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# 52012SC0413

**COMMISSION STAFF WORKING DOCUMENT eHealth Action Plan 2012-2020 – innovative healthcare for the 21st century Accompanying the document 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 /\* SWD/2012/0413 final \*/**

  

COMMISSION STAFF WORKING DOCUMENT

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

Accompanying the document

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

Disclaimer: This document is a European Commission staff working document for
informative purposes. It does not represent an official position of the
Commission on this issue, nor does it anticipate such a position.

1........... Introduction. 5

2........... The Context of the
initiative. 6

3........... The 2004 eHealth
Action Plan. 6

3.1........ An evaluation of the 2004
eHealth Action Plan. 7

4........... Problem definition. 9

4.1........ Sustainability of
healthcare and social systems. 9

4.2........ Ageing population and
growing incidence and prevalence of chronic diseases. 10

4.3........ Mobility of patients and
health professionals and shortage of professionals. 10

4.4........ Increased demand for high
quality of care and investing in expensive technologies. 11

4.5........ Slow deployment of
eHealth tools and services. 11

5........... Consultation of
interested parties. 12

5.1........ Stakeholder consultation. 12

5.2........ Internal expertise. 14

5.3........ External expertise and
input 14

5.3.1..... Task Force Report 14

6........... Evidence informed
eHealth Action Plan 2012 – 2020. 15

6.1........ Methodology. 16

6.2........ Results. 17

7........... Vision and objectives
of the eHealth Action Plan 2012 - 2020. 25

7.1........ General objectives. 25

7.2........ Specific objectives. 26

7.3........ Operational objectives. 26

8........... Added value of and
justification for acting at the EU level 26

9........... Next steps following
the Communication. 28

9.1........ Review by the Commission
of progress made. 28

10......... Bibliography of evidence
informed section. 29

ANNEX: Governance chart for interoperability. 0

EXECUTIVE SUMMARY

The eHealth Action Plan 2012- 2020 responds
to the requests of the EPSCO Council in its December 2009 Conclusions on Safe
and efficient healthcare through eHealth. Notably, the Council called upon the
Commission for support "to bring forward eHealth deployment and actual use
of Interoperable eHealth services within and between national healthcare
systems" and to "update the eHealth Action Plan".

Building on these requests, the operational
goal of the Action Plan is to break down persistent barriers and realise the
vision of the Europe 2020 Strategy in the area of eHealth. It aims to improve
the quality of life of European citizens; provide equal access to high quality
and sustainable health care systems to all European citizens; and enhance the
competitiveness of EU industry in the area of eHealth.

Since the adoption of
the first eHealth Action Plan in 2004, significant progress has been made. Notably,
political awareness around eHealth has risen significantly. This has led to
many EU Member States, regions and healthcare providers committing to:
widespread deployment of eHealth solutions, enhancing legal certainty and
improving technical guidance. While all the planned actions defined in the 2004
eHealth Action Plan  have been undertaken and progress has been made, challenges
and barriers still remain. Many of the challenges are related to demographic
change, an increase in the incidence of chronic diseases, the growing demand
for high quality services and the impossibility to increase the number of
resources accordingly. Increased mobility of citizens (patients and health
professionals) within the EU and a shortage of professionals also threaten the
future health systems as well as the principle of equity. In the face of all of
these challenges, eHealth can play a beneficial role. Today the range of
possible Information and Communication Technology (ICT)
applications in the health sector is enormous. The
technology has progressed significantly and many estimate that ICT
implementation can result in care that is higher in quality, safer and more
responsive to patients’ needs and, at the same time, more efficient
(appropriate, available, and less wasteful). eHealth advocates point to the
potential reduction in medication errors as a critical advantage of the
information system and electronic health record (EHR), but also the improvement
of accessibility  as a strategic instrument to decrease inequalities.

The eHealth Action Plan  2012 - 2020 was
developed following a public consultation drawing on expertise across the
eHealth stakeholder community, the recommendations of the eHealth Task Force
and the review of evidence. The new Action Plan has been designed following a
methodology of evidence-informed policy development which confirmed that the
main barriers to deploying eHealth solutions are lack of users' awareness of
the benefits, a lack of ehealth literacy, a lack of evidence of
cost-effectiveness and interoperability. It should be noted that eHealth
penetration, digital literacy and ICT use vary widely across EU Member States.
Socio-political and economic differences as well as variations in health systems,
health outcomes and health workforces also exist. As such, the cooperation and
partnership of all Members State and all stakeholders should be essential to
achieve the goals of the Action Plan.

The main body of evidence for the
effectiveness of eHealth services is currently concentrated in three areas:
health promotion and prevention, chronic diseases and mental health
intervention. While there is evidence of the effectiveness of telemedicine, cost-benefit
analysis is often lacking. Going forward, such evaluation will play an
important role in ensuring the success and the sustainability of future health
systems.

The findings discussed
in this staff working document point to a number of practices or approaches
that could be employed for improving and accelerating the adoption and use of
health ICTs. As these typically imply trade-offs with competing goals, policy
makers must determine whether the expected benefits from these practices are
likely to outweigh the costs of implementation in a particular situation. This
document highlights an absence of robust monitoring and evaluation of
programmes and projects. Measuring the impacts of ICTs is difficult for a
number of reasons, but would be crucial to demonstrate the real added value of
eHealth solutions. Consequently, the new eHealth Action Plan is addressing
evidence-based implementation of eHealth solutions, promoting evaluation and
research including the Health Technology Assessment (HTA) approach in order to
define the essential elements to ensure a successful and efficient deployment
of eHealth.

ICT
implementation may have effects that are multidimensional and often may be
uncertain in their reach and scope and difficult to control. In addition, the
realisation of benefits from ICT implementation strongly depends on contextual
conditions[1].
For example, moving to an EHR in its fullest form is not just a technical
innovation; it is a cultural transformation. Changes in management are vital
for successful uptake, and failure to build in processes for effecting the
necessary organisational transformations will reduce both uptake and impact.
Participation and involvement of Member State in this process is essential.

The adoption in
2011 of the Directive on the Application of Patients' Rights in Cross Border
Healthcare[2]
and its Article 14 establishing the eHealth Network, marks a further step
towards formal cooperation on eHealth. All Member States are now participating
in the eHealth Network, with the aim to maximise social and economic benefits
through eHealth systems and interoperability (one of the most important
barriers).

The actions
focus on European added value by means of pan-European policy and legislative
actions, transformative research and innovation, and interoperability and
deployment in order to facilitate a common eHealth and wellbeing  innovation
space, in which citizens' rights are protected, their mobility across the
European Union is facilitated and  equity and social cohesion for all is
promoted.

Considering all of the above, the
Commission will work to achieve following operational objectives:

–
achieving wider interoperability of eHealth
services;

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

–
facilitating  uptake and ensuring  wider
deployment;

–
promoting international cooperation.

1.           Introduction

The 2004 eHealth Action Plan[3] set out the first steps
necessary for widespread adoption of eHealth technologies across the EU.

In December 2009 within the framework of
the EPSCO Council, Member States adopted Council Conclusions on Safe and
efficient healthcare through eHealth[4].
In these Conclusions, the Council recognises the contribution that eHealth can
bring to healthcare systems, it underlines the common challenges all healthcare
systems are facing and called upon the Commission for support "to bring
forward eHealth deployment and actual use of Interoperable eHealth services
within and between national healthcare systems". Finally, the Council
specifically called on the Commission to "update the eHealth Action
Plan".

To respond to this call, to reflect the
progress made so far in eHealth and provide support to Member States and stakeholders to make further progress, the Commission is updating the eHealth Action
Plan. The new Action Plan will also be an opportunity to consolidate the
actions which have been undertaken or planned so far in a number of
initiatives, while providing for a global strategic vision on eHealth. This
Action Plan also aims at stimulating a policy debate on how innovation can
contribute to rethinking the way in which healthcare is provided today, by
considering the latest developments in technology, innovative services and the
growing impact of new media on the health and wellbeing systems.

In this document:

–
eHealth means ICT tools and services for 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. Examples include health
information networks, electronic health records, telemedicine services,
wearable and portable systems which communicate, health portals, and many other
ICT-based tools assisting disease prevention, diagnosis, treatment and follow
up.

