Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions on telemedicine for the benefit of patients, healthcare systems and society
Date: 2008-11-04
Institutions: European Commission
Subjects: EU research policy, diffusion of innovations, health policy, medical computing, medical device, medical research, telemedicine

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COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels, 4.11.2008 
COM(2008)689 final 

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

on telemedicine for the benefit of patients, healthcare systems and society 

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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 

on telemedicine for the benefit of patients, healthcare systems and society 

1. 

INTRODUCTION  

Telemedicine - the provision of healthcare services at a distance - can help improve the lives 
of European citizens, both patients and health professionals, while tackling the challenges to 
healthcare systems. 

European  citizens  are  getting  older  and  are  increasingly  living  with  chronic  diseases.  Their 
health  condition  often  requires  enhanced  medical  attention.  Medical  support  may  not  be 
available in remote areas and for certain specialities as easily or as frequently as their health 
condition would require.  

Telemedicine  can  improve  access  to  specialised  care  in  areas  suffering  from  a  shortage  of 
expertise, or in areas where access to healthcare is difficult. Telemonitoring can improve the 
quality  of  life  of  chronically  ill  patients  and  reduce  hospital  stays.  Services  such  as 
teleradiology  and  teleconsultation  can  help  to  shorten  waiting  lists,  optimise  the  use  of 
resources and enable productivity gains. 

The  benefits  go  beyond  improving  patient  care  and  healthcare  system  efficiency. 
Telemedicine can also make a significant contribution to the EU economy. This sector, where 
European industry - including thousands of small and medium-sized enterprises (SMEs) - is 
well  placed,  has  been  expanding  rapidly  in  the  past  decade  and  is  expected  to  continue  to 
grow at a fast pace. 

Despite  the  potential  of  telemedicine,  its  benefits  and  the  technical  maturity  of  the 
applications,  the  use  of  telemedicine  services  is  still  limited,  and  the  market  remains  highly 
fragmented. Although Member States have expressed their commitment to wider deployment 
of telemedicine, most telemedicine initiatives are no more than one-off, small-scale projects 
that are not integrated into healthcare systems. 

It  is  recognised  that  integrating  these  new  types  of  services  in  healthcare  systems  is  a 
challenging task. The aim of this Communication is to support and encourage Member States 
in this endeavour, by identifying and helping to address the main barriers hindering the wider 
use  of  telemedicine  and  by  providing  evidence  to  build  trust  and  acceptance.  The 
Communication defines a set of actions to be taken by Member States, the Commission and 
the broader stakeholders' community. It focuses in particular on: 

•  Building confidence in and acceptance of telemedicine services  

•  Bringing legal clarity 

•  Solving technical issues and facilitating market development 

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Regardless  of  the  efforts  in  which  the  Commission  and  other  stakeholders  are  willing  to 
engage, it is the Member States’ health authorities, primarily responsible for the organisation, 
financing and delivery of healthcare, that remain the principal actors with the ability to make 
telemedicine  a  reality  in  the  life  of  European  patients  -  in  full  respect  of  the  subsidiarity 
principle.  

The  proposed  actions  build  on  the  ongoing  collaboration  between  Member  States  and  the 
Commission as part of a number of Commission policy initiatives1,2, in particular the recently 
adopted  Renewed  social  agenda3.  It  is  also  in  line  with  the  resolution  of  the  European 
Parliament4  acknowledging  the  importance  of  telemedicine.  It  builds  on  the  extensive 
consultation  conducted  between  September  2007  and  June  2008,  involving  Member  States 
and the main stakeholder groups:  health  professionals,  patients and industry representatives. 
On  privacy  and  data  security  issues  the  European  Data  Protection  Supervisor  has  been 
consulted.  

Information  and 
recognised 
The  European  Commission,  having 
Communication  Technology  (ICT)  applications  for  Health  (eHealth),  and  telemedicine  in 
particular,  has  been  funding  research  and  development  in  this  area  for  twenty  years.  In  its 
Health Strategy5 and eHealth Action Plan6, the European Commission has further committed 
itself to supporting dynamic health systems and the beneficial use of new technologies. This 
commitment also led to external action through the European Commission's support to the use 
of telemedicine in developing countries.  

the  potential  of 

2. 

TELEMEDICINE – DEFINITION AND EXAMPLES  

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.  

