Current regulations regarding eHealth in Europe by Frank Lievens, Executive Secretariat ISfTeH Director, Managing Director Lievens-Lanckman bvba, Belgium

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Current Regulations Regarding
eHealth in Europe
F. Lievens1,2, M. Jordanova3
1Executive Secretariat ISfTeH, Switzerland
2Director, 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 site
http://ec.europa.eu/digital-agenda/en/eu-policy-ehealth
WHO: Legal Frameworks for eHealth
http://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 and
Networking 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 IT
21-22 October 2016, Chennai, India

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Free Online Knowledge Resources
Free download!
~5300 abstracts,
papers and PPT
Per year Per countryPer topic Evidence based
Free download!

23. 23 Thank You!