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# 52012DC0736

**COMMUNICATION FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT, THE COUNCIL, THE EUROPEAN ECONOMIC AND SOCIAL COMMITTEE AND THE COMMITTEE OF THE REGIONS eHealth Action Plan 2012-2020 - Innovative healthcare for the 21st century /\* COM/2012/0736 final \*/**

  

COMMUNICATION FROM THE COMMISSION TO
THE EUROPEAN PARLIAMENT, THE COUNCIL, THE EUROPEAN ECONOMIC AND SOCIAL
COMMITTEE AND THE COMMITTEE OF THE REGIONS

eHealth Action
Plan 2012-2020 - Innovative healthcare for the 21st century

TABLE OF CONTENTS

COMMUNICATION FROM THE COMMISSION TO THE
EUROPEAN PARLIAMENT, THE COUNCIL, THE EUROPEAN ECONOMIC AND SOCIAL COMMITTEE
AND THE COMMITTEE OF THE REGIONS eHealth Action Plan 2012-2020 - Innovative
healthcare for the 21st century............................................... 2

1........... Introduction.................................................................................................................... 3

2........... Challenges and Opportunities of
eHealth in Europe.......................................................... 4

2.1........ European healthcare systems
facing challenges................................................................. 4

2.2........ Opportunities: building on market
potential...................................................................... 5

2.3........ Barriers to deployment of eHealth................................................................................... 6

3........... Vision............................................................................................................................. 6

4........... Achieve wider interoperability
in eHealth Services........................................................... 7

4.1........ Addressing the technical and
semantic levels by fostering EU-wide standards, interoperability testing and
certification..................................................................................................................... 7

4.2........ Addressing the organisational
layer.................................................................................. 8

4.3........ Addressing legal issues.................................................................................................... 8

5........... Supporting research,
development, innovation and competitiveness in eHealth................ 10

5.1........ Supporting research, development
and innovation.......................................................... 10

5.2........ Fostering the development of a
competitive eHealth market........................................... 12

6........... Facilitating uptake and ensuring
wider deployment of eHealth......................................... 12

6.1........ Connecting Europe Facility........................................................................................... 12

6.2........ Cohesion policy............................................................................................................ 12

6.3........ Skills and digital health
literacy...................................................................................... 13

6.4........ Measuring the added value............................................................................................ 13

7........... Promoting policy dialogue and
international cooperation on eHealth at global level.......... 13

8........... Conclusions.................................................................................................................. 14

1.           Introduction

Information and Communication Technologies
(ICT) applied to health and healthcare systems can increase their efficiency, improve
quality of life and unlock innovation in health markets.[1]

However, this promise remains largely unfulfilled,
as expressed by Estonian President Toomas Hendrik Ilves, Chair of the
independent high-level eHealth Task Force: "We know that in healthcare
we lag at least 10 years behind virtually every other area in the
implementation of IT solutions. We know from a wide range of other services
that information technology applications can radically revolutionise and
improve the way we do things" (May 2012).[2]

The first eHealth Action Plan[3] was adopted in 2004. Since
then, the European Commission has been developing targeted policy initiatives
aimed at fostering widespread adoption of eHealth throughout the EU[4]. Member States have dynamically
responded by demonstrating a high level of commitment to the eHealth policy
agenda, notably through their participation in major large scale pilot projects
such as epSOS[5].
The adoption in 2011 of the Directive on the Application of Patients' Rights in
Cross Border Healthcare[6]
and its Article 14 establishing the eHealth Network, marked a further step
towards formal cooperation on eHealth, with the aim to maximise social and
economic benefits through interoperability and the implementation of eHealth
systems.

Notwithstanding this substantial progress,
barriers continue to exist that need to be addressed in order to reap all the
benefits from a fully mature and interoperable eHealth system in Europe.

The new eHealth Action Plan aims at addressing
and removing these barriers. It clarifies the policy domain and outlines the
vision for eHealth in Europe, in line with the objectives of the Europe 2020[7] Strategy and the Digital Agenda
for Europe[8].
It presents and consolidates actions to deliver the opportunities that eHealth
can offer, describes the EU's role and encourages Member States and
stakeholders to work together.

