Leping

Project: 101129188 — EST2EHDS — EU4H-2022-DGA-MS-IBA2 EU4H Ref. Associated with document MGAAres(2023)7314945 — Multi & Mono:-v1.1 26/10/2023 EUROPEAN HEALTH AND DIGITAL EXECUTIVE AGENCY (HADEA) Director GRANT AGREEMENT Project 101129188 — EST2EHDS PREAMBLE This Agreement (‘the Agreement’) is between the following parties: on the one part, the European Health and Digital Executive Agency (HADEA) (‘EU executive agency’ or ‘granting authority’), under the powers delegated by the European Commission (‘European Commission’), and on the other part, 1. ‘the coordinator’: SOTSIAALMINISTEERIUM (MSAE), PIC 998429731, established in Suur-Ameerika 1, TALLINN 10122, Estonia, Unless otherwise specified, references to ‘beneficiary’ or ‘beneficiaries’ include the coordinator and affiliated entities (if any). If only one beneficiary signs the grant agreement (‘mono-beneficiary grant’), all provisions referring to the ‘coordinator’ or the ‘beneficiaries’ will be considered — mutatis mutandis — as referring to the beneficiary. The parties referred to above have agreed to enter into the Agreement. By signing the Agreement and the accession forms, the beneficiaries accept the grant and agree to implement the action under their own responsibility and in accordance with the Agreement, with all the obligations and terms and conditions it sets out. The Agreement is composed of: Preamble Terms and Conditions (including Data Sheet) 1 Project: 101129188 — EST2EHDS — EU4H-2022-DGA-MS-IBA2 EU4H Ref. Associated with document MGAAres(2023)7314945 — Multi & Mono:-v1.1 26/10/2023 Annex 1 Description of the action1 Annex 2 Estimated budget for the action Annex 2a Additional information on unit costs and contributions (if applicable) Annex 3 Accession forms (if applicable)2 Annex 3a Declaration on joint and several liability of affiliated entities (if applicable)3 Annex 4 Model for the financial statements Annex 5 Specific rules (if applicable) 1 Template published on Portal Reference Documents. 2 Template published on Portal Reference Documents. 3 Template published on Portal Reference Documents. 2 Project: 101129188 — EST2EHDS — EU4H-2022-DGA-MS-IBA2 EU4H Ref. Associated with document MGAAres(2023)7314945 — Multi & Mono:-v1.1 26/10/2023 TERMS AND CONDITIONS TABLE OF CONTENTS GRANT AGREEMENT.................................................................................................................................................... 1 PREAMBLE........................................................................................................................................................................1 TERMS AND CONDITIONS...........................................................................................................................................3 DATASHEET...................................................................................................................................................................... 8 CHAPTER 1 GENERAL..............................................................................................................................................12 ARTICLE 1 — SUBJECT OF THE AGREEMENT ..................................................................................... 12 ARTICLE 2 — DEFINITIONS........................................................................................................................12 CHAPTER 2 ACTION................................................................................................................................................. 13 ARTICLE 3 — ACTION................................................................................................................................. 13 ARTICLE 4 — DURATION AND STARTING DATE...................................................................................13 CHAPTER 3 GRANT...................................................................................................................................................13 ARTICLE 5 — GRANT...................................................................................................................................13 5.1 Form of grant......................................................................................................................................13 5.2 Maximum grant amount..................................................................................................................... 14 5.3 Funding rate........................................................................................................................................14 5.4 Estimated budget, budget categories and forms of funding.............................................................. 14 5.5 Budget flexibility................................................................................................................................14 ARTICLE 6 — ELIGIBLE AND INELIGIBLE COSTS AND CONTRIBUTIONS......................................15 6.1 General eligibility conditions............................................................................................................. 15 6.2 Specific eligibility conditions for each budget category................................................................... 16 6.3 Ineligible costs and contributions...................................................................................................... 20 6.4 Consequences of non-compliance...................................................................................................... 21 CHAPTER 4 GRANT IMPLEMENTATION............................................................................................................ 21 SECTION 1 CONSORTIUM: BENEFICIARIES, AFFILIATED ENTITIES AND OTHER PARTICIPANTS........................................................................................................................................ 21 ARTICLE 7 — BENEFICIARIES................................................................................................................... 21 ARTICLE 8 — AFFILIATED ENTITIES....................................................................................................... 23 ARTICLE 9 — OTHER PARTICIPANTS INVOLVED IN THE ACTION................................................... 24 9.1 Associated partners.............................................................................................................................24 9.2 Third parties giving in-kind contributions to the action.................................................................... 24 9.3 Subcontractors.....................................................................................................................................24 3 Project: 101129188 — EST2EHDS — EU4H-2022-DGA-MS-IBA2 EU4H Ref. Associated with document MGAAres(2023)7314945 — Multi & Mono:-v1.1 26/10/2023 9.4 Recipients of financial support to third parties..................................................................................24 ARTICLE 10 — PARTICIPANTS WITH SPECIAL STATUS....................................................................... 25 10.1 Non-EU participants......................................................................................................................... 25 10.2 Participants which are international organisations...........................................................................25 10.3 Pillar-assessed participants............................................................................................................... 25 SECTION 2 RULES FOR CARRYING OUT THE ACTION...........................................................................28 ARTICLE 11 — PROPER IMPLEMENTATION OF THE ACTION............................................................ 28 11.1 Obligation to properly implement the action................................................................................... 28 11.2 Consequences of non-compliance.................................................................................................... 28 ARTICLE 12 — CONFLICT OF INTERESTS.............................................................................................. 28 12.1 Conflict of interests.......................................................................................................................... 28 12.2 Consequences of non-compliance.................................................................................................... 28 ARTICLE 13 — CONFIDENTIALITY AND SECURITY............................................................................ 28 13.1 Sensitive information........................................................................................................................29 13.2 Classified information...................................................................................................................... 29 13.3 Consequences of non-compliance.................................................................................................... 30 ARTICLE 14 — ETHICS AND VALUES...................................................................................................... 30 14.1 Ethics.................................................................................................................................................30 14.2 Values................................................................................................................................................ 30 14.3 Consequences of non-compliance.................................................................................................... 30 ARTICLE 15 — DATA PROTECTION.......................................................................................................... 30 15.1 Data processing by the granting authority....................................................................................... 30 15.2 Data processing by the beneficiaries............................................................................................... 31 15.3 Consequences of non-compliance.................................................................................................... 31 ARTICLE 16 — INTELLECTUAL PROPERTY RIGHTS (IPR) — BACKGROUND AND RESULTS — ACCESS RIGHTS AND RIGHTS OF USE................................................................................ 31 16.1 Background and access rights to background..................................................................................31 16.2 Ownership of results.........................................................................................................................32 16.3 Rights of use of the granting authority on materials, documents and information received for policy, information, communication, dissemination and publicity purposes...................................32 16.4 Specific rules on IPR, results and background................................................................................ 33 16.5 Consequences of non-compliance.................................................................................................... 33 ARTICLE 17 — COMMUNICATION, DISSEMINATION AND VISIBILITY............................................ 33 17.1 Communication — Dissemination — Promoting the action........................................................... 33 17.2 Visibility — European flag and funding statement......................................................................... 33 17.3 Quality of information — Disclaimer..............................................................................................34 4 Project: 101129188 — EST2EHDS — EU4H-2022-DGA-MS-IBA2 EU4H Ref. Associated with document MGAAres(2023)7314945 — Multi & Mono:-v1.1 26/10/2023 17.4 Specific communication, dissemination and visibility rules............................................................34 17.5 Consequences of non-compliance.................................................................................................... 34 ARTICLE 18 — SPECIFIC RULES FOR CARRYING OUT THE ACTION............................................... 34 18.1 Specific rules for carrying out the action........................................................................................ 35 18.2 Consequences of non-compliance.................................................................................................... 35 SECTION 3 GRANT ADMINISTRATION......................................................................................................... 35 ARTICLE 19 — GENERAL INFORMATION OBLIGATIONS.................................................................... 35 19.1 Information requests......................................................................................................................... 35 19.2 Participant Register data updates..................................................................................................... 35 19.3 Information about events and circumstances which impact the action............................................35 19.4 Consequences of non-compliance.................................................................................................... 35 ARTICLE 20 — RECORD-KEEPING............................................................................................................ 36 20.1 Keeping records and supporting documents.................................................................................... 36 20.2 Consequences of non-compliance.................................................................................................... 37 ARTICLE 21 — REPORTING........................................................................................................................ 37 21.1 Continuous reporting........................................................................................................................ 37 21.2 Periodic reporting: Technical reports and financial statements....................................................... 37 21.3 Currency for financial statements and conversion into euros..........................................................38 21.4 Reporting language...........................................................................................................................38 21.5 Consequences of non-compliance.................................................................................................... 39 ARTICLE 22 — PAYMENTS AND RECOVERIES — CALCULATION OF AMOUNTS DUE................. 39 22.1 Payments and payment arrangements.............................................................................................. 39 22.2 Recoveries.........................................................................................................................................39 22.3 Amounts due.....................................................................................................................................40 22.4 Enforced recovery.............................................................................................................................44 22.5 Consequences of non-compliance.................................................................................................... 45 ARTICLE 23 — GUARANTEES....................................................................................................................46 23.1 Prefinancing guarantee..................................................................................................................... 46 23.2 Consequences of non-compliance.................................................................................................... 46 ARTICLE 24 — CERTIFICATES................................................................................................................... 46 24.1 Operational verification report (OVR).............................................................................................46 24.2 Certificate on the financial statements (CFS).................................................................................. 46 24.3 Certificate on the compliance of usual cost accounting practices (CoMUC).................................. 47 24.4 Systems and process audit (SPA).....................................................................................................47 24.5 Consequences of non-compliance.................................................................................................... 47 5 Project: 101129188 — EST2EHDS — EU4H-2022-DGA-MS-IBA2 EU4H Ref. Associated with document MGAAres(2023)7314945 — Multi & Mono:-v1.1 26/10/2023 ARTICLE 25 — CHECKS, REVIEWS, AUDITS AND INVESTIGATIONS — EXTENSION OF FINDINGS..................................................................................................................................... 47 25.1 Granting authority checks, reviews and audits................................................................................ 47 25.2 European Commission checks, reviews and audits in grants of other granting authorities..............49 25.3 Access to records for assessing simplified forms of funding.......................................................... 49 25.4 OLAF, EPPO and ECA audits and investigations........................................................................... 49 25.5 Consequences of checks, reviews, audits and investigations — Extension of results of reviews, audits or investigations.................................................................................................................... 49 25.6 Consequences of non-compliance.................................................................................................... 51 ARTICLE 26 — IMPACT EVALUATIONS................................................................................................... 51 26.1 Impact evaluation............................................................................................................................. 51 26.2 Consequences of non-compliance.................................................................................................... 51 CHAPTER 5 CONSEQUENCES OF NON-COMPLIANCE.................................................................................. 51 SECTION 1 REJECTIONS AND GRANT REDUCTION.................................................................................51 ARTICLE 27 — REJECTION OF COSTS AND CONTRIBUTIONS...........................................................51 27.1 Conditions......................................................................................................................................... 51 27.2 Procedure.......................................................................................................................................... 52 27.3 Effects............................................................................................................................................... 52 ARTICLE 28 — GRANT REDUCTION........................................................................................................ 52 28.1 Conditions......................................................................................................................................... 52 28.2 Procedure.......................................................................................................................................... 52 28.3 Effects............................................................................................................................................... 53 SECTION 2 SUSPENSION AND TERMINATION............................................................................................53 ARTICLE 29 — PAYMENT DEADLINE SUSPENSION............................................................................. 53 29.1 Conditions......................................................................................................................................... 53 29.2 Procedure.......................................................................................................................................... 53 ARTICLE 30 — PAYMENT SUSPENSION...................................................................................................53 30.1 Conditions......................................................................................................................................... 53 30.2 Procedure.......................................................................................................................................... 54 ARTICLE 31 — GRANT AGREEMENT SUSPENSION..............................................................................54 31.1 Consortium-requested GA suspension............................................................................................. 54 31.2 EU-initiated GA suspension.............................................................................................................55 ARTICLE 32 — GRANT AGREEMENT OR BENEFICIARY TERMINATION......................................... 56 32.1 Consortium-requested GA termination............................................................................................ 56 32.2 Consortium-requested beneficiary termination................................................................................ 57 32.3 EU-initiated GA or beneficiary termination.................................................................................... 58 6 Project: 101129188 — EST2EHDS — EU4H-2022-DGA-MS-IBA2 EU4H Ref. Associated with document MGAAres(2023)7314945 — Multi & Mono:-v1.1 26/10/2023 SECTION 3 OTHER CONSEQUENCES: DAMAGES AND ADMINISTRATIVE SANCTIONS............... 62 ARTICLE 33 — DAMAGES...........................................................................................................................62 33.1 Liability of the granting authority....................................................................................................62 33.2 Liability of the beneficiaries............................................................................................................ 62 ARTICLE 34 — ADMINISTRATIVE SANCTIONS AND OTHER MEASURES....................................... 62 SECTION 4 FORCE MAJEURE.......................................................................................................................... 62 ARTICLE 35 — FORCE MAJEURE.............................................................................................................. 62 CHAPTER 6 FINAL PROVISIONS...........................................................................................................................63 ARTICLE 36 — COMMUNICATION BETWEEN THE PARTIES...............................................................63 36.1 Forms and means of communication — Electronic management................................................... 63 36.2 Date of communication.................................................................................................................... 63 36.3 Addresses for communication.......................................................................................................... 63 ARTICLE 37 — INTERPRETATION OF THE AGREEMENT.....................................................................64 ARTICLE 38 — CALCULATION OF PERIODS AND DEADLINES..........................................................64 ARTICLE 39 — AMENDMENTS.................................................................................................................. 64 39.1 Conditions......................................................................................................................................... 64 39.2 Procedure.......................................................................................................................................... 64 ARTICLE 40 — ACCESSION AND ADDITION OF NEW BENEFICIARIES........................................... 65 40.1 Accession of the beneficiaries mentioned in the Preamble............................................................. 65 40.2 Addition of new beneficiaries.......................................................................................................... 65 ARTICLE 41 — TRANSFER OF THE AGREEMENT................................................................................. 65 ARTICLE 42 — ASSIGNMENTS OF CLAIMS FOR PAYMENT AGAINST THE GRANTING AUTHORITY.................................................................................................................................66 ARTICLE 43 — APPLICABLE LAW AND SETTLEMENT OF DISPUTES.............................................. 66 43.1 Applicable law..................................................................................................................................66 43.2 Dispute settlement............................................................................................................................ 66 ARTICLE 44 — ENTRY INTO FORCE.........................................................................................................67 7 Project: 101129188 — EST2EHDS — EU4H-2022-DGA-MS-IBA2 EU4H Ref. Associated with document MGAAres(2023)7314945 — Multi & Mono:-v1.1 26/10/2023 DATA SHEET 1. General data Project summary: Project summary Estonia towards European Health Data Space (EHDS) for secondary use of health data (EST2EHDS) aims to promote the establishment of national health data access body, by expanding its minimum capabilities and working towards establishing its connection with HealthData@EU, for the development of the EHDS for secondary uses of health data. The objectives of the proposal are to establish and deploy services for a health data access body, including its minimum business capabilities, and to provide a best way to set up cross- border connections to the large-scale deployment of HealthData@EU, on the basis of the work conducted by the joint action ‘Towards the European Health Data Space’ (TEHDaS), and on the outcomes of the pilot project for the EHDS infrastructure based on 5 use cases that will run from 2022-2024 to test the setting up of a European network for secondary uses of data. The activities include setting up national dataset catalogue, analysing and proposing the best way to set up data access application management system, secure processing environments and cross-border gateway. Activities also include data quality improvement, focusing on delivering high quality data for secondary use on national level and cross-border and working towards connection to planned EHDS. Keywords: – HDAB, secondary use of health data, HealthData@EU, national dataset catalogue, metadata catalogue, Project number: 101129188 Project name: Estonia towards European Health Data Space for secondary use of health data Project acronym: EST2EHDS Call: EU4H-2022-DGA-MS-IBA2 Topic: EU4H-2022-DGA-MS-IBA-4 Type of action: EU4H Project Grants Granting authority: European Health and Digital Executive Agency Grant managed through EU Funding & Tenders Portal: Yes (eGrants) Project starting date: first day of the month following the entry into force date Project end date: starting date + months of duration Project duration: 36 months Consortium agreement: No 2. Participants List of participants: Total Max grant N° Role Short name Legal name Ctry PIC eligible costs amount (BEN and AE) 1 COO MSAE SOTSIAALMINISTEERIUM EE 998429731 401 517.50 321 214.00 1.1 AE TEHIK TERVISE JA HEAOLU INFOSÜSTEEMIDE KESKUS EE 895885405 1 904 600.00 1 523 680.00 Total 2 306 117.50 1 844 894.00 Coordinator: – SOTSIAALMINISTEERIUM (MSAE) 8 Project: 101129188 — EST2EHDS — EU4H-2022-DGA-MS-IBA2 EU4H Ref. Associated with document MGAAres(2023)7314945 — Multi & Mono:-v1.1 26/10/2023 3. Grant Maximum grant amount, total estimated eligible costs and contributions and funding rate: Total eligible costs Funding rate Maximum grant amount Maximum grant amount (BEN and AE) (%) (Annex 2) (award decision) 2 306 117.50 80 1 844 894.00 1 844 894.00 Grant form: Budget-based Grant mode: Action grant Budget categories/activity types: - A. Personnel costs - A.1 Employees, A.2 Natural persons under direct contract, A.3 Seconded persons - A.4 SME owners and natural person beneficiaries - B. Subcontracting costs - C. Purchase costs - C.1 Travel and subsistence - C.2 Equipment - C.3 Other goods, works and services - D. Other cost categories - D.1 Financial support to third parties - E. Indirect costs Cost eligibility options: - Standard supplementary payments - Limitation for subcontracting - Travel and subsistence: - Travel: Unit or Actual costs - Accommodation: Unit or Actual costs - Subsistence: Unit or Actual costs - Equipment: depreciation only - Costs for providing financial support to third parties (actual cost; max amount for each recipient: EUR 0.00) - Indirect cost flat-rate: 7% of the eligible direct costs (categories A-D, except volunteers costs and exempted specific cost categories, if any) - VAT: Yes - Other ineligible costs Budget flexibility: Yes (no flexibility cap) 4. Reporting, payments and recoveries 4.1 Continuous reporting (art 21) Deliverables: see Funding & Tenders Portal Continuous Reporting tool 9 Project: 101129188 — EST2EHDS — EU4H-2022-DGA-MS-IBA2 EU4H Ref. Associated with document MGAAres(2023)7314945 — Multi & Mono:-v1.1 26/10/2023 4.2 Periodic reporting and payments Reporting and payment schedule (art 21, 22): Reporting Payments Deadline Reporting periods Type Deadline Type (time to pay) RP No Month from Month to 30 days from entry into force/10 days before starting date/ Initial prefinancing financial guarantee (if required) – whichever is the latest 1 1 18 Periodic report 60 days after end Interim payment 90 days from of reporting period receiving periodic report 2 19 36 Periodic report 60 days after end Final payment 90 days from of reporting period receiving periodic report Prefinancing payments and guarantees: Prefinancing payment Prefinancing guarantee Guarantee Type Amount Division per participant amount Prefinancing 1 (initial) 553 468.20 n/a 1 - MSAE n/a 1.1 - TEHIK n/a Reporting and payment modalities (art 21, 22): Mutual Insurance Mechanism (MIM): No Restrictions on distribution of initial prefinancing: The prefinancing may be distributed only if the minimum number of beneficiaries set out in the call condititions (if any) have acceded to the Agreement and only to beneficiaries that have acceded. Interim payment ceiling (if any): 90% of the maximum grant amount No-profit rule: Yes Late payment interest: ECB + 3.5% Bank account for payments: EE891010220034796011 Conversion into euros: Double conversion Reporting language: Language of the Agreement 4.3 Certificates (art 24): Certificates on the financial statements (CFS): Conditions: Schedule: interim/final payment, if threshold is reached 10 Project: 101129188 — EST2EHDS — EU4H-2022-DGA-MS-IBA2 EU4H Ref. Associated with document MGAAres(2023)7314945 — Multi & Mono:-v1.1 26/10/2023 Standard threshold (beneficiary-level): - financial statement: requested EU contribution to costs ≥ EUR 325 000.00 4.4 Recoveries (art 22) First-line liability for recoveries: Beneficiary termination: Beneficiary concerned Final payment: Coordinator After final payment: Beneficiary concerned Joint and several liability for enforced recoveries (in case of non-payment): Limited joint and several liability of other beneficiaries — up to the maximum grant amount of the beneficiary Joint and several liability of affiliated entities — n/a 5. Consequences of non-compliance, applicable law & dispute settlement forum Applicable law (art 43): Standard applicable law regime: EU law + law of Belgium Dispute settlement forum (art 43): Standard dispute settlement forum: EU beneficiaries: EU General Court + EU Court of Justice (on appeal) Non-EU beneficiaries: Courts of Brussels, Belgium (unless an international agreement provides for the enforceability of EU court judgements) 6. Other Specific rules (Annex 5): Yes Standard time-limits after project end: Confidentiality (for X years after final payment): 5 Record-keeping (for X years after final payment): 5 (or 3 for grants of not more than EUR 60 000) Reviews (up to X years after final payment): 5 (or 3 for grants of not more than EUR 60 000) Audits (up to X years after final payment): 5 (or 3 for grants of not more than EUR 60 000) Extension of findings from other grants to this grant (no later than X years after final payment): 5 (or 3 for grants of not more than EUR 60 000) Impact evaluation (up to X years after final payment): 5 (or 3 for grants of not more than EUR 60 000) 11 Project: 101129188 — EST2EHDS — EU4H-2022-DGA-MS-IBA2 EU4H Ref. Associated with document MGAAres(2023)7314945 — Multi & Mono:-v1.1 26/10/2023 CHAPTER 1 GENERAL ARTICLE 1 — SUBJECT OF THE AGREEMENT This Agreement sets out the rights and obligations and terms and conditions applicable to the grant awarded for the implementation of the action set out in Chapter 2. ARTICLE 2 — DEFINITIONS For the purpose of this Agreement, the following definitions apply: Actions — The project which is being funded in the context of this Agreement. Grant — The grant awarded in the context of this Agreement. EU grants — Grants awarded by EU institutions, bodies, offices or agencies (including EU executive agencies, EU regulatory agencies, EDA, joint undertakings, etc.). Participants — Entities participating in the action as beneficiaries, affiliated entities, associated partners, third parties giving in-kind contributions, subcontractors or recipients of financial support to third parties. Beneficiaries (BEN) — The signatories of this Agreement (either directly or through an accession form). Affiliated entities (AE) — Entities affiliated to a beneficiary within the meaning of Article 187 of EU Financial Regulation 2018/10464 which participate in the action with similar rights and obligations as the beneficiaries (obligation to implement action tasks and right to charge costs and claim contributions). Associated partners (AP) — Entities which participate in the action, but without the right to charge costs or claim contributions. Purchases — Contracts for goods, works or services needed to carry out the action (e.g. equipment, consumables and supplies) but which are not part of the action tasks (see Annex 1). Subcontracting — Contracts for goods, works or services that are part of the action tasks (see Annex 1). In-kind contributions — In-kind contributions within the meaning of Article 2(36) of EU Financial 4 For the definition, see Article 187 Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council of 18 July 2018 on the financial rules applicable to the general budget of the Union, amending Regulations (EU) No 1296/2013, (EU) No 1301/2013, (EU) No 1303/2013, (EU) No 1304/2013, (EU) No 1309/2013, (EU) No 1316/2013, (EU) No 223/2014, (EU) No 283/2014, and Decision No 541/2014/EU and repealing Regulation (EU, Euratom) No 966/2012 (‘EU Financial Regulation’) (OJ L 193, 30.7.2018, p. 1): “affiliated entities [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 136(1) and 141(1) 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”. 12 Project: 101129188 — EST2EHDS — EU4H-2022-DGA-MS-IBA2 EU4H Ref. Associated with document MGAAres(2023)7314945 — Multi & Mono:-v1.1 26/10/2023 Regulation 2018/1046, i.e. non-financial resources made available free of charge by third parties. Fraud — Fraud within the meaning of Article 3 of EU Directive 2017/13715 and Article 1 of the Convention on the protection of the European Communities’ financial interests, drawn up by the Council Act of 26 July 19956, as well as any other wrongful or criminal deception intended to result in financial or personal gain. Irregularities — Any type of breach (regulatory or contractual) which could impact the EU financial interests, including irregularities within the meaning of Article 1(2) of EU Regulation 2988/957. Grave professional misconduct — Any type of unacceptable or improper behaviour in exercising one’s profession, especially by employees, including grave professional misconduct within the meaning of Article 136(1)(c) of EU Financial Regulation 2018/1046. Applicable EU, international and national law — Any legal acts or other (binding or non-binding) rules and guidance in the area concerned. Portal — EU Funding & Tenders Portal; electronic portal and exchange system managed by the European Commission and used by itself and other EU institutions, bodies, offices or agencies for the management of their funding programmes (grants, procurements, prizes, etc.). CHAPTER 2 ACTION ARTICLE 3 — ACTION The grant is awarded for the action 101129188 — EST2EHDS (‘action’), as described in Annex 1. ARTICLE 4 — DURATION AND STARTING DATE The duration and the starting date of the action are set out in the Data Sheet (see Point 1). CHAPTER 3 GRANT ARTICLE 5 — GRANT 5.1 Form of grant The grant is an action grant8 which takes the form of a budget-based mixed actual cost grant (i.e. a 5 Directive (EU) 2017/1371 of the European Parliament and of the Council of 5 July 2017 on the fight against fraud to the Union’s financial interests by means of criminal law (OJ L 198, 28.7.2017, p. 29). 6 OJ C 316, 27.11.1995, p. 48. 7 Council Regulation (EC, Euratom) No 2988/95 of 18 December 1995 on the protection of the European Communities financial interests (OJ L 312, 23.12.1995, p. 1). 8 For the definition, see Article 180(2)(a) EU Financial Regulation 2018/1046: ‘action grant’ means an EU grant to finance “an action intended to help achieve a Union policy objective”. 13 Project: 101129188 — EST2EHDS — EU4H-2022-DGA-MS-IBA2 EU4H Ref. Associated with document MGAAres(2023)7314945 — Multi & Mono:-v1.1 26/10/2023 grant based on actual costs incurred, but which may also include other forms of funding, such as unit costs or contributions, flat-rate costs or contributions, lump sum costs or contributions or financing not linked to costs). 5.2 Maximum grant amount The maximum grant amount is set out in the Data Sheet (see Point 3) and in the estimated budget (Annex 2). 5.3 Funding rate The funding rate for costs is 80% of the action’s eligible costs. Contributions are not subject to any funding rate. 5.4 Estimated budget, budget categories and forms of funding The estimated budget for the action is set out in Annex 2. It contains the estimated eligible costs and contributions for the action, broken down by participant and budget category. Annex 2 also shows the types of costs and contributions (forms of funding)9 to be used for each budget category. If unit costs or contributions are used, the details on the calculation will be explained in Annex 2a. 5.5 Budget flexibility The budget breakdown may be adjusted — without an amendment (see Article 39) — by transfers (between participants and budget categories), as long as this does not imply any substantive or important change to the description of the action in Annex 1. However: - changes to the budget category for volunteers (if used) always require an amendment - changes to budget categories with lump sums costs or contributions (if used; including financing not linked to costs) always require an amendment - changes to budget categories with higher funding rates or budget ceilings (if used) always require an amendment - addition of amounts for subcontracts not provided for in Annex 1 either require an amendment or simplified approval in accordance with Article 6.2 - other changes require an amendment or simplified approval, if specifically provided for in Article 6.2 - flexibility caps: not applicable. 9 See Article 125 EU Financial Regulation 2018/1046. 14 Project: 101129188 — EST2EHDS — EU4H-2022-DGA-MS-IBA2 EU4H Ref. Associated with document MGAAres(2023)7314945 — Multi & Mono:-v1.1 26/10/2023 ARTICLE 6 — ELIGIBLE AND INELIGIBLE COSTS AND CONTRIBUTIONS In order to be eligible, costs and contributions must meet the eligibility conditions set out in this Article. 6.1 General eligibility conditions The general eligibility conditions are the following: (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 4 (with the exception of costs relating to the submission of the final periodic report, which may be incurred afterwards; see Article 21) (iii) they must be declared under one of the budget categories set out in Article 6.2 and 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 or contributions (if any): (i) they must be declared under one of the budget categories set out in Article 6.2 and Annex 2 (ii) the units must: - be actually used or produced by the beneficiary in the period set out in Article 4 (with the exception of units relating to the submission of the final periodic report, which may be used or produced afterwards; see Article 21) - be necessary for the implementation of the action and (iii) the number of units must be identifiable and verifiable, in particular supported by records and documentation (see Article 20) (c) for flat-rate costs or contributions (if any): (i) they must be declared under one of the budget categories set out in Article 6.2 and Annex 2 15 Project: 101129188 — EST2EHDS — EU4H-2022-DGA-MS-IBA2 EU4H Ref. Associated with document MGAAres(2023)7314945 — Multi & Mono:-v1.1 26/10/2023 (ii) the costs or contributions to which the flat-rate is applied must: - be eligible - relate to the period set out in Article 4 (with the exception of costs or contributions relating to the submission of the final periodic report, which may be incurred afterwards; see Article 21) (d) for lump sum costs or contributions (if any): (i) they must be declared under one of the budget categories set out in Article 6.2 and Annex 2 (ii) the work must be properly implemented by the beneficiary in accordance with Annex 1 (iii) the deliverables/outputs must be achieved in the period set out in Article 4 (with the exception of deliverables/outputs relating to the submission of the final periodic report, which may be achieved afterwards; see Article 21) (e) for unit, flat-rate or lump sum costs or contributions according to usual cost accounting practices (if any): (i) they must fulfil the general eligibility conditions for the type of cost concerned (ii) the cost accounting practices must be applied in a consistent manner, based on objective criteria, regardless of the source of funding (f) for financing not linked to costs (if any): the results must be achieved or the conditions must be fulfilled as described in Annex 1. In addition, for direct cost categories (e.g. personnel, travel & subsistence, subcontracting and other direct costs) only costs that are directly linked to the action implementation and can therefore be attributed to it directly are eligible. They must not include any indirect costs (i.e. costs that are only indirectly linked to the action, e.g. via cost drivers). 6.2 Specific eligibility conditions for each budget category For each budget category, the specific eligibility conditions are as follows: Direct costs A. Personnel costs A.1 Costs for employees (or equivalent) are eligible as personnel costs if they fulfil the general eligibility conditions and are related to personnel working for the beneficiary under an employment contract (or equivalent appointing act) and assigned to the action. They must be limited to salaries, social security contributions, taxes and other costs linked to the remuneration, if they arise from national law or the employment contract (or equivalent appointing act) and be calculated on the basis of the costs actually incurred, in accordance with the following method: 16 Project: 101129188 — EST2EHDS — EU4H-2022-DGA-MS-IBA2 EU4H Ref. Associated with document MGAAres(2023)7314945 — Multi & Mono:-v1.1 26/10/2023 {daily rate for the person multiplied by number of day-equivalents worked on the action (rounded up or down to the nearest half-day)}. The daily rate must be calculated as: {annual personnel costs for the person divided by 215}. The number of day-equivalents declared for a person must be identifiable and verifiable (see Article 20). The total number of day-equivalents declared in EU grants, for a person for a year, cannot be higher than 215. The personnel costs may also include supplementary payments for personnel assigned to the action (including payments on the basis of supplementary contracts regardless of their nature), if: - 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 - 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 and A.3 Costs for natural persons working under a direct contract other than an employment contract and costs for seconded persons by a third party against payment are also eligible as personnel costs, if they are assigned to the action, fulfil the general eligibility conditions and: (a) work under conditions similar to those of an employee (in particular regarding the way the work is organised, the tasks that are performed and the premises where they are performed) and (b) the result of the work belongs to the beneficiary (unless agreed otherwise). They must be calculated on the basis of a rate which corresponds to the costs actually incurred for the direct contract or secondment and must not be significantly different from those for personnel performing similar tasks under an employment contract with the beneficiary. A.4 The work of SME owners for the action (i.e. owners of beneficiaries that are small and medium- sized enterprises10 not receiving a salary) or natural person beneficiaries (i.e. beneficiaries that are natural persons not receiving a salary) may be declared as personnel costs, if they fulfil the general 10 For the definition, see Commission Recommendation 2003/361/EC: micro, small or medium-sized enterprise (SME) are enterprises - engaged in an economic activity, irrespective of their legal form (including, in particular, self- employed persons and family businesses engaged in craft or other activities, and partnerships or associations regularly engaged in an economic activity) and - employing fewer than 250 persons (expressed in ‘annual working units’ as defined in Article 5 of the Recommendation) and which have an annual turnover not exceeding EUR 50 million, and/or an annual balance sheet total not exceeding EUR 43 million. 