Overall Readiness Statement to Start New Exchange for a Service Already in Routine Operations

DG SANTE eHDSI Wave 4 Production Environment Testing (PET) ESTONIA (EE) NCPeH Outcomes Summary Report Document Control Page Settings Value Document Title: EE NCPeH Outcomes Summary Report Project Title: eHealth DSI Document Authors: eHDSI Solution Provider Doc. Version: State of Play as of 19th of August, 2022 Status and concerned services: Wave 4 Pre-Production Testing for • Patient Summary (A) • Patient Summary (B) • ePrescription (A) Sensitivity: Restricted to eHMSEG, eHDSI Owner, eHDSI Solution Provider 1 Date: 02/05/2022 Link to the source Confluence https://webgate.ec.europa.eu/fpfis/wikis/x/muXzN page: Table of Contents 1. Services under Preparation to GoLive (Production Environment Testing sessions) (Wave 4) ... 3 2. Coverage Completed during last Acceptance Test Event (Wave 4 Formal & Upgrade PPT) ...... 4 3. Outstanding findings ................................................................................................................... 5 4. Closed Findings, Observations, Production Testing Sessions ..................................................... 7 Legend: PPT - Pre-production Formal / Upgrade Testing PET - Production Environment Testing Last updated: Aug 19, 2022 2  1. Services under Preparation to GoLive (Production Environment Testing sessions) (Wave 4) Partners in the Verification by the eDHSI SP. Planned Date of Production ID Link to the Session page Findings / Observations during the GoLive for the Environment Testing session for EE. services Session Conformance: no issues identified Functional: 2021-11-19 [EE (PS-A), • Findings: f-4, f-6, f-8, f-17 (new), f-18 S-9 EE (PS A) - LU (PS B) LU (PS-B)] Production (new) Environment Testing • Observations: o-2, o-3, o-4, o-5, o-6, o-8, o-21 Conformance: no issues identified 2021-11-24 [EE (PS-A), PT Functional: S-10 EE (PS A) - PT (PS B) (PS-B)] Production • Findings: f-4, f-6, f-8, f-17 (new), f-18 Environment Testing (new) • Observations: o-2, o-3, o-4, o-5, o-6, o-8, o-21 Conformance: no issues identified Functional: 2021-11-24 [EE (PS-A), FR • Findings: f-4, f-6, f-8, f-17 (new), f-18 S-11 EE (PS A) - FR (PS B) (PS-B)] Production (new) Environment Testing • Observations: o-2, o-3, o-4, o-5, o-6, o-8, o-21 2022-01-10 [PT (PS-A), EE Conformance: no issues identified S-12 PT (PS A) - EE (PS B) (PS-B)] Production Functional: no issues identified Environment Testing Conformance: eADC KPI report should be 2022-03-02 [EE (eP-A), PT checked to validate the fix applied by EE S-13 EE (eP A) - PT (eP B) (eP-B)] Production in future session. Environment Testing Functional: • Observations: o-2, o-16 Conformance: no issues identified. 2022-06-08 [EE (eP-A), PL Functional: S-14 EE (eP A) - PL (eP B) (eP-B)] Production • Observations: o-1, o-2, o-16, o-19, o- Environment Testing 20 3  2. Coverage Completed during last Acceptance Test Event (Wave 4 Formal & Upgrade PPT) Conformance Tests Required Conformance Service Available partners performed - WF with tests with partners partners Conformance testing PS-A (Conformance - min HR, CY, CZ, EE, FR, GR, HU, LU, MT, NL, HR, CY, CZ, EE, FR, GR, Yes 3 partners) PT, ES HU, LU, MT, NL, PT, ES PS-B (Conformance - min 3 HR, CY, CZ, EE, GR, IE, HR, CY, CZ, EE, GR, IE, LU, MT, PT, SI, ES Yes partners) LU, MT, PT, SI, ES eP-A (Conformance - min HR, CY, CZ, FI, GR, HU, HR, CY, CZ, FI, GR, HU, PL, PT, ES, SE Yes 3 partners) PL, PT, ES, SE eP-B (Conformance - min HR, CY, CZ, FI, GR, HU, IE, LU, PL, PT, ES, HR, CY, CZ, FI, GR, HU, Yes 3 partners) SE IE, LU, PL, PT, ES, SE Required evaluations Service Available partners Evaluations submitted submitted Functional testing PS-A (Functional - own PS HR, CY, CZ, EE, FR, GR, HU, LU, MT, NL, service evaluated by HR, GR, HU Yes PT, ES partners) PS-B (Functional - PS from HR, CY, CZ, EE, GR, IE, LU, MT, PT, SI, ES HR, CZ, PT, SI Yes partners evaluated) eP-A (Functional - own eP docs evaluated by HR, CY, CZ, FI, GR, HU, PL, PT, ES, SE FI, PL, SE Yes partners) eP-B (Functional - eP docs HR, CY, CZ, FI, GR, HU, IE, LU, PL, PT, ES, FI, PL, SE Yes from partners evaluated) SE eP-A (Functional - eD docs HR, CY, CZ, FI, GR, HU, PL, PT, ES, SE FI, PL, SE Yes from partners evaluated) eP-B (Functional - own eD HR, CY, CZ, FI, GR, HU, IE, LU, PL, PT, ES, docs evaluated by FI, PL, SE Yes SE partners) 4  3. Outstanding findings Service & Comments and/or Action Plan ID Finding Comments by the eHDSI Solution Provider Test Event by the NCPeH 16 Mar 2020 PPT W3, PS- A, Functional