2.           Challenges
and Opportunities of eHealth in Europe

2.1.        European
healthcare systems facing challenges

Public health expenditure in the EU's 27 Member
States was on average 5.9% of GDP in 1990, rose to 7.2% of GDP in 2010, and the
projections show that expenditure may continue to grow to 8.5% of GDP in 2060 due
to the ageing population and other socio-economic and cultural factors[9]. In addition, the long term care expenditure projection would on
average almost double over the projection period[10]. Concurrently,
the working age contingent is expected to fall
dramatically from 61% to 51% of the total population while the share of the
elderly (65+) and very old (80+) population in the EU is projected to grow
respectively from 17.4% in 2010 to 30.0% in 2060 and from 4.7% in 2010 to 12.1%
in 2060.[11]

The impact of these changes is already
being felt today and is particularly acute at a time of increased pressure on
public budgets, a steady decline in the number of health personnel,[12] higher incidence of chronic
diseases and growing demands and expectations from citizens for higher quality
services and social care.

Deep-rooted structural reforms are needed
to ensure the sustainability of the health systems while securing access to
services for all citizens. As part of those efforts, Europe must reduce its
overall regulatory burden while ensuring safety. eHealth and wellbeing are
areas with high growth potential and possibilities for innovation notably by
unlocking effective health data exchange. However, the challenges of the
economic crisis, market fragmentation and other barriers as discussed below
limit the benefits of eHealth for healthcare, the health systems, the economy and
the individual citizen and have prevented the market for health services from
developing as rapidly as was hoped for in 2007 when the
Commission selected eHealth as one of six promising lead markets.[13]

2.2.        Opportunities:
building on market potential

Despite the economic crisis, the market
potential of eHealth is strong. The global telemedicine
market has grown from $9.8 billion in 2010 to $11.6 billion in 2011, and is
expected to continue to expand to $27.3 billion in 2016, representing a
compound annual growth rate of 18.6%[14]. The well being market enabled by digital
technologies (mobile applications, devices) is rapidly growing. The convergence between wireless communication technologies and
healthcare devices and between health and social care is creating new
businesses. Redesigning the delivery of care and the 'silver economy' are
highly promising markets.

eHealth can benefit citizens, patients,
health and care professionals but also health organisations and public
authorities. eHealth – when applied effectively - delivers more personalised ‘citizen-centric’
healthcare, which is more targeted, effective and efficient and helps reduce
errors, as well as the length of hospitalisation. It facilitates socio-economic
inclusion and equality, quality of life and patient empowerment[15] through greater transparency,
access to services and information and the use of social media for health.

Such benefits have been demonstrated when
using telemedicine for managing chronic conditions, mental health and health
promotion[16].
Similar benefits have been identified for technology assisted therapies, which can
effectively complement routine clinical care and improve the cost-efficiency of
the treatments as well as when using interoperable
electronic health record and ePrescribing systems, if pursued with the
necessary rigour[17]. Once the value of
benefits begins to cover investment costs, the net benefit expands and becomes
substantial. In countries under adjustment programmes, eHealth has gained
significant importance as a means to improve the efficiency and effectiveness
of systems and their control, and the reduction of expenditures[18]. Finally,
facilitation of eHealth is one of the concrete actions to promote free movement
of EU citizens within the EU[19].

2.3.        Barriers
to deployment of eHealth

Despite the opportunities and benefits, major
barriers hamper the wider uptake of eHealth[20]:

·
lack of awareness of, and confidence in eHealth
solutions among patients, citizens and healthcare professionals;

·
lack of interoperability between eHealth
solutions;

·
limited large-scale evidence of the
cost-effectiveness of eHealth tools and services;

·
lack of legal clarity for health and wellbeing
mobile applications and the lack of transparency regarding the utilisation of
data collected by such applications;

·
inadequate or fragmented legal frameworks
including the lack of reimbursement schemes for eHealth services;

·
high start-up costs involved in setting up
eHealth systems;

·
regional differences in accessing ICT services,
limited access in deprived areas.

Several barriers can contribute to one
market failure e.g. the important issue of the lack of health data exchange can
only be tackled by addressing in a coordinated way fragmented legal frameworks,
lack of legal clarity and lack of interoperability.

