the European health systems. Main responsibility: WP6 Process Indicator(s) Target value Main data quality assurance experiences in Europe outreach 80% Main semantic interoperability experiences in Europe outreach 80% Output Indicator(s) Target value Solutions for data quality assurance assessed 100% Solutions for semantic interoperability assessed 100% Outcome/Impact Indicator(s) Target value Data quality assurance framework agreement btw MSs achieved 100% Relevant research questions (users’ view) covered by the Common Data Model 80% # Specific Objective Title and Description O3 Provide a catalogue of services to support the secondary use of health data across through the EHDS as well as the architecture and infrastructure options required to its deployment. Main responsibility: WP7 Process Indicator(s) Target value Analysis of data sharing initiatives 15 Set up of thematic workshops 4 Output Indicator(s) Target value Catalogue of services options catalogue 1 Catalogue of architecture options 1 Catalogue of infrastructure options 1 Outcome/Impact Indicator(s) Target value Number of stakeholders involved in the Users and Implementers Forum 20 Date: 2021-06-09 12 / 82 Doc Version: 1.0  Associated with document Ref. Ares(2021)4548885 - 13/07/2021 Number of Member States and other participating countries engaged to follow up the 10 Joint Action developments # Specific Objective Title and Description O4 Obtain a better understanding of citizens’ relationships with health data and to provide a European perspective to improve citizen’s engagement with, and trust in, data sharing and data portability while strengthening health data governance mechanisms for cross-sector data use and for data use in the common sectoral data spaces through co-design at EU level. Main responsibility: WP8 Process Indicator(s) Target value Collect international publications on the topic of citizen perception and engagement 60 by M6 Identify and engage health data citizen sensitization initiatives in countries 3 by M6 Number of national and EU-wide multi stakeholder workshops, conferences, events At least 4 (8.1) + 9 on citizen perception of health data and data altruism (8.2) = 13 by M24 Output Indicator(s) Target value Elaborate a set of practicable recommendations for the EHDS At least 3 by M24 Number of stakeholders (persons) representing national/regional/international 20 by M7, 80 by M24 authorities, organisations and projects/initiatives represented in the events Number of stakeholders (persons) reached out by newsletters 20 by M7; 80 by M24 Outcome/Impact Indicator(s) Target value Reaching citizens across all pilot countries through the website and the citizen survey. 50000 EU visitors 5000 respondent citizens by M17 Initial set of definitions, good practices and use cases of data altruism and altruism 1 set by M7 structures and functions for the future EHDS Final set of recommendations how to share lessons learned to be applied for the 1 set by M24 GDPR-compliant application of data altruism practices and adopt and harmonize identified good practices and implement use cases for the construction of national or European health data space # Specific Objective Title and Description O5 Outreach and engage national and international players, to the TEHDAS to reflect their needs and expectations, explore views on its economic sustainability and suggest concrete ways to integrate the results in the EHDS. Main responsibility: WP4 Process Indicator(s) Target value Number of country visits virtual or face-to-face 8 countries Date: 2021-06-09 13 / 82 Doc Version: 1.0  Associated with document Ref. Ares(2021)4548885 - 13/07/2021 Number of Policy and Project Forum 4 meetings in total Output Indicator(s) Target value Fact sheets describing key needs and expectations reflected in country visits 8 fact sheets produced Policy and Project Forum report with participants view on the value of exchanging 4 meeting secondary data reports Sustainability plan describing WPs and which existing data infrastructures can be 1 report leveraged and remain as a building block of EHDS. Outcome/Impact Indicator(s) Target value Number of health information system stakeholders (e.g., Ministry of Health, 4 Statistical Office, National Public Health Institute, Health Insurance fund) engaged stakeholde per country visit rs per country Number of MS/AC’s authorities, international organisations, initiatives, and projects Overall average represented in the fora participation of 2/3 of selected stakeholders including 10% of MS by M9, 50% of MS by M16 and 90% of MS or AC by M24 3 STAKEHOLDER - TARGET GROUPS The stakeholder and target groups for the TEHDAS Joint Action can be divided into the primary target group of the proposals emanating from the JA, those having direct interest in proposals, and the actors in the EHDS, in particular as regards the secondary use of data. The Joint Action will generate proposals for policy measures and their implementation, which are directed towards health data policy makers in the Member States, other participating countries and the European Union institutions and bodies. These policy makers in Member States and other participating countries include ministries and authorities responsible for health, research, innovation, and data protection. The corresponding bodies in the EU include in particular the relevant Directorates General in the Commission, the European Parliament, the European Data Protection Board, the European Medicines Agency, the eHealth Network and the European Centre for Disease Prevention and Control. Several groups of actors, stakeholders, will have a direct interest in the proposal but they can also bring in valuable insights and input the proposals. These stakeholders are traditionally grouped into citizens and patients, healthcare and healthcare professionals, researchers and academia, private sector companies, and authorities and regulators. The last group automatically participates in the work of the Joint Action due to its structure, but the range of authorities will only be partially covered, mainly through health ministries. A particular stakeholder group is formed by relevant international organisations, such as the World Health Organization, OECD, and standardisation organisations. They develop international data sharing policies, which influence the global environment where the European Date: 2021-06-09 14 / 82 Doc Version: 1.0  Associated with document Ref. Ares(2021)4548885 - 13/07/2021 Health Data Space will operate. The non-EU or third countries will be important partners in generating data and potentially using the data. The final stakeholders in the secondary use of data through the European Health Data Space form a wide spectrum of people and bodies which generate health data, use it in various secondary use cases, decide on or promote access, protection and use of health data, or have another interest towards health data. The following non-exhaustive list illustrates this variety: Stakeholders generating health data: • Individuals as citizens and patients • Healthcare providers including primary care, hospitals • Healthcare professionals • Research organisations, registries, biobanks • Companies involved in wellbeing, health, and health technology industries, Stakeholders utilising health data in the secondary use case: • Health information systems, analytical services providers and healthcare managers and professionals • Research organisations, universities, think tanks, medical charities • Pharmaceutical, medical devices and other health related industries, those using Artificial Intelligence (AI) • Local and national decision makers, parliamentarians, and councillors • National governments and authorities in public health, social care, statistics, Stakeholders guarding access to and protecting data • Civil society organisations, NGOs • National health data access and permit authorities • Data protection authorities and regulators • Organisations working on standardisation of health data. The Joint Action will take these stakeholders and target groups into account in the planning of its work. The wider primary audience will be consulted through the forums in WP 4 and consultation processes with national and EU bodies. Stakeholder organisations (typically NGOs) will be involved through the stakeholder consultation process described in Chapter 9. The results of the work will be promoted among stakeholders through the communication actions in WP 2. 4 POLITICAL RELEVANCE 4.1 Contribution to the Annual Work Plan The TEHDAS Joint Action addresses directly an issue at the heart of the Third Programme for the Union’s action in the field of health (2014-2020). The Joint Action is anchored to Thematic Priority 3.2 "Innovation and e-health" but its results - building blocks of the European Health Data Space - will contribute to many other Thematic Priorities of the Programme Regulation. The Annex I to the Programme Regulation lists the main thematic priorities: • Promote health, prevent diseases, and foster supportive environments for healthy lifestyles, • Protect Union citizens from serious cross-border health threats, • Contribute to innovative, efficient, and sustainable health systems • Facilitate access to better and safer healthcare for Union citizens Date: 2021-06-09 15 / 82 Doc Version: 1.0  Associated with document Ref. Ares(2021)4548885 - 13/07/2021 All the four Thematic Priorities underline the need for a health information and knowledge system, which contributes to evidence-based decision-making (sub-themes 1.6, 2.4, 3.7, 4.6). The 2020 work programme lists as one of its expected results “a GDPR-compliant data governance model ... for health(care)-related data”, which is at the heart the JA proposal. The objectives of the work programme and the guidance given by HaDEA on its implementation have been described in Chapter 2.1. The specific part of the 2020 work programme further notes that the Joint Action must build on the outcomes of the preparatory workshops with the Member States, other participating countries, and other experts by the Commission. For that purpose, the Commission provided an advance version of the report on Member States’ rules and systems on processing of health data, which this proposal considers. Particular attention has been given to the outcomes of past actions funded by the Health Programme on related topics and considering of ongoing negotiations of a legislative nature. 4.2 Added Value The Joint Action Towards the European Health Data Space will support a key objective of the EU, which is ensuring the seamless flow of health data in the context of the Single Market. The Joint Action will create EU added value by contributing to the legislative process for creating the European Health Data Space. The Joint Action will engage the key actors of the process, the Member States and other participating countries, in the design of elements of the forthcoming legislative measures and their future implementation. Through the dialogue with the Commission, the Joint Action will improve both the quality of the future legislation as well as its practical implement ability. The Joint Action will bring together actors relevant to secondary use of data in the EU. It will promote their networking through practical contacts and by suggesting the key criteria and functions for setting up such a network. One of the main outcomes of the Joint Action is a suggestion on knowledge-sharing and peer learning networking of the designated bodies in Member States and other participating countries. Such bodies may grant permits for data use, promote the use of health data, improve the interoperability of data cross-borders. The expected effects of the Joint Action are long-term by nature: legislative measures and implementation bodies suggested will be lasting societal structures in the EU health policy. The results will have a wide applicability in Member States and other participating countries. The advice and guidelines produced on use cases and interpretation of the General Data Protection Regulation (WP5) and on citizen perception of health data and data sharing practices (WP8) can be replicated in all Member States, other participating countries and regions. The Joint Action will also collect the best practice available in the EU on the secondary use of data. The proposed benchmarking and other infrastructure tools will help to assess data quality and interoperability and develop it further. WP6 and WP7 envisage architecture for the infrastructure and layers of interoperability (semantic, technical). The TEHDAS will not operate in a vacuum. It will continue the work carried out by the eHAction Joint Action and its predecessors and expand its work on secondary use of health data as foreseen in Article 14 of the Directive on Patients’ Rights in Cross-Border Healthcare. eHAction’s work on empowering people and patient access and use of data (eHAction WP4) and innovative use of health data (WP5) will be of relevance to TEHDAS. eHAction worked to develop a common vision of innovative use of data in healthcare, policy relevant actions on innovative use of big data and common principles for big data governance. This will be continued and expanded as part of several TEHDAS work packages. Date: 2021-06-09 16 / 82 Doc Version: 1.0  Associated with document Ref. Ares(2021)4548885 - 13/07/2021 It will also build on the work from BRIDGE Health and the Joint Action on Health Information (InfAct). InfAct builds towards the set-up of a research infrastructure for health information in Europe. Relevant work includes governance and operational structures and discussions held with policy makers and researchers across Europe to define services needed in relation to secondary use of data across Europe, assessing and piloting interoperability. InfAct has piloted a distributed infrastructure standing on the pillar of the European Interoperability Framework and the FAIR principles, which will be further investigated in TEHDAS. These projects are examples of the work carried out in the EU on health data and its use, whose results will be considered in the TEHDAS Joint Action. Through its nature as preparatory action towards the European Health Data Space, the TEHDAS Joint Action will create links to and between other projects and initiatives in the field of health data, such as the COVID-19 Data Portal of the European Commission, 1+Million Genomes initiative (1+MG), eHealth Digital Service Infrastructure, the European Reference Networks, European Joint Programme on Rare Diseases (EJP RD), Gaia-X, health-related European Research Infrastructure Consortiums (such as ELIXIR, EATRIS, ECRIN, BBMIR, Euro-Bioimaging), the Population Health Information Research Infrastructure (PHIRI) for COVID-19, and the DARWIN platform suggested by the European Medicines Agency. This will provide EU-added value in the light of the COVID-19 pandemic and in the preparation for future health pandemics and other health threats. TEHDAS underlines the need to link separate data systems, avoid data silos not to focus on single business cases and to consider the necessary links with other initiatives. 4.3 Pertinence of Geographic Coverage The TEHDAS Joint Action covers 25 European countries. 21 European Union Member States and 4 other European countries are represented. The EU Member States are Austria, Belgium, Croatia, Cyprus, Czechia, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Lithuania, Malta, the Netherlands, Portugal, Slovenia, Spain and Sweden, and the non-EU countries are Moldova, Norway, Serbia, and the United Kingdom. The population of these countries is over 458 million people (1 January 2020, Eurostat). The EU countries cover approximately 83 % of the EU population. Figure 3 Map of the 25 participating countries in TEHDAS Date: 2021-06-09 17 / 82 Doc Version: 1.0  Associated with document Ref. Ares(2021)4548885 - 13/07/2021 4.4 Context of the project work Health systems and health data systems vary between countries and regions, and in particular the concept of secondary use of health and social data is different. Diverging interpretations of data protection in EU Member States and other participating countries was one of the underlying reasons for the Joint Action. The TEHDAS Joint Action will address the needs of countries in different stages of development for the secondary use of health data and thus seeks to bridge disparities between health systems. The secondary use of health data carries great social value through its objectives which focus on the improvement of health system performance, the promotion of health in line with the definition set out by the WHO as being a state of complete physical, mental and social well-being and not merely the absence of disease or infirmity, and better research and innovation capacities in the EU. The results of the secondary use of health data may also lead to policies and programs targeting under-privileged groups and minorities, focussing on principles of diversity and equity in research and policymaking. Creating trust by all stakeholders in the secondary use of health data is one of the prerequisites for its effectiveness, a key component included in the work of WP5 on governance and linked with the citizen-centric approach for health data of WP8, assessing citizens’ perceptions on health data. Ethical, legal, and social issues (ELSI) will be a part of all work packages. The TEHDAS Joint Action has important political stakes, as described in Chapters 1 and 2. Data used in the Joint Action is non-personal, such as descriptions of health data systems and legislation. There will be no personal or identifiable health data, such as names or contact information. Strict compliance with the GDPR will be ensured by all WPs of the Joint Action. 5 METHODS AND MEANS Joint Actions are instruments, enabling the EU Member States and other participating countries to join forces with the support of the European Commission to design and provide common solutions to EU-wide technical or policy-related problems, or both. The aim is to strengthen European cooperation. The TEHDAS Joint Action offers a way to plan policy and implementation for the sharing of health data cross-borders in the EU and beyond (WP5), while engaging both Members States and key stakeholders in the process (WP4). Partners involved in the Joint Action are key influencers of today’s and tomorrow’s health policy in their respective Member States and other participating countries, and specifically designed for the Joint Action, thereby ensuring a close link with the effective policy adoption process both at national and EU-level. The TEHDAS Joint Action will provide a platform for Member States and other participating countries to collaborate on policy-related, legal, and organisational questions related to sharing of health data (WP5). The TEHDAS JA works also on semantic and technical issues (WP6 and WP7), thus covering all aspects of the European Interoperability Framework13F16, endorsed by the eHealth Network. Being primarily a policy-oriented Joint Action, TEHDAS will consider the constantly evolving policy environment, including legislative and policy guidance from the European Council and the Council of the EU, the opinions of the European Parliament and the proposals from the Commission in the field of health, artificial intelligence, and digital policies (Steering Group, WP5). The TEHDAS JA will bring together Member States’ and other participating countries’ strong knowledge, experience, and expectations towards sharing health data across EU borders in a unique way. Using their strong national networks, skills, capacities and close involvement in national and EU policy processes, JA partners can produce practicable recommendations for Date: 2021-06-09 18 / 82 Doc Version: 1.0  Associated with document Ref. Ares(2021)4548885 - 13/07/2021 EUlevel measures. Designated competent authorities of the participating Member States and other participating countries will form a policy and technical resource to plan for sustainable solutions and to engage governmental and non-governmental actors in the process of building the future EHDS. The diversity of participating countries will help to assess proposals regarding different stages of development and disparities between health systems and take the maturity in the secondary use of data into account. The TEHDAS JA will also build on existing achievements and dialogue with similar projects and activities (mapped in WP4), in which participants have been involved. This includes many previous Joint Actions and projects, the most relevant of which are described in Annex. Coordination will reduce overlaps and ensure that the new proposals consider earlier preparatory work and create links with current projects and processes. As the European Health Data Space is meant to integrate the complete health data ecosystem, JA partners will have the capacity to build on existing synergies to prevent data silos. The JA will also assess current best practices as a background for policy proposals (all Work Packages WP4-WP8). Finally, the TEHDAS JA will include mechanisms to involve various stakeholders in the process and identify their expectations, knowledge, and experience in the outputs of the Joint Action (WP4). The following governance methods are applied to ensure high-quality outputs: − The governance of the JA ensures close collaboration between the partners and implements a coherent review process of all documents produced by the 8 Work Packages. It ensures that all documents meet the expectations of all Partners. − When final documents are produced, such as policy papers or guidelines, the JA will bridge the gap between the different views and explain options considered. Interaction among partners, supported by the Coordinator, will be essential. − The project management structure will enable WP Leaders to obtain oversight and influence the format and structure of deliverables so that they are all aligned. − A stringent quality control will cover all deliverables, including the content, format, and language, which needs to be understandable to audiences not familiar with the topic. − The JA will produce a limited number of deliverables, some of them divided into several tasks, using “Milestones,” timed to fit the policy process. This also implements a continuous improvement process of the outputs. All TEHDAS Work Packages will consider the study on “Assessment of the EU Member States’ rules on health data in the light of GDPR” produced by the EU Health Support Consortium for the Commission. While the final report was still unpublished at the time of the drafting of this application, applicants obtained some advance information of the study results. The findings of this study will be particularly important for WP4, WP5 and WP8. 6 EXPECTED OUTCOMES The Joint Action will develop concepts and options necessary for efficient secondary use of health data. These will help to create and adopt through appropriate mechanisms common and transparent guidelines, principles, regulations, and decision-making should be available for the secondary use of health data in Europe, the EU Member States and other participating countries. This will enable better, faster, and easier access to health data for research organizations, policy makers, heath service developers and health professionals, consulting and management organisations, health industry and, very importantly, citizens. Date: 2021-06-09 19 / 82 Doc Version: 1.0  Associated with document Ref. Ares(2021)4548885 - 13/07/2021 Shared practices, cooperation and interaction mechanisms between data permit authorities and data controllers in the Member States and other participating countries will enable to foster an improved access to health data and across borders. It is expected that following the adoption of EU-wide legal instruments on secondary use of data, accompanied by financial support for practical action, benefits of wider secondary use of data start emerging as described below. However, this will only happen if countries invest in the use of data and the EU moves swiftly on creating the European Health Data Space to facilitate use of data across national borders. The volume of usage of existing health data will have increased and the benefits visible for a wide number of users, research and innovative development project teams using data for better health services, evidence-based health care, management and health products and care. The wealth of health data sources can be used to obtain a better understanding of health conditions and treatments. The trust of citizens will have increased towards the use of health data for public interest and transparency on the usage of personal health data will be improved, especially on the why, what and who is handling the data. Opportunities for cost-savings for data-users such as researchers when using digital data sources and remote access across the EU instead of traditional statistical data collection methods only. There will be an increased use of health data and better dissemination of European common rules and guidelines for the secondary use of health data. There will be options to combine health data with multisectoral data sources. Research focus will be redirected to health inequalities. There will be a potential to improve disease prevention and early warning mechanisms thanks to new avenues of data analytics, artificial intelligence, and machine learning. Artificial intelligence and machine learning will also set a new demand on the quality of healthcare data, databases, and repositories. 14 4F There will be increased evidence for health care practices with increased use of health data by researchers, health care professionals and policy makers. Data-based decision support for health professionals will increase the quality of care and harmonize health care procedures will considering key determinants of health. There will be more insight on how to make health care systems, health care practices and health management can be more effective thanks to a more effective use of health data. Public health and health policy makers can plan and monitor their activities more precisely and more aligned with regional, national, and European data, benchmark their own results more easily with other structures and develop more effective policies, practices and means. Health industry players will be able to make effective use of more available health data for the developments of new innovations and, for example, in different phases of drug and health device development. 14 Gómez-González, E. and Gómez, E., Artificial Intelligence in Medicine and Healthcare: applications, availability and societal impact, EUR 30197 EN, Publications Office of the European Union, Luxembourg, 2020, ISBN 978-92-76-18454-6, doi:10.2760/047666, JRC120214. Date: 2021-06-09 20 / 82 Doc Version: 1.0  Associated with document Ref. Ares(2021)4548885 - 13/07/2021 7 WORK PACKAGES 7.1 Overview of Work Packages (WPs) # WP Title WP Description WP1 Coordination of the project The Work Package ensures the coordination and management of the project and its implementation as planned. WP2 Dissemination of the project The Work Package makes available and promotes the results and deliverables of the project to the target groups and citizens. WP3 Evaluation of the project The Work Package verifies that the project is being implemented as planned and reaches the objectives. WP4 Outreach, engagement and The Work Package engages national and international sustainability stakeholders by integrating their needs and expectations and exploring their views on economic sustainability and promotes the implementation of the Joint Action’s results. WP5 Sharing data for health The Work Package develops options for a transparent and FAIR operational framework and governance models for the exchange and secondary use of health data, based on trust, citizen empowerment and a common good. WP6 Excellence in data quality The Work Package provides guidance on data quality assurance, and solutions for semantic interoperability. WP7 Connecting the dots The Work Package provides options for the technical interoperability elements of the EHDS, according to the European Interoperability Framework. WP8 Citizens The Work Package seeks to obtain a better understanding of citizens’ relationship with health data in the EU, to better inform and sensitize citizens regarding health data and recommends data altruism practices for the EHDS. 7.2 Work Packages (WP) Description WP No. WP1 WP Title Coordination of the project Start M1 Ending month M30 Lead Sitra Applicant # 1 Acronym Sitra PM 50 Date: 2021-06-09 21 / 82 Doc Version: 1.0  Associated with document Ref. Ares(2021)4548885 - 13/07/2021 Objectives The objective of the WP is the high-quality overall management of the project and the consortium. This includes establishing of the management structure, procedures, and guidelines for the operations, providing systematic monitoring of the activities, establishing reporting guidelines, providing technical and financial reporting, and delivering all necessary reports, including the Interim report and the Final report, administration of the Grant Agreement and the Consortium Agreement, and general risk and ethics assessment. The specific objectives are: O1.1 High quality project management O1.2 Timely and robust financial management and payments to beneficiaries O1.3 Proactive control of contractual obligations according to the Grant agreement and Consortium agreements O1.4 Sound internal communications between WPs and overall, according to the project management structure to keep participants informed and up to date O1.5 Close interaction with the European Commission and other EU institutions, agencies, and health policy entities Description of work WP1 provides the overall project coordination, project management, financial management, and risks and ethics management. This includes arranging the online and face-to-face (hybrid) meetings, conflict solving, and how information will be exchanged among participants. Project leadership: The TEHDAS Joint Action Coordinator will work in close cooperation with the project management team and WP leaders to implement this project. Task 1.1 Project coordination Lead partner: Sitra; Duration: M1-M30 WP1 leader leads the Project Steering Group and coordinates the project. Deliverables and milestones are M1.1, M1.2, and M1.4. Task 1.2 Project management Lead partner: Sitra; Duration: M1-M30 This task includes all processes listed in chapter 9. WP1 is responsible of the monitoring and overall execution of the project. Deliverables and milestones are D1.1, D1.2, and M1.3. Task 1.3 Financial management and reporting Lead partner: Sitra; Duration: M1-M30 The project has specific and clear financial management and reporting rules specified by the operating agency of the grant. WP1 is responsible on behalf of the whole project to manage the budget, report to the agency on the actual costs and manage project finances. Deliverables and milestones are D1.3, and D1.4. Task 1.4 Stakeholder cooperation and representing TEHDAS externally Lead partner: Sitra, Duration: M1-M30 Where stakeholder engagement is distributed in thematic work packages in focus groups as well as to Work Package 4 with a policy forum and project forum, the TEHDAS joint action needs bilateral engagement with target policy entities listed in Chapter 3. The most evident relationship is with the Date: 2021-06-09 22 / 82 Doc Version: 1.0  Associated with document Ref. Ares(2021)4548885 - 13/07/2021 European Commission and its’ operating agency HaDEA. WP1 is responsible of those relationships as well as representing TEHDAS externally. A milestone is M1.5. Deliverables (D) linked to this WP D1.1 Project Management Plan (M4) D1.2 Risk Management Plan (M4) D1.3 Interim report (M15) D1.4 Final report (M30) Milestones to be reached by this WP M1.1 Grant Agreement (M3) M1.2 Consortium Agreement (M3) M1.3 PSO Agreement (M3) M1.4 Progress reports to General Assembly (M5, M15, M27) M1.5 Stakeholder Forums (M9, M16, M28) WP No. WP2 WP