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
Date: 2012-12-06
Institutions: European Commission
Subjects: health care system, health expenditure, information technology, innovation, intergovernmental cooperation (EU), new technology, right to health, telemedicine

EUROPEAN 
COMMISSION 

Brussels, 6.12.2012  
COM(2012) 736 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 

{SWD(2012) 413 final} 
{SWD(2012) 414 final} 

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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. 

2. 

2.1. 

2.2. 

2.3. 

3. 

4. 

4.1. 

4.2. 

4.3. 

5. 

5.1. 

5.2. 

6. 

6.1. 

6.2. 

6.3. 

6.4. 

7. 

8. 

Introduction.................................................................................................................. 3 

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

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

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

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

Vision ........................................................................................................................... 6 

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

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

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

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

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

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

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

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

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

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

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

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

Promoting policy dialogue and international cooperation on eHealth at global level13 

Conclusions ................................................................................................................ 14 

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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  Plan3  was  adopted  in  2004.  Since  then,  the  European  Commission 
has  been  developing  targeted  policy  initiatives  aimed  at  fostering  widespread  adoption  of 
eHealth throughout the EU4. 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 epSOS5. The adoption in 2011 of the Directive on the 
Application of Patients' Rights in Cross Border Healthcare6 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  20207  Strategy  and  the  Digital  Agenda  for  Europe8.  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. 

1

2

3 
4

5

6

7

8

facing 

challenges 

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  
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 
sector. 
http://ec.europa.eu/information_society/activities/health/policy/ehtask_force/index_en.htm 
http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=COM:2004:0356:FIN:EN:PDF  
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) 
www.epsos.eu 
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. 
Communication from the Commission Europe 2020 a strategy for smart, sustainable and inclusive growth - com(2010) 2020 final 
http://ec.europa.eu/information_society/digital-agenda/index_en.htm 

health 

the 

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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  factors9.  In  addition,  the  long  term  care  expenditure  projection  would  on  average 
almost  double  over  the  projection  period10.  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 

9

10

11 

12

13

14

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  
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  
http://epp.eurostat.ec.europa.eu/portal/page/portal/product_details/publication?p_product_code=KE-
ET-10-001 
Green Paper on the European Workforce for Health COM(2008) 725 final of 10.12.2008 
http://ec.europa.eu/enterprise/policies/innovation/policy/lead-market-initiative/files/final-eval-lmi_en.pdf  
According to BCC Research study of March 2012 

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inclusion  and  equality,  quality  of  life  and  patient  empowerment15  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  promotion16.  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 rigour17. 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  expenditures18.  Finally,  facilitation  of  eHealth  is  one  of  the  concrete  actions  to 
promote free movement of EU citizens within the EU19. 

2.3. 

Barriers to deployment of eHealth 

Despite the opportunities and benefits, major barriers hamper the wider uptake of eHealth20:  

• 

• 

• 

• 

• 

• 

• 

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.  

15 

16
17 

18
19 
20

"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]. 
Staff Working Document Accompanying eHealth Action Plan – innovative healthcare for the 21st century. 
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 
Idem 
EU Citizenship Report 2010 – Dismantling the obstacles to EU citizens' rights COM(2010) 603 final (see action 7) 
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 

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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 interoperability21 framework, building on 
eHealth roadmaps and the general European Interoperability Framework22 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 

21

22

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. 
http://ec.europa.eu/isa/documents/isa_annex_ii_eif_en.pdf 

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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  general23.  In  eHealth  however,  such  standards  are  often  not  specific 
enough24. 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 
regulation25, 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  terminologies26  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  authentication27  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  program28  and  in  the  future  Horizon  2020  and  be  used  and 
maintained under the proposed Connecting Europe Facility (CEF, see 6.1). 

23

24

25

26
27 

28

EU Study on the specific policy needs for ICT standardisation, http://ec.europa.eu/enterprise/sectors/ict/files/full_report_en.pdf 
European countries on their journey towards national eHealth infrastructures, EU Study, http://www.ehealth-strategies.eu/ 
http://ec.europa.eu/enterprise/policies/european-standards/documents/official-documents/index_en.htm 
Among others www.epsos.eu and www.semantichealthnet.eu 
Directive  1999/93/EC  on  a  Community 
framework 
lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:31999L0093:EN:NOT 
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/ 

for  electronic 

signatures 

http://eur-

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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  services30  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-
202031 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 

29

30

31

http://ec.europa.eu/isa/documents/isa_annex_ii_eif_en.pdf 
http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=COM:2008:0689:FIN:EN:PDF  
http://ec.europa.eu/health/programme/policy/proposal2014_en.htm 

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with  official  medical  data  so  that  care  can  be  more  integrated,  personalised  and  useful  for 
patients32. 

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 protection33 with a view to modernising current data protection rules and 
strengthening their harmonisation34.  

The eHealth Task Force report and the responses to the public consultation35 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  computing36 
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 requirements37.  

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. 

32

33

34

35

36

37

eHealth Task Force Report of May 2012 
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 
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 
http://ec.europa.eu/information_society/activities/health/ehealth_ap_consultation/index_en.htm 
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 
Definition 
minimal 
http://csrc.nist.gov/publications/PubsSPs.html#800-145) 
http://ec.europa.eu/justice/data-protection/article-29/index_en.htm

management 

interaction. 

provider 

service 

effort 

NIST 

(The 

or 

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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 

38

39

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 
http://eur-
540 
healthcare 
lex.europa.eu/LexUriServ/LexUriServ.do?uri=COM:2012:0540:FIN:EN:PDF 
http://ec.europa.eu/health/medical-devices/files/meddev/2_1_6_ol_en.pdf 

professionals, 

COM(2012) 

available 

final, 

at 

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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 projects40;  

–  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 simulation42; 

• 

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 scale43.  

40 

41

42

43

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.  
http://ec.europa.eu/research/innovation-union/index_en.cfm?section=active-healthy-ageing&pg=implementation-plan  
Virtual Physiological Human http://ec.europa.eu/information_society/activities/health/research/fp7vph/index_en.htm 
National  eHealth  strategy 
http://www.itu.int/dms_pub/itu-d/opb/str/D-STR-E_HEALTH.05-2012-PDF-E.pdf 

toolkit.  World  Health  Organization  and  International  Telecommunication  Union  2012. 

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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 epSOS45 (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 

44

45

46

http://ec.europa.eu/commission_2010-2014/president/news/speeches-statements/pdf/20111019_2_en.pdf 
www.epsos.eu 
Staff Working Document SWD(2012) 61 of 14.3.2012 

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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 initiatives48 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.  

47

48

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 
http://ec.europa.eu/information_society/activities/health/docs/publications/2009/2009semantic-health-report.pdf and 
http://www.semantichealthnet.eu/ 

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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. 

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