–
ICT for wellbeing is the use of ICT in products,
services and processes, in order to directly or indirectly improve the quality
of life and wellbeing status of EU citizens. Wellbeing is a person’s experience
of positive and negative emotions, satisfaction, vitality, resilience, self-esteem
and sense of purpose and meaning. Social well-being has two main components: supportive
relationships and a feeling of trust and belonging; together they form a
picture of what everyone really wants: a fulfilling and happy life[5] . It is increasingly recognized
that the major factors of ill-health and the major assets for health are best
addressed by engaging non-health sectors and citizens[6].

–
Telemedicine is the provision of healthcare
services, through use of ICT, in situations where the health professional and
the patient (or two health professionals) are not in the same location. It
involves secure transmission of medical data and information, through text,
sound, images or other forms needed for the prevention, diagnosis, treatment
and follow-up of patients.

2.           the
Context of the initiative

The Europe 2020 Strategy emphasises that
knowledge and innovation are key to help Europe exit the current socio-economic
crisis[7]. In this context, it highlights the potential of Europe’s digital
economy to help Europe achieve smart, sustainable and inclusive growth.

The Digital Agenda for Europe ('DAE')[8], one of the flagship initiatives of the Europe 2020 Strategy aims to deliver sustainable economic and social
benefits from a digital single market. The sustainability of healthcare systems is identified as a priority area
which can greatly benefit from the use of information and communication technologies
(ICT) by enabling patient empowerment and continuity of care.

Innovation Union, also
a Europe 2020 flagship, aims to improve conditions and access to finance for
research and innovation in Europe, to ensure that innovative ideas can be
turned into products and services that create growth and jobs. Launched under
Innovation Union, the pilot European Innovation Partnership on Active and
Healthy Ageing[9], aims at increasing the average healthy lifespan in the EU by two
years by 2020. This will be achieved inter alia by scaling up uptake of
innovative eHealth tools and services which would lead to empowering citizens,
in particular older people, increasing sustainability of healthcare systems and
generating growth.

The new eHealth Action Plan 2012 - 2020
builds on the 2004 eHealth Action Plan which marked the
beginning of closer cooperation between EU Member States in the area of eHealth.
This led, in 2008, to more formal cooperation through the Large Scale Pilot
epSOS[10]
and eGovernance Initiative. The establishment of the eHealth Network, set up
under Article 14 of the Directive on the Application of Patients' Rights in
Cross Border Healthcare[11]
marks a further step towards formal cooperation on eHealth.[12] The eHealth Network will be
giving advice and endorsing guidelines. The Connecting Europe Facility (CEF)[13]
has been set up to facilitate the deployment of cross-border interoperable ICT
services of general interest, also eHealth. This new instrument, taking over
the expert work done by the eHealth Governance Initiative, will organise expert
groups for cross border deployment, including at the organisational level. (See
the governance chart in the annex).

3.           The
2004 eHealth Action Plan

The first
eHealth Action Plan defined the following main challenges:

·
Leadership from healthcare authorities and
providers, in particular focusing on financial and
organisational aspects, which are considered essential elements for the
successful deployment of eHealth.

·
Market fragmentation, lack of
interoperability, ineffective standardisation: The
main reasons for market fragmentation are related to lack of regulation and
standards at EU level, while healthcare systems remain highly regulated through
various national regulations.

·
Legal uncertainty in deploying eHealth (cross
border) services, ineffective funding, reimbursement, procurement and
sustainable business models

·
Limited awareness of benefits among
authorities and health professionals: the Action
Plan identified the need for a European-wide public health portal that would be
a flexible information technology platform to disseminate evidence-based
information on public health relevant to European citizens, while providing a
single point of access to information on health.

·
Specific concerns on privacy and protection
of personal data, leading to lack of confidence and wide acceptance: building trust is a prerequisite to the development of an
information society as well as eHealth services.

·
Insufficient infrastructure (for example the lack of broadband in remote areas, essential for
telemedicine services): a top priority for health providers using an eHealth
system is the speed in getting the desired, high-quality results. Online health
services can only work thanks to high speed broadband connections, which depend
on appropriate infrastructures.

3.1.        An
evaluation of the 2004 eHealth Action Plan

Since its
launch, the eHealth Action Plan has contributed to bringing forward specific
priority areas which have then been embedded in other policy initiatives and
projects. The most relevant ones are presented below following the structure of
the objectives of the 2004 eHealth Action Plan:

Increased
political awareness:

–
Council Conclusions on safe and efficient
healthcare through eHealth 2009;

–
Ministerial/conference Declarations[14];

–
DAE key actions 13 and 14;

–
European Innovation Partnership on "Active
and Healthy Ageing";

–
Article 14 of the recently adopted Directive on
the application of patients' rights in cross-border healthcare[15] as regards mutual assistance
and cooperation among Member States, including on the local and regional level,
for providing cross-border healthcare services;

Technical
guidance

–
European Commission Recommendation on
cross-border interoperability of electronic health records systems

Improving legal
certainty

–
Staff Working Paper on the Applicability of the existing
EU legal framework to telemedicine services – a follow-up action of the 2008
Communication on Telemedicine[16].
This Staff Working Document analyses the EU legal framework applicable to
telemedicine services and aims to enhance legal clarity in the sector ;

–
Directive on the application of patients' rights
in cross-border healthcare.

Commitment to
large-scale deployment of eHealth solutions:

–
epSOS project[17]
– defining services for a pan-European electronic patient summary and
ePrescription by creating building blocks for the future unification of the
European Information Space and considerably increasing the innovation potential
of European enterprises.

Significant progress has been achieved in
the area of increasing political awareness, committing to widespread deployment
of eHealth solutions, enhancing legal certainty and improving technical
guidance.

While progress has been made, the Report "Assessing the progress of the eHealth Action Plan
for the period 2004 – 2010"[18]
describes in addition to the achievements the remaining challenges. These include those actions which are the
most significant in their implications and in their scale (and are indeed those
which could be considered closest to a shift towards a European eHealth area):

–
identification of a common approach among the
Member States for patient identifiers;

–
identification of interoperability standards for
electronic health records (EHRs) among the Member States;

–
adoption of common schemes for conformity
testing and accreditation;

–
creation of a framework for greater legal
certainty of eHealth products and services;

–
provision of online services in telemedicine and
ePrescription by the majority of European health organisations and regions.

4.           Problem
definition

4.1.        Sustainability
of healthcare and social systems

The healthcare delivery systems in Member States are increasingly
faced with the challenges related to the growing demand for high quality
services and the impossibility to increase the number of resources accordingly.

An ageing population, a higher incidence of chronic diseases and a shortage
of financial and human resources devoted to healthcare are among the key
factors leading to this very challenging situation both for health and social
care systems. If current trends of fertility and
mortality continue there will be important changes in the age structure of the
population with a huge impact on the macroeconomic situation in Europe. Eurostat projects that by 2060 the EU population will be
both smaller and older than in 2008. Most countries will see a drop in both young (0-14) and working age populations (15-64). The
number of people aged 60 and above in the EU is now raising by more than two
million every year, roughly twice the rate observed until about three years
ago. The working age contingent, the main contributor
to social protection systems is expected to fall dramatically from 67% to 56%
of the total population. While the younger population shrinks, the share of the
elderly (65+) and very old (80+) population in the EU is projected to grow by
an average of 13% and 8% respectively.

Public expenditure on healthcare is expected to grow by 1½
percentage points of GDP in the EU by 2060. Institutional and policy changes as
well as demographic trends are expected to transform our societies
considerably, undermining intergenerational solidarity and creating new demands
on future generations.

Healthcare is a constantly growing
component of public finances. The share of total government spending on
healthcare has grown since the 1990s with the increases exceeding inflation
rates. Healthcare accounts for 9 % of GDP but represents between 12% and 15% of
government spending in most EU countries. The ongoing economic uncertainty
brings into sharp focus the fact that current healthcare models are financially
unsustainable. eHealth with its promise of more efficient and cost effective
care is critical to the survival of the system of healthcare in Europe.

On the other hand economists consider health
as a component of human capital or add it to economic models as a variable
termed “health capital”[19].
Being in good health has long been shown to impact positively on investment
into continuing education, reduce the natural human capital depreciation rate
and the number of work days lost. In addition, it delays retirement and
decreases hospital days – both of these contribute to systemic socio-economic
sustainability.

Without better tailored and more effective
health and social care services, Europe's social and health models will be
seriously jeopradised. For example, a recent report on health systems[20] emphasises the need to
increase effectiveness and efficiency in healthcare. Reduction of unnecessary
use of specialists and hospital care while improving primary healthcare
services and better use of personalised health systems can help deliver better
and more efficient care.