Title Dissemination of the project Start M1 Ending month M30 Lead Sitra Applicant # 1 Acronym Sitra PM 23 Objectives The WP creates an identity for the project and provides the key messages to communicate about the project which are recognisable and deliver the purpose and importance of the work. The WP will make the deliverables and results of the project well-known among target groups during and beyond the lifetime of the project. The project will be a relevant stakeholder in the public dialogue regarding the European Health Data Space and especially the future of the secondary use of health data in Europe. The specific objectives are: O2.1 To guarantee well-coordinated and timely communication in each stage of the Joint Action and to maximize the effective dissemination of the JA’s efforts and results. O2.2 Create an identity for the project and a shared idea of the key messages (goals & relevance) as basis of communication. O2.3 Make the deliverables and results of the project well-known among target groups during and beyond the lifetime of the project. Date: 2021-06-09 23 / 82 Doc Version: 1.0  Associated with document Ref. Ares(2021)4548885 - 13/07/2021 Description of work The basis of the strategic communications plan is to identify the relevant stakeholders as explained in Chapter 3, target groups and networks and to engage (and build trust) accordingly in collaboration with WP4. For the communication and dissemination activities to succeed, measurable goals for these activities will be set in the Dissemination Plan (MD2.1). Effective communications and a shared view of the possibilities of health data is based on dialogue and engagement between the JA and different stakeholders. WP2 focuses on public dissemination. WP4 focuses on stakeholder involvement at operational level to share technical, scientific and political expertise within TEHDAS between policy makers and relevant European initiatives. Date: 2021-06-09 24 / 82 Doc Version: 1.0  Associated with document Ref. Ares(2021)4548885 - 13/07/2021 To measure the effectiveness and the success of the dissemination activities and the success to reach the goals set in the beginning of the work, an on-going media analysis on the topic will be conducted as well as systematic social media monitoring. Also citizen polls can be a relevant tool. A more detailed stakeholder/target group analysis will be conducted in the beginning of the Joint Action but on a general level at least following groups and channels to reach them can be identified: Organisations and specialists working for/within TEHDAS Joint Action (Teams working space, webpage of the JA, quarterly newsletter, materials distributed via email, regular summits, General Assembly & online meetings, etc.) Stakeholders generating health data, i.e. individuals as citizens and patients, healthcare providers including primary care, hospitals, healthcare professionals, research organisations, registries, biobanks, companies involved in wellbeing, health, and health technology industries (main channels through which to reach them: dissemination of related deliverables via webpage and social media, newsletter, media coverage, final report of the JA) Stakeholders utilizing health data in the secondary use case, i.e. Health professionals, consulting and management organizations, health industry (meetings, briefings, webpage, social media, newsletter, media coverage, final report of the JA) Stakeholders guarding access to and protecting data, i.e. legislators, policy makers, data permit authorities and decision makers both on national and European level (meetings, briefings, webpage, newsletter, media coverage, final report of the JA) European citizens (identifying and understanding the on-going public debate on health data both on social media channels and in traditional media, surveys, possible online-seminars etc., in close relation to the work done in WP8) The Tasks of the WP2 are: Task 2.1 Plan dissemination activities Lead partner: Sitra; Duration: M1-M30 Strategic communication including timing of the communication activities with external events such as legal proposals from the European Commission, EU presidency events and other important external events. TEHDAS work is very much linked to other activities which take place planned or unplanned regardless of the timeline of our activities. Both proactive and reactive communications are needed to support TEHDAS and EHDS. A deliverable is MD2.1 Task 2.2 Create and maintain website for the JA Lead partner: Sitra; Duration:M1-M30 Website is of the first point of contact for stakeholders which are not in the inner circle of TEHDAS. They must serve wide range of stakeholders and provide up-to-date and accurate information of TEHDAS and EHDS and promote them and support the overall work. Deliverables are MD2.3 and MD2.4. Task 2.3 Maintain active presence and dialogue on social media and in other relevant channels Lead partner: Sitra, Duration: M1-M30 Social media presence is not a task of a single work package or an individual such as communication manager. However, TEHDAS will have an official social media accounts in selected social media channels as well as social media strategy. This task is responsible of the social media presence and dialogue and giving guidance to other project participants on how to engage stakeholders in a dialogue related to EHDS and its targets. Deliverables and milestones are MD2.2, M2.1 and M2.2. Task 2.4 Work packages related communications Date: 2021-06-09 25 / 82 Doc Version: 1.0  Associated with document Ref. Ares(2021)4548885 - 13/07/2021 Lead partner: Sitra; Duration: M1-M30 Thematic WPs have communication needs especially when a deliverable or milestone is completed. This task supports all WPs in their communication and manages possible public consultation processes on their behalf. Milestones are M2.4 and M2.5. Task 2.5 Maintain contacts and direct communication Lead partner: Sitra, Duration: M1-M30 While social media has replaced newsletters as a main communicational mechanism, newsletters and other targeted communications still serve a purpose in summarizing the progress for stakeholders which do not follow the project closely. A contact list of interested stakeholders is also needed to activate stakeholders regarding events and consultations. Milestone are M2.3 and M2.6. Task 2.6 Communication reach and tracking Lead partner: Sitra, Duration: M1-M30 Media and social media coverage are great tools to understand both generic and specialists’ discourse over EHDS. Understanding how our project is covered and how much visibility targeted communications reach will enable more efficient communication and possibility to adapt key messages if necessary. A milestone is M2.7. Deliverables (D) land Mandatory Deliverables (MD) inked to this WP MD2.1 Dissemination plan (M4) MD2.2 Leaflet (M4) MD2.3 Website (M3) MD2.4 Layman version final technical report (M30) Milestones to be reached by this WP M2.1 Open Call for Stakeholders (M2) M2.2 Quarterly newsletters (M3, M5, M8, M11, M14, M17, M20, M23) M2.3 Stakeholder consultations (M12, M16, M18) M2.4 Dissemination reports (M6, M12, M15, M18, M21, M24, M27) M2.5 Dissemination activity checks with WPs (M3, M7, M11, M15, M19, M23) M2.6 Stakeholder contact list (M3, M5, M8, M11, M14, M17, M20, M23, M29) M2.7 Coverage metrics and follow-up (M2, M6, M10, M14, M18, M22, M26, M30) WP No. WP3 WP Title Evaluation of the project Start M1 Ending month M30 Lead SPMS Applicant # 21 Acronym SPMS PM 11 Date: 2021-06-09 26 / 82 Doc Version: 1.0  Associated with document Ref. Ares(2021)4548885 - 13/07/2021 Objectives The success of this JA depends on the effectiveness in accomplishing defined goals and objectives. The overall aim of WP 3 is to assess the degree to which the TEHDAS JA achieves its defined objectives and has an impact in the target groups. The objectives are: O3.1 Develop a concise and structured internal evaluation plan with a focus on the general project objectives and the specific objectives of individual WPs. The evaluation plan will comprise three distinct components in the evaluation design: process evaluation, output evaluation, outcome evaluation. It will include a clear description of the methods for evaluation, indicators and measures of verification based on the specific objectives. This will ensure the adequate framework to assess if the Joint Action is being implemented as planned and reaches its foreseen objectives. The internal evaluation plan will describe the rational and design of evaluation activities so that quality assurance of deliverables is performed by partners that are not involved in the in the specific outputs/deliverables that are being assessed/evaluated. Also, to ensure consistency of deliverables and consistency of the quality review process (see Chapter 9.3), every deliverable to the target group should undergo a common, predefined, quality review checklist (to be provided to evaluators). The quality review will be incorporated as an integral part of the JA evaluation reports. Date: 2021-06-09 27 / 82 Doc Version: 1.0  Associated with document Ref. Ares(2021)4548885 - 13/07/2021 Description of work Task 3.1 Develop the evaluation strategy Lead partner: SPMS, Duration: M1-M5 The evaluation strategy will describe the rationale of project´s internal evaluation plan and will be developed at the beginning of the JA, in close collaboration with WP1. The evaluation strategy focus will be in defining a robust methodology to identify indicators that provide an insight into the extent to which processes, outputs and outcomes are being realized and meet user’s needs. The evaluation plan will outline evaluation objectives, systematic methods for collecting and measure evaluation data, what will be evaluated, responsibilities and roles for the evaluation and the timeline of evaluation activities. A deliverable is MD3.1. Task 3.2 Conduct evaluation activities Lead partner: SPMS, Duration: M5-M24 WP3 will verify and assess how the delivered inputs (i.e. deliverables) of the Action have satisfied the needs and expectations of the target group and how the JA coordination has achieved MS involvement, dissemination, and sustainability of project results. The evaluation activities will focus on the main target group but also on the performance of the WPs delivering input. WP3 will further analyse the impact of the work done by WP4-WP8 on the main priority areas defined in the JA. Evaluation methods and tools will be defined for data to be collected from WPs, WP leaders and relevant participants (as applicable) as well as from target group representatives. A milestone is M3.1. Task 3.3. Analyse evaluation data Lead partner: SPMS, Duration: M5-M30 WP3 will collect and analyse data and perform evaluation of the JA at regular intervals. The key deliverables will be continuously monitored, and results presented in the interim evaluation report and the final evaluation report. The interim evaluation report will give special attention to deviation from the timeline of the project plan. The final evaluation report will focus on the registry of milestones and deliverables achievement by each WP, including the quality of outputs. It will engage stakeholders in the analysis of gathered evidence to justify conclusions and ensure use of lessons learned. To ensure consistent quality of deliverables this WP will support, in collaboration with WP 1, a quality assurance framework to ensure every deliverable for the target group will undergo a predefined revision before approval by the Project Steering Group. To ensure quality in legal or technical aspects, this work may engage external matter experts in the revision panel. Deliverables and milestones are MD3.2, MD3.3, M3.2 and M3.3. Deliverables (D) and Mandatory Deliverables (MD) linked to this WP MD3.1 Evaluation plan (M5) The Evaluation Plan will define the design and timeline of project´s evaluation activities. MD3.2 Interim evaluation report (M16) The interim evaluation report will assess the intended outcomes, outputs, and the success indicators in the mid-term. MD3.3 Final evaluation report (M30) The final evaluation report will draw on the interim evaluation report to provide the results of the evaluation, with concluding remarks to the entire JA. Date: 2021-06-09 28 / 82 Doc Version: 1.0  Associated with document Ref. Ares(2021)4548885 - 13/07/2021 Milestones to be reached by this WP M3.1 Evaluation tools and templates (M9) M3.2 Draft interim evaluation report (M12) M3.3 Draft final evaluation report (M28) WP No. WP4 WP Title Outreach, engagement and sustainability Start M1 Ending month M27 Lead Sciensano Applicant # 1 3 6 12 16 21 22 24 Acronym Sitra Sciensano MZCR OKFŐ DHIR IPHS NIJZ SEHA “Batut” PM 8 29 3 4 5 1 5 4 Objectives The aim of this Work Package is, in close collaboration with all Work Packages, to outreach and engage national and international players, for TEHDAS to reflect their needs and expectations, and to explore views on its economic sustainability as well as to suggest concrete ways to integrate the results into the future EHDS. The objectives are: O4.1 Provide an overview of national health data developments which include a reflection on needs and expectations at national and international level to allow alignment of TEHDAS’ activities, O4.2 Create a solid base for regular exchange and support for current and future EHDS activities, O4.3 Explore views of the value that could be created to share secondary data across Europe and EHDS O4.4 Propose a sustainability plan with a roadmap for further EHDS implementation. Date: 2021-06-09 29 / 82 Doc Version: 1.0  Associated with document Ref. Ares(2021)4548885 - 13/07/2021 Description of work Task 4.1 Mapping countries expectations through country visits Lead partner: Sciensano; Partners: MZCR, OKFŐ, DHIR, RS, NIJZ, SEHA, DoH-IE (HRB), OKFŐ (SU) Duration: M1-M24 Through (virtual) country visits, a mapping is carried out to provide an overview of national health data developments and statuses, building on the Assessment of the EU Member States’ and other participating countries’ rules on health data in the light of GDPR report. Some countries have developed national health data hubs others have indicated interest in developing one. Making use of the diversity in Europe, a selection of countries in different stages of development and different health systems will be visited. The visits will allow to reflect on needs and expectations at national level and reflect on how TEHDAS and the EHDS can respond to them. MS/AC authorities and stakeholders will be mobilised and involved in the process providing an opportunity to exchange views. It will also provide an opportunity to familiarise TEHDAS to various stakeholders in the field. A subtask will respond to national needs put forward during the mapping exercise and respond by facilitating short targeted online training courses in collaboration with identified initiatives and projects in Task 4.2, which serves the capacity building needs in countries. WP leaders will be involved by providing an overview of what MS/AC authorities can expect from TEHDAS and will be engaged by providing input on what the mapping tool should include for their WP. Deliverables and milestones D4.1 and M4.1. Task 4.2 Policy and Project Forum to integrate in national and international landscape Lead partner: Sciensano; Partners: Sitra, MZCR, DHIR, NIJZ, SEHA, SEHA (PHAS), DoH-IE (HRB). Duration: M1-M27 To be integrated in the national and international landscape, it is key to engage with national and international stakeholders and initiatives. Two different levels of interaction are needed: policy level and project level. At policy level, MS/AC national authorities and international organisations will be engaged through a Political Forum. The progress of the different WPs will be presented and potential routes for sustainable interaction will be sought. At project level, connectivity with European initiatives and projects will be sought to build TEHDAS on previous projects. In preparation, a mapping exercise will be carried out to identify relevant initiatives TEHDAS. This includes, amongst others, BRIDGE Health, the Joint Action on Health Information (InfAct) PARENT, JASEHN, eHAction, eHDSI, the Health Research and Innovation Cloud, the European Open Science Cloud and the Population Health Information Research Infrastructure, the 1+ Million Genomes initiative, ELIXIR, Global Alliance for Genomics and Health GA4GH.org. These initiatives will be invited to participate to the Project Forum to share relevant outputs, to build on previous findings and to discuss potential synergies to avoid duplication. The Fora will bring key initiatives together, build on what has been done and strive towards making outcomes interoperable. Four Policy and Project Forum will be organised back to back in close collaboration with the WP leaders. As part of Task 4.2 and building on Task 4.1, this task will explore views on the value of sharing secondary data across Europe, potentially through an EHDS and ideas how to distribute the value (co-)created through EHDS. One of the Policy and Project Forum will be used to discuss this topic. The views and experience of MS/AC national authorities and international projects will be collected. Deliverables and milestones D4.2 and M4.2. Task 4.3 Sustainability plan Lead partner: Sitra; Partners: Sciensano, MZCR, OKFŐ, DHIR, OKFŐ (SU); Duration: M1-M24 In close collaboration with WP leaders, this task will develop a sustainability plan which considers also economic needs in setting up the EHDS; business models of designated agencies will be discussed in WP5. The sustainability plan will be a pragmatic approach to a roadmap providing recommendations on Date: 2021-06-09 30 / 82 Doc Version: 1.0  Associated with document Ref. Ares(2021)4548885 - 13/07/2021 future implementation of EHDS. It will pay timely attention to policy proposals on EU data spaces and consider their evolving implementation, if necessary, an interim version of the plan will be provided. Date: 2021-06-09 31 / 82 Doc Version: 1.0  Associated with document Ref. Ares(2021)4548885 - 13/07/2021 The sustainability plan will include outputs from each of the WPs including the results from the country visits. Task 4.3 will also map early on which existing data infrastructures can be leveraged on and could be building blocks of EHDS and assess how they could potentially be linked. Deliverables and milestones D4.3 and M4.3. Deliverables linked to this WP D4.1 Country fact sheet (M24) A fact sheet from each country visit will be provided providing an overview of the mapping exercise. D4.2 Policy and Project Forum Report (M27) The Policy and Project Forum Report provides the minutes and conclusions of the meetings. D4.3 Sustainability plan (M24) The sustainability plan will provide a pragmatic approach to a roadmap providing recommendations on future implementation of EHDS. It will provide the outputs of the different WPs and recommendations on how they can be taken up at national and international level. Milestones to be reached by this WP M4.1 Template of mapping tool and Expressions of Interest (M6) In close collaboration with all WPs leaders a template will be developed for the country visit mapping tool. It will provide the key topics that will be mapped through the exercise and describe the process for the country visits. A call for expression of interest will be launched to select countries for the mapping exercise based on the TEHDAS consortium. M4.2 Policy and Project Forum (M4, M9, M16, M26) M4.3 Mapping of the existing infrastructures to build on (M8) WP No. WP5 WP Title Sharing data for health Start M1 Ending month M24 Lead SEHA (Lead), VWS (Co-lead) Applicant # 1 2 3 4 5 6 7 8 9 Acronym Sitra ATNA Sciensan CH MoH- MZC RM MoSA FR-HDH o IF CY R PM 4 2 8 3 0 4 4 1 11 Applicant # 10 11 12 13 14 15 16 17 Acronym BMG 6th Y. OKFŐ DoH-IE MINS SAM- DHIR ATRM PE. AL LT PM 0,5 2 5 1 3 4 2 1,5 Applicant # 18 19 20 21 22 23 24 25 Acronym VWS MoHNO SPMS IPHS NIJZ IACS SEHA NHSC “Batut” Date: 2021-06-09 32 / 82 Doc Version: 1.0  Associated with document Ref. Ares(2021)4548885 - 13/07/2021 PM 15 3 6 1 4 8 16 4 Objectives Overall objective is: Setting options for the operational framework and governance models for the exchange and secondary use of health data between European countries, respecting the principles of transparency, trust, FAIRness*, citizen empowerment and common good. Specific objectives are: O5.1 Define and develop the evidence base for the secondary use of health data in EHDS, user perspectives. O5.2 Enable cross-border exchange and secondary use of health data through guidelines/recommendations for European countries when planning national legislation. O5.3 Create guidelines for an organizational framework for cross-border exchange of personal health data based on a single point of access model connecting centralized as well as decentralized systems in the EHDS and support national capacity building. O5.4 Develop options for governance models for the EHDS and support national capacity building. Date: 2021-06-09 33 / 82 Doc Version: 1.0  Associated with document Ref. Ares(2021)4548885 - 13/07/2021 Description of work The initial work is based primarily on two overarching perspectives. The first one is the userperspective, here limited to the scientific researchers’ and the policy-makers’ perspectives. The second perspective is the one of the data permit authority, however since data permit authorities may not be present as such in all European countries, we herein name these designated bodies health data access “permitters” and “providers.” In some European countries, the permitter and provider of health data for secondary use can be the same body. The perspectives of the permitters/providers from different countries are compiled to map and characterize the interpretation of GDPR, and the challenges in the application of policy and regulation. The analyses of the perspectives feed into the parallel work of forming a governance model for EHDS, by first defining preliminary elements for this. The work will be conducted according to an iterative process of two cycles, one cycle per year of the TEHDAS program. All four tasks will in principle start from the beginning of the programme, and feed into each other resulting in options for preliminary elements for governance models to be delivered at the end of the first cycle. These elements will then be tested against the users and the permitters/providers, followed by a finetuning and anchoring process engaging most of the relevant stakeholders. Eventually they will be transformed into proposed options for governance models. The work of WP5 includes regular dialogue with other TEHDAS work packages (e.g. WP4, WP6, WP7), and the outcome of WP5 will feed into these as well, and in some cases vice versa. Task 5.1 Define and develop the evidence base for the secondary use of health data in EHDS, user perspectives Task lead: Sciensano; Partners: MZCR, 6YPE, SAM-LT, MoH-NO (FHI), SPMS, IPHS “Batut”, NIJZ, IACS, SEHA, NHSC, DoH-IE (HRB), MoSA, NHSC (WSI), ATRM, MoH-CY; Duration: M1-M13 Task 5.1 aims to define and develop the evidence for secondary use of health data by identifying data sharing practices across Europe, to provide information to the European Health Data Space and the European Commission’s legislative proposals. This task involves three steps. Step one is to conduct a focused literature review to identify the barriers to cross-border sharing of health data for secondary use, for non-personal health data and personal health data under the GDPR following a rapid review methodology. Step two is to develop and set the framework for national and cross-border use cases (i.e. case studies) based on the literature review findings and prioritisation analysis. These use cases will map pan-European data flows focusing specifically on the user perspective. They will explore the purpose, requirements and type of data focusing on i) scientific research and innovation and ii) policy making (incl. regulatory) for public health purposes. In step three, an analysis of the literature review, stakeholder Date: 2021-06-09 34 / 82 Doc Version: 1.0  Associated with document Ref. Ares(2021)4548885 - 13/07/2021 engagement and use cases will help to identify and to evidence best practices for sharing data between European countries. The results will be complied as a report (D5.1) with scientific research and innovation (M5.1) and policy making (M5.2) use cases included as an annex. The task outputs will also inform other Work Packages, Tasks and Deliverables including Work Package 4 (T4.1) (D4.1) and Work Package 5 (T5.2) (T5.3) (D5.2) (D5.3) (D5.4). Task 5.2 Enabling the secondary use of data by aligning the interpretation of GDPR Task lead: SEHA; Partners: CHIF, MZCR, RM, OKFŐ, MINSAL, SAM-LT, DHIR, VWS, NIJZ, DoH-IE (HRB), CHIF (CHIP), ATRM, MoSA, MoH-CY, OKFŐ (SU); Duration: M1-M22 This task initiates partially from the analysis of use cases in Task 5.1. to provide a multi-national and eventually Pan-European health data access permitters'/providers' perspective on the interpretation of GDPR in relation to secondary use (including cross-border data exchange). It provides permitters' and providers' perspective, and legal interoperability. The work includes a mapping of the different national designated bodies having the function as health data access permitters and/or providers, with the aim of forming the conditions for future multilateral constructive networking. Information and knowledge from previous studies (e.g. the EUHealthSupport Study) will be supplemented with necessary surveys and interviews to provide a Pan-European permitters'/providers’ perspective. This includes economical sustainability aspects in the form of business models of the different designated bodies (thereby relating e.g. to WP4). A compilation of collected information will result in Milestone M5.3, thereby displaying a collected image of the situation in several member states when it comes to regulation and administration of health data for secondary use. This material will then be further processed and analysed in order to provide the foundation for the Deliverable 5.2, in the form of a Recommendation/Guidelines for all concerned European countries when planning national legislation on secondary use of health data. The outcome of this task will feed mainly into task 5.4, thereby contributing to legal interoperability in relation to EHDS. Deliverables and milestones are D5.2 and M5.3. Task 5.3 Best practises for EU-cross border sharing of personal health data Task lead: FR-HDH; Partners: Sitra (THL/Findata), VWS, IACS, FR-HDH (Inserm), FR-HDH (UT3); Duration: M1-M24 In order to identify best practices for EU-cross border sharing of personal health data (permitters' perspective and organisational interoperability), the four participating countries in this task offer a variety of solutions suitable for differing situations and the necessary level of maturity to be considered as a good practice. The subtasks will focus on the description of steps in accessing individual-level data for national and EU researchers in a selection of centralised (FIN, FR) and decentralised systems (NL, ES) and the establishment of a framework of a bi- or multilateral partnership agreement between structures responsible for the secondary use of health data. On this basis, use cases for cross-border collaborations for the secondary use of health data in centralised and decentralised systems will be identified, for example using the case of rare diseases. Recommendations for best practices for EU cross-border exchange including data access and data permit processes in different national settings will be elaborated and tested in an EU-wide workshop, paying attention to be realistic at different levels of maturity across Europe. Specific external legal expertise will be needed for the establishment and implementation of the bilateral partnership agreement. Such expertise requires knowledge of the legal framework cross border research collaborations and EU law which is not available internally. Deliverables and milestones are D5.3, M5.4, M5.5., M5.6. Task 5.4 Developing options for governance models for the EHDS Task lead: VWS; Partners: Sitra, ATNA, Sciensano, CHIF, RM, OKFŐ, MINSAL, MoH-NO, SPMS, IACS, SEHA, NHSC, CHIF (CHIP), RM (CDEU), BMG, NHSC (WSI), OKFŐ (SU); Duration: M1-M19 Date: 2021-06-09 35 / 82 Doc Version: 1.0  Associated with document Ref. Ares(2021)4548885 - 13/07/2021 This task will provide a synthesis of the other tasks of WP5, resulting in preliminary elements for governance models at the end of the first iterative cycle. The preliminary elements consider also horizontal governance for Data Spaces and clarifies health specific aspects in governance. Eventually, at the latter part of the second iterative cycle, final options for governance models for the EHDS. Task 5.4 works towards a deliverable that sets out options for governance models based on federated collaboration considering both centralised and decentralised solutions. It is a culmination resulting from an iterative process of selecting and integrating content of the mapping and identification exercises performed in other tasks under WP 5 (primarily T5.2). Deliverables and milestones are D5.4, M5.7, M5.8. Deliverables linked to this WP D5.1 Report on secondary use of health data through European case studies (M13) This deliverable will present best practices identified in European case studies on the secondary use of data to inform the European Health Data Space. This document will summarise on a multinational level the conclusions the respective user categories included (scientific researcher and innovator, and policymaker respectively). The document will also consolidate the analysis results of the literature review, use cases and stakeholder consultation. The use cases will be presented in an annex to the document. D5.2 Guidelines/Recommendations for European countries when planning national legislation on secondary use of health data (M22) This deliverable is a document presenting basic guidelines/recommendations intended to facilitate the planning (and implementation) of national legislation on secondary use of health data. These guidelines/recommendations are in turn based on a documented summary on a multinational level of the experiences and conclusions of pioneering European countries that already have a national legislation of this kind, in combination with the needs of other European countries in this respect. D5.3 Recommendations for best practices for EU cross-border exchange including data access and data permit processes in different national settings (M24) In order to identify best practises for EU-cross border sharing of personal health data this deliverable will focus on the description of steps in accessing individual-level data for national and EU researchers in a selection of centralized and decentralized systems and the establishment of a framework of a partnership agreement between structures responsible for the secondary use of health data. On this basis, use cases for cross-border collaborations for the secondary use of health data in centralized and decentralized systems will be identified. Recommendations for best practices for EU cross-border exchange including data access / data permit processes in different national settings will be elaborated and tested in an EU-wide workshop. D5.4 Options for governance models for the EHDS (M19) This deliverable is a document presenting well-established options for governance models for the EHDS, taking into consideration a Pan-European perspective in combination with the best interest of the concerned stakeholders in general and the citizen. Milestones to be reached by this WP M5.1 Use cases: Scientific research and innovation (M5) Identify and develop the use cases to represent the diversity of research user groups across Europe. The data collection will include and compile information regarding user purposes, requirements, type of data Date: 2021-06-09 36 / 82 Doc Version: 