17 Project: 101129188 — EST2EHDS — EU4H-2022-DGA-MS-IBA2 EU4H Ref. Associated with document MGAAres(2023)7314945 — Multi & Mono:-v1.1 26/10/2023 eligibility conditions and are calculated as unit costs in accordance with the method set out in Annex 2a. B. Subcontracting costs Subcontracting costs for the action (including related duties, taxes and charges, such as non- deductible or non-refundable value added tax (VAT)) are eligible, if they are calculated on the basis of the costs actually incurred, fulfil the general eligibility conditions and are awarded using the beneficiary’s usual purchasing practices — provided these ensure subcontracts with best value for money (or if appropriate the lowest price) and that there is no conflict of interests (see Article 12). Beneficiaries that are ‘contracting authorities/entities’ within the meaning of the EU Directives on public procurement must also comply with the applicable national law on public procurement. Subcontracting may cover only a limited part of the action. The tasks to be subcontracted 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 (or may be approved ex post in the periodic report, if the use of subcontracting does 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; ‘simplified approval procedure’). C. Purchase costs Purchase costs for the action (including related duties, taxes and charges, such as non-deductible or non-refundable value added tax (VAT)) are eligible if they fulfil the general eligibility conditions and are bought using the beneficiary’s usual purchasing practices — provided these ensure purchases with best value for money (or if appropriate the lowest price) and that there is no conflict of interests (see Article 12). Beneficiaries that are ‘contracting authorities/entities’ within the meaning of the EU Directives on public procurement must also comply with the applicable national law on public procurement. C.1 Travel and subsistence Purchases for travel, accommodation and subsistence must be calculated as follows: - travel: as unit costs in accordance with the method set out in Annex 2a if covered by Decision C(2021)3511 or otherwise as costs actually incurred and in line with the beneficiary’s usual practices on travel - accommodation: as unit costs in accordance with the method set out in Annex 2a if covered by Decision C(2021)3512 or otherwise as costs actually incurred and in line with the beneficiary’s usual practices on travel - subsistence: as unit costs in accordance with the method set out in Annex 2a if covered by 11 Commission Decision of 12 January 2021 authorising the use of unit costs for travel, accommodation and subsistence costs under an action or work programme under the 2021-2027 multi-annual financial framework (C(2021)35). 12 Commission Decision of 12 January 2021 authorising the use of unit costs for travel, accommodation and subsistence costs under an action or work programme under the 2021-2027 multi-annual financial framework (C(2021)35). 18 Project: 101129188 — EST2EHDS — EU4H-2022-DGA-MS-IBA2 EU4H Ref. Associated with document MGAAres(2023)7314945 — Multi & Mono:-v1.1 26/10/2023 Decision C(2021)3513 or otherwise as costs actually incurred and in line with the beneficiary’s usual practices on travel. C.2 Equipment Purchases of equipment, infrastructure or other assets used for the action must be declared as depreciation costs, calculated on the basis of the costs actually incurred and written off in accordance with international accounting standards and the beneficiary’s usual accounting practices. Only the portion of the costs that corresponds to the rate of actual use for the action during the action duration can be taken into account. Costs for renting or leasing equipment, infrastructure or other assets are also eligible, if they do not exceed the depreciation costs of similar equipment, infrastructure or assets and do not include any financing fees. C.3 Other goods, works and services Purchases of other goods, works and services must be calculated on the basis of the costs actually incurred. Such goods, works and services include, for instance, consumables and supplies, promotion, dissemination, protection of results, translations, publications, certificates and financial guarantees, if required under the Agreement. D. Other cost categories D.1 Financial support to third parties Costs for providing financial support to third parties (in the form of grants, prizes or similar forms of support; if any) are eligible, if and as declared eligible in the call conditions, if they fulfil the general eligibility conditions, are calculated on the basis of the costs actually incurred and the support is implemented in accordance with the conditions set out in Annex 1. These conditions must ensure objective and transparent selection procedures and include at least the following: (a) for grants (or similar): (i) the maximum amount of financial support for each third party (‘recipient’); this amount may not exceed the amount set out in the Data Sheet (see Point 3) or otherwise agreed with the granting authority (ii) the criteria for calculating the exact amount of the financial support (iii) the different types of activity that qualify for financial support, on the basis of a closed list (iv) the persons or categories of persons that will be supported and (v) the criteria and procedures for giving financial support 13 Commission Decision of 12 January 2021 authorising the use of unit costs for travel, accommodation and subsistence costs under an action or work programme under the 2021-2027 multi-annual financial framework (C(2021)35). 19 Project: 101129188 — EST2EHDS — EU4H-2022-DGA-MS-IBA2 EU4H Ref. Associated with document MGAAres(2023)7314945 — Multi & Mono:-v1.1 26/10/2023 (b) for prizes (or similar): (i) the eligibility and award criteria (ii) the amount of the prize and (iii) the payment arrangements. Indirect costs E. Indirect costs Indirect costs will be reimbursed at the flat-rate of 7% of the eligible direct costs (categories A-D, except volunteers costs and exempted specific cost categories, if any). Contributions Not applicable 6.3 Ineligible costs and contributions The following costs or contributions are ineligible: (a) costs or contributions that do not comply with the conditions set out above (Article 6.1 and 6.2), in particular: (i) costs related to return on capital and dividends paid by a beneficiary (ii) debt and debt service charges (iii) provisions for future losses or debts (iv) interest owed (v) currency exchange losses (vi) bank costs charged by the beneficiary’s bank for transfers from the granting authority (vii) excessive or reckless expenditure (viii) deductible or refundable VAT (including VAT paid by public bodies acting as public authority) (ix) costs incurred or contributions for activities implemented during grant agreement suspension (see Article 31) (x) in-kind contributions by third parties (b) costs or contributions declared under other EU grants (or grants awarded by an EU Member State, non-EU country or other body implementing the EU budget), except for the following cases: (i) Synergy actions: not applicable 20 Project: 101129188 — EST2EHDS — EU4H-2022-DGA-MS-IBA2 EU4H Ref. Associated with document MGAAres(2023)7314945 — Multi & Mono:-v1.1 26/10/2023 (ii) if the action grant is combined with an operating grant14 running during the same period and the beneficiary can demonstrate that the operating grant does not cover any (direct or indirect) costs of the action grant (c) costs or contributions for staff of a national (or regional/local) administration, for activities that are part of the administration’s normal activities (i.e. not undertaken only because of the grant) (d) costs or contributions (especially travel and subsistence) for staff or representatives of EU institutions, bodies or agencies (e) other : (i) country restrictions for eligible costs: not applicable (ii) costs or contributions declared specifically ineligible in the call conditions. 6.4 Consequences of non-compliance If a beneficiary declares costs or contributions that are ineligible, they will be rejected (see Article 27). This may also lead to other measures described in Chapter 5. CHAPTER 4 GRANT IMPLEMENTATION SECTION 1 CONSORTIUM: BENEFICIARIES, AFFILIATED ENTITIES AND OTHER PARTICIPANTS ARTICLE 7 — BENEFICIARIES The beneficiaries, as signatories of the Agreement, are fully responsible towards the granting authority for implementing it and for complying with all its obligations. They must implement the Agreement to their best abilities, in good faith and in accordance with all the obligations and terms and conditions it sets out. They must have the appropriate resources to implement the action and implement the action under their own responsibility and in accordance with Article 11. If they rely on affiliated entities or other participants (see Articles 8 and 9), they retain sole responsibility towards the granting authority and the other beneficiaries. They are jointly responsible for the technical implementation of the action. If one of the beneficiaries fails to implement their part of the action, the other beneficiaries must ensure that this part is implemented by someone else (without being entitled to an increase of the maximum grant amount and subject to an amendment; see Article 39). The financial responsibility of each beneficiary in case of recoveries is governed by Article 22. 14 For the definition, see Article 180(2)(b) of EU Financial Regulation 2018/1046: ‘operating grant’ means an EU grant to finance “the functioning of a body which has an objective forming part of and supporting an EU policy”. 21 Project: 101129188 — EST2EHDS — EU4H-2022-DGA-MS-IBA2 EU4H Ref. Associated with document MGAAres(2023)7314945 — Multi & Mono:-v1.1 26/10/2023 The beneficiaries (and their action) must remain eligible under the EU programme funding the grant for the entire duration of the action. Costs and contributions will be eligible only as long as the beneficiary and the action are eligible. The internal roles and responsibilities of the beneficiaries are divided as follows: (a) Each beneficiary must: (i) keep information stored in the Portal Participant Register up to date (see Article 19) (ii) inform the granting authority (and the other beneficiaries) immediately of any events or circumstances likely to affect significantly or delay the implementation of the action (see Article 19) (iii) submit to the coordinator in good time: - the prefinancing guarantees (if required; see Article 23) - the financial statements and certificates on the financial statements (CFS) (if required; see Articles 21 and 24.2 and Data Sheet, Point 4.3) - the contribution to the deliverables and technical reports (see Article 21) - any other documents or information required by the granting authority under the Agreement (iv) submit via the Portal data and information related to the participation of their affiliated entities. (b) The coordinator must: (i) monitor that the action is implemented properly (see Article 11) (ii) act as the intermediary for all communications between the consortium and the granting authority, unless the Agreement or granting authority specifies otherwise, and in particular: - submit the prefinancing guarantees to the granting authority (if any) - request and review any documents or information required and verify their quality and completeness before passing them on to the granting authority - submit the deliverables and reports to the granting authority - inform the granting authority about the payments made to the other beneficiaries (report on the distribution of payments; if required, see Articles 22 and 32) (iii) distribute the payments received from the granting authority to the other beneficiaries without unjustified delay (see Article 22). The coordinator may not delegate or subcontract the above-mentioned tasks to any other beneficiary or third party (including affiliated entities). 22 Project: 101129188 — EST2EHDS — EU4H-2022-DGA-MS-IBA2 EU4H Ref. Associated with document MGAAres(2023)7314945 — Multi & Mono:-v1.1 26/10/2023 However, coordinators which are public bodies may delegate the tasks set out in Point (b)(ii) last indent and (iii) above to entities with ‘authorisation to administer’ which they have created or which are controlled by or affiliated to them. In this case, the coordinator retains sole responsibility for the payments and for compliance with the obligations under the Agreement. Moreover, coordinators which are ‘sole beneficiaries’15 (or similar, such as European research infrastructure consortia (ERICs)) may delegate the tasks set out in Point (b)(i) to (iii) above to one of their members. The coordinator retains sole responsibility for compliance with the obligations under the Agreement. The beneficiaries must have internal arrangements regarding their operation and co-ordination, to ensure that the action is implemented properly. If required by the granting authority (see Data Sheet, Point 1), these arrangements must be set out in a written consortium agreement between the beneficiaries, covering for instance: - the internal organisation of the consortium - the management of access to the Portal - different distribution keys for the payments and financial responsibilities in case of recoveries (if any) - additional rules on rights and obligations related to background and results (see Article 16) - settlement of internal disputes - liability, indemnification and confidentiality arrangements between the beneficiaries. The internal arrangements must not contain any provision contrary to this Agreement. ARTICLE 8 — AFFILIATED ENTITIES The following entities which are linked to a beneficiary will participate in the action as ‘affiliated entities’: - TERVISE JA HEAOLU INFOSÜSTEEMIDE KESKUS (TEHIK), PIC 895885405, linked to SOTSIAALMINISTEERIUM (MSAE) Affiliated entities can charge costs and contributions to the action under the same conditions as the beneficiaries and must implement the action tasks attributed to them in Annex 1 in accordance with Article 11. Their costs and contributions will be included in Annex 2 and will be taken into account for the calculation of the grant. The beneficiaries must ensure that all their obligations under this Agreement also apply to their affiliated entities. 15 For the definition, see Article 187(2) EU Financial Regulation 2018/1046: “Where several entities satisfy the criteria for being awarded a grant and together form one entity, that entity may be treated as the sole beneficiary, including where it is specifically established for the purpose of implementing the action financed by the grant.” 23 Project: 101129188 — EST2EHDS — EU4H-2022-DGA-MS-IBA2 EU4H Ref. Associated with document MGAAres(2023)7314945 — Multi & Mono:-v1.1 26/10/2023 The beneficiaries must ensure that the bodies mentioned in Article 25 (e.g. granting authority, OLAF, Court of Auditors (ECA), etc.) can exercise their rights also towards the affiliated entities. Breaches by affiliated entities will be handled in the same manner as breaches by beneficiaries. Recovery of undue amounts will be handled through the beneficiaries. If the granting authority requires joint and several liability of affiliated entities (see Data Sheet, Point 4.4), they must sign the declaration set out in Annex 3a and may be held liable in case of enforced recoveries against their beneficiaries (see Article 22.2 and 22.4). ARTICLE 9 — OTHER PARTICIPANTS INVOLVED IN THE ACTION 9.1 Associated partners Not applicable 9.2 Third parties giving in-kind contributions to the action Other third parties may give in-kind contributions to the action (i.e. personnel, equipment, other goods, works and services, etc. which are free-of-charge), if necessary for the implementation. Third parties giving in-kind contributions do not implement any action tasks. They may not charge costs or contributions to the action and the costs for the in-kind contributions are not eligible. The third parties and their in-kind contributions should be set out in Annex 1. 9.3 Subcontractors Subcontractors may participate in the action, if necessary for the implementation. Subcontractors must implement their action tasks in accordance with Article 11. The costs for the subcontracted tasks (invoiced price from the subcontractor) are eligible and may be charged by the beneficiaries, under the conditions set out in Article 6. The costs will be included in Annex 2 as part of the beneficiaries’ costs. The beneficiaries must ensure that their contractual obligations under Articles 11 (proper implementation), 12 (conflict of interest), 13 (confidentiality and security), 14 (ethics), 17.2 (visibility), 18 (specific rules for carrying out action), 19 (information) and 20 (record-keeping) also apply to the subcontractors. The beneficiaries must ensure that the bodies mentioned in Article 25 (e.g. granting authority, OLAF, Court of Auditors (ECA), etc.) can exercise their rights also towards the subcontractors. 9.4 Recipients of financial support to third parties If the action includes providing financial support to third parties (e.g. grants, prizes or similar forms of support), the beneficiaries must ensure that their contractual obligations under Articles 12 (conflict of interest), 13 (confidentiality and security), 14 (ethics), 17.2 (visibility), 18 (specific rules for carrying out action), 19 (information) and 20 (record-keeping)also apply to the third parties receiving the support (recipients). 24 Project: 101129188 — EST2EHDS — EU4H-2022-DGA-MS-IBA2 EU4H Ref. Associated with document MGAAres(2023)7314945 — Multi & Mono:-v1.1 26/10/2023 The beneficiaries must also ensure that the bodies mentioned in Article 25 (e.g. granting authority, OLAF, Court of Auditors (ECA), etc.) can exercise their rights also towards the recipients. ARTICLE 10 — PARTICIPANTS WITH SPECIAL STATUS 10.1 Non-EU participants Participants which are established in a non-EU country (if any) undertake to comply with their obligations under the Agreement and: - to respect general principles (including fundamental rights, values and ethical principles, environmental and labour standards, rules on classified information, intellectual property rights, visibility of funding and protection of personal data) - for the submission of certificates under Article 24: to use qualified external auditors which are independent and comply with comparable standards as those set out in EU Directive 2006/43/EC16 - for the controls under Article 25: to allow for checks, reviews, audits and investigations (including on-the-spot checks, visits and inspections) by the bodies mentioned in that Article (e.g. granting authority, OLAF, Court of Auditors (ECA), etc.). Special rules on dispute settlement apply (see Data Sheet, Point 5). 10.2 Participants which are international organisations Participants which are international organisations (IOs; if any) undertake to comply with their obligations under the Agreement and: - to respect general principles (including fundamental rights, values and ethical principles, environmental and labour standards, rules on classified information, intellectual property rights, visibility of funding and protection of personal data) - for the submission of certificates under Article 24: to use either independent public officers or external auditors which comply with comparable standards as those set out in EU Directive 2006/43/EC - for the controls under Article 25: to allow for the checks, reviews, audits and investigations by the bodies mentioned in that Article, taking into account the specific agreements concluded by them and the EU (if any). For such participants, nothing in the Agreement will be interpreted as a waiver of their privileges or immunities, as accorded by their constituent documents or international law. Special rules on applicable law and dispute settlement apply (see Article 43 and Data Sheet, Point 5). 10.3 Pillar-assessed participants 16 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). 25 Project: 101129188 — EST2EHDS — EU4H-2022-DGA-MS-IBA2 EU4H Ref. Associated with document MGAAres(2023)7314945 — Multi & Mono:-v1.1 26/10/2023 Pillar-assessed participants (if any) may rely on their own systems, rules and procedures, in so far as they have been positively assessed and do not call into question the decision awarding the grant or breach the principle of equal treatment of applicants or beneficiaries. ‘Pillar-assessment’ means a review by the European Commission on the systems, rules and procedures which participants use for managing EU grants (in particular internal control system, accounting system, external audits, financing of third parties, rules on recovery and exclusion, information on recipients and protection of personal data; see Article 154 EU Financial Regulation 2018/1046). Participants with a positive pillar assessment may rely on their own systems, rules and procedures, in particular for: - record-keeping (Article 20): may be done in accordance with internal standards, rules and procedures - currency conversion for financial statements (Article 21): may be done in accordance with usual accounting practices - guarantees (Article 23): for public law bodies, prefinancing guarantees are not needed - certificates (Article 24): - certificates on the financial statements (CFS): may be provided by their regular internal or external auditors and in accordance with their internal financial regulations and procedures - certificates on usual accounting practices (CoMUC): are not needed if those practices are covered by an ex-ante assessment and use the following specific rules, for: - recoveries (Article 22): in case of financial support to third parties, there will be no recovery if the participant has done everything possible to retrieve the undue amounts from the third party receiving the support (including legal proceedings) and non-recovery is not due to an error or negligence on its part - checks, reviews, audits and investigations by the EU (Article 25): will be conducted taking into account the rules and procedures specifically agreed between them and the framework agreement (if any) - impact evaluation (Article 26): will be conducted in accordance with the participant’s internal rules and procedures and the framework agreement (if any) - grant agreement suspension (Article 31): certain costs incurred during grant suspension are eligible (notably, minimum costs necessary for a possible resumption of the action and costs relating to contracts which were entered into before the pre-information letter was received and which could not reasonably be suspended, reallocated or terminated on legal grounds) - grant agreement termination (Article 32): the final grant amount and final payment will be calculated taking into account also costs relating to contracts due for execution only after termination takes effect, if the contract was entered into before the pre-information letter was received and could not reasonably be terminated on legal grounds 26 Project: 101129188 — EST2EHDS — EU4H-2022-DGA-MS-IBA2 EU4H Ref. Associated with document MGAAres(2023)7314945 — Multi & Mono:-v1.1 26/10/2023 - liability for damages (Article 33.2): the granting authority must be compensated for 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 only if the damage is due to an infringement of the participant’s internal rules and procedures or due to a violation of third parties’ rights by the participant or one of its employees or individual for whom the employees are responsible. Participants whose pillar assessment covers procurement and granting procedures may also do purchases, subcontracting and financial support to third parties (Article 6.2) in accordance with their internal rules and procedures for purchases, subcontracting and financial support. Participants whose pillar assessment covers data protection rules may rely on their internal standards, rules and procedures for data protection (Article 15). The participants may however not rely on provisions which would breach the principle of equal treatment of applicants or beneficiaries or call into question the decision awarding the grant, such as in particular: - eligibility (Article 6) - consortium roles and set-up (Articles 7-9) - security and ethics (Articles 13, 14) - IPR (including background and results, access rights and rights of use), communication, dissemination and visibility (Articles 16 and 17) - information obligation (Article 19) - payment, reporting and amendments (Articles 21, 22 and 39) - rejections, reductions, suspensions and terminations (Articles 27, 28, 29-32) If the pillar assessment was subject to remedial measures, reliance on the internal systems, rules and procedures is subject to compliance with those remedial measures. Participants whose assessment has not yet been updated to cover (the new rules on) data protection may rely on their internal systems, rules and procedures, provided that they ensure that personal data is: - processed lawfully, fairly and in a transparent manner in relation to the data subject - collected for specified, explicit and legitimate purposes and not further processed in a manner that is incompatible with those purposes - adequate, relevant and limited to what is necessary in relation to the purposes for which they are processed - accurate and, where necessary, kept up to date - kept in a form which permits identification of data subjects for no longer than is necessary for the purposes for which the data is processed and - processed in a manner that ensures appropriate security of the personal data. 27 Project: 101129188 — EST2EHDS — EU4H-2022-DGA-MS-IBA2 EU4H Ref. Associated with document MGAAres(2023)7314945 — Multi & Mono:-v1.1 26/10/2023 Participants must inform the coordinator without delay of any changes to the systems, rules and procedures that were part of the pillar assessment. The coordinator must immediately inform the granting authority. Pillar-assessed participants that have also concluded a framework agreement with the EU, may moreover — under the same conditions as those above (i.e. not call into question the decision awarding the grant or breach the principle of equal treatment of applicants or beneficiaries) — rely on the provisions set out in that framework agreement. SECTION 2 RULES FOR CARRYING OUT THE ACTION ARTICLE 11 — PROPER IMPLEMENTATION OF THE ACTION 11.1 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, the call conditions and all legal obligations under applicable EU, international and national law. 11.2 Consequences of non-compliance If a beneficiary breaches any of its obligations under this Article, the grant may be reduced (see Article 28). Such breaches may also lead to other measures described in Chapter 5. ARTICLE 12 — CONFLICT OF INTERESTS 12.1 Conflict of interests The beneficiaries must take all measures to prevent any situation where the impartial and objective implementation of the Agreement could be compromised for reasons involving family, emotional life, political or national affinity, economic interest or any other direct or indirect interest (‘conflict of interests’). They must formally notify the granting authority without delay of any situation constituting or likely to lead to a conflict of interests and immediately take all the necessary steps to rectify this situation. The granting authority may verify that the measures taken are appropriate and may require additional measures to be taken by a specified deadline. 12.2 Consequences of non-compliance If a beneficiary breaches any of its obligations under this Article, the grant may be reduced (see Article 28) and the grant or the beneficiary may be terminated (see Article 32). Such breaches may also lead to other measures described in Chapter 5. ARTICLE 13 — CONFIDENTIALITY AND SECURITY 28 Project: 101129188 — EST2EHDS — EU4H-2022-DGA-MS-IBA2 EU4H Ref. Associated with document MGAAres(2023)7314945 — Multi & Mono:-v1.1 26/10/2023 13.1 Sensitive information The parties must keep confidential any data, documents or other material (in any form) that is identified as sensitive in writing (‘sensitive information’) — during the implementation of the action and for at least until the time-limit set out in the Data Sheet (see Point 6). If a beneficiary requests, the granting authority may agree to keep such information confidential for a longer period. Unless otherwise agreed between the parties, they may use sensitive information only to implement the Agreement. The beneficiaries may disclose sensitive information to their personnel or other participants involved in the action only if they: (a) need to know it in order to implement the Agreement and (b) are bound by an obligation of confidentiality. The granting authority may disclose sensitive information to its staff and to other EU institutions and bodies. It may moreover disclose sensitive information to third parties, if: (a) this is necessary to implement the Agreement or safeguard the EU financial interests and (b) the recipients of the information are bound by an obligation of confidentiality. The confidentiality obligations no longer apply if: (a) the disclosing party agrees to release the other party (b) the information becomes publicly available, without breaching any confidentiality obligation (c) the disclosure of the sensitive information is required by EU, international or national law. Specific confidentiality rules (if any) are set out in Annex 5. 13.2 Classified information The parties must handle classified information in accordance with the applicable EU, international or national law on classified information (in particular, Decision 2015/44417 and its implementing rules). Deliverables which contain classified information must be submitted according to special procedures agreed with the granting authority. Action tasks involving classified information may be subcontracted only after explicit approval (in writing) from the granting authority. 17 Commission Decision 2015/444/EC, Euratom of 13 March 2015 on the security rules for protecting EU classified information (OJ L 72, 17.3.2015, p. 53). 29 Project: 101129188 — EST2EHDS — EU4H-2022-DGA-MS-IBA2 EU4H Ref. Associated with document MGAAres(2023)7314945 — Multi & Mono:-v1.1 26/10/2023 Classified information may not be disclosed to any third party (including participants involved in the action implementation) without prior explicit written approval from the granting authority. Specific security rules (if any) are set out in Annex 5. 13.3 Consequences of non-compliance If a beneficiary breaches any of its obligations under this Article, the grant may be reduced (see Article 28). Such breaches may also lead to other measures described in Chapter 5. ARTICLE 14 — ETHICS AND VALUES 14.1 Ethics The action must be carried out in line with the highest ethical standards and the applicable EU, international and national law on ethical principles. Specific ethics rules (if any) are set out in Annex 5. 14.2 Values The beneficiaries must commit to and ensure the respect of basic EU values (such as respect for human dignity, freedom, democracy, equality, the rule of law and human rights, including the rights of minorities). Specific rules on values (if any) are set out in Annex 5. 14.3 Consequences of non-compliance If a beneficiary breaches any of its obligations under this Article, the grant may be reduced (see Article 28). Such breaches may also lead to other measures described in Chapter 5. ARTICLE 15 — DATA PROTECTION 15.1 Data processing by the granting authority Any personal data under the Agreement will be processed under the responsibility of the data controller of the granting authority in accordance with and for the purposes set out in the Portal Privacy Statement. For grants where the granting authority is the European Commission, an EU regulatory or executive agency, joint undertaking or other EU body, the processing will be subject to Regulation 2018/172518. 18 Regulation (EU) 2018/1725 of the European Parliament and of the Council of 23 October 2018 on the protection of natural persons with regard to the processing of personal data by the Union institutions, bodies, offices and agencies and on the free movement of such data, and repealing Regulation (EC) No 45/2001 and Decision No 1247/2002/EC (OJ L 295, 21.11.2018, p. 39). 30 Project: 101129188 — EST2EHDS — EU4H-2022-DGA-MS-IBA2 EU4H Ref. Associated with document MGAAres(2023)7314945 — Multi & Mono:-v1.1 26/10/2023 15.2 Data processing by the beneficiaries The beneficiaries must process personal data under the Agreement in compliance with the applicable EU, international and national law on data protection (in particular, Regulation 2016/67919). They must ensure that personal data is: - processed lawfully, fairly and in a transparent manner in relation to the data subjects - collected for specified, explicit and legitimate purposes and not further processed in a manner that is incompatible with those purposes - adequate, relevant and limited to what is necessary in relation to the purposes for which they are processed - accurate and, where necessary, kept up to date - kept in a form which permits identification of data subjects for no longer than is necessary for the purposes for which the data is processed and - processed in a manner that ensures appropriate security of the data. The beneficiaries may grant their personnel access to personal data only if it is strictly necessary for implementing, managing and monitoring the Agreement. The beneficiaries must ensure that the personnel is under a confidentiality obligation. The beneficiaries must inform the persons whose data are transferred to the granting authority and provide them with the Portal Privacy Statement. 15.3 Consequences of non-compliance If a beneficiary breaches any of its obligations under this Article, the grant may be reduced (see Article 28). Such breaches may also lead to other measures described in Chapter 5. ARTICLE 16 — INTELLECTUAL PROPERTY RIGHTS (IPR) — BACKGROUND AND RESULTS —ACCESS RIGHTS AND RIGHTS OF USE 16.1 Background and access rights to background The beneficiaries must give each other and the other participants access to the background identified as needed for implementing the action, subject to any specific rules in Annex 5. ‘Background’ means any data, know-how or information — whatever its form or nature (tangible or intangible), including any rights such as intellectual property rights — that is: (a) held by the beneficiaries before they acceded to the Agreement and 19 Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (‘GDPR’) (OJ L 119, 4.5.2016, p. 1). 31 Project: 101129188 — EST2EHDS — EU4H-2022-DGA-MS-IBA2 EU4H Ref. Associated with document MGAAres(2023)7314945 — Multi & Mono:-v1.1 26/10/2023 (b) needed to implement the action or exploit the results. If background is subject to rights of a third party, the beneficiary concerned must ensure that it is able to comply with its obligations under the Agreement. 16.2 Ownership of results The granting authority does not obtain ownership of the results produced under the action. ‘Results’ means any tangible or intangible effect of the action, such as data, know-how or information, whatever its form or nature, whether or not it can be protected, as well as any rights attached to it, including intellectual property rights. 16.3 Rights of use of the granting authority on materials, documents and information received for policy, information, communication, dissemination and publicity purposes The granting authority has the right to use non-sensitive information relating to the action and materials and documents received from the beneficiaries (notably summaries for publication, deliverables, as well as any other material, such as pictures or audio-visual material, in paper or electronic form) for policy, information, communication, dissemination and publicity purposes — during the action or afterwards. The right to use the beneficiaries’ materials, documents and information is granted in the form of a royalty-free, non-exclusive and irrevocable licence, which includes the following rights: (a) use for its own purposes (in particular, making them available to persons working for the granting authority or any other EU service (including institutions, bodies, offices, agencies, etc.) or EU Member State institution or body; copying or reproducing them in whole or in part, in unlimited numbers; and communication through press information services) (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 (including shortening, summarising, inserting other elements (e.g. 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) storage in paper, electronic or other form (f) archiving, in line with applicable document-management rules (g) the right to authorise third parties to act on its behalf or sub-license to third parties the modes of use set out in Points (b), (c), (d) and (f), if needed for the information, communication and publicity activity of the granting authority (h) processing, analysing, aggregating the materials, documents and information received and producing derivative works. 32 Project: 101129188 — EST2EHDS — EU4H-2022-DGA-MS-IBA2 EU4H Ref. Associated with document MGAAres(2023)7314945 — Multi & Mono:-v1.1 26/10/2023 The rights of use are granted for the whole duration of the industrial or intellectual property rights concerned. If materials or documents are subject to moral rights or third party rights (including intellectual property rights or rights of natural persons on their image and voice), the beneficiaries must ensure that they comply with their obligations under this Agreement (in particular, by obtaining the necessary licences and authorisations from the rights holders concerned). Where applicable, the granting authority will insert the following information: “© – [year] – [name of the copyright owner]. All rights reserved. Licensed to the [name of granting authority] under conditions.” 16.4 Specific rules on IPR, results and background Specific rules regarding intellectual property rights, results and background (if any) are set out in Annex 5. 16.5 Consequences of non-compliance If a beneficiary breaches any of its obligations under this Article, the grant may be reduced (see Article 28). Such a breach may also lead to other measures described in Chapter 5. ARTICLE 17 — COMMUNICATION, DISSEMINATION AND VISIBILITY 17.1 Communication — Dissemination — Promoting the action Unless otherwise agreed with the granting authority, the beneficiaries must promote the action and its results by providing targeted information to multiple audiences (including the media and the public), in accordance with Annex 1 and in a strategic, coherent and effective manner. Before engaging in a communication or dissemination activity expected to have a major media impact, the beneficiaries must inform the granting authority. 17.2 Visibility — European flag and funding statement Unless otherwise agreed with the granting authority, communication activities of the beneficiaries related to the action (including media relations, conferences, seminars, information material, such as brochures, leaflets, posters, presentations, etc., in electronic form, via traditional or social media, etc.), dissemination activities and any infrastructure, equipment, vehicles, supplies or major result funded by the grant must acknowledge EU support and display the European flag (emblem) and funding statement (translated into local languages, where appropriate): 33 Project: 101129188 — EST2EHDS — EU4H-2022-DGA-MS-IBA2 EU4H Ref. Associated with document MGAAres(2023)7314945 — Multi & Mono:-v1.1 26/10/2023 The emblem must remain distinct and separate and cannot be modified by adding other visual marks, brands or text. Apart from the emblem, no other visual identity or logo may be used to highlight the EU support. When displayed in association with other logos (e.g. of beneficiaries or sponsors), the emblem must be displayed at least as prominently and visibly as the other logos. For the purposes of their obligations under this Article, the beneficiaries may use the emblem without first obtaining approval from the granting authority. This does not, however, give them the right to exclusive use. Moreover, they may not appropriate the emblem or any similar trademark or logo, either by registration or by any other means. 17.3 Quality of information — Disclaimer Any communication or dissemination activity related to the action must use factually accurate information. Moreover, it must indicate the following disclaimer (translated into local languages where appropriate): “Funded by the European Union. Views and opinions expressed are however those of the author(s) only and do not necessarily reflect those of the European Union or [name of the granting authority]. Neither the European Union nor the granting authority can be held responsible for them.” 17.4 Specific communication, dissemination and visibility rules Specific communication, dissemination and visibility rules (if any) are set out in Annex 5. 17.5 Consequences of non-compliance If a beneficiary breaches any of its obligations under this Article, the grant may be reduced (see Article 28). Such breaches may also lead to other measures described in Chapter 5. ARTICLE 18 — SPECIFIC RULES FOR CARRYING OUT THE ACTION 34 Project: 101129188 — EST2EHDS — EU4H-2022-DGA-MS-IBA2 EU4H Ref. Associated with document MGAAres(2023)7314945 — Multi & Mono:-v1.1 26/10/2023 18.1 Specific rules for carrying out the action Specific rules for implementing the action (if any) are set out in Annex 5. 18.2 Consequences of non-compliance If a beneficiary breaches any of its obligations under this Article, the grant may be reduced (see Article 28). Such a breach may also lead to other measures described in Chapter 5. SECTION 3 GRANT ADMINISTRATION ARTICLE 19 — GENERAL INFORMATION OBLIGATIONS 19.1 Information requests The beneficiaries must provide — during the action or afterwards and in accordance with Article 7 — any information requested in order to verify eligibility of the costs or contributions declared, proper implementation of the action and compliance with the other obligations under the Agreement. The information provided must be accurate, precise and complete and in the format requested, including electronic format. 19.2 Participant Register data updates The beneficiaries must keep — at all times, during the action or afterwards — their information stored in the Portal Participant Register up to date, in particular, their name, address, legal representatives, legal form and organisation type. 19.3 Information about events and circumstances which impact the action The beneficiaries must immediately inform the granting authority (and the other beneficiaries) of any of the following: (a) events which are likely to affect or delay the implementation of the action or affect the EU’s financial interests, in particular: (i) changes in their legal, financial, technical, organisational or ownership situation (including changes linked to one of the exclusion grounds listed in the declaration of honour signed before grant signature) (ii) linked action information: not applicable (b) circumstances affecting: (i) the decision to award the grant or (ii) compliance with requirements under the Agreement. 19.4 Consequences of non-compliance 35 Project: 101129188 — EST2EHDS — EU4H-2022-DGA-MS-IBA2 EU4H Ref. Associated with document MGAAres(2023)7314945 — Multi & Mono:-v1.1 26/10/2023 If a beneficiary breaches any of its obligations under this Article, the grant may be reduced (see Article 28). Such breaches may also lead to other measures described in Chapter 5. ARTICLE 20 — RECORD-KEEPING 20.1 Keeping records and supporting documents The beneficiaries must — at least until the time-limit set out in the Data Sheet (see Point 6) — keep records and other supporting documents to prove the proper implementation of the action in line with the accepted standards in the respective field (if any). In addition, the beneficiaries must — for the same period — keep the following to justify the amounts declared: (a) for actual costs: adequate records and supporting documents to prove the costs declared (such as contracts, subcontracts, invoices and accounting records); in addition, the beneficiaries’ usual accounting and internal control procedures must enable direct reconciliation between the amounts declared, the amounts recorded in their accounts and the amounts stated in the supporting documents (b) for flat-rate costs and contributions (if any): adequate records and supporting documents to prove the eligibility of the costs or contributions to which the flat-rate is applied (c) for the following simplified costs and contributions: the beneficiaries do not need to keep specific records on the actual costs incurred, but must keep: (i) for unit costs and contributions (if any): adequate records and supporting documents to prove the number of units declared (ii) for lump sum costs and contributions (if any): adequate records and supporting documents to prove proper implementation of the work as described in Annex 1 (iii) for financing not linked to costs (if any): adequate records and supporting documents to prove the achievement of the results or the fulfilment of the conditions as described in Annex 1 (d) for unit, flat-rate and lump sum costs and contributions according to usual cost accounting practices (if any): the beneficiaries must keep any adequate records and supporting documents to prove that their cost accounting practices have been applied in a consistent manner, based on objective criteria, regardless of the source of funding, and that they comply with the eligibility conditions set out in Articles 6.1 and 6.2. Moreover, the following is needed for specific budget categories: (e) for personnel costs: time worked for the beneficiary under the action must be supported by declarations signed monthly by the person and their supervisor, unless another reliable time-record system is in place; the granting authority may accept alternative evidence supporting the time worked for the action declared, if it considers that it offers an adequate level of assurance 36 Project: 101129188 — EST2EHDS — EU4H-2022-DGA-MS-IBA2 EU4H Ref. Associated with document MGAAres(2023)7314945 — Multi & Mono:-v1.1 26/10/2023 (f) additional record-keeping rules: not applicable The records and supporting documents must be made available upon request (see Article 19) or in the context of checks, reviews, audits or investigations (see Article 25). 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 25), the beneficiaries must keep these 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 granting authority may accept non-original documents if they offer a comparable level of assurance. 20.2 Consequences of non-compliance If a beneficiary breaches any of its obligations under this Article, costs or contributions insufficiently substantiated will be ineligible (see Article 6) and will be rejected (see Article 27), and the grant may be reduced (see Article 28). Such breaches may also lead to other measures described in Chapter 5. ARTICLE 21 — REPORTING 21.1 Continuous reporting The beneficiaries must continuously report on the progress of the action (e.g. deliverables, milestones, outputs/outcomes, critical risks, indicators, etc; if any), in the Portal Continuous Reporting tool and in accordance with the timing and conditions it sets out (as agreed with the granting authority). Standardised deliverables (e.g. progress reports not linked to payments, reports on cumulative expenditure, special reports, etc; if any) must be submitted using the templates published on the Portal. 