1 eHealth in Europe: Rules and Regulations F. Lievens 1,2, M. Jordanova 3,4 1 Board Member, Secretary and Treasurer of ISfTeH, Switzerland 2 Director, Med-e-Tel, Belgium, 3 Space Technology & Research Institute, BAS, Bulgaria 4 Education Program Coordinator, Med-e-Tel,

2 Europe – km 2 - the 6 th largest continent – ~ 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 – km 2 – citizens – 24 official languages – 28 Countries Europe & EU

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 Telehealth eHealth Telemedicine (Telemonitoring, Teledermatorlogy, Telepathology …) mHealth Universal Health Coverage The Solution is eHealth

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  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  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 EU Policy & Supporting Actions

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 : /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 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 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 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 Coordinating EU Standards

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,

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,

13 More Info about EU eHealth Policy EC Public Health – eHealth Policy site DG Health Consumers’ site DG Connect’s site WHO: Legal Frameworks for eHealth

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 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 NGO in official relations with WHO 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

17 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 Mission Statement Worldwide Membership (89 countries as per September 2015)

18 Communication Tools Website ISfTeH Newsletter (quarterly) Member Announcements ISfTeH e-Journal

19 Annual Events 14 th 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 20 th ISfTeH International Conference October, 2015 Rio de Janeiro, Brazil

20 Free Online Knowledge Resources Free download! ~5000 abstracts, papers and PPT ~5000 abstracts, papers and PPT Per yearPer countryPer topic Evidence based Free download!

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

22 Thank You!