3.           Vision

The vision of this Action Plan is to
utilise and develop eHealth to address several of the most pressing health and
health systems challenges of the first half of the 21st century:

–
to improve chronic disease and multimorbidity
(multiple concurrent disease) management and to strengthen effective prevention
and health promotion practices;

–
to increase sustainability and efficiency of
health systems by unlocking innovation, enhancing patient/citizen-centric care
and citizen empowerment and encouraging organisational changes;

–
to foster cross-border healthcare, health
security, solidarity, universality and equity;

–
to improve legal and market conditions for
developing eHealth products and services.

The Action Plan addresses the barriers and
the following operational objectives:

–
achieving wider interoperability of eHealth
services;

–
supporting research, development and innovation
in eHealth and wellbeing to address the lack of availability of user-friendly
tools and services;

–
facilitating uptake and ensuring wider
deployment;

–
promoting policy dialogue and international
cooperation on eHealth at global level.

The Action Plan emphasises cross-border
activities but it should be noted that work done at the EU level has a strong
effect at the national level and vice versa. Therefore, the Action Plan
encourages national and regional authorities, healthcare and social care
professionals, industry, patients, service providers, researchers and EU
Institutions to closely work together.

4.           Achieve
wider interoperability in eHealth Services

The Commission recognises the need for an eHealth
interoperability[21] framework, building on eHealth roadmaps and the general European
Interoperability Framework[22] with its four levels of interoperability: legal, organisational, semantic
and technical.

The eHealth Network set up by Directive 2011/24/EU
is the main strategic and governance body at EU level to work towards
interoperability of cross-border eHealth services.

The Network has the task of producing guidelines
on eHealth, as foreseen in the same Directive, and on an interoperability
framework for cross border eHealth services.

By 2015, the Commission, with the endorsement of the eHealth Network, will propose an eHealth Interoperability Framework based on the results of studies, pilots and research projects.

4.1.        Addressing
the technical and semantic levels by fostering EU-wide standards,
interoperability testing and certification

Interoperability of ICT-enabled solutions and
of data exchange is the precondition for better coordination and integration
across the entire chain of healthcare delivery and health data exchange, while unlocking
the EU eHealth single market.

The use of European and international standards is a way to ensuring
the interoperability of ICT solutions in general[23]. In eHealth however, such
standards are often not specific enough[24].
With the advice of the eHealth Network, more detailed specifications, for
example for public procurement, will be identified in the framework of the new
EU standardization regulation[25],
contributing to the technical and semantic levels of the eHealth Interoperability
Framework. The eHealth Network has the specific objective to draw up guidelines
on a non-exhaustive list of data that are to be included in patients' summaries
and that can be shared between health professionals to enable continuity of
care and patient safety across borders.

In addition to, European and international
standards and specifications, interoperability testing, labelling and
certification processes are also essential. Several projects are successfully
testing and implementing standards, open and secure architecture, clinical
workflows and subsets of terminologies[26]
as well as making policy recommendations, to prepare the deployment of eHealth
services on a large scale. The Commission proposes to boost interoperability by
further developing and validating specifications and components.

From 2012
onwards the Commission will support the eHealth Network in producing guidelines
on a dataset for patient summary records to be exchanged across borders, common
measures for interoperable electronic identification and authentication[27] in eHealth and will enhance
security of health information and eHealth services and interoperability of
databases for medicinal products.

By 2015,
the Commission will seek the endorsement of the eHealth Network to:

•           establish
the semantic and technical cross-border interoperability specifications and
assets necessary for the eHealth Interoperability Framework;

•           propose
an EU interoperability testing, quality labelling and certification framework
for eHealth systems.

Assets,
such as vocabularies, will be taken from past projects or ongoing projects
developed under CIP, FP7, the ISA work program[28]
and in the future Horizon 2020 and be used and maintained under the proposed
Connecting Europe Facility (CEF, see 6.1).

4.2.        Addressing
the organisational layer

This aspect of interoperability is
concerned with how organisations, such as public administrations in different
Member States, cooperate to achieve their mutually agreed goals. In practice,
organisational interoperability implies integrating business processes and
related data exchange and finding instruments to formalise mutual assistance,
joint action and interconnected business processes in connection with
cross-border service provision.[29]

The epSOS project has defined how Member
States can cooperate and integrate their processes in order to deploy eHealth
services across Europe. The eHealth Network and the CEF foresee to implement
these results and thereby address the next phase of cross-border eHealth
processes.

Building on these developments, the Commission will support, from 2013, concrete steps towards greater integration of processes for cross-border eHealth. It will make proposals on organisational issues with the aim of facilitating cooperation in the EU.