21.2 Periodic reporting: Technical reports and financial statements In addition, the beneficiaries must provide reports to request payments, in accordance with the schedule and modalities set out in the Data Sheet (see Point 4.2): - for additional prefinancings (if any): an additional prefinancing report - for interim payments (if any) and the final payment: a periodic report. The prefinancing and periodic reports include a technical and financial part. The technical part includes an overview of the action implementation. It must be prepared using the template available in the Portal Periodic Reporting tool. The financial part of the additional prefinancing report includes a statement on the use of the previous prefinancing payment. The financial part of the periodic report includes: 37 Project: 101129188 — EST2EHDS — EU4H-2022-DGA-MS-IBA2 EU4H Ref. Associated with document MGAAres(2023)7314945 — Multi & Mono:-v1.1 26/10/2023 - the financial statements (individual and consolidated; for all beneficiaries/affiliated entities) - the explanation on the use of resources (or detailed cost reporting table, if required) - the certificates on the financial statements (CFS) (if required; see Article 24.2 and Data Sheet, Point 4.3). The financial statements must detail the eligible costs and contributions for each budget category and, for the final payment, also the revenues for the action (see Articles 6 and 22). All eligible costs and contributions incurred should be declared, even if they exceed the amounts indicated in the estimated budget (see Annex 2). Amounts that are not declared in the individual financial statements will not be taken into account by the granting authority. By signing the financial statements (directly in the Portal Periodic Reporting tool), the beneficiaries confirm that: - the information provided is complete, reliable and true - the costs and contributions declared are eligible (see Article 6) - the costs and contributions can be substantiated by adequate records and supporting documents (see Article 20) that will be produced upon request (see Article 19) or in the context of checks, reviews, audits and investigations (see Article 25) - for the final periodic report: all the revenues have been declared (if required; see Article 22). Beneficiaries will have to submit also the financial statements of their affiliated entities (if any). In case of recoveries (see Article 22), beneficiaries will be held responsible also for the financial statements of their affiliated entities. 21.3 Currency for financial statements and conversion into euros The financial statements must be drafted in euro. Beneficiaries with general accounts 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 (ECB website), calculated over the corresponding reporting period. If no daily euro exchange rate is published in the Official Journal for the currency in question, they must be converted at the average of the monthly accounting exchange rates published on the European Commission website (InforEuro), calculated over the corresponding reporting period. Beneficiaries with general accounts in euro must convert costs incurred in another currency into euro according to their usual accounting practices. 21.4 Reporting language The reporting must be in the language of the Agreement, unless otherwise agreed with the granting authority (see Data Sheet, Point 4.2). 38 Project: 101129188 — EST2EHDS — EU4H-2022-DGA-MS-IBA2 EU4H Ref. Associated with document MGAAres(2023)7314945 — Multi & Mono:-v1.1 26/10/2023 21.5 Consequences of non-compliance If a report submitted does not comply with this Article, the granting authority may suspend the payment deadline (see Article 29) and apply other measures described in Chapter 5. If the coordinator breaches its reporting obligations, the granting authority may terminate the grant or the coordinator’s participation (see Article 32) or apply other measures described in Chapter 5. ARTICLE 22 — PAYMENTS AND RECOVERIES — CALCULATION OF AMOUNTS DUE 22.1 Payments and payment arrangements Payments will be made in accordance with the schedule and modalities set out in the Data Sheet (see Point 4.2). They will be made in euro to the bank account indicated by the coordinator (see Data Sheet, Point 4.2) and must be distributed without unjustified delay (restrictions may apply to distribution of the initial prefinancing payment; see Data Sheet, Point 4.2). Payments to this bank account will discharge the granting authority from its payment obligation. The cost of payment transfers will be borne as follows: - the granting authority 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. Payments by the granting authority will be considered to have been carried out on the date when they are debited to its account. 22.2 Recoveries Recoveries will be made, if — at beneficiary termination, final payment or afterwards — it turns out that the granting authority has paid too much and needs to recover the amounts undue. The general liability regime for recoveries (first-line liability) is as follows: At final payment, the coordinator will be fully liable for recoveries, even if it has not been the final recipient of the undue amounts. At beneficiary termination or after final payment, recoveries will be made directly against the beneficiaries concerned. Beneficiaries will be fully liable for repaying the debts of their affiliated entities. In case of enforced recoveries (see Article 22.4): - the beneficiaries will be jointly and severally liable for repaying debts of another beneficiary under the Agreement (including late-payment interest), if required by the granting authority (see Data Sheet, Point 4.4) - affiliated entities will be held liable for repaying debts of their beneficiaries under the 39 Project: 101129188 — EST2EHDS — EU4H-2022-DGA-MS-IBA2 EU4H Ref. Associated with document MGAAres(2023)7314945 — Multi & Mono:-v1.1 26/10/2023 Agreement (including late-payment interest), if required by the granting authority (see Data Sheet, Point 4.4). 22.3 Amounts due 22.3.1 Prefinancing payments The aim of the prefinancing is to provide the beneficiaries with a float. It remains the property of the EU until the final payment. For initial prefinancings (if any), the amount due, schedule and modalities are set out in the Data Sheet (see Point 4.2). For additional prefinancings (if any), the amount due, schedule and modalities are also set out in the Data Sheet (see Point 4.2). However, if the statement on the use of the previous prefinancing payment shows that less than 70% was used, the amount set out in the Data Sheet will be reduced by the difference between the 70% threshold and the amount used. Prefinancing payments (or parts of them) may be offset (without the beneficiaries’ consent) against amounts owed by a beneficiary to the granting authority — up to the amount due to that beneficiary. For grants where the granting authority is the European Commission or an EU executive agency, offsetting may also be done against amounts owed to other Commission services or executive agencies. Payments will not be made if the payment deadline or payments are suspended (see Articles 29 and 30). 22.3.2 Amount due at beneficiary termination — Recovery In case of beneficiary termination, the granting authority will determine the provisional amount due for the beneficiary concerned. Payments (if any) will be made with the next interim or final payment. The amount due will be calculated in the following step: Step 1 — Calculation of the total accepted EU contribution Step 1 — Calculation of the total accepted EU contribution The granting authority will first calculate the ‘accepted EU contribution’ for the beneficiary for all reporting periods, by calculating the ‘maximum EU contribution to costs’ (applying the funding rate to the accepted costs of the beneficiary), taking into account requests for a lower contribution to costs and CFS threshold cappings (if any; see Article 24.5) and adding the contributions (accepted unit, flat-rate or lump sum contributions and financing not linked to costs, if any). After that, the granting authority will take into account grant reductions (if any). The resulting amount is the ‘total accepted EU contribution’ for the beneficiary. The balance is then calculated by deducting the payments received (if any; see report on the distribution of payments in Article 32), from the total accepted EU contribution: {total accepted EU contribution for the beneficiary 40 Project: 101129188 — EST2EHDS — EU4H-2022-DGA-MS-IBA2 EU4H Ref. Associated with document MGAAres(2023)7314945 — Multi & Mono:-v1.1 26/10/2023 minus {prefinancing and interim payments received (if any)}}. If the balance is positive, the amount will be included in the next interim or final payment to the consortium. If the balance is negative, it will be recovered in accordance with the following procedure: The granting authority will send a pre-information letter to the beneficiary concerned: - formally notifying the intention to recover, the amount due, the amount to be recovered and the reasons why and - requesting observations within 30 days of receiving notification. If no observations are submitted (or the granting authority decides to pursue recovery despite the observations it has received), it will confirm the amount to be recovered and ask this amount to be paid to the coordinator (confirmation letter). The amounts will later on also be taken into account for the next interim or final payment. 22.3.3 Interim payments Interim payments reimburse the eligible costs and contributions claimed for the implementation of the action during the reporting periods (if any). Interim payments (if any) will be made in accordance with the schedule and modalities set out the Data Sheet (see Point 4.2). 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 interim payment will be calculated by the granting authority in the following steps: Step 1 — Calculation of the total accepted EU contribution Step 2 — Limit to the interim payment ceiling Step 1 — Calculation of the total accepted EU contribution The granting authority will calculate the ‘accepted EU contribution’ for the action for the reporting period, by first calculating the ‘maximum EU contribution to costs’ (applying the funding rate to the accepted costs of each beneficiary), taking into account requests for a lower contribution to costs, and CFS threshold cappings (if any; see Article 24.5) and adding the contributions (accepted unit, flat-rate or lump sum contributions and financing not linked to costs, if any). After that, the granting authority will take into account grant reductions from beneficiary termination (if any). The resulting amount is the ‘total accepted EU contribution’. Step 2 — Limit to the interim payment ceiling The resulting amount is then capped to ensure that the total amount of prefinancing and interim payments (if any) does not exceed the interim payment ceiling set out in the Data Sheet (see Point 4.2). 41 Project: 101129188 — EST2EHDS — EU4H-2022-DGA-MS-IBA2 EU4H Ref. Associated with document MGAAres(2023)7314945 — Multi & Mono:-v1.1 26/10/2023 Interim payments (or parts of them) may be offset (without the beneficiaries’ consent) against amounts owed by a beneficiary to the granting authority — up to the amount due to that beneficiary. For grants where the granting authority is the European Commission or an EU executive agency, offsetting may also be done against amounts owed to other Commission services or executive agencies. Payments will not be made if the payment deadline or payments are suspended (see Articles 29 and 30). 22.3.4 Final payment — Final grant amount — Revenues and Profit — Recovery The final payment (payment of the balance) reimburses the remaining part of the eligible costs and contributions claimed for the implementation of the action (if any). The final payment will be made in accordance with the schedule and modalities set out in the Data Sheet (see Point 4.2). Payment is subject to the approval of the final periodic report. Its approval does not imply recognition of compliance, authenticity, completeness or correctness of its content. The final grant amount for the action will be calculated in the following steps: Step 1 — Calculation of the total accepted EU contribution Step 2 — Limit to the maximum grant amount Step 3 — Reduction due to the no-profit rule Step 1 — Calculation of the total accepted EU contribution The granting authority will first calculate the ‘accepted EU contribution’ for the action for all reporting periods, by calculating the ‘maximum EU contribution to costs’ (applying the funding rate to the total accepted costs of each beneficiary), taking into account requests for a lower contribution to costs, CFS threshold cappings (if any; see Article 24.5) and adding the contributions (accepted unit, flat-rate or lump sum contributions and financing not linked to costs, if any). After that, the granting authority will take into account grant reductions (if any). The resulting amount is the ‘total accepted EU contribution’. Step 2 — Limit to the maximum grant amount If the resulting amount is higher than the maximum grant amount set out in Article 5.2, it will be limited to the latter. Step 3 — Reduction due to the no-profit rule If the no-profit rule is provided for in the Data Sheet (see Point 4.2), the grant must not produce a profit (i.e. surplus of the amount obtained following Step 2 plus the action’s revenues, over the eligible costs and contributions approved by the granting authority). ‘Revenue’ is all income generated by the action, during its duration (see Article 4), for beneficiaries that are profit legal entities. 42 Project: 101129188 — EST2EHDS — EU4H-2022-DGA-MS-IBA2 EU4H Ref. Associated with document MGAAres(2023)7314945 — Multi & Mono:-v1.1 26/10/2023 If there is a profit, it will be deducted in proportion to the final rate of reimbursement of the eligible costs approved by the granting authority (as compared to the amount calculated following Steps 1 and 2 minus the contributions). The balance (final payment) is then calculated by deducting the total amount of prefinancing and interim payments already made (if any), from the final grant amount: {final grant amount minus {prefinancing and interim payments made (if any)}}. If the balance is positive, it will be paid to the coordinator. The final payment (or part of it) may be offset (without the beneficiaries’ consent) against amounts owed by a beneficiary to the granting authority — up to the amount due to that beneficiary. For grants where the granting authority is the European Commission or an EU executive agency, offsetting may also be done against amounts owed to other Commission services or executive agencies. Payments will not be made if the payment deadline or payments are suspended (see Articles 29 and 30). If the balance is negative, it will be recovered in accordance with the following procedure: The granting authority will send a pre-information letter to the coordinator: - formally notifying the intention to recover, the final grant amount, the amount to be recovered and the reasons why - requesting observations within 30 days of receiving notification. If no observations are submitted (or the granting authority decides to pursue recovery despite the observations it has received), it will confirm the amount to be recovered (confirmation letter), together with a debit note with the terms and date for payment. If payment is not made by the date specified in the debit note, the granting authority will enforce recovery in accordance with Article 22.4. 22.3.5 Audit implementation after final payment — Revised final grant amount — Recovery If — after the final payment (in particular, after checks, reviews, audits or investigations; see Article 25) — the granting authority rejects costs or contributions (see Article 27) or reduces the grant (see Article 28), it will calculate the revised final grant amount for the beneficiary concerned. The beneficiary revised final grant amount will be calculated in the following step: Step 1 — Calculation of the revised total accepted EU contribution Step 1 — Calculation of the revised total accepted EU contribution 43 Project: 101129188 — EST2EHDS — EU4H-2022-DGA-MS-IBA2 EU4H Ref. Associated with document MGAAres(2023)7314945 — Multi & Mono:-v1.1 26/10/2023 The granting authority will first calculate the ‘revised accepted EU contribution’ for the beneficiary, by calculating the ‘revised accepted costs’ and ‘revised accepted contributions’. After that, it will take into account grant reductions (if any). The resulting ‘revised total accepted EU contribution’ is the beneficiary revised final grant amount. If the revised final grant amount is lower than the beneficiary’s final grant amount (i.e. its share in the final grant amount for the action), it will be recovered in accordance with the following procedure: The beneficiary final grant amount (i.e. share in the final grant amount for the action) is calculated as follows: {{total accepted EU contribution for the beneficiary divided by total accepted EU contribution for the action} multiplied by final grant amount for the action}. The granting authority will send a pre-information letter to the beneficiary concerned: - formally notifying the intention to recover, the amount to be recovered and the reasons why and - requesting observations within 30 days of receiving notification. If no observations are submitted (or the granting authority decides to pursue recovery despite the observations it has received), it will confirm the amount to be recovered (confirmation letter), together with a debit note with the terms and the date for payment. Recoveries against affiliated entities (if any) will be handled through their beneficiaries. If payment is not made by the date specified in the debit note, the granting authority will enforce recovery in accordance with Article 22.4. 22.4 Enforced recovery If payment is not made by the date specified in the debit note, the amount due will be recovered: (a) by offsetting the amount — without the coordinator or beneficiary’s consent — against any amounts owed to the coordinator or beneficiary by the granting authority. In exceptional circumstances, to safeguard the EU financial interests, the amount may be offset before the payment date specified in the debit note. For grants where the granting authority is the European Commission or an EU executive agency, debts may also be offset against amounts owed by other Commission services or executive agencies. (b) by drawing on the financial guarantee(s) (if any) (c) by holding other beneficiaries jointly and severally liable (if any; see Data Sheet, Point 4.4) 44 Project: 101129188 — EST2EHDS — EU4H-2022-DGA-MS-IBA2 EU4H Ref. Associated with document MGAAres(2023)7314945 — Multi & Mono:-v1.1 26/10/2023 (d) by holding affiliated entities jointly and severally liable (if any, see Data Sheet, Point 4.4) (e) by taking legal action (see Article 43) or, provided that the granting authority is the European Commission or an EU executive agency, by adopting an enforceable decision under Article 299 of the Treaty on the Functioning of the EU (TFEU) and Article 100(2) of EU Financial Regulation 2018/1046. The amount to be recovered will be increased by late-payment interest at the rate set out in Article 22.5, from the day following the payment date in the debit note, up to and including the date the full payment is received. 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 2015/236620 applies. For grants where the granting authority is an EU executive agency, enforced recovery by offsetting or enforceable decision will be done by the services of the European Commission (see also Article 43). 22.5 Consequences of non-compliance 22.5.1 If the granting authority 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 the rate specified in the Data Sheet (Point 4.2). 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 on 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). If payments or the payment deadline are suspended (see Articles 29 and 30), payment will not be considered as late. 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. 22.5.2 If the coordinator breaches any of its obligations under this Article, the grant may be reduced (see Article 28) and the grant or the coordinator may be terminated (see Article 32). Such breaches may also lead to other measures described in Chapter 5. 20 Directive (EU) 2015/2366 of the European Parliament and of the Council of 25 November 2015 on payment services in the internal market, amending Directives 2002/65/EC, 2009/110/EC and 2013/36/EU and Regulation (EU) No 1093/2010, and repealing Directive 2007/64/EC (OJ L 337, 23.12.2015, p. 35). 45 Project: 101129188 — EST2EHDS — EU4H-2022-DGA-MS-IBA2 EU4H Ref. Associated with document MGAAres(2023)7314945 — Multi & Mono:-v1.1 26/10/2023 ARTICLE 23 — GUARANTEES 23.1 Prefinancing guarantee If required by the granting authority (see Data Sheet, Point 4.2), the beneficiaries must provide (one or more) prefinancing guarantee(s) in accordance with the timing and the amounts set out in the Data Sheet. The coordinator must submit them to the granting authority in due time before the prefinancing they are linked to. The guarantees must be drawn up using the template published on the Portal and fulfil the following conditions: (a) be provided by a bank or approved financial institution established in the EU or — if requested by the coordinator and accepted by the granting authority — by a third party or a bank or financial institution established outside the EU offering equivalent security (b) the guarantor stands as first-call guarantor and does not require the granting authority to first have recourse against the principal debtor (i.e. the beneficiary concerned) and (c) remain explicitly in force until the final payment and, if the final payment takes the form of a recovery, until five months after the debit note is notified to a beneficiary. They will be released within the following month. 23.2 Consequences of non-compliance If the beneficiaries breach their obligation to provide the prefinancing guarantee, the prefinancing will not be paid. Such breaches may also lead to other measures described in Chapter 5. ARTICLE 24 — CERTIFICATES 24.1 Operational verification report (OVR) Not applicable 24.2 Certificate on the financial statements (CFS) If required by the granting authority (see Data Sheet, Point 4.3), the beneficiaries must provide certificates on their financial statements (CFS), in accordance with the schedule, threshold and conditions set out in the Data Sheet. The coordinator must submit them as part of the periodic report (see Article 21). The certificates must be drawn up using the template published on the Portal, cover the costs declared on the basis of actual costs and costs according to usual cost accounting practices (if any), and fulfil the following conditions: 46 Project: 101129188 — EST2EHDS — EU4H-2022-DGA-MS-IBA2 EU4H Ref. Associated with document MGAAres(2023)7314945 — Multi & Mono:-v1.1 26/10/2023 (a) be provided by a qualified approved external auditor which is independent and complies with Directive 2006/43/EC21 (or for public bodies: by a competent independent public officer) (b) the verification must be carried out according to the highest professional standards to ensure that the financial statements comply with the provisions under the Agreement and that the costs declared are eligible. The certificates will not affect the granting authority's right to carry out its own checks, reviews or audits, nor preclude the European Court of Auditors (ECA), the European Public Prosecutor’s Office (EPPO) or the European Anti-Fraud Office (OLAF) from using their prerogatives for audits and investigations under the Agreement (see Article 25). If the costs (or a part of them) were already audited by the granting authority, these costs do not need to be covered by the certificate and will not be counted for calculating the threshold (if any). 24.3 Certificate on the compliance of usual cost accounting practices (CoMUC) Not applicable 24.4 Systems and process audit (SPA) Not applicable 24.5 Consequences of non-compliance If a beneficiary does not submit a certificate on the financial statements (CFS) or the certificate is rejected, the accepted EU contribution to costs will be capped to reflect the CFS threshold. If a beneficiary breaches any of its other obligations under this Article, the granting authority may apply the measures described in Chapter 5. ARTICLE 25 — CHECKS, REVIEWS, AUDITS AND INVESTIGATIONS — EXTENSION OF FINDINGS 25.1 Granting authority checks, reviews and audits 25.1.1 Internal checks The granting authority may — during the action or afterwards — check the proper implementation of the action and compliance with the obligations under the Agreement, including assessing costs and contributions, deliverables and reports. 25.1.2 Project reviews The granting authority may carry out reviews on the proper implementation of the action and compliance with the obligations under the Agreement (general project reviews or specific issues reviews). Such project reviews may be started during the implementation of the action and until the time-limit 21 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). 47 Project: 101129188 — EST2EHDS — EU4H-2022-DGA-MS-IBA2 EU4H Ref. Associated with document MGAAres(2023)7314945 — Multi & Mono:-v1.1 26/10/2023 set out in the Data Sheet (see Point 6). They will be formally notified to the coordinator or beneficiary concerned and will be considered to start on the date of the notification. If needed, the granting authority may be assisted by independent, outside experts. If it uses outside experts, the coordinator or beneficiary concerned will be informed and have the right to object on grounds of commercial confidentiality or conflict of interest. The coordinator or beneficiary concerned must cooperate diligently and 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 granting authority may request beneficiaries to provide such information to it directly. Sensitive information and documents will be treated in accordance with Article 13. The coordinator or beneficiary concerned may be requested to participate in meetings, including with the outside experts. For on-the-spot visits, the beneficiary concerned must allow access to sites and premises (including to the outside experts) 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 project review report will be drawn up. The granting authority will formally notify the project review report to the coordinator or beneficiary concerned, which has 30 days from receiving notification to make observations. Project reviews (including project review reports) will be in the language of the Agreement. 25.1.3 Audits The granting authority may carry out audits on the proper implementation of the action and compliance with the obligations under the Agreement. Such audits may be started during the implementation of the action and until the time-limit set out in the Data Sheet (see Point 6). They will be formally notified to the beneficiary concerned and will be considered to start on the date of the notification. The granting authority may use its own audit service, delegate audits to a centralised service or use external audit firms. If it uses an external firm, the beneficiary concerned will be informed and have the right to object on grounds of commercial confidentiality or conflict of interest. The beneficiary concerned must cooperate diligently and provide — within the deadline requested — any information (including complete accounts, individual salary statements or other personal data) to verify compliance with the Agreement. Sensitive information and documents will be treated in accordance with Article 13. For on-the-spot visits, the beneficiary concerned must allow access to sites and premises (including for the external audit firm) 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. 48 Project: 101129188 — EST2EHDS — EU4H-2022-DGA-MS-IBA2 EU4H Ref. Associated with document MGAAres(2023)7314945 — Multi & Mono:-v1.1 26/10/2023 On the basis of the audit findings, a draft audit report will be drawn up. The auditors will formally notify the draft audit report to the beneficiary concerned, which has 30 days from receiving notification to make observations (contradictory audit procedure). The final audit report will take into account observations by the beneficiary concerned and will be formally notified to them. Audits (including audit reports) will be in the language of the Agreement. 25.2 European Commission checks, reviews and audits in grants of other granting authorities Where the granting authority is not the European Commission, the latter has the same rights of checks, reviews and audits as the granting authority. 25.3 Access to records for assessing simplified forms of funding The beneficiaries must give the European Commission access to their statutory records for the periodic assessment of simplified forms of funding which are used in EU programmes. 25.4 OLAF, EPPO and ECA audits and investigations The following bodies may also carry out checks, reviews, audits and investigations — during the action or afterwards: - the European Anti-Fraud Office (OLAF) under Regulations No 883/201322 and No 2185/9623 - the European Public Prosecutor’s Office (EPPO) under Regulation 2017/1939 - the European Court of Auditors (ECA) under Article 287 of the Treaty on the Functioning of the EU (TFEU) and Article 257 of EU Financial Regulation 2018/1046. If requested by these bodies, the beneficiary concerned must provide full, accurate and complete information in the format requested (including complete accounts, individual salary statements or other personal data, including in electronic format) and allow access to sites and premises for on-the-spot visits or inspections — as provided for under these Regulations. To this end, the beneficiary concerned must keep all relevant information relating to the action, at least until the time-limit set out in the Data Sheet (Point 6) and, in any case, until any ongoing checks, reviews, audits, investigations, litigation or other pursuits of claims have been concluded. 25.5 Consequences of checks, reviews, audits and investigations — Extension of results of reviews, audits or investigations 22 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 248, 18/09/2013, p. 1). 23 Council Regulation (Euratom, EC) No 2185/96 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). 49 Project: 101129188 — EST2EHDS — EU4H-2022-DGA-MS-IBA2 EU4H Ref. Associated with document MGAAres(2023)7314945 — Multi & Mono:-v1.1 26/10/2023 25.5.1 Consequences of checks, reviews, audits and investigations in this grant Findings in checks, reviews, audits or investigations carried out in the context of this grant may lead to rejections (see Article 27), grant reduction (see Article 28) or other measures described in Chapter 5. Rejections or grant reductions after the final payment will lead to a revised final grant amount (see Article 22). Findings in checks, reviews, audits or investigations during the action implementation may lead to a request for amendment (see Article 39), to change the description of the action set out in Annex 1. Checks, reviews, audits or investigations that find systemic or recurrent errors, irregularities, fraud or breach of obligations in any EU grant may also lead to consequences in other EU grants awarded under similar conditions (‘extension to other grants’). Moreover, findings arising from an OLAF or EPPO investigation may lead to criminal prosecution under national law. 25.5.2 Extension from other grants Results of checks, reviews, audits or investigations in other grants may be extended to this grant, if: (a) the beneficiary concerned is found, in other EU 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 — within the time-limit for audits set out in the Data Sheet (see Point 6). The granting authority will formally notify the beneficiary concerned of the intention to extend the findings and the list of grants affected. If the extension concerns rejections of costs or contributions: the 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 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. If the extension concerns grant reductions: the notification will include: (a) an invitation to submit observations on the list of grants affected by the findings and (b) the correction rate for extrapolation, established on the basis of the systemic or recurrent errors and the principle of proportionality. 50 Project: 101129188 — EST2EHDS — EU4H-2022-DGA-MS-IBA2 EU4H Ref. Associated with document MGAAres(2023)7314945 — Multi & Mono:-v1.1 26/10/2023 The beneficiary concerned has 60 days from receiving notification to submit observations, revised financial statements or to propose a duly substantiated alternative correction method/rate. On the basis of this, the granting authority will analyse the impact and decide on the implementation (i.e. start rejection or grant reduction procedures, either on the basis of the revised financial statements or the announced/alternative method/rate or a mix of those; see Articles 27 and 28). 25.6 Consequences of non-compliance If a beneficiary breaches any of its obligations under this Article, costs or contributions insufficiently substantiated will be ineligible (see Article 6) and will be rejected (see Article 27), and the grant may be reduced (see Article 28). Such breaches may also lead to other measures described in Chapter 5. ARTICLE 26 — IMPACT EVALUATIONS 26.1 Impact evaluation The granting authority may carry out impact evaluations of the action, measured against the objectives and indicators of the EU programme funding the grant. Such evaluations may be started during implementation of the action and until the time-limit set out in the Data Sheet (see Point 6). They will be formally notified to the coordinator or beneficiaries and will be considered to start on the date of the notification. If needed, the granting authority may be assisted by independent outside experts. The coordinator or beneficiaries must provide any information relevant to evaluate the impact of the action, including information in electronic format. 26.2 Consequences of non-compliance If a beneficiary breaches any of its obligations under this Article, the granting authority may apply the measures described in Chapter 5. CHAPTER 5 CONSEQUENCES OF NON-COMPLIANCE SECTION 1 REJECTIONS AND GRANT REDUCTION ARTICLE 27 — REJECTION OF COSTS AND CONTRIBUTIONS 27.1 Conditions The granting authority will — at beneficiary termination, interim payment, final payment or afterwards — reject any costs or contributions which are ineligible (see Article 6), in particular following checks, reviews, audits or investigations (see Article 25). 51 Project: 101129188 — EST2EHDS — EU4H-2022-DGA-MS-IBA2 EU4H Ref. Associated with document MGAAres(2023)7314945 — Multi & Mono:-v1.1 26/10/2023 The rejection may also be based on the extension of findings from other grants to this grant (see Article 25). Ineligible costs or contributions will be rejected. 27.2 Procedure If the rejection does not lead to a recovery, the granting authority will formally notify the coordinator or beneficiary concerned of the rejection, the amounts and the reasons why. The coordinator or beneficiary concerned may — within 30 days of receiving notification — submit observations if it disagrees with the rejection (payment review procedure). If the rejection leads to a recovery, the granting authority will follow the contradictory procedure with pre-information letter set out in Article 22. 27.3 Effects If the granting authority rejects costs or contributions, it will deduct them from the costs or contributions declared and then calculate the amount due (and, if needed, make a recovery; see Article 22). ARTICLE 28 — GRANT REDUCTION 28.1 Conditions The granting authority may — at beneficiary termination, final payment or afterwards — reduce the grant for a beneficiary, if: (a) the beneficiary (or a person having powers of representation, decision-making or control, or person essential for the award/implementation of the grant) has committed: (i) substantial errors, irregularities or fraud or (ii) serious breach of obligations under this Agreement or during its award (including improper implementation of the action, non-compliance with the call conditions, submission of false information, failure to provide required information, breach of ethics or security rules (if applicable), etc.), or (b) the beneficiary (or a person having powers of representation, decision-making or control, or person essential for the award/implementation of the grant) has committed — in other EU 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 (see Article 25). The amount of the reduction will be calculated for each beneficiary concerned and proportionate to the seriousness and the duration of the errors, irregularities or fraud or breach of obligations, by applying an individual reduction rate to their accepted EU contribution. 28.2 Procedure If the grant reduction does not lead to a recovery, the granting authority will formally notify the coordinator or beneficiary concerned of the reduction, the amount to be reduced and the reasons why. 52 Project: 101129188 — EST2EHDS — EU4H-2022-DGA-MS-IBA2 EU4H Ref. Associated with document MGAAres(2023)7314945 — Multi & Mono:-v1.1 26/10/2023 The coordinator or beneficiary concerned may — within 30 days of receiving notification — submit observations if it disagrees with the reduction (payment review procedure). If the grant reduction leads to a recovery, the granting authority will follow the contradictory procedure with pre-information letter set out in Article 22. 28.3 Effects If the granting authority reduces the grant, it will deduct the reduction and then calculate the amount due (and, if needed, make a recovery; see Article 22). SECTION 2 SUSPENSION AND TERMINATION ARTICLE 29 — PAYMENT DEADLINE SUSPENSION 29.1 Conditions The granting authority may — at any moment — suspend the payment deadline if a payment cannot be processed because: (a) the required report (see Article 21) has not been submitted or is not complete or additional information is needed (b) there are doubts about the amount to be paid (e.g. ongoing audit extension procedure, queries about eligibility, need for a grant reduction, etc.) and additional checks, reviews, audits or investigations are necessary, or (c) there are other issues affecting the EU financial interests. 29.2 Procedure The granting authority will formally notify the coordinator of the suspension and the reasons why. The suspension will take effect the day the notification is sent. If the conditions for suspending the payment deadline are no longer met, the suspension will be lifted — and the remaining time to pay (see Data Sheet, Point 4.2) will resume. If the suspension exceeds two months, the coordinator may request the granting authority to confirm if the suspension will continue. If the payment deadline has been suspended due to the non-compliance of the report and the revised report is not submitted (or was submitted but is also rejected), the granting authority may also terminate the grant or the participation of the coordinator (see Article 32). ARTICLE 30 — PAYMENT SUSPENSION 30.1 Conditions The granting authority may — at any moment — suspend payments, in whole or in part for one or more beneficiaries, if: 53 Project: 101129188 — EST2EHDS — EU4H-2022-DGA-MS-IBA2 EU4H Ref. Associated with document MGAAres(2023)7314945 — Multi & Mono:-v1.1 26/10/2023 (a) a beneficiary (or a person having powers of representation, decision-making or control, or person essential for the award/implementation of the grant) 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 its award (including improper implementation of the action, non-compliance with the call conditions, submission of false information, failure to provide required information, breach of ethics or security rules (if applicable), etc.), or (b) a beneficiary (or a person having powers of representation, decision-making or control, or person essential for the award/implementation of the grant) has committed — in other EU 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. If payments are suspended for one or more beneficiaries, the granting authority will make partial payment(s) for the part(s) not suspended. If suspension concerns the final payment, the payment (or recovery) of the remaining amount after suspension is lifted will be considered to be the payment that closes the action. 30.2 Procedure Before suspending payments, the granting authority will send a pre-information letter to the beneficiary concerned: - formally notifying the intention to suspend payments and the reasons why and - requesting observations within 30 days of receiving notification. If the granting authority does not receive observations or decides to pursue the procedure despite the observations it has received, it will confirm the suspension (confirmation letter). Otherwise, it will formally notify that the procedure is discontinued. At the end of the suspension procedure, the granting authority will also inform the coordinator. The suspension will take effect the day after the confirmation notification is sent. If the conditions for resuming payments are met, the suspension will be lifted. The granting authority will formally notify the beneficiary concerned (and the coordinator) and set the suspension end date. During the suspension, no prefinancing will be paid to the beneficiaries concerned. For interim payments, the periodic reports for all reporting periods except the last one (see Article 21) must not contain any financial statements from the beneficiary concerned (or 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. ARTICLE 31 — GRANT AGREEMENT SUSPENSION 31.1 Consortium-requested GA suspension 31.1.1 Conditions and procedure 54 Project: 101129188 — EST2EHDS — EU4H-2022-DGA-MS-IBA2 EU4H Ref. Associated with document MGAAres(2023)7314945 — Multi & Mono:-v1.1 26/10/2023 The beneficiaries may request the suspension of the grant or any part of it, if exceptional circumstances — in particular force majeure (see Article 35) — make implementation impossible or excessively difficult. The coordinator must submit a request for amendment (see Article 39), with: - the reasons why - the date the suspension takes effect; this date may be before the date of the submission of the amendment request and - the expected date of resumption. The suspension will take effect on the day specified in the amendment. Once circumstances allow for implementation to resume, the coordinator must immediately request another amendment of the Agreement to set the suspension end date, the resumption date (one day after suspension end date), extend the duration and make other changes necessary to adapt the action to the new situation (see Article 39) — unless the grant has been terminated (see Article 32). The suspension will be lifted with effect from the suspension end date set out in the amendment. This date may be before the date of the submission of the amendment request. During the suspension, no prefinancing will be paid. Costs incurred or contributions for activities implemented during grant suspension are not eligible (see Article 6.3). 31.2 EU-initiated GA suspension 31.2.1 Conditions The granting authority may suspend the grant or any part of it, if: (a) a beneficiary (or a person having powers of representation, decision-making or control, or person essential for the award/implementation of the grant) 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 its award (including improper implementation of the action, non-compliance with the call conditions, submission of false information, failure to provide required information, breach of ethics or security rules (if applicable), etc.), or (b) a beneficiary (or a person having powers of representation, decision-making or control, or person essential for the award/implementation of the grant) has committed — in other EU 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 (c) other: (i) linked action issues: not applicable (ii) additional GA suspension grounds: not applicable. 55 Project: 101129188 — EST2EHDS — EU4H-2022-DGA-MS-IBA2 EU4H Ref. Associated with document MGAAres(2023)7314945 — Multi & Mono:-v1.1 26/10/2023 31.2.2 Procedure Before suspending the grant, the granting authority will send a pre-information letter to the coordinator: - formally notifying the intention to suspend the grant and the reasons why and - requesting observations within 30 days of receiving notification. If the granting authority does not receive observations or decides to pursue the procedure despite the observations it has received, it will confirm the suspension (confirmation letter). Otherwise, it will formally notify that the procedure is discontinued. The suspension will take effect the day after the confirmation notification is sent (or on a later date specified in the notification). Once the conditions for resuming implementation of the action are met, the granting authority will formally notify the coordinator a lifting of suspension letter, in which it will set the suspension end date and invite the coordinator to request an amendment of the Agreement to set the resumption date (one day after suspension end date), extend the duration and make other changes necessary to adapt the action to the new situation (see Article 39) — unless the grant has been terminated (see Article 32). The suspension will be lifted with effect from the suspension end date set out in the lifting of suspension letter. This date may be before the date on which the letter is sent. During the suspension, no prefinancing will be paid. Costs incurred or contributions for activities implemented during suspension are not eligible (see Article 6.3). The beneficiaries may not claim damages due to suspension by the granting authority (see Article 33). Grant suspension does not affect the granting authority’s right to terminate the grant or a beneficiary (see Article 32) or reduce the grant (see Article 28). ARTICLE 32 — GRANT AGREEMENT OR BENEFICIARY TERMINATION 32.1 Consortium-requested GA termination 32.1.1 Conditions and procedure The beneficiaries may request the termination of the grant. The coordinator must submit a request for amendment (see Article 39), with: - the reasons why - the date the consortium ends work on the action (‘end of work date’) and - the date the termination takes effect (‘termination date’); this date must be after the date of the submission of the amendment request. The termination will take effect on the termination date specified in the amendment. If no reasons are given or if the granting authority considers the reasons do not justify termination, it may consider the grant terminated improperly. 