A study ' European countries on their journey towards national
eHealth infrastructures'[21]
stated that when looking at financing sources for
development and investment in eHealth infrastructures and applications, a mixed
picture emerges. Across Europe, the primary sources of funding are government
or quasi-public sources, e.g. the general budget for health, as well as
dedicated ICT budgets or special levies on statutory health insurances.
Considering that individual service providers usually do not have an incentive
to establish eHealth infrastructures for all, this result is not surprising. To
compensate for market failure and allow a network effect to kick in, adopting a
‘public good’ perspective of eHealth infrastructure seems warranted. Recurring
public budgets dedicated specifically to “the reimbursement of eHealth
services” are still the exception, whereas there is widespread use of
project-based sourcing. Sometimes private and public insurance companies or
public technology or innovation agencies are involved in temporary financing.

4.2.        Ageing population and growing incidence and prevalence
of chronic diseases

As life expectancy increases, so does the
prevalence of chronic disease. Currently chronic disease is a global epidemic
which accounts for more than 60% of deaths[22]
and disability. The WHO recognised[23]
the rapidly growing magnitude of non communicable diseases that affects people
of all ages, gender, race and income levels, and further poor populations and
those living in vulnerable situations. The burden of chronic disease for the
health and social system and for the economy and work force is enormous. Improving
control and prevention of chronic conditions is a global challenge.

In fact, WHO is urging Member States to
draw upon, based on national contexts, the policies, strategies, programmes and
interventions, and tools on the prevention and control of Non-communicable
Diseases, in order to promote, establish or support and strengthen, as
appropriate, multisectoral national policies and plans.

Patient empowerment is essential to support
better control of chronic conditions. Against this backdrop there is clearly a
need for improved quality and more accessible information online, increasing
awareness and promotion of healthy lifestyles[24]
among citizens. In this context, innovative systems supporting patients to
better manage their conditions like, remote monitoring devices, can also
contribute to patient empowerment, leading to better managment and increased
quality of life[25].

4.3.        Mobility of patients and health professionals and
shortage of professionals

Due to growing levels of mobility of
patients and professionals, demand for cross-border services is rising.
Patients need secure and standard access to these services in cross-borders
situations.

The mobility of patients[26] and health professionals
within the EU is increasing.[27]
On the other hand, new threats put at risk the future health system and its
principle of equity. The number of practising physicians, general practitioners
and practising nurses and midwives per 100,000 inhabitants has increased in the
EU taken as a whole since the 1970s25. At the same time, the health
workforce is ageing. On average in the EU, more than 60% of physicians are more
than 45 years old, a proportion that has increased over time: from 44.4% in
1995 to more than 60% in 2008. In some countries, staff migration to countries
in need of staff and offering higher wages can become a problem for the country
of origin. A lack of and inadequately trained and practising staff combined
with migration are undermining the capacity of Member States to ensure
cost-effective delivery and equitable access to health care services.

eHealth can play a role in addressing the
current challenges of the health system, providing healthcare to remote areas
while decreasing the inequalities and variability of clinical practice in the
Member States. The 2010 EU Citizenship Report underlined the role of  eHealth
in facilitating cross border healthcare[28].

4.4.        Increased demand for high quality of care and investing
in expensive technologies

In 2006 the Council of the European Union
agreed to a set of Common Values and Principles in EU Health Systems. It
invited the European Commission to ensure that these values and principles are
respected when drafting specific proposals concerning health services. The
overarching values considered are: Universality, Access to good quality care, Equity,
Solidarity. The operating principles are: quality, safety, evidence based and ethical
care, patient involvement, redress when things go wrong, privacy and confidentiality.
However, health inequalities persist across the EU.

The quality of the healthcare system is often
associated with the use of sophisticated technologies and advanced, costly medicines.
A rising demand for services in a situation with limited resources that is
worsened by the recent economic crisis, makes cost-effectiveness one of the
most important goals in this area[29].
Investing in quality and containing cost while providing safety and equity
care is a mandatory goal for health systems. The use of interoperable EHRs has
been identified as a major opportunity for more efficient and better quality
healthcare. Other technologies to support administrative or clinical processes
provide a theoretical framework to ensure the quality and safety of the system.
The need to improve the general governance (decision-making and management) of
the health system has been tested by the Joint Report on Health Systems
previously mentioned.

4.5.        Slow
deployment of eHealth tools and services

Clinical and
healthcare workflows, care models, and business processes are significantly
more complex than equivalents in other sectors of the economy and less amenable
to standardisation and streamlining by conventional eBusiness systems. Below, the results of the public consultation and the available
evidence demonstrate other reasons and barriers for slow uptake of eHealth
solutions including: the 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 and the high start-up costs involved in setting up eHealth
systems.

Successful EHRs and
ePrescribing are not quick wins; they are sustainable wins. It takes at least
four, and more typically, up to nine years. Average time to annual net benefit
of the nine sites is seven years.[30]

5.           Consultation
of interested parties

5.1.        Stakeholder
consultation

A public consultation on the eHAP ran from
31 March to 31 May 2011. It sought the views of interested parties on the proposed
policy objectives to understand whether they were in line with their
expectations while verifying whether there were additional areas requiring
further action.

The draft questionnaire was discussed with
Member States representatives within the framework of the i2010 subgroup on
eHealth (Ad-hoc expert group on eHealth) during its meetings on 15 September
2010 and on 19 January 2011, when it was informally validated. It was also
presented during the European Health Policy Forum on 21 October 2010 and to the
eHealth Users – Stakeholders group, which included representatives of users of
eHealth including professionals, patients and healthcare managers[31].

The
consultation sought to validate four proposed objectives and to explore
possible actions to be undertaken in the next years. The four objectives
proposed were:

Objective 1: Increase awareness of the benefits
and opportunities of eHealth, and empower citizens, patients and healthcare
professionals.

Objective 2: Address issues currently impeding
eHealth interoperability

Objective 3: Improve legal certainty for
eHealth

Objective 4: Support research and innovation in
eHealth and development of a competitive European market.

239
participants contributed to the consultation, representing a wide range of
stakeholders including non-governmental organisations, academia, enterprises,
health and social care providers and public authorities from many Member
States.

The
majority of respondents underlined four main actions to address barriers
impeding the deployment of eHealth that the European Commission should take:

(1)
Supporting systematic evaluation of the benefits
and costs, effectiveness/usefulness of eHealth solutions;

(2)
Improving interoperability and strengthening the
evidence-based approach; and

(3)
Facilitating cooperation between Member States and regions and,

(4)
Exploring innovative financing and reimbursement
schemes.

Most of
participants (around 90-95%) agreed or partially agreed with the four main
actions mentioned above.

Regarding
specific actions for every objective, the majority of respondents believed that the main instrument
to increase patients' awareness and trust on eHealth is an information
campaign. Improving healthcare professionals' awareness and acceptance should
be addressed through the inclusion of eHealth in medical curricula and training
in the workplace; organising information campaigns and supporting the
dissemination of good practices and results at professional conferences both at
national and international level. Moreover, there is a strong need to provide
evidence-based input and research and encourage the promotion of the benefits
of eHealth by raising awareness as the evidence is being collected. According
to 71% of respondents, the Commission should support the deployment of ICT
systems for clinical use (decision support systems, EHR, ePrescription,
Radiology Information Systems etc.).

The main
action for the second objective, "address issues
currently impeding eHealth interoperability", is taking steps to advance technical
interoperability to facilitate de-fragmentation of the eHealth market. The
most effective way of supporting European cooperation is to harmonise
standards, profiles and technical specifications used to ensure cross border
eHealth interoperability.

Regarding
legal issues, most of the participants thought that encouraging professional
associations, scientific societies and civil society representatives to promote
the exchange of best practices through the development of guidelines and/or
codes of conduct for eHealth services is an important area of action for the
Commission. Data protection and liability should also be considered. The data
protection reform foresees facilitating the adoption of codes of conduct to
improve data protection in all sectors, including eHealth. The Commission
encourages the drafting of such codes of conduct, to be approved by data
protection authorities.

The objectives should be supported by
providing funding for the scaling up of innovative eHealth solutions, for
example by facilitating deployment of research results and providing more
flexible financing mechanisms to support research and innovation. More emphasis
should be put on international cooperation to promote benchmarking and
evaluation projects in order to provide evidence to support deployment of
eHealth solutions and to support new innovative solutions such as Virtual
Physiological Human, Personal Health Systems and ICT for Public Health.

The full
Report on the results of the public consultation is published on the Commission's
website[32].

