The PPT describes about the healthcare issues in Europe and how eHealth is becoming a solution for those issues. Also the policy for eHealth in Europe. For more information visit: http://www.transformhealth-it.org/

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eHealth in Europe:
Rules and Regulations
F. Lievens1,2
, M. Jordanova3,4
1
Board Member, Secretary and Treasurer of ISfTeH, Switzerland
2
Director, Med-e-Tel, Belgium, lievens@skynet.be
3
Space Technology & Research Institute, BAS, Bulgaria 4
Education 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 eHealthThe 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 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
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
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 ResourcesFree Online Knowledge Resources
Free download!
~5000 abstracts,
papers and PPT
~5000 abstracts,
papers and PPT
Per year Per countryPer 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

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Thank You!