56 Project: 101129188 — EST2EHDS — EU4H-2022-DGA-MS-IBA2 EU4H Ref. Associated with document MGAAres(2023)7314945 — Multi & Mono:-v1.1 26/10/2023 32.1.2 Effects The coordinator must — within 60 days from when termination takes effect — submit a periodic report (for the open reporting period until termination). The granting authority will calculate the final grant amount and final payment on the basis of the report submitted and taking into account the costs incurred and contributions for activities implemented before the end of work date (see Article 22). Costs relating to contracts due for execution only after the end of work are not eligible. If the granting authority does not receive the report within the deadline, only costs and contributions which are included in an approved periodic report will be taken into account (no costs/contributions if no periodic report was ever approved). Improper termination may lead to a grant reduction (see Article 28). After termination, the beneficiaries’ obligations (in particular Articles 13 (confidentiality and security), 16 (IPR), 17 (communication, dissemination and visibility), 21 (reporting), 25 (checks, reviews, audits and investigations), 26 (impact evaluation), 27 (rejections), 28 (grant reduction) and 42 (assignment of claims)) continue to apply. 32.2 Consortium-requested beneficiary termination 32.2.1 Conditions and procedure The coordinator may request the termination of the participation of one or more beneficiaries, on request of the beneficiary concerned or on behalf of the other beneficiaries. The coordinator must submit a request for amendment (see Article 39), with: - the reasons why - the opinion of the beneficiary concerned (or proof that this opinion has been requested in writing) - the date the beneficiary ends work on the action (‘end of work date’) - the date the termination takes effect (‘termination date’); this date must be after the date of the submission of the amendment request. If the termination concerns the coordinator and is done without its agreement, the amendment request must be submitted by another beneficiary (acting on behalf of the consortium). The termination will take effect on the termination date specified in the amendment. If no information is given or if the granting authority considers that the reasons do not justify termination, it may consider the beneficiary to have been terminated improperly. 32.2.2 Effects The coordinator must — within 60 days from when termination takes effect — submit: (i) a report on the distribution of payments to the beneficiary concerned 57 Project: 101129188 — EST2EHDS — EU4H-2022-DGA-MS-IBA2 EU4H Ref. Associated with document MGAAres(2023)7314945 — Multi & Mono:-v1.1 26/10/2023 (ii) a termination report from the beneficiary concerned, for the open reporting period until termination, containing an overview of the progress of the work, the financial statement, the explanation on the use of resources, and, if applicable, the certificate on the financial statement (CFS; see Articles 21 and 24.2 and Data Sheet, Point 4.3) (iii) a second request for amendment (see Article 39) with other amendments needed (e.g. reallocation of the tasks and the estimated budget of the terminated beneficiary; addition of a new beneficiary to replace the terminated beneficiary; change of coordinator, etc.). The granting authority will calculate the amount due to the beneficiary on the basis of the report submitted and taking into account the costs incurred and contributions for activities implemented before the end of work date (see Article 22). Costs relating to contracts due for execution only after the end of work are not eligible. The information in the termination report must also be included in the periodic report for the next reporting period (see Article 21). If the granting authority does not receive the termination report within the deadline, only costs and contributions which are included in an approved periodic report will be taken into account (no costs/ contributions if no periodic report was ever approved). If the granting authority does not receive the report on the distribution of payments within the deadline, it will consider that: - the coordinator did not distribute any payment to the beneficiary concerned and that - the beneficiary concerned must not repay any amount to the coordinator. If the second request for amendment is accepted by the granting authority, the Agreement is amended to introduce the necessary changes (see Article 39). If the second request for amendment is rejected by the granting authority (because it calls into question the decision awarding the grant or breaches the principle of equal treatment of applicants), the grant may be terminated (see Article 32). Improper termination may lead to a reduction of the grant (see Article 31) or grant termination (see Article 32). After termination, the concerned beneficiary’s obligations (in particular Articles 13 (confidentiality and security), 16 (IPR), 17 (communication, dissemination and visibility), 21 (reporting), 25 (checks, reviews, audits and investigations), 26 (impact evaluation), 27 (rejections), 28 (grant reduction) and 42 (assignment of claims)) continue to apply. 32.3 EU-initiated GA or beneficiary termination 32.3.1 Conditions The granting authority may terminate the grant 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 the action or the legal, financial, technical, organisational or ownership situation 58 Project: 101129188 — EST2EHDS — EU4H-2022-DGA-MS-IBA2 EU4H Ref. Associated with document MGAAres(2023)7314945 — Multi & Mono:-v1.1 26/10/2023 of a beneficiary is likely to substantially affect the implementation of the action or calls into question the decision to award the grant (including changes linked to one of the exclusion grounds listed in the declaration of honour) (c) following termination of one or more beneficiaries, the necessary changes to the Agreement (and their impact on the action) would call into question the decision awarding the grant or breach the principle of equal treatment of applicants (d) implementation of the action has become impossible or the changes necessary for its continuation would call into question the decision awarding the grant or breach the principle of equal treatment of applicants (e) a beneficiary (or person with unlimited liability for its debts) is subject to bankruptcy proceedings or similar (including insolvency, winding-up, administration by a liquidator or court, arrangement with creditors, suspension of business activities, etc.) (f) a beneficiary (or person with unlimited liability for its debts) is in breach of social security or tax obligations (g) a beneficiary (or person having powers of representation, decision-making or control, or person essential for the award/implementation of the grant) has been found guilty of grave professional misconduct (h) a beneficiary (or person having powers of representation, decision-making or control, or person essential for the award/implementation of the grant) has committed fraud, corruption, or is involved in a criminal organisation, money laundering, terrorism-related crimes (including terrorism financing), child labour or human trafficking (i) a beneficiary (or person having powers of representation, decision-making or control, or person essential for the award/implementation of the grant) was created under a different jurisdiction with the intent to circumvent fiscal, social or other legal obligations in the country of origin (or created another entity with this purpose) (j) a beneficiary (or person having powers of representation, decision-making or control, or person essential for the award/implementation of the grant) has committed: (i) substantial errors, irregularities or fraud or (ii) serious breach of obligations under this Agreement or during its award (including improper implementation of the action, non-compliance with the call conditions, submission of false information, failure to provide required information, breach of ethics or security rules (if applicable), etc.) (k) a beneficiary (or person having powers of representation, decision-making or control, or person essential for the award/implementation of the grant) has committed — in other EU 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 25) (l) despite a specific request by the granting authority, a beneficiary does not request — through the coordinator — an amendment to the Agreement to end the participation of one of its 59 Project: 101129188 — EST2EHDS — EU4H-2022-DGA-MS-IBA2 EU4H Ref. Associated with document MGAAres(2023)7314945 — Multi & Mono:-v1.1 26/10/2023 affiliated entities or associated partners that is in one of the situations under points (d), (f), (e), (g), (h), (i) or (j) and to reallocate its tasks, or (m) other: (i) linked action issues: not applicable (ii) additional GA termination grounds: not applicable. 32.3.2 Procedure Before terminating the grant or participation of one or more beneficiaries, the granting authority will send a pre-information letter to the coordinator or beneficiary concerned: - formally notifying the intention to terminate and the reasons why and - requesting observations within 30 days of receiving notification. If the granting authority does not receive observations or decides to pursue the procedure despite the observations it has received, it will confirm the termination and the date it will take effect (confirmation letter). Otherwise, it will formally notify that the procedure is discontinued. For beneficiary terminations, the granting authority will — at the end of the procedure — also inform the coordinator. The termination will take effect the day after the confirmation notification is sent (or on a later date specified in the notification; ‘termination date’). 32.3.3 Effects (a) for GA termination: The coordinator must — within 60 days from when termination takes effect — submit a periodic report (for the last open reporting period until termination). The granting authority will calculate the final grant amount and final payment on the basis of the report submitted and taking into account the costs incurred and contributions for activities implemented before termination takes effect (see Article 22). Costs relating to contracts due for execution only after termination are not eligible. If the grant is terminated for breach of the obligation to submit reports, the coordinator may not submit any report after termination. If the granting authority does not receive the report within the deadline, only costs and contributions which are included in an approved periodic report will be taken into account (no costs/contributions if no periodic report was ever approved). Termination does not affect the granting authority’s right to reduce the grant (see Article 28) or to impose administrative sanctions (see Article 34). The beneficiaries may not claim damages due to termination by the granting authority (see Article 33). 60 Project: 101129188 — EST2EHDS — EU4H-2022-DGA-MS-IBA2 EU4H Ref. Associated with document MGAAres(2023)7314945 — Multi & Mono:-v1.1 26/10/2023 After termination, the beneficiaries’ obligations (in particular Articles 13 (confidentiality and security), 16 (IPR), 17 (communication, dissemination and visibility), 21 (reporting), 25 (checks, reviews, audits and investigations), 26 (impact evaluation), 27 (rejections), 28 (grant reduction) and 42 (assignment of claims)) continue to apply. (b) for beneficiary termination: The coordinator must — within 60 days from when termination takes effect — submit: (i) a report on the distribution of payments to the beneficiary concerned (ii) a termination report from the beneficiary concerned, for the open reporting period until termination, containing an overview of the progress of the work, the financial statement, the explanation on the use of resources, and, if applicable, the certificate on the financial statement (CFS; see Articles 21 and 24.2 and Data Sheet, Point 4.3) (iii) a request for amendment (see Article 39) with any amendments needed (e.g. reallocation of the tasks and the estimated budget of the terminated beneficiary; addition of a new beneficiary to replace the terminated beneficiary; change of coordinator, etc.). The granting authority will calculate the amount due to the beneficiary on the basis of the report submitted and taking into account the costs incurred and contributions for activities implemented before termination takes effect (see Article 22). Costs relating to contracts due for execution only after termination are not eligible. The information in the termination report must also be included in the periodic report for the next reporting period (see Article 21). If the granting authority does not receive the termination report within the deadline, only costs and contributions included in an approved periodic report will be taken into account (no costs/ contributions if no periodic report was ever approved). If the granting authority does not receive the report on the distribution of payments within the deadline, it will consider that: - the coordinator did not distribute any payment to the beneficiary concerned and that - the beneficiary concerned must not repay any amount to the coordinator. If the request for amendment is accepted by the granting authority, the Agreement is amended to introduce the necessary changes (see Article 39). If the request for amendment is rejected by the granting authority (because it calls into question the decision awarding the grant or breaches the principle of equal treatment of applicants), the grant may be terminated (see Article 32). After termination, the concerned beneficiary’s obligations (in particular Articles 13 (confidentiality and security), 16 (IPR), 17 (communication, dissemination and visibility), 21 (reporting), 25 (checks, reviews, audits and investigations), 26 (impact evaluation), 27 (rejections), 28 (grant reduction) and 42 (assignment of claims)) continue to apply. 61 Project: 101129188 — EST2EHDS — EU4H-2022-DGA-MS-IBA2 EU4H Ref. Associated with document MGAAres(2023)7314945 — Multi & Mono:-v1.1 26/10/2023 SECTION 3 OTHER CONSEQUENCES: DAMAGES AND ADMINISTRATIVE SANCTIONS ARTICLE 33 — DAMAGES 33.1 Liability of the granting authority The granting authority cannot be held liable for any damage caused to the beneficiaries or to third parties as a consequence of the implementation of the Agreement, including for gross negligence. The granting authority cannot be held liable for any damage caused by any of the beneficiaries or other participants involved in the action, as a consequence of the implementation of the Agreement. 33.2 Liability of the beneficiaries The beneficiaries must compensate the granting authority 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, provided that it was caused by gross negligence or wilful act. The liability does not extend to indirect or consequential losses or similar damage (such as loss of profit, loss of revenue or loss of contracts), provided such damage was not caused by wilful act or by a breach of confidentiality. ARTICLE 34 — ADMINISTRATIVE SANCTIONS AND OTHER MEASURES Nothing in this Agreement may be construed as preventing the adoption of administrative sanctions (i.e. exclusion from EU award procedures and/or financial penalties) or other public law measures, in addition or as an alternative to the contractual measures provided under this Agreement (see, for instance, Articles 135 to 145 EU Financial Regulation 2018/1046 and Articles 4 and 7 of Regulation 2988/9524). SECTION 4 FORCE MAJEURE ARTICLE 35 — FORCE MAJEURE A party prevented by force majeure from fulfilling its obligations under the Agreement cannot be considered in breach of them. ‘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 other participants involved in the action), and - proves to be inevitable in spite of exercising all due diligence. 24 Council Regulation (EC, Euratom) No 2988/95 of 18 December 1995 on the protection of the European Communities financial interests (OJ L 312, 23.12.1995, p. 1). 62 Project: 101129188 — EST2EHDS — EU4H-2022-DGA-MS-IBA2 EU4H Ref. Associated with document MGAAres(2023)7314945 — Multi & Mono:-v1.1 26/10/2023 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. CHAPTER 6 FINAL PROVISIONS ARTICLE 36 — COMMUNICATION BETWEEN THE PARTIES 36.1 Forms and means of communication — Electronic management EU grants are managed fully electronically through the EU Funding & Tenders Portal (‘Portal’). All communications must be made electronically through the Portal, in accordance with the Portal Terms and Conditions and using the forms and templates provided there (except if explicitly instructed otherwise by the granting authority). Communications must be made in writing and clearly identify the grant agreement (project number and acronym). Communications must be made by persons authorised according to the Portal Terms and Conditions. For naming the authorised persons, each beneficiary must have designated — before the signature of this Agreement — a ‘legal entity appointed representative (LEAR)’. The role and tasks of the LEAR are stipulated in their appointment letter (see Portal Terms and Conditions). If the electronic exchange system is temporarily unavailable, instructions will be given on the Portal. 36.2 Date of communication The sending date for communications made through the Portal will be the date and time of sending, as indicated by the time logs. The receiving date for communications made through the Portal will be the date and time the communication is accessed, as indicated by the time logs. Formal notifications that have not been accessed within 10 days after sending, will be considered to have been accessed (see Portal Terms and Conditions). If a communication is exceptionally made on paper (by e-mail or postal service), general principles apply (i.e. date of sending/receipt). Formal notifications by registered post with proof of delivery will be considered to have been received either on 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 Portal can be accessed via the Europa website. 63 Project: 101129188 — EST2EHDS — EU4H-2022-DGA-MS-IBA2 EU4H Ref. Associated with document MGAAres(2023)7314945 — Multi & Mono:-v1.1 26/10/2023 The address for paper communications to the granting authority (if exceptionally allowed) is the official mailing address indicated on its website. For beneficiaries, it is the legal address specified in the Portal Participant Register. ARTICLE 37 — INTERPRETATION OF THE AGREEMENT The provisions in the Data Sheet take precedence over the rest of the Terms and Conditions of the Agreement. Annex 5 takes precedence over the Terms and Conditions; the Terms and Conditions take precedence over the Annexes other than Annex 5. Annex 2 takes precedence over Annex 1. ARTICLE 38 — CALCULATION OF PERIODS AND DEADLINES In accordance with Regulation No 1182/7125, 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. ‘Days’ means calendar days, not working days. ARTICLE 39 — AMENDMENTS 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 directly in the Portal Amendment tool. 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 25 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). 64 Project: 101129188 — EST2EHDS — EU4H-2022-DGA-MS-IBA2 EU4H Ref. Associated with document MGAAres(2023)7314945 — Multi & Mono:-v1.1 26/10/2023 - for a change of coordinator without its agreement: the opinion of the coordinator (or proof that this opinion has been requested in writing). The granting authority may request additional information. If the party receiving the request agrees, it must sign the amendment in the tool within 45 days of receiving notification (or any additional information the granting authority 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. An amendment enters into force on the day of the signature of the receiving party. An amendment takes effect on the date of entry into force or other date specified in the amendment. ARTICLE 40 — ACCESSION AND ADDITION OF NEW BENEFICIARIES 40.1 Accession of the beneficiaries mentioned in the Preamble The beneficiaries which are not coordinator must accede to the grant by signing the accession form (see Annex 3) directly in the Portal Grant Preparation tool, within 30 days after the entry into force of the Agreement (see Article 44). They will assume the rights and obligations under the Agreement with effect from the date of its entry into force (see Article 44). If a beneficiary does not accede to the grant within the above deadline, the coordinator must — within 30 days — request an amendment (see Article 39) to terminate the beneficiary and make any changes necessary to ensure proper implementation of the action. This does not affect the granting authority’s right to terminate the grant (see Article 32). 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 directly in the Portal Amendment tool. New beneficiaries will assume the rights and obligations under the Agreement with effect from the date of their accession specified in the accession form (see Annex 3). Additions are also possible in mono-beneficiary grants. ARTICLE 41 — TRANSFER OF THE AGREEMENT In justified cases, the beneficiary of a mono-beneficiary grant may request the transfer of the grant to a new beneficiary, provided that this would not call into question the decision awarding the grant or breach the principle of equal treatment of applicants. The beneficiary must submit a request for amendment (see Article 39), with 65 Project: 101129188 — EST2EHDS — EU4H-2022-DGA-MS-IBA2 EU4H Ref. Associated with document MGAAres(2023)7314945 — Multi & Mono:-v1.1 26/10/2023 - the reasons why - the accession form (see Annex 3) signed by the new beneficiary directly in the Portal Amendment tool and - additional supporting documents (if required by the granting authority). The new beneficiary will assume the rights and obligations under the Agreement with effect from the date of accession specified in the accession form (see Annex 3). ARTICLE 42 — ASSIGNMENTS OF CLAIMS FOR PAYMENT AGAINST THE GRANTING AUTHORITY The beneficiaries may not assign any of their claims for payment against the granting authority to any third party, except if expressly approved in writing by the granting authority on the basis of a reasoned, written request by the coordinator (on behalf of the beneficiary concerned). If the granting authority has not accepted the assignment or if the terms of it are not observed, the assignment will have no effect on it. In no circumstances will an assignment release the beneficiaries from their obligations towards the granting authority. ARTICLE 43 — APPLICABLE LAW AND SETTLEMENT OF DISPUTES 43.1 Applicable law The Agreement is governed by the applicable EU law, supplemented if necessary by the law of Belgium. Special rules may apply for beneficiaries which are international organisations (if any; see Data Sheet, Point 5). 43.2 Dispute settlement If a dispute concerns the interpretation, application or validity of the Agreement, the parties must bring action before the EU General Court — or, on appeal, the EU Court of Justice — under Article 272 of the Treaty on the Functioning of the EU (TFEU). For non-EU beneficiaries (if any), such disputes must be brought before the courts of Brussels, Belgium — unless an international agreement provides for the enforceability of EU court judgements. For beneficiaries with arbitration as special dispute settlement forum (if any; see Data Sheet, Point 5), the dispute will — in the absence of an amicable settlement — be settled in accordance with the Rules for Arbitration published on the Portal. If a dispute concerns administrative sanctions, offsetting or an enforceable decision under Article 299 TFEU (see Articles 22 and 34), the beneficiaries must bring action before the General Court — or, on appeal, the Court of Justice — under Article 263 TFEU. For grants where the granting authority is an EU executive agency (see Preamble), actions against 66 Project: 101129188 — EST2EHDS — EU4H-2022-DGA-MS-IBA2 EU4H Ref. Associated with document MGAAres(2023)7314945 — Multi & Mono:-v1.1 26/10/2023 offsetting and enforceable decisions must be brought against the European Commission (not against the granting authority; see also Article 22). ARTICLE 44 — ENTRY INTO FORCE The Agreement will enter into force on the day of signature by the granting authority or the coordinator, depending on which is later. SIGNATURES For the coordinator For the granting authority [--TGSMark#signature-998429731_75_210--] [--TGSMark#signature-service_75_210--] 67  Associated with document Ref. Ares(2023)7314945 - 26/10/2023 ANNEX 1 EU4Health Programme (EU4H) Description of the action (DoA) Part A Part B Project: 101129188 — EST2EHDS — EU4H-2022-DGA-MS-IBA2 Associated with document Ref. Ares(2023)7314945 - 26/10/2023 DESCRIPTION OF THE ACTION (PART A) COVER PAGE Part A of the Description of the Action (DoA) must be completed directly on the Portal Grant Preparation screens. PROJECT Grant Preparation (General Information screen) — Enter the info. Project number: 101129188 Project name: Estonia towards European Health Data Space for secondary use of health data Project acronym: EST2EHDS Call: EU4H-2022-DGA-MS-IBA2 Topic: EU4H-2022-DGA-MS-IBA-4 Type of action: EU4H-PJG Service: HADEA/A/01 Project starting date: first day of the month following the entry into force date Project duration: 36 months TABLE OF CONTENTS Project summary ......................................................................................................................................................3 List of participants .................................................................................................................................................. 3 List of work packages .............................................................................................................................................4 Staff effort ............................................................................................................................................................. 12 List of deliverables ................................................................................................................................................13 List of milestones (outputs/outcomes) .................................................................................................................. 19 List of critical risks ............................................................................................................................................... 21 2 Project: 101129188 — EST2EHDS — EU4H-2022-DGA-MS-IBA2 Associated with document Ref. Ares(2023)7314945 - 26/10/2023 PROJECT SUMMARY Project summary Grant Preparation (General Information screen) — Provide an overall description of your project (including context and overall objectives, planned activities and main achievements, and expected results and impacts (on target groups, change procedures, capacities, innovation etc)). This summary should give readers a clear idea of what your project is about. Use the project summary from your proposal. Estonia towards European Health Data Space (EHDS) for secondary use of health data (EST2EHDS) aims to promote the establishment of national health data access body, by expanding its minimum capabilities and working towards establishing its connection with HealthData@EU, for the development of the EHDS for secondary uses of health data. The objectives of the proposal are to establish and deploy services for a health data access body, including its minimum business capabilities, and to provide a best way to set up cross-border connections to the large-scale deployment of HealthData@EU, on the basis of the work conducted by the joint action ‘Towards the European Health Data Space’ (TEHDaS), and on the outcomes of the pilot project for the EHDS infrastructure based on 5 use cases that will run from 2022-2024 to test the setting up of a European network for secondary uses of data. The activities include setting up national dataset catalogue, analysing and proposing the best way to set up data access application management system, secure processing environments and cross-border gateway. Activities also include data quality improvement, focusing on delivering high quality data for secondary use on national level and cross-border and working towards connection to planned EHDS. LIST OF PARTICIPANTS PARTICIPANTS Grant Preparation (Beneficiaries screen) — Enter the info. Number Role Short name Legal name Country PIC 1 COO MSAE SOTSIAALMINISTEERIUM EE 998429731 1.1 AE TEHIK TERVISE JA HEAOLU INFOSÜSTEEMIDE EE 895885405 KESKUS 3 Project: 101129188 — EST2EHDS — EU4H-2022-DGA-MS-IBA2 Associated with document Ref. Ares(2023)7314945 - 26/10/2023 LIST OF WORK PACKAGES Work packages Grant Preparation (Work Packages screen) — Enter the info. Work Work Package name Lead Beneficiary Effort Start End Deliverables Package No (Person- Month Month Months) WP1 Project management and coordination 1 - MSAE 6.50 1 36 D1.1 – Project guide WP2 Dissemination 1 - MSAE 4.20 1 36 D2.1 – Communication and dissemination strategy D2.2 – Website D2.3 – Mid-term dissemination report D2.4 – Final dissemination report WP3 Evaluation 1 - MSAE 4.30 1 36 D3.1 – Evaluation plan D3.2 – Mid-term evaluation report D3.3 – Final evaluation report D3.4 – Specific action-level indicators WP4 Sustainability 1 - MSAE 3.50 1 36 D4.1 – Sustainability report WP5 Setting up national dataset catalogue 1 - TEHIK 24.00 1 36 D5.1 – Catalogue of datasets WP6 National data access application management 1 - MSAE 5.00 2 36 D6.1 – Proposal and action plan for system development, deployment and sustainability WP7 Secure processing environments 1 - MSAE 5.00 1 36 D7.1 – Proposal and action plan for secure processing environments WP8 Cross-border gateway 1 - MSAE 5.00 10 36 D8.1 – Proposal and action plan for cross- border gateway WP9 Datasets data quality improvement 1 - TEHIK 96.00 1 36 D9.1 – Data Quality Framework for secondary use of health data 4 Project: 101129188 — EST2EHDS — EU4H-2022-DGA-MS-IBA2 Associated with document Ref. Ares(2023)7314945 - 26/10/2023 Work package WP1 – Project management and coordination Work Package Number WP1 Lead Beneficiary 1. MSAE Work Package Name Project management and coordination Start Month 1 End Month 36 Objectives This WP aims to adequately manage and coordinate this project and it will have the following specific objectives: To provide technical, scientific, financial and administrative management and support To guide the efforts of the partners for the achievement of milestones To provide a project management guide in close collaboration with other WP leaders, that includes procedures for project management as well as for quality assurance To monitor progress to avoid deviations To ensure ethical compliance To communicate with HaDEA and DG SANTE To comply with the HaDEA rules regarding financial, legal and administrative issues To organize coordination meetings on a regular basis Description Tasks (T): T1.1 Consortium Operating Procedures Definition MoSA and TEHIK will develop a project guide for project management and quality assurance (by month 3), which will be the basis for managing the project throughout its lifecycle. It will also be a point of reference for all members and stakeholders. It will include administrative information as well as guidelines for financial reporting and presentating the standards for deliverables and reports to HaDEA. T1.2 Coordination of the project management Coordination and management of administrative and financial matters and providing support in administrative field to partners. Monitoring project progress, preparation of reports and communication with HaDEA services for coordination. T1.3 Consortium meeting Foreseen are the following meetings: Kick-off meeting: introduction and official start of project (by month 2) Regular meetings to review progress and address any issues (monthly) Closing event: final event summarizing all outcomes and benefits (by month 36) T1.4 Ethical management Provides ethical view and analysis as well as guidance on all aspects of the project, in compliance with the national law and EU regulations, as well as social rules, ethical values and moral principles. T1.5 Legal management Deals with legal issues related to the project, focusing on the Grant Agreement and the Consortium Agreement implementation as well as supporting partners in legal issues. Work package WP2 – Dissemination Work Package Number WP2 Lead Beneficiary 1. MSAE Work Package Name Dissemination 5 Project: 101129188 — EST2EHDS — EU4H-2022-DGA-MS-IBA2 Associated with document Ref. Ares(2023)7314945 - 26/10/2023 Start Month 1 End Month 36 Objectives This WP aims to disseminate information on the project deliverables and progress to contribute the establishment of the health data access body. Dissemination activities will be carried out both internally and externally and knowledge as well as experiences will be shared among all relevant stakeholders and partners. The methodologies will support the transparency and visibility of results and ensure the access to detailed and up-to-date information and communication platforms. Specific objectives of the WP2 are: To support and facilitate knowledge sharing about EHDS and health data access body services and infrastructures available. To actively identify and engage stakeholders to ensure that the results are in line with their needs and expectations. To ensure that the results and deliverables are easily accessible to partners, stakeholders and public. Description Tasks (T) T2.1 Communication and dissemination Communication strategy and its execution with reports, includes project content management system. T2.2 Visual identity and promotional materials Creating visual identity of the project and promotional materials, that will be updated mirroring the evolution and results of the project. T2.3 Event organisation including stakeholders In collaboration with WP1 tasks and participants, organisation and management of main events. T2.4 Project Web Portal, co-ordinated with the Web Portals of the other Member States. Setting up project web portal, co-ordinated with the web portals of the other member states. T2.5 On-line training tools Providing on-line training tools on how to use HDAB Work package WP3 – Evaluation Work Package Number WP3 Lead Beneficiary 1. MSAE Work Package Name Evaluation Start Month 1 End Month 36 Objectives General objectives: WP3 aims to guarantee a high impact in order to support the projects overall aims, focusing on the process as whole as well as individual work packages and tasks. WP3 will evaluate the quality of the project and ensure that the outputs are effective, innovative and fit for purpose. Specific objectives: To monitor and evaluate the working process, content and deliverable as well as added value of each work component. To evaluate the synergies between all work packages and components. 6 Project: 101129188 — EST2EHDS — EU4H-2022-DGA-MS-IBA2 Associated with document Ref. Ares(2023)7314945 - 26/10/2023 Description Tasks (T): T3.1 Evaluation plan Designing and writing the evaluation plan that includes a baseline evaluation; success criteria; indicators; metric; timing and responsibilities. T3.2 Mid-term evaluation report Designing and writing the mid-term evaluation report for the project. This will assess the intended outcomes, outputs and success indicators half-way at the project (month 6-20) T3.3 Final evaluation report Designing and writing the final evaluation report, that will be built on the mid-term evaluation report and final evaluations. Work package WP4 – Sustainability Work Package Number WP4 Lead Beneficiary 1. MSAE Work Package Name Sustainability Start Month 1 End Month 36 Objectives Specific objectives: To support the development and adoption of national policies related to an effective setting up of HDAB and align towards EHDS legislation. To generate recommendations and guidance for uptake of good practices on different levels of setting up HDAB, as described in WP-s of this project. Description Task (T): T4.1 Sustainability strategy Setting up sustainability strategy including policy and technical recommendations and sustainability action plans. Work package WP5 – Setting up national dataset catalogue Work Package Number WP5 Lead Beneficiary 1. TEHIK Work Package Name Setting up national dataset catalogue Start Month 1 End Month 36 Objectives The aim of WP5 is to set up national dataset catalogue with metadata health datasets, which is discoverable and accessible to data users both nationally and cross-border. WP5 also aims to provide a metadatabase accessible to data users, facilitating the transition from document-based to more granular data exchange. WP5 aims to display the HIS datasets in HDAB in both machine-readable and non-machine readable form. For this, two separate environments will be maintained. The displaying of HIS datasets in both machine-readable and non-machine 7 Project: 101129188 — EST2EHDS — EU4H-2022-DGA-MS-IBA2 Associated with document Ref. Ares(2023)7314945 - 26/10/2023 readable form contributes to the objectives of secondary use of health data by making the data accessible for different purposes. The tasks under this WP5 will be analysed and tailored to fit the results and guidelines from the TEHDaS project and to ensure the best ways for implementing the European Health Data Space Data Quality Framework on national level. The analysis will also take into account the pilot for EHDS infrastructure for secondary use and will support Estonia’s effort joining EHDS. Specific objectives: Analysis and design: AS-IS analysis and description of existing systems and infrastructures that contribute to setting up national dataset catalogue. Following results from TEHDaS project, analyse the best ways to implement the solutions and how to set up national dataset catalogue in compliance with EU guidelines and best practices from previous projects. Development and testing: Development of the proposed tasks according to the plan, including continuous evaluation. Deployment and operation: Deployment of operational solutions according to the plan. Description Tasks (T): T5.1 Describing common ICT infrastructure Describing data descriptions, codesystems, valuesets and, dataset rules used in the information systems under the Ministry of Social Affairs on a common basis to ensure data quality at the point of data creation. Development of environment for managing classifiers, managing of OID-s, data modelling portal with special functionalities for national health authorities, terminology server. T5.2 Metadatabase Provide a metadatabase accessible to data users on national level and cross-border, facilitating the transition from document-based to more granular data exchange. T5.3 Displaying the HIS datasets in machine-readable form in HDAB Management of the Data Modelling Portal for displaying the datasets in machine-readable form T5.4 Displaying the HIS datasets in non-machine-readable form in HDAB Management of the Information Portal for displaying the datasets in non-machine-readable form Work package WP6 – National data access application management system Work Package Number WP6 Lead Beneficiary 1. MSAE Work Package Name National data access application management system Start Month 2 End Month 36 Objectives WP6 general objective is to fulfil the prerequisites for setting up national data access application management system for joining EHDS, that enables health data access body to receive, process and reply to data access applications in a timely manner. This WP will focus on the analysis of the best ways to set up the national data access application management system and the tasks to TEHIK, that arise from that analysis. The analysis will include a feasibility plan, which will provide insight to the most effective ways to setting up the system on national level, the competent and responsible authority and resources needed. Based on the analysis, Estonia will maintain a system for responding to data requests and the capacity to respond to cross-border data access applications per month will be increased. Specific objectives: 8 Project: 101129188 — EST2EHDS — EU4H-2022-DGA-MS-IBA2 Associated with document Ref. Ares(2023)7314945 - 26/10/2023 Analysis and design: Consisting of AS-IS process analysis, best practices nationally and EU level previous studies and guidelines to setting up national data access application management system. Development and testing: Based on the analysis, the development plan of the system, testing and evaluation plan, including cross-border testing. Deployment and operation: Deployment plan and sustainability plan. Description Tasks (T): T6.1 AS-IS process analysis AS-IS process analysis T6.2 TO-BE analysis TO-BE analysis and plan Work package WP7 – Secure processing environments Work Package Number WP7 Lead Beneficiary 1. MSAE Work Package Name Secure processing environments Start Month 1 End Month 36 Objectives The new infrastructure for the secondary uses of health data needs to connect data users and data holders in a secure, controlled way and ensure secure processing environment for authorized participants. This WP7 will focus on the analysis of the best system setup and provide information about whether the secure processing environment is best to be built specifically in the health data field or by Statistics Estonia. The aim of WP7 is to describe the tasks and obligations of all user groups and to set the duties for data holders, thus resulting in a proposal and action plan to set up the secure processing environments as pointed out in the EHDS regulation proposal. After the analysis and realisation of the tasks described in proposal (which is described as a deliverable of this WP7), health data access body shall be able to provide access to electronic health data only through a secure processing environment and ensure regular audits of the secure processing environment. Specific objectives: Analysis and design: consisting of AS-IS analysis of current national infrastructures and stakeholders to be involved in setting up the secure processing environment. Development and testing: Based on the analysis, TO-BE analysis and proposal of the best system setup based on the best knowledge at that time (including definition of requirements in EHDS regulation proposal and HealthData@EU pilot). Development plan of the system, testing and evaluation plan, including cross-border testing. Proposal shall include configuration-driven systems that can facilitate the adjustment to possible provisions that may be set in the implemention of the EHDS Regulation in the future. Deployment and operation: Deployment plan and sustainability plan. Description Tasks (T): T7.1 AS-IS analysis Description of AS-IS situation, roles of different national authorities T7.2 TO-BE analysis 9 Project: 101129188 — EST2EHDS — EU4H-2022-DGA-MS-IBA2 Associated with document Ref. Ares(2023)7314945 - 26/10/2023 TO-BE system setup description Work package WP8 – Cross-border gateway Work Package Number WP8 Lead Beneficiary 1. MSAE Work Package Name Cross-border gateway Start Month 10 End Month 36 Objectives For the future European Health Data Space (EHDS) infrastructure to be set up and to ensure effective use of health data, Estonia will establish National Health Data Access Body, which takes into account the roles of different health organizations and different needs as well as use cases for secondary health data. To combine the national and EU needs in the most efficient way, an analysis needs to be done on how to best apply EHDS in Estonia. The general aim of this WP8 is to propose a best way to apply EHDS in the future in Estonia through thorough analysis, which includes the different roles, skills, technical capabilities, availability of resources and legislation. An analysis consists of use cases of different secondary health data, which include but are not limited to science and research, innovation and development of new health products or services, private sector, supporting policy making, quality management. While analysing the different use cases, a lot of attention needs to be given to defining prohibited purposes as well. This needs to be done to protect the data and ensure no harm done to people. Building blocks provided by the Central Services will be used as a reference implementation for HDAB to implement cross-border services. They are used as nodes at national level for cross-border data exchange. Specific objectives: Analysis and design: consisting of AS-IS analysis of current national infrastructures and stakeholders to be involved in setting up the cross-border gateway. Development and testing: Based on the analysis, TO-BE analysis and proposal of the best system setup, based on the best knowledge at that time, TEHDaS project outcomes and recommendations as well as HealthData@EU Pilot 5 use cases, focusing on national as well as EU needs, following the general guidelines in the chapter IV of “Proposal for a regulation of the European Parliament and of the Council on the European Health Data Space” Deployment and operation: Deployment plan and sustainability plan. Description Tasks (T): T8.1 AS-IS analysis Analysing the current national infrastructures and stakeholders to be involved in setting up the cross-border gateway. T8.2 Evaluating HealthData@EU Pilot results Evaluation of pilot study results and reflecting the national needs T8.3 TO-BE analysis and proposal Based on best knowledge, an analysis of best TO-BE setup and proposal to set up cross-border gateway in Estonia Work package WP9 – Datasets data quality improvement Work Package Number WP9 Lead Beneficiary 1. TEHIK Work Package Name Datasets data quality improvement Start Month 1 End Month 36 10 Project: 101129188 — EST2EHDS — EU4H-2022-DGA-MS-IBA2 Associated with document Ref. Ares(2023)7314945 - 26/10/2023 Objectives The aim of WP9 is to focus on monitoring and improving data quality in order to provide high quality health data for secondary use on national level and cross-border. General aim of this WP is to improve the data quality already at the point of data collection, develop data control module and framework for monitoring and improving data quality. Specific objectives: Analysis and design: AS-IS data quality assessment, description of existing systems and infrastructures that contribute to data quality Development and testing: Following results from TEHDaS project, the European Health Data Space Data Quality Framework, analysing the best ways to implement the framework on national level. Developing and implementing Data Quality Framework (in accordance with TEHDAS recommendations) for secondary use of health data. Choosing and implementing data quality improvement tools. Deployment and operation: Development of the proposed tasks according to the plan, including continuous evaluation Description Tasks (T): T9.1 AS-IS analysis Analysing the AS-IS data quality T9.2 Developing Data Quality Framework for secondary use of health data Developing and implementing Data Quality Framework (in accordance with TEHDAS recommendations) for secondary use of health data T9.3 Implementing Data Quality Framework for secondary use of health data Developing and implementing Data Quality Framework (in accordance with TEHDAS recommendations) for secondary use of health data T9.4 Choosing and implementing tools to monitor, report and track fixing data quality problems. Choosing and implementing tools to monitor, report and track fixing data quality problems. T9.5 Monitoring, reporting and fixing data quality problems Monitoring, reporting and fixing data quality problems 11 Project: 101129188 — EST2EHDS — EU4H-2022-DGA-MS-IBA2 Associated with document Ref. Ares(2023)7314945 - 26/10/2023 STAFF EFFORT Staff effort per participant Grant Preparation (Work packages - Effort screen) — Enter the info. Participant WP1 WP2 WP3 WP4 WP5 WP6 WP7 WP8 WP9 Total Person-Months 1 - MSAE 5.00 2.70 2.80 2.00 3.00 3.00 3.00 21.50 1.1 - TEHIK 1.50 1.50 1.50 1.50 24.00 2.00 2.00 2.00 96.00 132.00 Total Person-Months 6.50 4.20 4.30 3.50 24.00 5.00 5.00 5.00 96.00 153.50 12 Project: 101129188 — EST2EHDS — EU4H-2022-DGA-MS-IBA2 Associated with document Ref. Ares(2023)7314945 - 26/10/2023 LIST OF DELIVERABLES Deliverables Grant Preparation (Deliverables screen) — Enter the info. The labels used mean: Public — fully open ( automatically posted online) Sensitive — limited under the conditions of the Grant Agreement EU classified —RESTREINT-UE/EU-RESTRICTED, CONFIDENTIEL-UE/EU-CONFIDENTIAL, SECRET-UE/EU-SECRET under Decision 2015/444 Deliverable Deliverable Name Work Lead Beneficiary Type Dissemination Level Due Date No Package (month) No D1.1 Project guide WP1 1 - MSAE R — Document, report SEN - Sensitive 3 D2.1 Communication and dissemination strategy WP2 1 - MSAE R — Document, report SEN - Sensitive 3 D2.2 Website WP2 1 - MSAE DEC —Websites, patent PU - Public 36 filings, videos, etc D2.3 Mid-term dissemination report WP2 1 - MSAE R — Document, report PU - Public 27 D2.4 Final dissemination report WP2 1 - MSAE R — Document, report PU - Public 36 D3.1 Evaluation plan WP3 1 - MSAE R — Document, report PU - Public 5 D3.2 Mid-term evaluation report WP3 1 - MSAE R — Document, report PU - Public 24 D3.3 Final evaluation report WP3 1 - MSAE R — Document, report PU - Public 36 D3.4 Specific action-level indicators WP3 1 - MSAE R — Document, report SEN - Sensitive 36 D4.1 Sustainability report WP4 1 - MSAE R — Document, report PU - Public 36 D5.1 Catalogue of datasets WP5 1 - TEHIK DATA — data sets, PU - Public 36 microdata, etc D6.1 Proposal and action plan for development, WP6 1 - MSAE R — Document, report SEN - Sensitive 36 deployment and sustainability 13 Project: 101129188 — EST2EHDS — EU4H-2022-DGA-MS-IBA2 Associated with document Ref. Ares(2023)7314945 - 26/10/2023 Deliverables Grant Preparation (Deliverables screen) — Enter the info. The labels used mean: Public — fully open ( automatically posted online) Sensitive — limited under the conditions of the Grant Agreement EU classified —RESTREINT-UE/EU-RESTRICTED, CONFIDENTIEL-UE/EU-CONFIDENTIAL, SECRET-UE/EU-SECRET under Decision 2015/444 Deliverable Deliverable Name Work Lead Beneficiary Type Dissemination Level Due Date No Package (month) No D7.1 Proposal and action plan for secure WP7 1 - MSAE R — Document, report SEN - Sensitive 36 processing environments D8.1 Proposal and action plan for cross-border WP8 1 - MSAE R — Document, report SEN - Sensitive 36 gateway D9.1 Data Quality Framework for secondary use WP9 1 - TEHIK R — Document, report SEN - Sensitive 36 of health data 14 Project: 101129188 — EST2EHDS — EU4H-2022-DGA-MS-IBA2 Associated with document Ref. Ares(2023)7314945 - 26/10/2023 Deliverable D1.1 – Project guide Deliverable Number D1.1 Lead Beneficiary 1. MSAE Deliverable Name Project guide Type R — Document, report Dissemination Level SEN - Sensitive Due Date (month) 3 Work Package No WP1 Description Project guide will describe the operational management procedure. Sensitive due to internal management guidelines. Deliverable D2.1 – Communication and dissemination strategy Deliverable Number D2.1 Lead Beneficiary 1. MSAE Deliverable Name Communication and dissemination strategy Type R — Document, report Dissemination Level SEN - Sensitive Due Date (month) 3 Work Package No WP2 Description The strategy will define specific communication and dissemination activities, key stakeholders, their main topics and means to reach them. Sensitive due to internal management guidelines. Deliverable D2.2 – Website Deliverable Number D2.2 Lead Beneficiary 1. MSAE Deliverable Name Website Type DEC —Websites, patent Dissemination Level PU - Public filings, videos, etc Due Date (month) 36 Work Package No WP2 Description Website dedicated to the project is accessible to the public. Deliverable D2.3 – Mid-term dissemination report Deliverable Number D2.3 Lead Beneficiary 1. MSAE Deliverable Name Mid-term dissemination report Type R — Document, report Dissemination Level PU - Public Due Date (month) 27 Work Package No WP2 Description Written dissemination report in English. 