Proposed audit in Estonia - eHealth - DG(SANTE)/2018-6522 - 12 to 16 March 2018

Ref. Ares(2018)1243037 - 06/03/2018 EUROPEAN COMMISSION DIRECTORATE-GENERAL FOR HEALTH AND FOOD SAFETY Health and food audits and analysis DG(SANTE)/2018-6522 ANNEX I AUDIT PLAN ESTONIA FROM 12 TO 16 MARCH 2018 in order to assess the National Contact Point for eHealth's readiness for joining the Cross Border eHealth Information Services Network 1. INTRODUCTION On 27th February 2018, the Director of the Estonian Health and Welfare Information System Centre requested the Director of Directorate F of the Directorate General for Health and and Food Safety, to audit the organisation in its function as National Contact Point for eHealth (NCPeH). Supporting documentation, including a self-assessment report, accompanied the request. The audit is scheduled for 12 to 16 March 2018 and will be carried out in accordance with the audit framework adopted by the eHealth Digital Service Infrastructure Member State Expert Group (eHMSEG) on 18 December 2017. 2. OBJECTIVES AND SCOPE The objective of the audit is to assess the readiness of the NCPeH for joining the Cross Border eHealth Information System (CBeHIS) Network, by verifying compliance with the readiness criteria agreed by the eHMSEG. Particular emphasis will be given to verifying that appropriate policies and processes are in place, are communicated throughout the organisation and are being implemented in order to preserve the confidentiality, integrity and availability of information. The scope of the audit covers the organisation of the NCPeH and its activities in relation to the services implemented, being ePrescription-B (dispensation of electronic prescriptions originating from other EU Member States), including activities carried out by suppliers. 3. EVIDENCE COLLECTION AND CONFIDENTIALITY The audit team will collect evidence from interviews with staff and through the verification of documents, databases and other information sources. The audit team will treat all information gathered in the context of the audit as confidential information. The auditors and interpreters are bound by the confidentiality rules pertaining to staff of the European Commission. In case that confidential information is sent to the auditors, the NCPeH should ensure that this is sent through secure and/or encrypted communication means. 4. LANGUAGE REGIME The working language of the audit team is English. The European Commission will provide interpreters who will interpret to and from the Estonian language whenever necessary. 2 5. WORK SCHEDULE In order to manage the time, the audit team proposes the following work schedule. Monday 12/3/2018 08:30 – 09:00 Introductory words 09:00 – 10:00 The NCPeH within the national infrastructure 10:00 – 12:00 Organisational and contractual domains 12:00 – 13:00 Lunch 13:00 – 17:30 Organisational and contractual domains Tuesday 13/3/2018 08:30 – 12:30 Operational services domain 12:30 – 13:30 Lunch 13:30 – 17:30 Information security domain Wednesday 14/3/2018 08:30 – 12:30 Semantics domain 12:30 – 13:30 Lunch 13:30 – 17:30 Technical domain Thursday 15/3/2018 08:30 – 12:30 Clarification meeting covering any of the domains 12:30 – 13:30 Lunch 13:30 – 17:30 Audit team preparation for the closing meeting Friday 16/3/2018 10:00 – 12:00 Closing meeting The meeting venue will be at Uus-Tatari 25/Veerenni 13, 10134 Tallinn 3 Ref. Ares(2018)1243037 - 06/03/2018 EUROPEAN COMMISSION DIRECTORATE-GENERAL FOR HEALTH AND FOOD SAFETY Health and food audits and analysis Director Grange, SANTE.F5 WR/ams Subject: Reference number: DG(SANTE)/2018-6522 Proposed audit in Estonia from 12 to 16 March 2018 in order to assess the Estonian National Contact Point for eHealth's readiness for joining the Cross Border eHealth Information Services Network Dear Ms Reinhold, Thank you for your letter of 27 February 2018, in which you request an audit of the Estonian Health and Welfare Information Systems Centre, the National Contact Point for eHealth. I propose that the audit will take place from 12 to 16 March 2018. Please find attached to this letter the proposed audit plan. The audit team will comprise 4 auditors from the Directorate-General for Health and Food Safety and 2 interpreters. The team leader will be Mr Wim Riepma (telephone: +353 46 9061 962, e-mail: S ANTE-F 5-EHEALTH@ec. europa, eu). A copy of the draft audit report on the audit's findings will be sent to you in due course. You will be given the opportunity to comment upon the findings and recommendations before the report is finalised. Please contact the team leader should you require any further information or assistance. The reference number should be used in all future correspondence. Yours sincerely, 4aoIa Colombo Director Enel: Audit Plan Ms Katrin Reinhold Director Health and Welfare Information Systems Centre (HWISC) Veerenni 13/Uus-Tatari 25 10134 Tallinn Estonia European Commission, Grange, Dunsany C15 DA39, Co. Meath, Ireland - Office: GRAN 01/096 Tel.: direct line (+353 46) 9061 962, Internal n°: 962, switchboard: (+353 46) 9061 700. Fax: (+353 46) 9061 705