According to ArtDecor its R 1..1, 15 Mar 2021 which in turn means that we are In the PS Functional Requirements, the agent causing the PPT W4, PS- allowed to use nullFlavor="NI". allergic reaction is considered as 'basic', that is the reason A, Functional Would it be better to remove why when missing, and it has considered a finding. the agent overall from Estonian Solution Provider on 23 Mar 2021: this situation can be 24 Sep 2021 PS? Agent causing the considered as having a medium impact, given that in the f- PET W3, PS- original narrative part of the Section and in the Level 1 PDF allergic reaction not 4 A, Functional the information about the agent causing the allergic coded 29 Mar 2021 reaction is provided (in Estonian). A Health Professional 19 Nov Allergy data was initially planned attending a patient with an allergy would need to use a 2021 to be nationally available in translation tool or, when possible and feasible (using a 24 Nov 2020, but due to covid language understood by both), ask the patient or relative 2021 developments this has been about that information. PET W4, PS- postponed to 2022. A, Functional 16 Mar 2020 PPT W3, PS- Medication entries 29 Mar 2021 A, Functional are repeated three Depending on the situation the times. The situation doctors will still prescribe the 24 Aug 2021 happens as well in Solution Provider on 23 Mar 2021: this situation can be prescriptions as they have so far, PET W3, PS- the narrative part considered as having a medium impact. Health so for the repeated prescriptions f- A, Functional and in the Level 1 professional can be confused especially when the number it is expected to see 3 6 PDF prescriptions with the same of distinct medications is high (mentioned for other PS test 19 Nov 2021 data that contained more repetitions) and the start date is data, but different prescription 24 Nov not indicated. number. Statistically, about half 2021 The same medicinal of the prescriptions prescribed in PET W4, PS- product repeated Estonia are repeated A, Functional several times. prescriptions. 5  Service & Comments and/or Action Plan ID Finding Comments by the eHDSI Solution Provider Test Event by the NCPeH 16 Mar 2020 06 May 2021 PPT W3, PS- We discussed the topic internally A, Functional and eventually HWISC feels that Date of onset of medication is considered a 'basic' element there is no right way to present in the PS Functional Requirements. 24 Aug 2021 the data (time, when the PET W3, PS- Solution Provider on 23 Mar 2021: this situation can be prescription was issued isn't A, Functional Onset date of considered as having a minor impact, especially when f- really correct and the time it was medication not dispensed is also not correct). providing the date of onset of the health problem for which 8 19 Nov present Since „The agreed data elements the medication is prescribed. 2021 must be sent by each NCPeH, Only in some situations, it would be more relevant: e.g. 24 Nov even if there is no content recent prescriptions causing an adverse reaction, to 2021 available (exceptional values are evaluate a lack of efficacy of a treatment. PET W4, PS- allowed)“ we should be fine, A, Functional since we are sending the element itself and using UNK. The way to represent the package size was not understood by the receiver of the document (eP and eD). This issue was discussed during the Joint Online meeting of the STF on June 10 and it was proposed to prepare a Change Proposal to introduce a new data element that would allow the complete description of complex medications. Package size is provided Solution Provider on 03 Aug 2020: minor impact. multiplying the Update July 2020: we will wait The eP documents from EE contain the detailed description volume of the units for the change proposal to fix of the medicinal product in the case of complex 16 Mar 2020 times the number this issue, since the additional medications such as Lantus. Lantus -as well as other f- PPT W3, eP- of units in the text element solution (which medicinal products- have a variety of presentations as 10 A & eP- package. was accepted the last time) isn't regards number of units in the package and volume per B, Functional a proper solution. Additionally using unit. The description of the package is present in the the originalText 02 Apr 2021: Situation is the original narrative plus in the originalText sub-element of element to provide same. the capacityQuantity element. Therefore, the dispenser will the units per find the information needed about the exact presentation package. prescribed. UPDATE on 04 Aug 2020: also the Level 1 PDF contains the detailed description of the package. Solution Provider on 12 Oct 2021 The CP-eHealthDSI-063: Improve Medication Information Representation (https://webgate.ec.europa.eu/fpfis/wikis/x/UYm1Nw) was submitted on 30 Sep 2021. 