15 Project: 101129188 — EST2EHDS — EU4H-2022-DGA-MS-IBA2 Associated with document Ref. Ares(2023)7314945 - 26/10/2023 Deliverable D2.4 – Final dissemination report Deliverable Number D2.4 Lead Beneficiary 1. MSAE Deliverable Name Final dissemination report Type R — Document, report Dissemination Level PU - Public Due Date (month) 36 Work Package No WP2 Description Written dissemination report in English. Deliverable D3.1 – Evaluation plan Deliverable Number D3.1 Lead Beneficiary 1. MSAE Deliverable Name Evaluation plan Type R — Document, report Dissemination Level PU - Public Due Date (month) 5 Work Package No WP3 Description Written plan in English. Deliverable D3.2 – Mid-term evaluation report Deliverable Number D3.2 Lead Beneficiary 1. MSAE Deliverable Name Mid-term evaluation report Type R — Document, report Dissemination Level PU - Public Due Date (month) 24 Work Package No WP3 Description Written report in English. Deliverable D3.3 – Final evaluation report Deliverable Number D3.3 Lead Beneficiary 1. MSAE Deliverable Name Final evaluation report Type R — Document, report Dissemination Level PU - Public Due Date (month) 36 Work Package No WP3 Description Written report in English. 16 Project: 101129188 — EST2EHDS — EU4H-2022-DGA-MS-IBA2 Associated with document Ref. Ares(2023)7314945 - 26/10/2023 Deliverable D3.4 – Specific action-level indicators Deliverable Number D3.4 Lead Beneficiary 1. MSAE Deliverable Name Specific action-level indicators Type R — Document, report Dissemination Level SEN - Sensitive Due Date (month) 36 Work Package No WP3 Description Report on specific action-level indicators, as defined in the call document. Sensitive due to internal management guidelines. Deliverable D4.1 – Sustainability report Deliverable Number D4.1 Lead Beneficiary 1. MSAE Deliverable Name Sustainability report Type R — Document, report Dissemination Level PU - Public Due Date (month) 36 Work Package No WP4 Description Final sustainability report at the EU level. Deliverable D5.1 – Catalogue of datasets Deliverable Number D5.1 Lead Beneficiary 1. TEHIK Deliverable Name Catalogue of datasets Type DATA — data sets, Dissemination Level PU - Public microdata, etc Due Date (month) 36 Work Package No WP5 Description National catalogue of datasets available Deliverable D6.1 – Proposal and action plan for development, deployment and sustainability Deliverable Number D6.1 Lead Beneficiary 1. MSAE Deliverable Name Proposal and action plan for development, deployment and sustainability Type R — Document, report Dissemination Level SEN - Sensitive Due Date (month) 36 Work Package No WP6 Description Written proposal in Estonian, with abstract in English. Sensitive due to internal management guidelines. 17 Project: 101129188 — EST2EHDS — EU4H-2022-DGA-MS-IBA2 Associated with document Ref. Ares(2023)7314945 - 26/10/2023 Deliverable D7.1 – Proposal and action plan for secure processing environments Deliverable Number D7.1 Lead Beneficiary 1. MSAE Deliverable Name Proposal and action plan for secure processing environments Type R — Document, report Dissemination Level SEN - Sensitive Due Date (month) 36 Work Package No WP7 Description Written proposal in Estonian, with abstract in English. Sensitive due to internal management guidelines. Deliverable D8.1 – Proposal and action plan for cross-border gateway Deliverable Number D8.1 Lead Beneficiary 1. MSAE Deliverable Name Proposal and action plan for cross-border gateway Type R — Document, report Dissemination Level SEN - Sensitive Due Date (month) 36 Work Package No WP8 Description Written proposal in Estonian, with abstract in English Sensitive due to internal management guidelines. Deliverable D9.1 – Data Quality Framework for secondary use of health data Deliverable Number D9.1 Lead Beneficiary 1. TEHIK Deliverable Name Data Quality Framework for secondary use of health data Type R — Document, report Dissemination Level SEN - Sensitive Due Date (month) 36 Work Package No WP9 Description Data Quality Framework for secondary use of health data available. Written in Estonian. Sensitive due to internal management guidelines. 18 Project: 101129188 — EST2EHDS — EU4H-2022-DGA-MS-IBA2 Associated with document Ref. Ares(2023)7314945 - 26/10/2023 LIST OF MILESTONES Milestones Grant Preparation (Milestones screen) — Enter the info. Milestone Milestone Name Work Package No Lead Beneficiary Means of Verification Due Date No (month) 1 Kick-off meeting – fixed date and agenda WP1 1-MSAE Definition of the date and agenda of a meeting 1 aimed at launching the project. Date and agenda of the kick-off meeting fixed 2 Kick-off meeting WP2 1-MSAE Official start of the project. Meeting takes place 1 3 Event calendar WP2 1-MSAE Plan the events, including opening and closing 4 events, dialogues, community meetings. Event calendar published 4 Draft evaluation plan available WP3 1-MSAE The evaluation plan with indicators for the project 3 and each WP will be available for the consortium, EC and public. The evaluation plan has been submitted to the Portal 5 Draft mid-term evaluation report is available WP3 1-MSAE The evaluation report with assessment of the 20 project and each WP will be available for the consortium, EC and public. Evaluation plan has been presented in the Consortium 6 Draft final evaluation report available WP3 1-MSAE The evaluation report with the final assessment of 33 the project and each WP will be available for the consortium, EC and public. The evaluation plan has been submitted in the portal. 7 First sustainability plan WP4 1-MSAE First sustainability plan. First sustainability plan 18 delivered 8 Analysis for setting up national dataset WP5 1-TEHIK AS-IS description as well as proposed best ways 5 catalogue to set up the national dataset catalogue and required tasks. Analysis done 9 Catalogue of datasets WP5 1-TEHIK A publicly available catalogue of national 36 19 Project: 101129188 — EST2EHDS — EU4H-2022-DGA-MS-IBA2 Associated with document Ref. Ares(2023)7314945 - 26/10/2023 Milestones Grant Preparation (Milestones screen) — Enter the info. Milestone Milestone Name Work Package No Lead Beneficiary Means of Verification Due Date No (month) datasets including tools and descriptions to facilitate their discovery and use for secondary use. A catalogue of national datasets including tools and descriptions to facilitate their discovery and use for secondary use is publicily available 10 Development plan for national data access WP6 1-MSAE Based on analysis, a development plan for 30 application management system management system to record and process data access applications, issue data permits, and reply to data access applications made by data users. Development plan available 11 Proposal for a secure processing environment WP7 1-MSAE Based on the analysis, a proposal for a 36 secure processing environment infrastructure to provide a secure, privacy-preserving processing environment as a service to data users. Proposal available 12 Development plan WP8 1-MSAE Development plan based on analysis on how to 36 best set up the digital gateway for cross-border services and infrastructures. Analysis done and Development plan available 13 Data quality assessment WP9 1-TEHIK AS-IS data quality assessment. Data quality 18 assessment done 14 Data quality improvement tools implemented WP9 1-TEHIK Tools to monitor, report and track fixing data 36 quality problems implemented. Activities to improve data quality concluded. Data quality improvement tools implemented 20 Project: 101129188 — EST2EHDS — EU4H-2022-DGA-MS-IBA2 Associated with document Ref. Ares(2023)7314945 - 26/10/2023 LIST OF CRITICAL RISKS Critical risks & risk management strategy Grant Preparation (Critical Risks screen) — Enter the info. Risk Description Work Package Proposed Mitigation Measures number No(s) 1 Inappropriate connection to national infrastructure WP5 Ensuring appropriate set-up of HDAB (technical, semantic, organisational) and set up/ deployment of national health data access bodies 2 Difficulties amending national legislation to enable WP1, WP5 Implement measure to allow legal convergence the access to health data by data users and availability of datasets 3 Multiple health datasets catalogue exist and are not WP5 Harmonize standards and practices and federate existing dataset catalogues linked 4 National dataset catalogues description are not WP5 Internal and external controls on submission, approval and maintenance of datasets publicly available descriptions 5 Poor data discovery and data user knowledge of the WP5 Enable data discovery to allow data users to find suitable data through promotion and existence of the infrastructure communication activities 6 Burdensome and complicated submission of data WP6 Focusing on ensuring smooth IT access access applications 7 Burdensome and inefficient handling of data access WP6 Focusing on sufficient labour capacity and workforce as well as IT infrastructural applications (national and EU level) and issuance development to process data requests of data permits to data users/authorization of data requests 8 Irregular and inconsistent connection/interface WP5 Sufficient effort on creating a consistent connection between data users and data holders/health data access bodies 9 Health data access body does not set up a secure WP7 The deliverable of this project is an analysis, proposal and action plan for setting up a secure processing environment (art 50) processing environment. 21 Project: 101129188 — EST2EHDS — EU4H-2022-DGA-MS-IBA2 Associated with document Ref. Ares(2023)7314945 - 26/10/2023 Critical risks & risk management strategy Grant Preparation (Critical Risks screen) — Enter the info. Risk Description Work Package Proposed Mitigation Measures number No(s) This should follow guidelines and security checks, cybersecurity rules on appropriate secure environments 10 Difficulties in (up)loading data in the secure WP7 Dissemination plan in place as well as a proposal for the set up of seamless connections processing environment by the data holders 11 Health data access body does not ensure smooth WP6 Following the guidance to ensure smooth access. extraction and access to requested electronic health data indicated in the data access application by the data user and in line with the data permit granted (art 44) 12 Disrespect of privacy of natural persons and WP6 Focusing on protecting the privacy and correct procedures incorrect anonymization of electronic health data devoid of personal data by data holders 13 Risk of re-identification of natural persons from the WP5 Sufficient data protection measures in place dataset provided 14 Risk of storage of electronic health data for a longer WP5 Controls and specific guidelines in place period of time exceeding the initial 5 years allowed by data permits 15 Risk of the unauthorised reading, copying, WP7 Controls and specific guidelines in place modification or removal of electronic health data hosted in the secure processing environment through state-of-the-art technological means 16 Risk of not fully achieving the objectives of the WP1 Controls before and during the implementation of the projects: grant agreement and regulation due to insufficient uptake or quality/delays in the implementation of the Controlling the project management system to fulfil the policy objectives, ensuring a selected projects or contracts systematic involvement of all actors, establishing a regular project management reporting complemented by on-site-visits on a case-by-case basis, including risk reports to senior management, as well as maintaining appropriate budgetary flexibility. 22 Project: 101129188 — EST2EHDS — EU4H-2022-DGA-MS-IBA2 Associated with document Ref. Ares(2023)7314945 - 26/10/2023 Critical risks & risk management strategy Grant Preparation (Critical Risks screen) — Enter the info. Risk Description Work Package Proposed Mitigation Measures number No(s) Basing the model grant agreements and service contracts on the model provided by the Commission. Mandatory signature of all staff members involved in the management of the grant agreements/contracts to the code of good administrative behaviour; staff attendance regular training; and use of networks to exchange best practices. Control of the project technical implementation and contractors'/beneficiaries' meetings and case by case on-site-visits. Controls at the end of the project: Performing ex-post audits on a sample of transactions to verify on-the-spot the eligibility of cost claims to prevent, detect and correct material errors. 17 Risk of inefficient or non-economic use of funds WP1 The existing control system proved to be able to prevent and/or to detect errors and/or awarded, both for grants due to complexity of irregularities, and in case of errors or irregularities, to correct them. It will be adapted to funding rules include the new actions and to ensure that residual error rates (after correction) remain below the threshold of 2%. 18 Risk of fraud or criminal activities due to partial WP1 Control system in place, described in project management and evaluation part. assurance from the third parties' internal control systems due to the large number of heterogeneous contractors and beneficiaries, each operating their own control system 23 Project 101129188 - EST2EHDS - EU4H-2022-DGA-MS-IBA2 Associated with document Ref. Ares(2023)7314945 - 26/10/2023 EU Grants: Description of the action (DoA) — Annex 1 DESCRIPTION OF THE ACTION (PART B) COVER PAGE PROJECT Project name: [Estonia towards EHDS for secondary use of health data] EU4Health Programme (EU4H) Application proposal for Direct Grant to Member States’ authorities, Ministry of Social Affairs of Estonia Project acronym: [EST2EHDS] EU4H-2022-DGA-MS-IBA-4 (DI-g-22-22.01) Coordinator contact: Jaanika Merilo, Ministry of Social Affairs TABLE OF CONTENTS DESCRIPTION OF THE ACTION ................................................................................................................................... 1 (PART B) ........................................................................................................................................................................ 1 COVER PAGE ............................................................................................................................................................. 1 1. RELEVANCE ........................................................................................................................................................... 2 1.1 Background and general objectives .................................................................................................................... 2 1.2 Needs analysis and specific objectives ............................................................................................................... 2 1.3 Complementarity with other actions and innovation — European added value .................................................... 6 2. QUALITY ................................................................................................................................................................. 7 2.1 Concept and methodology .................................................................................................................................. 7 2.2 Consortium set-up............................................................................................................................................... 8 2.3 Project teams, staff and experts .......................................................................................................................... 8 2.4 Consortium management and decision-making................................................................................................. 10 2.5 Project management, quality assurance and monitoring and evaluation strategy .............................................. 10 2.6 Cost effectiveness and financial management .................................................................................................. 11 3. IMPACT ................................................................................................................................................................. 12 3.1 Impact and ambition .......................................................................................................................................... 12 3.2 Communication, dissemination and visibility...................................................................................................... 12 3.3 Sustainability and continuation .......................................................................................................................... 13 4. WORKPLAN, SUBCONTRACTING AND TIMING ................................................................................................. 15 4.1 Work plan ......................................................................................................................................................... 15 Subcontracting ................................................................................................................................................. 16 Timetable ......................................................................................................................................................... 19 5. OTHER .................................................................................................................................................................. 24 5.1 Ethics ................................................................................................................................................................ 24 5.2 Security............................................................................................................................................................. 24 6. DECLARATIONS ................................................................................................................................................... 24 #@APP-FORM-EU4H@# #@PRJ-SUM-PS@# [This document is tagged. Do not delete the tags; they are needed for the processing.] 1 Project 101129188 - EST2EHDS - EU4H-2022-DGA-MS-IBA2 Associated with document Ref. Ares(2023)7314945 - 26/10/2023 EU Grants: Description of the action (DoA) — Annex 1 1. RELEVANCE 1.1 Background and general objectives Background and general objectives Describe the background and rationale of the project. How is the project relevant to the scope of the call? How does the project address the general objectives of the call? What is the project’s contribution to the priorities of the call? In the Data Governance Act, under the Article 7, a provision for bodies to support the re-use of protected public sector data is set out. This is personal data or commercially sensitive and the proposed European Health Data Space (EHDS) will build upon this, extending this function for health. Several Member States have set up health competent data access bodies, while other Member States aim to set up such structures. Health data access bodies aim to provide core services for a common ICT infrastructure and crosscutting services such as terminology, interoperability, etc. This project supports The Eu4Health Programme, which aims to strengthen the national health system through improved health data use and re-use, development of digital tools and services, digital transformation of healthcare; enhancing access to healthcare; developing and implementing EU health legislation and evidence-based decision making; and integrated work among Member States' health systems. In the specific case of Estonia, there is a need to support and promote the establishment of the national health data access body, Health and Welfare Information Systems Center (TEHIK), by expanding its minimum business capabilities, establishing its connection with HealthData@EU and related services for the development of the EHDS for secondary uses of health data. In this context, the general objective of this project is to Estonia to establish and deploy services for a health data access body, including its minimum business capabilities, and to provide a best way to set up cross-border connections to the large-scale deployment of HealthData@EU, on the basis of the work conducted by the joint action ‘Towards the European Health Data Space’ (TEHDaS), and on the outcomes of the pilot project for the EHDS infrastructure based on 5 use cases that will run from 2022-2024 to test the setting up of a European network for secondary uses of data. The contribution of this action to the priorities of the call is that it supports the establishment and capabilities enlargement and alignment with EU standards of national health data access bodies and related services and infrastructures across the EU. The action will also consider requirements of specific areas of health data, including those linked to quality of health data and for statistical purposes, as part of the data and infrastructure ecosystem of the planned EHDS for secondary uses of health data. Additionally, this project complements Estonia’s efforts to expand the health data sharing services to patients provided by MyHealth@EU for ensuring the continuity of care for people/individuals while they are travelling abroad in the Union in the pillar of primary use of health data of the European Health Data Space. 1.2 Needs analysis and specific objectives Needs analysis and specific objectives Describe how the objectives of the project are based on a sound needs analysis in line with the specific objectives of the call. What issue/challenge/gap does the project aim to address? The objectives should be clear, measureable, realistic and achievable within the duration of the project. For each objective, define appropriate indicators for measuring achievement (including a unit of measurement, baseline value and target value). Owing to the insufficient level of connection and persisting fragmentation on health data legislation in Europe evidenced by the impact assessment conducted on the policy options for the EHDS and evaluation of Article 14 of the Directive 2011/24/EU on cross-border healthcare, the main objective of this application is to support Estonia’s efforts to establish a health data access body including to be part of a secure peer- to-peer infrastructure to foster secondary use of health data. 2 Project 101129188 - EST2EHDS - EU4H-2022-DGA-MS-IBA2 Associated with document Ref. Ares(2023)7314945 - 26/10/2023 EU Grants: Description of the action (DoA) — Annex 1 To ensure a consistent roll-out of health data access bodies and associated infrastructures in the context of the EHDS, this action shall be consistent with and will build as much as possible on the ongoing cooperation in the joint action ‘Towards the European Health Data Space’ (TEHDaS), the pilot for the EHDS infrastructure for secondary uses and the proposed EHDS legislation. The specific objectives, milestones and indicators of the project are laid out below. Due to limited resources for the upcoming years and the specific need to comprehensively analyse the existing national infrastructures and national authorities’ competences and capabilities, the objective of this proposal can focus on fully implementing only some of the proposed business capabilities. We find the best way to ensure the establishment of national health data access body and connecting to EHDS is to set up national services and infrastructures as described in detail below but conduct a detailed analysis for the other business capabilities. This ensures the best possible use of resources nationally and EU level. Based on the results of the analyses we aim to achieve the business capabilities in cooperation with other national authorities, who are not part of this consortium. Since the analyses results are supposed to give an overview of the state entities involved and the planned cost structure, we are not able to point out specific tasks to achieve all business capabilities proposed in the call. Developments in the European Health Data Space require us to share health data across Europe. For this, it is necessary to completely restructure the data release process, as well as develop a very large and very secure data distribution environment (we are not sure that the X-road we have developed so far can fully do this). We also have a problem with data quality in Estonia, because through years, data exchange has been built through different partners, and that is where the biggest inconsistency in quality comes from. With this project we wish to ensure data integrity regardless of the standard/structure in use. Therefore, within the framework of this project, we focus on the basic pillar - data quality, and analyze how much we need to develop or restructure processes to fully ensure the health data space, which requires the involvement of a very large project team. SPECIFIC OBJECTIVES This proposal’s general objective will be pursued through the completion of the following specific objectives during the project duration of 36 months: O.1 Setting up national services and infrastructures: setting up functional health data access body and providing services and infrastructures to allow the interaction between health data access body, data holders, and data users. The services and infrastructures shall allow: a) health data access body to receive, process and reply to data access applications (Note: Analysis and proposal including action plan for setting up data access application management system is in the scope of this proposal. This is due to comprehensive analysis needed to successfully set up and implement the system on national level, including all stakeholders with different roles. For the best value for money, implementation of the actions proposed in the plan will be carried out outside this project). b) provide access to data users to discoverable and accessible catalogues of metadata health datasets; c) provide a metadatabase accessible to data users, facilitating the transition from document-based to more granular data exchange. d) and provide the best way to implement secure processing environments on national level (Note: Analysis and proposal including action plan for setting up secure processing environments is in the scope of this proposal. This is due to comprehensive analysis needed to successfully set up and implement the system on national level, including all stakeholders with different roles. For the best value for money and to fully implement some of the business capabilities, implementation of the actions proposed in the plan will be carried out outside this project). O.2 Proposing a best way to setting up cross-border services and infrastructures: analysis and proposal for setting up a digital gateway for the health data access body to participate in the cross-border infrastructure for secondary uses of health data (HealthData@EU), when it becomes available, by ensuring: a) the connection of the health data access body to entities authorised to participate in the infrastructure for secondary uses of health data across borders; b) the connection of the health data access body to the central services provided by the Commission. Analysis and proposal including action plan for cross-border services is in the scope of this proposal. This is due to comprehensive analysis needed to successfully set up and implement the system and including all stakeholders with different roles both on national level and cross- 3 Project 101129188 - EST2EHDS - EU4H-2022-DGA-MS-IBA2 Associated with document Ref. Ares(2023)7314945 - 26/10/2023 EU Grants: Description of the action (DoA) — Annex 1 border. For the best value for money and to fully implement some of the business capabilities, implementation of the actions proposed in the plan will be carried out outside this project. O.3 Enhancing data quality: provide support and tools to enhance the quality of the health data made available by data holders to the health data access body and to ensure that the data available is semantically and technically interoperable between health data access bodies and data holders. a) Developing and implementing Data Quality Framework (in accordance with TEHDAS recommendations) for secondary use of health data. b) Choosing and implementing tools to monitor, report and track fixing data quality problems. c) Describing data descriptions, codesystems, valuesets and, dataset rules in the information systems of the Ministry of Social Affairs on a common basis to ensure data quality at the point of data creation. MILESTONES In terms of specific mandatory milestones, at the end of the project’s implementation period, health data access bodies are expected to have in place appropriate infrastructure for secondary uses of health data, including the following four business digital capabilities. 1. M.1 Proposal for a management system to record and process data access applications, issue data permits, and reply to data access applications made by data users; 2. M.2 publicly available catalogue of national datasets including tools and descriptions to facilitate their discovery and use for secondary use; 3. M.3 proposal for a secure processing environment infrastructure to provide a secure, privacy-preserving processing environment as a service to data users; 4. M.4 proposal for a digital gateway to connect with other authorised participants and with the core services of the EHDS infrastructure for secondary uses of health data (HealthData@EU). In addition, at the end of the project’s implementation period, health data access body is expected to have developed Data Quality Improvement Framework based on TEHDaS project results and implemented tools for monitoring and enhancing data quality (M.5). INDICATORS The achievement of the objectives and milestones defined above will be measured with the following action-level indicators: O.1 # Indicator Baseline Target YES, ONE, with publicly available catalogue of national datasets including tools and descriptions to facilitate their discovery Health data access bodies (HDAB) established and use for secondary 1 NO (and number of them) use; with data quality monitoring and improvement tools; and description and action plan for implementing the rest of the common business capabilities. 4 Project 101129188 - EST2EHDS - EU4H-2022-DGA-MS-IBA2 Associated with document Ref. Ares(2023)7314945 - 26/10/2023 EU Grants: Description of the action (DoA) — Annex 1 YES, an action plan based on the analysis will describe the steps Is the HDAB able to receive, process and reply that need to be taken to 2 to national data access applications, and to NO set up the data access issue data permits management system. Until then, this is done by issuing cleaned, analysed data. TBD in AS-IS analysis, TBD in TO-BE Number of data access applications that the reported analysis, reported 3 HDAB can receive, process and reply per during during regular reporting month regular activities reporting activities TBD in AS-IS analysis, < 2 months. Further reported discussed in TO-BE Average time to process a data access 4 during analysis, reported application regular during regular reporting reporting activities activities YES and publicly 5 Is there a health dataset catalogue available? NO available Number of datasets published in the dataset YES, >10 datasets 6 NO catalogue published Do the datasets contain a description of the YES and in a common 7 NO contents? format After the analysis Is the HDAB able to provide a secure 8 NO results have been processing environment to data users? implemented Average time to set up a secure processing 9 - < 1 month environment O.2 # Indicator Baseline Target YES, after the Is the HDAB connected to the HealthData@EU implementation of 10 NO infrastructure?; proposal and action plan. YES, after the implementation of proposal and action Is the HDAB able to receive, process and reply plan for setting up 11 to cross-border data access applications, and NO cross-border to issue data permits gateway.The capacity to answer to multi- country requests too 5 Project 101129188 - EST2EHDS - EU4H-2022-DGA-MS-IBA2 Associated with document Ref. Ares(2023)7314945 - 26/10/2023 EU Grants: Description of the action (DoA) — Annex 1 Number of cross-border health data access Depending on the 12 applications that the HDAB can receive, 0 analysis results process and reply per month O.3 # Indicator Baseline Target Yes, data exchange validation tools; 13 List of tools available for enhancing data quality NO secondary use of data validation tools YES, also cross-border Are the datasets semantically and technically 14 NO and following a interoperable? common format These measurements will be collected regularly from health data access bodies and reported during their annual reporting activity. The project will report on the latest version of indicators for health data access bodies and the other action-level indicators specified in the call document. #@COM-PLE-CP@# 1.3 Complementarity with other actions and innovation — European added value Complementarity with other actions and innovation Explain how the project builds on the results of past activities carried out in the field and describe its innovative aspects. Explain how the activities are complementary to other activities carried out by other organisations. Illustrate the European dimension of the activities: trans-national dimension of the project; impact/interest for a number of EU countries; possibility to use the results in other countries, potential to develop mutual trust/cross-border cooperation among EU countries, etc. Which countries will benefit from the project (directly and indirectly)? Where will the activities take place? The evaluation of Article 14 of the Directive 2011/24/EU on cross-border healthcare indicated that progress in cross-border exchange of health data and interoperability is lagging. Currently, the level of utilisation of health data for secondary uses and comparison across Member States by data users is limited and a common EU-level infrastructure/framework for the secondary use of health data inexistent. In Estonia there are substantial national challenges to interoperability and data portability, hampering continuity of care and efficiency of healthcare systems. Therefore, action at national level has only limited scope and does not fully address the EU-wide issue. Estonia faces challenges regarding the reuse of health data, including within and across national borders: a) Lack of interoperability between data holders; b) Lack of the necessary technical infrastructures for enabling re-use of health data; c) Lack of a common mechanism for receiving, processing and replying to health data access applications. These challenges justify action at European level to reduce legal diversity and boost secondary use of health data. The innovative aspect of the EHDS Regulation is the deployment of an IT infrastructure and network to allow the secondary use of health data for researchers, innovators, regulators and policy makers in a trusted and secure way that preserves privacy. Therefore, this project aims to fulfil the objective set out in the Regulation. Ultimately, this generates a European Union added value of increasing the potential for use of health data and effectiveness of measures since a common legal basis for secondary use of health data will yield efficiency gains for data users in the area of health and benefits for European citizens. In the long run, the establishment of health data access bodies and a common governance framework covering secondary uses of health data will facilitate coordination and cross- border and mutual trust. The setting up of health data access bodies will also allow to foster cooperation with data users from third countries. 6 Project 101129188 - EST2EHDS - EU4H-2022-DGA-MS-IBA2 Associated with document Ref. Ares(2023)7314945 - 26/10/2023 EU Grants: Description of the action (DoA) — Annex 1 To ensure a consistent rollout of health data access bodies and associated infrastructures in the context of the EHDS, this action and related activities are consistent with and build on the ongoing cooperation and recommendations of the joint action ‘Towards the European Health Data Space’ (TEHDaS), the results of the 2022-2024 pilot project for the EHDS infrastructure for secondary uses on five use cases and the proposed EHDS legislation. The efforts towards the deployment of an infrastructure for secondary use will also complement other health actions at European level, such as efforts towards the attainment of the Europe Beating Cancer Plan and other priorities in the EU4Health programme. The activities set out in this application form will take place in Estonia. This action will complement the services, infrastructures and activities that have been/are being developed and have been carried out/are being carried out at the national level. #§COM-PLE-CP§# #§PRJ-OBJ-PO§# #§REL-EVA-RE§# #@QUA-LIT-QL@# #@CON-MET-CM@# 2. QUALITY 2.1 Concept and methodology Concept and methodology Outline the approach and methodology behind the project. Explain why they are the most suitable for achieving the project’s objectives. The approach used for this project consists of three different parts that are relevant for achieving each business capability. As a baseline, a self-assessment on the status of the current business capability will be done. For each business capability, the first action is to conduct an analysis on how to best achieve the mandatory deliverables and how to design the set up of specific actions and tasks. The “AS-IS” situation is analysed and “TO-BE” described. Assessment of the gap is done and a feasible action plan will be developed. This is seen as the key part of the project, since it has to take into account the national and EU level stakeholders, legislation, existing infrastructure and the results of currently ongoing projects, joint action ‘Towards the European Health Data Space’ (TEHDaS), the pilot for the EHDS infrastructure for secondary uses and the proposed EHDS legislation. The second action consists of development of the solution(s) and testing. Development is done based on the analysis and specific goals. Monitoring of following the plan will be done regulary and the success will be assessed. Testing is a key part behind the project methodology, as it is the phase where following actions can be fine-tuned to result in best possible outcome. Third action consists of deployment and operation, which, as a result of comprehensive analysis and design as well as high-quality development and testing, is expected to be executed as planned. This also includes the sustainability planning, which will ensure the continuity of work towards EHDS. The aforementioned approach chosen for this project is expected to ensure that the allocation of resources is done in the best way for Estonia and EU. Focusing on the comprehensive analysis first will give the project team a valuable insight on how to get the best results and cooperate on national and EU level. The evaluation of the project is done following the specific indicators and methodology that will be specified in the analyses. This will include the regular evaluation of the quality and the effectiveness of the actions and mechanisms put in place by the project. WP3 will focus on evaluation of the project, throughout all work packages and tasks described in this proposal. The project managers involved in this project will ensure a sustainable and comprehensive overview of all the action tasks, the MoSA project manager will focus on managing the project in general as well as the WP-s 6-8, which will result in national level proposal and action plan for setting up national data access management system, secure processing environment and cross-border gateway. Since Estonia has many different national entities that may be incluced in achieving those aforementioned business capabilities in most efficient way, the methodology behind the project has to support focusing on the analysis and action plan first. 