Telemedicine  encompasses  a  wide variety of services. Those most often mentioned in peer-
reviews  are  teleradiology,  telepathology,  teledermatology,  teleconsultation,  telemonitoring, 
telesurgery  and  teleophthalmology.  Other  potential  services  include  call  centres/online 
information  centres  for  patients,  remote  consultation/e-visits  or  videoconferences  between 
health professionals.  

Health  information  portals,  electronic  health  record  systems7,  electronic  transmission  of 
prescriptions or referrals (e-prescription, e-referrals) are not regarded as telemedicine services 
for the purpose of this Communication.  

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COM(2005) 229 final, 1.06.2005 
COM(2007) 860 final, 21.12.2007  
COM(2008) 412 final, 2.07.2008  
European Parliament resolution 2006/2275(INI) of 23 May 2007 
COM(2007) 630 final, 23.10.2007 
COM(2004) 356 final, 30.4.2004 
The  issue  of  electronic  health  records  has  been  addressed  in  a  recent  Commission  Recommendation: 
C(2008) 3282 final, 2.07.2008 

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In the following section, telemonitoring and teleradiology services are outlined in more detail 
as together they encompass most of the challenges that are relevant to the implementation of 
telemedicine services in general.  

2.1. 

Telemonitoring: a major opportunity for chronic disease management  

Telemonitoring is a telemedicine service aimed at monitoring the health status of patients at a 
distance8.  Data  can  be  collected  either  automatically  through  personal  health  monitoring 
devices9 or through active patient collaboration (e.g. by entering weight or daily blood sugar 
level  measurements  into  a  web-based  tool).  Data,  once  processed  and  shared  with  relevant 
health  professionals,  may  be  used  to  optimise  the  patient's  monitoring  and  treatment 
protocols.  

Telemonitoring is particularly useful in the case of individuals with chronic illnesses (such as 
diabetes or chronic heart failure – see also box below). Many of these patients - who are often 
elderly people - need regular monitoring because of the prolonged duration of their disease, 
the nature of their health condition and the drugs that they are using. 

Telemonitoring  supports  patients  and  health  professionals.  Its  use  can  allow  symptoms  and 
abnormal  health  parameters  to  be  detected  earlier  than  during  a  routine  or  emergency 
consultation,  and  corrective  measures  thus  to  be  taken  before  more  serious  complications 
appear. It may also result in less frequent visits to healthcare facilities, thereby increasing the 
quality of life for patients.  

Telemonitoring has been chosen as an example for its specific characteristics: 

•  It can contribute to re-organisation and re-deployment of healthcare resources, for instance 
by  reducing  hospital  visits,  thus  contributing  to  the  greater  efficiency  of  healthcare 
systems. 

•  It has proven to increase quality of care for patients, in particular chronically ill patients. In 
the  context  of  an  ageing  population  and  an  increasing  burden  of  chronic  diseases,  the 
benefits its wider deployment can provide are crucial. 

•  It  requires  a  coherent  approach  and  partnership  involving  patients,  health  professionals, 

healthcare providers, payers and the industry, to ensure sustainability of the services. 

Investment from industry in the development of telemonitoring services has been significant, 
resulting in technically mature applications. Patients' compliance is high and some healthcare 
authorities have already acknowledged the need for these services. Yet, most telemonitoring 
services are still limited to the status of temporary projects without clear prospects for wider 
use and proper integration into healthcare systems. Commitment by healthcare providers and 
concerted action between all stakeholders are needed in order to ensure wider deployment of 
these types of services throughout the EU. 

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Paré G et al. . Systematic review of home telemonitoring for chronic diseases: the evidence base. J AM 
Med Inform Assoc. 2007;14:269-277. 
Electronic  devices,  which  might  be  portable,  wearable  or  implantable  collect  data  on  specific  health 
parameters  

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The example of chronic heart failure and the use of telemonitoring 

Over six million people in Europe suffer from chronic heart failure. The burden on patients' 
quality of life and mortality and on healthcare systems' costs is considerable10.  

Telemonitoring  services  for  patients  with  chronic  heart  disease  enable  closer  monitoring  of 
their disease and contribute to treatment at the earliest possible stage. Dyspnoea (difficulty in 
breathing) and/or rapid increase in weight, which are key parameters to monitor on a daily 
basis, often signify aggravation of the disease. Early modification of treatment based on the 
monitoring  data  may  stabilise  the  condition,  make  consultations  unnecessary  and  avoid  or 
shorten hospital stays.  