1.0  Associated with document Ref. Ares(2021)4548885 - 13/07/2021 through an analysis of use cases, previous relevant studies, and stakeholder consultation. This milestone considers analysis of data on a spectrum of identifiability. M5.2 Use cases: Policymaking for public health purposes (M5) Identify and develop the use cases to represent the diversity of policy makers across Europe. The data collection will include and compile information regarding purposes, requirements, type of data through an analysis of relevant case studies, previous relevant studies, and stakeholder consultation. This milestone considers analysis of data on a spectrum of identifiability. M5.3 GDPR interpretations in the secondary use of health data in different member states and other participating countries (M6) Data collection concluded and compiled regarding health data access permitters and providers in the different MS regarding GDPR interpretations based on the use cases above. M5.4 Description of steps in accessing individual-level data for national and EU researchers in a selection of centralized systems and decentralized systems (M12) M5.5 Guideline document for a peer-to- peer and cross-border partnership for the secondary use of health data (M12) M5.6 Compilation of best practices for EU cross-border exchange including data access and data permit processes in different national settings (M24) M5.7 Analysis of health specific governance aspects for an EHDS (M5) M5.8 Analysis of the capacity of existing EU structures and options on how the governance aspects defined in M5.7 can be made within the current structures or with new structures (M7) WP No. WP6 WP Title Excellence in data quality Start M1 Ending month M24 Lead IACS (Lead), RM (Co-lead) Applicant # 1 2 3 5 7 9 12 14 18 Acronym Sitra ATNA Sciensano MoH-CY RM FR-HDH OKFŐ MINSAL VWS PM 7 2 2 0 13 10,5 4 4 2 Applicant # 19 20 23 24 6 Acronym MoH-NO SPMS IACS SEHA MZCR PM 4 7 30,75 2 1 Objectives WP6 will be providing solutions for the trustworthy secondary use of health and health care data with a view to fostering the digital transformation of the European health systems. This overarching objective will be developed throughout two operational objectives: O6.1 Developing the EHDS data quality assurance framework for a secondary use of real-world health data. O6.2 Developing the EHDS Semantic Interoperability framework From the perspective of information users and data producers, data are deemed of quality if data faithfully depict the real-world construct that it aims at representing. For the TEHDAS JA, the real-world construct has to do with the digital transformation of the health systems in Europe, that must rely on the secondary use of massive data; thus, data routinely collected by Date: 2021-06-09 37 / 82 Doc Version: 1.0  Associated with document Ref. Ares(2021)4548885 - 13/07/2021 multiple data holders and controllers in multiple sites throughout the European Union. The secondary use of health data, beyond the legal, governance and ethical questions, has as the main challenge to ensure that data collected and stored for different purposes is accurate to provide high-quality real-world evidence and by this means, inform national and European decision-making processes in a trustworthy and timely manner. In addition, the increasing use of sophisticated methodologies (for example, development of pragmatic trials, the use predictive machine learning or exploratory artificial intelligence approaches) creates also new demands on data quality. In that sense, the secondary use of real-world data (RWD) requires a quality assurance framework, but also guidance on what methods and techniques has been proved reliable to ensure the production of accurate evidence; thus, it will be needed to explore what methods and techniques allow the mitigation of data incompleteness and missingness, how to achieve semantic interoperability, how to reach over time data consistency, or conduct unbiased analyses. Notably, excellence in the secondary use of real-world data should fit-for-purpose; so, data quality must be responsive to the needs of the different information users. So, policy makers (e.g., in their role of planning and financing), regulators (e.g., in their legislative role), health technology assessment agencies (e.g., as regulators for the approval of high-value technologies), insurers (e.g., in the role of services purchasers), providers (e.g., pursuing the delivery of high-quality services), patients (e.g., as beneficiaries of the health system), citizens (e.g., as active agents for health promotion), the health industry in Europe (e.g., in their role of producers of high-value goods and services) and researchers (e.g., in their role of producers of real-world evidence). WP6 developments will have to be consistent with the architectural design in WP7 (i.e.., a peer-to-peer federated infrastructure whose nodes are of a different nature (member states, other participating countries, cross-national institutions, research infrastructures) and with the need of translating the data quality framework into a legal proposal. Description of work T6.1 Develop the EHDS Data quality assurance framework (DQAF) Date: 2021-06-09 38 / 82 Doc Version: 1.0  Associated with document Ref. Ares(2021)4548885 - 13/07/2021 Task leader: RM, Partners: Sitra (THL), ATNA, Sciensano, FR-HDH, OKFŐ, MINSAL, SPMS, IACS, RM (CDEU), FR-HDH (Inserm), FR-HDH (AMU), DoH-IE (HRB), OKFŐ (SU); MoH-NO (Hdir) Duration: M1-M24 Subtask 6.1.1: Assessment of DQAF good practices. Partners involved: RM, Sitra (THL), ATNA, Sciensano, FR-HDH, OKFŐ, MINSAL, SPMS, IACS, RM (CDEU), FRHDH (Inserm), FR-HDH (AMU), DoH-IE (HRB), OKFŐ (SU). This task will analyse the implementation of DQAF and data quality policies in the context of P2P federated infrastructures. Though not exclusively, features to analyse in those experiences will be: the quality of metadata, anonymization and pseudonymization methods, conditions for the use of synthetic data, solutions for the treatment of missingness and incompleteness, data heterogeneity, solutions for the reuse of semi-structured and unstructured data, or methodologies on data visualization and preanalytic metrics. Special attention will be paid to high-profile methods such as comparative effectiveness studies, predictive machine learning and deep learning techniques. Out of this analysis, T6.1 DQAF will detail data entry requisites (dimensions such as accuracy, coherence, timeliness, consistency and trustfulness), some of them legally bound, and provide recommendations on data quality governance (e.g., how to include new data sources, how to ex ante check data quality or when data should be audited). For the purposes of this task a scoping review on those more relevant DQAF experiences will be carried out. Secondarily, in-depth interviews will be conducted with the coordinator of such experiences. In addition, a review on the current legislation of health data quality frameworks will be also conducted. For the purposes of this task a scoping review on those more relevant DQAF experiences will be carried out. Secondarily, in-depth interviews will be conducted with the coordinator of such experiences. In addition, a review on the current legislation of health data quality frameworks will be also conducted. Subtask 6.1.2 Assessment of existing European legislation. Partners involved: RM, Sitra (THL), ATNA, Sciensano, FR-HDH, OKFŐ, MINSAL, SPMS, IACS, RM (CDEU), FRHDH (Inserm), FR-HDH (AMU), DoH-IE (HRB), OKFŐ (SU). European legislation regulating the use of data models and encoding systems (e.g., INSPIRE) will be retrieved and analysed. In addition, a scoping review on methodologies for the adequate use of RWD will shed light on the discovery of quality issues in original datasets; (e.g. outlier values, anomalous distributions, risk -of multidimensionality, heterogeneity, etc.). Deliverables and milestones referred to task 6.1 are D6.1 and M6.1 T6.2 Develop the EHDS Semantic Interoperability Framework Date: 2021-06-09 39 / 82 Doc Version: 1.0  Associated with document Ref. Ares(2021)4548885 - 13/07/2021 Task leader: IACS, Partners: Sitra (THL), ATNA, RM, FR-HDH, OKFŐ, MINSAL, MoH-NO (E-helse), SPMS, SEHA, FR-HDH (Inserm), FR-HDH (HCL), FR-HDH (ANS), BMG (Gematik), VWS(Nictiz), OKFŐ (SU), MZCR, E-helse-NO; Duration: M3-M20 Inspired by the Refined eHealth European Interoperability Framework (ReEIF) this task will explore semantic interoperability to harmonize the semantic integration of health data and metadata from any relevant data source into the EHDS according to FAIR principles. Legal and organizational interoperability is developed in WP5 and technological interoperability in WP7. T6.2 is composed of two subtasks to cope with this objective are: Subtask 6.2.1: Assessment of existing Common Data Models for P2P federated infrastructures. Partners involved: IACS, Sitra (THL), ATNA, RM, FR-HDH, OKFŐ, MINSAL, MoH-NO (E-helse), SPMS, SEHA, FR-HDH (Inserm), FR-HDH (HCL), FR-HDH (ANS), BMG (Gematik), VWS(Nictiz), OKFŐ (SU), A scoping review meant to analyse data models and encoding systems proven suitable for P2P federated infrastructures (e.g., InSite (EHR4CR, EHR2EDC), TriNetX, OHDSI, EHDEN, INFACT JA, PARENT JA, BBMRI, ELIXIR, EU Platform for RD registration, ERNJP RD, S); this analysis will map out national and international standards for semantic harmonization (e.g., SNOMED CT, LOINC, ICD, NOMESCO, CIAP, ORPHACODES, etc.) and common data models (e.g., OMOP); and, A link with the X-ehealth JA will be ensured. Subtask 6.2.2: Development of a EHDS semantic interoperability framework. Partners involved: IACS, Sitra (THL), ATNA, RM, FR-HDH, OKFŐ, MINSAL, VWS(Nictiz), MoH-NO (E-helse), SPMS, SEHA, FR-HDH (Inserm), FR-HDH (HCL), FR-HDH (ANS), BMG (Gematik), VWS(Nictiz), OKFŐ (SU), MZCR A subtask that aims the development of the EHDS semantic interoperability framework compliant with FAIR principles and common data model (CDM) in accordance with those data sources available in the federation for secondary use. A workshop with TEHDAS competent authorities will be conducted to reach a consensus on the final EHDS common data model. Deliverables and milestones are D6.2 and M6.2. Deliverables linked to this WP D6.1 EHDS data quality assurance framework (M12, M24). The deliverable will contain two types of contents: 1) the requisites for the inclusion of data in the EHDS, including semantic interoperability; among those, the document will identify those features that could be legally bound; and 2) guidance on how to get data included in the EHDS, including requisites for data interoperability (i.e., data model and encoding systems) and recommendations for data quality governance. In Month 24, D6.1 will be upgraded with the EHDS sematic interoperability framework delivered in Month 20. D6.2 EHDS Semantic interoperability framework (M20) The deliverable will propose a semantic interoperability framework for the EHDS including the common data model for the EHDS. (NB T6.2 links with WP5 as the semantic interoperability framework is a key feature of the governance of a federated infrastructure. Its deliverable should also link with WP7 as the CDM is the underlying layer supporting part of the services envisaged). Milestones to be reached by this WP M6.1 Identification of those features that could be legally bound and provide advice to the European Commission (M9) M6.2 Identification of relevant encoding standards and data models for semantic harmonization (M12) WP No. WP7 Date: 2021-06-09 40 / 82 Doc Version: 1.0  Associated with document Ref. Ares(2021)4548885 - 13/07/2021 WP Title Connecting the dots Start M1 Ending month M24 Lead IACS Applicant # 1 2 3 5 6 7 9 Acronym Sitra ATNA Sciensano MoH-CY MZCR RM FR- HDH PM 19 3 5 0 2 3 1 Applicant # 12 14 19 20 23 24 Acronym OKFŐ MINSAL MoH-NO SPMS IACS SEHA PM 5 3 3 8 45,5 3 Objectives This work package will detail the technical options to provide an effective secondary use of health data through the EHDS. In this way, these solutions represent the technical interoperability elements of the EHDS, according to the European Interoperability Framework. The key concept for the envisaged EHDS is a federated peer-to-peer system, that interconnect node of different typologies (data permit authorities, European level health data providers, research infrastructures, data altruism bodies etc.). The EHDS nodes will operate regularly in an independent manner, providing services to their users, but as part of the federation they will be connected. The interconnection will be implemented through a series of specific EHDS services deployed on to provide federation-wide features, such as: announcement, authentication, data discovery, data retrieval, data analytics, etc. Work package deliverables will consist of the catalogue of required and advanced services to be implemented in the nodes aiming to join the EHDS and the options for the architecture and the infrastructure elements required for an effective deployment of the services. WP objectives are: O7.1 Study existing initiatives on secondary use of health data focusing on the requirements for their deployment O7.2 Foster the participation of future users of the EHDS and EHDS implementers on MSs, institutions or industry, to participate in the co-design of the services for secondary use of health data as well to provide architecture and infrastructure options. O7.3 Define the options for the EHDS services for secondary use of health data. O7.4 Detail the architecture and infrastructure options of the EHDS services for secondary use of health data, fully compliant with legal frameworks and with total guarantee of privacy and security. Date: 2021-06-09 41 / 82 Doc Version: 1.0  Associated with document Ref. Ares(2021)4548885 - 13/07/2021 Description of work Task 7.1 Technical and operational expertise of existing initiatives of data sharing and secondary use of health and biomedical data Task lead: Sitra (CSC) Partners: ATNA, SPMS, IACS, FR-HDH. Duration: M1-M10. Inquire and gather existing knowledge on public and/or private initiatives on data sharing and the secondary use of health and biomedical data. Selection of the data sharing initiatives to be analysed. The selection criteria will be to cover a wide typology of the data sharing initiatives (national data hubs or permit authorities, data sharing repositories from health services, European Reference Networks, and other regional, national, or supra- national institutions or initiatives of special interest, etc.). No more than 15 data sharing initiatives are expected to be analysed. The selection will be coordinated with WP5 Task 4.2 and Task 5.3. Partners involved: Sitra (CSC), IACS. Gather specific information for each of data sharing initiatives selected. Technical information elements to be gathered: services offered, architecture, software solutions and the specific infrastructure requirements derived for each element (computing, storage, and connectivity). Operational information gathered: number of sustained users, overall usage, infrastructure providers, etc. Organisational information gathered: mission, scope, international dimension, etc. Quality of service information gathered: Use of standards, Provenance, Customer service, Training, etc. Other aspects will be defined during the Project development. Partners involved: Sitra (CSC), ATNA, SPMS, FR-HDH. The output of this task will be the technical and operational analysis report with the aforementioned information. The analysis report will serve to aid in the design of the services to be described in Task 7.3 and to aid in the proposal of architecture and infrastructure options to be described in Task 7.4. A milestone is M7.1. Partners involved: Sitra (CSC), ATNA, SPMS, IACS, FR-HDH. Task 7.2 WP7 Permanent Advisory Group Task lead: Sitra (VTT), Partners: MINSAL, SPMS, IACS, SEHA, DoH-IE (HRB), SEHA (NBHW), FR-HDH. Duration: M01-M24. Set up a Work Package permanent Advisory Group, WPAG, to drive the engagement of future users of the EHDS (researchers, policymakers, etc.) as well as the technical implementers (public or private companies, institutions, etc.) in the co-design and validation of the services and architecture options. Partners involved: Sitra (VTT), IACS. Determining the users and implementers participants of the WPAG that will be later contacted with an open call as described in chapter 8.2. This activity will be conveyed tightly with WP2 and WP4, to ensure an effective dissemination of call for participation to potential participants. Set up of thematic workshops (services, architecture, infrastructure, etc.). During the initial period of the joint action will be focused on capturing the demands, while during the last period of the joint action will be focused on validating the options proposed. Due to the uncertainty caused by the Covid-19 pandemics, it is expected that the workshops will be mostly in virtual format, complemented by a dedicated interaction dashboard in the Joint Action webpage, where users and implementers will provide their feedback “offline” after the participation in the workshops. Partners Involved: Sitra (VTT), MINSAL, SPMS, IACS, SEHA, DoH-IE (HRB), SEHA (NBHW), FR-HDH. This task will produce three different options: 1) a report on EHDS services expectations, to be used as input for Task 7.3; 2) a report on architecture and infrastructure expectations and experiences, to be used as input for Task 7.4; and 3) a validation report on the proposed services and architecture and infrastructure solutions, to be included in the final deliverable of the current WP. Milestones are M7.2, M7.3 and M7.4. Partners involved: Sitra (VTT), IACS Task 7.3 Definition of services for secondary use of data within the EHDS Date: 2021-06-09 42 / 82 Doc Version: 1.0  Associated with document Ref. Ares(2021)4548885 - 13/07/2021 Date: 2021-06-09 43 / 82 Doc Version: 1.0  Associated with document Ref. Ares(2021)4548885 - 13/07/2021 Task lead: IACS. Partners: Sitra (CSC), Sciensano, MZCR, FR-HDH, OKFŐ, MINSAL, OKFŐ (SU) Duration: M01-M18. Description of the services to be implemented in the federated nodes that will support the secondary use of health data within the EHDS, in an incremental manner. Initial set of services will cover required features for basic operation (announcement, authentication, data discover, etc.). A second set of services will cover advanced features (data analytics, data visualization, etc.). Further sets will focus on how to steer health data resource development (e.g. improving adherence to FAIR principles). This tier scheme is intended to facilitate the incorporation to the EHDS depending on the level of maturity of the participating nodes or enabling nodes to join later if the requirements are not met. Analysis of the services’ requirements from the Joint Action call expectations; WP5 inputs (business cases, usage patterns, legal and institutional interoperability); the WP6 inputs (data quality framework; semantic interoperability); WP8 (citizens engagement); and expertise gathered in Task 7.1 and Task 7.2. Partners Involved: IACS, Sitra (CSC), FR-HDH, OKFŐ, OKFŐ (SU). Design of the EHDS services for secondary use of the data as an Application Programme Interface (API). It includes name of the service, input parameters, service outputs and the error codes to audit service problems. Service validation protocol will be also provided aligned with WP5 options for governance models, to admit new nodes to the federation. Task 7.2 Forum will be aid in terms of validation and adjustment on the services design with users, in an iterative manner. Partners Involved: IACS, Sitra (CSC), FR-HDH, OKFŐ, OKFŐ (SU). The outputs of this task will be the catalogue of the EHDS services for secondary use of health data, accurately described as an API, and the services including the tier of complexity categorization. The catalogue will also include the users and implementers validation suggestions. The catalogue will be used in Task 7.4 to propose the architecture and infrastructure options and will be included in the final deliverable of the WP. Deliverables and milestone are D7.1 and M7.5. Partners: IACS, Sitra (CSC), Sciensano, MZCR, FR-HDH, OKFŐ, MINSAL, OKFŐ (SU). Task 7.4 Options for EHDS architecture and infrastructure of the EHDS services’ deployment Task lead: IACS. Partners: Sitra (VTT), ATNA, Sciensano, RM, OKFŐ, BMG (FDZ), RM (CDEU), OKFŐ (SU), FR-HDH. Duration: M09-M24. To provide specific options for the architecture and the infrastructure that will support the deployment of the EHDS services among participating nodes. This task will use as inputs the outputs of three earlier tasks, especially Task 7.1, about the existing solutions deployed in existing data sharing initiatives, and the service catalogue described in Task 7.3. This task will also consider specific requirements of the governance models studied in WP5, data quality elements described in WP6 and citizen engagement elements analysed in WP8. Specification of the services designed in Task 7.3. It includes the actors involved (users, data permit authorities, data holders, etc.) and the interaction flows between them (sequence of actions to provide a service). Partners involved: IACS, Sitra (VTT), FR-HDH, OKFŐ, OKFŐ (SU). Description of the options for the specific architecture and infrastructure that will support them. This includes the technological substrate of the federation including types of nodes expected in the federation (regular nodes, super nodes, directory nodes, etc.), computational capacities of the nodes, communication protocols to be used to set up and maintain the connectivity in the federation, storage capacities of the nodes, networking capacities of the federation, etc. As for the services’ options, architecture and infrastructure options will be categorized in complexity tiers to ease its adoption. Description of the options for the software solutions to be used in the federation. Partners involved: IACS, Sitra (VTT), OKFŐ, OKFŐ (SU). In close collaboration with WP6, there will be analysed solutions to for data security, data privacy through pseudonymisation and anonymisation requirements and data administration and management activities, including the specific elements enablers of the FAIR principles. The software layer will rely extensively on Connecting Europe Facility (CEF) Building Blocks (eID, eDelivery) and, in all cases, open Date: 2021-06-09 44 / 82 Doc Version: 1.0  Associated with document Ref. Ares(2021)4548885 - 13/07/2021 standards and open software solutions will be the prime alternative to be proposed. Partners involved: IACS, Sitra (VTT), OKFŐ, OKFŐ (SU), MoH-NO, BMG (FDZ), RM (CDEU). This task will also have a direct linkage with implementers via the Task 7.2 Forum, in terms of validation and adjustment on the architecture and infrastructure options, in an iterative manner. The outputs of this task will be the architecture and infrastructure options to support EHDS services for secondary use of data. The architecture and infrastructure options will also include the implementers validation suggestions. The options will be a fundamental part of the overall WP deliverable. Deliverables and milestones are D7.2 and M7.6. Partners involved: IACS, Sitra (VTT), ATNA, Sciensano, RM, OKFŐ, MoH-NO, BMG (FDZ), RM (CDEU), OKFŐ (SU), FR-HDH. Deliverables (D) linked to this WP D7.1 Options for the minimum set of services for secondary use of health data in the EHDS (M12) Document containing the API of services options required to be deployed in MS or other institutions wanting to join the EHDS federation for the basic operation of the EHDS. D7.2 Options for the services and services architecture and infrastructure for secondary use of data in the EHDS. (M24) Document containing the API of the service options for basic and advanced EHDS operation, as well as the options for the architecture and infrastructure that will sustain the actual deployment of the services in MS or other institutions wanting to join the EHDS. Milestones to be reached by this WP M7.1 Technical and operational analysis report of existing data sharing and/or secondary use initiatives in health and biomedical sciences. (M8) M7.2 Report on EHDS services users’ expectations. (M9) M7.3 Report on EHDS architecture and infrastructure implementers’ expectations / experiences. (M16) M7.4 Validation report on the proposed services and architecture and infrastructure solutions. (M22) M7.5 Catalogue of the EHDS services for secondary use of health data. (M10) M7.6 Report on architecture and infrastructure options to support EHDS services for secondary use of data. (M22) WP No. WP8 WP Title Citizens Start M1 Ending month M24 Lead FR-HDH, OKFŐ Applicant # 1 3 4 5 6 9 12 19 25 Acronym Sitra Sciensano CHIF MoH- MZCR FR-HDH OKFŐ MoHNO NHSC CY PM 5 17,5 4 0 1 19 23 2 14 Date: 2021-06-09 45 / 82 Doc Version: 1.0  Associated with document Ref. Ares(2021)4548885 - 13/07/2021 Objectives WP8 will provide evidence for decision-makers and healthcare professionals in the European Union so that they can more effectively promote the secondary use of health data and the acceptance thereof by citizens. Health data may indeed contribute to health promotion, disease prevention, fostering healthy lifestyles and development of innovative, efficient and sustainable health systems – as well as protecting EU citizens from serious cross-border health threats and facilitating access to high quality, safe healthcare for EU citizens. WP8 will do so by identifying citizen perceptions and attitudes on health data, ways of engaging citizens around their health data, defining data altruism practices in the EU, as well as identifying key features, conditions, and determinants of integrating health related data captured and shared by individuals and data altruist organizations, in close alignment with the Data Governance Act. In order to achieve this goal, WP8 has the following specific objectives: O8.1 Obtain a better understanding of citizens' perception towards the sharing of their health data in a European perspective. O8.2 Improved citizen capacity to engage with data and improve citizen trust in data sharing: identify ways to better inform citizens better about the use of their health data including data portability and raise awareness, sensitize around innovation, and promote the role of citizens as actors of innovation. The design and implementation of this objective will be underpinned by equality and diversity principles. O8.3 Better understand tools of change management to empower citizens and enable them to become actors of health data. O8.4 Improve policymaking and facilitate decisions on which data generated and held by citizens can be used, how and by whom for the public good and interest (scientific research, public health, sustainable healthcare systems) purposes in a manner compliant with GDPR. O8.5 Strengthen the health data governance mechanisms at the EU level and in the Member States and other participating countries relevant for cross-sector data use and for data use in the common sectoral data spaces, by involving citizens, in line with the FAIR principles considering the developments and decisions of other health sector-specific stakeholders, authorities, agencies and care providers or researchers, as well as the input from other TEHDAS work packages (5,6 and 7). Date: 2021-06-09 46 / 82 Doc Version: 1.0  Associated with document Ref. Ares(2021)4548885 - 13/07/2021 Description of work Task 8.1 Preparatory phase of online consultation in three pilot countries Task leader: FR-HDH, Partners: Sciensano, NHSC, FR-HDH (UT3), NHSC (WSI); Duration: M1-M10 Preparatory phase of online consultation in three pilot countries, including a pan-European qualitative assessment with literature review and interviews on stakeholders’ and citizens’ perceptions of health data. Develop common research protocol. Conduct extensive desk research and a comprehensive literature review on health data perception as well as pedagogical material. Conduct 15-20 interviews by country with public and private stakeholders of the healthcare system and patient representatives in pilot countries to assess their experiences / opinions on citizens’ perception of the use of health data. Conduct detailed interview analysis for each country. Consolidate interview results. Issue summary report of findings. Develop health-data related affirmations and a questionnaire for consultation forum. Translate material or each country. A milestone is M8.1. Task 8.2 Conduct online consultation to collect citizens’ perceptions Task leader: Sciensano; Partners: FR-HDH, FR-HDH (UT3), NHSC, NHSC (WSI) Duration: M1-M17 Conduct online consultation to collect citizens’ perceptions on a set of health-data related affirmations and questionnaires to be integrated with pedagogical material. Extract, consolidate and compare results across countries. - Launch procurement. Design and set up consultation platform, integrating questionnaires, affirmations, and interactive engagement tools. Plan and conduct communication campaign in collaboration with WP2 to launch consultation platform and to encourage citizen Date: 2021-06-09 47 / 82 Doc Version: 1.0  Associated with document Ref. Ares(2021)4548885 - 13/07/2021 participation. Launch and monitor consultation pl platform. Conduct extraction, analysis, consolidation, and comparison of results. Publish results as part of a communication campaign, at EU and national levels. A milestone is M8.2. Task 8.3 Develop recommendations for the EHDS to ensure citizen sensitization and engagement with health data Lead: FR-HDH, Partners: Sciensano, NHSC, NHSC (WSI), FR-HDH (UT3) Duration: M18 - M24 Conduct 1 workshop/ focus groups per country to discuss results and develop recommendations. Consolidate recommendations for each country. Organize one EU-wide multi-stakeholder workshop to discuss results and develop recommendations for the EHDS (TEHDAS stakeholders, patient associations etc), as an annex to an existing conference, e.g. HIMSS 2022 or TEHDAS events. Develop draft final recommendations document for the EHDS. Deliverables and milestones are D8.1 and M8.3. T8.4 Overview of national data altruism definitions and systems Task leader: OKFŐ, Partners: Sitra, CHIF, MZCR, MoH-NO (Hdir), CHIF (CHIP), OKFŐ (SU); Duration M1M7 In this task, information and learnings delivered by the Study referred to in Chapter 5, will be integrated and matched with findings of a literature review carried out by the Member States, and other participating countries, aiming to map options, use cases and good practices how data altruism can increase effectiveness of data governance structures and functions of primary and secondary use of citizens’ health and health-related data across Europe. Identified data types for use cases in altruism: clinical data (EHR, etc.), research data, consumer data (wearables, mobile health, direct to consumer genetics/DNA tests). Also, citizen science based on data sharing is possible. The task will co-operate with task 8.1-8.3 to receive additional information through the interviews, questionnaire, and survey to assess citizens’ and stakeholders’ perception of the sharing of health data. The task will provide an initial set of: • Overview for definitions of data altruism for the future EHDS. • How data altruism / data altruism bodies need to be considered in EHDS governance (link to WP5) • Identification of good practices and risks for implementing data altruism practices and how data altruism helps health data access points or other health data governance structures involving citizens. • Findings how requirements for consent and accessibility are dealt with by different types of data altruism practices. (incl. identification of potential barriers and opportunities) Milestone is M8.4. Task 8.5 Recommend ways to foster GDPR-compliant data altruism mechanisms for the EHDS Task leader: OKFŐ; Partners: Sitra, CHIF, NHSC, NHSC (WSI), CHIF (CHIP), OKFŐ (SU), MoH-NO; Duration M8-M24 The task will organise EU-wide multi stakeholder online workshops, in the frame of Work Package Permanent Advisory Group meetings, to