7 Project 101129188 - EST2EHDS - EU4H-2022-DGA-MS-IBA2 Associated with document Ref. Ares(2023)7314945 - 26/10/2023 EU Grants: Description of the action (DoA) — Annex 1 The project manager from TEHIK will ensure the technical tasks to be carried out according to common national best practices but also giving insight to the analyses, having a constant overview of how the projects technical tasks are moving towards the aim of the whole project. #§CON-MET-CM§# #@CON-SOR-CS@# 2.2 Consortium set-up Consortium cooperation and division of roles (if applicable) Describe the participants (Beneficiaries, Affiliated Entities and Associated Partners, if any) and explain how they will work together to implement the project. How will they bring together the necessary expertise? How will they complement each other? In what way does each of the participants contribute to the project? Show that each has a valid role and adequate resources to fulfil that role. Note: When building your consortium you should think of organisations that can help you reach objectives and solve problems. The Estonia’s application is composed by several participants, enabling the Health Data Access Body to be complemented by its partners’ expertise to ensure the necessary competence and capacity to deliver on the expected responsibilities: HDAB function: Health and Welfare Information Systems Centre (TEHIK) will be appointed as the Health Data Access Body since it has the resources, capabilities and competencies to fill this role. There is yet to be a formal regulation for the HDAB appointment, as detailed analyses of TEHIK as the HDAB, TEHIK´s internal roles and action plans, shall be conducted within the scope of this project. HDAB will focus on deploying services to facilitate the secondary use of health data, to ensure readiness to participate in cross-border exchange and reuse of health data. Other participants: Ministry of Social Affairs will coordinate the project in general as well as administrative WP-s 1-4 and WP-s 6-8, which are analyses and propose the best way to set up specific environments described in those WP-s. Beneficiary: Ministry of Social Affairs (MoSA/MSAE) Affiliated Entity: Health and Welfare Information Systems Centre (TEHIK). MoSA and TEHIK have the know-how, qualifications and resources to successfully implement the project and contribute their share. 2.3 Project teams, staff and experts Project teams and staff Describe the project teams and how they will work together to implement the project. List the staff included in the project budget (budget category A) by function/profile (e.g. project manager, senior expert/, junior expert, trainers/teachers, technical personnel, administrative personnel etc. — use the same profiles as in the detailed budget table, if any) and describe briefly their tasks. Provide CVs of all key actors (if required). Name and Organisation Role/tasks/professional profile and expertise function Jaanika Merilo Ministry of Role: Project manager (MSAE side) Social Affairs (MSAE) Position: Special Advisor Summary: Jaanika is since March 2023 Special Advisor in Ministry of Social Affairs of Estonia responsible for innovation and international co-operation in eHealth and social services. Jaanika is a representative of Estonia in European Commission workgroup of European Health Data Space and national contact-point in eHealth Network. She is also responsible for international co-operation and projects and co-operation with private sector to support innovation. 8 Project 101129188 - EST2EHDS - EU4H-2022-DGA-MS-IBA2 Associated with document Ref. Ares(2023)7314945 - 26/10/2023 EU Grants: Description of the action (DoA) — Annex 1 E-mail: [email protected] Kerli Linna TEHIK Phone: +37253459132 Position: Head of Data Management Division, Health and Welfare Information Systems Center (TEHIK) Summary: I have been working on semantic interoperability terminolgy and data exchange standards for over 10 years as data management analyst and later on as the head of the team responsible for implementing healthcare terminology and data exchange standards in Estonian National Health Information System. Involvement in working groups and organisations: epSOS and EHDSI eEHRxF and eHAction WP6.1 Common Semantic Strategy WG eHN Subgroup on Semantics SNOMED General Assembly rep for Estonia HL7 Internaional rep for TEHIK as organisational member E-mail: [email protected] Scharlett TEHIK Hansson Phone: +372 7943 900 Position: Product manager/project manager, Health and Welfare Information Systems Center (TEHIK) Summary: The main of the work is to develop and maintain high quality information system, from business analysis to deployment of the systems. Also it entails training of the users and keeping the high data quality inside the systems and data collection. E-mail: [email protected] Jüri Tali TEHIK Phone: +372 5111247 Position: Product manager/project manager, Health and Welfare Information Systems Center (TEHIK) Summary: Software architect/ system engineer; to develop and maintain systems interoperability, also intertwine with new technology platforms and newer practices. E-mail: [email protected] Aivi Saar, Data TEHIK Quality Manager Position: Product manager/project manager, Health and Welfare Information Systems Center (TEHIK) Summary: Senior Expert in Data Quality 9 Project 101129188 - EST2EHDS - EU4H-2022-DGA-MS-IBA2 Associated with document Ref. Ares(2023)7314945 - 26/10/2023 EU Grants: Description of the action (DoA) — Annex 1 Outside resources (subcontracting, seconded staff, etc) If you do not have all skills/resources in-house, describe how you intend to get them (contributions of members, partner organisations, subcontracting, etc.). If there is subcontracting, please also complete the table in section 4. TEHIK and Ministry of Social Affairs do not have the necessary IT development or translation competences in house and thus subcontracting is necessary. This is also how the national IT projects in TEHIK are performed. The procurements are done according to national procurement rules and regulations, which take also into account the best-value-for-money aspect upon choosing the subcontractor. As a small country, the field of secondary health data use is relatively small in Estonia, which is why experts of the field are also scarce. Additional expertise is retrieved from professionals (healthcare service providers and scientists) of the Estonian healthcare field and colleagues from international partner institutions, when necessary. 2.4 Consortium management and decision-making Consortium management and decision-making (if applicable) Explain the management structures and decision-making mechanisms within the consortium. Describe how decisions will be taken and how regular and effective communication will be ensured. Describe methods to ensure planning and control. Note: The concept (including organisational structure and decision-making mechanisms) must be adapted to the complexity and scale of the project. Management structure within consortium The management structure of this project has been designed to best respond the needs to set up HDAB and the connection to EHDS on EU level. Coordination role is fulfilled by MoSA, as well as management of WP-s 1-4 and 6-8. MoSA will ensure the implementation of best practices and suitable policies for sustainable project results and it will respect traditional and accepted project management standards and principles. Each work package and each task planned within each work package has a time schedule which needs close monitoring and careful evaluation, this will be established through and effective internal communication. Management activities are focused not only on executing the project but also for ensuring the sustainability after the project deadline. Decisions will be made after discussion within the consortium and the meeting protocols will be documented and saved. Consortium meetings will be regular, the regularity shall be brought out in detail in the WP1: project management. Since MoSA and TEHIK are located in the same area (capital of Estonia, Tallinn), foreseen are no issues regarding communication, that might arise from travelling costs etc. Communication via e-mail, phone calls, virtual and in-person meetings is expected to be consistent throughough the project period. MoSA project manager will be in charge of creating the project meetings calendar and organizing the planned meetings. The decision-making mechanisms are adapted to the scale of the project, all decisions that are brought out in the WP-s and tasks, are approved by MoSA as well as TEHIK, additional tasks or changes shall be approved by both partners before the work on these tasks shall begin. Financial matters are to be discussed with both partners’ financial departments during the project period. #§CON-SOR-CS§# #@PRJ-MGT-PM@# 2.5 Project management, quality assurance and monitoring and evaluation strategy Project management, quality assurance and monitoring and evaluation strategy Describe the measures planned to ensure that the project implementation is of high quality and completed in time. Describe the methods to ensure good quality, monitoring, planning and control. 10 Project 101129188 - EST2EHDS - EU4H-2022-DGA-MS-IBA2 Associated with document Ref. Ares(2023)7314945 - 26/10/2023 EU Grants: Description of the action (DoA) — Annex 1 Describe the evaluation methods and indicators (quantitative and qualitative) to monitor and verify the outreach and coverage of the activities and results (including unit of measurement, baseline and target values). The indicators proposed to measure progress should be relevant, realistic and measurable. Project management strategy used in this project will be based on PM2 methodology (https://www.pm2alliance.eu/), picture for reference. This methodology describes the lifecycle of a project and tasks included in different phases, as well as overall quality monitoring and evaluation. The project work plan will be composed in the beginning of the project by project managers and it will be followed and updated during the duration of the project. Methods to ensure good quality include consistant monitoring and evaluation, comprehensive analyses and work plan before tasks and compliance with national and EU level guidelines and recommendations. #§PRJ-MGT-PM§# #@FIN-MGT-FM@# 2.6 Cost effectiveness and financial management Cost effectiveness and financial management Describe the measures adopted to ensure that the proposed results and objectives will be achieved in the most cost- effective way. Indicate the arrangements adopted for the financial management of the project and, in particular, how the financial resources will be allocated and managed within the consortium. Do NOT compare and justify the costs of each work package, but summarize briefly why your budget is cost effective. Cost-effectiveness and financial management is the key for the progress of this project. MoSA financial department will be included in coordination of the project and resources. This supports the adequate use of resources. Project coordinators in collaboration with WP leaders will take relevant action for keeping and reporting financial data according to the Grant Agreement and communication means will be used to keep all participators updated. For maximising cost-effectiveness, the financial contributions are carefully communicated, defined and shared. As for the grant amount, the indicative range was exceeded due to the following circumstances. Estonia is a small country with limited resources and so far the processes and infrastructure for secondary use of health data have not fully analysed, standardised or developed. However, we see the opportunity to use the grant resources to develop the needed infrastructure supporting standardised and suitable quality data for secondary use cases. During the project activities we will analyse at the state level, how the process of secondary use of health data should be organised and the need to develop additional secure processing environments or data access bodies. We will also assess the current level of data quality and develop and implement the Data Quality Framework for secondary use of health data to meet the needs of data users. 11 Project 101129188 - EST2EHDS - EU4H-2022-DGA-MS-IBA2 Associated with document Ref. Ares(2023)7314945 - 26/10/2023 EU Grants: Description of the action (DoA) — Annex 1 Due to several different impact factors (such as inflation, increase in the cost of living and the invasion of Russia in Ukraine) the prices of development have also increased. In order to successfully complete the project in 36 months and considering the abovementioned points, the requested grant was raised above the indicative range. #§FIN-MGT-FM§# #@RSK-MGT-RM@# 3. IMPACT 3.1 Impact and ambition Impact and ambition — Progress beyond the state-of-the-art Define the short, medium and long-term effects of the project. Who are the target groups? How will the target groups benefit concretely from the project and what would change for them? Does the project aim to trigger change/innovation? If so, describe them and the degree of ambition (progress beyond the status quo/state-of-the-art). The project effects the following target groups: • T.1 Estonia’s competent authorities (health data access bodies); • T.2 Data users; • T3 Data holders; • T.4 Estonians and all EU citizens. Primarily, Estonia’s competent authorities, that is health data access bodies, are directly impacted by the project implementation in the short term, as they are responsible for enabling the resources necessary to set up and deploy the infrastructure and connect the national health authority bodies. At the same time, governmental bodies are responsible for legal aspects of the project implementation. The national legislation needs to be updated to enable the cross-border exchange of data sets for secondary use, and clarify who will have an access in compliance with the General Data Protection Regulation. Secondly, the project directly affects data users such as researchers, regulators, innovators, and policy makers who will need and request access to health data sets to national health access bodies. They will need to adapt to the new IT tools and procedures in order to access health data sets. Thirdly, the project will also impact data holders in Estonia who control datasets covered by the EHDS legislation. Data holder will need to submit a dataset description and, in some cases, a data quality and utility label for datasets they hold. Moreover, once a permit is issued, they will need to make data identified in this permit available to HDABs. Finally, Estonians and all the European citizens are the indirect project beneficiaries from increased and improved research studies, personalised medicine and targeted policymaking. The ambitiousness of the proposal stems from the deepening of the digital single market and further integration of cross-border rules that will facilitates access to health services and goods. #§IMP-ACT-IA§# #@COM-DIS-VIS-CDV@# 3.2 Communication, dissemination and visibility Communication, dissemination and visibility of funding Describe the communication and dissemination activities which are planned in order to promote the activities/results and maximise the impact (to whom, which format, how many, etc.). Clarify how you will reach the target groups, relevant stakeholders, policymakers and the general public and explain the choice of the dissemination channels. Describe how the visibility of EU funding will be ensured. 12 Project 101129188 - EST2EHDS - EU4H-2022-DGA-MS-IBA2 Associated with document Ref. Ares(2023)7314945 - 26/10/2023 EU Grants: Description of the action (DoA) — Annex 1 The objective of the communication and dissemination activities will be to raise awareness and demand among data users regarding the provision of cross-border access to health data sets and inform citizens on the secondary uses of their heath data and their rights in respect of privacy provisions. Communication activities will entail educational and training initiatives to empower and support the project beneficiaries as well as other Member States entering operation. As detailed in Activity 4 Dissemination, Training and Support, Estonia will put in place and exploit differentiated communication channels: • Project Content Management System; • Project Web Portal, co-ordinated with the Web Portals of the other Member States; • On-line Training Tools; • Social Media and web channels. An overall communication strategy will be defined and as far as possible aligned with the other Member States. Specific communication and educational sessions will be organized in order to inform and train data users and data holders and future members of the health data access bodies. #§COM-DIS-VIS-CDV§# #@SUS-CON-SC@# 3.3 Sustainability and continuation Sustainability, long-term impact and continuation Describe the follow-up of the project after the EU funding ends. How will the project impact be ensured and sustained? What will need to be done? Which parts of the project should be continued or maintained? How will this be achieved? Which resources will be necessary to continue the project? How will the results be used? Are there any possible synergies/complementarities with other (EU funded) activities that can build on the project results? The HealthData@EU cross-border infrastructure for secondary use of health data will enable the public, private, not for profit entities, as well as individual researchers to have access to health data for research, innovation, policy making, educational activities, patient safety, regulatory activities or personalised medicine, in line with the purposes set out in the Regulation. Access to data for secondary use should contribute to the general interest of the society. Activities for which access in the context of the Regulation is lawful may include using the electronic health data for tasks carried out by public bodies, such as exercise of public duty, including public health surveillance, planning and reporting duties, health policy making, ensuring patient safety, quality of care, and the sustainability of health care systems. The provision of the data should also support activities related to scientific research (including private research), development and innovation, producing goods and services for the health or care sectors, such as innovation activities or training of AI algorithms that could protect the health or care of natural persons. In some cases, the information of some natural persons (such as genomic information of natural persons with a certain disease) could support the diagnosis or treatment of other natural persons. This process may require the support of health data access bodies for processing or linking data. Cooperation between Member States’ respective health data access bodies, and with the Commission, will be crucial to achieve a high level of trust and security, enhancing the continuity of the project. The funds will complement other EU funded activities promoted under the umbrella EU4Health programme such as the Europe Beating Cancer Plan. Additional funding is available for Member States under Connecting Europe Facility (CEF), the Digital Europe Programme (DEP), the Recovery and Resilience Facility (RRF), or the European Regional Development Fund (ERDF) to support the development and deployment of the HealthData@EU cross-border infrastructure for secondary use of health data. The proposed action will support the development and maintenance of HDAB business capabilities as described in the work packages. After the development and deployment, the maintenance will be discussed in detail in the sustainability plan, but funding for it will be ensured nationally as it has been previously. #§SUS-CON-SC§# 13 Project 101129188 - EST2EHDS - EU4H-2022-DGA-MS-IBA2 Associated with document Ref. Ares(2023)7314945 - 26/10/2023 EU Grants: Description of the action (DoA) — Annex 1 14 Project 101129188 - EST2EHDS - EU4H-2022-DGA-MS-IBA2 Associated with document Ref. Ares(2023)7314945 - 26/10/2023 EU Grants: Description of the action (DoA) — Annex 1 #@WRK-PLA-WP@# 4. WORKPLAN, SUBCONTRACTING AND TIMING 4.1 Work plan Work plan Provide a brief description of the overall structure of the work plan (list of work packages or graphical presentation (Pert chart or similar)). 15 Project 101129188 - EST2EHDS - EU4H-2022-DGA-MS-IBA2 Associated with document Ref. Ares(2023)7314945 - 26/10/2023 EU Grants: Description of the action (DoA) — Annex 1 The project consists of 4 general WP-s (WP1-WP4) and 5 WP-s (WP5-WP9) for different business capabilities for setting up HDAB and working towards its connection to EHDS. WP1: Project management and coordination WP2: Dissemination WP3: Evaluation WP4: Sustainability WP5: Setting up national dataset catalogue: - Analysis and design - Development and testing - Deployment and Operation WP6: National data access application management system - Analysis and design - Proposal for implementation and action plan WP7: Secure processing environments - Analysis and design - Proposal for implementation and action plan WP8: Cross-border gateway - Analysis and design - Proposal for implementation and action plan WP9: Datasets data quality improvement - Analysis and design - Development and testing - Deployment and Operation Subcontracting Subcontracting Give details on subcontracted project tasks (if any) and explain the reasons why (as opposed to direct implementation by the Beneficiaries/Affiliated Entities). Subcontracting — Subcontracting means the implementation of ‘action tasks’, i.e. specific tasks which are part of the EU grant and are described in Annex 1 of the Grant Agreement. 16 Project 101129188 - EST2EHDS - EU4H-2022-DGA-MS-IBA2 Associated with document Ref. Ares(2023)7314945 - 26/10/2023 EU Grants: Description of the action (DoA) — Annex 1 Note: Subcontracting concerns the outsourcing of a part of the project to a party outside the consortium. It is not simply about purchasing goods or services. We normally expect that the participants have sufficient operational capacity to implement the project activities themselves. Subcontracting should therefore be exceptional. Include only subcontracts that comply with the rules (i.e. best value for money and no conflict of interest; no subcontracting of coordinator tasks). Work Package No Subcontract No Subcontract Description Estimated Costs Justification Best-Value-for-Money (continuous Name (including task number and (EUR) (why is subcontracting (how do you intend to numbering linked to (subcontracted BEN/AE to which it is linked) necessary?) ensure it?) WP) action tasks) WP5 S5.1 IT Development of 517 500 TEHIK and Ministry of The subcontracting will developments environment for managing Social Affairs do not have be made according to classifiers, managing of the necessary IT national procurement OID-s, Data Modelling development or translation rules and regulations, Portal with special competences in house which takes also into functionalities for national and thus subcontracting is account the best-value- health authorities, necessary. This is also for-money aspect upon including licence for how the national IT choosing the terminology server projects in TEHIK are subcontractor performed. The T5.1, linked to AE TEHIK procurements are done according to national procurement rules and regulations. WP5 S5.2 IT Development of 100 000 TEHIK and Ministry of The subcontracting will developments Information Portal Social Affairs do not have be made according to accessible to data users the necessary IT national procurement on national level and development or translation rules and regulations, cross-border, facilitating competences in house which takes also into the transition from and thus subcontracting is account the best-value- document-based to more necessary. This is also for-money aspect upon granular data exchange. how the national IT choosing the projects in TEHIK are subcontractor T5.2 and T5.4 (partly), performed. The linked to AE TEHIK procurements are done according to national procurement rules and regulations. 17 Project 101129188 - EST2EHDS - EU4H-2022-DGA-MS-IBA2 Associated with document Ref. Ares(2023)7314945 - 26/10/2023 EU Grants: Description of the action (DoA) — Annex 1 WP5 S5.3 IT Development for displaying 197 500 TEHIK and Ministry of The subcontracting will developments HIS datasets in HDAB-s Social Affairs do not have be made according to Data Modelling Portal in the necessary IT national procurement non-machine readable development or translation rules and regulations, form, mapping datasets competences in house which takes also into CDA-FHIR and thus subcontracting is account the best-value- necessary. This is also for-money aspect upon T5.3 and T5.4 (partly), how the national IT choosing the linked to AE TEHIK projects in TEHIK are subcontractor performed. The procurements are done according to national procurement rules and regulations. WP6 S6.1 Analysis T6.2, linked to BEN MoSA 100 000 Ministry of Social Affairs The subcontracting will does not have the be made according to necessary competences in national procurement house thus subcontracting rules and regulations, is necessary. which takes also into account the best-value- for-money aspect upon choosing the subcontractor WP7 S7.1 Analysis T7.1 and T7.2, linked to 100 000 Ministry of Social Affairs The subcontracting will BEN MoSA does not have the be made according to necessary competences in national procurement house thus subcontracting rules and regulations, is necessary. which takes also into account the best-value- for-money aspect upon choosing the subcontractor WP8 S8.1 Analysis T8.1 and T8.3, linked to 100 000 Ministry of Social Affairs The subcontracting will BEN MoSA does not have the be made according to necessary competences in national procurement rules and regulations, which takes also into 18 Project 101129188 - EST2EHDS - EU4H-2022-DGA-MS-IBA2 Associated with document Ref. Ares(2023)7314945 - 26/10/2023 EU Grants: Description of the action (DoA) — Annex 1 house thus subcontracting account the best-value- is necessary. for-money aspect upon choosing the subcontractor WP9 S9.1 IT development Development of data 300 000 TEHIK and Ministry of The subcontracting will control module used to Social Affairs do not have be made according to monitor and ensure data the necessary IT national procurement quality. development or translation rules and regulations, competences in house which takes also into T9.4, linked to AE TEHIK and thus subcontracting is account the best-value- necessary. This is also for-money aspect upon how the national IT choosing the projects in TEHIK are subcontractor performed. The procurements are done according to national procurement rules and regulations. Other issues: TEHIK and Ministry of Social Affairs do not have the necessary IT development or translation competences in house and thus subcontracting is necessary. This is also how the national IT projects in TEHIK are If subcontracting for the project goes beyond 30% of the total eligible costs, give specific reasons. performed. The procurements are done according to national procurement rules and regulations. Timetable Timetable (projects of more than 2 years) Fill in cells in beige to show the duration of activities. Repeat lines/columns as necessary. Note: Use actual calendar years and quarters. In the timeline you should indicate the timing of each activity per WP. You may add additional columns if your project is longer than 6 years. YEAR 1 (2023) YEAR 2 (2024) YEAR 3 (2025) YEAR 4 (2026) YEAR 5 YEAR 6 ACTIVITY Q Q Q Q Q Q Q Q Q Q Q Q Q Q Q Q Q Q Q Q Q Q Q Q 1 2 3 4 1 2 3 4 1 2 3 4 1 2 3 4 1 2 3 4 1 2 3 4 19 Project 101129188 - EST2EHDS - EU4H-2022-DGA-MS-IBA2 Associated with document Ref. Ares(2023)7314945 - 26/10/2023 EU Grants: Description of the action (DoA) — Annex 1 Work Package 1: Project management and coordination Task 1.1 - Consortium Operating Procedures Definition Task 1.2 - Coordination of the project management Task 1.3 - Consortium meeting Task 1.4 - Ethical management Task 1.5 - Legal management Work Package 2: Dissemination Task 2.1 - Communication and dissemination Task 2.2 - Visual identity and promotional materials Task 2.3 - Event organisation including stakeholders Task 2.4 - Project Web Portal, co- ordinated with the Web Portals of the other Member States Task 2.5 - On-line training tools Work Package 3: Evaluation 20 Project 101129188 - EST2EHDS - EU4H-2022-DGA-MS-IBA2 Associated with document Ref. Ares(2023)7314945 - 26/10/2023 EU Grants: Description of the action (DoA) — Annex 1 Task 3.1 - Evaluation plan Task 3.2 – Mid-term evaluation report Task 3.3 – Final evaluation report Work Package 4: Sustainability Task 4.1 – Sustainability strategy Work Package 5: Setting up national dataset catalogue Task 5.1 - Describing common ICT infrastructure Task 5.2 - Metadatabase Task 5.3 - Displaying the HIS datasets in machine-readable form in HDAB Task 5.4 - Displaying the HIS datasets in non-machine-readable form in HDAB Work Package 6: National data access application management system T6.1 - AS-IS process analysis on national data access application management 21 Project 101129188 - EST2EHDS - EU4H-2022-DGA-MS-IBA2 Associated with document Ref. Ares(2023)7314945 - 26/10/2023 EU Grants: Description of the action (DoA) — Annex 1 T6.2 - TO-BE analysis and plan for management system Work Package 7: Secure processing environments T7.1 - AS-IS process analysis T7.2 – TO-BE analysis and plan for secure processing environment Work Package 8: Cross-border gateway T8.1 – AS-IS analysis T8.2 - Evaluating HealthData@EU Pilot results T8.3 - TO-BE analysis and proposal Work Package 9: Datasets data quality improvement T9.1 - AS-IS analysis T9.2 - Developing Data Quality Framework for secondary use of health data T9.3 - Implementing Data Quality Framework for secondary use of health data 22 Project 101129188 - EST2EHDS - EU4H-2022-DGA-MS-IBA2 Associated with document Ref. Ares(2023)7314945 - 26/10/2023 EU Grants: Description of the action (DoA) — Annex 1 T9.4 - Choosing and implementing tools to monitor, report and track fixing data quality problems. T9.5 - Monitoring, reporting and fixing data quality problems #§WRK-PLA-WP§# 23 Project 101129188 - EST2EHDS - EU4H-2022-DGA-MS-IBA2 Associated with document Ref. Ares(2023)7314945 - 26/10/2023 EU Grants: Description of the action (DoA) — Annex 1 #@ETH-ICS-EI@# 5. OTHER 5.1 Ethics Ethics If the Call document contains a section on ethics, describe ethics issues that may arise during the project implementation and the measures you intend to take to solve/avoid them. Risk of re-identification of natural persons from the dataset provided Risk of storage of electronic health data for a longer period of time exceeding the initial 5 years allowed by data permits Risk of the unauthorised reading, copying, modification or removal of electronic health data hosted in the secure processing environment through state-of-the-art technological means. Ethics issues are described in more detail in the ethics management plan under WP1, the measures intended to take to solve or avoid the issues, are also described in the plan. #§ETH-ICS-EI§# #@SEC-URI-SU@# 5.2 Security Security If the Call document contains a section on security, describe security issues that may arise during the project implementation and the measures you intend to take to solve/avoid them. Indicate if there is need for EU classification of information (Decision 2015/444) or any other specific security measures. The health data access bodies, as entities empowered to provide access to health data for secondary uses, will process personal health data in different forms and provide access to third parties to such data, both as part of services provided within and across borders. Health data access body will ensure the fulfilment of legal obligations with respect to data protection and security, described in detail under each WP in the analysis and proposal phase. #§SEC-URI-SU§# #@DEC-LAR-DL@# 6. DECLARATIONS Higher funding rate (if applicable) YES/NO Do you fulfil the conditions set out in the Call document for a higher funding rate? YES If YES, explain and provide details. According to the indications provided by HaDEA, countries whose GNI per inhabitant is less than 90% of the EU average can apply for exceptional utility. Estonia’s GNI index is below 90% of the average. Double funding Information concerning other EU grants for this project Please note that there is a strict prohibition of double funding from the EU budget (except YES/NO under EU Synergies actions). 24 Project 101129188 - EST2EHDS - EU4H-2022-DGA-MS-IBA2 Associated with document Ref. Ares(2023)7314945 - 26/10/2023 EU Grants: Description of the action (DoA) — Annex 1 We confirm that to our best knowledge neither the project as a whole nor any parts of it have YES benefitted from any other EU grant (including EU funding managed by authorities in EU Member States or other funding bodies, e.g. EU Regional Funds, EU Agricultural Funds, etc). If NO, explain and provide details. We confirm that to our best knowledge neither the project as a whole nor any parts of it are YES (nor will be) submitted for any other EU grant (including EU funding managed by authorities in EU Member States or other funding bodies, e.g. EU Regional Funds, EU Agricultural Funds, etc). If NO, explain and provide details. Financial support to third parties (if applicable) If in your project the maximum amount per third party will be more than the threshold amount set in the Call document, justify and explain why the higher amount is necessary in order to fulfil your project’s objectives. NOT applicable #§DEC-LAR-DL§# 25 Project 101129188 - EST2EHDS - EU4H-2022-DGA-MS-IBA2 Associated with document Ref. Ares(2023)7314945 - 26/10/2023 EU Grants: Description of the action (DoA) — Annex 1 LIST OF PREVIOUS PROJECTS List of previous projects Please provide a list of your previous projects for the last 4 years. Participant Project Reference No Period (start Role Amount Website (if any) and Title, Funding and end date) (COO, (EUR) programme BEN, AE, OTHER) Health and Connecting Europe 01.01.2017 – 369782 Welfare Facility 2014-2020CEF 31.12.2020 Information TELECOM CALLS FOR Systems PROPOSALS 2015CEF- Centre TC-2015-2 Deployment of Generic Cross Border eHealth Services in Estonia TENtec number2692228 Health and H2020-SC1-DTH-2018- 1.09.2020 – 44187,5 https://www.x- Welfare 2020 / H2020-SC1-DTH- 30.11.2022 ehealth.eu/ Information 2019-2 Systems Centre X-eHealth: eXchanging electronic Health Records ina commom framework’ — ‘X- eHealth’ 2 000 000 Health and EE-INNOVATION-0002 01.02.2021- partner https://www.tehik. Welfare Health Sense, Green ICT 30.04.2024 ee/health-sense; Information https://eeagrants. Systems org/archive/2014- Centre 2021/projects/EE- INNOVATION- 0002 369 782 Health and Connecting Europe 01.01.2017 – Direct https://www.tehik. Welfare Facility 2014-2020 CEF 31.12.2020 grant ee/projektid?field_ Information TELECOM CALLS FOR category_value=A Systems PROPOSALS 2015CEF- ll&page=2 Centre TC-2015-2. Deployment of Generic Cross Border eHealth Services in Estonia. AGREEMENT No INEA/CEF/ICT/A2015/11 56737 148 478 Health and Emergency Support 07.11.2020- Direct https://www.tehik. Welfare Instrument – adaptation 03.07.2021 grant ee/projektid?field_ Information of national contact category_value=h Systems tracing ealth&page=2 Centre 26 Project 101129188 - EST2EHDS - EU4H-2022-DGA-MS-IBA2 Associated with document Ref. Ares(2023)7314945 - 26/10/2023 EU Grants: Description of the action (DoA) — Annex 1 app and backend solutions to join the European Federation Gateway Service ESTONIA — AGREEMENT NUMBER LC-01591187 HISTORY OF CHANGES PUBLICATION VERSION CHANGE DATE 1.0 15.04.2021 Initial version (new MFF). 2.0 01.06.2022 Consolidation, formatting and layout changes. Tags added. 3.0 03.08.2023 In part A some additions were done related to the dissemination level, deliverables. - updated the dissemination level of Project Guide to sensitive. - Mid-term and final dissemination reports were added to WP2 - updated the wording of D3.2 and D3.3 from “plan” to “report” - updated the milestone MS11 from development plan to “proposal for a secure processing environment”. Part B was amended as following: - p1 – changed the coordinator contact to Jaanika Merilo - p3 – added section of explanation before the „specific objectives“ - p6 – added the sentence confirming the reporting of the indicators - „The project will report on the latest version of indicators for health data access bodies and the other action-level indicators specified in the call document.“ - p8 – HDAB function was explained additionally with the sentence – „There is yet to be a formal regulation for the HDAB appointment, as detailed analyses of TEHIK as the HDAB, TEHIK´s internal roles and action plans, shall be conducted within the scope of this project.“ - p9 – Coordinator contact updated in the staff table (Taavi Annus replaced by Janaika Merilo) - p10 – Details added to address the ESR concern regarding use of outside Resources – „As a small country, the field of secondary health data use is relatively small in Estonia, which is why experts of the field are also scarce. Additional expertise is retrieved from professionals (healthcare service providers and scientists) of the Estonian healthcare 27 Project 101129188 - EST2EHDS - EU4H-2022-DGA-MS-IBA2 Associated with document Ref. Ares(2023)7314945 - 26/10/2023 EU Grants: Description of the action (DoA) — Annex 1 field and colleagues from international partner institutions, when necessary.“ 4.0 21.09.2023 - p 8 – updated the acronym of Beneficiary: Ministry of Social Affairs to both (MoSA/MSAE) so it would be understood in all documents. - p11-12 – As raised in the ESR, justification on the higher grant request as the indicative range was added – „ As for the grant amount, the indicative range was exceeded due to the following circumstances. Estonia is a small country with limited resources and so far the processes and infrastructure for secondary use of health data have not fully analysed, standardised or developed. However, we see the opportunity to use the grant resources to develop the needed infrastructure supporting standardised and suitable quality data for secondary use cases. During the project activities we will analyse at the state level, how the process of secondary use of health data should be organised and the need to develop additional secure processing environments or data access bodies. We will also assess the current level of data quality and develop and implement the Data Quality Framework for secondary use of health data to meet the needs of data users. Due to several different impact factors (such as inflation, increase in the cost of living and the invasion of Russia in Ukraine) the prices of development have also increased. In order to successfully complete the project in 36 months and considering the abovementioned points, the requested grant was raised above the indicative range.“ - following comment raised in the Evaluation Summary Report “Consider increasing the coverage of the minimum digital capabilities, and better align the list of specific deliverables and/or milestones in section E or further justify if this is not possible to be implemented.” has been addressed on p. 3 - p 17-18 – updated the subcontracting costs for S5.1 and S5.3 to align them with the information provided with the updated budget and SYGMA. 28  Associated with document Ref. Ares(2023)7314945 - 26/10/2023 START (DETAILED BUDGET TABLE (AG) — PROPOSAL/GRANT PREPARATION) PROJECT DATA Project number: 210933860 Project acronym: EST2EHDS Participant short name: MSAE Participant PIC: 998429731 WORK PACKAGES & TRAVELS Index Name Description Number of travels Delete PROJECT MANAGEMENT AND Managing and coordinating the project, guiding the 1 1 COORDINATION efforts for the achievement of milestones Dissemination of information on the project 2 DISSEMINATION deliverables and progress Evaluating the qualiy of the project and ensuring that 3 EVALUATION the outputs are effective, innovative and fit for purpose Supporting the fevelopment and adoption of national policies related to an effective setting up of HDAB, 4 SUSTAINABILITY aligning towards EHDS legislation, generating recommendations and guidance SETTING UP NATIONAL Setting up national dataset catalogue and supporting 5 DATASET CATALOGUE effort joining EHDS NATIONAL DATA ACCESS Fulfilling the prerequisites for setting up national data 6 APPLICATION MANAGEMENT access application management system for joining SYSTEM EHDS SECURE PROCESSING Analysis of the best system setup and most suitable 7 ENVIRONMENTS location for the secure processing environment Analysis and proposal on how to best apply EHDS in 8 CROSS-BORDER GATEWAY Estonia DATASET DATA QUALITY 9 Monitoring and improving data quality IMPROVEMENT  a Associated with document Ref. Ares(2023)7314945 - 26/10/2023 DETAILED BUDGET TABLE (ACTION GRANTS) Project number: 210933860 24.10.2023 12:19 Project acronym: EST2EHDS Participant short name: MSAE Participant PIC: 998429731 ATTENTION: This table should be filled out one per participant (beneficiary, affiliated entity) ATTENTION: This table may ONLY contain eligible costs (i.e. costs that comply with the eligibility rules of the grant agreement that is part of your call documents). At proposal stage and during grant preparation, it should contain estimated costs/income. Costs must be estimated in EUR. ATTENTION! List each budgeted cost item ONLY once in this table, for the main WP. ATTENTION! White cells mean that you are required to enter data. Blue cells are calculated automatically. ACTION GRANT BUDGET TABLE (PER PARTICIPANT) PROJECT COSTS A. Personnel costs Costs (actual or unit costs) Time Rate Total Also working for other work ! monthly rates allowed for budgeting because simpler to establish the approximate costs; cost reporting will have to (months/other of work on Type of rate (amount) (EUR) packages? YES/NO and which Description of project role/activities/responsibilities be done according to MGA (usually daily rates) the action) (monthly/other) WP a b c=a*b WORK PACKAGE 1 PROJECT MANAGEMENT AND COORDINATION A.1 Employees (or equivalent) Project managing role for the whole project. Activities described in WP-s 1-4 as well as partticipaing in the analyses in WP-s 6-8. Administrative part related to communication with EC. MoSA project manager is in the position to give nation-wide and cross-border perspective to the project and ensuring fulfilling general EHDS aims on EU level.Project managing role for the whole project. Project managers monthly 3 500,00 5,00 17 500,00 YES, WP2, 3, 4, 6, 7, 8 Activities described in WP-s 1-4 as well as participating in the analyses in WP-s 6-8. Administrative part related to communication with EC. MoSA project manager is in the position to give nation-wide and cross-border perspective to the project and ensuring fulfilling general EHDS aims on EU level. Select a staff category monthly 0,00 0,00 0,00 Other [category 1] monthly 0,00 0,00 0,00 [category 2] monthly 0,00 0,00 0,00 Total employees (or equivalent) 17 500,00 A.2 + A.3 Natural persons under direct contract and seconded persons Select a staff category monthly 0,00 0,00 0,00 Select a staff category monthly 0,00 0,00 0,00 Other [category 1] monthly 0,00 0,00 0,00 [category 2] monthly 0,00 0,00 0,00  Total natural persons under direct contract and seconded persons 0,00 Associated with document Ref. Ares(2023)7314945 - 26/10/2023 A.4 SME owners and natural person beneficiaries without salary SME owners/natural person beneficiaries without salary daily 0,00 0,00 0,00 Total SME owners and natural person beneficiaries without salary 0,00 Total personnel for this WP 17 500,00 WORK PACKAGE 2 DISSEMINATION A.1 Employees (or equivalent) Project managing role for the whole project. Activities described in WP-s 1-4 as well as participating in the analyses in WP-s 6-8. Administrative part related to Project managers monthly 3 500,00 2,70 9 450,00 YES, WP1, 3, 4, 6, 7, 8 communication with EC. MoSA project manager is in the position to give nation-wide and cross-border perspective to the project and ensuring fulfilling general EHDS aims on EU level. Select a staff category monthly 0,00 0,00 0,00 Other [category 1] monthly 0,00 0,00 0,00 [category 2] monthly 0,00 0,00 0,00 Total employees (or equivalent) 9 450,00 A.2 + A.3 Natural persons under direct contract and seconded persons Select a staff category monthly 0,00 0,00 0,00 Select a staff category monthly 0,00 0,00 0,00 Other [category 1] monthly 0,00 0,00 0,00 [category 2] monthly 0,00 0,00 0,00 Total natural persons under direct contract and seconded persons 0,00 A.4 SME owners and natural person beneficiaries without salary SME owners/natural person beneficiaries without salary daily 0,00 0,00 0,00 Total SME owners and natural person beneficiaries without salary 0,00 Total personnel for this WP 9 450,00 WORK PACKAGE 3 EVALUATION A.1 Employees (or equivalent) Project managing role for the whole project. Activities described in WP-s 1-4 as well as participating in the analyses in WP-s 6-8. Administrative part related to Project managers monthly 3 500,00 2,80 9 800,00 YES, WP1, 2, 4, 6, 7, 8 communication with EC. MoSA project manager is in the position to give nation-wide and cross-border perspective to the project and ensuring fulfilling general EHDS aims on EU level. Project managers monthly 0,00 0,00 0,00 Select a staff category monthly 0,00 0,00 0,00 Other [category 1] monthly 0,00 0,00 0,00 [category 2] monthly 0,00 0,00 0,00 Total employees (or equivalent) 9 800,00 A.2 + A.3 Natural persons under direct contract and seconded persons Select a staff category monthly 0,00 0,00 0,00 Select a staff category monthly 0,00 0,00 0,00 Other  [category 1] monthly 0,00 0,00 0,00 Associated with document Ref. Ares(2023)7314945 - 26/10/2023 [category 2] monthly 0,00 0,00 0,00 Total natural persons under direct contract and seconded persons 0,00 A.4 SME owners and natural person beneficiaries without salary SME owners/natural person beneficiaries without salary daily 0,00 0,00 0,00 Total SME owners and natural person beneficiaries without salary 0,00 Total personnel for this WP 9 800,00 WORK PACKAGE 4 SUSTAINABILITY A.1 Employees (or equivalent) Project managing role for the whole project. Activities described in WP-s 1-4 as well as participating in the analyses in WP-s 6-8. Administrative part related to Project managers monthly 3 500,00 2,00 7 000,00 YES, WP1, 2, 3, 6, 7, 8 communication with EC. MoSA project manager is in the position to give nation-wide and cross-border perspective to the project and ensuring fulfilling general EHDS aims on EU level. Select a staff category monthly 0,00 0,00 0,00 Other [category 1] monthly 0,00 0,00 0,00 [category 2] monthly 0,00 0,00 0,00 Total employees (or equivalent) 7 000,00 A.2 + A.3 Natural persons under direct contract and seconded persons Select a staff category monthly 0,00 0,00 0,00 Select a staff category monthly 0,00 0,00 0,00 Other [category 1] monthly 0,00 0,00 0,00 [category 2] monthly 0,00 0,00 0,00 Total natural persons under direct contract and seconded persons 0,00 A.4 SME owners and natural person beneficiaries without salary SME owners/natural person beneficiaries without salary daily 0,00 0,00 0,00 Total SME owners and natural person beneficiaries without salary 0,00 Total personnel for this WP 7 000,00 WORK PACKAGE 5 SETTING UP NATIONAL DATASET CATALOGUE A.1 Employees (or equivalent) Select a staff category monthly 0,00 0,00 0,00 Select a staff category monthly 0,00 0,00 0,00 Other [category 1] monthly 0,00 0,00 0,00 [category 2] monthly 0,00 0,00 0,00 Total employees (or equivalent) 0,00 A.2 + A.3 Natural persons under direct contract and seconded persons Select a staff category monthly 0,00 0,00 0,00 Select a staff category monthly 0,00 0,00 0,00 Other [category 1] monthly 0,00 0,00 0,00 [category 2] monthly 0,00 0,00 0,00  Total natural persons under direct contract and seconded persons 0,00 Associated with document Ref. Ares(2023)7314945 - 26/10/2023 A.4 SME owners and natural person beneficiaries without salary SME owners/natural person beneficiaries without salary daily 0,00 0,00 0,00 Total SME owners and natural person beneficiaries without salary 0,00 Total personnel for this WP 0,00 NATIONAL DATA ACCESS APPLICATION MANAGEMENT WORK PACKAGE 6 SYSTEM A.1 Employees (or equivalent) Project managing role for the whole project. Activities described in WP-s 1-4 as well as participating in the analyses in WP-s 6-8. Administrative part related to Project managers monthly 3 500,00 3,00 10 500,00 YES, WP-s 1, 2, 3, 4, 7, 8 communication with EC. MoSA project manager is in the position to give nation-wide and cross-border perspective to the project and ensuring fulfilling general EHDS aims on EU level. Select a staff category monthly 0,00 0,00 0,00 Other [category 1] monthly 0,00 0,00 0,00 [category 2] monthly 0,00 0,00 0,00 Total employees (or equivalent) 10 500,00 A.2 + A.3 Natural persons under direct contract and seconded persons Select a staff category monthly 0,00 0,00 0,00 Select a staff category monthly 0,00 0,00 0,00 Other [category 1] monthly 0,00 0,00 0,00 [category 2] monthly 0,00 0,00 0,00 Total natural persons under direct contract and seconded persons 0,00 A.4 SME owners and natural person beneficiaries without salary SME owners/natural person beneficiaries without salary daily 0,00 0,00 0,00 Total SME owners and natural person beneficiaries without salary 0,00 Total personnel for this WP 10 500,00 WORK PACKAGE 7 SECURE PROCESSING ENVIRONMENTS A.1 Employees (or equivalent) Project managing role for the whole project. Activities described in WP-s 1-4 as well as participating in the analyses in WP-s 6-8. Administrative part related to Project managers monthly 3 500,00 3,00 10 500,00 YES, WP-s 1, 2, 3, 4, 6, 8 communication with EC. MoSA project manager is in the position to give nation-wide and cross-border perspective to the project and ensuring fulfilling general EHDS aims on EU level. Select a staff category monthly 0,00 0,00 0,00 Other [category 1] monthly 0,00 0,00 0,00 [category 2] monthly 0,00 0,00 0,00 Total employees (or equivalent) 10 500,00 A.2 + A.3 Natural persons under direct contract and seconded persons Select a staff category monthly 0,00 0,00 0,00 Select a staff category monthly 0,00 0,00 0,00 Other [category 1] monthly 0,00 0,00 0,00  [category 2] monthly 0,00 0,00 0,00 Associated with document Ref. Ares(2023)7314945 - 26/10/2023 Total natural persons under direct contract and seconded persons 0,00 A.4 SME owners and natural person beneficiaries without salary SME owners/natural person beneficiaries without salary daily 0,00 0,00 0,00 Total SME owners and natural person beneficiaries without salary 0,00 Total personnel for this WP 10 500,00 WORK PACKAGE 8 CROSS-BORDER GATEWAY A.1 Employees (or equivalent) Project managing role for the whole project. Activities described in WP-s 1-4 as well as participating in the analyses in WP-s 6-8. Administrative part related to Project managers monthly 3 500,00 3,00 10 500,00 YES, WP-s 1, 2, 3, 4, 6, 7 communication with EC. MoSA project manager is in the position to give nation-wide and cross-border perspective to the project and ensuring fulfilling general EHDS aims on EU level. Select a staff category monthly 0,00 0,00 0,00 Other [category 1] monthly 0,00 0,00 0,00 [category 2] monthly 0,00 0,00 0,00 Total employees (or equivalent) 10 500,00 A.2 + A.3 Natural persons under direct contract and seconded persons Select a staff category monthly 0,00 0,00 0,00 Select a staff category monthly 0,00 0,00 0,00 Other [category 1] monthly 0,00 0,00 0,00 [category 2] monthly 0,00 0,00 0,00 Total natural persons under direct contract and seconded persons 0,00 A.4 SME owners and natural person beneficiaries without salary SME owners/natural person beneficiaries without salary daily 0,00 0,00 0,00 Total SME owners and natural person beneficiaries without salary 0,00 Total personnel for this WP 10 500,00 WORK PACKAGE 9 DATASET DATA QUALITY IMPROVEMENT A.1 Employees (or equivalent) Select a staff category monthly 0,00 0,00 0,00 Select a staff category monthly 0,00 0,00 0,00 Other [category 1] monthly 0,00 0,00 0,00 [category 2] monthly 0,00 0,00 0,00 Total employees (or equivalent) 0,00 A.2 + A.3 Natural persons under direct contract and seconded persons Select a staff category monthly 0,00 0,00 0,00 Select a staff category monthly 0,00 0,00 0,00 Other [category 1] monthly 0,00 0,00 0,00 [category 2] monthly 0,00 0,00 0,00 Total natural persons under direct contract and seconded persons 0,00  A.4 SME owners and natural person beneficiaries without salary Associated with document Ref. Ares(2023)7314945 - 26/10/2023 SME owners/natural person beneficiaries without salary daily 0,00 0,00 0,00 Total SME owners and natural person beneficiaries without salary 0,00 Total personnel for this WP 0,00 Total personnel (all WPs) 75 250,00 B. Subcontracting costs Also used for other work Costs packages? Description of subcontracted project tasks/activities (actual costs) YES/NO and which WP WORK PACKAGE 1 PROJECT MANAGEMENT AND COORDINATION 1 [Subcontract short name] 0,00 2 [Subcontract short name] 0,00 Total subcontracting for this WP 0,00 WORK PACKAGE 2 DISSEMINATION 1 [Subcontract short name] 0,00 2 [Subcontract short name] 0,00 Total subcontracting for this WP 0,00 WORK PACKAGE 3 EVALUATION 1 [Subcontract short name] 0,00 2 [Subcontract short name] 0,00 Total subcontracting for this WP 0,00 WORK PACKAGE 4 SUSTAINABILITY 1 [Subcontract short name] 0,00 2 [Subcontract short name] 0,00 Total subcontracting for this WP 0,00 WORK PACKAGE 5 SETTING UP NATIONAL DATASET CATALOGUE 1 [Subcontract short name] 0,00 2 [Subcontract short name] 0,00 Total subcontracting for this WP 0,00 NATIONAL DATA ACCESS APPLICATION MANAGEMENT WORK PACKAGE 6 SYSTEM Proposal and action plan for development of national data access application management system, deployment and 1 [Analysis] 100 000,00 sustainability. Main deliverable achieved by subcontracting but project managers from MoSA and TEHIK give valuable insight and lead the composing of the analysis and proposal. Total subcontracting for this WP 100 000,00 WORK PACKAGE 7 SECURE PROCESSING ENVIRONMENTS Proposal and action plan for development of secure processing environment, deployment and sustainability. 