1. 1 mHealth & EC Policies Claude Agnès Henrioul Health and Well-Being, European Commission Directorate General Connections Networks, Content & Technologies Geneva, ITU, 25 September 2012

2. 2 EC Policies and Strategies in mHealth Definition of the e/mHealth Market Digital Agenda for Europe 2010-2020 Draft eHealth Action Plan 2012-2020 FP6 & FP7 Projects Agenda

3. 3 Definition of the eHealth/mHealth Market * The eHealth market can be defined as comprising the following four interrelated major categories of applications: 1. Clinical information systems a) Specialised tools for health professionals within care institutions (e.g., hospitals). Examples are Radiology Information Systems, Nursing Information Systems, Medical Imaging, Computer Assisted Diagnosis, Surgery Training and Planning Systems. b) Tools for primary care and/or for outside the care institutions such as general practitioner and pharmacy information systems. 2. Telemedicine and homecare, personalised health systems and services, such as disease management services, remote patient monitoring (e.g. at home), tele-consultation, tele-care, tele-medicine, and tele-radiology. 3. Integrated regional/national health information networks and distributed electronic health record systems and associated services such as e-prescriptions or e-referrals (cross border EHR+ePrescription) 4. Secondary usage non-clinical systems a) Systems for health education and health promotion of patients/citizens such as health portals or online health information services. b) Specialised systems for researchers and public health data collection and analysis such as bio-statistical programs for infectious diseases, drug development, and outcomes analysis. c) Support systems such as supply chain management, scheduling systems, billing systems administrative and management systems, which support clinical processes but are not used directly by patients or healthcare professionals. Lead Market Initiative - eHealth Taskforce report 2007 eHealthhttp://ec.europa.eu/information_society/activities/health/policy/lmi_ehealth/index_en.htm mHealth in all market segments

4. 4 Relevant Policy Hooks European Innovation Partnership on Active and Healthy Ageing (EIP AHA) Digital Agenda for Europe 2010-2020, Key Actions 13 & 14 eHealth Action Plan 2012-2020 - Innovative Healthcare for the 21st Century (under preparation) Adoption: October 2012 Guidelines on the qualification and classification of standalone software used in healthcare within the regulatory framework of medical devices (DG SANCO, Medical Devices Unit) January 2012 Implicit classification of mHealth apps, telemedicine and web based systems Revision of the regulatory framework for medical devices new and emerging technologies have challenged the current framework consolidation and simplification College debate: 26 September 2012 Commission Staff Working Paper on the applicability of existing EU legal framework to telemedicine services Licensing; conditions for processing health data; issue of reimbursement; new Directive 2011/24 on the patients rights in cross-border healthcare; liability Adoption: October 2012 Privacy, security related directives

5. 5 Digital Agenda for Europe 2010-2020 7 Pillars 101 Actions (eHealth: 75 & 76) 16 Key Actions (eHealth:13 & 14)

6. 6 The 7 Pillars of the DAE 1. Vibrant Single Market 2. Interoperability and Standards 3. Trust and Security 4. Fast and Ultra Fast Internet Access 5. Research & Innovation 6. Digital Literacy, skills and Inclusion 7. ICT for Societal challenges (including eHealth )

7. 7 DAE Actions on eHealth Action 75 - Key Action 13 - Give Europeans secure online access to their medical health data by 2015 and achieve wider deployment of telemedicine services by 2020 (leading to empowerment) 3 pilots funded, one project in negotiation Staff working paper on legal framework for telemedicine planned for Autumn 2012 Action 76 - Key Action 14 - Recommendation to define minimum common set of patient data eHealth Network to adopt guidelines in first half of 2013

8. 8 Draft eHealth Action Plan Innovative Healthcare for the 21st Century Duration: 2012-2020 Adoption: October 2012 Policy Context Proposed Objectives / Actions

9. 9 European e-Health Action Plan: Communication COM(2004)356 Asks commitment of MS to work together to implement eHealth Advocates the development of common interoperability approaches and standards for patient identifiers, medical data messaging, electronic health records; Calls for legal clarity and leadership to implement eHealth