4.3.        Addressing
legal issues

Bringing down legal barriers is vital for
deploying eHealth in Europe. The Directive on the application of patients’
rights in cross-border healthcare will contribute to achieving such an
objective as it clarifies patients' rights to receive cross-border healthcare,
including remotely via telemedicine.

The Commission Staff Working Paper on the
applicability of the existing EU legal framework to telemedicine services[30] clarifies the EU legislation
applicable to issues such as reimbursement, liability, licensing of healthcare
professionals and data protection encountered when providing telemedicine
across borders.

From 2013 the Commission will engage in
discussions on legal issues affecting eHealth, within the eHealth Network and
other fora, such as the European Innovation Partnership on Active and Healthy
Ageing (EIP AHA), as well as cross-sectoral legal work linking eHealth to other
ICT-led innovation, with the first conclusions foreseen in 2013-2014.

The Commission will also initiate
discussions among the Member States on reimbursement schemes for eHealth
services based on criteria of effectiveness and efficiency.

In 2013 the
Commission will launch a study under the upcoming Health Programme 2014-2020[31] aimed at examining Member
States' laws on electronic health records in order to make recommendations to
the eHealth Network on legal aspects of interoperability.

Empowering citizens and patients: review
of data protection rules

It is essential to establish safeguards to
allow citizens to use health and well being applications with confidence and
subsequently ensure 'the integration of user-generated data with official
medical data so that care can be more integrated, personalised and useful for
patients[32].

Effective data protection is vital for
building trust in eHealth. It is also a key driver for its successful cross-border
deployment, in which harmonisation of rules concerning cross border exchange of
health data is essential.

In January 2012, the Commission adopted a
proposal for a regulation setting out a general EU framework for data
protection[33]
with a view to modernising current data protection rules and strengthening
their harmonisation[34].

The eHealth Task Force report and the
responses to the public consultation[35]
for the eHealth Action Plan both point to a strong interest in discussing the
concept of 'ownership' and control of data while providing more clarity on the
conditions for accessing and re-using health data for research and public
health purposes and the flow of such data across health and care systems, if
suitably protected.

Data protection issues also need to be
addressed in respect to the use of cloud computing[36] infrastructures and services
for health and wellbeing data processing.

eHealth and wellbeing ICT initiatives should
integrate the principle of privacy by design and by default as well as make use
of Privacy Enhancing Technologies (PET's), as foreseen in the proposed Data
Protection Regulation. The latter contains new principles which will allow the
deployment of trustworthy tools e.g. the principle that controllers will be
accountable for their data processing, carry out data protection impact
assesments and comply with strenghtened security requirements[37].

In response to the recommendations of the
eHealth Task Force and following the adoption of the
proposed Data Protection Regulation, the Commission will make use of the
mechanisms foreseen in the Regulation, to provide guidance on the application
of the EU data protection law in respect of health services.

Tackling the lack of clarity on legal
and other issues around 'mobile health' ('mHealth') and 'health & wellbeing
applications'

The growth in the mobile health and
wellbeing market has been accompanied by a rapid increase in the number of software
applications for mobile devices (or 'apps'). Such applications potentially
offer information, diagnostic tools, possibilities to 'self-quantify' as well
as new modalities of care. They are blurring the distinction between the
traditional provision of clinical care by physicians, and the
self-administration of care and wellbeing. Network operators, equipment
suppliers, software developers and healthcare professionals are all seeking
clarity on the roles they could play in the value chain for mobile health.

The Commission has proposed on 26 September 2012 two Regulations to
strengthen the European regulatory framework for medical devices and in
vitro diagnostic medical devices. These proposals, accompanied by a
Communication on safe, effective and innovative medical devices and in vitro
diagnostic medical devices for the benefit of patients, consumers and
healthcare professionals, aim at improving the level of health protection in
the EU, while at the same time improving the functioning of the internal market
and fostering innovation and competitiveness of these two sectors.[38]

The Commission also published in 2012
guidelines on 'stand-alone software used in healthcare within the regulatory
framework of medical devices'[39]
in order to define the criteria for the qualification
of stand-alone software as a medical device and the application of the risk
classification criteria to such software.