discuss new definitions, good practices of data altruism and altruism structures and functions for the future EHDS. Workshops will be focused on the key use cases. Results of the workshops will be extracted, analysed, and consolidated by the contributors of the task. Results will be disseminated as part of an important communication campaign by newsletters, online conferences, and a winter/summer school event. Experiences and learnings of the communication campaign will be introduced and taken into consideration in the final report delivered by the task. The task will provide a final report (D8.2.) including recommendations how to • share lessons learned to be applied for the GDPR-compliant application of data altruism practices, Date: 2021-06-09 48 / 82 Doc Version: 1.0  Associated with document Ref. Ares(2021)4548885 - 13/07/2021 • adopt and harmonize identified good practices and implement use cases for the construction of national or European health data spaces. Deliverables and milestones are D8.2, M8.5 and M8.6. Deliverables (D) linked to this WP D8.1 Qualitative study conducted amongst key stakeholders (public, private actors, and patient / citizen groups) to assess citizen’s perception of health data (M24) D.8.2 Report on lessons learned to be applied and recommendations for data altruism practices in the implementation of construction of national and European health data spaces (M24) Milestones to be reached by this WP M8.1 Literature review of citizen’s perception of and engagement with health data in Europe (M10) M8.2 Publication of results from comparative overview of citizen’s perception of and engagement with health data in selected countries: Belgium, France, UK(M17) M8.3 Publication of recommendations the European Health Data Space to ensure citizen sensitization and engagement with health data (M24) M8.4 Presentation of a first set (catalogue) of data altruism definitions, use cases and findings about consent and accessibility issues (means of verification: catalogue approved by stakeholders;) (M7) M8.5 Publication of an overview (prepared to launch a communication campaign) about the results of EU-wide multi stakeholder workshops, with a special regard to updated definitions, needs, solutions, experiences, and good practices of data altruism (altruism structures and functions) for the future EHDS (means of verification: published in TEHDAS webpage;) (M15) M8.6 Recommendations to foster GDPR-compliant data altruism mechanisms for the EHDS (means of verification: report;) (M16) Date: 2021-06-09 49 / 82 Doc Version: 1.0 Associated with document Ref. Ares(2021)4548885 - 13/07/2021  Associated with document Ref. Ares(2021)4548885 - 13/07/2021 7.3 Timetable and Milestones Table 2 Project timetable as a GANTT chart  Associated with document Ref. Ares(2021)4548885 - 13/07/2021 Date: 2021-06-09 42 / 82 Doc Version: 1.0  Associated with document Ref. Ares(2021)4548885 - 13/07/2021 Table 3 Project milestones M# WP Leading Acceptance Delivery Month No. Applicant criteria M1.1 WP1 Sitra Signed M3 M1.2 WP1 Sitra Signed M3 M1.3 WP1 Sitra Signed M3 M1.4 WP1 Sitra Delivered M5, M15, M27 M1.5 WP1 Sitra Arranged M9, M16, M28 M2.1 WP2 Sitra Arranged M2 M2.2 WP2 Sitra Sent M3, M5, M8, M11, M14, M17, M20, M23 M2.3 WP2 Sitra Arranged M12, M16, M18 M2.4 WP2 Sitra Delivered M6, M12, M15, M18, M21, M24, M27 M2.5 WP2 Sitra Done M3, M7, M11, M15, M19, M23 M2.6 WP2 Sitra Updated M3, M5, M8, M11, M14, M17, M20, M23, M29 M2.7 WP2 Sitra Checked M2, M6, M10, M14, M18, M22, M26, M30 M3.1 WP3 SPMS Delivered M9 M3.2 WP3 SPMS Delivered M12 M3.3 WP3 SPMS Delivered M28 M4.1 WP4 Sciensano Delivered M6 M4.2 WP4 Sciensano Arranged M4, M9, M16, M26 M4.3 WP4 Sitra Delivered M8 M5.1 WP5 Sciensano Delivered M4 M5.2 WP5 Sciensano Delivered M5 M5.3 WP5 SEHA Delivered M6 M5.4 WP5 FR-HDH Delivered M12 M5.5 WP5 FR-HDH Delivered M12 M5.6 WP5 FR-HDH Delivered M24 M5.7 WP5 VWS Delivered M5 M5.8 WP5 VWS Delivered M7 M6.1 WP6 RM Delivered M9 M6.2 WP6 IACS Delivered M12 M7.1 WP7 Sitra Delivered M8 Date: 2021-06-09 53 / 82 Doc Version: 1.0  Associated with document Ref. Ares(2021)4548885 - 13/07/2021 M7.2 WP7 Sitra Delivered M9 M7.3 WP7 Sitra Delivered M16 M7.4 WP7 Sitra Delivered M22 M7.5 WP7 IACS Delivered M10 M7.6 WP7 IACS Delivered M22 M8.1 WP8 FR-HDH Delivered M10 M8.2 WP8 Sciensano Delivered M17 M8.3 WP8 FR-HDH Delivered M24 M8.4 WP8 OKFŐ Delivered M7 M8.5 WP8 OKFŐ Prepared to M15 launch a communication champaign M8.6 WP8 OKFŐ Delivered M16 8 DELIVERABLES Table 4 Project deliverables and mandatory deliverables No. WP Lead Deliverable content Disseminati Deliver No. on Level y D1.1 WP1 Sitra Project Management Plan CO M4 D1.2 WP1 Sitra Risk Management Plan CO M4 D1.3 WP1 Sitra Interim Report PU M15 D1.4 WP1 Sitra Final Report PU M30 D3.1 WP3 SPMS A document that outlines the design and CO M5 timeline of project´s evaluation activities. D3.2 WP3 SPMS A report that assesses process, output, and CO M13 outcome indicators in the mid-term. D3.3 WP3 SPMS A report that provides the results of the JA CO M24 evaluation, with concluding remarks. D4.1 WP4 Sciensano A fact sheet from each country visit will be PU M24 provided providing an overview of the mapping exercise. D4.2 WP4 Sciensano The Policy and Project Forum Report PU M27 provides the minutes and conclusions of the meetings. Date: 2021-06-09 54 / 82 Doc Version: 1.0  Associated with document Ref. Ares(2021)4548885 - 13/07/2021 D4.3 WP4 Sitra The sustainability plan will provide a PU M24 pragmatic approach to a roadmap providing recommendations on future implementation of EHDS. It will consider the outputs of the different WPs and recommend how they can be taken up at national and international level. D5.1 WP5 Sciensano This deliverable is a document which PU M13 summarizes on a multinational level the conclusions regarding the purposes, requirements, type of data etc of the respective user categories included (scientific researcher and innovator, and policymaker respectively). The use cases are presented in an annex to the document. D5.2 WP5 SEHA This deliverable is a document presenting PU M22 basic guidelines/recommendations intended to facilitate the planning (and implementation) of national legislation on secondary use of health data. D5.3 WP5 FR-HDH This deliverable is a document presenting PU M24 recommendations for best practices for EU cross-border exchange including data access / data permit processes in different national settings will be elaborated. D5.4 WP5 VWS This deliverable is a document presenting PU M19 well-established options for governance models for the EHDS, taking into consideration a Pan-European perspective in combination with the best interest of the concerned stakeholders in general and the citizen. D6.1 WP6 RM The deliverable will contain the requisites PU M12, for the inclusion of data in the EHDS, M24 including semantic interoperability, and the guidance on how to get data included in the EHDS, including requisites for data interoperability and recommendations for data quality governance. D6.2 WP6 IACS The deliverable will propose a semantic PU M20 interoperability framework for the EHDS including the common data model for the EHDS. Date: 2021-06-09 55 / 82 Doc Version: 1.0  Associated with document Ref. Ares(2021)4548885 - 13/07/2021 D7.1 WP7 IACS Document containing the API of basic PU M12 services options required to be deployed in MS or other institutions wanting to join the EHDS federation for the basic operation of the EHDS. D7.2 WP7 IACS Document containing the API of the service PU M24 options for basic and advanced EHDS operation, as well as the options for the architecture and infrastructure that will sustain the actual deployment of the services in MS or other institutions wanting to join the EHDS. D8.1 WP8 FR-HDH Based on the analysis of citizens’ perception PU M24 of health data in three pilot countries, this deliverable aims to provide recommendation son how to better consider and engage citizens in the future European Health Data Space. D8.2 WP8 OKFŐ A report that provides the PU M24 recommendations for data altruism practices. MD2.1 WP2 Sitra Dissemination plan CO M4 MD2.2 WP2 Sitra A summary leaflet promoting the project PU M4 MD2.3 WP2 Sitra The Project website summarizing the PU (and CO) M3 project objectives and progress. MD2.4 WP2 Sitra A summary of the outcomes, including main PU M30 results, achievement, benefits. The booklet is written for the interested public. MD3.1 WP3 SPMS A plan for the evaluation activities, including CO M5 indicators, data sources, methods, and stakeholder analysis. MD3.2 WP3 SPMS Interim evaluation report PU M16 MD3.3 WP3 SPMS Final evaluation report PU M24 9 PROJECT MANAGEMENT 9.1 Methods The project management in a project such as TEHDAS which involves 25 countries and multiple organisations within each country requires specific structures and methods. Many of the traditional project management methodologies nor more recent agile project management are not suitable for European Joint Actions. JAs are characterised by multiple stakeholders which do not work full time in project, yet all partners contribute to a wide range of deliverables in multiple work packages which are each lead by different people in multiple countries. Date: 2021-06-09 56 / 82 Doc Version: 1.0  Associated with document Ref. Ares(2021)4548885 - 13/07/2021 TEHDAS aims to follow good practises in project management which are widely recognised but adjusted to the needs of the project. TEHDAS utilizes the European Commission PM2 project management tools and processes. Where possible the processes are named according to PM2 for clarity. Besides PM2 the TEHDAS project management methods can be identified to fall into a category of Integrated Project Management (IPM). IPM is often used in project which is implemented by multiple teams are which depend on each other and which deliverables are interlinked. This is very much the case in TEHDAS. In TEHDAS the main project document is this project plan which set the objectives, task, and deliverables as well as project team and responsibilities. While the plan is commonly agreed the challenge throughout the project is communication and keeping the direction. The processes described in chapter 9.3 are key to keep the project focused and reactive to changes. 9.2 Governance, Roles, Responsibilities Figure 4 TEHDAS Governance General Assembly General Assembly, GA, is an event where all project beneficiaries meet face to face in a yearly meeting. GAs will take place on Q2 2021, Q2 2022 and Q2 2023. Additional virtual GAs may be organized on Q4 2021 and Q4 2022 if needed. During the GAs, all WPs will present their outcomes and report on the progress. Beside the WPs, the Coordinator will report on overall progress, budget, and inform of necessary amendments to the budget as well as Consortium agreement changes. Project Steering Group Project Steering Group, PSG, is responsible of aligning different WPs and their activities and outcomes. PSG is chaired by the Coordinator and it meets regularly on monthly basis. PSG also meets during GA meetings and twice a year face-to-face (Q1 and Q3). Monthly meetings have a standard structure where WP leads will inform PSG on the WP progress using progress report template. Potential risks will be identified and discussed, and actions can be taken in the PSG. PSG can also make executive decisions on budgetary changes which do not need Consortium Agreement or Grant Agreement changes and are allowed by HaDEA rules. Such decisions can for example be transfer of budget from one budget line to another. Work Packages The work of the Joint Action is done in Work Packages (WPs), which are explained in detail in Chapter 7 in this document. A WP is a major subdivision of the proposed action and holds a set Date: 2021-06-09 57 / 82 Doc Version: 1.0  Associated with document Ref. Ares(2021)4548885 - 13/07/2021 of coherent tasks grouped together to facilitate the project management. Each WP has a WP lead which leads and manages the WP and reports of its progress to the Project Steering Group. A WP might have more than one lead or a co-lead. Project Support Office The Project Support Office (PSO) provides services, which facilitate project management. In this Joint Action these are simple support functions such as organizing meetings, scheduling meetings, collecting, analysing, and reporting on project progress, maintaining a central project data and information repository and monitoring adherence to agreed working methods. The PSO does not help only the Coordinator but also each WP lead can use the services of the PSO. The PSO supports in keeping coherent structure and language in the project outputs. Work Package permanent Advisory Group The Work Package Permanent Advisory Group, WPAG, is a group consisting of external stakeholders such as patient organisations or other non-profit NGOs, industry associations, technical experts, healthcare organisations, university hospitals, other health programme project representatives or other stakeholder experts. The WPAGs are permanent and started at the suitable time of the work of the WPs. They are expected to provide knowledge and support for the WP in the substance work. WPAGs meet on the invitation of the WP lead together with other WP members in a WP meeting or on a separate meeting. An WPAG member does not have access to WP working space but a dedicated WPAG working space where WP members and WPAG members can exchange knowledge and draft deliverables. Besides providing expertise and knowledge, WPAGs can bring wider acceptance to the WP work as stakeholders are involved in a dialogue with WP members. The WPAGs are a means to involve stakeholders in the WP work and are always started on the decision by the PSG at the suggestion of the WP lead. Not all WPs have a WPAG. In the beginning of the TEHDAS Joint Action an open call for participation in WPAGs and the Stakeholder Forum will be launched. Organisations interested in taking part in WPAGs will choose which WPs they want to contribute to and justify their participation. WP leads will suggest to the PSG the choice of the organisations based on pre-set criteria. The goal is to give equal opportunity for participation and to involve wide range of stakeholders in the WPAGs. WP4 will focus on involving two stakeholder groups: policy makers and international projects relevant to TEHDAS. The Policy Forum will bring together Ministries of Health and Ministries of Research to inform them about the plans, progress, and outputs of the project. Input will also be requested on their views on the added value of having an EHDS and sharing data across Europe. The Project Forum has similar aims but focusses on existing projects relevant to TEHDAS. The Project Forum will connect the relevant players to the WPs leads to assure TEHDAS builds on existing knowledge and expertise. Stakeholder Forum Stakeholder Forum, SF, is an event where external stakeholders can follow the Joint Action progress and discuss with the participants on the issues linked to it. The SF takes place after the General Assembly and is organised by the Coordinator together with WP4. SF is open for any stakeholders but is limited with capacity and requires registration. The SF is expected to be organised in Q2/2021, Q2 2022 and Q2 2023. The Coordinator will make a proposal to the PSG on the composition of the SF based on the open call for interest. Meetings TEHDAS aims at offering an online participation possibility to all meetings to increase effectiveness, reduce travel time constraints and broaden participation. Further, many meetings will be organised online only. The capability of partners to participate online will be paid special attention. Meetings will be conducted, and their documentation provided in English. Date: 2021-06-09 58 / 82 Doc Version: 1.0  Associated with document Ref. Ares(2021)4548885 - 13/07/2021 Observers The Commission, and on invitation other EU institutions and agencies, may participate to TEHDAS meetings as observers. The observers have a right to speak in the meetings. If an observer wants to present a specific topic to a meeting it needs to be agreed before the meeting with the chair of the meeting and added to the agenda of the meeting. The observers do not have voting rights in TEHDAS meetings, and the participation is not reimbursed from the project budget. Observers have access to the TEHDAS working space to view the working documents, meeting minutes and other relevant documents. 9.3 Processes & Artefacts Processes and Artefact are adjusted from the European Commission PM2 into the needs of the TEHDAS Joint Action. The key processes in TEHDAS project management are change management, risk management, issue management and quality management and acceptance. Project progress reporting One of the main challenges in the project which involves such a variety of participants in multiple counties is to keep track of the project progress and be able to proactively make changes when needed. The WP1 will follow each WP through PSG meetings where standard progress reports are required in each meeting. The WP1 will generate a project progress report based on the WP progress report regularly to communicate the state of the project to all participants. The PM2 project progress report is adjusted and used as a template for WP progress reporting. Change management Change management for all subjects which related to Grant agreement, Consortium agreement or project Deliverables are managed centrally within the WP1 Coordination. The Coordination team monitors the project and can proactively launch change management process with contract partners depending on the change needed. Changes which fall into WP1 Coordination are called Major changes. Each Major change is managed according to the change and with the contract partner they relate to. Minor changes in the project are for example changes in Milestones, responsible person changes in participating organisations or work method changes which does not have an impact to Deliverables. Minor changes are launched within WPs and taken into Project Steering group for approval by the WP leader. PSG keeps track of approved Minor changes in change log. Risk management The coordination WP1 keep track of project risks in a risk log. The risk log includes identified risks and potential response actions. The risk log is revised quarterly in the PSG meetings. Issue management Issues are unplanned events that might have project scope, time, cost, quality, risk, or stakeholder satisfaction impact. Issues are managed according to their severity. Each project partner can raise Minor issue to WP chair, and they can be managed within the WP meetings and decisions taken logged to WP meeting minutes. Major issues are taken to PSG meetings by the WP leaders. Major issues and the decisions taken will be logged into Issue management log. Each major issue will have a dedicated Issue number and can therefore be traced and referred through multiple PSG meetings. Quality management and acceptance of project Milestones and Deliverables TEHDAS has reporting requirements towards the European Commission. Deliverables will be submitted for evaluation through EC Funding and Tenders portal. Prior to the submission, each Date: 2021-06-09 59 / 82 Doc Version: 1.0  Associated with document Ref. Ares(2021)4548885 - 13/07/2021 Deliverable will go through an internal quality review process, by a quality review team that supports WP1 coordination activities, in collaboration with WP 3 project evaluation activities. It is characterised as following: 1. WP leader submits a Draft Deliverable (DD) to TEHDAS internal quality review team (QRT). The deadline is PSG -4 weeks. QRT makes a quality review of content presentation, structure, format, and language of the DD and coherence with other TEHDAS outputs. The purpose is to ensure consistency of different WP deliverables and avoid minor problems that hamper PSG content evaluation and challenge project´s relevance. 2. TEHDAS internal quality review team reports to WP leader the quality review comments, remarks and requested changes (if applicable). The deadline is PSG -3 weeks. 3. Submission of the modified DD and QRT report to the PSG. Deadline PSG -2 weeks. 4. PSG members written comments/question regarding the DD. Deadline PSG -1 week. 5. Presentation of the DD by the corresponding WP chair in the PSG and followed by discussion based on the written comments/questions. 6. The PSG Accepts, Accepts with minor changes, Requests major changes, or Rejects the DD. • If the DD is accepted with minor changes, the WP leader can revise the DD and go ahead to process step 7. • If major changes have been requested the corresponding WP chair can change the DD and restart the quality review process from point number 3. • A rejected DD cannot be taken back to PSG. The corresponding WP leader will need to supply a plan to revise the DD and after the plan has been accepted by the PSG and executed, a new DD can start the process from quality review process step 1. 7. After Acceptance, the Deliverable will be submitted to an external evaluation according to the Grant Agreement. WP3 evaluation will do internal evaluation of the TEHDAS project as a whole and that process is described in the evaluation plan. Documentation and version control Project documentation is key part of transparency. Each official entity in TEHDAS which are named in chapter 9.2 have meetings. Official meetings will have, and agenda and meeting minutes. They are stored in the project space and are accessible by all participants of the TEHDAS project. TEHDAS outputs whether Milestones or Deliverables are generated in WPs. Each output will have multiple drafts. It is in the responsibility of the WP leader to decide which versions of draft documents are relevant to be saved into the project space. An output shall have internal log of change history and version history. TEHDAS will produce documents in English but partners are free to translate them into their national languages. 9.4 Quality & Capacity of the Partnership Joint Actions are projects which bring European countries together. Each country which participates in the EU health programme can appoint a Competent Authority to represent the country in the Joint Action. In TEHDAS joint action the Competent Authorities vary three main categories. Health ministries form the biggest category with 13 countries being represented by their ministry of health. Second category are national health institutions with 8 countries and the third category is formed by either regional agencies or other type of public bodies. Date: 2021-06-09 60 / 82 Doc Version: 1.0  Associated with document Ref. Ares(2021)4548885 - 13/07/2021 The Joint Actions are non-competitive projects and designation is done by the ministries of health in each country. The ministries of health are part of governments which receive their legitimacy in democratic elections from the people. The designation of a specific institution or their ability to act on behalf of their country cannot therefore be questioned. The geographical coverage of participating countries is good with 25 countries. As in the European Union Member States hold primary responsibility for organising and delivering health services the JA partnership has 25 separate ways of managing them. That brings diversity to the project and ensures that the outputs consider wide range of experiences all over Europe. The designated competent authorities have added national Affiliated Entities in work packages to bring needed expertise from specific areas of health. There are altogether 23 Affiliated Entities including hospitals, research centres, institutes of public health and universities. These organisations bring added value to thematic questions especially on data quality and infrastructure domains. 9.5 Capacity of the staff to carry out the project The responsibility of the coordination in the Join Action is with The Finnish Innovation Fund Sitra. Sitra is an independent public fund under the supervision of the Finnish Parliament. As a fund directly accountable to the Finnish Parliament, the decision-making processes are tied to parliamentary systems including a supervisory board consisting of Members of the Parliament. The health data is becoming more diverse and in the future more and more health data is generated by individuals using wearables and home diagnostics. Another near-term trend is that health data is merged with cross-sectoral data for new innovations and services. Sitra has been in the centre of this change with a project called the fair data economy. Because of both the sectoral and horizontal data knowledge Sitra is well placed to lead the planning of the European Health Data Space. The key resources in the project include the coordinator and work package leaders who form the Project Steering Group. The following partners have taken the responsibility for these functions and placed their key staff at the disposal of TEHDAS. WP1 – Coordination: Sitra Sitra is a future-oriented public think-do-and-connect tank that promotes sustainable well-being and Finland's competitiveness. Sitra collaborates with partners from different sectors to research, trial and implement bold new ideas that shape the future. The coordinator and the WP1 leader is Markus Kalliola, MSc, from Sitra. He has vast expertise in health data and project management including European health policy projects in the European Commission. Markus Kalliola took part in the creation of eHDSI and setting up the ERNs during 2013-2016 as an official in DG SANTE. From 2017-2020 he has worked in Sitra related to the secondary use of health data in the ISAACUS-project and horizontal data policies in the Fair data economy project. WP2 – Dissemination: Sitra The Joint Action’s Communications Lead and WP2’s leader is Jukka Vahti, M.A. from Sitra, where he works as leading expert at the communications and public affairs. He has versatile experience both in communications and journalism on societal topics. In Sitra Jukka Vahti has worked with multiple projects in relation to renewing the Finnish healthcare system. He has also been actively involved in ISAACUS-project on the secondary use of health data and in the IHAN-project that aims to create the European model of fair data economy. WP3 – Evaluation: SPMS SPMS is a State-Owned Enterprise with three major functions: the Portuguese Health Ministry Central Purchasing, the National IT authority, and the Portuguese representative for eHealth cross-border affairs. SPMS’s purpose is to provide shared services in the area of health and care, Date: 2021-06-09 61 / 82 Doc Version: 1.0  Associated with document Ref. Ares(2021)4548885 - 13/07/2021 in order to “centralise, optimise and rationalise” the procurement within the Portuguese National Health System. WP3 lead is Cátia Sousa Pinto, MD, Public Health Spc. She has expertise in Health Information Systems and worked as Head of Epidemiology and Surveillance Division in the Portuguese General Directorate of Health where she coordinated the execution of the real-time mortality information system in Portugal and implementation of the national electronic infectious diseases surveillance system based on clinical and laboratory data. She was the national focal point for ECDC and WHO for public health surveillance. Since 2018, she works at the Advanced analytics and intelligence Unit at SPMS, Ministry of Health, in secondary use of health data and AI strategic planning and operation activities. She has previous experience in international collaboration in several European projects. WP4 – Outreach, engagement and sustainability: Sciensano Sciensano is a research institute and the national public health institute of Belgium. Sciensano's core business is scientific research in the fields of public health, animal health and food safety. The WP4 lead is Petronille Bogaert, MSc, MPH, PhD candidate. She is Head of the Unit EU Health Information Systems and president of the EUPHA section on Public Health Monitoring and Reporting. She has vast knowledge about European health information systems and project management by coordinating three consecutive projects in health information: BRIDGE Health, the Joint Action on Health Information (InfAct) and the Population Health Information Research Infrastructure (PHIRI). WP5 – Sharing data for health: SEHA and VWS The Swedish eHealth Agency SEHA aims to contribute to improved health care, care and the nation's health by pursuing development of a national e-health infrastructure. The activities focus on promoting public involvement and providing support for professionals and decisionmakers. The Ministry of Health, Welfare and Sport is the Dutch Ministry responsible for public health, health care, quality of life, social work and sport. WP5 is led by Michel Silvestri from the Swedish eHealth Agency SEHA and Hanneke Landman from Ministry of Health, Welfare and Sport in the Netherlands. Michel Silvestri, PhD, has a background as senior lecturer at Karolinska Institutet followed by clinical healthcare experience at managerial level, as well as policymaking of healthcare and social care in the Stockholm region. Michel Silvestri, with wide experience of international collaboration and of the challenges of digital transformation, is head of unit within Strategy and Coordination of the Swedish eHealth Agency since 2019 where he is also coordinating the Swedish efforts in the X-eHealth programme. Hanneke Landman, MSc, is a political scientist with a background in the policy of supervision of social health care and medical devices. She has been working as a senior policy officer at the ministry for 4 years. She is currently working on the consent request for the exchange of medical data and AI. WP6 – Excellence in data quality: IACS and RM The Institute for Health Sciences in Aragon (IACS) is the entity that promotes knowledge in Biomedicine and Health Sciences in Aragon. The IACS carries out its activity with the expectation of contributing to high quality care in the public health system, supporting innovation, research of excellence and benchmark training, as well as supporting the creation of wealth and economic growth. The WP6 is led by Enrique Bernal-Delgado, MD PhD MPH MHecon, who currently holds the position of senior scientist in the Institute for Health Sciences in Aragon (IACS). He leads the Data Date: 2021-06-09 62 / 82 Doc Version: 1.0  Associated with document Ref. Ares(2021)4548885 - 13/07/2021 Science for Health Services and Policy Research group, being their research domains of interest the analysis of unwarranted variation in health care, the comparative effectiveness of health care interventions and policies, and the methodological developments for an accurate use of real-world data. With considerable experience in the leadership of national (ATLASVPM, REDISSEC) and international research initiatives built on RWD (ECHO, ICTUS Net) he is currently contributing to the development of research infrastructures in Europe to increase capacity in the secondary use of health data (INFACT JA, PHIRI). See bio here https://orcid.org/0000- 00020961-3298 The WP6 is co-lead by Regional Midtjylland from Denmark. WP7 - Connecting the dots: IACS WP7 is led by Juan González-García, PhD, from the Institute for Health Sciences in Aragon (IACS), Spain. Juan has developed a strong career in data analytics, simulation, and performance analytics of parallel applications in world-class research centres such as the Barcelona Supercomputing Center and the IBM T.J Watson Research Center. Currently he is the IACS’ Biocomputing Unit manager where he applies parallel and distributed computing fundamentals to develop new big-data-based methodologies on real-world data analytics and exploring new research lines on how using cognitive computing in health systems research, personalized medicine, and personalized care. WP8 – Citizens: FR-HDH and OKFŐ The French Health Data Hub is a public interest group created by law in 2019. It is established between 56 actors, as set out by ministerial decree, mostly from the public sector. Its vision is to guarantee a transparent, easy and unified access to health data to improve the quality of care and patient support. National Healthcare Service Center (ÁEEK) is the largest supplier and supporter of healthcare services in Hungary. It possesses ownership rights of state-owned Hungarian hospitals. The institute provides operations methodology, strong management support and systemic background to manage hospitals efficiently and perform their ultimate goals: quality, efficiency and patient focus. WP8 is led by Louisa Stüwe and Caroline Guillot from the French Health Data Hub (FR-HDH) and Istvan Csizmadia from the National Healthcare Service Center of Hungary. Louisa Stüwe, MPA, MPH, is currently in charge of international relations at the FR-HDH. Before joining the FR-HDH, Louisa has managed strategic projects linked to the health sector, research, and innovation, both as a consultant or in organizations such as the French Ministry of Health, a multinational pharmaceutical company and international organizations including the World Health Organization and the World Bank Group. Caroline Guillot, PhD, is the FR-HDH’s director for citizen and patient association relations. Previously, Caroline has conducted and coordinated various research projects and sociological studies. For five years, she was Head of the Diabetes Lab of the French Diabetes Federation, enabling patients and partners to co-construct innovations, products and services that respond to the needs and expectations of diabetic patients and improve their quality of life. István Csizmadia, MSc in Economics and Health Care Management (male): István leads international programmes and projects at National Healthcare Service Centre (ÁEEK), Hungary. He has extensive (30+ years) experience in a) Preparing, planning and managing EU funded programmes, b) Strategic planning, c) Preparing and submitting applications for EU grant, d) Implementing and coordinating EU projects, e) Evaluating applications and monitoring projects, f) Generating and providing support to innovation, cluster, logistic, transport, energy, environment and health programmes and projects, g) Working with international organizations e.g. EU COM, EU Council, UN organizations, h) Preparing and implementing bilateral and Date: 2021-06-09 63 / 82 Doc Version: 1.0  Associated with document Ref. Ares(2021)4548885 - 13/07/2021 multilateral international agreements. Since June 2018 he has been the Work Package leader of WP5 ‘Innovative use of health data’ in eHAction. Previously he used to be the representative of Hungary in the Programme Committee of the Third Health Programme 2014-2020 and the Steering Group on Health Promotion, Disease Prevention and Management of NonCommunicable Diseases (SGPP), as well as the Head of Subgroup for sharing and analysing experiences, best practices, to build up success factors for the effective use of Structural Funds for health investments in the Reflection Process On Modern, Responsive And Sustainable Health Systems. He has master's degree in Health Management, professional qualification of Health Care Manager and Economics, professional qualification of transport and logistics. 