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Saatja: Liisa Lvova </O=SOTSIAALMINISTEERIUM/OU=EXCHANGE ADMINISTRATIVE GROUP (FYDIBOHF23SPDLT)/CN=RECIPIENTS/CN=LIISA LVOVA73C> Saaja: Marika Vaher Teema: FW: eHDSI: MS-EE Operational compliance check Ja see oli teine kiri, kus olid lisamaterjalid. Liisa From: Liisa Lvova <[email protected]> Date: Friday, 11. March 2022 at 20:51 To: "Annouri, Ilias" <[email protected]> Cc: "BE GEN qa4.ehdsi" <[email protected]>, "[email protected]" <[email protected]> Subject: Re: eHDSI: MS-EE Operational compliance check Dear colleagues, Hope you’ve had a peaceful last week! Please find additional information regarding Estonian operational compliance check. There are still 2 points marked in green, where data is missing and I’m waiting input from our system administrator. I’ll forward you the information as soon as I have it. Stay safe and kind regards, Liisa From: Liisa Lvova <[email protected]> Date: Friday, 25. February 2022 at 13:08 To: "Annouri, Ilias" <[email protected]> Cc: "BE GEN qa4.ehdsi" <[email protected]>, "[email protected]" <[email protected]> Subject: Re: eHDSI: MS-EE Operational compliance check Dear Ilias, I hope to finish the Excel sheet by next Friday, depending on our information security teams availability. In case I need more time, I’ll let you know 😊 In the meanwhile, I hope you have a peaceful weekend ahead and kind regards, Liisa From: Liisa Lvova <[email protected]> Date: Monday, 14. February 2022 at 16:10 To: "Annouri, Ilias" <[email protected]>, Viljar Pallo <[email protected]> Cc: "BE GEN qa4.ehdsi" <[email protected]>, "[email protected]" <[email protected]> Subject: Re: eHDSI: MS-EE Operational compliance check Dear Ilias, Thank you for sending the feedback. I’ll finish reading the enormous number of e-mails that I received while on vacation and I’ll let you know after this when you might expect to get the updated version and additional evidence 😊 Kind regards, Liisa From: "Annouri, Ilias" <[email protected]> Date: Tuesday, 1. February 2022 at 19:14 To: Liisa Lvova <[email protected]>, Viljar Pallo <[email protected]> Cc: "BE GEN qa4.ehdsi" <[email protected]>, "[email protected]" <[email protected]> Subject: RE: eHDSI: MS-EE Operational compliance check Tähelepanu! Tegemist on väljastpoolt asutust saabunud kirjaga. Tundmatu saatja korral palume linke ja faile mitte avada. Dear Liisa, Viljar, Thank you for providing the evidence to support the Operational Compliance Check of the Estonian National Contact Point for eHealth to continue operations on the Cross Border eHealth Information Services Network for the service ePrescription country A and B. We have examined the evidence in order to determine whether we can perform an effective assessment. This means essentially that the evidence is relevant in response to the criteria and that it is up to date. At this stage we are not identifying findings or recommendations, only identifying whether it is assessable. In general, the provided self-assessment and evidence give us limited possibility to assess all the criteria. Even if it is mentioned that nothing has changed, our expectation is to see evidence that documentation or arrangements are still valid and up-to-date. Therefore, we would like to request some additional evidence or clarifications. Please find attached a list of the observations and questions we have made during the evidence review. We would in particular like to request additional clarification/evidence for the requirements which are assessed as NOK (column H), however, we would also advise to provide additional evidence/clarifications for the requirements for which additional evidence is requested in column I, as it would help us (during the preparation of the operational compliance check) if the evidence can be provided upfront. Especially in cases when the evidence is in Estonian, it gives us time for any translation to English. We would like to request this information to be provided to us soon, so that we can strive together to be ready to perform the operational compliance check by the end of February or beginning of March 2022, provided that most of the evidence is sufficient. Please do not hesitate to contact us if