5.2.        Internal expertise

The
Inter-service Steering Group on the eHealth Action Plan was established in
December 2010 to support the drafting of the Communication. The following
services were consulted: SG, LS, COMP, DIGIT, ECFIN, EMPL, ENTR, ENVI, JUST, JRC,
MARKT, REGIO, RELEX, RTD, SANCO, TAXUD[33].

The group
held three meetings: 8 February 2011, 14 April 2011 and 25 April 2012.

5.3.        External expertise and input

Member States, within the framework of the
i2010 subgroup on eHealth (Ad-hoc expert group on eHealth) at its meetings on
15 September 2010 and 19 January 2011, supported the public consultation
questionnaire. The latter was also presented on 21 October 2010 to the eHealth
Users – Stakeholders group during the European Health Policy Forum.

The eHealth Action Plan was discussed
during the eHealth Week in Budapest in May 2011 and eHealth Week in Copenhagen in May 2012 at a meeting of the eHealth Stakeholder Group.

5.3.1.     Task
Force Report

As
requested by 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. The Task Force was chaired by the Estonian
President, Mr Toomas Hendrik Ilves and met four times.  Its final Report was
presented on 7 May 2012 at eHealth week in Copenhagen.[34]

The
Report highlights the critical preconditions for implementing eHealth
effectively:

·
Individuals are the owners and controllers of
their own health data, with the right to make decisions over access to the data
and to be informed about how it will be used. This principle is outlined in EU
law and European jurisprudence but is rarely fully implemented in health
systems.

·
Large amounts of data currently sit in different
silos within health and social care systems. If this data is released in an
appropriate manner and used effectively it could transform the way that care is
provided.

·
The health sector has been slow to adopt new
communication tools for a variety of institutional, economic and personal
reasons. However, patients will increasingly demand that their health
professionals and institutions use the same ubiquitous technology they use in
everyday life.

·
Full transparency on the performance of health
professionals and institutions enables patients to make more informed choices
about where and how they want to be treated. This will have real impact on
resource allocation in health, as funding follows the patients.

·
Service providers need to be aware that there
may be sub-groups of the population that are outside the reach of eHealth tools
- those without access to the internet/computers and individuals that choose
not to interact intensively with technology.

The five
recommendations presented in the Report are:

1.
Create a legal framework and space to manage the
explosion of health data. This needs to put in place the safeguards that will
allow citizens to use health apps with confidence that their data is handled
appropriately and subsequently it will create the conditions for the
integration of user-generated data with official medical data so that care can
be more integrated, personalised and useful for patients.

–
Create a 'beacon group' of Member States and regions committed to open data and eHealth. A leadership group from regions and
countries that have invested in eHealth applications (such as Denmark, Sweden, Estonia, Spain) could be pioneers. The EU could facilitate such a group and finance
experts who can evaluate eHealth projects from inception to delivery.

–
Support health literacy. As doctors are no
longer the sole arbiters and interpreters of medical information for patients
and as patients are playing a more active role, health data thus needs to be
translatable into information that citizens understand.

–
New rules are needed to define how to integrate
official data and user data to create a more holistic picture of situation of
the patient in health care as well provide early feedback for preventive care.
Certification of applications should be based on a set of principles for how
health related data should be treated rather than regulation. Health
institutions must publish the data on their performance and health outcomes.

–
Re-orient EU funding and policies - specific
budget lines need to be agile, responsive and should foster the development of
good ideas into fast prototyping and testing. Require transparency from
institutions in health systems through procurement and funding criteria.

6.           Evidence
informed eHealth Action Plan 2012 – 2020

In May 2005,
the 58th World Health Assembly adopted a resolution acknowledging
the Mexico Statement on Health Research, urging Member States “to establish
or strengthen mechanisms to transfer knowledge in support of evidence-based
public health and health-care delivery systems, and evidence based
health-related policies”[35].

The eHAP
respects this resolution and, considering the hierarchy of evidence to decision
making[36]
(table 1), the impact assessment upon which it is based represents an
additional scientific instrument to support and validate suggestions from
experts and stakeholders who participated in the Public Consultation.

Table 1:
Designations of levels of evidence [37]

Level of evidence || Study design

I || Evidence obtained from a systematic review of all relevant randomised controlled trials

II || Evidence obtained from at least one properly-designed randomised controlled trial

III-1 || Evidence obtained from well-designed pseudorandomised controlled trials (alternate allocation or some other method)

III-2 || Evidence obtained from comparative studies (including systematic reviews of such studies) with concurrent controls and allocation not randomised, cohort studies, case-control studies, or interrupted time series with a control group

III-3 || Evidence obtained from comparative studies with historical control, two or more single arm studies, or interrupted time series without a parallel control group

IV || Evidence obtained from case series, either post-test or pre-test/post-test

The objective of this section is to analyse
the current scientific evidence supporting the objectives and actions of the
new eHealth Acton Plan according to the evidence informed policy recommendation[38].

6.1.        Methodology

Considering the revised hierarchy of the evidence
and following recent recommendations, a systematic mini-review of systematic reviews,
meta-analysis, health technology assessment (HTA) reports and other policy
reports in response to specific research questions has been conducted.

Research questions

1.           What are the main barriers and/or facilitators to
deployment of eHealth solutions?

2.           What is the current status
of eHealth in the EU and how to ensure successful and sustainable deployment of
eHealth?

3.           What is the evidence of
the effectiveness and efficiency of eHealth and what research areas still need
to gather large scale evidence to support wide deployment of telemedicine by
2020?

Literature Search

In order to respond to the questions above,
a specific and restricted search in different sources was conducted.

In the context of the Methotelemed study[39], the European Commission
funded an exhaustive systematic review of reviews on effectiveness of
telemedicine. The literature search included extensive sources and databases up
until January 2009. The results of this review which included 80 scientific
papers were published in a peer reviewed journal[40].

After this date, the current literature
search was conducted in Medline (Limit: meta-analysis) and Centre for Reviews
and Dissemination (DARE and HTA) from 2009 to February 2012. The following
terms were used for search: Telemedicine [MeSH Terms], eHealth, telecare,
telehome, medical record system computerized [MeSH Terms].

Policy reports were selected from European
studies published since 2004, papers from WHO, OECD, and another studies
supporting benchmarking activities.

Papers included in this review were
selected based on the following criteria: 1) Design: systematic review,
meta-analysis, and evidence based policy recommendations; 2) Intervention and
technology: any eHealth solution or service which describes a specific and
reproducible intervention for any health field; 3) Participants: any
stakeholder; 4) Outcomes: information about primary indicators/outcomes
obtained with a reproducible, scientific and good quality methodology
(minimising bias) is mandatory; 5) Answering at least one research question.

Exclusion criteria: systematic reviews/
meta-analysis from Medline without clear methodology in the abstract;
interventions that are too complex or involving many different technologies making
it impossible to extract individual outcomes.

Initial screening of identified articles
was based on their abstracts. Articles from electronic data bases lacking an
electronic abstract were initially excluded. The documents were classified
according to research questions and objectives of the eHealth Action Plan. Data
on the effectiveness of telemedicine were re-grouped by major topic.

6.2.        Results

From the 106 references regarding
systematic reviews, meta-analysis and HTA reports, 57 documents were selected. Additionally
to 20 policy documents or studies met the inclusion criteria. In total, 76
documents were analysed in order to respond to the research questions. All
references can be found in the bibliography section.

From 76 documents, 53 focused on
telemedicine or eHealth service, 5 on health information systems and EHR, and
18 were benchmarking studies or policy documents which reported on eHealth in
general.

What are the main barriers and/or
supporting factors to deploy eHealth solutions?

Six papers
reported information about the barriers or facilitators to deploy eHealth
solutions. The main barriers were the lack of awareness of, confidence in the
benefit of eHealth; lack of user-friendly eHealth solutions; lack of
interoperability between eHealth solutions; and limited large-scale evidence of
the cost-effectiveness of potential improvements in healthcare processes.

McGinn et al[41] reported a systematic review
on users’ perceived barriers and facilitators to shared EHR implementation from
60 publications and they found that physicians, healthcare professionals and
managers share many common supporting factors and barriers. Patients seem to
have different views. While similarities can be found between groups,
inter-group differences also show how the unique perspective of each user group
needs to be taken into account. The results confirm that financial, time-
related, and technical barriers are the most-cited barriers to EHR acceptance
and adoption for patients, professionals and managers.

