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DG SANTE eHDSI Wave 5 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 10th of February, 2023 Status and concerned services: Wave 5 Production Environment Testing for: • ePrescription (B) Sensitivity: Restricted to eHMSEG, eHDSI Owner, eHDSI Solution Provider Date: 10/02/2023 Link to the source Confluence https://webgate.ec.europa.eu/fpfis/wikis/x/muXzN 1 page: Table of Contents 1. Services under Preparation to GoLive (Production Environment Testing sessions) (Wave 5) ... 3 2. Coverage Completed during last Acceptance Test Event (Wave 5 Formal & Upgrade PPT) ...... 3 3. Summary of Outstanding findings .............................................................................................. 4 4. Outstanding findings ................................................................................................................... 4 5. Closed Findings, Observations, Production Testing Sessions ..................................................... 5 Legend: PPT - Pre-production Formal / Upgrade Testing PET - Production Environment Testing Last updated: Feb 10, 2023 2  1. Services under Preparation to GoLive (Production Environment Testing sessions) (Wave 5) Partners in the Production Verification by the eDHSI SP. Planned Date of ID Environment Testing Link to the Session page Findings / Observations GoLive for the Session during the session for EE. services Conformance: 2023-01-12 [PL (eP-A), EE (eP- • finding: f-29 (new) S-15 PL (eP-A) - EE (eP-B) B)] Production Environment Functional: Testing • observation: o-27 (new) 2. Coverage Completed during last Acceptance Test Event (Wave 5 Formal & Upgrade PPT) Conformance Tests Required Conformance Service Available partners performed - WF with tests with partners partners Conformance testing PS-A (Conformance - min CY, CZ, EL, ES, FR, HR, HU, IE, LU, LV, IE, CY, PT, LV, HU Passed 3 partners) MT, NL, PT PS-B (Conformance - min 3 CY, CZ, EL, ES, HR, IE, IT, LU, LV, MT, PT, LV, PT, SI, IE, HR Passed partners) SI eP-A (Conformance - min CY, CZ, EL, ES, FI, HR, HU, IE, LT, LV, PL, CY, IE, PT, SE, PL, LT, HU Passed 3 partners) PT, SE eP-B (Conformance - min CY, CZ, EL, ES, FI, HR, HU, IE, IT, LT, LV, SE, LT, CY, IE, PL, PT Passed 3 partners) PL, PT, SE Required evaluations Service Available partners Evaluations submitted submitted Functional testing PS-A (Functional - own PS CY, CZ, EL, ES, FR, HR, HU, IE, LU, LV, service evaluated by IE, PT, CY, LV, HU Yes MT, NL, PT partners) 3  Conformance Tests Required Conformance Service Available partners performed - WF with tests with partners partners PS-B (Functional - PS from CY, CZ, EL, ES, HR, IE, IT, LU, LV, MT, PT, IE, PT, LV Yes partners evaluated) SI eP-A (Functional - own eP CY, CZ, EL, ES, FI, HR, HU, IE, LT, LV, PL, docs evaluated by SE, LT, CZ, FI Yes PT, SE partners) eP-B (Functional - eP docs CY, CZ, EL, ES, FI, HR, HU, IE, IT, LT, LV, LT, SE, CZ, HR, HU, CY Yes from partners evaluated) PL, PT, SE eP-A (Functional - eD docs CY, CZ, EL, ES, FI, HR, HU, IE, LT, LV, PL, LT, SE, CZ, FI Yes from partners evaluated) PT, SE eP-B (Functional - own eD CY, CZ, EL, ES, FI, HR, HU, IE, IT, LT, LV, docs evaluated by SE (2), LT, CZ, HR, HU Yes PL, PT, SE partners) 3. Summary of Outstanding findings Outstanding Impact Decision has been taken by Decision has Planned to be fixed by findings been taken on f-10 Minor eHMSEG regarding continuing routine operations 2020-08-20 Original plan: 2023 4. Outstanding findings Service & Test Comments and/or Action Plan ID Finding Comments by the eHDSI Solution Provider Event by the NCPeH 4  Service & Test Comments and/or Action Plan ID Finding Comments by the eHDSI Solution Provider Event by the NCPeH 16 Mar 2020 f- Package size is Update July 2020: we will wait The way to represent the package size was not understood PPT W3, eP-A 10 provided for the change proposal to fix by the receiver of the document (eP and eD). & eP-B, multiplying the this issue, since the additional Functional This issue was discussed during the Joint Online meeting of volume of the text element solution (which the STF on June 10 and it was proposed to prepare a units times the was accepted the last time) isn't Change Proposal to introduce a new data element that number of units in a proper solution. would allow the complete description of complex the package. 02 Apr 2021: Situation is the medications. Additionally using same. Solution Provider on 03 Aug 2020: minor impact. the originalText element to The eP documents from EE contain the detailed description provide the units of the medicinal product in the case of complex per package. medications such as Lantus. Lantus -as well as other medicinal products- have a variety of presentations as regards number of units in the package and volume per unit. The description of the package is present in the original narrative plus in the originalText sub-element of the capacityQuantity element. Therefore, the dispenser will find the information needed about the exact presentation 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. 12 Jan 2023 f- Provided audit on 09 Feb 2023: we are currently Solution provider on 10 Jan 2023: PET Wave 5, 29 messages do not working on finding a solution for eP-A & eP-B, This issue is probably related to the fact that evidence are contain signature. the issue. Conformance taken from the local disk, since the expected audit messages are not present in the database. This is most probably a database related issue (PostgreSQL) that needs to be investigated and fixed on EE side. The Estonian team already contacted us with question related to this issue. Solution Provider on 10 Feb 2023: this issue is considered as having minor impact. 5. 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 5 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