9.6 Risk Analysis and Treatment Risks will be analysed and treated by using established methodologies for continuous project planning, monitoring and control, especially Open Project Management Methodology OpenPM². The Project has a clear management and reporting structure, and its deliverables include Project Management Plan, Risk Management Plan, and Dissemination Plan. Project risks are identified, assessed, approved and reported throughout the project and e.g. all internal disagreements and internal and external conflicts solved as early as possible. Internal risks are related to project management, internal communications, and consortium ability and efficiency in dealing with its tasks and fulfilling its purposes. External risks are related to stakeholders, impacts and changes in the society. The Consortium Agreement will ensure that the risks on the legal side within the Consortium are considerably low. Table 5 Risks and their treatment ID Risk Title/Description Likelihood Impact Proposed Risk Treatment and (1-5) (1-5) contingency plan R1 Ineffective coordination 2 3 Effective coordination is ensured by the well-thought managerial structure and transparent procedures. R2 Ineffective overall 1 3 Effective management is ensured management through good PMO office services. R3 Conflicts in the 2 4 All partners are experienced and Consortium motivated to reach the project objectives. The management structure is clear, the project deliverables include Project Management Plan, Risk Management Plan, and the Dissemination Plan. The Consortium Agreement will be comprehensive. Decreasing R1 and R2 decreases R3. Project partners are experienced with virtual collaboration and meetings, effective documenting and sharing. R4 Ineffective collaboration 2 3 Project Steering group meets regularly between WPs to mitigate this risk. R5 Coordination problems 3 2 The coordinator, WP leaders and Task within an individual WP leaders will monitor progress and flag problems early enough to enable fast mitigation. Date: 2021-06-09 64 / 82 Doc Version: 1.0  Associated with document Ref. Ares(2021)4548885 - 13/07/2021 R6 Delays with deliverables 4 1 Planning within Work Packages has distributed deliverables along the project lifecycle. Strong project management in place. R7 Problems with 3 2 Subcontracting is in a small role in this subcontracting project. Partners have extensive experience in subcontracting. R8 Budget overspending 1 4 Reduce: Continuous monitoring of budgeted and actual costs. R9 Change of key staff in the 5 1 Accept: With 8 WPs it is expected that coordination, WP, and some exchange of persons will take Task leaders. place. Each CA is advised to make contingency plans for their staff. R10 Change of requirements 5 2 Accept: New EU regulation is already in for deliverables due process for data spaces. WPs are external events such as adviced to make description of new EU laws, budgets deliverables enough generic so that changes or similar there is a room for change during the project. If the risk materializes severely changes in contracts might be needed. R11 The deliverables will not 2 4 Reduce: One of the main target groups meet the needs of the (EC) is consulted during the planning target groups phase to mitigate the risk. Participants and their experience are expected to mitigate this risk towards other target groups that cannot be consulted during the planning phase. R12 Lack of consensus with 3 3 WP4 aims to include external parties and between early on into the project to assure their stakeholders involvement, strengthening communication and collaboration which facilitates consensus. Further discussion and consensus building happens through the stakeholder forum and WPAGs. Adopting dialogue methods in communication. Active stakeholder engagement. Participatory meetings. Clear communication e.g. not using abbreviations. 9.7 Financial management The Finnish Innovation Fund Sitra funds organisations and their projects and has robust routines for reviewing project progress reports, accounting, and distributing capital according to agreed budgets. In TEHDAS Joint Action Sitra provides an experienced Financial Officer to the project Date: 2021-06-09 65 / 82 Doc Version: 1.0  Associated with document Ref. Ares(2021)4548885 - 13/07/2021 management team and will set up routines according to requirements from HaDEA and what has been agreed in the Grant and Consortium agreements. As stated in the Consortium agreement each Competent Authority is responsible of their own and their Affiliated Entities reporting. As Coordinator Sitra will ensure the establishment of a proper reporting mechanism including the reporting templates, the collection, analysis, and evaluation of financial data from all project partners, continuous budget planning and budget monitoring as well as required audit certificates. In addition to what is required by HaDEA for the reporting periods, Sitra will keep up-to-date tracking of the expenses and regularly report to the Steering committee as well as to the General Assembly. In case of any deviations or major financial issues, Sitra will implement appropriate solutions in accordance with the rules set out in the GA and CA. Sitra will ensure that payments will be made to CAs according to the TEHDAS budget in this proposal and reports received during the project according to the payment schedule agreed with HaDEA. 10 BUDGET 10.1 Content description and justification Overall budget Building the overall budget was a complex task. The project has 25 Competent Authorities and multiple Affiliated Entities. Our approach towards the budget was to first agree on the substance work packages and discuss what were the objectives, tasks, and deliverables. Only after all work packages had a good picture of what to produce, we started the budget discussion. Firstly, we estimated roughly how many person months each task would require. Each WP leader was responsible of their own estimations and gave a range of necessary person months. As in all European projects a person month costs have a wide cost difference. In our case they vary between 2115,00 euros to 10.000,00 euros. Depending on which organizations participate in which Work Package and Task and how the overall participation is split between countries had an impact to the final amount of person months (PM) for the project. Our initial average cost estimate was 5.000,00 euros for a PM. After each country had their calculations done the final average cost was 6.500,00 euros for a PM. This required reductions in person months and streamlining the work package tasks. The outcome is presented in the table below. Table 6 Proposed budget and funding. Item Budget Percentage Direct costs Personnel costs 3 377 745,00 81% Subcontracting 183 000,00 4% Travel 238 700,00 6% Other goods and services 94 636,00 2% Indirect costs 272 585, 67 7% Total eligible costs 4 166 666,67 100% Funding EU Funding 2 500 000,00 60 % Date: 2021-06-09 66 / 82 Doc Version: 1.0  Associated with document Ref. Ares(2021)4548885 - 13/07/2021 Partners’ co-funding 1 666 666,67 40% Total Funding 4 166 666,67 100% Distribution of work The work has been distributed to the different Work Packages as shown in the table below. The project management is designed to be extremely focused activity with less than 10% of the total person months. Dissemination WP2 and Outreach, engagement, and sustainability W4 are focused on having dialogue with either wider public (WP2) or more targeted stakeholders (WP4). Together they are more than 15% of the total budget. As other WPs also contain direct stakeholder engagement (WP7 19 PMs, WP1 5PMs) and WP8 includes citizen dialogue (44,5 PMs) the whole project could be seen very much focused on outwards rather than inwards. The total proportion of these activities is 24% of the project budget. This is an intentional use of budget and entails that building the European Health Data Space cannot happen in closed group but requires engaging stakeholders broadly. The main tangible deliverables are created in work packages 5 to 8. The size of the work package is defined by the tasks as well as interest of participating organisations to get involved in the work. The largest WP is the WP5 which was also most popular among participants. More participants mean more coordination efforts as well as more fragmented work. It is also expected that large WPs require more meetings to come into common conclusions on the deliverables. For these reasons, the thematic Work Packages are not even in size. Table 7 Person months in work packages Work package name Effort PM Percentage WP1 - Coordination 50 9,48% WP2 - Dissemination 23 4,36% WP3 - Evaluation 11 2,09% WP4 – Outreach, engagement and 59 11,19% sustainability WP5 – Sharing data for health 109 20,67% WP6 – Excellence in data quality 89,25 16,93% WP7 – Connecting the dots 100,5 19,06% WP8 - Citizens 85,5 16,22% Total 527,25 100,00% Other costs The personnel costs are more than 80% of the total costs. During the pandemic, all European organizations have learned new working habits and the creation of this project plan is one example. We have estimated less travelling than usually in European projects as the project will rely on hybrid and online meetings regardless of the COVID situation. With the new skills and tools to work remotely we had the courage to limit travelling to 6% of the total costs. At minimum, each participating organization receives 6.000,00 euros travelling budget. That is calculated to include three yearly general assembly meetings and additional face-to-face workshop, altogether 6 meetings with 1.000,00 estimated costs each. Date: 2021-06-09 67 / 82 Doc Version: 1.0  Associated with document Ref. Ares(2021)4548885 - 13/07/2021 Work Package leaders have additional travelling costs, and the coordinator is expected to have the most travelling during the project. Table 8 Summary of meetings during the Joint Action (estimate) Meeting Number of Number Duration Hybrid meetings of (days) (H) or participa online nts (O) General Assemblies (GA) 5 52 1,5 3H+2O Project Steering Group (PSG) 24 20 H=1, O=0,5 3H+21O WP Meetings 30 15 1 5H+25O WP Workshops 5 20 1,5 H WP Advisory groups (WPAG) 8 10 0,5 O Policy Forum meetings 2 52 1 H Project Forum meetings 2 20 1 H Stakeholder Forum (SF), linked to GA 3 80 1 H Subcontracting is also extremely limited. We estimate 4% and 183.000 euros to subcontracting. When a task is subcontracted it is thoroughly considered. The aim of the work to be delivered is that it represents the participating organizations and stakeholders which have participated in the work. Subcontracting is used to tasks where expertise is not within the participants and has been clearly defined in the detailed budget tables in chapter 10.4. Other goods and services are 2% and contains mainly yearly General assembly meetings as well as workshops organized by the Work Packages including facilities, catering, and other costs. 10.2 Summary of Effort Table 9 Person months per applicant Applicant WP1 WP2 WP3 WP4 WP5 WP6 WP7 WP8 Total PM 1-Sitra 50 23 0 8 4 7 19 5 116 2-ATNA 0 0 0 0 2 2 3 0 7 3-Sciensano 0 0 0 29 8 2 5 17.5 61,5 4-CHIF 0 0 0 0 3 0 0 4 7 5-MoH-CY 0 0 0 0 0 0 0 0 0 6-MZCR 0 0 0 3 4 1 2 1 11 7-RM 0 0 0 0 4 13 3 0 20 8-MoSA 0 0 0 0 0 0 0 0 0 9-FR-HDH 0 0 0 0 11 10,5 4 19 44,5 10-BMG 0 0 0 0 0 0 0 0 0 Date: 2021-06-09 68 / 82 Doc Version: 1.0  Associated with document Ref. Ares(2021)4548885 - 13/07/2021 11-6YPE 0 0 0 0 2 0 0 0 2 12- OKFŐ 0 0 0 4 5 4 5 23 41 13-DoH-IE 0 0 0 0 0 0 0 0 0 14-MINSAL 0 0 0 0 3 4 3 0 10 15-SAM-LT 0 0 0 0 4 0 0 0 4 16-DHIR 0 0 0 5 2 0 0 0 7 17-ATRM 0 0 0 0 0 0 0 0 0 18-VWS 0 0 0 0 15 2 0 0 17 19-MoH-NO 0 0 0 0 3 4 0 2 9 20-SPMS 0 0 11 0 6 7 8 0 32 21-IPHS “Batut” 0 0 0 1 1 0 0 0 2 22-NIJZ 0 0 0 5 4 0 0 0 9 23-IACS 0 0 0 0 8 30,75 45,5 0 84,25 24-SEHA 0 0 0 4 16 2 3 0 25 25-NHSC 0 0 0 0 4 0 0 14 18 Total PM 50 23 11 59 109 89,25 100,5 85,5 527,25 10.3 Third-Party Contributions N/A 10.4 Detailed Budget The detailed budget includes all participating organisations, regardless of their request to the subsidy for the in-kind work to be carried out. Some participating organisations have indicated to request no budget for their in-kind contribution. That means that they will contribute but are not requesting budget from the project. Thus, some of the participants have zero in the detailed budget below for contributing to the work (A) as well as Table 8 above but they still benefit from travel allocation (C). As they participate in work packages, person months have been indicated in the relevant work package tables for contribution. Each contribution has a meaning, and everyone bears a responsibility for a specific task. Applicant No. & Short Name #1 Suomen itsenäisyyden juhlarahasto / The Finnish Innovation Fund Sitra (Sitra) (A) Direct personnel costs Staff function Monthly Cost Estimated Sum Cost (€) Person-month Project lead / coordinator 10.200,00 10 102.000,00 Date: 2021-06-09 69 / 82 Doc Version: 1.0  Associated with document Ref. Ares(2021)4548885 - 13/07/2021 Senior lead in the field of 9.800,00 13 127.400,00 health data Project manager 7.200,00 20 144.000,00 Communication specialist 7.200,00 23 165.600,00 Financial specialist 5.700,00 13 74.100,00 Project assistant 4.050,00 8 32.400,00 Total person Total Costs (€) for (A) month 87 645.500,00 Justification WP1 and WP2 lead. Task lead in 4.4. Contributor in Tasks 4.2, 5.4, 8.5 and 8.6. (B) Direct costs of Costs (€) Task(s)/Justification subcontracting WP2 website, video 53.000,00 Many communication activities including website production, graphic design, creation, video streaming in general assembly meetings, media / social media coverage graphic design to create leaflet and following media surveillance reach metrics will be subcontracted. Total Costs (€) of (B) 53.000,00 (C) Other direct costs (C.1) Travel Costs (€) Justification 40.000,00 The coordination team is estimated to participate 10 events yearly with average of two participants / meeting. An average cost of 1000 euros per meeting. The events are WP workshops, conferences, general assembly meetings as well as bilateral meetings with key stakeholders including the European Commission and other European institutions and agencies. (C.3) Other goods and services Costs (€) Justification 37.636,00 The costs are related to organising meetings/conferences. There are three general assembly meetings and three stakeholder forums. 1.000,00 Certificate on financial statements Total Costs (€) of (C) 78.636,00 (D) Indirect Costs Total Costs (€) (Max. 7% on A, B and C) 54.399,52 Total estimated eligible costs 831.535,52 Applicant No. & Short Name CSC - IT Center for Science (CSC) Affiliated to #1 Sitra (A) Direct personnel costs Staff function Monthly Cost Estimated Sum Cost (€) Person-month Date: 2021-06-09 70 / 82 Doc Version: 1.0  Associated with document Ref. Ares(2021)4548885 - 13/07/2021 Senior expert 6220 9 55.980 Total person month Total Costs (€) for (A) 9 55.980 Justification Participation in Tasks 7.1 and 7.3 Total Costs (€) of (B) 0 Total Costs (€) of (C) 0 (D) Indirect Costs Total Costs (€) (Max. 7% on A, B and C) 3.918,6 Total estimated eligible costs 59.898,6 Applicant No. & Short Name Finnish institute for health and welfare (THL) Affiliated to #1 Sitra (A) Direct personnel costs Staff function Monthly Cost Estimated Sum Cost (€) Person-month Senior Expert 7150 7 50050 Senior Expert 6210 3 18630 Total person month Total Costs (€) for (A) 10 68680 Justification Participation in Tasks 6.1 and 6.2. THL/Findata participation in Task 5.3 Total Costs (€) of (B) 0 Total Costs (€) of (C) 0 (D) Indirect Costs Total Costs (€) (Max. 7% on A, B and C) 4807,60 Total estimated eligible costs 73487,6 Applicant No. & Short Name Technical Research Centre of Finland (VTT) Affiliated to #1 Sitra (A) Direct personnel costs Staff function Monthly Cost Estimated Sum Cost (€) Person-month Senior Expert 7664 10 76.640 Total person Total Costs (€) for (A) month 10 76.640 Justification Participation in Tasks 7.2 and Task 7.4 Total Costs (€) of (B) 0 Total Costs (€) of (C) 0 Date: 2021-06-09 71 / 82 Doc Version: 1.0  Associated with document Ref. Ares(2021)4548885 - 13/07/2021 (D) Indirect Costs Total Costs (€) (Max. 7% on A, B and C) 5.364,8 Total estimated eligible costs 82.004,8 Applicant No. & Short Name #2 Bundesministerium für Soziales, Gesundheit, Pflege und Konsumentenschutz (ATNA) (A) Direct personnel costs Staff function Monthly Cost Estimated Sum Cost (€) Person-month Senior level manager in the field of health 9825 3,5 34387,5 data Expert in the field of health data 6450 3 19350 Project manager 4525 0,5 2262,5 Total person Total Costs (€) for month (A) 7 56000 Justification Contribution in tasks 5.4, 6.1, 6.2, 7.1 and 7.4 Total Costs (€) of (B) 0 (C) Other direct costs (C.1) Travel Costs (€) Justification 6.000,00 3 yearly General assembly meetings, 3 face-to-face workshops during the joint action. Total Costs (€) of (C) 6.000,00 (D) Indirect Costs Total Costs (€) (Max. 7% on A, B and C) 4.340,00 Total estimated eligible costs 66.340,00 Applicant No. & Short Name #3 Sciensano (Sciensano) (A) Direct personnel costs Staff function Monthly Cost Estimated Sum Cost (€) Person-month Junior scientist in the field of 6.608,20 8.954,00 40,5 20,5 267.631,92 health data 7.822,16 0,5 183.557,00 Senior scientist in the field of 3.911,08 health data Communication specialist Total person Total Costs (€) for (A) month 61,5 455.100,00 Justification Lead of WP4 outreach, engagement and sustainability. Task lead in 5.4 and 8.3. Contributor in 5.4, 6.1, 6.2, 7.3, 7.4, 8.1 and 8.3 Date: 2021-06-09 72 / 82 Doc Version: 1.0  Associated with document Ref. Ares(2021)4548885 - 13/07/2021 (B) Direct costs of subcontracting Costs (€) Task(s)/Justification Citizen survey online platform 70.000 Subcontracting for a service provider and ICT support for the online deliberative platform in task 8.2 to have citizen dialogue. Costs include a subscription fee for the backend of the deliberative platform, website design and technical support. Total Costs (€) of (B) 70.000 (C) Other direct costs (C.1) Travel Costs (€) Justification 20.000 3 yearly General assembly meetings, 3 face- toface workshops during the joint action. 3 WP leaders’ face-to-face workshops. Additional travel from WP4 and country visits. (C.3) Other goods and services Costs (€) Justification Date: 2021-06-09 73 / 82 Doc Version: 1.0  Associated with document Ref. Ares(2021)4548885 - 13/07/2021 15.000 WP4 Policy and project forums meetings. Number of meetings: 4 Policy forums and 4 Project Forums. To be integrated in the national and international landscape, it is key to engage with national and international stakeholders and initiatives. Two different levels of interaction are needed: policy level and project level. At policy level, MS/AC national authorities and international organisations will be engaged through a Political Forum. The progress of the different WPs will be presented and potential routes for sustainable interaction will be sought. At project level, connectivity with European initiatives and projects will be sought to build TEHDAS on previous projects. In preparation, a mapping exercise will be carried out to identify relevant initiatives TEHDAS. This includes, amongst others, BRIDGE Health, the Joint Action on Health Information (InfAct) PARENT, JASEHN, eHAction, eHDSI, the Health Research and Innovation Cloud, the European Open Science Cloud and the Population Health Information Research Infrastructure, the 1+ Million Genomes initiative, ELIXIR, Global Alliance for Genomics and Health GA4GH.org. These initiatives will be invited to participate to the Project Forum to share relevant outputs, to build on previous findings and to discuss potential synergies to avoid duplication. The Fora will bring key initiatives together, build on what has been done and strive towards making outcomes interoperable. Four Policy and Project Forum will be organised back to back in close collaboration with the WP leaders. As part of Task 4.2 and building on Task 4.1, this task will explore views on the value of sharing secondary data across Europe, potentially through an EHDS and ideas how to distribute the value (co-)created through EHDS. One of the Policy and Project Forum will be used to discuss this topic. The views and experience of MS/AC national authorities and international projects will be collected. 1.000,00 Certificate on financial statements Total Costs (€) of (C) 36.000 (D) Indirect Costs Total Costs (€) (Max. 7% on A, B and C) 39.277,00 Date: 2021-06-09 74 / 82 Doc Version: 1.0  Associated with document Ref. Ares(2021)4548885 - 13/07/2021 Total estimated eligible costs 600.377,00 Applicant No. & Short Name #4 Hrvatski zavod za zdravstveno osiguranje / Croatian Health Insurance Fund (CHIF) (A) Direct personnel costs Staff function Monthly Cost Estimated Sum Cost (€) Person-month Senior Lead in the field of health 2.450,00 1 2.450,00 data Senior Expert in the field of health 2.115,00 3 6.345,00 data Total person Total Costs (€) for month (A) 4 8.795,00 Justification Contribution in tasks 5.2, 5.4, 8.4 and 8.5 Total Costs (€) of (B) 0 (C) Other direct costs (C.1) Travel Costs (€) Justification 3.000,00 3 yearly General assembly meetings Total Costs (€) of (C) 3.000,00 (D) Indirect Costs Total Costs (€) (Max. 7% on A, B and C) 825,65 Total estimated eligible costs 12.620,65 Applicant No. & Short Name Hrvatski zavod za javno zdravstvo / Croatian Institute of Public Health (CIPH) Affiliated to #4 CHIF (A) Direct personnel costs Staff function Monthly Cost Estimated Sum Cost (€) Person-month Senior Expert in the field of health 3.811,73 0,5 1.905,86 data Expert in the field of health data 1641,65 2,5 4.104,14 Total person Total Costs (€) for (A) month 3 6.010,00 Justification Contribution in tasks 5.2, 5.4, 8.4, 8.5 Total Costs (€) of (B) 0 (C.1) Travel Costs (€) Justification 3.000,00 3 yearly General assembly meetings Total Costs (€) of (C) 3.000,00 (D) Indirect Costs Total Costs (€) Date: 2021-06-09 75 / 82 Doc Version: 1.0  Associated with document Ref. Ares(2021)4548885 - 13/07/2021 (Max. 7% on A, B and C) 630,70 Total estimated eligible costs 9.640,70 Applicant No. & Short Name #5 Ministry of Health of the Republic of Cyprus (MoH-CY) (A) Direct personnel costs Staff function Monthly Cost Estimated Sum Cost (€) Person-month Total person Total Costs (€) for (A) month Justification WP6, 7 and 8 Total Costs (€) of (B) (C) Other direct costs (C.1) Travel Costs (€) Justification 10.000,00 3 yearly General assembly meetings, 3 face- toface workshops during the joint action. Additional travelling added because of multiple persons involved without contribution budget. Total Costs (€) of (C) 0 (D) Indirect Costs Total Costs (€) (Max. 7% on A, B and C) 700,00 Total estimated eligible costs 10.700,00 Applicant No. & Short Name #6 Ministerstvo Zdravotnictvi Ceske Republiky (MZCR) (A) Direct personnel costs Staff function Monthly Cost Estimated Sum Cost (€) Person-month Senior Expert in the field of health 4.000,00 11 44.000,00 data Total person Total Costs (€) for (A) month 11 44.000,00 Justification Contribution in tasks 4.1, 4.2, 4.3, 5.1, 5.2, 6.2, 7.3, 8.4 Total Costs (€) of (B) 0 (C) Other direct costs (C.1) Travel Costs (€) Justification 6.000,00 3 yearly General assembly meetings, 3 face- toface workshops during the joint action. Total Costs (€) of (C) 6.000,00 (D) Indirect Costs Total Costs (€) (Max. 7% on A, B and C) 3.500,00 Total estimated eligible costs 53.500,00 Date: 2021-06-09 76 / 82 Doc Version: 1.0  Associated with document Ref. Ares(2021)4548885 - 13/07/2021 Applicant No. & Short Name #7 Region Midtjylland / Region of Central Denmark (RM) (A) Direct personnel costs Staff function Monthly Cost Estimated Sum Cost (€) Person-month Senior Level Manager 9.000,00 4 36.000 80.000 Senior Expert in the field of 8.000 10 19.998 health data Project 6.666 3 Manager Total person Total Costs (€) for (A) month 17 136.000 Justification WP 6 co-leader, Contribution in tasks 5.2, 5.4, 7.4 Total Costs (€) of (B) 0 (C) Other direct costs (C.1) Travel Costs (€) Justification 6.000,00 3 yearly General assembly meetings, 3 face- toface workshops during the joint action. Total Costs (€) of (C) 6.000,00 (D) Indirect Costs Total Costs (€) (Max. 7% on A, B and C) 9.940,00 Total estimated eligible costs 151.940 Applicant No. & Short Name Central Denmark EU Office (CDEU) Affiliated to #7 RM (A) Direct personnel costs Staff function Monthly Cost Estimated Sum Cost (€) Person-month Senior Expert in the field of health 8.000,00 3 24.000,00 data Total person Total Costs (€) for (A) month 3 24.000,00 Justification Participation in Tasks 6.1, 5.4 and 7.4 Total Costs (€) of (B) 0 Total Costs (€) of (C) 0 (D) Indirect Costs Total Costs (€) (Max. 7% on A, B and C) 1.680,00 Date: 2021-06-09 77 / 82 Doc Version: 1.0  Associated with document Ref. Ares(2021)4548885 - 13/07/2021 Total estimated eligible costs 25.680,00 Applicant No. & Short Name #8 Sotsiaalministeerium / Ministry of Social Affairs (MoSA) (A) Direct personnel costs Staff function Monthly Cost Estimated Sum Cost (€) Person-month Senior expert in the field of 0 1 0 health data Total person Total Costs (€) for (A) month 1 0 Justification EE will participate with 1 Person Month to WP5 in tasks 5.1 and 5.2. EE is not requesting budget and therefore the total cost is 0 euros. Total Costs (€) of (B) 0 (C) Other direct costs (C.1) Travel Costs (€) Justification 6.000,00 3 yearly General assembly meetings, 3 face- toface workshops during the joint action. Total Costs (€) of (C) 6.000,00 (D) Indirect Costs Total Costs (€) (Max. 7% on A, B and C) 420,00 Total estimated eligible costs 6.420,00 Applicant No. & Short Name #9 Plateforme des données de santé / Health Data Hub (FR-HDH) (A) Direct personnel costs Staff function Monthly Cost Estimated Sum Cost (€) Person-month Senior Expert in the field of 6.966,00 24,5 170.667,00 health data Senior Expert in the field of 7.000,00 3 21.000,00 health data Total person Total Costs (€) for (A) month 27,5 191.667,00 Justification WP8 Co-leader and task lead of 8.1, Task leader in 5.3, contribution to tasks 5.3, 6.1, 6.2, 7.3, 7.4, 8.1 and 8.2 (B) Direct costs of subcontracting Costs (€) Task(s)/Justification Legal and other expertise linked 20.000,00 Task lead in 5.3 which requires specific external EU to task 5.3 legal and partnership framework expertise Total Costs (€) of (B) 20.000,00 Date: 2021-06-09 78 / 82 Doc Version: 1.0  Associated with document Ref. Ares(2021)4548885 - 13/07/2021 (C) Other direct costs (C.1) Travel Costs (€) Justification 12.000,00 3 yearly General assembly meetings, 3 face- toface workshops during the joint action. 