6  Service & Comments and/or Action Plan ID Finding Comments by the eHDSI Solution Provider Test Event by the NCPeH Solution Provider on 25 Jan 2022: this finding considered as having medium impact on eHDSI. Translated information about medical devices could be very useful during an emergency. It is a reality that such 19 Nov No coded information might not be even readily available nationally 2021 information for the during an emergency contact, therefore, the attending 24 Nov Medical Device in Since increasing the value sets is physician would be careful when ordering/interpreting an f- 2021 the entry, a task for eHDSI, then NCPeH imaging test with which an implant might interfere. 17 PET W4, PS- information in can not provide an action plan 30 new SNOMED CT concepts are included in the value set A, Functional Estonian in the for this. of eHDSIMedicalDevice for Wave 5: CP-eHealthDSI-049: narrative and in the Extend eHDSIMedicalDevice Value Set. In total, there are Level 1 PDF 100 codes for medical devices in the value set. In addition, the reviewing of concepts in this Value Set is planning during the next STF Semantic WG meeting on 03 Feb 2022. MSs can provide their proposals for the SNOMED GPS extensions until the end of February 2022. Solution Provider on 25 Jan 2022 : this finding considered as having medium impact on eHDSI. Translated information about surgical procedures could be very useful during an emergency (e.g. knowing a past surgery referring to the implantation of a medical device or to the transplantation of an organ). It is a reality that such No coded information might not be even readily available nationally 19 Nov information for the during an emergency contact, therefore, the attending 2021 Surgical procedures Since increasing the value sets is physician would be careful when ordering/interpreting an f- 24 Nov in the entry, a task for eHDSI, then NCPeH imaging test with which an implant might interfere. 18 2021 information in can not provide an action plan PET W4, PS- Estonian in the for this. 519 new SNOMED CT concepts for surgical procedures A, Functional narrative and in the were included in the value set of eHDSIProcedure for Wave Level 1 PDF 4: CP-eHealthDSI-053: Extend the value set for procedures. In total, there are 621 codes for surgical procedures in the value set. Also the reviewing of concepts in this Value Set is planning during the next STF Semantic WG meeting on 03 Feb 2022. MSs can provide their proposals for the SNOMED GPS extensions until the end of February 2022. 4. Closed Findings, Observations, Production Testing Sessions The closed findings, observations and Production Testing sessions can be found at the following link: https://webgate.ec.europa.eu/fpfis/wikis/x/qOXzN 7 Ref. Ares(2019)6366348 - 15/10/2019 ANNEX Commission services' assessment and verification of the Action Plan submitted by the National Contact Point for eHealth (NCPeH) of Estonia in response to Report ref. DG(SANTE) 2019-6841 of the audit carried out from 25 to 26 March 2019 in order to assess the organisation's readiness for joining the Cross Border eHealth Information Service Network for the new service ePrescription-A N° Recommendation Action Proposed by the competent authority Commission services' assessment of the competent authority's response 1 To ensure that the data controllers and data Information provided by Estonian NCPeH in Satisfactory processors for the new eP-A service and their preparation for Go live discussions at respective responsibilities are comprehensively eHMSEG on 16 May 2019: Assessment through audio conference on 3 identified, in line with readiness criterion C.9. October 2019, and additional information Associated finding: No 1 Self assessment document will be provided on 8 October 2019. complemented accordingly (by the 15th of May 2019). Data controllers (Population The evidence provided by the NCPeH Register, Estonian Medical Prescription demonstrated that the recommendation has Center, Register of Medicinal Products, been satisfactorily addressed. Health Information System) and processors (Ministry of the Interior, Estonian Health Insurance Fund, Estonian Health and Welfare Information Systems Centre, Agency of Medicines, Ministry of Social