1 [Analysis] 100 000,00 Main deliverable achieved by subcontracting but project managers from MoSA and TEHIK give valuable insight and lead the composing of the analysis and proposal. Total subcontracting for this WP 100 000,00 WORK PACKAGE 8 CROSS-BORDER GATEWAY  Proposal and action plan for development of cross-border gateway, deployment and sustainability. Main deliverable 1 [Analysis] 100 000,00 achieved Associated by subcontracting with document but project managers Ref. Ares(2023)7314945 from - 26/10/2023 MoSA and TEHIK give valuable insight and lead the composing of the analysis and proposal. Total subcontracting for this WP 100 000,00 WORK PACKAGE 9 DATASET DATA QUALITY IMPROVEMENT 1 [Subcontract short name] 0,00 2 [Subcontract short name] 0,00 Total subcontracting for this WP 0,00 Total subcontracting (all WPs) 300 000,00 C. Purchase costs C.1 Travel and subsistence Costs Description (e.g. international/not international; place of Costs (unit cost) Also part of other work activity/destination; number of days; number of persons (actual costs) packages? (speakers, personnel and participants whose costs are Amount per Total YES/NO and which WP covered); transport means; average price per person; Number of units unit ( EUR) subsistence costs/daily allowances) WORK PACKAGE 1 PROJECT MANAGEMENT AND COORDINATION 1 [Travel short name] Speakers Travel costs 0,00 0,00 0,00 0,00 Accommodation costs 0,00 0,00 0,00 0,00 Subsistence costs 0,00 0,00 0,00 0,00 Personnel Travel costs 0,00 0,00 0,00 0,00 Accommodation costs 0,00 0,00 0,00 0,00 Subsistence costs 0,00 0,00 0,00 0,00 Participants Travel costs 0,00 0,00 0,00 0,00 Accommodation costs 0,00 0,00 0,00 0,00 Subsistence costs 0,00 0,00 0,00 0,00 Total travel costs for this travel 0,00 Total accommodation costs for this travel 0,00 Total subsistence costs for this travel 0,00 Total travel 0,00 Total travel costs for this WP 0,00 Total accommodation costs for this WP 0,00 Total subsistence costs for this WP 0,00 Total travel for this WP 0,00 0,00 WORK PACKAGE 2 DISSEMINATION Total travel costs for this WP 0,00 Total accommodation costs for this WP 0,00 Total subsistence costs for this WP 0,00 Total travel for this WP 0,00 0,00 WORK PACKAGE 3 EVALUATION  Total travel costs for this WP 0,00 Associated with document Ref. Ares(2023)7314945 - 26/10/2023 Total accommodation costs for this WP 0,00 Total subsistence costs for this WP 0,00 Total travel for this WP 0,00 0,00 WORK PACKAGE 4 SUSTAINABILITY Total travel costs for this WP 0,00 Total accommodation costs for this WP 0,00 Total subsistence costs for this WP 0,00 Total travel for this WP 0,00 0,00 WORK PACKAGE 5 SETTING UP NATIONAL DATASET CATALOGUE Total travel costs for this WP 0,00 Total accommodation costs for this WP 0,00 Total subsistence costs for this WP 0,00 Total travel for this WP 0,00 0,00 NATIONAL DATA ACCESS APPLICATION MANAGEMENT WORK PACKAGE 6 SYSTEM Total travel costs for this WP 0,00 Total accommodation costs for this WP 0,00 Total subsistence costs for this WP 0,00 Total travel for this WP 0,00 0,00 WORK PACKAGE 7 SECURE PROCESSING ENVIRONMENTS Total travel costs for this WP 0,00 Total accommodation costs for this WP 0,00 Total subsistence costs for this WP 0,00 Total travel for this WP 0,00 0,00 WORK PACKAGE 8 CROSS-BORDER GATEWAY Total travel costs for this WP 0,00 Total accommodation costs for this WP 0,00 Total subsistence costs for this WP 0,00 Total travel for this WP 0,00 0,00 WORK PACKAGE 9 DATASET DATA QUALITY IMPROVEMENT Total travel costs for this WP 0,00 Total accommodation costs for this WP 0,00 Total subsistence costs for this WP 0,00 Total travel for this WP 0,00 0,00 Total travel costs (all WPs) 0,00 Total accommodation (all WPs) 0,00 Total subsistence (all WPs) 0,00 Total travel and subsistence (all WPs) 0,00 C.2 Equipment WORK PACKAGE 1 PROJECT MANAGEMENT AND COORDINATION C.2.1 Purchase (depreciation/full cost) Costs (actual costs) Depreciation Rate of use for the Also part of other work method (e.g. Number of months action (100% or Total Description of tasks/activities for which the equipment is Price packages? YES/NO and which 36 month or 60 allocated to the action less if used also for (EUR) needed WP month) other purposes)  Depreciation Rate of use for the Also part of other work method (e.g. Number of months action (100% or Total Description of tasks/activities for which the equipment is Price packages? YES/NO and which 36 month or 60 allocated to the action less if used also for (EUR) needed WP month) other purposes) a b c d e =(c/b *d) * a Associated with document Ref. Ares(2023)7314945 - 26/10/2023 1 [Equipment short name] 0,00 0 0,00 0% 0,00 2 [Equipment short name] 0,00 0 0,00 0% 0,00 ATTENTION! Can be used only if full cost option in the grant 3 [Equipment short name] 0,00 0,00 agreement Total depreciation 0,00 C.2.2 Rental and leasing (rate of use/full cost) Costs (actual costs) Rate of use for the Also part of other work action (100% or Total Description of tasks/activities for which the equipment is Monthly rent/fee Number of months of use for the action packages? YES/NO and which less if used also for (EUR) needed WP other purposes) a b c d= a*b*c 1 [Equipment short name] 0,00 0,00 0% 0,00 2 [Equipment short name] 0,00 0,00 0% 0,00 ATTENTION! Can be used only if full cost option in the grant 3 [Equipment short name] 0,00 0,00 agreement Total rental and leasing 0,00 Total equipment for this WP 0,00 WORK PACKAGE 2 DISSEMINATION C.2.1 Purchase (depreciation/full cost) Costs (actual costs) Depreciation Rate of use for the Also part of other work method (e.g. Number of months action (100% or Total Description of tasks/activities for which the equipment is Price packages? YES/NO and which 36 month or 60 allocated to the action less if used also for (EUR) needed WP month) other purposes) a b c d e =(c/b *d) * a 1 [Equipment short name] 0,00 0 0,00 0% 0,00 2 [Equipment short name] 0,00 0 0,00 0% 0,00 ATTENTION! Can be used only if full cost option in the grant 3 [Equipment short name] 0,00 0,00 agreement Total depreciation 0,00 C.2.2 Rental and leasing (rate of use/full cost) Costs (actual costs) Rate of use for the Also part of other work action (100% or Total Description of tasks/activities for which the equipment is Monthly rent/fee Number of months of use for the action packages? YES/NO and which less if used also for (EUR) needed WP other purposes) a b c d= a*b*c 1 [Equipment short name] 0,00 0,00 0% 0,00 2 [Equipment short name] 0,00 0,00 0% 0,00 ATTENTION! Can be used only if full cost option in the grant 3 [Equipment short name] 0,00 0,00 agreement Total rental and leasing 0,00 Total equipment for this WP 0,00 WORK PACKAGE 3 EVALUATION C.2.1 Purchase (depreciation/full cost) Costs (actual costs) Depreciation Rate of use for the Also part of other work method (e.g. Number of months action (100% or Total Description of tasks/activities for which the equipment is Price packages? YES/NO and which 36 month or 60 allocated to the action less if used also for (EUR) needed WP month) other purposes) a b c d e =(c/b *d) * a 1 [Equipment short name] 0,00 0 0,00 0% 0,00 2 [Equipment short name] 0,00 0 0,00 0% 0,00 ATTENTION! Can be used only if full cost option in the grant 3 [Equipment short name] 0,00 0,00 agreement Total depreciation 0,00 C.2.2 Rental and leasing (rate of use/full cost) Costs (actual costs) Also part of other work Description of tasks/activities for which the equipment is packages? YES/NO and which  Rate of use for the Also part of other work action (100% or Total Description of tasks/activities for which the equipment is Monthly rent/fee Number of months of use for the action packages? YES/NO and Associated which with document Ref. Ares(2023)7314945 - 26/10/2023 less if used also for (EUR) needed WP other purposes) a b c d= a*b*c 1 [Equipment short name] 0,00 0,00 0% 0,00 2 [Equipment short name] 0,00 0,00 0% 0,00 ATTENTION! Can be used only if full cost option in the grant 3 [Equipment short name] 0,00 0,00 agreement Total rental and leasing 0,00 Total equipment for this WP 0,00 WORK PACKAGE 4 SUSTAINABILITY C.2.1 Purchase (depreciation/full cost) Costs (actual costs) Depreciation Rate of use for the Also part of other work method (e.g. Number of months action (100% or Total Description of tasks/activities for which the equipment is Price packages? YES/NO and which 36 month or 60 allocated to the action less if used also for (EUR) needed WP month) other purposes) a b c d e =(c/b *d) * a 1 [Equipment short name] 0,00 0 0,00 0% 0,00 2 [Equipment short name] 0,00 0 0,00 0% 0,00 ATTENTION! Can be used only if full cost option in the grant 3 [Equipment short name] 0,00 0,00 agreement Total depreciation 0,00 C.2.2 Rental and leasing (rate of use/full cost) Costs (actual costs) Rate of use for the Also part of other work action (100% or Total Description of tasks/activities for which the equipment is Monthly rent/fee Number of months of use for the action packages? YES/NO and which less if used also for (EUR) needed WP other purposes) a b c d= a*b*c 1 [Equipment short name] 0,00 0,00 0% 0,00 2 [Equipment short name] 0,00 0,00 0% 0,00 ATTENTION! Can be used only if full cost option in the grant 3 [Equipment short name] 0,00 0,00 agreement Total rental and leasing 0,00 Total equipment for this WP 0,00 WORK PACKAGE 5 SETTING UP NATIONAL DATASET CATALOGUE C.2.1 Purchase (depreciation/full cost) Costs (actual costs) Depreciation Rate of use for the Also part of other work method (e.g. Number of months action (100% or Total Description of tasks/activities for which the equipment is Price packages? YES/NO and which 36 month or 60 allocated to the action less if used also for (EUR) needed WP month) other purposes) a b c d e =(c/b *d) * a 1 [Equipment short name] 0,00 0 0,00 0% 0,00 2 [Equipment short name] 0,00 0 0,00 0% 0,00 ATTENTION! Can be used only if full cost option in the grant 3 [Equipment short name] 0,00 0,00 agreement Total depreciation 0,00 C.2.2 Rental and leasing (rate of use/full cost) Costs (actual costs) Rate of use for the Also part of other work action (100% or Total Description of tasks/activities for which the equipment is Monthly rent/fee Number of months of use for the action packages? YES/NO and which less if used also for (EUR) needed WP other purposes) a b c d= a*b*c 1 [Equipment short name] 0,00 0,00 0% 0,00 2 [Equipment short name] 0,00 0,00 0% 0,00 ATTENTION! Can be used only if full cost option in the grant 3 [Equipment short name] 0,00 0,00 agreement  Total rental and leasing 0,00 Associated with document Ref. Ares(2023)7314945 - 26/10/2023 Total equipment for this WP 0,00 NATIONAL DATA ACCESS APPLICATION MANAGEMENT WORK PACKAGE 6 SYSTEM C.2.1 Purchase (depreciation/full cost) Costs (actual costs) Depreciation Rate of use for the Also part of other work method (e.g. Number of months action (100% or Total Description of tasks/activities for which the equipment is Price packages? YES/NO and which 36 month or 60 allocated to the action less if used also for (EUR) needed WP month) other purposes) a b c d e =(c/b *d) * a 1 [Equipment short name] 0,00 0 0,00 0% 0,00 2 [Equipment short name] 0,00 0 0,00 0% 0,00 ATTENTION! Can be used only if full cost option in the grant 3 [Equipment short name] 0,00 0,00 agreement Total depreciation 0,00 C.2.2 Rental and leasing (rate of use/full cost) Costs (actual costs) Rate of use for the Also part of other work action (100% or Total Description of tasks/activities for which the equipment is Monthly rent/fee Number of months of use for the action packages? YES/NO and which less if used also for (EUR) needed WP other purposes) a b c d= a*b*c 1 [Equipment short name] 0,00 0,00 0% 0,00 2 [Equipment short name] 0,00 0,00 0% 0,00 ATTENTION! Can be used only if full cost option in the grant 3 [Equipment short name] 0,00 0,00 agreement Total rental and leasing 0,00 Total equipment for this WP 0,00 WORK PACKAGE 7 SECURE PROCESSING ENVIRONMENTS C.2.1 Purchase (depreciation/full cost) Costs (actual costs) Depreciation Rate of use for the Also part of other work method (e.g. Number of months action (100% or Total Description of tasks/activities for which the equipment is Price packages? YES/NO and which 36 month or 60 allocated to the action less if used also for (EUR) needed WP month) other purposes) a b c d e =(c/b *d) * a 1 [Equipment short name] 0,00 0 0,00 0% 0,00 2 [Equipment short name] 0,00 0 0,00 0% 0,00 ATTENTION! Can be used only if full cost option in the grant 3 [Equipment short name] 0,00 0,00 agreement Total depreciation 0,00 C.2.2 Rental and leasing (rate of use/full cost) Costs (actual costs) Rate of use for the Also part of other work action (100% or Total Description of tasks/activities for which the equipment is Monthly rent/fee Number of months of use for the action packages? YES/NO and which less if used also for (EUR) needed WP other purposes) a b c d= a*b*c 1 [Equipment short name] 0,00 0,00 0% 0,00 2 [Equipment short name] 0,00 0,00 0% 0,00 ATTENTION! Can be used only if full cost option in the grant 3 [Equipment short name] 0,00 0,00 agreement Total rental and leasing 0,00 Total equipment for this WP 0,00 WORK PACKAGE 8 CROSS-BORDER GATEWAY C.2.1 Purchase (depreciation/full cost) Costs (actual costs) Depreciation Rate of use for the Also part of other work method (e.g. Number of months action (100% or Total Description of tasks/activities for which the equipment is Price packages? YES/NO and which 36 month or 60 allocated to the action less if used also for (EUR) needed WP month) other purposes)  Also part of other work Description of tasks/activities for which the equipment is packages? YES/NO and which needed WP a b c d e =(c/b *d) * a 1 [Equipment short name] 0,00 0 0,00 0% 0,00 Associated with document Ref. Ares(2023)7314945 - 26/10/2023 2 [Equipment short name] 0,00 0 0,00 0% 0,00 ATTENTION! Can be used only if full cost option in the grant 3 [Equipment short name] 0,00 0,00 agreement Total depreciation 0,00 C.2.2 Rental and leasing (rate of use/full cost) Costs (actual costs) Rate of use for the Also part of other work action (100% or Total Description of tasks/activities for which the equipment is Monthly rent/fee Number of months of use for the action packages? YES/NO and which less if used also for (EUR) needed WP other purposes) a b c d= a*b*c 1 [Equipment short name] 0,00 0,00 0% 0,00 2 [Equipment short name] 0,00 0,00 0% 0,00 ATTENTION! Can be used only if full cost option in the grant 3 [Equipment short name] 0,00 0,00 agreement Total rental and leasing 0,00 Total equipment for this WP 0,00 WORK PACKAGE 9 DATASET DATA QUALITY IMPROVEMENT C.2.1 Purchase (depreciation/full cost) Costs (actual costs) Depreciation Rate of use for the Also part of other work method (e.g. Number of months action (100% or Total Description of tasks/activities for which the equipment is Price packages? YES/NO and which 36 month or 60 allocated to the action less if used also for (EUR) needed WP month) other purposes) a b c d e =(c/b *d) * a 1 [Equipment short name] 0,00 0 0,00 0% 0,00 2 [Equipment short name] 0,00 0 0,00 0% 0,00 ATTENTION! Can be used only if full cost option in the grant 3 [Equipment short name] 0,00 0,00 agreement Total depreciation 0,00 C.2.2 Rental and leasing (rate of use/full cost) Costs (actual costs) Rate of use for the Also part of other work action (100% or Total Description of tasks/activities for which the equipment is Monthly rent/fee Number of months of use for the action packages? YES/NO and which less if used also for (EUR) needed WP other purposes) a b c d= a*b*c 1 [Equipment short name] 0,00 0,00 0% 0,00 2 [Equipment short name] 0,00 0,00 0% 0,00 ATTENTION! Can be used only if full cost option in the grant 3 [Equipment short name] 0,00 0,00 agreement Total rental and leasing 0,00 Total equipment for this WP 0,00 Total equipment (all WPs) 0,00 C.3 Other goods, works and services WORK PACKAGE 1 PROJECT MANAGEMENT AND COORDINATION Costs Also part of other work Description of tasks/activities for which the goods/services (actual costs) packages? YES/NO and which are needed; types of goods services needed; how much WP Consumables 0,00 Conferences, seminars, workshops, trainings & events 0,00 Information & publications 0,00 Other expenses 1 IPR costs 0,00  2 Bank fees (pre-financing guarantee) 0,00 Associated with document Ref. Ares(2023)7314945 - 26/10/2023 3 Audit fees (CFS) 0,00 4 Project evaluation 0,00 [5 short name other] 0,00 [6 short name other] 0,00 Total goods, works and services for this WP 0,00 WORK PACKAGE 2 DISSEMINATION Costs Also part of other work Description of tasks/activities for which the goods/services (actual costs) packages? YES/NO and which are needed; types of goods services needed; how much WP Consumables 0,00 Conferences, seminars, workshops, trainings & events 0,00 Information & publications 0,00 Other expenses 1 IPR costs 0,00 2 Bank fees (pre-financing guarantee) 0,00 3 Audit fees (CFS) 0,00 4 Project evaluation 0,00 [5 short name other] 0,00 [6 short name other] 0,00 Total goods, works and services for this WP 0,00 WORK PACKAGE 3 EVALUATION Costs Also part of other work Description of tasks/activities for which the goods/services (actual costs) packages? YES/NO and which are needed; types of goods services needed; how much WP Consumables 0,00 Conferences, seminars, workshops, trainings & events 0,00 Information & publications 0,00 Other expenses 1 IPR costs 0,00 2 Bank fees (pre-financing guarantee) 0,00 3 Audit fees (CFS) 0,00 4 Project evaluation 0,00 [5 short name other] 0,00 [6 short name other] 0,00 Total goods, works and services for this WP 0,00 WORK PACKAGE 4 SUSTAINABILITY Costs Also part of other work Description of tasks/activities for which the goods/services (actual costs) packages? YES/NO and which are needed; types of goods services needed; how much WP Consumables 0,00 Conferences, seminars, workshops, trainings & events 0,00 Information & publications 0,00 Other expenses 1 IPR costs 0,00 2 Bank fees (pre-financing guarantee) 0,00 3 Audit fees (CFS) 0,00  4 Project evaluation 0,00 Associated with document Ref. Ares(2023)7314945 - 26/10/2023 [5 short name other] 0,00 [6 short name other] 0,00 Total goods, works and services for this WP 0,00 WORK PACKAGE 5 SETTING UP NATIONAL DATASET CATALOGUE Costs Also part of other work Description of tasks/activities for which the goods/services (actual costs) packages? YES/NO and which are needed; types of goods services needed; how much WP Consumables 0,00 Conferences, seminars, workshops, trainings & events 0,00 Information & publications 0,00 Other expenses 1 IPR costs 0,00 2 Bank fees (pre-financing guarantee) 0,00 3 Audit fees (CFS) 0,00 4 Project evaluation 0,00 [5 short name other] 0,00 [6 short name other] 0,00 Total goods, works and services for this WP 0,00 NATIONAL DATA ACCESS APPLICATION MANAGEMENT WORK PACKAGE 6 SYSTEM Costs Also part of other work Description of tasks/activities for which the goods/services (actual costs) packages? YES/NO and which are needed; types of goods services needed; how much WP Consumables 0,00 Conferences, seminars, workshops, trainings & events 0,00 Information & publications 0,00 Other expenses 1 IPR costs 0,00 2 Bank fees (pre-financing guarantee) 0,00 3 Audit fees (CFS) 0,00 4 Project evaluation 0,00 [5 short name other] 0,00 [6 short name other] 0,00 Total goods, works and services for this WP 0,00 WORK PACKAGE 7 SECURE PROCESSING ENVIRONMENTS Costs Also part of other work Description of tasks/activities for which the goods/services (actual costs) packages? YES/NO and which are needed; types of goods services needed; how much WP Consumables 0,00 Conferences, seminars, workshops, trainings & events 0,00 Information & publications 0,00 Other expenses 1 IPR costs 0,00 2 Bank fees (pre-financing guarantee) 0,00 3 Audit fees (CFS) 0,00 4 Project evaluation 0,00 [5 short name other] 0,00  [6 short name other] 0,00 Associated with document Ref. Ares(2023)7314945 - 26/10/2023 Total goods, works and services for this WP 0,00 WORK PACKAGE 8 CROSS-BORDER GATEWAY Costs Also part of other work Description of tasks/activities for which the goods/services (actual costs) packages? YES/NO and which are needed; types of goods services needed; how much WP Consumables 0,00 Conferences, seminars, workshops, trainings & events 0,00 Information & publications 0,00 Other expenses 1 IPR costs 0,00 2 Bank fees (pre-financing guarantee) 0,00 3 Audit fees (CFS) 0,00 4 Project evaluation 0,00 [5 short name other] 0,00 [6 short name other] 0,00 Total goods, works and services for this WP 0,00 WORK PACKAGE 9 DATASET DATA QUALITY IMPROVEMENT Costs Also part of other work Description of tasks/activities for which the goods/services (actual costs) packages? YES/NO and which are needed; types of goods services needed; how much WP Consumables 0,00 Conferences, seminars, workshops, trainings & events 0,00 Information & publications 0,00 Other expenses 1 IPR costs 0,00 2 Bank fees (pre-financing guarantee) 0,00 3 Audit fees (CFS) 0,00 4 Project evaluation 0,00 [5 short name other] 0,00 [6 short name other] 0,00 Total goods, works and services for this WP 0,00 Total goods, works and services (all WPs) 0,00 Total purchase costs (all WPs) 0,00 D. Other cost categories D.1. Financial support to third parties WORK PACKAGE 1 PROJECT MANAGEMENT AND COORDINATION Also used for other work Costs Description of support scheme (estimated number of Financial support to third parties packages? recipients; maximum amount per recipient) (actual costs) YES/NO and which WP [Support scheme short name] 0,00 [Support scheme short name] 0,00 0,00  Total other cost category D.1 for this WP 0,00 Associated with document Ref. Ares(2023)7314945 - 26/10/2023 WORK PACKAGE 2 DISSEMINATION Also used for other work Costs Description of support scheme (estimated number of Financial support to third parties packages? recipients; maximum amount per recipient) (actual costs) YES/NO and which WP [Support scheme short name] 0,00 [Support scheme short name] 0,00 0,00 Total other cost category D.1 for this WP 0,00 WORK PACKAGE 3 EVALUATION Also used for other work Costs Description of support scheme (estimated number of Financial support to third parties packages? recipients; maximum amount per recipient) (actual costs) YES/NO and which WP [Support scheme short name] 0,00 [Support scheme short name] 0,00 0,00 Total other cost category D.1 for this WP 0,00 WORK PACKAGE 4 SUSTAINABILITY Also used for other work Costs Description of support scheme (estimated number of Financial support to third parties packages? recipients; maximum amount per recipient) (actual costs) YES/NO and which WP [Support scheme short name] 0,00 [Support scheme short name] 0,00 0,00 Total other cost category D.1 for this WP 0,00 WORK PACKAGE 5 SETTING UP NATIONAL DATASET CATALOGUE Also used for other work Costs Description of support scheme (estimated number of Financial support to third parties packages? recipients; maximum amount per recipient) (actual costs) YES/NO and which WP [Support scheme short name] 0,00 [Support scheme short name] 0,00 0,00 Total other cost category D.1 for this WP 0,00 NATIONAL DATA ACCESS APPLICATION MANAGEMENT WORK PACKAGE 6 SYSTEM Also used for other work Costs Description of support scheme (estimated number of Financial support to third parties packages? recipients; maximum amount per recipient) (actual costs) YES/NO and which WP [Support scheme short name] 0,00 [Support scheme short name] 0,00 0,00 Total other cost category D.1 for this WP 0,00 WORK PACKAGE 7 SECURE PROCESSING ENVIRONMENTS Also used for other work Description of support scheme (estimated number of packages? recipients; maximum amount per recipient) YES/NO and which WP  Also used for other work Costs Description of support scheme (estimated number of Financial support to third parties packages? recipients; maximum amount per recipient) (actual costs) YES/NO and which WP Associated with document Ref. Ares(2023)7314945 - 26/10/2023 [Support scheme short name] 0,00 [Support scheme short name] 0,00 0,00 Total other cost category D.1 for this WP 0,00 WORK PACKAGE 8 CROSS-BORDER GATEWAY Also used for other work Costs Description of support scheme (estimated number of Financial support to third parties packages? recipients; maximum amount per recipient) (actual costs) YES/NO and which WP [Support scheme short name] 0,00 [Support scheme short name] 0,00 0,00 Total other cost category D.1 for this WP 0,00 WORK PACKAGE 9 DATASET DATA QUALITY IMPROVEMENT Also used for other work Costs Description of support scheme (estimated number of Financial support to third parties packages? recipients; maximum amount per recipient) (actual costs) YES/NO and which WP [Support scheme short name] 0,00 [Support scheme short name] 0,00 0,00 Total other cost category D.1 for this WP 0,00 Total D.1 (all WPs) 0,00 Total other cost categories (all WPs) 0,00 E. Indirect costs Costs (flat-rate) Total estimated direct costs (on which indirect cost flat-rate is based, 375 250,00 see GA eligibility article) ALL WORK PACKAGES Flat-rate (%) 7% ATTENTION! Check that the rate is in line with the call conditions. Put 0% if you receive an EU Operating Grant and are not eligible to charge indirect costs” Total indirect costs 26 267,50 Total indirect costs 26 267,50 TOTAL COSTS PARTICIPANT 401 517,50 PROJECT INCOME EU CONTRIBUTION (GRANT) Amount (EUR)  Total costs 401 517,50 Associated with document Ref. Ares(2023)7314945 - 26/10/2023 Single Funding rate (%) 80% ATTENTION! Enter funding rate from the call conditions. Maximum EU contribution 321 213,99 Requested EU contribution 321 213,99 ATTENTION❗ In order to avoid rounding issues, please request 1 cent less than the maximum EU contribution. EU CONTRIBUTION 321 213,99 REVENUES AND CONTRIBUTIONS BY THIRD PARTIES Revenues Income generated by the action Amount Description of the income (type of generated income and (EUR) number of users, etc) ALL WORK PACKAGES Estimated income generated by the action 0,00 Total income generated by the action 0,00 Revenues 0,00 In-kind contributions by third parties In-kind contributions by third parties Amount Description of the contribution (type of contribution, (EUR) donor, purpose etc) ALL WORK PACKAGES Estimated in-kind contributions by third parties 0,00 Total in-kind contributions 0,00 In-kind contributions 0,00 Financial contributions by third parties Financial contributions by third parties Amount Description of the contribution (type of contribution, (EUR) donor, purpose, etc) ALL WORK PACKAGES Estimated financial contributions by third parties 0,00 Total financial contributions 0,00 Financial contributions 0,00 TOTAL REVENUES AND CONTRIBUTIONS BY THIRD PARTIES 0,00 OWN RESOURCES Amount (EUR) Own resources 80 303,51 OWN RESOURCES 80 303,51 TOTAL INCOME PARTICIPANT 401 517,50  a Associated with document Ref. Ares(2023)7314945 - 26/10/2023 DETAILED BUDGET TABLE (ACTION GRANTS) Project number: 210933860 27.02.2023 01:49 Project acronym: EST2EHDS Participant short name: TEHIK Participant PIC: 912681925 ATTENTION: This table should be filled out one per participant (beneficiary, affiliated entity) ATTENTION: This table may ONLY contain eligible costs (i.e. costs that comply with the eligibility rules of the grant agreement that is part of your call documents). At proposal stage and during grant preparation, it should contain estimated costs/income. Costs must be estimated in EUR. ATTENTION! List each budgeted cost item ONLY once in this table, for the main WP. ATTENTION! White cells mean that you are required to enter data. Blue cells are calculated automatically. ACTION GRANT BUDGET TABLE (PER PARTICIPANT) PROJECT COSTS A. Personnel costs Costs (actual or unit costs) Time Rate Total Also working for other work ! monthly rates allowed for budgeting because simpler to establish the approximate costs; cost reporting will have to (months/other of work on Type of rate (amount) (EUR) packages? YES/NO and which Description of project role/activities/responsibilities be done according to MGA (usually daily rates) the action) (monthly/other) WP a b c=a*b WORK PACKAGE 1 PROJECT MANAGEMENT AND COORDINATION A.1 Employees (or equivalent) Project manager in technical aspects, managing TEHIK team and communication with EC. Working in close Project managers monthly 5 000,00 1,50 7 500,00 Yes, all WP-s collaboration with project manager from MoSA to achieve goals, ensure the deliverables to be delivered. Select a staff category monthly 0,00 0,00 0,00 Other [category 1] monthly 0,00 0,00 0,00 [category 2] monthly 0,00 0,00 0,00 Total employees (or equivalent) 7 500,00 A.2 + A.3 Natural persons under direct contract and seconded persons Select a staff category monthly 0,00 0,00 0,00 Select a staff category monthly 0,00 0,00 0,00 Other [category 1] monthly 0,00 0,00 0,00 [category 2] monthly 0,00 0,00 0,00 Total natural persons under direct contract and seconded persons 0,00 A.4 SME owners and natural person beneficiaries without salary SME owners/natural person beneficiaries without salary daily 0,00 0,00 0,00 Total SME owners and natural person beneficiaries without salary 0,00 Total personnel for this WP 7 500,00 WORK PACKAGE 2 DISSEMINATION Associated with document Ref. Ares(2023)7314945 - 26/10/2023 A.1 Employees (or equivalent) Project manager in technical aspects, managing TEHIK team and communication with EC. Working in close Project managers monthly 5 000,00 1,50 7 500,00 Yes, all WP-s collaboration with project manager from MoSA to achieve goals, ensure the deliverables to be delivered. Select a staff category monthly 0,00 0,00 0,00 Other [category 1] monthly 0,00 0,00 0,00 [category 2] monthly 0,00 0,00 0,00 Total employees (or equivalent) 7 500,00 A.2 + A.3 Natural persons under direct contract and seconded persons Select a staff category monthly 0,00 0,00 0,00 Select a staff category monthly 0,00 0,00 0,00 Other [category 1] monthly 0,00 0,00 0,00 [category 2] monthly 0,00 0,00 0,00 Total natural persons under direct contract and seconded persons 0,00 A.4 SME owners and natural person beneficiaries without salary SME owners/natural person beneficiaries without salary daily 0,00 0,00 0,00 Total SME owners and natural person beneficiaries without salary 0,00 Total personnel for this WP 7 500,00 WORK PACKAGE 3 EVALUATION A.1 Employees (or equivalent) Project manager in technical aspects, managing TEHIK team and communication with EC. Working in close Project managers monthly 5 000,00 1,50 7 500,00 Yes, all WP-s collaboration with project manager from MoSA to achieve goals, ensure the deliverables to be delivered. Project managers monthly 0,00 0,00 0,00 Select a staff category monthly 0,00 0,00 0,00 Other [category 1] monthly 0,00 0,00 0,00 [category 2] monthly 0,00 0,00 0,00 Total employees (or equivalent) 7 500,00 A.2 + A.3 Natural persons under direct contract and seconded persons Select a staff category monthly 0,00 0,00 0,00 Select a staff category monthly 0,00 0,00 0,00 Other [category 1] monthly 0,00 0,00 0,00 [category 2] monthly 0,00 0,00 0,00 Total natural persons under direct contract and seconded persons 0,00 A.4 SME owners and natural person beneficiaries without salary SME owners/natural person beneficiaries without salary daily 0,00 0,00 0,00 Total SME owners and natural person beneficiaries without salary 0,00 Total personnel for this WP 7 500,00 WORK PACKAGE 4 SUSTAINABILITY  A.1 Employees (or equivalent) Associated withmanager Project document Ref. Ares(2023)7314945 in technical - 26/10/2023 aspects, managing TEHIK team and communication with EC. Working in close Project managers monthly 5 000,00 1,50 7 500,00 Yes, all WP-s collaboration with project manager from MoSA to achieve goals, ensure the deliverables to be delivered. Select a staff category monthly 0,00 0,00 0,00 Other [category 1] monthly 0,00 0,00 0,00 [category 2] monthly 0,00 0,00 0,00 Total employees (or equivalent) 7 500,00 A.2 + A.3 Natural persons under direct contract and seconded persons Select a staff category monthly 0,00 0,00 0,00 Select a staff category monthly 0,00 0,00 0,00 Other [category 1] monthly 0,00 0,00 0,00 [category 2] monthly 0,00 0,00 0,00 Total natural persons under direct contract and seconded persons 0,00 A.4 SME owners and natural person beneficiaries without salary SME owners/natural person beneficiaries without salary daily 0,00 0,00 0,00 Total SME owners and natural person beneficiaries without salary 0,00 Total personnel for this WP 7 500,00 WORK PACKAGE 5 SETTING UP NATIONAL DATASET CATALOGUE A.1 Employees (or equivalent) Project manager in technical aspects, managing TEHIK team and communication with EC. Working in close Project managers monthly 5 000,00 12,00 60 000,00 Yes, all WP-s collaboration with project manager from MoSA to achieve goals, ensure the deliverables to be delivered. TEHIK software architect ensuring the deliverables are in line with common guidelines and best practices in TEHIK. Technical personnel monthly 5 000,00 6,00 30 000,00 Yes, WP 9 Aim is to develop and maintain systems interoperability, also intertwine with new technology platforms and newer practices. TEHIK data management specialist ensuring the development of high quality system and data management Technical personnel monthly 5 000,00 6,00 30 000,00 Yes, WP 9 done in line with common guidelines and best practices for EHDS Other [category 1] monthly 0,00 0,00 0,00 [category 2] monthly 0,00 0,00 0,00 Total employees (or equivalent) 120 000,00 A.2 + A.3 Natural persons under direct contract and seconded persons Select a staff category monthly 0,00 0,00 0,00 Select a staff category monthly 0,00 0,00 0,00 Other [category 1] monthly 0,00 0,00 0,00 [category 2] monthly 0,00 0,00 0,00 Total natural persons under direct contract and seconded persons 0,00 A.4 SME owners and natural person beneficiaries without salary SME owners/natural person beneficiaries without salary daily 0,00 0,00 0,00 Total SME owners and natural person beneficiaries without salary 0,00  Total personnel for this WP 120 000,00 NATIONAL DATA ACCESS APPLICATION MANAGEMENT Associated with document Ref. Ares(2023)7314945 - 26/10/2023 WORK PACKAGE 6 SYSTEM A.1 Employees (or equivalent) Project manager in technical aspects, managing TEHIK team and communication with EC. Working in close Project managers monthly 5 000,00 2,00 10 000,00 Yes, all WP-s collaboration with project manager from MoSA to achieve goals, ensure the deliverables to be delivered. Select a staff category monthly 0,00 0,00 0,00 Other [category 1] monthly 0,00 0,00 0,00 [category 2] monthly 0,00 0,00 0,00 Total employees (or equivalent) 10 000,00 A.2 + A.3 Natural persons under direct contract and seconded persons Select a staff category monthly 0,00 0,00 0,00 Select a staff category monthly 0,00 0,00 0,00 Other [category 1] monthly 0,00 0,00 0,00 [category 2] monthly 0,00 0,00 0,00 Total natural persons under direct contract and seconded persons 0,00 A.4 SME owners and natural person beneficiaries without salary SME owners/natural person beneficiaries without salary daily 0,00 0,00 0,00 Total SME owners and natural person beneficiaries without salary 0,00 Total personnel for this WP 10 000,00 WORK PACKAGE 7 SECURE PROCESSING ENVIRONMENTS A.1 Employees (or equivalent) Project manager in technical aspects, managing TEHIK team and communication with EC. Working in close Project managers monthly 5 000,00 2,00 10 000,00 Yes, all WP-s collaboration with project manager from MoSA to achieve goals, ensure the deliverables to be delivered. Select a staff category monthly 0,00 0,00 0,00 Other [category 1] monthly 0,00 0,00 0,00 [category 2] monthly 0,00 0,00 0,00 Total employees (or equivalent) 10 000,00 A.2 + A.3 Natural persons under direct contract and seconded persons Select a staff category monthly 0,00 0,00 0,00 Select a staff category monthly 0,00 0,00 0,00 Other [category 1] monthly 0,00 0,00 0,00 [category 2] monthly 0,00 0,00 0,00 Total natural persons under direct contract and seconded persons 0,00 A.4 SME owners and natural person beneficiaries without salary SME owners/natural person beneficiaries without salary daily 0,00 0,00 0,00 Total SME owners and natural person beneficiaries without salary 0,00 Total personnel for this WP 10 000,00 WORK PACKAGE 8 CROSS-BORDER GATEWAY  A.1 Employees (or equivalent) Associated withmanager Project document Ref. Ares(2023)7314945 in technical - 26/10/2023 aspects, managing TEHIK team and communication with EC. Working in close Project managers monthly 5 000,00 2,00 10 000,00 Yes, all WP-s collaboration with project manager from MoSA to achieve goals, ensure the deliverables to be delivered. Select a staff category monthly 0,00 0,00 0,00 Other [category 1] monthly 0,00 0,00 0,00 [category 2] monthly 0,00 0,00 0,00 Total employees (or equivalent) 10 000,00 A.2 + A.3 Natural persons under direct contract and seconded persons Select a staff category monthly 0,00 0,00 0,00 Select a staff category monthly 0,00 0,00 0,00 Other [category 1] monthly 0,00 0,00 0,00 [category 2] monthly 0,00 0,00 0,00 Total natural persons under direct contract and seconded persons 0,00 A.4 SME owners and natural person beneficiaries without salary SME owners/natural person beneficiaries without salary daily 0,00 0,00 0,00 Total SME owners and natural person beneficiaries without salary 0,00 Total personnel for this WP 10 000,00 WORK PACKAGE 9 DATASET DATA QUALITY IMPROVEMENT A.1 Employees (or equivalent) Project manager in technical aspects, managing TEHIK team and communication with EC. Working in close Project managers monthly 5 000,00 12,00 60 000,00 Yes, all WP-s collaboration with project manager from MoSA to achieve goals, ensure the deliverables to be delivered. TEHIK software architect ensuring the deliverables are in line with common guidelines and best practices in TEHIK. Technical personnel monthly 5 000,00 6,00 30 000,00 Yes, WP5 Aim is to develop and maintain systems interoperability, also intertwine with new technology platforms and newer practices. TEHIK data management specialist ensuring the development of high quality system and data management Technical personnel monthly 5 000,00 6,00 30 000,00 Yes, WP5 done in line with common guidelines and best practices for EHDS. Responsible for analyses as well. TEHIK data quality managing specialist responsible for Technical personnel monthly 5 000,00 36,00 180 000,00 No data quality tasks described in this WP. TEHIK data quality managing specialist responsible for Technical personnel monthly 5 000,00 36,00 180 000,00 No data quality tasks described in this WP. Other [category 1] monthly 0,00 0,00 0,00 [category 2] monthly 0,00 0,00 0,00 Total employees (or equivalent) 480 000,00 A.2 + A.3 Natural persons under direct contract and seconded persons Select a staff category monthly 0,00 0,00 0,00 Select a staff category monthly 0,00 0,00 0,00 Other [category 1] monthly 0,00 0,00 0,00 [category 2] monthly 0,00 0,00 0,00 Total natural persons under direct contract and seconded persons 0,00  A.4 SME owners and natural person beneficiaries without salary Associated with document Ref. Ares(2023)7314945 - 26/10/2023 SME owners/natural person beneficiaries without salary daily 0,00 0,00 0,00 Total SME owners and natural person beneficiaries without salary 0,00 Total personnel for this WP 480 000,00 Total personnel (all WPs) 660 000,00 B. Subcontracting costs Also used for other work Costs packages? Description of subcontracted project tasks/activities (actual costs) YES/NO and which WP WORK PACKAGE 1 PROJECT MANAGEMENT AND COORDINATION 1 [Subcontract short name] 0,00 2 [Subcontract short name] 0,00 Total subcontracting for this WP 0,00 WORK PACKAGE 2 DISSEMINATION 1 [Subcontract short name] 0,00 2 [Subcontract short name] 0,00 Total subcontracting for this WP 0,00 WORK PACKAGE 3 EVALUATION 1 [Subcontract short name] 0,00 2 [Subcontract short name] 0,00 Total subcontracting for this WP 0,00 WORK PACKAGE 