This point was
also reported by a study on the benchmarking of acute hospitals[42]. According to medical directors, this situation might be due
to prevailing interoperability problems. The medical directors identified interoperability
between different departments’ electronic patient record systems as the largest barrier to their implementation - 46% agreed that it was a barrier.
This was followed by the lack of financial incentives for the staff to
use these systems, a barrier that is more evident in large hospitals: 76% of medical
directors in large hospitals agree that it is a barrier compared to only 46 %
in the smallest hospitals. No clear barriers or impacts were identified
concerning the adoption of telemonitoring. The low rate of implementation of
telemonitoring might be explained by the medical directors’ lack of perception
that, in their hospitals, it will lead to improvements in quality of care if
implemented. Seventy-eight per cent of medical directors state that
telemonitoring would have little or no impact on the improvement of the quality
of life of patients.

Moreover,
patients were the only user group to identify supporting factors in a larger
proportion than barriers and to consider autonomy (health empowerment and
improved health self-management), as a positive EHR implementation factor.
Patients highlight two factors, perceived usefulness and motivation to use
EHRs, as main supporting factors for implementing EHR. Stakeholder groups
identified[43]
the following important characteristics of an Internet-based virtual clinic:
being based on personal needs; having the facility to communicate; being quick
and easy to use.

Other study[44]results indicated
that consumers are ready to accept EHRs as long as they can be assured of the
security of the system. Professionals' acceptance is a key factor in supporting
deployment and usability of eHealth. Professionals play a relevant role in motivating
patients to use ICT and to support self-management and autonomy. However, that
is only possible if they believe eHealth is useful and effective. Another study
published by the European Commission[45]
showed that European general practitioners (GPs) are positive about the role of
ICT in health care. They have a clear idea of what would facilitate a wider diffusion
of eHealth use. However, while eHealth users do not perceive any major
barriers, non-users are more critical. A lack of IT training for GPs is
probably the strongest hindering factor. The former result is well in line with
other data indicating that only a minority of GPs in Greece (38%), Latvia (29%), Poland (30%) and Romania (10%) receive IT support from professional service providers
— compared to 74% on average across the 27 EU Member States as a whole.

Patients' attitudes about the use of Web
messaging and online access to their EHR were mostly positive. At the same
time, clinicians were less positive about using electronic communication than
their patients[46]

Hardiker and
Grant[47]
in a systematic review of 50 articles looking for barriers and factors that
affect engagement with eHealth services, recommended:  targeted efforts to
engage those underserved by eHealth; maximizing exposure to eHealth across all
groups of society; improving access to computers and the internet; appropriate
design and delivery; ensuring content is relevant to different audiences;
capitalizing on the interest in Social Computing; and clarifying the role of
health workers in the delivery of eHealth.

JRC-IPTS found within
its analysis of Integrated Personal Health and Care Services in Europe, found  that
the frontrunners, in terms of eHealth and IPHS deployment (i.e.g. Denmark, England and, Scotland), show a combination of policy towards integrated care, incentives
framework and funding mechanisms in place. Moreover, they offer official
portals for public health services providing access to health information to
citizens, patients and even health professionals. In this manner, they
encourage empowerment[48].

What is the current status of eHealth in
the EU and how to ensure successful and sustainable deployment of eHealth in
the current socio-economic situation?

12 documents were analysed to respond this
question.

Health systems, health outcomes and the workforce
in terms of number and qualifications are different across the EU Member States.
Almost half of all Europeans show inadequate or problematic levels of health
literacy, according to the results of the European Health Literacy Survey
presented in November 2011 at the European Health Literacy Conference.[49] Low health literacy is
associated with reduced use of preventive services and management of chronic
conditions, and higher mortality. Health literacy is shown as a driver for
change for equity and sustainability, influencing the health attitudes of healthy
people, people at risk and patients.

The Nairobi
Call for Action[50]
emphasizes the need to support empowerment by ensuring basic education for all
citizens; by building on existing resources and networks to ensure
sustainability and enhance community participation; by designing health
literacy interventions based on community needs and priorities in their
political, social and cultural context and by ensuring that communities are
able to access and act on knowledge and overcome any barriers to health. By improving
people’s access to health information, and their capacity to apply it
effectively, health literacy is critical to empowerment. Improving health
literacy is an important element of strategies to reduce health inequity.

In general, all
papers analysed showed that ICT penetration[51],
digital literacy and ICT use is very different in European countries[52],[53]. European countries have
made substantial progress towards modern eHealth infrastructures and
implementations, thereby leading the rest of the world. Following the 2004
eHealth Action Plan the EU Member States committed themselves “to develop a
national or regional roadmap for eHealth.” Various non-EU countries also
followed this vision. In a study funded by European Commission[54] reported that by the end of
2006 most of the EU Member States had published high level official policy
documents on their eHealth implementation strategy. In 2010, almost all have
detailed documents outlining concrete eHealth goals, implementation measures,
and sometimes also their past achievements. In line with the objectives of the
eHealth Action Plan 2004, “health authorities' leadership” is visible across
the EU. Table 2 identifies key fields of national level activities and the
sometimes considerable increase recorded between 2006 and 2010:

Table 1: Key fields of national level
eHealth activities in the EU27 countries, 2006 and 2010

Reported eHealth activities || Total 2006 eHealth ERA || Total 2010 eHealth Strategies || Delta

Legal activities || 14 || 22 || 8

Evaluation || 5 || 21 || 16

EHR Patient Summary || 27 || 27 || 0

ePrescription || 16 || 22 || 6

Telehealth || 23 || 27 || 4

Patient ID || 24 || 26 || 2

Professional ID || 13 || 22 || 9

Citizen card || 22 || 25 || 3

Professional card || 7 || 18 || 9

Standards (technical/semantic) || 19 || 27 || 8

Source: eHealth Strategies study, 2010

Another
indication of the strong political commitment at the national policy level is
the growing establishment of permanent administrative support structures. Also,
the current participation in the epSOS project (Smart Open Services for European Patients) undertaken by
23 countries
shows the political commitment and interest in the
issues.

However, other
studies show that telemedicine services such as telehealth,  telecare (the home
monitoring of patients) or health information networks linking hospitals,
laboratories, pharmacies, primary care and social centres often remain small
local telehealth or telemedicine experiments, or there are only plans to
undertake pilots. Another study[55]
 demonstrates telemonitoring of outpatients remaining at low levels: only 8% of European acute hospitals
do it. Nevertheless, videoconferencing facilities are relatively common.
They are available in nearly 40% of the European hospitals surveyed. The most
general use of videoconferencing (64%) is for consultation between internal
medical staff and external healthcare providers.

Since 2004,
rapid development has taken place in the eHealth area in Europe where GPs[56] use a basic ICT infrastructure
consisting of computers (87%) and Internet connections (from 61 to 81%).
However, in some countries, the share of practices using a computer is as low
as 65% (Malta, Romania) or 57% (Latvia). There are considerable differences
between the countries, with broadband penetration ranging from 93% in Finland to 5% in Romania.

The electronic
storage of administrative and medical patient data, the use of a computer
during consultation with patients and other uses of ICT in healthcare are
becoming more and more everyday practices. At the same time, there is still
room for improvement when it comes to electronic networks connecting their IT
systems with other health actors, the electronic exchange of patient data and
electronic interactions with patients. From the data collected for this study, Denmark, the Netherlands, Finland, Sweden and the UK emerge as the European frontrunners in eHealth
use by GPs. On the other side there is a group of countries where the use of
eHealth at large or the use of advanced applications still leaves considerable
room for improvement. This group consists of Greece, Latvia, Lithuania, Poland and Romania. In between lies the large group of average performers, consisting of
the remaining 15 Member States. A gap remains between readiness for use and
actual use of eHealth. In 2007, further to connections to other health actors,
the Internet and other, dedicated networks can also be used for electronic
transfer of patient data. Use rates are again moderate to low and show
considerable variations.

What is the evidence on the
effectiveness and efficiency of eHealth and what research areas still need to
build large scale evidence to support wide deployment of telemedicine by 2020?

50 papers on the effectiveness and
efficiency of telemedicine services have been analysed. The first results of
this systematic review show that the number of trials and projects on
telemedicine has dramatically increased in recent years. There is a great
variability of trials, technologies, interventions, methodologies, outcomes and
indicators which made the assessment difficult. In general, most of the papers
confirmed the potential benefits by showing data on effectiveness. However,
cost-benefit analysis is often lacking. Great effort should be made in
supporting strong evaluation, especially economic evaluation, to ensure the
success and the sustainability of the heath system.