Two review papers systematically analysed scientific publications issued respectively between 
1966  and  199311  and  between  1966  and  200612  on  telemonitoring  of  chronic  heart  failure. 
The  studies  concluded,  on  the  basis  of  available  data,  that  telemonitoring  might  be  an 
effective strategy for disease management, especially in high-risk heart failure patients. Both 
articles  noted  also  that  the  evidence  base  for  telemonitoring  in  heart  failure  is  still  very 
limited and that cost-effectiveness, scalability, safety and acceptability to patients need to be 
further assessed. 

2.2. 

Teleradiology: a way to optimise management of scarce resources 

Teleradiology  is  a  telemedicine  service  which  involves  the  electronic  transmission  of 
radiographic  images  from  one  geographical  location  to  another  for  the  purposes  of 
interpretation and consultation13.  

Teleradiology has developed alongside the gradual shift in medical imaging from film-based 
technologies.  Well  structured  professional  organisations  and  early 
to  digital-based 
establishment of standards have supported this development. 

Teleradiology  can  help  healthcare  facilities  to  cope  with  peak  workloads,  ensure  round-the-
clock services, reduce waiting lists for specific examinations and, above all, cut costs.  

Teleradiology has been chosen as an example for its specific features: 

•  It is currently the telemedicine service in the most advanced stage of deployment. 

•  It is usually carried out as an outsourced service, on a commercial contract basis. 

•  The service can be offered in a national or cross-border mode involving other EU countries 

or third countries. 

The most important challenge for teleradiology is to ensure that it develops in a manner that 
benefits  patient  care  and  ensures  overall  patient  safety,  and  does  not  in  any  way  reduce  the 
quality  of  radiology  services  provided  to  the  citizen.  Therefore,  urgent  action  needs  to  be 
taken to obtain legal clarity, including assurance of high quality in patient care.  

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McMurray et al. The burden of heart failure. Eur Heart J Suppl 4 (2002): D50-D58.  
Louis AA et al. A systematic review of telemonitoring for the management of heart failure. Eur J Heart 
Fail. 2003 Oct;5(5):583-90. 
Chaudhry SI et al. Telemonitoring for patients with chronic heart failure: a systematic review. J Card 
Fail. 2007 Feb;13(1):56-62. 
European Society of Radiology, Nov. 2006. 

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3. 

TELEMEDICINE: MAKING IT HAPPEN!  

In  the  eHealth  High  Level  Conference  Declaration  of  May  200814,  Member  States' 
representatives  acknowledged  the  urgency  of  ensuring  wider  deployment  of  telemedicine 
services and innovative ICT tools for chronic disease management. 

The  aim  of  this  Communication  is  to  support  Members  States  in  achieving  large-scale  and 
beneficial deployment of telemedicine services, by focusing on three strategic sets of actions: 

(1) 

Building confidence in and acceptance of telemedicine services  

(2) 

Bringing legal clarity 

(3) 

Solving technical issues and facilitating market development. 

These  different  sets  of  actions  are  partially  interlinked.  Building  acceptance  among  health 
professionals,  for  instance,  is  closely  related  to  the  existence  of  a  coherent  legal  framework 
for carrying out specific telemedicine services, such as teleradiology. 

3.1. 

Building confidence in and acceptance of telemedicine services  

There is limited evidence of the effectiveness and cost-effectiveness of telemedicine services 
on  a  large  scale.  Awareness,  confidence  and  acceptance  by  health  authorities,  professionals 
and patients still need to be strengthened.  

(a) 

Scientific evidence of effectiveness and cost-efficiency in a large-scale 
setting  

Various  studies  have  demonstrated  benefits  on  a  small  scale  for  patients  and  healthcare 
systems. Commonly accepted methodologies for assessing effectiveness, such as those used to 
assess pharmaceutical products, must be further developed.  

It can be difficult to put a precise monetary value on the factors that are contributing to gains 
in  effectiveness  and  cost  savings,  such  as:  fewer  adverse  health  events;  fewer  prescriptions; 
more time spent at work or better quality of life of patients. Savings on health costs may occur 
in  a  sector  other  than  the  sector  where  the  investments  have  been  made.  For  instance, 
investment in telemonitoring for chronic heart failure patients in the primary care sector may 
result in savings in hospitals through fewer or shorter hospital stays. The benefits of action, as 
well as the full consequences of inaction, can sometimes only be observed over long periods 
of time and in a broad context.  

To obtain sustained, large-scale telemedicine programmes, it will be essential for the cost of 
these  services  to  be  reimbursed.  However,  the  readiness  of  health  authorities'  to  reimburse 
certain  types  of  these  services,  in  particular  telemonitoring,  will  very  much  depend  on  the 
outcomes of effectiveness and cost-effectiveness studies.  