6 additional meetings as a WP leader. (C.3) Other goods and services Costs (€) Justification 5.000,00 FR-HDH is a task lead in Task 5.3. which includes four partners. There is estimated one workshop between those partners. In the WP8 FR-HDH is a WP leader and for 8.1. one workshop has been planned. Each workshop is estimated 2.500,00 euros. Total Costs (€) of (C) 17.000,00 (D) Indirect Costs Total Costs (€) (Max. 7% on A, B and C) 16.006,69 Total estimated eligible costs 244.673,69 Applicant No. & Short Name Institut national de la santé et de la recherche médicale (Inserm) Affiliated to #9 FR-HDH (A) Direct personnel costs Staff function Monthly Cost Estimated Sum Cost (€) Person-month Senior Expert in the field of 5000 8 40000 health data Total person Total Costs (€) for month (A) 8 40000 Justification Participation in Tasks 5.3 (Inserm US 14 rare disease team from Orphanet) to provide cross-border use case for rare diseases, significant data quality experience and input for 6.1 (Inserm US 10 Center for Epidemiology on Medical Causes of Death) to support tasks related to the data quality assurance framework and work on the semantic interoperability framework for 6.2 (Inserm US 14) Total Costs (€) of (B) 0 (C) Other direct costs Total Costs (€) of (C) 0 (D) Indirect Costs Total Costs (€) (Max. 7% on A, B and C) 2.800,00 Date: 2021-06-09 79 / 82 Doc Version: 1.0  Associated with document Ref. Ares(2021)4548885 - 13/07/2021 Total estimated eligible costs 42.800,00 Applicant No. & Short Name Hospices Civils de Lyon (HCL) Affiliated to #9 FR-HDH (A) Direct personnel costs Staff function Monthly Estimated Sum Cost (€) Cost Person-month Senior Expert in the field of 9.170 1.5 13.755 health data Total person month Total Costs (€) for (A) 1.5 13.755 Justification Participation in Task 6.2 to bring in significant experience and contribution to data formats, in particular OMOP Total Costs (€) of (B) 0 (C) Other direct costs Total Costs (€) of (C) 0 (D) Indirect Costs Total Costs (€) (Max. 7% on A, B and C) 962,85 Total estimated eligible costs 14.717,85 Applicant No. & Short Name UNIVERSITE PAUL SABATIER TOULOUSE III (UT3) Affiliated to #9 FR-HDH (A) Direct personnel costs Staff function Monthly Cost Estimated Sum Cost (€) Person-month Senior Expert in the field of 8100 4 32.400 health data Total person Total Costs (€) for month (A) 4 32.400 Justification Active participation in setting up the partnership framework agreement for task 5.3 and in-depth research on existing good practices in crossborder health data sharing initiatives, 8.1, and participation in 8.2 and 8.3 defining the questionnaire for the online consultation Total Costs (€) of (B) 0 Date: 2021-06-09 80 / 82 Doc Version: 1.0  Associated with document Ref. Ares(2021)4548885 - 13/07/2021 Total Costs (€) of (C) 0 (D) Indirect Costs Total Costs (€) (Max. 7% on A, B and C) 2268,00 Total estimated eligible costs 34.668,00 Applicant No. & Short Name Université Aix-Marseille (AMU) Affiliated to #9 FR-HDH (A) Direct personnel costs Staff function Monthly Cost Estimated Sum Cost (€) Person-month Senior Expert in the field of 9.826 3 29.478 health data Total person Total Costs (€) for (A) month 3 29.478 Justification Participation in Task 6.1 for providing experience and direct contribution to develop data visualisation framework for EHDS Total Costs (€) of (B) 0 Total Costs (€) of (C) 0 (D) Indirect Costs Total Costs (€) (Max. 7% on A, B and C) 2.063,46 Total estimated eligible costs 31.541,46 Applicant No. & Short Name Agence du Numérique en Santé (ANS) Affiliated to #9 FR-HDH (A) Direct personnel costs Staff function Monthly Cost Estimated Sum Cost (€) Person-month Senior Expert in the field of 8400 0.5 4200 health data Total person Total Costs (€) for (A) month 0.5 4200 Date: 2021-06-09 81 / 82 Doc Version: 1.0  Associated with document Ref. Ares(2021)4548885 - 13/07/2021 Justification Participation in Task 6.2 to provide in depth-experience with for data interoperability issues and to be a reviewer of all documentation produced Total Costs (€) of (B) 0 Total Costs (€) of (C) 0 (D) Indirect Costs Total Costs (€) (Max. 7% on A, B and C) 294,00 Total estimated eligible costs 4494,00 Applicant No. & Short Name #10 Bundesinstitut für Arzneimittel und Medizinprodukte / Forschungsdatenzentrum, Bundesinstitut für Arzneimittel und Medizinprodukte / Bundesministerium für Gesundheit (BMG) (A) Direct personnel costs Staff function Monthly Cost Estimated Sum Cost (€) Person-month Senior Expert in the field of health 0 0,5 0 data Total person Total Costs (€) for (A) month 0,5 0 Justification BMG will contribute to tasks 5.4 with 0,50 PM. BMG has not requesting budget from the project and therefore the total costs is 0 euros. Total Costs (€) of (B) 0 (C) Other direct costs (C.1) Travel Costs (€) Justification 4.000,00 3 yearly General assembly meetings, 1 face- toface workshops during the joint action. (C.3) Other goods and services Costs (€) Justification Total Costs (€) of (C) 4.000,00 (D) Indirect Costs Total Costs (€) (Max. 7% on A, B and C) 280,00 Total estimated eligible costs 4.280,00 Applicant No. & Short Name Forschungsdatenzentrum (FDZ) Affiliated to #10 - BMG (A) Direct personnel costs Staff function Monthly Cost Estimated Sum Cost (€) Person-month Senior Expert in the field of health 0 0 0 data Date: 2021-06-09 82 / 82 Doc Version: 1.0  Associated with document Ref. Ares(2021)4548885 - 13/07/2021 Total person Total Costs (€) for (A) month 0 0 Justification Total Costs (€) of (B) 0 (C) Other direct costs (C.1) Travel Costs (€) Justification 3.000,00 3 yearly General assembly meetings. Total Costs (€) of (C) 3.000,00 (D) Indirect Costs Total Costs (€) (Max. 7% on A, B and C) 210,00 Total estimated eligible costs 3.210,00 Applicant No. & Short Name Gematik, (GEMATIK) Affiliated to #10 - BMG (A) Direct personnel costs Staff function Monthly Cost Estimated Sum Cost (€) Person-month Senior Expert in the field of health 0 0 0 data Total person Total Costs (€) for (A) month 0 0 Justification Total Costs (€) of (B) 0 (C) Other direct costs (C.1) Travel Costs (€) Justification 3.000,00 3 yearly General assembly meetings. Total Costs (€) of (C) 3.000,00 (D) Indirect Costs Total Costs (€) (Max. 7% on A, B and C) 210,00 Total estimated eligible costs 3.210,00 Applicant No. & Short Name #11 Dioikisi 6is Ygeionomikis Perifereias Peloponnisou Ionion Nyson Ipeirou Kai Dytikis Ellades / 6th Health Region of Peloponnese, Ionian Islands, Epirus, and Western Greece (6th Y. PE.) (A) Direct personnel costs Staff function Monthly Cost Estimated Sum Cost (€) Person-month Date: 2021-06-09 83 / 82 Doc Version: 1.0  Associated with document Ref. Ares(2021)4548885 - 13/07/2021 Senior Expert in the field of health 3.170,00 2 6.340,00 data Total person Total Costs (€) for (A) month 2 6.340,00 Justification Contribution in task 5.1 Total Costs (€) of (B) 0 (C) Other direct costs (C.1) Travel Costs (€) Justification 6.000,00 3 yearly General assembly meetings, 3 face- toface workshops during the joint action. Total Costs (€) of (C) 6.000,00 (D) Indirect Costs Total Costs (€) (Max. 7% on A, B and C) 863,80 Total estimated eligible costs 13.203,80 Applicant No. & Short Name #12 Országos Kórházi Főigazgatóságot / National Healthcare Service Center (OKFŐ) (A) Direct personnel costs Staff function Monthly Cost Estimated Sum Cost (€) Person-month Senior Lead in the field of health 3.700,00 6 22.200,00 data Senior Expert in the field of health 3.500,00 8 28.000,00 data Junior Expert in the field of 2.800,00 5 14.000,00 health data Financial Specialist 2.800,00 3 8.400,00 Total person Total Costs (€) for (A) month 22 72.600,00 Justification WP 8 Leader, Contributor in tasks 4.1, 4.3, 5.2, 5.4, 6.1, 6.2, 7.3 and 7.4. Total Costs (€) of (B) 0 (C) Other direct costs (C.1) Travel Costs (€) Justification 6.000,00 3 yearly General assembly meetings, 3 face- toface workshops during the joint action. 6 additional meetings as a WP leader. (C.3) Other goods and services Costs (€) Justification Total Costs (€) of (C) 6.000,00 (D) Indirect Costs Total Costs (€) (Max. 7% on A, B and C) 5.502,00 Date: 2021-06-09 84 / 82 Doc Version: 1.0  Associated with document Ref. Ares(2021)4548885 - 13/07/2021 Total estimated eligible costs 84.102,00 Applicant No. & Short Name Semmelweis Egyetem / Semmelweis University, (SU) Affiliated to #12 - OKFŐ (A) Direct personnel costs Staff function Monthly Cost Estimated Sum Cost (€) Person-month Senior Legal Expert 3.675,00 4 14.700,00 Senior Expert in the field of health 3.800,00 6 22.800,00 data Junior Expert in the field of 2.800,00 6 16.800,00 health data Financial Specialist 2.800,00 3 8.400,00 Total person Total Costs (€) for (A) month 19 62.700,00 Justification Contributor in tasks 4.1, 4.3, 5.2, 5.4, 6.1, 6.2, 7.3 and 7.4. Cooperation with OKFŐ as WP8 leader. Total Costs (€) of (B) 0 (C) Other direct costs (C.3) Other goods and services Costs (€) Justification 10.000,00 Workshops for T8.4 and T8.5. Two workshops has been planned for both Tasks with 2.500,00 euros budget for each workshop. (C.1) Travel Costs (€) Justification 6.000,00 Yearly general assembly meetings, face-to-face workshops during the joint action Total Costs (€) of (C) 16.000,00 (D) Indirect Costs Total Costs (€) (Max. 7% on A, B and C) 5.509,00 Total estimated eligible costs 84.209,00 Applicant No. & Short Name #13 Department of Health (DoH-IE) (A) Direct personnel costs Staff function Monthly Cost Estimated Sum Cost (€) Person-month Senior Expert 0 0 0 Total person Total Costs (€) for (A) month 0 0 Justification Total Costs (€) of (B) 0 (C) Other direct costs Date: 2021-06-09 85 / 82 Doc Version: 1.0  Associated with document Ref. Ares(2021)4548885 - 13/07/2021 (C.1) Travel Costs (€) Justification 3.000,00 3 yearly General assembly meetings, 3 face- toface workshops during the joint action. Total Costs (€) of (C) 0 (D) Indirect Costs Total Costs (€) (Max. 7% on A, B and C) 210,00 Total estimated eligible costs 3.210,00 Applicant No. & Short Name Health Research Board (HRB) Affiliated to #13 – DoH-IE (A) Direct personnel costs Staff function Monthly Cost Estimated Sum Cost (€) Person-month Senior Expert in the field of health 0 0 0 data Total person Total Costs (€) for (A) month 0 0 Justification (B) Direct costs of subcontracting Costs (€) Task(s)/Justification Total Costs (€) of (B) 0 (C) Other direct costs (C.1) Travel Costs (€) Justification 3.000,00 3 yearly General assembly meetings, 3 face- toface workshops during the joint action. Total Costs (€) of (C) 3.000,00 (D) Indirect Costs Total Costs (€) (Max. 7% on A, B and C) 210,00 Total estimated eligible costs 3.210,00 Applicant No. & Short Name #14 Ministero della Salute (MINSAL) (A) Direct personnel costs Staff function Monthly Cost Estimated Sum Cost (€) Person-month Senior Expert in the field of health 7.000,00 10 70.000,00 data Total person Total Costs (€) for (A) month 10 70.000,00 Justification Contribution in tasks 5.2, 5.4, 6.1, 6.2, 7.2, 7.3 Total Costs (€) of (B) 0 (C) Other direct costs Date: 2021-06-09 86 / 82 Doc Version: 1.0  Associated with document Ref. Ares(2021)4548885 - 13/07/2021 (C.1) Travel Costs (€) Justification 6.000,00 3 yearly General assembly meetings, 3 face- toface workshops during the joint action. Total Costs (€) of (C) 6.000,00 (D) Indirect Costs Total Costs (€) (Max. 7% on A, B and C) 5.320,00 Total estimated eligible costs 81.320,00 Applicant No. & Short Name #15 Lietuvos Resbublikos Sveikatos Apsaugos Ministerija / Ministry of Health of the Republic of Lithuania (SAM-LT) (A) Direct personnel costs Staff function Monthly Cost Estimated Sum Cost (€) Person-month Senior Expert in the field of 3.200,00 4 12.800,00 health data Total person Total Costs (€) for (A) month 4 12.800,00 Justification Contribution in tasks 5.1 and 5.2 Total Costs (€) of (B) 0 (C) Other direct costs (C.1) Travel Costs (€) Justification 6.000,00 3 yearly General assembly meetings, 3 face- toface workshops during the joint action. Total Costs (€) of (C) 6.000,00 (D) Indirect Costs Total Costs (€) (Max. 7% on A, B and C) 1.316,00 Total estimated eligible costs 20.116,00 Applicant No. & Short Name #16 Ministry for Health – Government of Malta / Directorate Health Information and Research - Ministry for Health (DHIR) (A) Direct personnel costs Staff function Monthly Cost Estimated Sum Cost (€) Person-month Senior Expert in the field of 6.500,00 7 45.500,00 health data Total person Total Costs (€) for (A) month 7 45.500,00 Justification Contribution in tasks 4.1, 4.2, 4.3 and 5.2 Total Costs (€) of (B) 0 (C) Other direct costs (C.1) Travel Costs (€) Justification Date: 2021-06-09 87 / 82 Doc Version: 1.0  Associated with document Ref. Ares(2021)4548885 - 13/07/2021 6.000,00 3 yearly General assembly meetings, 3 face- toface workshops during the joint action. Total Costs (€) of (C) 6.000,00 (D) Indirect Costs Total Costs (€) (Max. 7% on A, B and C) 3.605,00 Total estimated eligible costs 55.105,00 Applicant No. & Short Name #17 Agentia de Transplant / Transplant Agency of the Republic of Moldova (ATRM) (A) Direct personnel costs Staff function Monthly Cost Estimated Sum Cost (€) Person-month Senior Expert in the field of 0 0 0 health data Total person Total Costs (€) for (A) month 0 0 Justification (B) Direct costs of Costs (€) Task(s)/Justification subcontracting Total Costs (€) of (B) 0 (C) Other direct costs (C.1) Travel Costs (€) Justification 6.000,00 3 yearly General assembly meetings, 3 face- toface workshops during the joint action. Total Costs (€) of (C) 6.000,00 (D) Indirect Costs Total Costs (€) (Max. 7% on A, B and C) 420,00 Total estimated eligible costs 6.420,00 Applicant No. & Short Name #18 NLNA, Ministerie van Volksgezondheid, Welzijn en Sport / Welfare and Sports, Directorate Information Policy of the Ministry of Health (VWS) (A) Direct personnel costs Staff function Monthly Cost Estimated Sum Cost (€) Person-month Senior Expert in the field of 10.000,00 15 150.000,00 health data Total person Total Costs (€) for (A) month 15 150.000,00 Justification WP5 Co-leader, Task Lead for T5.2 and contribution to T5.1, and T5.4. Date: 2021-06-09 88 / 82 Doc Version: 1.0  Associated with document Ref. Ares(2021)4548885 - 13/07/2021 (B) Direct costs of Costs (€) Task(s)/Justification subcontracting Legal expertise 20.000,00 Task 5.4 is expected to involve external experts in the field of legal services for specific and focused EU law problems for which in-house legal advice cannot be found. Total Costs (€) of (B) 20.000,00 (C) Other direct costs (C.1) Travel Costs (€) Justification 9.000,00 3 yearly General assembly meetings, 3 faceto-face workshops during the joint action. 3 additional meetings as a WP leader. (C.3) Other goods and services Costs (€) Justification 5.000,00 Workshops in WP5. Two workshops with a budget of 2.500,00 euros each. Total Costs (€) of (C) 14.000,00 (D) Indirect Costs Total Costs (€) (Max. 7% on A, B and C) 12.888,00 Total estimated eligible costs 196.880,00 Applicant No. & Short Name Stichting Nationaal ICT Instituut in de Zorg (Nictiz) Affiliated to #18 VWS (A) Direct personnel costs Staff function Monthly Cost Estimated Sum Cost (€) Person-month (Senior) Expert in the field of 10.000 2 20.000 health data Total person Total Costs (€) for month (A) 2 20.000 Justification Nictiz will contribute to Task 6.2 Total Costs (€) of (B) 0 (C) Other direct costs (C.1) Travel Costs (€) Justification 3.000,00 3 face-to-face workshops Total Costs (€) of (C) 3.000,00 (D) Indirect Costs Total Costs (€) Date: 2021-06-09 89 / 82 Doc Version: 1.0  Associated with document Ref. Ares(2021)4548885 - 13/07/2021 (Max. 7% on A, B and C) 1.610,00 Total estimated eligible costs 24.610,00 Applicant No. & Short Name #19 E-helseavdelningen, The Norwegian Ministry of Health and Care Services (MoH-NO) (A) Direct personnel costs Staff function Monthly Cost Estimated Sum Cost (€) Person-month Senior Expert in the field of 8.000,00 1 8.000,00 health data Total person Total Costs (€) for (A) month 1 8.000,00 Justification Contribution in tasks 5.4 Total Costs (€) of (B) 0 (C) Other direct costs (C.1) Travel Costs (€) Justification 6.000,00 3 yearly General assembly meetings, 3 face- toface workshops during the joint action. (C.3) Other goods and services Costs (€) Justification Total Costs (€) of (C) 6.000,00 (D) Indirect Costs Total Costs (€) (Max. 7% on A, B and C) 980,00 Total estimated eligible costs 14.980,00 Applicant No. & Short Name Helsedirektoratet / Norwegian Directorate of Health (Hdir) Affiliated to #19 MoH-NO (A) Direct personnel costs Staff function Monthly Cost Estimated Sum Cost (€) Person-month Senior Expert in the field of 8.000,00 4 32.000,00 health data Total person Total Costs (€) for month (A) 4 32.000,00 Justification Hdir will contribute to Task 6.1 and 8.4 Total Costs (€) of (B) 0 Total Costs (€) of (C) 0 (D) Indirect Costs Total Costs (€) Date: 2021-06-09 90 / 82 Doc Version: 1.0  Associated with document Ref. Ares(2021)4548885 - 13/07/2021 (Max. 7% on A, B and C) 2.240,00 Total estimated eligible costs 34.240,00 Applicant No. & Short Name Direktorat for e-helse / Norwegian Directorate for eHealth (Ehelse) Affiliated to #19 MoH-NO (A) Direct personnel costs Staff function Monthly Cost Estimated Sum Cost (€) Person-month Senior Expert in the field of 8.000,00 2 16.000,00 health data Total person Total Costs (€) for month (A) 2 16.000,00 Justification E-Helse will contribute to Task 6.2 Total Costs (€) of (B) 0 Total Costs (€) of (C) 0 (D) Indirect Costs Total Costs (€) (Max. 7% on A, B and C) 1.120,00 Total estimated eligible costs 17.120,00 Applicant No. & Short Name Folkehelseinstituttet / Norwegian institute for public health (FHI) Affiliated to #19 MoH-NO (A) Direct personnel costs Staff function Monthly Cost Estimated Sum Cost (€) Person-month Senior Expert in the field of 8.000,00 2 16.000,00 health data Total person Total Costs (€) for month (A) 2 16.000,00 Justification E-Helse will contribute to Task 5.1 Total Costs (€) of (B) 0 Total Costs (€) of (C) 0 (D) Indirect Costs Total Costs (€) Date: 2021-06-09 91 / 82 Doc Version: 1.0  Associated with document Ref. Ares(2021)4548885 - 13/07/2021 (Max. 7% on A, B and C) 1.120,00 Total estimated eligible costs 17.120,00 Applicant No. & Short Name #20 SPMS – Servicos Partilhados do Ministerio de Saude EPE / Shared Services of the Ministry of Health, EPE (SPMS) (A) Direct personnel costs Staff function Monthly Cost Estimated Sum Cost (€) Person-month Director 7.400,00 4,0 29.600,00 Chief of office/Unit coordinator 6.000,00 6,00 36.000,00 eHealth business and technical 4.000,00 22,0 88.000,00 experts Total person Total Costs (€) for (A) month 32 153.600,00 Justification WP 3 leader, Contributions in tasks 5.1, 5.4, 6.1, 6.2, 7.1 and 7.2 Total Costs (€) of (B) 0 (C) Other direct costs (C.1) Travel Costs (€) Justification 6000,00 Participation in three General Assembly meetings Total Costs (€) of (C) 6.000,00 (D) Indirect Costs Total Costs (€) (Max. 7% on A, B and C) 11172,00 Total estimated eligible costs 170.772,00 Applicant No. & Short Name #21 Institute za Zastitu Zoravlja Srbijedr Milan Jovanovic Batut / Institute of Public Health of Republic of Serbia "Dr Milan Jovanovic Batut" (IPHS “Batut”) (A) Direct personnel costs Staff function Monthly Cost Estimated Sum Cost (€) Person-month Senior Expert in the field of 2.000,00 2 4.000,00 health data Total person Total Costs (€) for (A) month 2 4.000,00 Justification Contribution in tasks 4.1 and 5.1 (B) Direct costs of Costs (€) Task(s)/Justification subcontracting Total Costs (€) of (B) 0 Date: 2021-06-09 92 / 82 Doc Version: 1.0  Associated with document Ref. Ares(2021)4548885 - 13/07/2021 (C) Other direct costs (C.1) Travel Costs (€) Justification 6.000,00 3 yearly General assembly meetings, 3 face- toface workshops during the joint action. Total Costs (€) of (C) 6.000,00 (D) Indirect Costs Total Costs (€) (Max. 7% on A, B and C) 700,00 Total estimated eligible costs 10.700,00 Applicant No. & Short Name #22 Nacionalni Institut za Javno Zdravje / National Institute of Public Health (NIJZ) (A) Direct personnel costs Staff function Monthly Cost Estimated Sum Cost (€) Person-month Senior Expert in the field of health 4.200,00 9 37.800,00 data Total person Total Costs (€) for (A) month 9 37.800,00 Justification Participation in Tasks: 4.1, 4.2, 5.1, 5.2. (B) Direct costs of subcontracting Costs (€) Task(s)/Justification Total Costs (€) of (B) 0 (C) Other direct costs (C.1) Travel Costs (€) Justification 6.000,00 3 yearly General assembly meetings, 3 face- toface workshops during the joint action. Total Costs (€) of (C) 6.000,00 (D) Indirect Costs Total Costs (€) (Max. 7% on A, B and C) 3.066,00 Total estimated eligible costs 46.866,00 Applicant No. & Short Name #23 Instituto Aragonés de Ciencias de la Salud (IACS) (A) Direct personnel costs Staff function Monthly Cost Estimated Sum Cost (€) Person-month Data scientist 4.755,00 27 128.385,00 Senior Researcher in the field of 6.300,00 17 107.100,00 health data Researcher in the field of health 3.400,00 17 57.800,00 data Biocomputation responsible 5.560,00 5 27.800,00 Date: 2021-06-09 93 / 82 Doc Version: 1.0  Associated with document Ref. Ares(2021)4548885 - 13/07/2021 IACS JA coordinator, Policy 6.910,00 4 27.640,00 transfer coordinator Innovation Coordinator 6.200,00 2 12.400,00 Project officer 3.500,00 12,25 42.875,00 Total person Total Costs (€) for month (A) 84,25 404.400,00 Justification Work package leader in WP6 and WP7, Contribution in tasks 5.1, 5.3 and 5.4 (B) Direct costs of subcontracting Costs (€) Task(s)/Justification Total Costs (€) of (B) 0 (C) Other direct costs (C.1) Travel Costs (€) Justification 15.000,00 3 yearly General assembly meetings, 3 faceto-face workshops during the joint action. As a WP6 and WP7 leader, additional meetings for both leaders. (C.3) Other goods and services Costs (€) Justification 14.000,00 Workshops in WP6 and WP7 1.000,00 Certificate on financial services Total Costs (€) of (C) 30.000,00 (D) Indirect Costs Total Costs (€) (Max. 7% on A, B and C) 30.408,00 Total estimated eligible costs 464.808,0 0 Applicant No. & Short Name #24 E-hälsomyndigheten / Swedish eHealth Agency (SEHA) (A) Direct personnel costs Staff function Monthly Cost Estimated Sum Cost (€) Personmonth Senior Lead 12.800,00 4 51.200,00 Senior Expert in the field of health 10.500,00 10 105.000,00 data Project Manager 8.400,00 7 58.800,00 Total person Total Costs (€) for (A) month 21 215.000,00 Justification WP Leader in WP5, contributor in tasks 4.1, 4.2, 6.2 and 7.2 (B) Direct costs of sub-contracting Costs (€) Task(s)/Justification Legal expertise 20.000,00 Task 5.2 is expected to have needs for external legal expertise on international and Date: 2021-06-09 94 / 82 Doc Version: 1.0  Associated with document Ref. Ares(2021)4548885 - 13/07/2021 EU-specific data regulation due to lack of inhouse legal resources. Total Costs (€) of (B) 20.000,00 (C) Other direct costs (C.1) Travel Costs (€) Justification 12.000,00 3 yearly General assembly meetings, 3 face-to-face workshops during the joint action. 6 additional meetings as a WP leader. (C.3) Other goods and services Costs (€) Justification 5.000,00 WP5 workshops. Two workshops planned with a budget of 2.500,00 euros each. Total Costs (€) of (C) 17.000,00 (D) Indirect Costs Total Costs (€) (Max. 7% on A, B and C) 17.640,00 Total estimated eligible costs 269.640,00 Applicant No. & Short Name Folkhälsomyndigheten / Public health agency of Sweden (PHAS) Affiliated to #24 – SEHA (A) Direct personnel costs Staff function Monthly Cost Estimated Sum Cost (€) Person-month Senior Expert in the field of health 7.500,00 2 15.000,00 data Total person Total Costs (€) for (A) month 2 15.000,00 Justification The PHAS will contribute to tasks 4.2. Total Costs (€) of (B) 0 Total Costs (€) of (C) 0 (D) Indirect Costs Total Costs (€) (Max. 7% on A, B and C) 1.050,00 Total estimated eligible costs 16.050,00 Applicant No. & Short Name Socialstyrelsen / National Board of Health and Welfare (NBHW) Affiliated to #24 – SEHA (A) Direct personnel costs Staff function Monthly Cost Estimated Sum Cost (€) Person-month Date: 2021-06-09 95 / 82 Doc Version: 1.0  Associated with document Ref. Ares(2021)4548885 - 13/07/2021 Senior Expert in the field of health 10.000,00 2 20.000,00 data Total person Total Costs (€) for (A) month 2 20.000,00 Justification The NBHW will contribute to tasks 7.2. Total Costs (€) of (B) 0 (C) Other direct costs Total Costs (€) of (C) 0 (D) Indirect Costs Total Costs (€) (Max. 7% on A, B and C) 1.400,00 Total estimated eligible costs 21.400,00 Applicant No. & Short Name #25 The NHS Confederation (NHSC) (A) Direct personnel costs Staff function Monthly Cost Estimated Sum Cost (€) Person-month Senior Expert in the field of health 7.450,00 4 29.800,00 data Expert in the field of health data 7.000,00 11 77.000,00 Total person Total Costs (€) for (A) month 15 106.800,00 Justification The NHSC will lead and coordinate the UK input to WP5 and WP8. WP5: 5.1, 5.4 WP8: 8.1, 8.2, 8.3 and 8.5 Total Costs (€) of (B) 0 (C) Other direct costs (C.1) Travel Costs (€) Justification 4.200,00 3 yearly General assembly meetings Total Costs (€) of (C) 4.200,00 (D) Indirect Costs Total Costs (€) (Max. 7% on A, B and C) 7.770,00 Total estimated eligible costs 118.770,00 Applicant No. & Short Name Genome Research Limited / Wellcome Sanger Institute (WSI) (Affiliated to #25 – NHSC (A) Direct personnel costs Staff function Monthly Cost Estimated Sum Cost (€) Person-month Senior Expert in the field of health 7.000 3 21,000.00 data Date: 2021-06-09 96 / 82 Doc Version: 1.0  Associated with document Ref. Ares(2021)4548885 - 13/07/2021 Total person Total Costs (€) for (A) month 3 21,000.00 Justification Senior UK Expert contributing to WP 5 and WP8. WP5: 5.1, 5.4 WP8: 8.1, 8.2, 8.3 and 8.5 Total Costs (€) of (B) 0 (C) Other direct costs (C.1) Travel Costs (€) Justification 1.500,00 Participation on two TEHDAS workshops in WP8 Total Costs (€) of (C) 1.500,00 (D) Indirect Costs Total Costs (€) (Max. 7% on A, B and C) 1.575,00 Total estimated eligible costs 24.075,00 11 PREVIOUS AND CURRENT GRANTS RELEVANT TO THE PROGRAMME According to the guidance received from HaDEA it is not necessary to list all project by the participants in this section. The participants in this project are mostly Ministries of Health and public institutions which are very experienced in other EU joint actions, health programme and H2020 projects. The applicants have been partners in several important EU project such as the EU Health Programme Joint Action projects ADVANTAGE, CANCON, CHRODIS-PLUS, InfAct, eHAction, EMERGE, EUnetHTA JA, EU-JAMRAI. EU-JAV, GAPP, HA-REACT, Healthy GateWays, infACT, INTEGRATE, iPAAC, JAHEE, JAMIE, JAMS, JANPA, JARC, JAseHN, JATC, RD-ACTION, SHARP, VISTART and X-eHealth. Annex describes how the most relevant of these projects link to the Joint Action. 12 CURRENT APPLICATIONS RELEVANT TO THE PROGRAMME N/A 13 EXCEPTIONAL UTILITY N/A 14 COLLABORATING STAKEHOLDERS Due to the short timeframe in the preparation phase the partners decided to choose collaborating stakeholders once the project has started. The Joint Action will publish an open call on the TEHDAS project website in the beginning of 2021. The open call will ensure equal opportunity for all stakeholders to express their interest and elaborate their contribution to the Joint Action. The stakeholders will have an opportunity to choose which WPs they are interested in and to justify their participation. Contracting collaborating stakeholders at this stage would have benefitted those who have good contacts to partners and would have not been in keeping with the objective of engaging stakeholders broadly in the process of building the European Health Data Space. i eHealth Network Refined eHealth European Interoperability Framework. Brussels, 2015. https://ec.europa.eu/health/sites/health/files/ehealth/docs/ev_20151123_co03_en.pdf Retrieved 2020-10-14. Date: 2021-06-09 97 / 82 Doc Version: 1.0 Grant Agreement number: 101035467 — TEHDAS — HP-JA-2020 / HP-JA-2020-1 ESTIMATED BUDGET FOR THE ACTION Associated with document Ref. Ares(2021)4548885 - 13/07/2021 Estimated eligible1 costs (per budget category) EU contribution Action's estimated receipts Financial B. Direct D. Indirect Reimbursement Maximum EU Maximum Income contributions A. Direct C. Other Action’s costs of Total costs generated given by third personnel costs direct costs costs2 rate %3 contribution4 grant amount5 total receipts subcontracting by the action parties to the beneficiaries A.1 Employees C.1 Travel (or equivalent) C.2 Equipment A.2 Natural persons under C.3 Other goods direct contract and services and seconded persons Cost form6 Actual Actual Actual Flat-rate7 7% d= a b c e = a+b+c+d f g=e*f h i j k=i+j 0.07 * (a+b+c) 1. Sitra 645 500.00 53 000.00 78 636.00 54 399.52 831 535.52 60.00 498 921.31 498 921.31 0.00 0.00 0.00 - VTT 76 640.00 0.00 0.00 5 364.80 82 004.80 60.00 49 202.88 49 202.88 0.00 0.00 0.00 - CSC 55 980.00 0.00 0.00 3 918.60 59 898.60 60.00 35 939.16 35 939.16 0.00 0.00 0.00 - THL 68 680.00 0.00 0.00 4 807.60 73 487.60 60.00 44 092.56 44 092.56 0.00 0.00 0.00 Σ beneficiary 846 800.00 53 000.00 78 636.00 68 490.52 1 046 926.52 628 155.91 628 155.91 0.00 0.00 0.00 2. ATNA 56 000.00 0.00 6 000.00 4 340.00 66 340.00 60.00 39 804.00 39 804.00 0.00 0.00 0.00 3. Sciensano 455 100.00 70 000.00 36 000.00 39 277.00 600 377.00 60.00 360 226.20 360 226.20 0.00 0.00 0.00 4. CHIF 8 795.00 0.00 3 000.00 825.65 12 620.65 60.00 7 572.39 7 572.39 0.00 0.00 0.00 - CIPH 6 010.00 0.00 3 000.00 630.70 9 640.70 60.00 5 784.42 5 784.42 0.00 0.00 0.00 Σ beneficiary 14 805.00 0.00 6 000.00 1 456.35 22 261.35 13 356.81 13 356.81 0.00 0.00 0.00 5. MoH-CY 0.00 0.00 10 000.00 700.00 10 700.00 60.00 6 420.00 6 420.00 0.00 0.00 0.00 6. MZCR 44 000.00 0.00 6 000.00 3 500.00 53 500.00 60.00 32 100.00 32 100.00 0.00 0.00 0.00 7. RM 136 000.00 0.00 6 000.00 9 940.00 151 940.00 60.00 91 164.00 91 164.00 0.00 0.00 0.00 - CDEU 24 000.00 0.00 0.00 1 680.00 25 680.00 60.00 15 408.00 15 408.00 0.00 0.00 0.00 Σ beneficiary 160 000.00 0.00 6 000.00 11 620.00 177 620.00 106 572.00 106 572.00 0.00 0.00 0.00 8. MoSA 0.00 0.00 6 000.00 420.00 6 420.00 60.00 3 852.00 3 852.00 0.00 0.00 0.00 Page 1 of 4 Grant Agreement number: 101035467 — TEHDAS — HP-JA-2020 / HP-JA-2020-1 ESTIMATED BUDGET FOR THE ACTION Associated with document Ref. Ares(2021)4548885 - 13/07/2021 Estimated eligible1 costs (per budget category) EU contribution Action's estimated receipts Financial B. Direct D. Indirect Reimbursement Maximum EU Maximum Income contributions A. Direct C. Other Action’s costs of Total costs generated given by third personnel costs direct costs costs2 rate %3 contribution4 grant amount5 total receipts subcontracting by the action parties to the beneficiaries A.1 Employees C.1 Travel (or equivalent) C.2 Equipment A.2 Natural persons under C.3 Other goods direct contract and services and seconded persons Cost form6 Actual Actual Actual Flat-rate7 7% d= a b c e = a+b+c+d f g=e*f h i j k=i+j 0.07 * (a+b+c) 9. FR-HDH 191 667.00 20 000.00 17 000.00 16 006.69 244 673.69 60.00 146 804.21 146 804.21 0.00 0.00 0.00 - Inserm 40 000.00 0.00 0.00 2 800.00 42 800.00 60.00 25 680.00 25 680.00 0.00 0.00 0.00 - HCL 13 755.00 0.00 0.00 962.85 14 717.85 60.00 8 830.71 8 830.71 0.00 0.00 0.00 - UT3 32 400.00 0.00 0.00 2 268.00 34 668.00 60.00 20 800.80 20 800.80 0.00 0.00 0.00 - AMU 29 478.00 0.00 0.00 2 063.46 31 541.46 60.00 18 924.88 18 924.88 0.00 0.00 0.00 - ANS 4 200.00 0.00 0.00 294.00 4 494.00 60.00 2 696.40 2 696.40 0.00 0.00 0.00 Σ beneficiary 311 500.00 20 000.00 17 000.00 24 395.00 372 895.00 223 737.00 223 737.00 0.00 0.00 0.00 10. BMG 0.00 0.00 4 000.00 280.00 4 280.00 60.00 2 568.00 2 568.00 0.00 0.00 0.00 - GEMATIK 0.00 0.00 3 000.00 210.00 3 210.00 60.00 1 926.00 1 926.00 0.00 0.00 0.00 - FDZ 0.00 0.00 3 000.00 210.00 3 210.00 60.00 1 926.00 1 926.00 0.00 0.00 0.00 Σ beneficiary 0.00 0.00 10 000.00 700.00 10 700.00 6 420.00 6 420.00 0.00 0.00 0.00 11. 6th Y. PE. 6 340.00 0.00 6 000.00 863.80 13 203.80 60.00 7 922.28 7 922.28 0.00 0.00 0.00 12. OKFŐ 72 600.00 0.00 6 000.00 5 502.00 84 102.00 60.00 50 461.20 50 461.20 0.00 0.00 0.00 - SU 62 700.00 0.00 16 000.00 5 509.00 84 209.00 60.00 50 525.40 50 525.40 0.00 0.00 0.00 Σ beneficiary 135 300.00 0.00 22 000.00 11 011.00 168 311.00 100 986.60 100 986.60 0.00 0.00 0.00 13. DoH-IE 0.00 0.00 3 000.00 210.00 3 210.00 60.00 1 926.00 1 926.00 0.00 0.00 0.00 - HRB 0.00 0.00 3 000.00 210.00 3 210.00 60.00 1 926.00 1 926.00 0.00 0.00 0.00 Page 2 of 4 Grant Agreement number: 101035467 — TEHDAS — HP-JA-2020 / HP-JA-2020-1 ESTIMATED BUDGET FOR THE ACTION Associated with document Ref. Ares(2021)4548885 - 13/07/2021 Estimated eligible1 costs (per budget category) EU contribution Action's estimated receipts Financial B. Direct D. Indirect Reimbursement Maximum EU Maximum Income contributions A. Direct C. Other Action’s costs of Total costs generated given by third personnel costs direct costs costs2 rate %3 contribution4 grant amount5 total receipts subcontracting by the action parties to the beneficiaries A.1 Employees C.1 Travel (or equivalent) C.2 Equipment A.2 Natural persons under C.3 Other goods direct contract and services and seconded persons Cost form6 Actual Actual Actual Flat-rate7 7% d= a b c e = a+b+c+d f g=e*f h i j k=i+j 0.07 * (a+b+c) Σ beneficiary 0.00 0.00 6 000.00 420.00 6 420.00 3 852.00 3 852.00 0.00 0.00 0.00 14. MINSAL 70 000.00 0.00 6 000.00 5 320.00 81 320.00 60.00 48 792.00 48 792.00 0.00 0.00 0.00 15. SAM-LT 12 800.00 0.00 6 000.00 1 316.00 20 116.00 60.00 12 069.60 12 069.60 0.00 0.00 0.00 16. DHIR 45 500.00 0.00 6 000.00 3 605.00 55 105.00 60.00 33 063.00 33 063.00 0.00 0.00 0.00 17. ATRM 0.00 0.00 6 000.00 420.00 6 420.00 60.00 3 852.00 3 852.00 0.00 0.00 0.00 18. VWS 150 000.00 20 000.00 14 000.00 12 880.00 196 880.00 60.00 118 128.00 118 128.00 0.00 0.00 0.00 - Nictiz 20 000.00 0.00 3 000.00 1 610.00 24 610.00 60.00 14 766.00 14 766.00 0.00 0.00 0.00 Σ beneficiary 170 000.00 20 000.00 17 000.00 14 490.00 221 490.00 132 894.00 132 894.00 0.00 0.00 0.00 19. MoH-NO 8 000.00 0.00 6 000.00 980.00 14 980.00 60.00 8 988.00 8 988.00 0.00 0.00 0.00 - Hdir 32 000.00 0.00 0.00 2 240.00 34 240.00 60.00 20 544.00 20 544.00 0.00 0.00 0.00 - FHI 16 000.00 0.00 0.00 1 120.00 17 120.00 60.00 10 272.00 10 272.00 0.00 0.00 0.00 - E-helse 16 000.00 0.00 0.00 1 120.00 17 120.00 60.00 10 272.00 10 272.00 0.00 0.00 0.00 Σ beneficiary 72 000.00 0.00 6 000.00 5 460.00 83 460.00 50 076.00 50 076.00 0.00 0.00 0.00 20. SPMS 153 600.00 0.00 6 000.00 11 172.00 170 772.00 60.00 102 463.20 102 463.20 0.00 0.00 0.00 21. IPHS "Batut" 4 000.00 0.00 6 000.00 700.00 10 700.00 60.00 6 420.00 6 420.00 0.00 0.00 0.00 22. NIJZ 37 800.00 0.00 6 000.00 3 066.00 46 866.00 60.00 28 119.60 28 119.60 0.00 0.00 0.00 23. IACS 404 400.00 0.00 30 000.00 30 408.00 464 808.00 60.00 278 884.80 278 884.80 0.00 0.00 0.00 Page 3 of 4 Grant Agreement number: 101035467 — TEHDAS — HP-JA-2020 / HP-JA-2020-1 ESTIMATED BUDGET FOR THE ACTION Associated with document Ref. Ares(2021)4548885 - 13/07/2021 Estimated eligible1 costs (per budget category) EU contribution Action's estimated receipts Financial B. Direct D. Indirect Reimbursement Maximum EU Maximum Income contributions A. Direct C. Other Action’s costs of Total costs generated given by third personnel costs direct costs costs2 rate %3 contribution4 grant amount5 total receipts subcontracting by the action parties to the beneficiaries A.1 Employees C.1 Travel (or equivalent) C.2 Equipment A.2 Natural persons under C.3 Other goods direct contract and services and seconded persons Cost form6 Actual Actual Actual Flat-rate7 7% d= a b c e = a+b+c+d f g=e*f h i j k=i+j 0.07 * (a+b+c) 24. SEHA 215 000.00 20 000.00 17 000.00 17 640.00 269 640.00 60.00 161 784.00 161 784.00 0.00 0.00 0.00 - PHAS 15 000.00 0.00 0.00 1 050.00 16 050.00 60.00 9 630.00 9 630.00 0.00 0.00 0.00 - NBHW 20 000.00 0.00 0.00 1 400.00 21 400.00 60.00 12 840.00 12 840.00 0.00 0.00 0.00 Σ beneficiary 250 000.00 20 000.00 17 000.00 20 090.00 307 090.00 184 254.00 184 254.00 0.00 0.00 0.00 25. NHSC 106 800.00 0.00 4 200.00 7 770.00 118 770.00 60.00 71 262.00 71 262.00 0.00 0.00 0.00 - WSI 21 000.00 0.00 1 500.00 1 575.00 24 075.00 60.00 14 445.00 14 445.00 0.00 0.00 0.00 Σ beneficiary 127 800.00 0.00 5 700.00 9 345.00 142 845.00 85 707.00 85 707.00 0.00 0.00 0.00 Σ consortium 3 377 745.00 183 000.00 333 336.00 272 585.67 4 166 666.67 60.007 2 500 000.00 2 500 000.00 0.00 0.00 0.00 1 See Article 6 for the eligibility conditions. 