Given the complexity created by 'mHealth' and 'health and wellbeing
applications' in particular, further clarification is needed on the legal
framework applicable to these specific areas. The rapid
developments in this sector raise questions about the applicability of the
current frameworks, the use of the data collected through these applications by
individuals and medical professionals, and whether or not and how they will be
integrated in healthcare systems. Clarity of information and
'user-friendliness' are also important to consider. This needs to be achieved without
over-regulating as it is an emerging cluster of technologies with lower costs
and risks, but also with lower profitability.

The challenges include ensuring that the
market for health and wellbeing applications meets citizens' demands for
quality and transparency. This
should be facilitated by high-quality and comprehensible information on the use
and performance of these applications and ensuring interoperability between
health and wellbeing areas.

In response
to the recommendations of the eHealth Task Force, it is proposed that by 2014,
the Commission will adopt a Green Paper on mHealth and health and wellbeing
applications.

5.           Supporting
research, development, innovation and competitiveness in eHealth

5.1.        Supporting
research, development and innovation

Short-term and mid-term research priorities
include health and wellbeing solutions for citizens and health professionals,
better quality of care, including of chronic diseases, while increasing
citizens’ autonomy, mobility and safety. Particular attention is paid to the
design and user-centricity of mobile technologies and applications. There will
be an additional focus on ways of analysing and mining large amounts of data
for the benefit of individual citizens, researchers, practitioners, businesses and
decision makers.

Longer-term research objectives address
topics that can promote synergies between related science and technologies, and
accelerate discoveries in the area of health and wellbeing. They include in
silico medicine for improving disease management as well as prediction,
prevention, diagnosis, and treatment of diseases. The eHealth Task Force
recommended earmarking EU funds for user-driven innovation, support for fast
prototyping and low thresholds for access to funding. To maximise the impact of
the EU level measures, the full spectrum of research and innovation activities
will be supported. These include:

–
Public-Private Partnerships and other actions
involving research and innovation and translation of knowledge to clinical
trials and demonstration projects[40];

–
Pre-Commercial Procurement and Public Procurement of Innovation for new
products, scalability, interoperability and effective eHealth solutions
supported by defined standards and common guidelines.

Deployment as well as research and innovation
of care for an ageing population, including the ehealth solutions are also addressed
by the Strategic Implementation Plan of the EIP AHA
(SIP)[41].
It aims at enabling citizens to live independently for longer and in better
health, make the cost of care more sustainable, expand the market for
innovative products and services and increase EU's global competitiveness. Horizon
2020 and the upcoming Health Programme 2014-2020 will contribute to the aims of
the EIP AHA.

During the period 2014-2020, research and innovation will be supported under "Health, demographic change and wellbeing" of Horizon 2020, in the areas of: · an ICT and computational science and engineering framework for digital, personalised, and predictive medicine, including advanced modelling and simulation[42]; · innovative instruments, tools and methods for unlocking the value of data and for advanced analytics, diagnostics and decision making; · new digital media, web and mobile technologies and applications, as well as digital instruments that integrate healthcare and social care systems and support health promotion and prevention; · eHealth systems and services with strong user involvement, focusing on interoperability and the integration of emerging patient-centric technologies for cost-effective healthcare. From 2012, the Commission encourages Member States involvement in the EIP AHA to help them develop and share their national (including regional) eHealth strategies, taking into account international recommendations, and deploying promising solutions for active and healthy ageing at a larger scale[43].

5.2.        Fostering
the development of a competitive eHealth market

Ensuring the right legal and market
conditions for entrepreneurs to develop products and services in the fields of
eHealth and wellbeing is important to support market growth in this area. The Commission will support, starting within FP7, mechanisms such as
SME networking, eHealth week, and business modeling studies to facilitate
closer cooperation among stakeholders, research bodies, industry and those
responsible for implementing ICT tools and services, to enable faster and wider
take-up of research results in the market. The Commission will support
networking of European high technology incubators, which would provide legal
and other advice and training to eHealth startups.

Between
2013-2020, the Commission will support actions to improve the market conditions
for entrepreneurs developing products and services in the fields of eHealth and
ICT for wellbeing.

6.           Facilitating
uptake and ensuring wider deployment of eHealth

6.1.        Connecting
Europe Facility

Among other objectives, the Connecting
Europe Facility (CEF)[44]
sets out to facilitate the deployment of cross-border interoperable ICT
services of general interest such as eHealth by overcoming the barriers of the
high initial investment costs and risks associated with this deployment. The
results of the large scale pilot epSOS[45]
(ending in 2013) and other projects and studies will be adapted and taken
forward in the CEF.