10. 10 A New e-Health Action Plan: Why? To reflect the progress made so far To ensure more coherence between health policy developments and eHealth deployment To scale up eHealth for empowerment, efficiency and innovation in healthcare To contribute to more jobs and growth Requested in Council Conclusions (December 2009)

11. 11 New action plan will address the key issues considered to be important* in public consultation: Increase awareness of the benefits and opportunities of eHealth, and empower citizens, patients and healthcare professionals Address issues currently impeding eHealth interoperability Improve legal certainty for eHealth Support research and innovation in eHealth and development of a competitive European market * over 90% agreed / partially agreed Addressing the issues that count:

12. 12 Tackle eHealth challenges related to: Personal Health (improve Chronic Disease Management, prevention and health promotion) Health systems (unlocking innovation, enhancing patient-centric care, encouraging organisational changes) Legal / socio-economic aspects (cross-border healthcare, legal and market conditions) eHealth Action Plan: vision

13. 13 eHealth Action Plan: overall policy goals Improve quality of life and wellbeing of citizens Providing Europeans with equal access to high quality and sustainable healthcare services Enhancing competitiveness of EU industry

14. 14 Operational objectives 1.Setting up an eHealth Interoperability Framework Addressing technical / organisational / legal layers Legal layers: telemedicine, data protection, mHealth 2.Supporting Research, Development, Innovation & Competitiveness in eHealth 3.Ensuring wider deployment of eHealth 4.Facilitating uptake of eHealth 5.Promoting policy dialogue & international cooperation on eHealth on global level

15. 15 Addressing the legal layer Staff Working Paper on the applicability of the EU legal framework to cross-border telemedicine, adoption in October 2012 Support for legal work linking eHealth and ICT-led innovation Guidance on how to apply EU data protection law in the area of health data (empowering citizens and patients following adoption of DP regulation) Tackle the lack of legal clarity around mHealth and Health & Wellbeing apps: Green Paper on Legal Framework applicable to Health & Wellbeing Apps by 2014

16. 16 eHealth Action Plan - Conclusions eHealth Action Plan responds to climate of budgetary constraints of health systems; ageing population; citizens expectations Promoting innovation for: better health and care; transparency and empowerment; more skilled workforce; more efficient and sustainable health and care systems; new business opportunities in Europe and beyond Scheduled Adoption by the EC: end of October 2012

17. 17 Proposal for a Regulation on Medical Devices Scheduled for adoption by the EC: 26 September 2012 mHealth and health and wellbeing apps not satisfactorily covered in the Proposed Regulation on MD Question to regulate or not addressed in a Green Paper on Health and Wellbeing Apps Green Paper scheduled for adoption by the EC: end of 2014

18. 18 EC funded eHealth Research (FP7) or Deployment (CIP) Projects with mHealth Elements AP@home (diabetes) CAALYX (FP6, continuation in CIP) CD-MEDICS (point-of care diagnostics) HeartCycle (cvd, tailored drugs for patients) Help4Mood (depression recovery) ICT4DEPRESSION (depression recovery) INTERSTRESS (psychological stress) METABO (diabetes) Mobiguide (clinical-guideline-based guidance for professionals and patients) MONARCA (mental health, bipolar disease) MovingLife (road mapping for mHealth, primary focus for clinical-medical use) Nephron+ (renal care) REACTION (diabetes) Renewing Health (large CIP covers three most prevalent chronic diseases, includes mobile element) SENSORART (cvd) SmartPersonalHealth (road mapping, Continua health alliance, final report available) SmartHEALTH (point of care diagnostics, FP6) StrokeBack (stroke) One project on Patient Guidance Decision Support System Research Projects under negotiation with strong mobile elements

19. 19 More information and contacts ec.europa.eu/ehealth @EU_ehealth @EU_ehealthweek EU.ehealth Ehealthweek.eu claude-agnes.henrioul@ec.europa.eu