2 The indirect costs claimed must be free of any amounts covered by an operating grant (received under any EU or Euratom funding programme). A beneficiary that receives an operating grant during the action's duration cannot claim any indirect costs for the year(s)/reporting period(s) covered by the operating grant (see Article 6.2.D). 3 See Article 5.2 for the reimbursement rate. 4 This is the theoretical amount of the EU contribution, if the reimbursement rate is applied to all the budgeted costs. This theoretical amount is capped by the 'maximum grant amount'. 5 The 'maximum grant amount' is the maximum grant amount decided by the Agency. It normally corresponds to the requested grant, but may be lower. 6 See Article 5 for the cost forms. 7 Flat rate : 7% of eligible direct costs. Page 4 of 4 Grant Agreement number: 101035467 — TEHDAS Associated with document Ref. Ares(2021)4548885 - 13/07/2021 ANNEX 3 ACCESSION FORM FOR BENEFICIARIES BUNDESMINISTERIUM FUER SOZIALES, GESUNDHEIT, PFLEGE UND KONSUMENTENSCHUTZ (ATNA), established in Radetzkystrasse 2, WIEN 1030, Austria, (‘the beneficiary’), represented for the purpose of signing this Accession Form by the undersigned, hereby agrees to become beneficiary No (‘2’) in Grant Agreement No 101035467 (‘the Grant Agreement’) between SUOMEN ITSENAISYYDEN JUHLARAHASTO and the European Health and Digital Executive Agency (‘the EU’), represented by the European Commission ('the Commission'), for the action entitled Towards the European Health DAta Space Joint Action (TEHDAS). and mandates the coordinator to submit and sign in its name and on its behalf any amendments to the Agreement, in accordance with Article 39. By signing this Accession Form, the beneficiary accepts the grant and agrees to implement it in accordance with the Agreement, with all the obligations and conditions it sets out. SIGNATURE For the beneficiary/new beneficiary/new coordinator [--TGSMark#signature-999467243_75_210--] Robert SCHARINGER with ECAS id nshariro signed in the Participant Portal on 16/07/2021 at 12:43:41 (transaction id SigId-93583-xzKKN jPPZu92aJOxogFFfAiyEvwFCHhAYcdk6lR4hud3Y8Eze7OLwrk2KQmd ViIYGOkR2RslG1mR1AznFzQsXiq-yntOf97TTHqL2QVETsEsmO-kVAc 97m1gOA6iRYMA1jADuDv9zxrzO2wo2zu3m0To1hiCs1yh7BtzgZzM VyzMzHOuOehqylBGFq7xKlFf6BrxZa0). Timestamp by third party at 2021.07.16 13:43:46 CEST 1 Grant Agreement number: 101035467 — TEHDAS Associated with document Ref. Ares(2021)4548885 - 13/07/2021 ANNEX 3 ACCESSION FORM FOR BENEFICIARIES SCIENSANO (Sciensano), established in JULIETTE WYTSMANSTRAAT 14, ELSENE 1050, Belgium, VAT number: BE0693876830, (‘the beneficiary’), represented for the purpose of signing this Accession Form by the undersigned, hereby agrees to become beneficiary No (‘3’) in Grant Agreement No 101035467 (‘the Grant Agreement’) between SUOMEN ITSENAISYYDEN JUHLARAHASTO and the European Health and Digital Executive Agency (‘the EU’), represented by the European Commission ('the Commission'), for the action entitled Towards the European Health DAta Space Joint Action (TEHDAS). and mandates the coordinator to submit and sign in its name and on its behalf any amendments to the Agreement, in accordance with Article 39. By signing this Accession Form, the beneficiary accepts the grant and agrees to implement it in accordance with the Agreement, with all the obligations and conditions it sets out. SIGNATURE For the beneficiary/new beneficiary/new coordinator [--TGSMark#signature-906160809_75_210--] Herman Van Oyen with ECAS id n0026p8g signed in the Participant Portal on 20/07/2021 at 11:19:29 (transaction id SigId-9533-gxjWxu zvqAIRdMYqhNVvezk1dGPiIOGKfVjDP1wJr50qvKa5CauqNbbc7c9hS 9Skg2JCQfhiEzJxEEFn3zyi5s0-rS0vSrmBGYCpb7KrNobvPe-zzWDFHu ZKefAi4YYX3wr40Zk1FhAEH39ULFAiL3v71tuK4AAmead0L4ziq0RMu B4BpLVZS8eYWqUG28xk1lCT5W). Timestamp by third party at 2021.07.20 12:19:34 CEST 2 Grant Agreement number: 101035467 — TEHDAS Associated with document Ref. Ares(2021)4548885 - 13/07/2021 ANNEX 3 ACCESSION FORM FOR BENEFICIARIES HRVATSKI ZAVOD ZA ZDRAVSTVENO OSIGURANJE (CHIF), established in MARGARETSKA 3, ZAGREB 10000, Croatia, VAT number: HR3580261, (‘the beneficiary’), represented for the purpose of signing this Accession Form by the undersigned, hereby agrees to become beneficiary No (‘4’) in Grant Agreement No 101035467 (‘the Grant Agreement’) between SUOMEN ITSENAISYYDEN JUHLARAHASTO and the European Health and Digital Executive Agency (‘the EU’), represented by the European Commission ('the Commission'), for the action entitled Towards the European Health DAta Space Joint Action (TEHDAS). and mandates the coordinator to submit and sign in its name and on its behalf any amendments to the Agreement, in accordance with Article 39. By signing this Accession Form, the beneficiary accepts the grant and agrees to implement it in accordance with the Agreement, with all the obligations and conditions it sets out. SIGNATURE For the beneficiary/new beneficiary/new coordinator [--TGSMark#signature-952813541_75_210--] Lucian Vukelić with ECAS id n00292h5 signed in the Participant Portal on 29/07/2021 at 08:18:05 (transaction id SigId-66217-Gdar GkBW66zGFAzgApqyNNbAFzf8QdSEvUitzfi0WGSeLEiKpzfHX4NFYX h76D8Tf9ygYskAbURQw3rBx9ZBXqH-yntOf97TTHqmetnCnXPXja-K 50lZvPD77fzwXzL8loLgvXzzdTLovSfvH2yyxzVunqd1bpzbIT9Qzs2ht uTOfszhCAo3IULRtN739vMAjOKo5Rr). Timestamp by third party at 2021.07.29 09:18:10 CEST 3 Grant Agreement number: 101035467 — TEHDAS Associated with document Ref. Ares(2021)4548885 - 13/07/2021 ANNEX 3 ACCESSION FORM FOR BENEFICIARIES Ministry of Health of the Republic of Cyprus (MoH-CY), established in 1 Prodromou Street & 17 Chilonos Street 1 & 17, Nicosia 1448, Cyprus, (‘the beneficiary’), represented for the purpose of signing this Accession Form by the undersigned, hereby agrees to become beneficiary No (‘5’) in Grant Agreement No 101035467 (‘the Grant Agreement’) between SUOMEN ITSENAISYYDEN JUHLARAHASTO and the European Health and Digital Executive Agency (‘the EU’), represented by the European Commission ('the Commission'), for the action entitled Towards the European Health DAta Space Joint Action (TEHDAS). and mandates the coordinator to submit and sign in its name and on its behalf any amendments to the Agreement, in accordance with Article 39. By signing this Accession Form, the beneficiary accepts the grant and agrees to implement it in accordance with the Agreement, with all the obligations and conditions it sets out. SIGNATURE For the beneficiary/new beneficiary/new coordinator [--TGSMark#signature-994267946_75_210--] Olga KALAKOUTA with ECAS id nkalakoo signed in the Participant Portal on 19/07/2021 at 12:35:25 (transaction id SigId-6030-NKjJ4uR e4hVv66UESvbmBJc8WSrzHezMsBV6A0w0o1wfSf1Gm0FzomxDKvLl pmzKU8V88CP9Vx2bZF5TiJV1ZvG-jpJZscgsw0K70AXNlOzb60-q1NN YFzM5zssMMqmegzzshzVDT35oObS7ezYwtQuy1hdwJLfjFejoP9ANJ oSy4o1MtxcH89p8mX7Dcl7oqqXtKJ0). Timestamp by third party at 2021.07.19 13:35:32 CEST 4 Grant Agreement number: 101035467 — TEHDAS Associated with document Ref. Ares(2021)4548885 - 13/07/2021 ANNEX 3 ACCESSION FORM FOR BENEFICIARIES MINISTERSTVO ZDRAVOTNICTVI CESKE REPUBLIKY (MZCR), established in PALACKEHO NAMESTI 375/4, PRAHA 12801, Czech Republic, (‘the beneficiary’), represented for the purpose of signing this Accession Form by the undersigned, hereby agrees to become beneficiary No (‘6’) in Grant Agreement No 101035467 (‘the Grant Agreement’) between SUOMEN ITSENAISYYDEN JUHLARAHASTO and the European Health and Digital Executive Agency (‘the EU’), represented by the European Commission ('the Commission'), for the action entitled Towards the European Health DAta Space Joint Action (TEHDAS). and mandates the coordinator to submit and sign in its name and on its behalf any amendments to the Agreement, in accordance with Article 39. By signing this Accession Form, the beneficiary accepts the grant and agrees to implement it in accordance with the Agreement, with all the obligations and conditions it sets out. SIGNATURE For the beneficiary/new beneficiary/new coordinator [--TGSMark#signature-924144512_75_210--] Martin ZEMAN with ECAS id nzemmrti signed in the Participant Portal on 25/08/2021 at 07:47:54 (transaction id SigId-76420-WLZwI TU5ClaZsjzwMHEbrhgag68uuMsyznOh1qyIznPbRhJeDS7LMcnb4ze AYrDMFG6870Zp4rmXT1f0FcBdl9e-rS0vSrmBGYC4qPWkzdfTt3-AipV XsE2Ug6zQgxTUPG3sH9Ulhm2NEc6KiWOPWuqNU1bBQaVwy5twHj 46RpJInzYA0g0XqumCJTB4J0AzKvp9JG). Timestamp by third party at 2021.08.25 08:48:04 CEST 5 Grant Agreement number: 101035467 — TEHDAS Associated with document Ref. Ares(2021)4548885 - 13/07/2021 ANNEX 3 ACCESSION FORM FOR BENEFICIARIES REGION MIDTJYLLAND (RM), established in Skottenborg 26, VIBORG 8800, Denmark, VAT number: DK29190925, (‘the beneficiary’), represented for the purpose of signing this Accession Form by the undersigned, hereby agrees to become beneficiary No (‘7’) in Grant Agreement No 101035467 (‘the Grant Agreement’) between SUOMEN ITSENAISYYDEN JUHLARAHASTO and the European Health and Digital Executive Agency (‘the EU’), represented by the European Commission ('the Commission'), for the action entitled Towards the European Health DAta Space Joint Action (TEHDAS). and mandates the coordinator to submit and sign in its name and on its behalf any amendments to the Agreement, in accordance with Article 39. By signing this Accession Form, the beneficiary accepts the grant and agrees to implement it in accordance with the Agreement, with all the obligations and conditions it sets out. SIGNATURE For the beneficiary/new beneficiary/new coordinator [--TGSMark#signature-997381452_75_210--] Jane Baad Jensen with ECAS id n0064tf2 signed in the Participant Portal on 09/08/2021 at 06:56:30 (transaction id SigId-6656-LRijT7y 5OHxzTWJ9LczyYjUvBUIM2gvOVB0WL845dxSzX5qYIvglQTCRrYOQI Y59zOEX9Xdzu64NA86dzNZZstr0-yntOf97TTHqdDioHdsXzeo-1Ozc dTi17dzTESBdy4ziWKarr20RBzKBOguPfGBYVhbaFktCq0cTllGRSoP D2LcGkDOHI0aW6RmdSzu8jtsMvl6). Timestamp by third party at 2021.08.09 07:56:37 CEST 6 Grant Agreement number: 101035467 — TEHDAS Associated with document Ref. Ares(2021)4548885 - 13/07/2021 ANNEX 3 ACCESSION FORM FOR BENEFICIARIES SOTSIAALMINISTEERIUM (MoSA), established in Suur-Ameerika 1, TALLINN 10122, Estonia, (‘the beneficiary’), represented for the purpose of signing this Accession Form by the undersigned, hereby agrees to become beneficiary No (‘8’) in Grant Agreement No 101035467 (‘the Grant Agreement’) between SUOMEN ITSENAISYYDEN JUHLARAHASTO and the European Health and Digital Executive Agency (‘the EU’), represented by the European Commission ('the Commission'), for the action entitled Towards the European Health DAta Space Joint Action (TEHDAS). and mandates the coordinator to submit and sign in its name and on its behalf any amendments to the Agreement, in accordance with Article 39. By signing this Accession Form, the beneficiary accepts the grant and agrees to implement it in accordance with the Agreement, with all the obligations and conditions it sets out. SIGNATURE For the beneficiary/new beneficiary/new coordinator [--TGSMark#signature-998429731_75_210--] Marika PRISKE with ECAS id nprmaika signed in the Participant Portal on 10/08/2021 at 08:49:11 (transaction id SigId-4931-Odtpx6 4lRPfleBtTg4NMUPv7w9tl3pRTZzGoJlnmfd371lm3zQTd7mFMDcMz Ilk0YwSFGV3IlKLrSTGV51fUBO0-jpJZscgsw0KI5zvPP5v2mq-k5pIT7i GtR2624rklGmzzUzdzcqhBn0ycNHtERwhkQ6pNKtcUVerWuYtxNqT s9c36IeMvBkmaS5zRGx6jPZxxNm). Timestamp by third party at 2021.08.10 09:49:16 CEST 7 Grant Agreement number: 101035467 — TEHDAS Associated with document Ref. Ares(2021)4548885 - 13/07/2021 ANNEX 3 ACCESSION FORM FOR BENEFICIARIES PLATEFORME DES DONNEES DE SANTE (FR-HDH), established in 9 RUE GEORGES PITARD, Paris 75015, France, VAT number: FR66130003783, (‘the beneficiary’), represented for the purpose of signing this Accession Form by the undersigned, hereby agrees to become beneficiary No (‘9’) in Grant Agreement No 101035467 (‘the Grant Agreement’) between SUOMEN ITSENAISYYDEN JUHLARAHASTO and the European Health and Digital Executive Agency (‘the EU’), represented by the European Commission ('the Commission'), for the action entitled Towards the European Health DAta Space Joint Action (TEHDAS). and mandates the coordinator to submit and sign in its name and on its behalf any amendments to the Agreement, in accordance with Article 39. By signing this Accession Form, the beneficiary accepts the grant and agrees to implement it in accordance with the Agreement, with all the obligations and conditions it sets out. SIGNATURE For the beneficiary/new beneficiary/new coordinator [--TGSMark#signature-895824586_75_210--] Stephanie Combes with ECAS id n003cp4i signed in the Participant Portal on 25/07/2021 at 19:01:53 (transaction id SigId-28502-MkxA WLKPYpdQGXRpdlMaTo5uj3lg5ZAwVP1CFu4KJ85n056EOzMNm17 6IMpYVrltgegYbqKhgjpaB0XWyjrvLK-yntOf97TTHqmetnCnXPXja-lK xqFb0GLJx3X0IvrjgHJBzJzOZRXZzaR2GkmhF4aSwID7WT3of5VpjBw pRE6tL1fpp6KebRzqjbhR8TMpzP2N4). Timestamp by third party at 2021.07.25 20:02:02 CEST 8 Grant Agreement number: 101035467 — TEHDAS Associated with document Ref. Ares(2021)4548885 - 13/07/2021 ANNEX 3 ACCESSION FORM FOR BENEFICIARIES BUNDESMINISTERIUM FUER GESUNDHEIT (BMG), established in ROCHUSTRASSE 1, BONN 53123, Germany, (‘the beneficiary’), represented for the purpose of signing this Accession Form by the undersigned, hereby agrees to become beneficiary No (‘10’) in Grant Agreement No 101035467 (‘the Grant Agreement’) between SUOMEN ITSENAISYYDEN JUHLARAHASTO and the European Health and Digital Executive Agency (‘the EU’), represented by the European Commission ('the Commission'), for the action entitled Towards the European Health DAta Space Joint Action (TEHDAS). and mandates the coordinator to submit and sign in its name and on its behalf any amendments to the Agreement, in accordance with Article 39. By signing this Accession Form, the beneficiary accepts the grant and agrees to implement it in accordance with the Agreement, with all the obligations and conditions it sets out. SIGNATURE For the beneficiary/new beneficiary/new coordinator [--TGSMark#signature-998954889_75_210--] Judith haugwitz with ECAS id n002x29v signed in the Participant Portal on 23/07/2021 at 08:49:44 (transaction id SigId-19595-T12YR EXx8UxJ6yafL4bnMpaTWw6zWeoPjEiB79XS68ObkidcxtfLv269Dwjgd Hwat1HzaEGGZQuMHI8ZgkmM19-yntOf97TTHqmetnCnXPXja-qSMz mQFr1zmgIFVUkFbBJDXj1R8veBTaN3SvOupYXegnfqSrBZOaYJxuSP5 HO9FWL7rUdTchZLzcIYhbCVO7TlG). Timestamp by third party at 2021.07.23 09:49:49 CEST 9 Grant Agreement number: 101035467 — TEHDAS Associated with document Ref. Ares(2021)4548885 - 13/07/2021 ANNEX 3 ACCESSION FORM FOR BENEFICIARIES DIOIKISI 6IS YGEIONOMIKIS PERIFEREIAS PELOPONNISOU IONION NYSON IPEIROU KAI DYTIKIS ELLADAS (6th Y. PE.), established in IPATIS 1, PATRAS 26 441, Greece, VAT number: EL999100797, (‘the beneficiary’), represented for the purpose of signing this Accession Form by the undersigned, hereby agrees to become beneficiary No (‘11’) in Grant Agreement No 101035467 (‘the Grant Agreement’) between SUOMEN ITSENAISYYDEN JUHLARAHASTO and the European Health and Digital Executive Agency (‘the EU’), represented by the European Commission ('the Commission'), for the action entitled Towards the European Health DAta Space Joint Action (TEHDAS). and mandates the coordinator to submit and sign in its name and on its behalf any amendments to the Agreement, in accordance with Article 39. By signing this Accession Form, the beneficiary accepts the grant and agrees to implement it in accordance with the Agreement, with all the obligations and conditions it sets out. SIGNATURE For the beneficiary/new beneficiary/new coordinator [--TGSMark#signature-915909600_75_210--] Ioannis Karvelis with ECAS id n003c0n7 signed in the Participant Portal on 16/07/2021 at 12:58:46 (transaction id SigId-93839-HJHzIT gS5TQzUHaK8lx2GWwTVMXDCHHmKzOhidkmR0IVyzYIeM4iY59UC SHsi8BNFPgVkUh72ilcnYfbteGfNZ0-yntOf97TTHqL2QVETsEsmO-M1 q6yVh7UxgxeYYYjgtj0HtmXhDfb3ph8o7fBxv3uf1FsfPsdrQazfAsR8el 1zcw0CzzyQ5OMnFwWfZFWzSXzVn0). Timestamp by third party at 2021.07.16 13:58:51 CEST 10 Grant Agreement number: 101035467 — TEHDAS Associated with document Ref. Ares(2021)4548885 - 13/07/2021 ANNEX 3 ACCESSION FORM FOR BENEFICIARIES ORSZAGOS KORHAZI FOIGAZGATOSAG (OKFŐ), established in DIOS AROK 3, BUDAPEST 1125, Hungary, VAT number: HU15845883, (‘the beneficiary’), represented for the purpose of signing this Accession Form by the undersigned, hereby agrees to become beneficiary No (‘12’) in Grant Agreement No 101035467 (‘the Grant Agreement’) between SUOMEN ITSENAISYYDEN JUHLARAHASTO and the European Health and Digital Executive Agency (‘the EU’), represented by the European Commission ('the Commission'), for the action entitled Towards the European Health DAta Space Joint Action (TEHDAS). and mandates the coordinator to submit and sign in its name and on its behalf any amendments to the Agreement, in accordance with Article 39. By signing this Accession Form, the beneficiary accepts the grant and agrees to implement it in accordance with the Agreement, with all the obligations and conditions it sets out. SIGNATURE For the beneficiary/new beneficiary/new coordinator [--TGSMark#signature-891516331_75_210--] Zoltán Jenei with ECAS id n005mzc2 signed in the Participant Portal on 12/08/2021 at 17:23:05 (transaction id SigId-4663-bWZjb6DCzxo baoOAKjuW0xL4mj5EZR6CXLRPszT0A20N241MJjMSjGBizgrbQZ7zL LBfLxVE9zWGI3TQWGSBWaN-rS0vSrmBGYC4qPWkzdfTt3-NDGKG1 lBIUqaX5ctw7CwpztQ1m2tXeX3TApE4xxwzLCXWYpGqAZcjNXEHNS rZDlGL8lWU3aWQLoWhE8Xt88oo4). Timestamp by third party at 2021.08.12 18:23:12 CEST 11 Grant Agreement number: 101035467 — TEHDAS Associated with document Ref. Ares(2021)4548885 - 13/07/2021 ANNEX 3 ACCESSION FORM FOR BENEFICIARIES DEPARTMENT OF HEALTH (DoH-IE), established in Block 1, Miesian Plaza, 50 – 58 Lower Baggot Street, Dublin D02 XW14, Ireland, (‘the beneficiary’), represented for the purpose of signing this Accession Form by the undersigned, hereby agrees to become beneficiary No (‘13’) in Grant Agreement No 101035467 (‘the Grant Agreement’) between SUOMEN ITSENAISYYDEN JUHLARAHASTO and the European Health and Digital Executive Agency (‘the EU’), represented by the European Commission ('the Commission'), for the action entitled Towards the European Health DAta Space Joint Action (TEHDAS). and mandates the coordinator to submit and sign in its name and on its behalf any amendments to the Agreement, in accordance with Article 39. By signing this Accession Form, the beneficiary accepts the grant and agrees to implement it in accordance with the Agreement, with all the obligations and conditions it sets out. SIGNATURE For the beneficiary/new beneficiary/new coordinator [--TGSMark#signature-972459824_75_210--] Alan CAHILL with ECAS id ncahilal signed in the Participant Portal on 03/08/2021 at 10:31:44 (transaction id SigId-16938-d1FmC9bC DFxdwVcQcpuAkWREdnl8vSbRaYtfAXhJM2ziV9QQjRRbNrzszT0ajb GoXqem7lyCrFDs7Wuze1E8vMy-rS0vSrmBGYCf5hdFt0R2zu-mwqB oIyqEExG0KOsjxSQ0xSRw4LxUTzdndKdAH3ihiFhmBPWfNFgNOqR AFgCIPlowFbbPsA1is6nCxJxjnmXMO). Timestamp by third party at 2021.08.03 11:31:48 CEST 12 Grant Agreement number: 101035467 — TEHDAS Associated with document Ref. Ares(2021)4548885 - 13/07/2021 ANNEX 3 ACCESSION FORM FOR BENEFICIARIES MINISTERO DELLA SALUTE (MINSAL), established in Via Giorgio Ribotta 5, ROMA 00144, Italy, VAT number: N/A, (‘the beneficiary’), represented for the purpose of signing this Accession Form by the undersigned, hereby agrees to become beneficiary No (‘14’) in Grant Agreement No 101035467 (‘the Grant Agreement’) between SUOMEN ITSENAISYYDEN JUHLARAHASTO and the European Health and Digital Executive Agency (‘the EU’), represented by the European Commission ('the Commission'), for the action entitled Towards the European Health DAta Space Joint Action (TEHDAS). and mandates the coordinator to submit and sign in its name and on its behalf any amendments to the Agreement, in accordance with Article 39. By signing this Accession Form, the beneficiary accepts the grant and agrees to implement it in accordance with the Agreement, with all the obligations and conditions it sets out. SIGNATURE For the beneficiary/new beneficiary/new coordinator [--TGSMark#signature-999531942_75_210--] Giuseppe Viggiano with ECAS id n001zb0n signed in the Participant Portal on 20/07/2021 at 14:08:52 (transaction id SigId-1080-DscdTz YRd2IozZm3zKWpGsrO3OZ8c9u7rmYPx3RlNIzjetbvSzoSXuzQmQK4 pSw2J3VUqJ81vK7tdzpCJgn25j7m-yntOf97TTHqmetnCnXPXja-fmvsI Vf8p7jO13Yu1PyocNhn4pLFn28O7MDHrrK1krTMdAnQFHjcSA7wS WkQp2VjpzLJXME7l5nd1zwhWRe3US). Timestamp by third party at 2021.07.20 15:08:56 CEST 13 Grant Agreement number: 101035467 — TEHDAS Associated with document Ref. Ares(2021)4548885 - 13/07/2021 ANNEX 3 ACCESSION FORM FOR BENEFICIARIES LIETUVOS RESPUBLIKOS SVEIKATOS APSAUGOS MINISTERIJA (SAM-LT), established in VILNIAUS G 33, VILNIUS LT 01506, Lithuania, (‘the beneficiary’), represented for the purpose of signing this Accession Form by the undersigned, hereby agrees to become beneficiary No (‘15’) in Grant Agreement No 101035467 (‘the Grant Agreement’) between SUOMEN ITSENAISYYDEN JUHLARAHASTO and the European Health and Digital Executive Agency (‘the EU’), represented by the European Commission ('the Commission'), for the action entitled Towards the European Health DAta Space Joint Action (TEHDAS). and mandates the coordinator to submit and sign in its name and on its behalf any amendments to the Agreement, in accordance with Article 39. By signing this Accession Form, the beneficiary accepts the grant and agrees to implement it in accordance with the Agreement, with all the obligations and conditions it sets out. SIGNATURE For the beneficiary/new beneficiary/new coordinator [--TGSMark#signature-933839468_75_210--] Neringa Viliunaite with ECAS id n002eu0d signed in the Participant Portal on 20/07/2021 at 07:49:01 (transaction id SigId-6473-y73Ma Jn7kZOsSCnjztJiidEv5Ys8gQyCbNkdoe8zjjIiBahS2kXzewN3gA8rS7K VlJiVPgpy08uBB2IRcZQJKVW-rS0vSrmBGYCpb7KrNobvPe-NDXt1LK zQDYBnvcAKzvqqd9FjLZYMkP3U5lS7t5HoZvzqngXg3mFzx3OczcpG YOYThuDhrnmmi2EtdH1mG543RO). Timestamp by third party at 2021.07.20 08:49:06 CEST 14 Grant Agreement number: 101035467 — TEHDAS Associated with document Ref. Ares(2021)4548885 - 13/07/2021 ANNEX 3 ACCESSION FORM FOR BENEFICIARIES Ministry for Health - Government of Malta (DHIR), established in Palazzo Castellania, Merchants Street 15, Valletta VLT 200, Malta, VAT number: MT12979127, (‘the beneficiary’), represented for the purpose of signing this Accession Form by the undersigned, hereby agrees to become beneficiary No (‘16’) in Grant Agreement No 101035467 (‘the Grant Agreement’) between SUOMEN ITSENAISYYDEN JUHLARAHASTO and the European Health and Digital Executive Agency (‘the EU’), represented by the European Commission ('the Commission'), for the action entitled Towards the European Health DAta Space Joint Action (TEHDAS). and mandates the coordinator to submit and sign in its name and on its behalf any amendments to the Agreement, in accordance with Article 39. By signing this Accession Form, the beneficiary accepts the grant and agrees to implement it in accordance with the Agreement, with all the obligations and conditions it sets out. SIGNATURE For the beneficiary/new beneficiary/new coordinator [--TGSMark#signature-974144423_75_210--] Joseph RAPA with ECAS id nraparjo signed in the Participant Portal on 12/08/2021 at 08:13:40 (transaction id SigId-4590-9XAm5mrHA QgQrAeDTzWj18yC8UseCzqi3XA5szocqYTPk6Y95u1ozRVMrnKUhp dSKispzPfuXeyhZSovMN2FEwq-jpJZscgsw0Kn625v6UOd1S-3yFNJ6s WqutcMLocmHLUET0oQPsKBVKp7gzQn1UZ2NCjZ9UioXCzamQFO 3qYqy5QKanfYBCoINIxghzgTP5TSDG). Timestamp by third party at 2021.08.12 09:13:46 CEST 15 Grant Agreement number: 101035467 — TEHDAS Associated with document Ref. Ares(2021)4548885 - 13/07/2021 ANNEX 3 ACCESSION FORM FOR BENEFICIARIES AGENTIA DE TRANSPLANT (ATRM), established in STRADA TESTEMITEANU 29, CHISINAU 2025, Moldova, (‘the beneficiary’), represented for the purpose of signing this Accession Form by the undersigned, hereby agrees to become beneficiary No (‘17’) in Grant Agreement No 101035467 (‘the Grant Agreement’) between SUOMEN ITSENAISYYDEN JUHLARAHASTO and the European Health and Digital Executive Agency (‘the EU’), represented by the European Commission ('the Commission'), for the action entitled Towards the European Health DAta Space Joint Action (TEHDAS). and mandates the coordinator to submit and sign in its name and on its behalf any amendments to the Agreement, in accordance with Article 39. By signing this Accession Form, the beneficiary accepts the grant and agrees to implement it in accordance with the Agreement, with all the obligations and conditions it sets out. SIGNATURE For the beneficiary/new beneficiary/new coordinator [--TGSMark#signature-973591911_75_210--] Vladimir Bolocan with ECAS id n006aojs signed in the Participant Portal on 18/07/2021 at 09:13:01 (transaction id SigId-99056-TqXJCM V9JPMAzhzeMr9ObzjUYNF3H4iO5V3zuu3cIgRKeqXVj1O4GlzjaJzbc2u nNh3lZWq8Z3XrcWwKOsH2zrJa-yntOf97TTHqL2QVETsEsmO-obPXN Bx4RXdzj7M1DyGLiS07eDrPn4wDFQckP7eQKZmcV2IZrK55PZXfhdTs HF0DbsR5gB3bN2AMhzzkA0fWQn0). Timestamp by third party at 2021.07.18 10:13:08 CEST 16 Grant Agreement number: 101035467 — TEHDAS Associated with document Ref. Ares(2021)4548885 - 13/07/2021 ANNEX 3 ACCESSION FORM FOR BENEFICIARIES MINISTERIE VAN VOLKSGEZONDHEID, WELZIJN EN SPORT (VWS), established in PARNASSUSPLEIN 5, DEN HAAG 2500 EJ, Netherlands, (‘the beneficiary’), represented for the purpose of signing this Accession Form by the undersigned, hereby agrees to become beneficiary No (‘18’) in Grant Agreement No 101035467 (‘the Grant Agreement’) between SUOMEN ITSENAISYYDEN JUHLARAHASTO and the European Health and Digital Executive Agency (‘the EU’), represented by the European Commission ('the Commission'), for the action entitled Towards the European Health DAta Space Joint Action (TEHDAS). and mandates the coordinator to submit and sign in its name and on its behalf any amendments to the Agreement, in accordance with Article 39. By signing this Accession Form, the beneficiary accepts the grant and agrees to implement it in accordance with the Agreement, with all the obligations and conditions it sets out. SIGNATURE For the beneficiary/new beneficiary/new coordinator [--TGSMark#signature-998886601_75_210--] Ron ROOZENDAAL with ECAS id nroozenr signed in the Participant Portal on 11/08/2021 at 10:46:04 (transaction id SigId-17223-qmdT Y6iEIj7jp9vHRHFjuG0h8FOyaTvApt15tcekT1dT5GFPvUpkG1vW0ddi ws545MYBzN45oa8EiyVDH8zdAn-jpJZscgsw0KI5zvPP5v2mq-jdwoT EtruSaLVBHagXxeADERDBblzJ24sxpzc7azgcRFqZOtRcspsI6SaSyj3o hzIaaBJLzfXOtYC1Ijy6G3CUD). Timestamp by third party at 2021.08.11 11:46:12 CEST 17 Grant Agreement number: 101035467 — TEHDAS Associated with document Ref. Ares(2021)4548885 - 13/07/2021 ANNEX 3 ACCESSION FORM FOR BENEFICIARIES THE NORWEGIAN MINISTRY OF HEALTH AND CARE SERVICES (MoH-NO), established in R6 Teatergata 9, 0030 Oslo 8011, Norway, (‘the beneficiary’), represented for the purpose of signing this Accession Form by the undersigned, hereby agrees to become beneficiary No (‘19’) in Grant Agreement No 101035467 (‘the Grant Agreement’) between SUOMEN ITSENAISYYDEN JUHLARAHASTO and the European Health and Digital Executive Agency (‘the EU’), represented by the European Commission ('the Commission'), for the action entitled Towards the European Health DAta Space Joint Action (TEHDAS). and mandates the coordinator to submit and sign in its name and on its behalf any amendments to the Agreement, in accordance with Article 39. By signing this Accession Form, the beneficiary accepts the grant and agrees to implement it in accordance with the Agreement, with all the obligations and conditions it sets out. SIGNATURE For the beneficiary/new beneficiary/new coordinator [--TGSMark#signature-892752693_75_210--] Ole T. Andersen with ECAS id n005tk7e signed in the Participant Portal on 04/08/2021 at 08:54:09 (transaction id SigId-26917-TRjVtW W4mNzzHIZ68XVAGsJA3ozxNyQh5fIX41GLtdqi0JjIkzYxY5jnxUHJbLn 6A07ztQ3Dis64rua5irYM83zW-rS0vSrmBGYCf5hdFt0R2zu-qzgaiFyO PxSjoIHZKvWHZB8mMCJzpzXnPRYDjuYWLGLObQLWujf81F410w5M MNongzgC4ssG7IRKGN4PYmDNlQu). Timestamp by third party at 2021.08.04 09:54:14 CEST 18 Grant Agreement number: 101035467 — TEHDAS Associated with document Ref. Ares(2021)4548885 - 13/07/2021 ANNEX 3 ACCESSION FORM FOR BENEFICIARIES SPMS - SERVICOS PARTILHADOS DO MINISTERIO DA SAUDE EPE (SPMS), established in AVENIDA DA REPUBLICA, 61, LISBOA 1050 189, Portugal, VAT number: PT509540716, (‘the beneficiary’), represented for the purpose of signing this Accession Form by the undersigned, hereby agrees to become beneficiary No (‘20’) in Grant Agreement No 101035467 (‘the Grant Agreement’) between SUOMEN ITSENAISYYDEN JUHLARAHASTO and the European Health and Digital Executive Agency (‘the EU’), represented by the European Commission ('the Commission'), for the action entitled Towards the European Health DAta Space Joint Action (TEHDAS). and mandates the coordinator to submit and sign in its name and on its behalf any amendments to the Agreement, in accordance with Article 39. By signing this Accession Form, the beneficiary accepts the grant and agrees to implement it in accordance with the Agreement, with all the obligations and conditions it sets out. SIGNATURE For the beneficiary/new beneficiary/new coordinator [--TGSMark#signature-950932323_75_210--] Luis Goes Pinheiro with ECAS id n006a5hr signed in the Participant Portal on 12/08/2021 at 14:40:54 (transaction id SigId-2727-LcwihY C2tJOSVEbyavXHXAbQzOSuVQ5D0vxEZ1uJsXH6zZc6NLEMyRvSsOQ LRl3dzHcT83GxIa8TmzHUFk2OFzd-rS0vSrmBGYC4qPWkzdfTt3-VYG U6WE8Zv9iqUFujRf3YYr98CRj1Z1GaoIKoL02Fgw8e6BxFcIBO22TJVa 7LWrDjib82Kr3sXbzgoBwSXUEVm). Timestamp by third party at 2021.08.12 15:41:00 CEST 19 Grant Agreement number: 101035467 — TEHDAS Associated with document Ref. Ares(2021)4548885 - 13/07/2021 ANNEX 3 ACCESSION FORM FOR BENEFICIARIES INSTITUT ZA ZASTITU ZDRAVLJA SRBIJEDR MILAN JOVANOVIC BATUT (IPHS "Batut"), established in DR SUBOTICA STREET 5, BEOGRAD 11000, Serbia, VAT number: RS102000930, (‘the