Providing decision makers with direct
financial figures, statistical data etc., is not enough, since the ultimate
strategic objective is to improve the efficiency and quality of clinical care
through health ICTs. Methodological difficulties are further exacerbated by
data limitations, definition problems and the lack of appropriate sets of
indicators on adoption, use and outcome of ICTs which can be compared over
time, within and across countries and comparing low cost technologies with
expensive ones. Key elements should be investigated, for example, in the field
of chronic heart failure, more large-scale trials are required to identify six
key elements relating to telephone support and telemonitoring: the best
healthcare practices including the optimal frequency of follow up; the patients
who benefit; the levels of staffing required; patients' views on the user
friendliness of technologies; evidence on efficiency and organizational models[57]. At this point, the recent
publication of the Whole System Demonstrator[58]
shows very good outcomes. These data could play a key role in the future HTA
and decision making process.[59]

Findings illustrate the
potential benefits that can result from ICT implementation according to four
broad, inter-related categories of objectives61: increasing quality
of care and efficiency; reducing operating costs of clinical services; reducing
administrative costs; and enabling entirely new modes of care.

The socio-economic gains are analysed in the study EHR IMPACT (01-2008/02-2009)[60] to support
ongoing initiatives and implementation work by the European Commission, Member State governments, private investors, and other actors. The study aims to improve
awareness of the benefits and provide new empirical evidence on the
socio-economic impact and lessons learnt from successfully implemented systems.

The study shows that the average cumulative
socio-economic returns (SER), but not
financial return, is 78% over the evaluation timescales of between 9 and 13
years. This confirms that investments
in interoperable EHR and ePrescribing systems, if pursued with the necessary
rigour, are worthwhile. Once the value of benefits
begins to cover costs, the net benefit expands and becomes substantial. Annual
net benefit in 2010 reaches between €1.2 million for the smaller-scale sites
and over €170 million for Diraya, which serves more than 8 million people. The
annual SER increases considerably towards the end of the time scale. The
positive SER justifies the wider deployment of interoperable EHR and ePrescribing
systems.

The EHR IMPACT study shows interoperability
is a prime driver of benefits. It makes life easier for different users and
provides gains that rely on access to information regardless of place and time,
and from re-using information for multiple purposes. Without meaningful sharing
and exchange of information, the gains would be marginal and not justify the
cost of investments.

Most of studies responded to three types of
interventions: chronic conditions management (27 papers), metal/psychiatric
health (12 papers), and health promotion and prevention (8 papers). Eleven
documents focused on different interventions or aspects like teledermatology,
tele-intensive care, telestroke, etc .

(1) eHealth
for improving chronic disease management: these interventions included
tele-homecare, telemonitoring in general or for specific diseases like chronic
health failure, respiratory diseases, diabetes etc.

Most of the papers showed some benefit,
mostly associated to reduction in hospital readmission. However, the data are
heterogeneous. Successful adoption and use generally depended on the
simultaneous implementation of new service delivery models, integrated models
and organisational partnerships[61].

In an extrapolation exercise[62], JRC-IPTS modelled the care
institutions' eHealth adoption and expenditure of eHealth by care institutions
focusing ion three main chronic conditions (Chronic Heart Failure, COPD and
Diabetes) and Telecare. Moreover, the Commonhealth project[63] has published outcomes on
cost-effectiveness in several locations and guidelines for integrated eCare
services provision based on the evidence they collected.

The Internet can be part of an effective
method to increase empowerment of patients who are e.g. suffering from
diabetes, depression, infertility or arthritis. Because of the low quality of
evidence we found, the results should be interpreted with caution. The clinical
relevance of the findings can be questioned because the significant effects we
found were, in general, small[64].
However, the outcome empowerment usually refers to achieving self-efficacy,
autonomy and control. Although many researchers underline that these tools are
closely related to the concept of empowerment, it is still unclear how
empowerment is defined, how it should be measured and what is the level of its
impact on health outcomes. These gaps indicate the need for more unambiguous
research outcomes that lead to better insight into the conditions under which
Web-based interventions are effective and how their effectiveness could be
maximized.

Krishna et al. [65] conducted a review of 25
papers; and concluded that standard care with reminders, disease monitoring and
management, and education through cell phone voice and short message can help
improve health outcome and care processes. However, due to the possibility of
bias and errors in the review process and the unknown quality of studies including
these conclusions may not be reliable.

(2) eHealth for mental health: Most of the studies in this area reported the same benefits as
face to face consultation. Several authors supported the use of tele-psychiatry
when traditional care is not possible (for instance waiting lists, shortage of professionals
in rural areas, etc)[66],[67]. However, more research
is needed to identify those patients who benefit and to conduct analysis of
cost-effectiveness.

Behavioural therapy through the Internet,
computer, and telephone applications, even in substance abuse and addiction
(alcohol and smoking addictions) are at least as effective as conventional
services[68],
especially when personalised and interactive settings are utilised.

(3) eHealth impact on health promotion
and primary prevention: these interventions
included health promotion on healthy behaviour (physical and dietary behaviour,
smoking, obesity, alcohol consumption). These findings demonstrate that online
interventions have the capacity to influence voluntary behaviours which are
routinely targeted by social marketing campaigns. Given the high reach and low
cost of online technologies, it may a good tool for increased public health
campaigns that blend interpersonal online systems with mass-media outreach.
Such a combination of approaches could help individuals achieve personal goals
that, at an individual level, help citizens improve the quality of their lives
and at a state level, contribute to healthier societies.

Also, Cugelman B et al[69]
found that online interventions have the capacity to influence voluntary
behaviours. On the other hand, Car et al [70]
showed that due to the small number of studies and their variable
methodological quality, the evidence is too weak to draw any conclusions about
implications for the design and delivery of interventions for online health
literacy. There is a need for well-designed randomised control trials to
investigate the effects of such interventions. These should involve different
participants (in terms of health status, age, socio-economic group and gender)
to analyse the extent to which online health literacy reduces a barrier to
using the internet for health information. Trials should be conducted in
different settings and should examine interventions to enhance citizens' online
health literacy (search, appraisal and use of online health information) like
IT training courses, measuring outcomes up to at least one year after the
intervention to estimate the sustainability of the intervention effects.

7.           vision
and objectives of the eHealth Action Plan 2012 - 2020

The proposed eHealth Action Plan will run
from 2012 until 2020, mirroring the timeline of Europe 2020, the Digital Agenda
for Europe and Innovation Union.

The vision of this Action Plan is to
utilise and develop eHealth to address several of the most pressing 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, enhance patient/citizen-centric care
and citizen empowerment; and encourage organisational changes;

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

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

7.1.        General
objectives

The overall
policy goal of this Action Plan is to address the challenges outlined above,
breaking down persistent barriers and realising the vision of the Europe 2020
Strategy in the area of eHealth.

7.2.        Specific objectives

(5)
Improve the quality of life of European citizens

(6)
Provide equal access to high quality and
sustainable health care systems to all European citizens

(7)
Enhance the competitiveness of EU industry
through business and expansion of new markets.

7.3.        Operational objectives

The Action Plan addresses following
operational objectives:

–
achieving wider interoperability of eHealth
services;

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

–
facilitating  uptake and ensuring  wider
deployment;

–
promoting international cooperation.

The Action Plan emphasises cross-border
activities but it should be noted that work done at the EU level has a strong
effect at a 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 the EU Institutions to
work together towards achieving the objectives listed above.

It should be noted that all operational
objectives are closely linked and mutually reinforcing.

8.           Added
value of and justification for acting at the EU level

Responsibility to define the way to
organise and deliver health services and medical care lies within the Member
States. In several other areas supporting action from the Commission would be
possible, notably under Articles 168, 173, 179 or 114 TFUE.

Taking action
at EU level is particularly important given the Commission's role of
coordinating Member States' actions and encouraging cooperation between them.
Moreover, issues related to cross-border aspects of health (for example, legal
uncertainty in particular in the area of recognition of qualifications and
liability), identification of common barriers, coordination on common standards
and aspects related to the internal market of eHealth applications, as well as
the provision of evidence and methodology to assess the effectiveness of
eHealth applications, are best addressed at EU level.

Despite their primary competence in the
field, Member States require and value the strategic and technical guidance of
the Commission in this area[71].
The EPSCO Council has explicitly requested the Commission to provide such
guidance by updating the existing eHealth Action Plan. In the Council
Conclusions of 1st December 2009 on safe and efficient healthcare
through eHealth[72],
Member States demonstrated their intention "to bring forward eHealth
deployment and actual use of Interoperable eHealth services within and between
national healthcare systems".