Affairs) will be specified. Data protection impact has been updated with eP-A service. UPDATED INFORMATION PROVIDED BY NCPeH ON 28 AUGUST 2019: Document “andmekaitsealane mõjuhinnang II etapp”. UPDATED INFORMATION PROVIDED BY NCPeH ON 8 October 2019: The list of data controllers and processors was provided for the Estonian parties that process personal data in cross border situations as country A. Date: 10 October 2019 Page: 1 ANNEX Commission services' assessment and verification of the Action Plan submitted by the National Contact Point for eHealth (NCPeH) of Estonia in response to Report ref. DG(SANTE) 2019-6841 of the audit carried out from 25 to 26 March 2019 in order to assess the organisation's readiness for joining the Cross Border eHealth Information Service Network for the new service ePrescription-A N° Recommendation Action Proposed by the competent authority Commission services' assessment of the competent authority's response 2 To ensure that the Patient Information Notice for Information provided by Estonian NCPeH in Satisfactory the new eP-A service is available, in line with preparation for Go live discussions at readiness criterion C.14. eHMSEG on 16 May 2019: Assessment through audio conference on 3 October 2019. Associated finding: No 2 PIN will be published by the 15th of May 2019. The evidence provided by the NCPeH demonstrated that the recommendation has UPDATED INFORMATION PROVIDED been satisfactorily addressed. BY NCPeH ON 28 AUGUST 2019: Document “Patsiendi teavitamine eP-A EST”. 3 To ensure that the dissemination plan for the Information provided by Estonian NCPeH in Satisfactory beneficiaries of the new eP-A service is available, preparation for Go live discussions at in line with readiness criterion O.12. eHMSEG on 16 May 2019: Assessment through audio conference on 3 October 2019. Associated finding: No 3 In addition to the notifying of the parties concerned we’ve done so far, we will include The evidence provided by the NCPeH a concrete list of digital distribution demonstrated that the recommendation has been satisfactorily addressed. channels, where we will publish informative articles. As soon as we have exact information when and what countries are going live (Estonia as eP-A) we may continue with our dissemination plan and produce different posters, information materials and publish digital banners (main focus). UPDATED INFORMATION PROVIDED BY NCPeH ON 28 AUGUST 2019: Date: 10 October 2019 Page: 2 ANNEX Commission services' assessment and verification of the Action Plan submitted by the National Contact Point for eHealth (NCPeH) of Estonia in response to Report ref. DG(SANTE) 2019-6841 of the audit carried out from 25 to 26 March 2019 in order to assess the organisation's readiness for joining the Cross Border eHealth Information Service Network for the new service ePrescription-A N° Recommendation Action Proposed by the competent authority Commission services' assessment of the competent authority's response Document “dissemination”. 4 To ensure that the conformance testing process is Information provided by Estonian NCPeH in Satisfactory documented, in line with readiness criterion T.21. preparation for Go live discussions at eHMSEG on 16 May 2019: Assessment through audio conference on 3 Associated finding: No 4 October 2019. We will add separate annexes for testing, adding NCP-B Pre-Projectathon and The evidence provided by the NCPeH references to the testing framework by the demonstrated that the recommendation has 15th of May 2019. Self assessment plan will been satisfactorily addressed. be updated. UPDATED INFORMATION PROVIDED BY NCPeH ON 28 AUGUST 2019: Documents “testplaan”, “CPTP-a” and “CPTP-b” 5 To ensure that the process and the associated Information provided by Estonian NCPeH in Satisfactory NCPeH roles and responsibilities to implement the preparation for Go live discussions at measurements required by the eHDSI Monitoring eHMSEG on 16 May 2019: Assessment through audio conference on 3 Framework are documented, in line with readiness October 2019. criterion O.11. Service pass will be amended accordingly by the 15th of May 2019. Sending of the KPIs The evidence provided by the NCPeH Associated finding: No 5 will be specified and added references to demonstrated that the recommendation has monitoring framework, also roles and been satisfactorily addressed. responsibilities will be updated in service pass. UPDATED INFORMATION PROVIDED Date: 10 October 2019 Page: 3 ANNEX Commission services' assessment and verification of the Action