beneficiary’), represented for the purpose of signing this Accession Form by the undersigned, hereby agrees to become beneficiary No (‘21’) in Grant Agreement No 101035467 (‘the Grant Agreement’) between SUOMEN ITSENAISYYDEN JUHLARAHASTO and the European Health and Digital Executive Agency (‘the EU’), represented by the European Commission ('the Commission'), for the action entitled Towards the European Health DAta Space Joint Action (TEHDAS). and mandates the coordinator to submit and sign in its name and on its behalf any amendments to the Agreement, in accordance with Article 39. By signing this Accession Form, the beneficiary accepts the grant and agrees to implement it in accordance with the Agreement, with all the obligations and conditions it sets out. SIGNATURE For the beneficiary/new beneficiary/new coordinator [--TGSMark#signature-941063349_75_210--] Verica JOVANOVIC with ECAS id njovveri signed in the Participant Portal on 16/07/2021 at 07:12:12 (transaction id SigId-88315-K5TMkx XvChxvRtdzzzLL6IGHEjWnfYHEcScQ2rYd09GxmZYlPntOJtSqOw6EGk0 PkQzpwknPAHrwezOWT8ezsu9W-yntOf97TTHqL2QVETsEsmO-znPfzL HK9IgbB3ST5fKD55DhWSzjr8yKHXniHHAWML8iSsbx2WXD7LU5ozww rTgUBvG0ny2p1CE9xUCkRAv05sy). Timestamp by third party at 2021.07.16 08:12:17 CEST 20 Grant Agreement number: 101035467 — TEHDAS Associated with document Ref. Ares(2021)4548885 - 13/07/2021 ANNEX 3 ACCESSION FORM FOR BENEFICIARIES NACIONALNI INSTITUT ZA JAVNO ZDRAVJE (NIJZ), established in TRUBARJEVA CESTA 2, LJUBLJANA 1000, Slovenia, VAT number: SI44724535, (‘the beneficiary’), represented for the purpose of signing this Accession Form by the undersigned, hereby agrees to become beneficiary No (‘22’) in Grant Agreement No 101035467 (‘the Grant Agreement’) between SUOMEN ITSENAISYYDEN JUHLARAHASTO and the European Health and Digital Executive Agency (‘the EU’), represented by the European Commission ('the Commission'), for the action entitled Towards the European Health DAta Space Joint Action (TEHDAS). and mandates the coordinator to submit and sign in its name and on its behalf any amendments to the Agreement, in accordance with Article 39. By signing this Accession Form, the beneficiary accepts the grant and agrees to implement it in accordance with the Agreement, with all the obligations and conditions it sets out. SIGNATURE For the beneficiary/new beneficiary/new coordinator [--TGSMark#signature-948891346_75_210--] Milan Krek with ECAS id n003bif0 signed in the Participant Portal on 26/07/2021 at 11:28:30 (transaction id SigId-34919-0p1nJNoep WKzXFDSwczzrX1vxiUYR61puwFM7nn4LqPTDjBi0wMxVJRBATRW oXutd0FBcFsyYtyjQv9wAYczzsT-yntOf97TTHqmetnCnXPXja-JCBos 4qYZzP57fVVaJNvwzyA9aoJxPXEy85vznfa7YzLn1WFKMYJhRyZCq5 kaxYXGETfBBzUoCg8sPvFku92MSb). Timestamp by third party at 2021.07.26 12:28:35 CEST 21 Grant Agreement number: 101035467 — TEHDAS Associated with document Ref. Ares(2021)4548885 - 13/07/2021 ANNEX 3 ACCESSION FORM FOR BENEFICIARIES INSTITUTO ARAGONES DE CIENCIAS DE LA SALUD (IACS), established in AVENIDA SAN JUAN BOSCO 13, ZARAGOZA 50009, Spain, VAT number: ESQ5000654C, (‘the beneficiary’), represented for the purpose of signing this Accession Form by the undersigned, hereby agrees to become beneficiary No (‘23’) in Grant Agreement No 101035467 (‘the Grant Agreement’) between SUOMEN ITSENAISYYDEN JUHLARAHASTO and the European Health and Digital Executive Agency (‘the EU’), represented by the European Commission ('the Commission'), for the action entitled Towards the European Health DAta Space Joint Action (TEHDAS). and mandates the coordinator to submit and sign in its name and on its behalf any amendments to the Agreement, in accordance with Article 39. By signing this Accession Form, the beneficiary accepts the grant and agrees to implement it in accordance with the Agreement, with all the obligations and conditions it sets out. SIGNATURE For the beneficiary/new beneficiary/new coordinator [--TGSMark#signature-998462032_75_210--] sandra GARCIA-ARMESTO with ECAS id ngarcisx signed in the Participant Portal on 16/07/2021 at 12:08:36 (transaction id SigId- 93091-zWLzcNtszkAvDd6RznA5YeW2srD3cbGV3NruNFXcC60f8hRTP8 WRW9nh9425pcZbdg2pzzGF4ZnkzNCGEzJEodKo- yntOf97TTHqL2QVETsEsmO-kp3cLq3zfoefRYOQ1nzNxzmtZUbUkrwzfe MK7ryLNfrCYuQruvy8tAKD76Z1k5STn35cPxrLl4kDwD36TzGqk3q). Timestamp by third party at 2021.07.16 13:08:44 CEST 22 Grant Agreement number: 101035467 — TEHDAS Associated with document Ref. Ares(2021)4548885 - 13/07/2021 ANNEX 3 ACCESSION FORM FOR BENEFICIARIES E-HALSOMYNDIGHETEN (SEHA), established in SANK ERIKSGATAN 117, STOCKHOLM 118 60, Sweden, VAT number: SE202100655201, (‘the beneficiary’), represented for the purpose of signing this Accession Form by the undersigned, hereby agrees to become beneficiary No (‘24’) in Grant Agreement No 101035467 (‘the Grant Agreement’) between SUOMEN ITSENAISYYDEN JUHLARAHASTO and the European Health and Digital Executive Agency (‘the EU’), represented by the European Commission ('the Commission'), for the action entitled Towards the European Health DAta Space Joint Action (TEHDAS). and mandates the coordinator to submit and sign in its name and on its behalf any amendments to the Agreement, in accordance with Article 39. By signing this Accession Form, the beneficiary accepts the grant and agrees to implement it in accordance with the Agreement, with all the obligations and conditions it sets out. SIGNATURE For the beneficiary/new beneficiary/new coordinator [--TGSMark#signature-933263676_75_210--] Michele Silvestri with ECAS id n002v8z3 signed in the Participant Portal on 02/08/2021 at 10:57:16 (transaction id SigId-6075-IosvIX UNe4cZRaenbr0SnpvS6LjnptHvrzpSNlJFvbXDVyfkAKviP7ru396GbV aPpPhALCWVGQ8TjQzi9qIPzcm-rS0vSrmBGYCf5hdFt0R2zu-mBRm BpbbZ2pDh0vfP6q5Lzr3abVF9TJJByBs5NrXtEXMutJgzmedqg8TIop dtDihenjak2KNiHYhd9pUdpKdXc). Timestamp by third party at 2021.08.02 11:57:22 CEST 23 Grant Agreement number: 101035467 — TEHDAS Associated with document Ref. Ares(2021)4548885 - 13/07/2021 ANNEX 3 ACCESSION FORM FOR BENEFICIARIES THE NHS CONFEDERATION (NHSC), established in 2ND FLOOR 18 SMITH SQUARE, LONDON SW1P 3HZ, United Kingdom, VAT number: GB788186860, (‘the beneficiary’), represented for the purpose of signing this Accession Form by the undersigned, hereby agrees to become beneficiary No (‘25’) in Grant Agreement No 101035467 (‘the Grant Agreement’) between SUOMEN ITSENAISYYDEN JUHLARAHASTO and the European Health and Digital Executive Agency (‘the EU’), represented by the European Commission ('the Commission'), for the action entitled Towards the European Health DAta Space Joint Action (TEHDAS). and mandates the coordinator to submit and sign in its name and on its behalf any amendments to the Agreement, in accordance with Article 39. By signing this Accession Form, the beneficiary accepts the grant and agrees to implement it in accordance with the Agreement, with all the obligations and conditions it sets out. SIGNATURE For the beneficiary/new beneficiary/new coordinator [--TGSMark#signature-892794888_75_210--] Rosie Richards with ECAS id n0045gsf signed in the Participant Portal on 27/07/2021 at 10:42:41 (transaction id SigId-44495-i0iHhn 3LJmzcSrwVjido2DCOt6M2refjWXg1TRZQgRTWUbFe3WMLOgLFbxO aYxt9Wvgojp6HR6nF7RodkQYthO-yntOf97TTHqmetnCnXPXja-R15h b4tIkkZvuNOSea7i2Yd4mQzbxe7OUjAxRMnO0E2ABniVtGj8wac8UTt bzGvaH6r07d4X7oNXXpABLUjMjh). Timestamp by third party at 2021.07.27 11:42:49 CEST 24  Associated with document Ref. Ares(2021)4548885 - 13/07/2021 i print format A4 MODEL ANNEX 4 CHAFEA MGA — MULTI landscape FINANCIAL STATEMENT FOR [BENEFICIARY [name]/AFFILIATED ENTITY [name]] FOR REPORTING PERIOD [reporting period] 1 Receipts EU contribution Eligible costs (per budget category) Financial contributions Reimburseme Maximum EU A. Direct personnel B. Direct costs of C. Other direct 2 Income generated Requested EU D. Indirect costs Total costs given by third Total receipts 3 4 costs subcontracting costs by the action nt rate % constribution contribution parties to the beneficiaries A.1 Employees (or C.1 Travel equivalent) A.2 Natural persons C.2 Equipment under direct contract and seconded persons C.3 Other goods and services 6 5 Actual Actual Actual Flat-rate Cost form 7% d= e= a b c f g h= f + g i j k 0,07 * (a + b + c) a+ b + c + d [short name beneficiary / affiliated entity] The beneficiary/affiliated entity hereby confirms that: The information provided is complete, reliable and true. The costs declared are eligible (see Article 6). The costs can be substantiated by adequate records and supporting documentation that will be produced upon request or in the context of checks, reviews, audits and investigations (see Articles 12, 13 and 17). For the last reporting period: that all the receipts have been declared (see Article 5.3.3). i Please declare all eligible costs, even if they exceed the amounts indicated in the estimated budget (see Annex 2). Only amounts that were declared in your individual financial statements can be taken into account lateron, in order to replace other costs that are found to be ineligible. 1 See Article 6 for the eligibility conditions. 2 The indirect costs claimed must be free of any amounts covered by an operating grant (received under any EU or Euratom funding programme). A beneficiary that receives an operating grant during the duration of the action cannot claim any indirect costs for the year(s) covered by the operating grant (see Article 6.2.D). 3 See Article 5.2 for the reimbursement rate 4 This is the theoretical amount of EU contribution that the system calculates automatically (by multiplying the reimbursement rate by the total costs declared). The amount you request (in the column 'requested EU contribution') may have to be less. 5 See Article 5 for the cost forms. 6 Flat rate : 7% of eligible direct costs.  Associated with document Ref. Ares(2021)4548885 - 13/07/2021 ANNEX 5 MODEL FOR THE CERTIFICATE ON THE FINANCIAL STATEMENT (CFS) This document sets out: - the objectives and scope of the independent report of factual findings on costs declared under a EU grant agreement financed under the Health Programme (2014-2020) or Consumer Programme (2014-2020) and - a model for the certificate on the financial statement (CFS). 1. Background and subject matter [OPTION 1 for actions with one RP and NO interim payments: Within 60 days of the end of the reporting period, the coordinator must submit to the Commission a final report, which should include (among other documents and unless otherwise specified in Article 15 of the Grant Agreement) a certified financial statement (CFS; see proposed model below) for each beneficiary and (if applicable) each affiliated entity, if: - it requests an EU contribution of EUR 150 000 or more as reimbursement of actual costs and - the maximum EU contribution indicated for that beneficiary/affiliated entity in the estimated budget (see Annex 2) as reimbursement of actual costs is EUR 200 000 or more.] [OPTION 2 for actions with several RPs and interim payments: Within 60 days of the end of each reporting period, the coordinator must submit to the Commission a periodic report, which should include (among other documents and unless otherwise specified in Article 15 of the Grant Agreement) a certified financial statement (CFS; see proposed model below) for each beneficiary and (if applicable) each affiliated entity, if: - the cumulative amount of EU contribution the beneficiary/affiliated entity requests as reimbursement of actual costs is EUR 150 000 or more and - the maximum EU contribution indicated for that beneficiary/affiliated entity in the estimated budget (see Annex 2) as reimbursement of actual costs is EUR 200 000 or more. The CFS must be submitted every time the cumulative amount of payments requested (i.e. including in previous financial statements) reaches the threshold (i.e. a first certificate once the cumulative amount reaches 150 000, a second certificate once it reaches 300 000, a third certificate once it reaches 450 000, etc.). Once the threshold is reached, the CFS must cover all reporting periods for which no certificate has yet been submitted.] 1  Associated with document Ref. Ares(2021)4548885 - 13/07/2021 The beneficiary must provide the CFS for itself and, if applicable, for its affiliated entity(ies). The purpose of the audit on which the CFS is based is to give the Agency ‘reasonable assurance’1 that costs declared as eligible costs under the grant (and, if relevant, receipts generated in the course of the action) are being claimed by the beneficiary in accordance with the relevant legal and financial provisions of the Grant Agreement. The scope of the audit is limited to the verification of eligible costs included in the CFS. The audit must be conducted in line with point 3 below. Certifying auditors must carry out the audits in compliance with generally accepted audit standards and indicate which standards they have applied. They must bear in mind that, to establish a CFS, they must carry out a compliance audit and not a normal statutory audit. The eligibility criteria in the Grant Agreement always override normal accounting practices. The beneficiary and the auditor are expected to address any questions on factual data or detailed calculations before the financial statement and the accompanying certificate are submitted. It is also recommended that the beneficiary take into account the auditor’s preliminary comments and suggestions in order to avoid a qualified opinion or reduce the scope of the qualifications. Since the certificate is the main source of assurance for cost claims and payments, it will be easier to consider amounts as eligible if a non-qualified certificate is provided. The submission of a certificate does not affect the Agency’s right to carry out its own assessment or audits. Neither does the reimbursement of costs covered by a certificate preclude the Agency or the Commission, the European Anti-Fraud Office or the European Court of Auditors from carrying out checks, reviews, audits and investigations in accordance with Article 17 of the Grant Agreement. The Agency expects the certificates to be issued by auditors according to the highest professional standards. 2. Auditors who may deliver a certificate The beneficiary is free to choose a qualified external auditor, including its usual external auditor, provided that: - the external auditor is independent from the beneficiary and - the provisions of Directive 2006/43/EC2 are complied with. 1 This means a high degree of confidence. 2 Directive 2006/43/EC of the European Parliament and of the Council of 17 May 2006 on statutory audits of annual accounts and consolidated accounts or similar national regulations (OJ L 157, 9.6.2006, p. 87). 2  Associated with document Ref. Ares(2021)4548885 - 13/07/2021 Independence is one of the qualities that permit the auditor to apply unbiased judgement and objective consideration to established facts to arrive at an opinion or a decision. It also means that the auditor works without direction or interference of any kind from the beneficiary. Auditors are considered as providing services to the beneficiary/affiliated entity under a purchase contract within the meaning of Article 9 of the Grant Agreement. This means that the costs of the CFS may normally be declared as costs incurred for the action, if the cost eligibility rules set out in Articles 6 and 9.1.1 of the Grant Agreement are fulfilled (especially: best value for money and no conflict of interests; see also below eligibility of costs of other goods and services). Where the beneficiary/affiliated entity uses its usual external auditor, it is presumed that they already have an agreement that complies with these provisions and there is no obligation to find new bids. Where the beneficiary/affiliated entity uses an external auditor who is not their usual external auditor, it must select an auditor following the rules set out in Article 9.1.1. Public bodies can choose an external auditor or a competent public officer. In the latter case, the auditor’s independence is usually defined as independence from the audited beneficiary ‘in fact and in appearance’. A preliminary condition is that this officer was not involved in any way in drawing up the financial statements. Relevant national authorities establish the legal capacity of the officer to carry out audits of that specific public body. The certificate should refer to this appointment. 3. Audit methodology and expected results 3.1 Verification of eligibility of the costs declared The auditor must conduct its verification on the basis of inquiry and analysis, (re)computation, comparison, other accuracy checks, observation, inspection of records and documents and by interviewing the beneficiary (and the persons working for it). The auditor must examine the following documentation:  the Grant Agreement and any amendments to it;  the periodical and/or final report(s);  for personnel costs o salary slips; o time sheets; o contracts of employment; o other documents (e.g. personnel accounts, social security legislation, invoices, receipts, etc.); o proofs of payment;  for subcontracting o the call for tender; o tenders (if applicable); o justification for the choice of subcontractor; o contracts with subcontractors; o invoices; o declarations by the beneficiary; o proofs of payment; 3  Associated with document Ref. Ares(2021)4548885 - 13/07/2021 o other documents: e.g. national rules on public tendering if applicable, EU Directives, etc.;  for travel and subsistence costs o the beneficiary’s internal rules on travel; o transport invoices and tickets (if applicable); o declarations by the beneficiary; o other documents (proofs of attendance such as minutes of meetings, reports, etc.); o proofs of payment;  for equipment costs o invoices; o delivery slips / certificates of first use; o proofs of payment; o depreciation method of calculation;  for costs of other goods and services o invoices; o proofs of payment; and o other relevant accounting documents. General eligibility rules The auditor must verify that the costs declared comply with the general eligibility rules set out in Article 6.1 of the Grant Agreement. In particular, the costs must:  be actually incurred;  be linked to the subject of the Grant Agreement and indicated in the beneficiary's estimated budget (i.e. the latest version of Annex 2);  be necessary to implement the action which is the subject of the grant;  be reasonable and justified, and comply with the requirements of sound financial management, in particular as regards economy and efficiency;3  have been incurred during the action, as defined in Article 3 of the Grant Agreement (with the exception of the invoice for the audit certificate and costs relating to the submission of the final report);  not be covered by another EU or Euratom grant (see below ineligible costs);  be identifiable, verifiable and, in particular, recorded in the beneficiary's accounting records and determined according to the applicable accounting standards of the country where it is established and its usual cost-accounting practices;  comply with the requirements of applicable national laws on taxes, labour and social security;  be in accordance with the provisions of the Grant Agreement (see, in particular, Articles 6 and 9-11a) and  have been converted to euro at the rate laid down in Article 15.6 of the Grant Agreement: 3 To be assessed in particular on the basis of the procurement and selection procedures for service providers. 4  Associated with document Ref. Ares(2021)4548885 - 13/07/2021 o for beneficiaries with accounts established in a currency other than the euro: Costs incurred in another currency must be converted into euros at the average of the daily exchange rates published in the C series of the EU Official Journal determined over the corresponding reporting period. If no daily euro exchange rate is published in the EU Official Journal for the currency in question, the rate used must be the average of the monthly accounting rate established by the Commission and published on its website; o for beneficiaries with accounts established in euro: Costs incurred in another currency should be converted into euros applying the beneficiary’s usual accounting practice. The auditor must verify whether expenditure includes VAT and, if so, verify that the beneficiary: - cannot recover the VAT (this must be supported by a statement from the competent body) and - is not a public body acting as a public authority. The auditor should base his/her audit approach on the confidence level following a review of the beneficiary's internal control system. When using sampling, the auditor should indicate and justify the sampling size. Specific eligibility rules In addition, the auditor must verify that the costs declared comply with the specific cost eligibility rules set out in Article 6.2 and Articles 9.1.1, 10.1.1, 11.1.1, 11a.1.1 and 11a.2.1 of the Grant Agreement. Personnel costs The auditor must verify that:  personnel costs have been charged and paid in respect of the actual time devoted by the beneficiary’s personnel to implementing the action (justified on the basis of time sheets or other relevant time-recording system);  personnel costs were calculated on the basis of annual gross salary, wages or fees (plus obligatory social charges, but excluding any other costs) specified in an employment or other type of contract, not exceeding the average rates corresponding to the beneficiary’s usual policy on remuneration;  the work was carried out during the period of implementation of the action, as defined in Article 3 the Grant Agreement and  the personnel costs are not covered by another EU or Euratom grant (see below ineligible costs);  for additional remunerations: the 2 conditions set out in Article 6.2.A.1 are met (i.e. that it is part of the beneficiary’s usual remuneration practices and is paid in a consistent manner whenever the same kind of work or expertise is required and that the criteria used to calculate the supplementary payments are objective and generally applied by the beneficiary, regardless of the source of funding used);  for in-house consultants: the 3 conditions set out in Article 6.2.A.2 of the Grant Agreement are met (i.e. that the in-house consultant works under the beneficiary’s 5  Associated with document Ref. Ares(2021)4548885 - 13/07/2021 instructions, that the result of the work carried out belongs to the beneficiary, and that the costs are not significantly different from those for personnel performing similar tasks under an employment contract). The auditor should have assurance that the management and accounting system ensures proper allocation of the personnel costs to various activities carried out by the beneficiary and funded by various donors. Subcontracting costs The auditor must verify that:  the subcontracting complies with best value for money (or lowest price) and that there was no conflict of interests;  the subcontracting was necessary to implement the action for which the grant is requested;  the subcontracting was provided for in Annex 1 and Annex 2 or agreed to by the Agency at a later stage;  the subcontracting is supported by accounting documents in accordance with national accounting law  public bodies have complied with the national rules on public procurement. Travel and subsistence costs The auditor must verify that travel and subsistence costs:  have been charged and paid in accordance with the beneficiary's internal rules or usual practices;  are not covered by another EU or Euratom grant (see below ineligible costs);  were incurred for travels linked to action tasks set out in Annex 1 of the Grant Agreement. Equipment costs The auditor must verify that:  the equipment is purchased, rented or leased at normal market prices;  public bodies have complied with the national rules on public procurement;  the equipment is written off, depreciation has been calculated according to the tax and accounting rules applicable to the beneficiary and only the portion of the depreciation corresponding to the duration of the action has been declared and  the costs are not covered by another EU or Euratom grant (see below ineligible costs). Costs of other goods and services The auditor must verify that:  the purchase complies with best value for money (or lowest price) and that there was no conflict of interests;  public bodies have complied with the national rules on public procurement;  the costs are not covered by another EU or Euratom grant (see below ineligible costs). 6  Associated with document Ref. Ares(2021)4548885 - 13/07/2021 Ineligible costs The auditor must verify that the beneficiary has not declared any costs that are ineligible under Article 6.4 of the Grant Agreement:  costs relating to return on capital;  debt and debt service charges;  provisions for future losses or debts;  interest owed;  doubtful debts;  currency exchange losses;  bank costs charged by the beneficiary’s bank for transfers from the Agency;  excessive or reckless expenditure;  deductible VAT;  VAT incurred by a public body acting as a public authority;  costs incurred during suspension of the implementation of the action;  in-kind contributions from third parties;  costs declared under other EU or Euratom grants (including those awarded by a Member State and financed by the EU or Euratom budget or awarded by bodies other than the Agency for the purpose of implementing the EU or Euratom budget); in particular, indirect costs if the beneficiary is already receiving an operating grant financed by the EU or Euratom budget in the same period;  costs incurred for permanent staff of a national administration for activities that are part of its normal activities (i.e. not undertaken only because of the grant);  costs incurred for staff or representatives of EU institutions, bodies or agencies. 3.2 Verification of receipts The auditor must verify that the beneficiary has declared receipts within the meaning of Article 5.3.3 of the Grant Agreement, i.e.:  income generated by the action (e.g. from the sale of products, services and publications, conference fees) and  financial contributions given by third parties, specifically to be used for costs that are eligible under the action. 3.3 Verification of the beneficiary’s accounting system The auditor must verify that:  the accounting system (analytical or other suitable internal system) makes it possible to identify sources of financing for the action and related expenses incurred during the contractual period and  expenses/income under the grant have been recorded systematically using a numbering system that distinguishes them from expenses/income for other projects. 7  Associated with document Ref. Ares(2021)4548885 - 13/07/2021 Certificate on the financial statement (CFS) To [Beneficiary/affiliated entity’s full name address] We, [full name of the audit firm/organisation], established in [full address/city/country], represented for signature of this audit certificate by [name and function of an authorised representative], hereby certify that: 1. We have conducted an audit relating to the costs declared in the financial statement of [name of beneficiary/affiliated entity] (the [‘beneficiary’][‘affiliated entity’]), to which this audit certificate is attached and which is to be presented to the Consumers, Health, Agriculture and Food Executive Agency under Grant Agreement No [insert number] — [insert acronym], covering costs for the following reporting period(s): [insert reporting period(s)]. 2. We confirm that our audit was carried out in accordance with generally accepted auditing standards in compliance with ethical rules and on the basis of the provisions of the Grant Agreement and its Annexes (and in particular the audit methodology described in Annex 5). 3. The financial statement was examined and all necessary tests of [all][[X]%] of the supporting documentation and accounting records were carried out in order to obtain reasonable assurance that, in our opinion and on the basis of our audit  total costs of EUR [insert number] ([insert amount in words]) are eligible, i.e.:  actual;  determined in accordance with the [beneficiary’s][affiliated entity’s] accounting principles;  incurred during the period referred to in Article 3 of the Grant Agreement;  recorded in the [beneficiary’s][affiliated entity’s] accounts (at the date of this audit certificate);  comply with the specific eligibility rules in Article 6.2 of the Grant Agreement;  do not contain costs that are ineligible under Article 6.4 of the Grant Agreement, in particular:  costs relating to return on capital;  debt and debt service charges;  provisions for future losses or debts;  interest owed;  doubtful debts;  currency exchange losses; 8  Associated with document Ref. Ares(2021)4548885 - 13/07/2021  bank costs charged by the [beneficiary’s][affiliated entity’s] bank for transfers from the Agency;  excessive or reckless expenditure;  deductible VAT;  VAT incurred by a public body acting as a public authority;  costs incurred during suspension of the implementation of the action;  in-kind contributions provided by third parties;  costs declared under other EU or Euratom grants (including those awarded by a Member State and financed by the EU or Euratom budget or awarded by bodies other than the Agency for the purpose of implementing the EU or Euratom budget); in particular, indirect costs if the [beneficiary][affiliated entity] is already receiving an operating grant financed by the EU or Euratom budget in the same period;  costs incurred for permanent staff of a national administration, for activities that are part of its normal activities (i.e. not undertaken only because of the grant);  costs incurred for staff or representatives of EU institutions, bodies or agencies;  [are claimed according to the euro conversion rate referred to in Article 15.6 of the Grant Agreement;]  total receipts of EUR [insert number] ([insert amount in words]) have been declared under Article 5.3.3 of the Grant Agreement and  the [beneficiary’s][affiliated entity’s] accounting procedures are in compliance with the accounting rules of the state in which it is established and permit direct reconciliation of the costs incurred for the implementation of the action covered by the EU grant with the overall statement of accounts relating to its overall activity. [However, our audit opinion is qualified for:  costs of EUR [insert number]  receipts of EUR [insert number] which in our opinion do not comply with the applicable rules.] 4. We are qualified/authorised to deliver this audit certificate [(for additional information, see appendix to this certificate)]. 5. The [beneficiary][affiliated entity] paid a price of EUR [insert number]) (including VAT of EUR [insert number]) for this audit certificate. [OPTION 1: These costs are eligible (i.e. incurred within 60 days of the end of the action referred to in Article 3 of the Grant Agreement) and included in the financial statement.][OPTION 2: These costs were not included in the financial statement.] Date, signature and stamp 9  Digitally sealed by the European Commission Date: 2021.07.13 23:15:17 CEST This electronic receipt is a digitally signed version of the document submitted by your organisation. Both the content of the document and a set of metadata have been digitally sealed. This digital signature mechanism, using a public-private key pair mechanism, uniquely binds this eReceipt to the modules of the Funding & Tenders Portal of the European Commission, to the transaction for which it was generated and ensures its full integrity. Therefore a complete digitally signed trail of the transaction is available both for your organisation and for the issuer of the eReceipt. Any attempt to modify the content will lead to a break of the integrity of the electronic signature, which can be verified at any time by clicking on the eReceipt validation symbol. More info about eReceipts can be found in the FAQ page of the Funding & Tenders Portal. (https://ec.europa.eu/info/funding-tenders/opportunities/portal/screen/support/faq) Commission européenne/Europese Commissie, 1049 Bruxelles/Brussel, BELGIQUE/BELGIË - Tel. +32 22991111