The experience of epSOS has shown that
bringing Member States together to build and deploy interoperable infra- and
info-structures also contributes to deployment at national, regional and local
level.

By the end of 2013, the Commission will prepare the governance for the large scale deployment of interoperable eHealth services under the CEF 2014 – 2020, taking into account the recommendations of the eHealth Network.

6.2.        Cohesion
policy

The European Regional Development Fund
(ERDF) provides in the current programming period (2007-2013) approximately EUR
15 billion to ICT priorities (or 4.4% of total cohesion policy funds) to ensure
access to basic broadband (EUR 2.3 billion) and supporting ICT applications and
services for citizens and SMEs (EUR 12.7 billion), for the 27 Member States. The
'Elements for a Common Strategic Framework 2014 to 2020'[46], defines several key actions for
ERDF, which contribute to the wider use of ehealth services, such as to deploy
innovative ICT applications that contribute to meeting societal challenges and
opportunities such as eHealth, modernisation,
structural transformation and sustainability of health systems (in particular
integrated health and social care), leading to measurable improvements in
health outcomes, including e-health measures. It also
defines key action on reducing health inequalities, aiming to improve the
access to services by marginalised groups. The EIP AHA provides a strategic
plan to enable and accelerate the deployment of innovation, including eHealth
for active and healthy ageing.

During the
period 2013-2020, the Commission will leverage the CEF and the ERDF for
the large scale deployment of innovative tools, the replicability of good
practices and services for health, ageing and wellbeing, with a particular
attention to improving equal access to services.

6.3.        Skills
and digital health literacy

On the one hand, patient empowerment and
digital health literacy are essential for successful eHealth deployment. On the
other hand, eHealth facilitates patients managing their own conditions or
healthy citizens benefiting from prevention measures. However, a significant
barrier lies in the lack of awareness of eHealth opportunities and challenges for
users (citizens, patients, health and social care professionals).[47]

From 2013,
starting with the Competitiveness and Innovation Programme and continuing under
Horizon 2020, the Commission will support activities aiming at increasing
citizens’ digital health literacy. For professionals (health and scientific
communities) the focus will be on developing evidence-based clinical practice
guidelines for telemedicine services with particular emphasis on nursing and
social care workers.

6.4.        Measuring
the added value

It is essential to measure and assess the added value of innovative eHealth products and services
to achieve wider evidence-based eHealth deployment and create a competitive
environment for eHealth solutions. The close cooperation between Member States
and stakeholders in Health Technology Assessment (HTA) under the Directive on
Patients' Rights in Cross Border Healthcare and the EIP AHA will contribute to
improving assessment methodologies and sharing clinical evidence on eHealth
technologies and services.

From 2014,
sets of common indicators will be made available to measure the added value and
benefit of eHealth solutions, based on work funded by the Commission in
partnership with stakeholders.

During the
period 2013-2016, the Commission will assess cost benefits, productivity gains
and business models, notably through Health Technology Asessment (HTA) .

7.           Promoting
policy dialogue and international cooperation on eHealth at global level

The WHO, OECD and other international bodies
have underlined the importance of a global coordinated approach to tackle the
specific issues related to eHealth. Recent initiatives[48] have outlined the challenges
of interoperability and specifically of the use of common terminologies at
international level as some of the key components for market growth. In this
context, the EU signed in 2010 a Memorandum of Understanding with the United
States of America on interoperable eHealth systems and skills.

From 2013 the Commission shall enhance its work on data collection and benchmarking activities in health care with relevant national and international bodies to include more specific eHealth indicators and assess the impact and economic value of eHealth implementation. From 2013 the Commission shall promote policy discussions on eHealth at global level to foster interoperability, the use of international standards, develop ICT skills, compare evidence of the effectiveness of eHealth, and promote ecosystems of innovation in eHealth.

8.           Conclusions

EU health systems are under severe
budgetary constraints, while having to respond to the challenges of an ageing
population, rising expectations of citizens, and mobility of patients and
health professionals. Fostering a spirit of innovation in eHealth in Europe is
the way forward to ensure better health and better and safer care for EU
citizens, more transparency and empowerment, a more skilled workforce, more
efficient and sustainable health and care systems, better and more responsive
public administrations, new business opportunities and a more competitive
European economy that can benefit from international trade in eHealth.