you have any questions. Many thanks! Have a nice evening. Kind regards / Met vriendelijke groet, Ilias Annouri | CGI | TAXUD/SANTE QA4 | Project Manager T: + 32 2 70 86284 | M: +32 473 33 42 14 | ilias.annouri @cgi.com <http://ilias.annouri%[email protected]> | www.cgi.com <http://www.cgi.com/> CGI Belgium, registered office in Brussels, Belgium | Registration Number: 0441.137.687 Registered Office: Vuurberg – Airport Plaza, Building C Kyoto, Leonardo Da Vincilaan 19, B–1831 Diegem, Belgium CONFIDENTIALITY NOTICE: Proprietary/Confidential Information belonging to CGI Group Inc. and its affiliates may be contained in this message. If you are not a recipient indicated or intended in this message (or responsible for delivery of this message to such person), or you think for any reason that this message may have been addressed to you in error, you may not use or copy or deliver this message to anyone else. In such case, you should destroy this message and are asked to notify the sender by reply e-mail. “Go Green” - Please consider a sustainable environment before printing this message From: Liisa Lvova <[email protected]> Sent: Friday, 21 January 2022 09:20 To: Torron Mack, Tomas <[email protected]> Cc: BE GEN qa4.ehdsi <[email protected]>; [email protected]; HYPPONEN Konstantin <[email protected]>; VAN HAASTERT Hugo <[email protected]>; Annouri, Ilias <[email protected]>; Viljar Pallo <[email protected]> Subject: Re: eHDSI: MS-EE Operational compliance check EXTERNAL SENDER: Do not click any links or open any attachments unless you trust the sender and know the content is safe. EXPÉDITEUR EXTERNE: Ne cliquez sur aucun lien et n’ouvrez aucune pièce jointe à moins qu’ils ne proviennent d’un expéditeur fiable, ou que vous ayez l'assurance que le contenu provient d'une source sûre. Dear Tomas, As discussed with Konstantin, I will send you the initial necessary documentation, but I will be on vacation until 14th of February and HWISC will be ready to conduct the operational audit in second half of February. Now, for the request of the operational audit, an official letter will be sent out to [email protected] <mailto:[email protected]> via our document management system, which will include the same documents as I am sending you now: * a statement regarding the service(s) for which the NCPeH requests the operational compliance check * a description of the Member State's health care system including the role and responsibility of each actor therein relevant to a service – a health information system statute. * a description of the organisation of the NCPeH (including legal entity, organigram, quality management system, information security management system, and IT service management system) – tehikpõhimäärus.pdf and HWISC structure.png * the Membr States self-assessment based on the eHDSI Readiness Criteria Checklist and documents, which prove the assessment – Operational audit_wiki.pdf and OP Audit.zip. If you should have any additional questions while I’m away, my fellow project manager Viljar Pallo ([email protected] <mailto:[email protected]> ) will help you as much as he can, but I’m hoping that you will not torture him much 😊 Kind regards and hope to hear from you soon! Liisa From: "Torron Mack, Tomas" <[email protected] <mailto:[email protected]> > Date: Tuesday, 23. November 2021 at 14:03 To: Liisa Lvova <[email protected] <mailto:[email protected]> > Cc: "BE GEN qa4.ehdsi" <[email protected] <mailto:[email protected]> >, "[email protected] <mailto:[email protected]> " <[email protected] <mailto:[email protected]> >, HYPPONEN Konstantin <[email protected] <mailto:[email protected]> >, VAN HAASTERT Hugo <[email protected] <mailto:[email protected]> >, "Annouri, Ilias" <[email protected] <mailto:[email protected]> > Subject: eHDSI: MS-EE Operational compliance check Dear Liisa, I contact you on behalf of the eHDSI compliance check team (my colleague Ilias is currently absent). As mentioned by Natalia Zylinska in the email below, the European Commission (DG SANTE) has entrusted CGI (www.cgi.com <http://www.cgi.com> ) with the conduct of eHDSI compliance checks. The “Framework for the NCPeH Compliance Checks with the eHDSI Requirements” requires that an operational compliance check is performed before the end of a 3 year period in routine operations. (https://webgate.ec.europa.eu/fpfis/wikis/display/EHDSI/4.