Plan submitted by the National Contact Point for eHealth (NCPeH) of Estonia in response to Report ref. DG(SANTE) 2019-6841 of the audit carried out from 25 to 26 March 2019 in order to assess the organisation's readiness for joining the Cross Border eHealth Information Service Network for the new service ePrescription-A N° Recommendation Action Proposed by the competent authority Commission services' assessment of the competent authority's response BY NCPeH ON 28 AUGUST 2019: Document “Teenusepass” 6 To ensure that incident management is aligned Information provided by Estonian NCPeH in Satisfactory with the eHDSI Country Service Desk Guideline, preparation for Go live discussions at in line with readiness criterion OS.8. eHMSEG on 16 May 2019: Assessment through audio conference on 3 October 2019. Associated finding: No 6 Jira will be amended in accordance with eHDSI service desk guide, paragraph 2.3.1 by The evidence provided by the NCPeH the 15th of May (one additional subcategory demonstrated that the recommendation has added, to distinguish eP-A and B). been satisfactorily addressed. UPDATED INFORMATION PROVIDED BY NCPeH ON 28 AUGUST 2019: Folder “jira_profiles” and document “Teenusepass”. 7 To ensure that methods and procedures to monitor Information provided by Estonian NCPeH in Satisfactory service capacity for the new eP-A service are preparation for Go live discussions at documented and in place, in line with readiness eHMSEG on 16 May 2019: Assessment through audio conference on 3 criterion OS.21. October 2019. Expected capacity is defined in the service Associated finding: No 7 pass (max 8 patients per day), but some The evidence provided by the NCPeH formatting changes will be made to clarify the demonstrated that the recommendation has content. We will specify monitoring of our been satisfactorily addressed. overall services and extract eP-A data from there. Daily monitoring will be in place (time of the query, how many prescriptions have been bought etc), checking for possible errors Date: 10 October 2019 Page: 4 ANNEX Commission services' assessment and verification of the Action Plan submitted by the National Contact Point for eHealth (NCPeH) of Estonia in response to Report ref. DG(SANTE) 2019-6841 of the audit carried out from 25 to 26 March 2019 in order to assess the organisation's readiness for joining the Cross Border eHealth Information Service Network for the new service ePrescription-A N° Recommendation Action Proposed by the competent authority Commission services' assessment of the competent authority's response and notifying monitoring center. Amendments in service pass will be done by the 15th of June 2019. UPDATED INFORMATION PROVIDED BY NCPeH ON 28 AUGUST 2019: Documents “monitooring” and “Teenusepass” 8 To ensure that the risks associated with the new Information provided by Estonian NCPeH in Satisfactory eP-A service are clearly identified in the Business preparation for Go live discussions at Impact and Risk Assessments, in line with eHMSEG on 16 May 2019: Assessment through audio conference on 3 readiness criterion IS.3. October 2019. Most of the risks included in the assessment Associated finding: No 8 are applicable for both, eP-B and eP-A, but The evidence provided by the NCPeH additional assessment will be ordered and demonstrated that the recommendation has conducted by the end of June 2019. been satisfactorily addressed. UPDATED INFORMATION PROVIDED BY NCPeH ON 28 AUGUST 2019: Document “Risk assessment” 9 To ensure that the Business Continuity Plan Information provided by Estonian NCPeH in Satisfactory includes requirements related to the new eP-A preparation for Go live discussions at service, in line with readiness criterion IS.11. eHMSEG on 16 May 2019: Assessment through audio conference on 3 October 2019. Associated finding: No 9 Documents will be updated by the end of Date: 10 October 2019 Page: 5 ANNEX Commission services' assessment and verification of the Action Plan submitted by the National Contact Point for eHealth (NCPeH) of Estonia in response to Report ref. DG(SANTE) 2019-6841 of the audit carried out from 25 to 26 March 2019 in order to assess the organisation's readiness for joining the Cross Border eHealth Information Service Network for the new service ePrescription-A N° Recommendation Action Proposed by the competent authority Commission services' assessment of the competent authority's response June 2019. The evidence provided by the NCPeH demonstrated that the recommendation has UPDATED INFORMATION PROVIDED been