Member States
also called upon the Commission to reflect on the progress made so far, to
ensure more coherence between health policy developments and eHealth deployment
and identify and address in a coordinated manner barriers hampering the
deployment of eHealth services which are preventing patients, healthcare
systems and society as a whole from fully benefitting from ICT. This shows that
Member States welcome the contribution and the added value the Commission
brings in supporting the common goals of ensuring high quality, efficient
healthcare systems also through the use of ICT solutions. In consistency and
complementarity of EU level actions, Member States are encouraged to develop
national eHealth Strategies according to international recommendations[73]. These national strategies
should integrate the European Innovation Partnership on Active and Healthy
Ageing objectives and targets

This action
plan responds to the call for support made by Member States in full respect of
the principle of subsidiarity. The Action Plan also reinforces the common
principles for healthcare in the European Union: universality, access to good
quality care, equity and solidarity[74].

The actions focus on European added value
by means of pan-European policy actions, transformative research and
innovation, and interoperability and deployment in order to facilitate a common
eHealth and Well Being  innovation space, in which citizens' rights are
protected, their mobility across the European Union is facilitated and  equity
and social cohesion for all is promoted.

The European Commission can provide the
platform not only for sharing best practices, experts and lessons learned from
number of pilots supported by national and EU programmes, but also can provide
guidance on technical and legal framework developments to ensure cross border
interoperability and legal certainty. The Commission's role in the area of
building trust and improved user acceptance would also be important. A
European-wide policy initiative would as well support convergence for common
solutions, avoid further market fragmentation and prevent Member States adopting
different individual, organisational and technical directions and missing the
opportunity to build a common basis for interoperable eHealth applications.

In this context, the policy approach in the
Action Plan primarily focuses on cooperation through involvement in pilot
projects, the new eHealth Network of Member States[75], the fruitful exchange between
health ministries of the Member States and stakeholders, the sharing of best
practice, the use of the open method of coordination and the realisation of the
Internal Market.

9.           Next
steps following the Communication

As set out in the Action Plan, a number of
actions will be implemented at the EU level in 2012 - 2020.

9.1.        Review
by the Commission of progress made

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

10.         bibliography
of evidence informed section

References for "What are the main barriers and/or supporting factors to
deploy eHealth solutions? "

Deloitte & Ipsos Belgium. "eHealth
Benchmarking III" SMART 2009/0022. European
Commission 2011. http://ec.europa.eu/information\_society/eeurope/i2010/docs/benchmarking/ehealth\_benchmarking\_3\_final\_report.pdf
Dobrev A, Haesner M, Hüsing T, Korte W, Meyer I.
"Benchmarking ICT use among General Practitioners in Europe"  European
Commission 2008. http://ec.europa.eu/information\_society/eeurope/i2010/docs/benchmarking/gp\_survey\_final\_report.pdf
Hardiker NR, Grant MJ. Barriers and facilitators
that affect public engagement with eHealth services. Stud Health Technol
Inform. 2010;160(Pt 1):13-7
McGinn CA, Grenier S, Duplantie J, Shaw N,
Sicotte C, Mathieu L, Leduc Y, Légaré F, Gagnon MP. Comparison of user
groups' perspectives of barriers and facilitators to implementing
electronic health records: a systematic review. BMC Med. 2011 Apr 28;9:46
Lluch M. Strategic Intelligence Monitor on
Personal Health Systems Phase 2 (SIMPHS 2) Evidence consolidation - Report
on best practices and key drivers of success. EC JRC 2012.
Young LB, Chan PS, Cram P. Staff acceptance of
tele-ICU coverage: a systematic review. Chest 2011; 139(2): 279-288

References for "What is the current status of eHealth in the EU and how to
ensure a successful and sustainable deployment of eHealth in the current
socio-economic situation?"

Achieving better Value for money in health care.
OECD Health Policy Studies.2009 OCDE publications.
ww.oecd.org/[ublishing/corrigenda.
Atlas eHealth country profiles: based on the
findings of the second global survey on eHealth. (Global Observatory for
eHealth Series, 1). WHO 2011. http://www.who.int/goe
Dobrev A, Haesner M, Hüsing T, Korte W, Meyer I.
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Benchmarking of health information and
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Deloitte & Ipsos Belgium. eHealth
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Explaining AMCham Eu's position on investment in
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Improving Health Sector Efficiency: The Role of
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Stroetmann K, Artmann J, Stroetmann V.
"European Countries on their Journey towards National eHealth
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Lluch M. Strategic Intelligence Monitor on
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Mental Health

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              ANNEX:
Governance chart for interoperability

[1]               Improving Health Sector Efficiency: The Role of
Information and Communication Technologies.   OECD 2010. http://www.oecd.org/document/61/0,3746,en\_2649\_33929\_45501565\_1\_1\_1\_1,00.html

[2]               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.

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

[4]               http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:C:2009:302:0012:0014:EN:PDF

[5]               New Economics Foundation (2011).Measuring our
progress: the power of well-being. London, New Economics Foundation (http://www.wikiprogress.org/images//Measuring\_our\_progress
webReady.pdf, accessed 30 May 2012)

[6]               Governance for Health and Wellbeing in the 21st
century.

                http://www.euro.who.int/\_\_data/assets/pdf\_file/0019/171334/RC62BD01-Governance-for-Health-Web.pdf

[7]               EU2020 strategy, op.cit. p.
3.

[8]               http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=COM:2010:0245:FIN:EN:PDF

[9]               http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=COM:2012:0083:FIN:EN:PDF

[10]             The epSOS pilot commits 23
National Health Ministries to work together for the deployment of interoperable
patient summaries         and ePrescription solutions throughout Europe.

[11]             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.

[12]             The Network "aims at
delivering sustainable economic and social benefits of European eHealth systems
and services and interoperable applications, with a view to achieving a high
level of trust and security, enhancing continuity of care and ensuring access
to safe and high-quality healthcare".

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

[14]             Member States have strengthened their cooperation in
the field of eHealth through Ministerial Declarations following the annual
eHealth Conferences (2003- 2010) and a set of high level meetings between State
Secretaries (and/or equivalent level) to define European eHealth Governance.
This shows that eHealth has risen in the health policy agenda and has developed
growing political importance.

[15]             http://www.consilium.europa.eu/uedocs/cms\_data/docs/pressdata/en/lsa/119514.pdf

[16]          Communication of
the Commission on telemedicine for the benefit of patients, healthcare systems
and society, COM(2008)689,

http://eurlex.europa.eu/LexUriServ/LexUriServ.do?uri=COM:2008:0689:FIN:EN:PDF

[17]             http://www.epsos.eu/

[18]             http://ec.europa.eu/information\_society/activities/health/docs/policy/ehap\_assess082011.pdf

[19]             See sources from the economic
literature discussed in Codagnone (2009a: p. 27)

[20]             Joint
Report on Health Systems, the European Commission and the Economic Policy
Committee(AWG), 2010, http://ec.europa.eu/economy\_finance/publications/occasional\_paper/2010/op74\_en.htm

[21]             http://www.ehealth-strategies.eu/report/eHealth\_Strategies\_Final\_Report\_Web.pdf

[22]             Monitoring Financial Flows for
Health Research 2006: The changing landscape of health research for development. 71. 2006. Global
Forum for Health Research

[23]            http://apps.who.int/iris/bitstream/10665/23846/1/B130\_R7-en.pdf

[24]             Whether provided through web
2.0 or more traditional public and private information portals.

[25]             See JRC IPTS Strategic Intelligence Monitor on Personal
Health Systems Phase 2 Report on best practices and key drivers of success at http://is.jrc.ec.europa.eu/pages/TFS/SIMPHS2.html

[26]             Patient mobility is addressed specifically in a
Communication from the Commission, COM(2004), entitled Follow-up to the high
level reflection process on patient mobility and healthcare developments in the
European Union.

[27]             Regulation 1408/71 that co-ordinates social security
legal schemes has recently been amended to streamline and modernise access to
health care across borders, particularly when undue delays occur in the
patient’s home Member State. In January 2004, the Commission adopted a proposal
for a Directive on services in the internal market (COM(2004)2 final) which
lays down a framework for the provision of services in the internal market,
including health services, and for their reimbursement by the relevant health
insurance institutions when healthcare is provided in another Member State.

[28]             EU Citizenship Report 2010 - Dismantling the obstacles
to EU citizens’ rights COM(2010) 603 final (pp. 8 and 9).

