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eHealth in Europe: Rules and Regulations

F. Lievens1,2, M. Jordanova3,4

1Board Member, Secretary and Treasurer of ISfTeH, Switzerland2Director, Med-e-Tel, Belgium, lievens@skynet.be

3Space Technology & Research Institute, BAS, Bulgaria 4Education Program Coordinator, Med-e-Tel, mjordan@bas.bg

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• 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

Europe & EU

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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

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mHealth

Universal Health Coverage

The Solution is eHealth

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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

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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

EU Policy & Supporting Actions

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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

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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

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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

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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

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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/

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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/

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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-safety

DG Connect’s sitehttp://ec.europa.eu/digital-agenda/en/eu-policy-ehealth

WHO: Legal Frameworks for eHealthhttp://www.who.int/goe/publications/ehealth_series_vol5/en/

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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

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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

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NGO in official relations with WHO

www.isfteh.org

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

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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)

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Communication Tools

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

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Annual Events

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

20th ISfTeH International Conference 28-30 October, 2015 Rio de Janeiro, Brazil

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Free Online Knowledge Resources

Free download!

~5000 abstracts, papers and PPT

Per year Per country Per topic Evidence based

Free download!

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

22Thank You!