The Commission will closely monitor the
implementation of this Action Plan and report on the progress made and the
results achieved.

[1]               eHealth is the use of ICT in
health products, services and processes combined with organisational change in
healthcare systems and new skills, in order to improve health of citizens,
efficiency and productivity in healthcare delivery, and the economic and social
value of health. eHealth covers the interaction between patients and
health-service providers, institution-to-institution transmission of data, or
peer-to-peer communication between patients and/or health professionals

[2]               At the invitation of
Commission Vice-President Kroes and Commissioner Dalli, a Task Force of thought
leaders from politics, health and ICT was convened in May 2011. Its role was to
examine the transformational role of technology in addressing the major
challenges facing the health sector. http://ec.europa.eu/information\_society/activities/health/policy/ehtask\_force/index\_en.htm

[3]               http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=COM:2004:0356:FIN:EN:PDF

[4]               Examples include: eHealth
action plan COM(2004) 356 final; the Lead Market Initiative for Europe and the
associated eHealth Roadmap [COM(2007) 860 final Annex I – Commission Staff
Working Document: SEC(2007) 1729], the Commission Recommendation on
cross-border interoperability of electronic health record systems
(2008/594/EC), the Communication on benefits of telemedicine for patients
healthcare systems and society (COM(2008)689 final)

[5]               www.epsos.eu

[6]               The Network was established
under Article 14 of Directive 2011/24/EU on the application of patients' rights
in cross-border healthcare, http://eurlex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2011:088:0045:0065:EN:PDF
- OJ L 88, 4.4.2011,p.45.

[7]               Communication
from the Commission Europe 2020 a strategy for smart, sustainable and inclusive
growth - com(2010) 2020 final

[8]               http://ec.europa.eu/information\_society/digital-agenda/index\_en.htm

[9]               See the 2012 Ageing Report: Economic and budgetary projections
for the 27 EU Member States (2010-2060), chapter 3 at http://ec.europa.eu/economy\_finance/publications/european\_economy/2012/2012-ageing-report\_en.htm

[10]             See the 2012 Ageing Report: Economic and budgetary projections
for the 27 EU Member States (2010-2060), chapter 4 at http://ec.europa.eu/economy\_finance/publications/european\_economy/2012/2012-ageing-report\_en.htm

[11]             http://epp.eurostat.ec.europa.eu/portal/page/portal/product\_details/publication?p\_product\_code=KE-ET-10-001

[12]             Green Paper on the European
Workforce for Health COM(2008) 725 final of 10.12.2008

[13]             http://ec.europa.eu/enterprise/policies/innovation/policy/lead-market-initiative/files/final-eval-lmi\_en.pdf

[14]             According to BCC Research study
of March 2012

[15]             "Patient empowerment is a process to help people
gain control, which includes people taking the initiative, solving problems,
and taking decisions, and can be applied to different settings in health and
social care, and self management” [ENOPE 2012].

[16]             Staff Working Document
Accompanying eHealth Action Plan – innovative healthcare for the 21st
century.

[17]             Economic Impact of Interoperable Electronic Health
Records and ePrescription in Europe (01-2008/02-2009): http://ec.europa.eu/information\_society/activities/health/docs/publications/201002ehrimpact\_study-final.pdf

[18]             Idem

[19]             EU
Citizenship Report 2010 – Dismantling the obstacles to EU citizens' rights
COM(2010) 603 final (see action 7)

[20]             More information in the Staff
Working Document Accompanying eHealth Action Plan – innovative healthcare for
the 21st century. See also recommendations of the EU eHealth Task
Force

[21]             Interoperability is where two
or more eHealth applications (e.g. EHRs) can exchange, understand and act on
citizen/patient and other health-related information and knowledge among
linguistically and culturally disparate clinicians, patients and other actors
or organisations within and across health system jurisdictions, in a collaborative
manner.