satisfactorily addressed. BY NCPeH ON 28 AUGUST 2019: Document “Piiriülese andmevahetusplatvormi äritalitluspidevuse plaan” 10 To ensure that the Disaster Recovery Plan Information provided by Estonian NCPeH in Satisfactory considers all assets which are specific for the new preparation for Go live discussions at eP-A service configurations, in line with readiness eHMSEG on 16 May 2019: Assessment through audio conference on 3 criterion IS.12. October 2019. Disaster recovery plan will be amended by Associated finding: No 10 the end of June 2019. The evidence provided by the NCPeH demonstrated that the recommendation has UPDATED INFORMATION PROVIDED been satisfactorily addressed. BY NCPeH ON 28 AUGUST 2019: Documents “OpenncptaasteplaaneP-A” and “OpenncptaasteplaaneP-B”. 11 To ensure that the NCPeH interfaces with new Information provided by Estonian NCPeH in Satisfactory external services required under the eP-A service, preparation for Go live discussions at as well as other eP-A related configurations eHMSEG on 16 May 2019: Assessment through audio conference on 3 required under OS.19, are managed through October 2019. configuration management, in line with readiness Configuration management database will be criteria OS.19 and IS.14. updated by the end of June 2019. The evidence provided by the NCPeH demonstrated that the recommendation has UPDATED INFORMATION PROVIDED Date: 10 October 2019 Page: 6 ANNEX Commission services' assessment and verification of the Action Plan submitted by the National Contact Point for eHealth (NCPeH) of Estonia in response to Report ref. DG(SANTE) 2019-6841 of the audit carried out from 25 to 26 March 2019 in order to assess the organisation's readiness for joining the Cross Border eHealth Information Service Network for the new service ePrescription-A N° Recommendation Action Proposed by the competent authority Commission services' assessment of the competent authority's response Associated finding: No 11 BY NCPeH ON 28 AUGUST 2019: been satisfactorily addressed. Document “confmanagement” 12 To ensure that policies for the processing and Information provided by Estonian NCPeH in Satisfactory safeguarding of personally identifiable information preparation for Go live discussions at related to the new eP-A service are clearly eHMSEG on 16 May 2019: Assessment through audio conference on 3 established for the Helpdesk, in line with readiness October 2019. criterion IS.20. Helpdesk tickets notifications will be categorized and only available to certain The evidence provided by the NCPeH Associated finding: No 12 people. Implementation done by the end of demonstrated that the recommendation has June 2019. Amendments to HWISC data been satisfactorily addressed. protection document are being made by the end of June 2019. UPDATED INFORMATION PROVIDED BY NCPeH ON 28 AUGUST 2019: Document “isikuandmete töötlemise põhimõtted”. 13 To ensure that relevant NCPeH technical Information provided by Estonian NCPeH in Satisfactory documentation (such as the ‘Estonian Cross- preparation for Go live discussions at Border eHealth Architecture’ and the "Teenuse eHMSEG on 16 May 2019: Assessment through audio conference on 3 pass") includes all the essential elements for the October 2019. new eP-A service, in line with readiness criteria Update will be conducted in service pass by T.1 and T.2-1. the end of May 2019. The evidence provided by the NCPeH demonstrated that the recommendation has Associated finding: No 13 UPDATED INFORMATION PROVIDED been satisfactorily addressed. BY NCPeH ON 28 AUGUST 2019: Date: 10 October 2019 Page: 7 ANNEX Commission services' assessment and verification of the Action Plan submitted by the National Contact Point for eHealth (NCPeH) of Estonia in response to Report ref. DG(SANTE) 2019-6841 of the audit carried out from 25 to 26 March 2019 in order to assess the organisation's readiness for joining the Cross Border eHealth Information Service Network for the new service ePrescription-A N° Recommendation Action Proposed by the competent authority Commission services' assessment of the competent authority's response Document “Estonian CEF crossborder eHealth architecture v 0.9”. UPDATED INFORMATION PROVIDED BY NCPeH ON 3 OCTOBER 2019: Document “Estonian CEF crossborder eHealth architecture v 1.0”. 