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Current Regulations Regarding eHealth in Europe

F. Lievens1,2, M. Jordanova3

1Executive Secretariat ISfTeH, Switzerland2Director, Med-e-Tel, Belgium, lievens@skynet.be

3Space Technology & Research Institute, BAS, Bulgaria, mjordan@bas.bg

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– 10 180 000 km2 - the World’s Second Smallest 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 …– 28 European countries are members of the

European Union

– Europe makes 44% of the world’s wine– The second most active volcano in the world is also

in Europe

Europe

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Complex Relations

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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

• The costs of health & social care will rise up to ~9% of EU GDP in 2050

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Telehealth

eHealth

Telemedicine(Telemonitoring,

Teledermatorlogy, Telepathology …) mHealth

Universal Health Coverage

The Solution is eHealth

Promises• Quick, timely high quality

affordable healthcare for all, everywhere, at any time;

• Overcoming shortage of healthcare staff and funding;

• Optimization of patient care;• Optimization of the work of

medical staff;• Enhancing preventive care;• Protecting human rights;• Educating and thus empowering

citizens;• …

Source”eHealth is Worth it: The economic benefits of implemented eHealth solutions at 10 European sites (2006) www.ehealth-impact.org/

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• 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

Rules and Regulations

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Why EU Cooperation• eHealth has great cross-border potential and is not bound to local

setting • Quality argument: Ensure continuity and quality of care across borders

provided in emergencies or on occasional basis • Research argument: enhance the quality of eHealth research, more data

→EU wide, better pilots →many MS; share experience • Shortage of resources: address the lack of funding and legal expertise by

pooling resources and expertise • Economic argument: strengthen the eHealth market by promoting

interoperability and addressing its fragmentation

eHealth Summit: "EU Address: The EU eHealth Strategy: Connecting Member States“, Tapani Phia, 2015, http://www.slideshare.net/3GDR/ehealth-summit-eu-address-the-eu-ehealth-strategy-connecting-member-states-by-dr-tapani-phia

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The Rules and Regulations are Based on

– The European Union Treaty • Free movement, data protection, competition …

– General legislation• Privacy protection: Dir 95/46/EC, Arts. 8-12• Electronic identification services• eCommerce Directives• Medical Devices Directives: Safety requirements• General Product Safety and Liability Requirements (Dir 85/374/EEC,

2001/95/EC)• Strategy for the Digital Single Market adopted by the EC on 6 May 2015

– EU Directive 2011/24 on Cross-border Health Care– Green Paper on mHealth (April 2014)– EU legal framework applicable on lifestyle and wellbeing apps – National data protection legislation– Patients Rights laws– Health provider regulations concerning information processing – …

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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

Strategic parts: eHealth Network eHealth Interoperability Framework Green Paper on mHealth

eHealth Policy

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EU eHealth Network

• eHealth Network • Governs the cooperation

improvement of Member States• Gives direction on main eHealth

developments under the eHealth Action Plan

• Article 14 of Directive 2011/24/EU• Adopts guidelines

• Patient summary data• ePrescriptions

eHealth projects

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Connecting Europe Facility – Supports Building of the Connections

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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 eHealth Policy•Policy instruments

• Communications, Recommendations, Directives• Stakeholders‘ Group (users, industry)• Strategy studies, road maps …

•Research and development• Financing research & innovation • Cooperation with health services, industry, universities …

•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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EU is a 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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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/

EU is a Leader in eHealth Legislation

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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

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Communication Tools

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

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Annual Events

15th edition of Med-e-Tel: The International Educational andNetworking Forum for eHealth, Telemedicine and Health ICT 5-7 April, 2017 Luxembourg, G.D. of Luxembourg

21st ISfTeH International Conference & 7th International Conference on Transforming Healthcare with IT21-22 October 2016, Chennai, India

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