[22]             http://ec.europa.eu/isa/documents/isa\_annex\_ii\_eif\_en.pdf

[23]             EU Study on the specific policy
needs for ICT standardisation, http://ec.europa.eu/enterprise/sectors/ict/files/full\_report\_en.pdf

[24]             European countries on their
journey towards national eHealth infrastructures, EU Study,
http://www.ehealth-strategies.eu/

[25]             http://ec.europa.eu/enterprise/policies/european-standards/documents/official-documents/index\_en.htm

[26]             Among others www.epsos.eu and www.semantichealthnet.eu

[27]             Directive 1999/93/EC on a
Community framework for electronic signatures http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:31999L0093:EN:NOT

[28]             The ISA programme helps
European public administrations setting up efficient cross-border and
cross-sector electronic information exchange and collaboration. The ISA Joinup
platform allows professionals to share interoperability solutions for public
administrations and to find semantic interoperability assets. https://joinup.ec.europa.eu/

[29]             http://ec.europa.eu/isa/documents/isa\_annex\_ii\_eif\_en.pdf

[30]             http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=COM:2008:0689:FIN:EN:PDF

[31]             http://ec.europa.eu/health/programme/policy/proposal2014\_en.htm

[32]             eHealth Task Force Report of May 2012

[33]             Commission proposal for a
regulation on the protection of individuals with regard to the processing of
personal data and on the free movement of such data: http://ec.europa.eu/justice/data-protection/document/review2012/com\_2012\_11\_en.pdf

[34]             See EDPS Opinion on the data protection reform package,
para. 298 and 299, 7 March 2012:

                http://www.edps.europa.eu/EDPSWEB/webdav/site/mySite/shared/Documents/Consultation/Opinions/2012/12-03-07\_EDPS\_Reform\_package\_EN.pdf

[35]             http://ec.europa.eu/information\_society/activities/health/ehealth\_ap\_consultation/index\_en.htm

[36]             Cloud computing is a model for enabling ubiquitous,
convenient, on-demand network access to a shared pool of configurable computing
resources (e.g., networks, servers, storage, applications, and services) that
can be rapidly provisioned and released with minimal management effort or
service provider interaction. (The NIST Definition http://csrc.nist.gov/publications/PubsSPs.html#800-145)

[37]             http://ec.europa.eu/justice/data-protection/article-29/index\_en.htm

[38]             Proposal for Regulation of the
European Parliament and of the Council on medical devices, and amending
Directive 2011/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No
1223/2009, COM(2012) 542 final, available at http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=COM:2012:0542:FIN:EN:PDF;
Proposal for a Regulation of the European Parliament and of the Council on in
vitro diagnostic medical devices, COM(2012) 541 final, available at http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=COM:2012:0541:FIN:EN:PDF;
Communication from the Commission to the European Parliament, the Council, the
European Economic and Social Committee and the Committee of the Regions on
Safe, effective and innovative medical devices and in vitro diagnostic
medical devices for the benefit of patients, consumers and healthcare
professionals, COM(2012) 540 final, available at http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=COM:2012:0540:FIN:EN:PDF

[39]             http://ec.europa.eu/health/medical-devices/files/meddev/2\_1\_6\_ol\_en.pdf

[40]             Projects designed to prove the
viability of new technologies offering potential economic advantage but which
cannot be commercialised directly or to stimulate the up-take of innovative
services or products by demonstrating the impact potential and the technical,
organisational or legal feasibility of operational pilot services based upon
the take-up of completed R&D work or already tested prototype services.

[41]             http://ec.europa.eu/research/innovation-union/index\_en.cfm?section=active-healthy-ageing&pg=implementation-plan

[42]             Virtual Physiological Human http://ec.europa.eu/information\_society/activities/health/research/fp7vph/index\_en.htm

[43]             National eHealth strategy
toolkit. World Health Organization and International Telecommunication Union
2012. http://www.itu.int/dms\_pub/itu-d/opb/str/D-STR-E\_HEALTH.05-2012-PDF-E.pdf

[44]             http://ec.europa.eu/commission\_2010-2014/president/news/speeches-statements/pdf/20111019\_2\_en.pdf

[45]             www.epsos.eu

[46]             Staff Working Document
SWD(2012) 61 of 14.3.2012

[47]             See evidence overview in Staff Working
Document Accompanying the eHealth Action Plan and responses to the eHealth
Action Plan consultation. http://ec.europa.eu/information\_society/activities/health/docs/policy/ehap2012public-consult-report.pdf

[48]             http://ec.europa.eu/information\_society/activities/health/docs/publications/2009/2009semantic-health-report.pdf
and http://www.semantichealthnet.eu/

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