14 To ensure that the ‘Dispensed Prescribed Information provided by Estonian NCPeH in Satisfactory Medicine’ workflow in the ‘Estonian Cross- preparation for Go live discussions at Border eHealth Architecture’ document accurately eHMSEG on 16 May 2019: Assessment through audio conference on 3 describes the data processing activities related to October 2019. the eP-A service, in line with readiness criterion Update will be conducted in service pass by T.12. the end of May 2019. The evidence provided by the NCPeH demonstrated that the recommendation has Associated finding: No 14 UPDATED INFORMATION PROVIDED been satisfactorily addressed. BY NCPeH ON 28 AUGUST 2019: Document “Estonian CEF crossborder eHealth architecture v 0.9” UPDATED INFORMATION PROVIDED BY NCPeH ON 3 OCTOBER 2019: Document “Estonian CEF crossborder eHealth architecture v 1.0”. Date: 10 October 2019 Page: 8 Ref. Ares(2019)6366348 - 15/10/2019 EUROPEAN COMMISSION DIRECTORATE-GENERAL FOR HEALTH AND FOOD SAFETY Health and food audits and analysis Director Grange SANTE.F5 TF/ams Subject: Verification of implementation of corrective actions Audit in Estonia from 25 to 26 March 2019 in order to assess the National Contact Point for eHealth's readiness for joining the Cross Border eHealth Information Service Network for the new service ePrescription-A Ref.: DG(SANTE) 2019-6841 Dear Ms Reinhold, I am writing to inform you that the audit team has now verified the implementation of the actions taken in response to the recommendations made following the above-mentioned audit. I am pleased to inform you that the audit team concluded that all recommendations have been satisfactorily addressed. Yours sincerely, (e-signed) Paola Colombo Director Enclosure: Annex Ms Katrin Reinhold Director Health and Welfare Information Systems Centre (HWISC) Veerenni 13/Uus-Tatari 25 10134 Tallinn Estonia European Commission, Grange, Dunsany, Co. Meath C15 DA39, Ireland - Office: GRAN 01/114 Tel.: direct line (+353 46) 9061 757, internal n°: 70757, switchboard: (+353 46) 9061 700. Fax: (+353 46) 9061 705 To the eHealth Member States Expert Group via eHMSEG Secretariat ([email protected]) Subject: Overall Readiness Statement to Start New Exchange for a Service Already in Routine Operations On behalf of Health and Welfare Information Systems Centre (HWISC) I declare that our National Contact Point for eHealth is ready to start the Cross-Border eHealth Information Services providing the ePrescription service as Country A in Wave 4 with Poland. This readiness and adherence of the National Contact Point for eHealth to legal, organizational, semantic and technical criteria is demonstrated by the successful outcome of testing and auditing. With this statement I include the following documents: 1. Outcomes Summary Report (Wave 4) 2. Verification of implementation of corrective actions The Outcomes Summary Report includes open findings, which are evaluated as minor or medium impact, no findings with major impact have been identified. I kindly ask our open findings to be assessed and I undertake to notify the eHMSEG immediately of any change that could have a significant influence on the validity of the above statement. Therefore, I apply to start new exchange for ePrescription Country A service with Poland in Routine Operations. Tallinn, 22.08.2022 Signed digitally Tanel Tera On behalf of Director of Health and Welfare Information Systems Centre To the eHealth Member States Expert Group via eHMSEG Secretariat ( [email protected] ) Subject: Overall Readiness Statement to S tart N ew E xchange for a S ervice A lready in Routine Operations On behalf of Health and Welfare Information Systems Centre (HWISC) I declare that our National Contact Point for eHealth is ready to start the Cross- B order eHealth Information Services providing the ePrescription service as Countr y A in Wave 4 with Poland . This readiness and adherence of the National Contact Point for eHealth to legal, organizational, semantic and technical criteria is demonstrated by the successful outcome of testing and auditing . With this statement I include the following documents : Outcome s Summary Report (Wave 4) V erification of implementation of corrective actions The Outcome s Summary Report includes open findings, which are evaluated as minor or medium impact, no findings with major impact have been identified . I kindly ask our open findings to be assessed and I undertake to notify the e HMSEG immediately of any change that could have a significant influence on the validity of the above statement. Therefore , I apply to start new exchange for ePrescription Country A service with Poland in Routine Operations . Tallinn, 22 . 0 8 .202 2 Sign ed digitally Tanel Tera On behalf of Director of Health and Welfare Information Systems Centre