+eHDSI+COMPLIANCE+CHECKS+SERVICES <https://urldefense.com/v3/__https:/webgate.ec.europa.eu/fpfis/wikis/display/EHDSI/4.*eHDSI*COMPLIANCE*CHECKS*SERVICES__;KysrKw!!AaIhyw!9iPPny6vJyJV_wvpClzfbEdwCW7ak24Lqsc-SxqHLAqmj9mzwRPdhTDT-kITbEM$> ) This is applicable to MS Estonia, for which we understand that the following services are in operations: * e-Prescription B, go-live date : 2019.01.21 * e-Prescription A, go-live date : 2020.06.01 In first instance, we would like to know the status of preparation of the MS Estonia NCPeH for such an operational compliance check. The Framework requires for an operational compliance check: * a statement regarding the service(s) for which the NCPeH requests the operational compliance check; * a description of the Member State's health care system including the role and responsibility of each actor therein relevant to a service; * a description of the organisation of the NCPeH (including legal entity, organigram, quality management system, information security management system, and IT service management system); * the Member States self-assessment based on the eHDSI Readiness Criteria Checklist and documents, which prove the assessment. For the last bullet point, as per the email below, the eHDSI Readiness Criteria checklist has been amended to include the aspects to cover for operational compliance checks. We would appreciate your feedback on this topic, and remain available for any further clarifications. Best regards, Tomás Torrón Mack | CGI | QA4 Contract Manager, Director Consulting M: +32 473 23 56 45 | [email protected] <mailto:[email protected]> | www.cgi.com <http://www.cgi.com/> Message classification: X CGI Public Internal Confidential Highly Confidential European Commission Publicly available Commission Use Sensitive Non Classified EU Restricted CGI Belgium, registered office in Brussels, Belgium | Registration Number: 0441.137.687 Registered Office: Vuurberg – Airport Plaza, Building C Kyoto, Leonardo Da Vincilaan 19, B–1831 Diegem, Belgium CONFIDENTIALITY NOTICE: Proprietary/Confidential Information belonging to CGI Group Inc. and its affiliates may be contained in this message. If you are not a recipient indicated or intended in this message (or responsible for delivery of this message to such person), or you think for any reason that this message may have been addressed to you in error, you may not use or copy or deliver this message to anyone else. In such case, you should destroy this message and are asked to notify the sender by reply e-mail. “Go Green” - Please consider a sustainable environment before printing this message. From: SANTE EHDSI SECRETARIAT <[email protected] <mailto:[email protected]> > Sent: Monday, October 25, 2021 1:03 PM To: Fordell Lotta <[email protected] <mailto:[email protected]> >; SANTE EHDSI SECRETARIAT <[email protected] <mailto:[email protected]> >; Penttinen Tiina <[email protected] <mailto:[email protected]> >; Kauranne Paavo <[email protected] <mailto:[email protected]> >; Liisa Lvova <[email protected] <mailto:[email protected]> > Cc: HYPPONEN Konstantin (SANTE) <[email protected] <mailto:[email protected]> >; VAN HAASTERT Hugo (SANTE) <[email protected] <mailto:[email protected]> >; Annouri, Ilias <[email protected] <mailto:[email protected]> > Subject: FI and EE Operational compliance check Dear Lotta and Liisa, I can confirm that now the eHDSI Readiness Criteria have been updated. https://webgate.ec.europa.eu/fpfis/wikis/x/fPzzN <https://urldefense.com/v3/__https:/webgate.ec.europa.eu/fpfis/wikis/x/fPzzN__;!!AaIhyw!5xIx0_zv9TC6iUxYHsHTfZIWENgz07B6v_8ktIf0YLBOMCiZE4PyIpDe7Bl0PvePbPg$> All the points, where you will find information how to act during the operational compliance check are applicable to this type of the compliance. I put in cc Konstantin and Hugo as they will shortly replace me. And Ilias is the contact point in the CGI company, which will perform the operational compliance check. You will find all the info in the eHDSI Framework for Compliance check which was adopted by the eHMSEG last Wednesday. Best Natalia