eHealth in Europe: Rules and Regulations

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eHealth in Europe Rules and Regulations
F. Lievens1,2, M. Jordanova3,4 1Board Member,
Secretary and Treasurer of ISfTeH,
Switzerland 2Director, Med-e-Tel, Belgium,
lievens_at_skynet.be 3Space Technology
Research Institute, BAS, Bulgaria 4Education
Program Coordinator, Med-e-Tel, mjordan_at_bas.bg
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Europe EU

• Europe
• 10 180 000 km2 - the 6th largest continent
• 742 452 000 people
• gt220 languages and 5 time zones
• 50 internationally recognised sovereign states (
  4 dependencies 5 with limited recognition)
• gt500 regions with different culture, economic
  development, needs, expectations, traditions
• European Union
• 4 324 782 km2
• 508 191 116 citizens
• 24 official languages
• 28 Countries

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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
• gt70 of healthcare costs are spent on chronic
  diseases
• gt100 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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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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EU Policy Supporting Actions

• 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

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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) gt 450 projects, gt
  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

Adapted from T. Piha, Med-e-Tel 2014
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Coordinating EU Standards
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
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The Leader in eHealth Legislation
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
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 Connects sitehttp//ec.europa.eu/digital
-agenda/en/eu-policy-ehealth WHO Legal
Frameworks for eHealth http//www.who.int/goe/publ
ications/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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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
www.isfteh.org
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Mission Statement
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
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
20th ISfTeH International Conference 28-30
October, 2015 Rio de Janeiro, Brazil

• 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

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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!