1. E-Health: Proposal and call for a new working group Oslo, 18 April, 2015 E-Health: Preparing for the Helsinki conference Proposal and call for a new working group Oslo, 18 April, 2015 European Partnership for Supervisory Organisations in health services and social care Presentation by Mari Murel Research and Policy officer by EPSO 0

2. Lay out of the presentation E-Health as topic -introduction Recent developments in Europe E-Health working group Feedback and discussion 1

3. E-Health Wide topic with variety of terminology: telehealth, mhealth, telemedicine, teleconsultation, telemonitoring, e-nursing, smart care, teledermatology, telecardiology… What about supervision? Where and when does supervision start? Challenges for Healthcare Practioners, hospitals and for Health Law 2

4. Recent developments eHealth in Europe: Empowering Patients and Offering Better Connected Healthcare Services 27th January 2015 Brussels – Topics: legal aspects and uncertainties of eHealth and mHealth services, digital health literacy – E-Health interoperability framework proposed 2015 by European Commission – E-Health action plan 2012-20 – Green paper on mHealth (adopted on 10 April 2014 ) – Staff Working Paper on legal issues in Telemedicine 3

5. Recent developments – eHealth network (ministries) – EpSOS- The European eHealth Project on cross-boarder Services – Digital Security, Electronic health records – Teleconsultation, Telemedicine& e-Health topic for ISfTeH (international federation of national associations who represent their country’s Telemedicine and eHealth stakeholders). 4

6. Recent developments – Code of practice for Telehealth services (Developed under the TeleSCoPE project (co-funded by the EU Health Programme) – Good practice examples from the Region of Southern Denmark(Syddanmark) : Welfare technology, Age friendly environments. (Henriette Hansen South Denmark European Office) 5

7. e-Health Working group One of the topics of next EPSO conference in Helsinki in 30th September – Supervision, regulator point of view – What do we already know? – What do we want to know? – What are the risks and benefits for the healthcare sector of delivering eHealth/ using eHealth products? – Suggested topic “e-Health and National Self-Medication program. – Speakers : Pekka Kurki(FIN), Stefan Visscher (NL) 6

8. e-Health Working group What is the approach of Supervisory organisations ? Dutch IGZ example approach by Stefan Visscher: There are basically two approaches to regulatory oversight of eHealth that thread together perfectly: What are the risk and benefits of an eHealth product? Does the manufacturer comply to legislation? The Medical Device Directive 93/42/EEC might apply here as well as privacy/ data protection legislation. Additionally, the eHealth ISO 13131 should be followed. Doctors/ nurses and healthcare institutions should introduce and put into service new techniques in such a way that delivering good quality of care is still guaranteed. This can only be done, when for example the healthcare professionals are trained. 7

9. e-Health Working group What is the approach of Supervisory organisations ? Call for EPSO eHealth workgroup! What can EPSO do and in what form? Exchange of experience, share knowledge, workshops, pilots… Feedback, suggestions, how do proceed 8

10. Info and coordination via EPSO www.epsonet.eu mmurel@esponet.eu www.epsonet.eu mmurel@esponet.eu EPSO member access username: EPSOMEMBER Password: epsomember 9