4 SUSTAINABILITY 1 [Subcontract short name] 0,00 2 [Subcontract short name] 0,00 Total subcontracting for this WP 0,00 WORK PACKAGE 5 SETTING UP NATIONAL DATASET CATALOGUE Development of environment for managing classifiers, managing of OID-s, data modelling portal with special 1 [IT development] 517 500,00 functionalities for national health authorities, including licence for terminology server Development of Information Portal accessible to data users on national level and cross-border, facilitating the 2 [IT development] 100 000,00 transition from document-based to more granular data exchange. Development for displaying HIS datasets in HDAB-s Data 3 [IT development] 197 500,00 Modelling Portal in non-machine readable form, mapping datasets CDA-FHIR Total subcontracting for this WP 815 000,00 NATIONAL DATA ACCESS APPLICATION MANAGEMENT WORK PACKAGE 6 SYSTEM 1 [Subcontract short name] 0,00 Total subcontracting for this WP 0,00 WORK PACKAGE 7 SECURE PROCESSING ENVIRONMENTS 1 [Subcontract short name] 0,00 Total subcontracting for this WP 0,00 WORK PACKAGE 8 CROSS-BORDER GATEWAY 1 [Subcontract short name] 0,00 Total subcontracting for this WP 0,00 WORK PACKAGE 9 DATASET DATA QUALITY IMPROVEMENT  Development of data control module used to monitor and 1 [IT development] 300 000,00 ensure data quality. Associated with document Ref. Ares(2023)7314945 - 26/10/2023 2 [Subcontract short name] 0,00 Total subcontracting for this WP 300 000,00 Total subcontracting (all WPs) 1 115 000,00 C. Purchase costs C.1 Travel and subsistence Costs Description (e.g. international/not international; place of Costs (unit cost) Also part of other work activity/destination; number of days; number of persons (actual costs) packages? (speakers, personnel and participants whose costs are Amount per Total YES/NO and which WP covered); transport means; average price per person; Number of units unit ( EUR) subsistence costs/daily allowances) WORK PACKAGE 1 PROJECT MANAGEMENT AND COORDINATION 1 [Travel short name] Speakers Travel costs 0,00 0,00 0,00 0,00 Accommodation costs 0,00 0,00 0,00 0,00 Subsistence costs 0,00 0,00 0,00 0,00 Personnel Travel costs 0,00 0,00 0,00 0,00 Accommodation costs 0,00 0,00 0,00 0,00 Subsistence costs 0,00 0,00 0,00 0,00 Participants Travel costs 0,00 0,00 0,00 0,00 Accommodation costs 0,00 0,00 0,00 0,00 Subsistence costs 0,00 0,00 0,00 0,00 Total travel costs for this travel 0,00 Total accommodation costs for this travel 0,00 Total subsistence costs for this travel 0,00 Total travel 0,00 Total travel costs for this WP 0,00 Total accommodation costs for this WP 0,00 Total subsistence costs for this WP 0,00 Total travel for this WP 0,00 0,00 WORK PACKAGE 2 DISSEMINATION Total travel costs for this WP 0,00 Total accommodation costs for this WP 0,00 Total subsistence costs for this WP 0,00 Total travel for this WP 0,00 0,00 WORK PACKAGE 3 EVALUATION Total travel costs for this WP 0,00 Total accommodation costs for this WP 0,00 Total subsistence costs for this WP 0,00 Total travel for this WP 0,00 0,00 WORK PACKAGE 4 SUSTAINABILITY Total travel costs for this WP 0,00  Total accommodation costs for this WP 0,00 Associated with document Ref. Ares(2023)7314945 - 26/10/2023 Total subsistence costs for this WP 0,00 Total travel for this WP 0,00 0,00 WORK PACKAGE 5 SETTING UP NATIONAL DATASET CATALOGUE Total travel costs for this WP 0,00 Total accommodation costs for this WP 0,00 Total subsistence costs for this WP 0,00 Total travel for this WP 0,00 0,00 NATIONAL DATA ACCESS APPLICATION MANAGEMENT WORK PACKAGE 6 SYSTEM Total travel costs for this WP 0,00 Total accommodation costs for this WP 0,00 Total subsistence costs for this WP 0,00 Total travel for this WP 0,00 0,00 WORK PACKAGE 7 SECURE PROCESSING ENVIRONMENTS Total travel costs for this WP 0,00 Total accommodation costs for this WP 0,00 Total subsistence costs for this WP 0,00 Total travel for this WP 0,00 0,00 WORK PACKAGE 8 CROSS-BORDER GATEWAY Total travel costs for this WP 0,00 Total accommodation costs for this WP 0,00 Total subsistence costs for this WP 0,00 Total travel for this WP 0,00 0,00 WORK PACKAGE 9 DATASET DATA QUALITY IMPROVEMENT Total travel costs for this WP 0,00 Total accommodation costs for this WP 0,00 Total subsistence costs for this WP 0,00 Total travel for this WP 0,00 0,00 Total travel costs (all WPs) 0,00 Total accommodation (all WPs) 0,00 Total subsistence (all WPs) 0,00 Total travel and subsistence (all WPs) 0,00 C.2 Equipment WORK PACKAGE 1 PROJECT MANAGEMENT AND COORDINATION C.2.1 Purchase (depreciation/full cost) Costs (actual costs) Depreciation Rate of use for the Also part of other work method (e.g. Number of months action (100% or Total Description of tasks/activities for which the equipment is Price packages? YES/NO and which 36 month or 60 allocated to the action less if used also for (EUR) needed WP month) other purposes) a b c d e =(c/b *d) * a 1 [Equipment short name] 0,00 0 0,00 0% 0,00 2 [Equipment short name] 0,00 0 0,00 0% 0,00 ATTENTION! Can be used only if full cost option in the grant 3 [Equipment short name] 0,00 0,00 agreement Total depreciation 0,00  C.2.2 Rental and leasing (rate of use/full cost) Costs (actual costs) Associated with document Ref. Ares(2023)7314945 - 26/10/2023 Rate of use for the Also part of other work action (100% or Total Description of tasks/activities for which the equipment is Monthly rent/fee Number of months of use for the action packages? YES/NO and which less if used also for (EUR) needed WP other purposes) a b c d= a*b*c 1 [Equipment short name] 0,00 0,00 0% 0,00 2 [Equipment short name] 0,00 0,00 0% 0,00 ATTENTION! Can be used only if full cost option in the grant 3 [Equipment short name] 0,00 0,00 agreement Total rental and leasing 0,00 Total equipment for this WP 0,00 WORK PACKAGE 2 DISSEMINATION C.2.1 Purchase (depreciation/full cost) Costs (actual costs) Depreciation Rate of use for the Also part of other work method (e.g. Number of months action (100% or Total Description of tasks/activities for which the equipment is Price packages? YES/NO and which 36 month or 60 allocated to the action less if used also for (EUR) needed WP month) other purposes) a b c d e =(c/b *d) * a 1 [Equipment short name] 0,00 0 0,00 0% 0,00 2 [Equipment short name] 0,00 0 0,00 0% 0,00 ATTENTION! Can be used only if full cost option in the grant 3 [Equipment short name] 0,00 0,00 agreement Total depreciation 0,00 C.2.2 Rental and leasing (rate of use/full cost) Costs (actual costs) Rate of use for the Also part of other work action (100% or Total Description of tasks/activities for which the equipment is Monthly rent/fee Number of months of use for the action packages? YES/NO and which less if used also for (EUR) needed WP other purposes) a b c d= a*b*c 1 [Equipment short name] 0,00 0,00 0% 0,00 2 [Equipment short name] 0,00 0,00 0% 0,00 ATTENTION! Can be used only if full cost option in the grant 3 [Equipment short name] 0,00 0,00 agreement Total rental and leasing 0,00 Total equipment for this WP 0,00 WORK PACKAGE 3 EVALUATION C.2.1 Purchase (depreciation/full cost) Costs (actual costs) Depreciation Rate of use for the Also part of other work method (e.g. Number of months action (100% or Total Description of tasks/activities for which the equipment is Price packages? YES/NO and which 36 month or 60 allocated to the action less if used also for (EUR) needed WP month) other purposes) a b c d e =(c/b *d) * a 1 [Equipment short name] 0,00 0 0,00 0% 0,00 2 [Equipment short name] 0,00 0 0,00 0% 0,00 ATTENTION! Can be used only if full cost option in the grant 3 [Equipment short name] 0,00 0,00 agreement Total depreciation 0,00 C.2.2 Rental and leasing (rate of use/full cost) Costs (actual costs) Rate of use for the Also part of other work action (100% or Total Description of tasks/activities for which the equipment is Monthly rent/fee Number of months of use for the action packages? YES/NO and which less if used also for (EUR) needed WP other purposes) a b c d= a*b*c 1 [Equipment short name] 0,00 0,00 0% 0,00 2 [Equipment short name] 0,00 0,00 0% 0,00  ATTENTION! Can be used only if full cost option in the grant 3 [Equipment short name] 0,00 0,00 agreement Associated with document Ref. Ares(2023)7314945 - 26/10/2023 Total rental and leasing 0,00 Total equipment for this WP 0,00 WORK PACKAGE 4 SUSTAINABILITY C.2.1 Purchase (depreciation/full cost) Costs (actual costs) Depreciation Rate of use for the Also part of other work method (e.g. Number of months action (100% or Total Description of tasks/activities for which the equipment is Price packages? YES/NO and which 36 month or 60 allocated to the action less if used also for (EUR) needed WP month) other purposes) a b c d e =(c/b *d) * a 1 [Equipment short name] 0,00 0 0,00 0% 0,00 2 [Equipment short name] 0,00 0 0,00 0% 0,00 ATTENTION! Can be used only if full cost option in the grant 3 [Equipment short name] 0,00 0,00 agreement Total depreciation 0,00 C.2.2 Rental and leasing (rate of use/full cost) Costs (actual costs) Rate of use for the Also part of other work action (100% or Total Description of tasks/activities for which the equipment is Monthly rent/fee Number of months of use for the action packages? YES/NO and which less if used also for (EUR) needed WP other purposes) a b c d= a*b*c 1 [Equipment short name] 0,00 0,00 0% 0,00 2 [Equipment short name] 0,00 0,00 0% 0,00 ATTENTION! Can be used only if full cost option in the grant 3 [Equipment short name] 0,00 0,00 agreement Total rental and leasing 0,00 Total equipment for this WP 0,00 WORK PACKAGE 5 SETTING UP NATIONAL DATASET CATALOGUE C.2.1 Purchase (depreciation/full cost) Costs (actual costs) Depreciation Rate of use for the Also part of other work method (e.g. Number of months action (100% or Total Description of tasks/activities for which the equipment is Price packages? YES/NO and which 36 month or 60 allocated to the action less if used also for (EUR) needed WP month) other purposes) a b c d e =(c/b *d) * a 1 [Equipment short name] 0,00 0 0,00 0% 0,00 2 [Equipment short name] 0,00 0 0,00 0% 0,00 ATTENTION! Can be used only if full cost option in the grant 3 [Equipment short name] 0,00 0,00 agreement Total depreciation 0,00 C.2.2 Rental and leasing (rate of use/full cost) Costs (actual costs) Rate of use for the Also part of other work action (100% or Total Description of tasks/activities for which the equipment is Monthly rent/fee Number of months of use for the action packages? YES/NO and which less if used also for (EUR) needed WP other purposes) a b c d= a*b*c 1 [Equipment short name] 0,00 0,00 0% 0,00 2 [Equipment short name] 0,00 0,00 0% 0,00 ATTENTION! Can be used only if full cost option in the grant 3 [Equipment short name] 0,00 0,00 agreement Total rental and leasing 0,00 Total equipment for this WP 0,00 NATIONAL DATA ACCESS APPLICATION MANAGEMENT WORK PACKAGE 6 SYSTEM C.2.1 Purchase (depreciation/full cost) Costs (actual costs) Depreciation Rate of use for the Also part of other work method (e.g. Number of months action (100% or Total Description of tasks/activities for which the equipment is Price packages? YES/NO and which 36 month or 60 allocated to the action less if used also for (EUR) needed WP month) other purposes)  Depreciation Rate of use for the Also part of other work method (e.g. Number of months action (100% or Total Description of tasks/activities for which the equipment is Price packages? YES/NO and which 36 month or 60 allocated to the action less if used also for (EUR) needed WP month) other purposes) a b c d e =(c/b *d) * a Associated with document Ref. Ares(2023)7314945 - 26/10/2023 1 [Equipment short name] 0,00 0 0,00 0% 0,00 2 [Equipment short name] 0,00 0 0,00 0% 0,00 ATTENTION! Can be used only if full cost option in the grant 3 [Equipment short name] 0,00 0,00 agreement Total depreciation 0,00 C.2.2 Rental and leasing (rate of use/full cost) Costs (actual costs) Rate of use for the Also part of other work action (100% or Total Description of tasks/activities for which the equipment is Monthly rent/fee Number of months of use for the action packages? YES/NO and which less if used also for (EUR) needed WP other purposes) a b c d= a*b*c 1 [Equipment short name] 0,00 0,00 0% 0,00 2 [Equipment short name] 0,00 0,00 0% 0,00 ATTENTION! Can be used only if full cost option in the grant 3 [Equipment short name] 0,00 0,00 agreement Total rental and leasing 0,00 Total equipment for this WP 0,00 WORK PACKAGE 7 SECURE PROCESSING ENVIRONMENTS C.2.1 Purchase (depreciation/full cost) Costs (actual costs) Depreciation Rate of use for the Also part of other work method (e.g. Number of months action (100% or Total Description of tasks/activities for which the equipment is Price packages? YES/NO and which 36 month or 60 allocated to the action less if used also for (EUR) needed WP month) other purposes) a b c d e =(c/b *d) * a 1 [Equipment short name] 0,00 0 0,00 0% 0,00 2 [Equipment short name] 0,00 0 0,00 0% 0,00 ATTENTION! Can be used only if full cost option in the grant 3 [Equipment short name] 0,00 0,00 agreement Total depreciation 0,00 C.2.2 Rental and leasing (rate of use/full cost) Costs (actual costs) Rate of use for the Also part of other work action (100% or Total Description of tasks/activities for which the equipment is Monthly rent/fee Number of months of use for the action packages? YES/NO and which less if used also for (EUR) needed WP other purposes) a b c d= a*b*c 1 [Equipment short name] 0,00 0,00 0% 0,00 2 [Equipment short name] 0,00 0,00 0% 0,00 ATTENTION! Can be used only if full cost option in the grant 3 [Equipment short name] 0,00 0,00 agreement Total rental and leasing 0,00 Total equipment for this WP 0,00 WORK PACKAGE 8 CROSS-BORDER GATEWAY C.2.1 Purchase (depreciation/full cost) Costs (actual costs) Depreciation Rate of use for the Also part of other work method (e.g. Number of months action (100% or Total Description of tasks/activities for which the equipment is Price packages? YES/NO and which 36 month or 60 allocated to the action less if used also for (EUR) needed WP month) other purposes) a b c d e =(c/b *d) * a 1 [Equipment short name] 0,00 0 0,00 0% 0,00 2 [Equipment short name] 0,00 0 0,00 0% 0,00 ATTENTION! Can be used only if full cost option in the grant 3 [Equipment short name] 0,00 0,00 agreement Total depreciation 0,00 C.2.2 Rental and leasing (rate of use/full cost) Costs (actual costs) Also part of other work Description of tasks/activities for which the equipment is packages? YES/NO and which  Rate of use for the Also part of other work action (100% or Total Description of tasks/activities for which the equipment is Monthly rent/fee Number of months of use for the action packages? YES/NO and Associated which with document Ref. Ares(2023)7314945 - 26/10/2023 less if used also for (EUR) needed WP other purposes) a b c d= a*b*c 1 [Equipment short name] 0,00 0,00 0% 0,00 2 [Equipment short name] 0,00 0,00 0% 0,00 ATTENTION! Can be used only if full cost option in the grant 3 [Equipment short name] 0,00 0,00 agreement Total rental and leasing 0,00 Total equipment for this WP 0,00 WORK PACKAGE 9 DATASET DATA QUALITY IMPROVEMENT C.2.1 Purchase (depreciation/full cost) Costs (actual costs) Depreciation Rate of use for the Also part of other work method (e.g. Number of months action (100% or Total Description of tasks/activities for which the equipment is Price packages? YES/NO and which 36 month or 60 allocated to the action less if used also for (EUR) needed WP month) other purposes) a b c d e =(c/b *d) * a 1 [Equipment short name] 0,00 0 0,00 0% 0,00 2 [Equipment short name] 0,00 0 0,00 0% 0,00 ATTENTION! Can be used only if full cost option in the grant 3 [Equipment short name] 0,00 0,00 agreement Total depreciation 0,00 C.2.2 Rental and leasing (rate of use/full cost) Costs (actual costs) Rate of use for the Also part of other work action (100% or Total Description of tasks/activities for which the equipment is Monthly rent/fee Number of months of use for the action packages? YES/NO and which less if used also for (EUR) needed WP other purposes) a b c d= a*b*c 1 [Equipment short name] 0,00 0,00 0% 0,00 2 [Equipment short name] 0,00 0,00 0% 0,00 ATTENTION! Can be used only if full cost option in the grant 3 [Equipment short name] 0,00 0,00 agreement Total rental and leasing 0,00 Total equipment for this WP 0,00 Total equipment (all WPs) 0,00 C.3 Other goods, works and services WORK PACKAGE 1 PROJECT MANAGEMENT AND COORDINATION Costs Also part of other work Description of tasks/activities for which the goods/services (actual costs) packages? YES/NO and which are needed; types of goods services needed; how much WP Consumables 0,00 Conferences, seminars, workshops, trainings & events 0,00 Information & publications 0,00 Other expenses 1 IPR costs 0,00 2 Bank fees (pre-financing guarantee) 0,00 3 Audit fees (CFS) 5 000,00 4 Project evaluation 0,00 [5 short name other] 0,00 [6 short name other] 0,00 Total goods, works and services for this WP 5 000,00 WORK PACKAGE 2 DISSEMINATION Costs Associated with document Ref. Ares(2023)7314945 - 26/10/2023 Also part of other work Description of tasks/activities for which the goods/services (actual costs) packages? YES/NO and which are needed; types of goods services needed; how much WP Consumables 0,00 Conferences, seminars, workshops, trainings & events 0,00 Information & publications 0,00 Other expenses 1 IPR costs 0,00 2 Bank fees (pre-financing guarantee) 0,00 3 Audit fees (CFS) 0,00 4 Project evaluation 0,00 [5 short name other] 0,00 [6 short name other] 0,00 Total goods, works and services for this WP 0,00 WORK PACKAGE 3 EVALUATION Costs Also part of other work Description of tasks/activities for which the goods/services (actual costs) packages? YES/NO and which are needed; types of goods services needed; how much WP Consumables 0,00 Conferences, seminars, workshops, trainings & events 0,00 Information & publications 0,00 Other expenses 1 IPR costs 0,00 2 Bank fees (pre-financing guarantee) 0,00 3 Audit fees (CFS) 0,00 4 Project evaluation 0,00 [5 short name other] 0,00 [6 short name other] 0,00 Total goods, works and services for this WP 0,00 WORK PACKAGE 4 SUSTAINABILITY Costs Also part of other work Description of tasks/activities for which the goods/services (actual costs) packages? YES/NO and which are needed; types of goods services needed; how much WP Consumables 0,00 Conferences, seminars, workshops, trainings & events 0,00 Information & publications 0,00 Other expenses 1 IPR costs 0,00 2 Bank fees (pre-financing guarantee) 0,00 3 Audit fees (CFS) 0,00 4 Project evaluation 0,00 [5 short name other] 0,00 [6 short name other] 0,00 Total goods, works and services for this WP 0,00 WORK PACKAGE 5 SETTING UP NATIONAL DATASET CATALOGUE Costs Also part of other work Description of tasks/activities for which the goods/services (actual costs) packages? YES/NO and which are needed; types of goods services needed; how much WP  Consumables 0,00 Associated with document Ref. Ares(2023)7314945 - 26/10/2023 Conferences, seminars, workshops, trainings & events 0,00 Information & publications 0,00 Other expenses 1 IPR costs 0,00 2 Bank fees (pre-financing guarantee) 0,00 3 Audit fees (CFS) 0,00 4 Project evaluation 0,00 [5 short name other] 0,00 [6 short name other] 0,00 Total goods, works and services for this WP 0,00 NATIONAL DATA ACCESS APPLICATION MANAGEMENT WORK PACKAGE 6 SYSTEM Costs Also part of other work Description of tasks/activities for which the goods/services (actual costs) packages? YES/NO and which are needed; types of goods services needed; how much WP Consumables 0,00 Conferences, seminars, workshops, trainings & events 0,00 Information & publications 0,00 Other expenses 1 IPR costs 0,00 2 Bank fees (pre-financing guarantee) 0,00 3 Audit fees (CFS) 0,00 4 Project evaluation 0,00 [5 short name other] 0,00 [6 short name other] 0,00 Total goods, works and services for this WP 0,00 WORK PACKAGE 7 SECURE PROCESSING ENVIRONMENTS Costs Also part of other work Description of tasks/activities for which the goods/services (actual costs) packages? YES/NO and which are needed; types of goods services needed; how much WP Consumables 0,00 Conferences, seminars, workshops, trainings & events 0,00 Information & publications 0,00 Other expenses 1 IPR costs 0,00 2 Bank fees (pre-financing guarantee) 0,00 3 Audit fees (CFS) 0,00 4 Project evaluation 0,00 [5 short name other] 0,00 [6 short name other] 0,00 Total goods, works and services for this WP 0,00 WORK PACKAGE 8 CROSS-BORDER GATEWAY Costs Also part of other work Description of tasks/activities for which the goods/services (actual costs) packages? YES/NO and which are needed; types of goods services needed; how much WP Consumables 0,00 Conferences, seminars, workshops, trainings & events 0,00  Information & publications 0,00 Associated with document Ref. Ares(2023)7314945 - 26/10/2023 Other expenses 1 IPR costs 0,00 2 Bank fees (pre-financing guarantee) 0,00 3 Audit fees (CFS) 0,00 4 Project evaluation 0,00 [5 short name other] 0,00 [6 short name other] 0,00 Total goods, works and services for this WP 0,00 WORK PACKAGE 9 DATASET DATA QUALITY IMPROVEMENT Costs Also part of other work Description of tasks/activities for which the goods/services (actual costs) packages? YES/NO and which are needed; types of goods services needed; how much WP Consumables 0,00 Conferences, seminars, workshops, trainings & events 0,00 Information & publications 0,00 Other expenses 1 IPR costs 0,00 2 Bank fees (pre-financing guarantee) 0,00 3 Audit fees (CFS) 0,00 4 Project evaluation 0,00 [5 short name other] 0,00 [6 short name other] 0,00 Total goods, works and services for this WP 0,00 Total goods, works and services (all WPs) 5 000,00 Total purchase costs (all WPs) 5 000,00 D. Other cost categories D.1. Financial support to third parties WORK PACKAGE 1 PROJECT MANAGEMENT AND COORDINATION Also used for other work Costs Description of support scheme (estimated number of Financial support to third parties packages? recipients; maximum amount per recipient) (actual costs) YES/NO and which WP [Support scheme short name] 0,00 [Support scheme short name] 0,00 0,00 Total other cost category D.1 for this WP 0,00 WORK PACKAGE 2 DISSEMINATION Also used for other work Costs Description of support scheme (estimated number of Financial support to third parties packages? recipients; maximum amount per recipient) (actual costs) YES/NO and which WP [Support scheme short name] 0,00 [Support scheme short name] 0,00  0,00 Associated with document Ref. Ares(2023)7314945 - 26/10/2023 Total other cost category D.1 for this WP 0,00 WORK PACKAGE 3 EVALUATION Also used for other work Costs Description of support scheme (estimated number of Financial support to third parties packages? recipients; maximum amount per recipient) (actual costs) YES/NO and which WP [Support scheme short name] 0,00 [Support scheme short name] 0,00 0,00 Total other cost category D.1 for this WP 0,00 WORK PACKAGE 4 SUSTAINABILITY Also used for other work Costs Description of support scheme (estimated number of Financial support to third parties packages? recipients; maximum amount per recipient) (actual costs) YES/NO and which WP [Support scheme short name] 0,00 [Support scheme short name] 0,00 0,00 Total other cost category D.1 for this WP 0,00 WORK PACKAGE 5 SETTING UP NATIONAL DATASET CATALOGUE Also used for other work Costs Description of support scheme (estimated number of Financial support to third parties packages? recipients; maximum amount per recipient) (actual costs) YES/NO and which WP [Support scheme short name] 0,00 [Support scheme short name] 0,00 0,00 Total other cost category D.1 for this WP 0,00 NATIONAL DATA ACCESS APPLICATION MANAGEMENT WORK PACKAGE 6 SYSTEM Also used for other work Costs Description of support scheme (estimated number of Financial support to third parties packages? recipients; maximum amount per recipient) (actual costs) YES/NO and which WP [Support scheme short name] 0,00 [Support scheme short name] 0,00 0,00 Total other cost category D.1 for this WP 0,00 WORK PACKAGE 7 SECURE PROCESSING ENVIRONMENTS Also used for other work Costs Description of support scheme (estimated number of Financial support to third parties packages? recipients; maximum amount per recipient) (actual costs) YES/NO and which WP [Support scheme short name] 0,00 [Support scheme short name] 0,00 0,00 Total other cost category D.1 for this WP 0,00 WORK PACKAGE 8 CROSS-BORDER GATEWAY  Also used for other work AssociatedDescription with document Ref. Ares(2023)7314945 - 26/10/2023 Costs of support scheme (estimated number of Financial support to third parties packages? recipients; maximum amount per recipient) (actual costs) YES/NO and which WP [Support scheme short name] 0,00 [Support scheme short name] 0,00 0,00 Total other cost category D.1 for this WP 0,00 WORK PACKAGE 9 DATASET DATA QUALITY IMPROVEMENT Also used for other work Costs Description of support scheme (estimated number of Financial support to third parties packages? recipients; maximum amount per recipient) (actual costs) YES/NO and which WP [Support scheme short name] 0,00 [Support scheme short name] 0,00 0,00 Total other cost category D.1 for this WP 0,00 Total D.1 (all WPs) 0,00 Total other cost categories (all WPs) 0,00 E. Indirect costs Costs (flat-rate) Total estimated direct costs (on which indirect cost flat-rate is based, 1 780 000,00 see GA eligibility article) ALL WORK PACKAGES Flat-rate (%) 7% ATTENTION! Check that the rate is in line with the call conditions. Put 0% if you receive an EU Operating Grant and are not eligible to charge indirect costs” Total indirect costs 124 600,00 Total indirect costs 124 600,00 TOTAL COSTS PARTICIPANT 1 904 600,00 PROJECT INCOME EU CONTRIBUTION (GRANT) Amount (EUR) Total costs 1 904 600,00 Single Funding rate (%) 80% ATTENTION! Enter funding rate from the call conditions. Maximum EU contribution 1 523 680,00 Requested EU contribution 1 523 679,99 ATTENTION❗ In order to avoid rounding issues, please request 1 cent less than the maximum EU contribution. EU CONTRIBUTION 1 523 679,99 REVENUES AND CONTRIBUTIONS BY THIRD PARTIES Revenues Associated with document Ref. Ares(2023)7314945 - 26/10/2023 Income generated by the action Amount Description of the income (type of generated income and (EUR) number of users, etc) ALL WORK PACKAGES Estimated income generated by the action 0,00 Total income generated by the action 0,00 Revenues 0,00 In-kind contributions by third parties In-kind contributions by third parties Amount Description of the contribution (type of contribution, (EUR) donor, purpose etc) ALL WORK PACKAGES Estimated in-kind contributions by third parties 0,00 Total in-kind contributions 0,00 In-kind contributions 0,00 Financial contributions by third parties Financial contributions by third parties Amount Description of the contribution (type of contribution, (EUR) donor, purpose, etc) ALL WORK PACKAGES Estimated financial contributions by third parties 0,00 Total financial contributions 0,00 Financial contributions 0,00 TOTAL REVENUES AND CONTRIBUTIONS BY THIRD PARTIES 0,00 OWN RESOURCES Amount (EUR) Own resources 380 920,01 OWN RESOURCES 380 920,01 TOTAL INCOME PARTICIPANT 1 904 600,00  DETAILED BUDGET TABLE (ACTION GRANTS) Associated with document Ref. Ares(2023)7314945 - 26/10/2023 Project number: 210933860 Project acronym: EST2EHDS Participant short name: MSAE Participant PIC: 998429731 CONSOLIDATED COSTS PER WORK PACKAGE (PER PARTICIPANT) COSTS PER WORK PACKAGE A.1 Employees C. Purchase costs D. Other cost categories A.2 + A.3 Natural persons B. Subcontracting E. Indirect costs under direct contract and A.4 SME owners costs Total seconded persons C.1 Travel and C.3 Other goods, D.1 Financial support to C.1 Travel C.1 Accommodation C.1 Subsistence C.2 Equipment subsistence work and services third parties e = flat-rate * (a1 + a2 + a3 + a5 + b [+ a1 - a2 a3 b c1 c1a c1b c1c c2 c3 d1 c1] + [c1a + c1b + c1c] + c2 + c3 + d1 + d2 + d3 + d4 + d5 + d6) WP1 PROJECT MANAGEMENT AND 17 500,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 17 500,00 COORDINATION WP2 DISSEMINATION 9 450,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 9 450,00 WP3 EVALUATION 9 800,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 9 800,00 WP4 SUSTAINABILITY 7 000,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 7 000,00 WP5 SETTING UP NATIONAL DATASET 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 CATALOGUE WP6 NATIONAL DATA ACCESS APPLICATION 10 500,00 0,00 100 000,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 110 500,00 MANAGEMENT SYSTEM WP7 SECURE PROCESSING ENVIRONMENTS 10 500,00 0,00 100 000,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 110 500,00 WP8 CROSS-BORDER GATEWAY 10 500,00 0,00 100 000,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 110 500,00 WP9 DATASET DATA QUALITY IMPROVEMENT 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 TOTAL COSTS PARTICIPANT 75 250,00 0,00 300 000,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 26 267,50 401 517,50  DETAILED BUDGET TABLE (ACTION GRANTS) Associated with document Ref. Ares(2023)7314945 - 26/10/2023 Project number: 210933860 Project acronym: EST2EHDS Participant short name: TEHIK Participant PIC: 912681925 CONSOLIDATED COSTS PER WORK PACKAGE (PER PARTICIPANT) COSTS PER WORK PACKAGE A.1 Employees C. Purchase costs D. Other cost categories A.2 + A.3 Natural persons B. Subcontracting E. Indirect costs under direct contract and A.4 SME owners costs Total seconded persons C.1 Travel and C.3 Other goods, D.1 Financial support to C.1 Travel C.1 Accommodation C.1 Subsistence C.2 Equipment subsistence work and services third parties e = flat-rate * (a1 + a2 + a3 + a5 + b [+ a1 - a2 a3 b c1 c1a c1b c1c c2 c3 d1 c1] + [c1a + c1b + c1c] + c2 + c3 + d1 + d2 + d3 + d4 + d5 + d6) WP1 PROJECT MANAGEMENT AND 7 500,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 5 000,00 0,00 12 500,00 COORDINATION WP2 DISSEMINATION 7 500,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 7 500,00 WP3 EVALUATION 7 500,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 7 500,00 WP4 SUSTAINABILITY 7 500,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 7 500,00 WP5 SETTING UP NATIONAL DATASET 120 000,00 0,00 815 000,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 935 000,00 CATALOGUE WP6 NATIONAL DATA ACCESS APPLICATION 10 000,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 10 000,00 MANAGEMENT SYSTEM WP7 SECURE PROCESSING ENVIRONMENTS 10 000,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 10 000,00 WP8 CROSS-BORDER GATEWAY 10 000,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 10 000,00 WP9 DATASET DATA QUALITY IMPROVEMENT 480 000,00 0,00 300 000,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 780 000,00 TOTAL COSTS PARTICIPANT 660 000,00 0,00 1 115 000,00 0,00 0,00 0,00 0,00 0,00 5 000,00 0,00 124 600,00 1 904 600,00  DETAILED BUDGET TABLE (ACTION GRANTS) Associated with document Ref. Ares(2023)7314945 - 26/10/2023 Project number: 210933860 Project acronym: EST2EHDS ATTENTION! Delete columns that do not apply for your grant. CONSOLIDATED COSTS PER WORK PACKAGE (PROJECT) PROJECT COSTS PER WORK PACKAGE A.1 Employees D. Other cost C. Purchase costs A.2 + A.3 Natural categories B. Subcontracting E. Indirect costs persons under direct A.4 SME owners costs D.1 Financial contract and seconded C.1 Travel and C.3 Other goods, persons subsistence C.1 Travel C.1 Accommodation C.1 Subsistence C.2 Equipment works and services support to third Total parties e = flat-rate * (a1 + a2 + a3 + a5 + b [+ a1 - a2 a3 b c1 c1a c1b c1c c2 c3 d1 c1] + [c1a + c1b + c1c] + c2 + c3 + d1 + d2 + d3 + d4 + d5 + d6) PARTICIPANT [MoSA] TOTAL COSTS PARTICIPANT 75 250,00 300 000,00 26 267,50 401 517,50 (Proposal Step) TOTAL COSTS PARTICIPANT 0,00 (Grant Preparation Step) PARTICIPANT [TEHIK] TOTAL COSTS PARTICIPANT 660 000,00 1 115 000,00 5 000,00 124 600,00 1 904 600,00 (Proposal Step) TOTAL COSTS PARTICIPANT 0,00 (Grant Preparation Step)  Grant Agreement number: 101129188 — EST2EHDS — EU4H-2022-DGA-MS-IBA2 EU4H Ref. Associated with document MGAAres(2023)7314945 — Multi & Mono:-v1.1 26/10/2023 ANNEX 2 ESTIMATED BUDGET FOR THE ACTION Estimated eligible1 costs (per budget category) Estimated EU contribution2 Direct costs Indirect costs EU contribution to eligible costs Maximum B. Total costs Maximum EU D. Other cost Requested EU grant amount6 A. Personnel costs Subcontracting C. Purchase costs E. Indirect costs 3 Funding rate %4 categories contribution5 contribution costs A.1 Employees A.4 SME owners B. Subcontracting C.2 Equipment C.3 Other goods, D.1 Financial E. Indirect costs (or equivalent) and natural person C.1 Travel and subsistence works and support to third beneficiaries services parties A.2 Natural persons under direct contract Travel Accommodation Subsistence A.3 Seconded persons Forms of funding Unit7 or Unit7 or Unit7 or Actual costs Unit costs7 Actual costs Actual costs Actual costs Actual costs Flat-rate costs8 actual costs actual costs actual costs e = flat-rate * (a1 + a3 + b + f=a+b+ a1 a3 b c1a c1b c1c c2 c3 d1 U g = f * U% h m c1a + c1b + c1c c+d+e + c2 + c3 + d1) 1 - MSAE 75 250.00 0.00 300 000.00 0.00 0.00 0.00 0.00 0.00 0.00 26 267.50 401 517.50 80 321 214.00 321 214.00 321 214.00 1.1 - TEHIK 660 000.00 0.00 1 115 000.00 0.00 0.00 0.00 0.00 5 000.00 0.00 124 600.00 1 904 600.00 80 1 523 680.00 1 523 680.00 1 523 680.00 Σ consortium 735 250.00 0.00 1 415 000.00 0.00 0.00 0.00 0.00 5 000.00 0.00 150 867.50 2 306 117.50 1 844 894.00 1 844 894.00 1 844 894.00 1 See Article 6 for the eligibility conditions. All amounts must be expressed in EUR (see Article 21 for the conversion rules). 2 The consortium remains free to decide on a different internal distribution of the EU funding (via the consortium agreement; see Article 7). 3 Indirect costs already covered by an operating grant (received under any EU funding programme) are ineligible (see Article 6.3). Therefore, a beneficiary/affiliated entity that receives an operating grant during the action duration cannot declare indirect costs for the year(s)/reporting period(s) covered by the operating grant, unless they can demonstrate that the operating grant does not cover any costs of the action. This requires specific accounting tools. Please immediately contact us via the EU Funding & Tenders Portal for details. 4 See Data Sheet for the funding rate(s). 5 This is the theoretical amount of the EU contribution to costs, if the reimbursement rate is applied to all the budgeted costs. This theoretical amount is then capped by the 'maximum grant amount'. 6 The 'maximum grant amount' is the maximum grant amount decided by the EU. It normally corresponds to the requested grant, but may be lower. 7 See Annex 2a 'Additional information on the estimated budget' for the details (units, cost per unit). 8 See Data Sheet for the flat-rate. Page 1 of 1  Associated with document Ref. Ares(2023)7314945 - 26/10/2023 ANNEX 2a ADDITIONAL INFORMATION ON UNIT COSTS AND CONTRIBUTIONS SME owners/natural person beneficiaries without salary See Additional information on unit costs and contributions (Annex 2a and 2b) Travel and subsistence See Additional information on unit costs and contributions (Annex 2a and 2b) 1  Associated with document Ref. Ares(2023)7314945 - 26/10/2023 ANNEX 4 EU4H MGA — MULTI + MONO FINANCIAL STATEMENT FOR [PARTICIPANT NAME] FOR REPORTING PERIOD [NUMBER] 1 2 Eligible costs (per budget category) EU contribution Revenues Direct costs Indirect costs EU contribution to eligible costs Total requested EU Income generated by the Total costs Requested EU contribution action A. Personnel costs B. Subcontracting costs C. Purchase costs D. Other cost categories 2 3 4 E. Indirect costs Funding rate % Maximum EU contribution contribution A.4 SME owners and C.3 Other goods, works and D.X Financial support to A.1 Employees (or equivalent) natural person B. Subcontracting C.1 Travel and subsistence C.2 Equipment E. Indirect costs services third parties beneficiaries A.2 Natural persons under direct contract Travel Accommodation Subsistence A.3 Seconded persons Forms of funding Actual costs 5 Actual costs 5 5 5 Actual costs Actual costs Actual costs 6 Unit costs Unit or actual costs Unit or actual costs Unit or actual costs Flat-rate costs e= f= a1 a3 b c1a c1b c1c c2 c3 d1a flat-rate * (a1 + a3 + b + c1a + U g = f*U% h m (i) n a+b+c+d+e c1b + c1c + c2 + c3 + d1a) XX – [short name beneficiary/affiliated entity] The beneficiary/affiliated entity hereby confirms that: The information provided is complete, reliable and true. The costs and contributions declared are eligible (see Article 6). The costs and contributions 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 19, 20 and 25). For the last reporting period: that all the revenues have been declared (see Article 22). i Please declare all eligible costs and contributions, 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 costs/contributions that are found to be ineligible. 1 See Article 6 for the eligibility conditions. All amounts must be expressed in EUR (see Article 21 for the conversion rules). 2 If you have also received an EU operating grant during this reporting period, you cannot claim indirect costs - unless you can demonstrate that the operating grant does not cover any costs of the action. This requires specific accounting tools. Please contact us immediately via the Funding & Tenders Portal for details. 3 See Data Sheet for the reimbursement rate(s). 4 This is the theoretical amount of EU contribution to costs that the system calculates automatically (by multiplying the reimbursement rates by the costs declared). The amount you request (in the column 'requested EU contribution') may be less. 5 See Annex 2a 'Additional information on the estimated budget' for the details (units, cost per unit). 6 See Data Sheet for the flat-rate.  Associated with document Ref. Ares(2023)7314945 - 26/10/2023 ANNEX 5 SPECIFIC RULES ETHICS (— ARTICLE 14) Ethics Actions involving activities raising ethics issues must be carried out in compliance with: - ethical principles and 1 - applicable EU, international or national law, including Directive 2005/28 and 2 Regulation 536/2014 . The beneficiaries must pay particular attention to the principle of proportionality, the right to privacy, the right to the protection of personal data, the right to the physical and mental integrity of a person, the right to non-discrimination, the need to ensure protection of the environment and high levels of human health protection. Before the beginning of an action task raising an ethical issue, the beneficiaries must have obtained all approvals or other mandatory documents needed for implementing the task, notably from any (national or local) ethics committee or other bodies such as data protection authorities. The documents must be kept on file and be submitted upon request by the coordinator to the granting authority. If they are not in English, they must be submitted together with an English summary, which shows that the documents cover the action tasks in question and includes the conclusions of the committee or authority concerned (if any). INTELLECTUAL PROPERTY RIGHTS (IPR) — BACKGROUND AND RESULTS — ACCESS RIGHTS AND RIGHTS OF USE (— ARTICLE 16) List of background The beneficiaries must, where industrial and intellectual property rights (including rights of third parties) exist prior to the Agreement, establish a list of these pre-existing industrial and intellectual property rights, specifying the rights owners. The coordinator must — before starting the action — submit this list to the granting authority. 1 Commission Directive 2005/28/EC of 8 April 2005 laying down principles and detailed guidelines for good clinical practice as regards investigational medicinal products for human use, as well as the requirements for authorisation of the manufacturing or importation of such products (OJ L 91, 9.4.2005, p. 13). 2 Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC (OJ L 158, 27.5.2014, p. 1). 1  Associated with document Ref. Ares(2023)7314945 - 26/10/2023 Rights of use of the granting authority on results for information, communication, dissemination and publicity purposes The granting authority also has the right to exploit non-sensitive results of the action for information, communication, dissemination and publicity purposes, using any of the following modes: - use for its own purposes (in particular, making them available to persons working for the granting authority or any other EU service (including institutions, bodies, offices, agencies, etc.) or EU Member State institution or body; copying or reproducing them in whole or in part, in unlimited numbers; and communication through press information services) - distribution to the public in hard copies, in electronic or digital format, on the internet including social networks, as a downloadable or non-downloadable file - editing or redrafting (including shortening, summarising, changing, correcting, cutting, inserting elements (e.g. meta-data, legends or other graphic, visual, audio or text elements extracting parts (e.g. audio or video files), dividing into parts or use in a compilation - translation (including inserting subtitles/dubbing) in all official languages of EU - storage in paper, electronic or other form - archiving in line with applicable document-management rules - the right to authorise third parties to act on its behalf or sub-license to third parties, including if there is licensed background, any of the rights or modes of exploitation set out in this provision - processing, analysing, aggregating the results and producing derivative works - disseminating the results in widely accessible databases or indexes (such as through ‘open access’ or ‘open data’ portals or similar repositories, whether free of charge or not. The beneficiaries must ensure these rights of use for the whole duration they are protected by industrial or intellectual property rights. If results are subject to moral rights or third party rights (including intellectual property rights or rights of natural persons on their image and voice), the beneficiaries must ensure that they comply with their obligations under this Agreement (in particular, by obtaining the necessary licences and authorisations from the rights holders concerned). Access rights for the granting authority, EU institutions, bodies, offices or agencies and national authorities to results for policy purposes The beneficiaries must grant access to their results — on a royalty-free basis — to the granting authority, other EU institutions, bodies, offices or agencies, for developing, implementing and monitoring EU policies or programmes. Such access rights are limited to non-commercial and non-competitive use. 2  Associated with document Ref. Ares(2023)7314945 - 26/10/2023 The access rights also extend to national authorities of EU Member States or associated countries, for developing, implementing and monitoring their policies or programmes in this area. In this case, access is subject to a bilateral agreement to define specific conditions ensuring that: - the access will be used only for the intended purpose and - appropriate confidentiality obligations are in place. Moreover, the requesting national authority or EU institution, body, office or agency (including the granting authority) must inform all other national authorities of such a request. Access rights for third parties to ensure continuity and interoperability Where the call conditions impose continuity or interoperability obligations, the beneficiaries must make the materials, documents and information and results produced in the framework of the action available to the public (freely accessible on the Internet under open licences or open source licences). COMMUNICATION, DISSEMINATION AND VISIBILITY (— ARTICLE 17) Communication and dissemination plan The beneficiaries must provide a detailed communication and dissemination plan, setting out the objectives, key messaging, target audiences, communication channels, social media plan, planned budget and relevant indicators for monitoring and evaluation. Additional communication and dissemination activities The beneficiaries must engage in the following additional communication and dissemination activities: - present the project (including project summary, coordinator contact details, list of participants, European flag and funding statement and project results) on the beneficiaries’ websites or social media accounts - for actions involving publications, mention the action and the European flag and funding statement on the cover or the first pages following the editor's mention - for actions involving public events, display signs and posters mentioning the action and the European flag and funding statement - upload the public project results to the EU4Health Project Results platform, available through the Funding & Tenders Portal . SPECIFIC RULES FOR CARRYING OUT THE ACTION (— ARTICLE 18) Durability Unless exempted by the granting authority, the beneficiaries must commit to continue to use and maintain after the end of the action equipment bought and eligible at full cost, for activities pursuing the action’s objectives. Such equipment must be used for these purposes — for at least five years after the end of the action (see Data Sheet, Point 1) or until the end of its economic lifespan (i.e. until it has been fully depreciated) — whichever is earlier. 3  Associated with document Ref. Ares(2023)7314945 - 26/10/2023 Specific rules for blending operations When implementing blending operations, the beneficiaries acknowledge and accept that: - the grant depends on the approved financing from the Implementing Partner and/or public or private investors for the project - they must inform the granting authority both about the approval for financing and the financial close — within 15 days - the payment deadline for the first prefinancing is automatically suspended until the granting authority is informed about the approval for financing - both actions will be managed and monitored in parallel and in close coordination with the Implementing Partner, in particular: - all information, data and documents (including the due diligence by the Implementing Partner and the signed agreement) may be exchanged and may be relied on for the management of the other action (if needed) - issues in one action may impact the other (e.g. suspension or termination in one action may lead to suspension also of the other action; termination of the grant will normally suspend and exit from further financing and vice versa, etc.) - the granting authority may disclose confidential information also to the Implementing Partner. 4  Digitally sealed by the European Commission Date: 2023.10.26 21:15:32 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