eHealth in Europe: Rules and Regulations

1. eHealth in Europe: Rules and Regulations F. Lievens1,2, M. Jordanova3,4 1Board Member, Secretary and Treasurer of ISfTeH, Switzerland 2Director, Med-e-Tel, Belgium, lievens@skynet.be 3Space Technology & Research Institute, BAS, Bulgaria 4Education Program Coordinator, Med-e-Tel, mjordan@bas.bg

2. Europe & EU • Europe • 10 180 000 km2 - the 6th largest continent • ~742 452 000 people • >220 languages and 5 time zones • 50 internationally recognised sovereign states (+ 4 dependencies + 5 with limited recognition) • >500 regions with different culture, economic development, needs, expectations, traditions … • European Union • 4 324 782 km2 • 508 191 116 citizens • 24 official languages • 28 Countries

3. Main European Healthcare Issues • Growing demand of medical specialists due to • Increasing and ageing population • Movement of people (including immigration) • Unprecedented speed of distribution of pathogens … • Rising health costs • >70% of healthcare costs are spent on chronic diseases • >100 million citizens, above the age of 15, have a chronic disease • Forecast: The costs of health & social care will rise substantially to about 9% of EU GDP in 2050

4. The Solution is eHealth Universal Health Coverage mHealth

5. EU eHealth Rules and Regulations • Challenges • Address health issues • Answer needs & expectations • Respect local legislation, traditions, cultural & economic differences • Goals • Increase healthcare quality, access and safety by making eHealth part of health policy and by coordinating EU countries' political, financial and technical strategies • Improve citizens' health by making life-saving information available between countries using eHealth tools • Ensure sustainability of health systems

6. EU Policy & Supporting Actions • The eHealth Action Plan endorsed by the European Council in 2004 • The first formal commitment expressed by all Member States to cooperate closely in the area of eHealth • Europe 2020 Strategy / eHealth Action Plan 2012-2020 • Goal: Moving EU towards a “European eHealth Area” by coordinating actions and promoting synergies between related policies and stakeholders, so as to develop better solutions, prevent market fragmentation and disseminate best practices • Specific objectives: • To create an electronic health record architecture • To set up health information networks between points of care to coordinate reactions to health threats • To ensure online health services such as information on healthy living and illness prevention and • To develop teleconsultation, ePrescribing, eReferral and eReimbursement capabilities

7. eHealth in the EU Legal Context • Wide range of legal issues are relevant to eHealth, ranging across contract law, employment and market laws, and even criminal law, etc. • But 3 areas of legislation are essential for eHealth flourishing: • Data Protection, Confidentiality and Security (Directive 95/46/EC on Data Protection) • Product and Services Liability , i.e. to what extent rules on liability for goods and services cover the provision of healthcare using eHealth tools (Directive 97/7/EC on Distance Contracting) • Trade and Competition Law, i. e. buying, selling and using eHealth Tools and Services (Articles 81 and 82 of the Treaty on the European Communities) Adapted from Legally eHealth - Putting eHealth in its European Legal Context, DOI : 10.2759/18427, EC, 2008

8. Implementing EU Policy • Research and development • Research Projects (since 1988) > 450 projects, > €1 billion • Cooperation with health services, industry, universities … • Horizon 2020 - financing research & innovation • Policy instruments • Communications, Recommendations, Directives • Stakeholders‘ Group (users, industry) • Strategy studies, road maps … • Support to deployment (since 2007) • Market validation and implementation • Competitiveness and Innovation • Connecting Europe Facility (interconnected transport, energy and digital networks …) to support implementation of large scale cross-border eHealth services and connecting infrastructures • Work with national health systems (since 2011) • Collaboration of MS in the eHealth Network • Deployment of the results of projects Adapted from T. Piha, Med-e-Tel 2014

9. eHealth in The European Legal Context • eHealth Action Plan 2012-2020 • Article 14 of Directive 2011/24/EU on patients' rights in cross-border care • Strategy for the Digital Single Market adopted by the EC on 6 May 2015 • Green Paper on mHealth • Implementing act on prescriptions - Article 11 paving way to guidelines on cross-border ePrescription • eHealth Network • Governs the cooperation improvement of EU Member States • Gives direction on main eHealth developments under the eHealth Action Plan eHealth Network Political body Preparatory body eHealth projects Adapted from T. Piha, Med-e-Tel 2014

10. Coordinating EU Standards The European Code of Practice for Telehealth Services provides a much needed quality benchmark that builds trust among service users and carers; and helps with service reforms

11. The Leader in eHealth Legislation Countries with established privacy legislation Established legislation to protect privacy of digitized health-related data WHO: Legal Frameworks for eHealth, 2013, http://www.who.int/goe/publications/ehealth_series_vol5/en/

12. The Leader in eHealth Legislation Legislation granting individuals the right to access their EHR Legislation allowing individuals to request inaccuracies of their health-related data be corrected within an EHR Legislation on sharing health-related data (through an EHR) within the same health facility WHO: Legal Frameworks for eHealth, 2013, http://www.who.int/goe/publications/ehealth_series_vol5/en/

13. More Info about EU eHealth Policy EC Public Health – eHealth Policy site http://ec.europa.eu/health/ehealth/policy/index_en.htm DG Health Consumers’ site http://http://ec.europa.eu/dgs/health_food-safetyDG Connect’s sitehttp://ec.europa.eu/digital-agenda/en/eu-policy-ehealth WHO: Legal Frameworks for eHealth http://www.who.int/goe/publications/ehealth_series_vol5/en/

14. Summary • Europe, and especially the EU, has done a lot towards wide development and implementation of eHealth • EU may serve as an example of how eHealth regulations are build respecting the interests of different countries and implemented at international level • Yet, Europe does not have a monopoly on how eHealth has to be regulated. Europe is always ready to coordinate actions, share expertise, exchange knowledge and learn from the rest of the world because eHealth is truly GLOBAL • The CHALLENGE for most countries is how to expand the health services to meet growing needs with limited resources, i.e. to achieve UNIVERSAL HEALTH COVERAGE (UHC). This requires a strong, efficient, well-run health system; access to essential medicines and technologies and sufficient, motivated health workers

15. With almost 20000 known diseases, most of them spread worldwide, there is no single national healthcare system that is able to dedicate human or financial resources to deal with all of them. In the globalized world it is time to learn from others! International cooperation and coordination is the only way forward. It is time to combine the best practices from different countries and cultures from all over the world

16. The way forward is collaboration and cooperation in order to make the benefits of science, information and technology, available to all. A major international forum helps bringing experts and stakeholders together NGO in official relations with WHO www.isfteh.org

17. Mission Statement The ISfTeH exists to facilitate the international dissemination of knowledge and experience in Telemedicine and eHealth and to provide access to recognized experts in the field worldwide Worldwide Membership (89 countries as per September 2015)

18. Website www.isfteh.org ISfTeH Newsletter (quarterly) Member Announcements ISfTeH e-Journal CommunicationTools

19. 14th edition of Med-e-Tel: The International Educational and Networking Forum for eHealth, Telemedicine and Health ICT 6-8 April, 2016 Luxembourg, G.D. of Luxembourg Annual Events 20th ISfTeH International Conference 28-30 October, 2015 Rio de Janeiro, Brazil

20. Free Online Knowledge Resources ~5000 abstracts, papers and PPT Free download! Free download! Evidence based Per year Per topic Per country

21. A wise man learns by the mistakes of others, a fool – by his own. Latin proverb

22. Thank You!