[29]             Joint Report on Health Systems, the European Commission
and the Economic Policy Committee(AWG), 2010,

 http://ec.europa.eu/economy\_finance/publications/occasional\_paper/2010/op74\_en.htm

[30]          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

[31]             This group has been replaced by the eHealth Stakeholder
group.

[32]             http://ec.europa.eu/information\_society/activities/health/docs/policy/ehap2012public-consult-report.pdf

[33]             Some DGs have changed since the
launch of the ISSG

[34]             http://ec.europa.eu/information\_society/activities/health/docs/policy/taskforce/redesigning\_health-eu-for2020-ehtf-report2012.pdf

[35]             World Health Assembly: Resolution on health research.
2005 http://www.who.int/rpc/meetings/58th\_WHA\_resolution.pdf 
World Health Organization

[36]             Merlin t, Weston A, Tooher. "Extending an evidence
hierarchy to include topics other than treatment: revising the Australian
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[37]             NHMRC. A guide to the development, implementation and
evaluation of clinical practice guidelines. Canberra, ACT: National Health and
Medical Research Council, Commonwealth of Australia; 1999

[38]             Lewin S, Bosch-Capblanch X, Oliver S, et al
"Guidance for evidence-informed policies about Health system: Assessing
how much confidence to place in the research evidence." PloS Med 2012; 9,
3:e1001187

[39]             Methotelemed study Methodology to assess Telemedicine
Applications (02-2009/02-2010) SMART 208/0064 http://ec.europa.eu/information\_society/activities/health/studies/published/index\_en.htm#Methodology\_to\_assess\_Telemedicine\_Applications

[40]             Anne G. Ekelanda, Alison Bowesb, Signe Flottorpc
"Effectiveness of telemedicine: A systematic review of Reviews". International journal of medical informatics 2010; 7 9 : 736–771

[41]             McGinn C et al. Comparision of user group's
perspectives of barriers and facilitators to implementing electronic health
records:  a systematic review. BMC Medicine 2011, 9:46

http://www.biomedcentral.com/1741-7015/9/46

[42]             Deloitte & Ipsos Belgium. "eHealth
Benchmarking III" SMART 2009/0022. European
Commission 2011. http://ec.europa.eu/information\_society/eeurope/i2010/docs/benchmarking/ehealth\_benchmarking\_3\_final\_report.pdf

[43]             Armstrong N et al Stakeholder perspectives on the
development of a virtual clinic for diabetes care: qualitative study.  J Med
Internet Res. 2007 Aug 9;9(3):e23.

[44]             Chanabhai P, Holt A, Consumers are ready to accept the
transition to online and electronic records if they can be assured of the
security measures. MedGenMed. 2007 Jan 11;9(1):8..

[45]             Alexander Dobrev, Marten Haesner, Tobias Hüsing, Werner
B. Korte, Ingo Meyer. "Benchmarking ICT use among General Practitioners in
Europe"  European Commission 2008.
http://ec.europa.eu/information\_society/eeurope/i2010/docs/benchmarking/gp\_survey\_final\_report.pdf

[46]             Hassol A et al. Patient experiences and attitudes about
access to a patient electronic health care record and linked web messaging.J Am
Med Inform Assoc. 2004 Nov-Dec;11(6):505-13.

[47]             Hardiker NR, Grant M Barriers and facilitators that
affect public engagement with eHealth services. J Stud Health Technol Inform.
2010;160(Pt 1):13-7.

[48]             JRC IPTS Strategic Intelligence Monitor on Personal
Health Systems Phase 2 Country Studies Summary and Evidence Consolidation.
Available at http://is.jrc.ec.europa.eu/pages/TFS/SIMPHS2.html

[49]             http://inthealth.eu/research/health-literacy-hls-eu/

[50]             (World Health Organization) 2009. The Nairobi Call for
Action. Final draft. World Conference on Health Promotion.

[51]             Atlas eHealth country profiles: based on the findings
of the second global survey on eHealth. (Global Observatory for eHealth Series,
1). WHO 2011. http://www.who.int/goe

[52]             Ingo
Meyer, Tobias Hüsing, Maike Didero, Werner B. Korte. eHealth Benchmarking
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[53]             Deloitte & Ipsos Belgium. "eHealth
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[54]          Karl A. Stroetmann, Jörg Artmann, Veli N.
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Countries on their Journey towards National eHealth Infrastructures". European Commission 2011. ISBN:
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[55]             Deloitte
& Ipsos Belgium. "eHealth Benchmarking III" SMART 2009/0022. European Commission 2011. http://ec.europa.eu/information\_society/eeurope/i2010/docs/benchmarking/ehealth\_benchmarking\_3\_final\_report.pdf

[56]             Alexander Dobrev, Marten Haesner, Tobias Hüsing, Werner B.
Korte, Ingo Meyer. "Benchmarking ICT use among General Practitioners in
Europe"  European Commission 2008. http://ec.europa.eu/information\_society/eeurope/i2010/docs/benchmarking/gp\_survey\_final\_report.pdf

[57]             Garcia Lizana F. Telemonitoring for chronic heart
failure: not ready for prime time. Cochrane Database Syst Rev. 2010 Aug
9;8:ED000009

[58]            Steventon A et al. Effect of telehealth on use of
secondary care and mortality: findings from the Whole System Demonstrator
cluster randomised trial. BMJ. 2012 Jun 21;344:e3874. doi: 10.1136/bmj.e3874

[59]          Ongoing large scale pilot 'RenewingHealth', is
pooling together the expertise of European experts and the know-how of local
and regional healthcare providers who deliver telehealth services. This project
is one of the largest multicentric clinical trial-type exercise across Europe in the field of telemonitoring and telecare services that will fundamentally enhance
the body of evidence on the effectiveness of such services. It involves nine
countries, and is expected to cover eventually about 8,000 patients.

[60]             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

[61]             Garcia
Lizana F, Yanes Lopez V. Information and communications technologies in CHF
management programmes. Organizational challenges and evidence status. Agencia
de Evaluacion de Tecnologias Sanitarias (AETS)Madrid 2009 http://www.isciii.es/htdocs/publicaciones/documentos/56\_Tecnol\_Inform\_Comunic\_en\_ICC.pdf

[62]             JRC IPTS Strategic Intelligence Monitor on Personal
Health Systems Phase 2 Impact Assessment Report. http://is.jrc.ec.europa.eu/pages/TFS/SIMPHS2.html

[63]             CommonWell is a project co-funded by the EC's ICT
Policy Support Programme at four sites in Europe: UK, DE, NL and ES. http://commonwell.eu/norm/commonwell-home/.

[64]             David Samoocha,David J Bruinvels, Nieke A Elbers,et al.
Effectiveness of Web-based Interventions on Patient Empowerment: A Systematic
Review and Meta-analysis. J Med Internet Res. 2010 Apr-Jun; 12(2): e23.

[65]             Krishna S, Boren SA, Balas EA. Healthcare via cell
phones: a systematic review. Telemedicine and e-Health 2009; 15(3): 231-240

[66]             Garcia-Lizana F, Munoz-Mayorga I. Telemedicine for depression:
a systematic review. Perspectives in Psychiatric Care, 2010; 46(2):119-126

[67]             Sloan DM, Gallagher MW, Feinstein BA, Lee DJ, Pruneau
GM. Efficacy of telehealth treatments for posttraumatic stress-related
symptoms: a meta-analysis. Cognitive Behaviour Therapy 2011; 40(2): 111-125

[68]             Ohinmaa A, Chatterley P, Nguyen T, Jacobs P. Telehealth
in substance abuse and addiction: review of the literature on smoking, alcohol,
drug abuse and gambling. HTA report 2010. Institute of Health Economics (IHE). Edmonton http://www.ihe.ca/documents/Telehealth%20in%20Addiction-Final%202%20Arto.pdf

[69]             Cugelman B, Thelwall M, Dawes P Online interventions
for social marketing health behavior change campaigns: a meta-analysis of
psychological architectures and adherence factors.

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[70]             Car J, Lang B, Colledge A, Ung C, Majeed A. Interventions
for enhancing consumers' online health literacy. Cochrane Database Syst Rev.
2011 Jun 15;(6):CD007092

[71]             The majority of Member States agree that eHealth would
provide a useful tool to meet the challenges faced by European healthcare
systems.

[72]             http://www.consilium.europa.eu/uedocs/cms\_data/docs/pressdata/en/lsa/111613.pdf

[73]             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

[74]             Council
Conclusions on Common values and principles in European Union Health Systems.

[75]             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,

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