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Actions 

•  The  Commission  will  support  the  development,  by  2011,  of  guidelines  for  consistent 
assessment  of  the  impact  of  telemedicine  services,  including  effectiveness  and  cost-
effectiveness.  This  will  be  based  on  the  work  of  experts  in  the  field,  Commission-
supported studies, large-scale pilot schemes and relevant research projects.  

Telemedicine  industry  players,  in  particular  SMEs,  do  not  have  the  financial  capacity  to 
engage  alone  in  large-scale  telemonitoring  trials  as  do  pharmaceutical  companies.  Stronger 
intervention by the public sector, fully respecting the Community law on state aid and public 
procurement, seems to be necessary. Public-private partnerships can also be an instrument for 
the deployment of large-scale telemonitoring projects. 

Actions 

•  In 2010, the Commission, via its Competitiveness and Innovation Programme, will support 
a  large-scale  telemonitoring  pilot  project.  This  will  include  a  network  of  procurers  and 
payers of healthcare services. 

(b) 

Confidence  and  acceptance  of  telemedicine  solutions  by  health 
professionals, patients and health authorities 

Healthcare  systems  focus  on  meeting  the  needs  of  patients.  Achieving  telemedicine’s 
potential,  therefore,  depends  on  patients  being  convinced  of  its  ability  to  satisfy  their 
healthcare  needs.  Acceptance  by  patients  depends  crucially  on  acceptance  by  the  health 
professionals treating them, given the high degree of trust the former place in the latter.  

An  important  factor  for  ensuring  the  confidence  and  acceptance  of  health  professionals  is 
enhanced  dissemination  of  the  evidence  base  regarding  the  effectiveness  of  telemedicine 
services, their safety features and user-friendliness.  

For  both  health  professionals  and  patients,  adequate  needs  assessment  and  training  actions 
will play an important role in ensuring that the necessary skills and familiarity with the tools 
are  present,  as  well  as  a  fair  understanding  of  the  context  of  interaction  in  which  they  are 
operated.  

Member  States  are  responsible  for  the  organisation,  provision  and  funding  of  national 
healthcare.  The  leadership  of  their  health  authorities  in  achieving  wider  deployment  of 
telemedicine is essential. Collecting evidence and sharing good practice on implementation of 
telemedicine services and reimbursement schemes are therefore critical in order to secure the 
necessary acceptance and commitment on the part of the health authorities.  

The  wider  deployment  of  telemedicine,  and  telemonitoring  in  particular,  raises  new  ethical 
concerns, in particular because of the way in which the patient-doctor relationship is affected. 
Health  professionals  and  patient  organisations  have  signalled  their  intention  to  work  on 
European-wide  guidelines  to  address  these  issues.  The  Commission  will  welcome  any 
initiative in this area driven by users' needs and aimed at enhancing trust and acceptance of 
telemedicine among patients and health professionals in the best interests of safety and care.  

Privacy  and  security  related  aspects  are  also  major  components  of  building  trust  and 
confidence in telemedicine systems. The respect of rights and fundamental freedoms, like the 

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fundamental rights to private life and to the protection of personal data, must be guaranteed 
during the collection and processing of personal data, in particular when relating to health. As 
any  other  transmission  of  personal  health-related  data,  telemedicine  can  pose  a  risk  to  data 
protection  right  (in  the  sense  that  disclosure  of  a  medical  condition  or  diagnosis  could 
adversely affect an individual's personal and professional life). Data privacy aspects should be 
systematically  assessed  whenever  telemedicine  services  are  provided.  In  all  cases  it  is 
essential  that  the  Member  States'  and  Community  provisions  on  the  protection  of  personal 
data are complied with.  

Actions 

•  The  Commission  will  continue  to  contribute  to  European  collaboration  between  health 
professionals  and  patients  in  key  areas  with  the  potential  for  greater  application  of 
telemedicine, in order to make specific recommendations on how to improve confidence in 
and  acceptance  of  telemedicine,  also  taking  into  account  ethical  and  privacy  related 
aspects.  

•  Member States are urged to assess their needs and priorities in telemedicine by the end of 
2009. These priorities should form part of the national health strategies to be presented and 
discussed at the 2010 eHealth Ministerial Conference. 

•  The  Commission  will  support  the  collection  of  good  practice  on  deployment  of 

telemedicine services in the different Member States. 

3.2. 

Bringing legal clarity 

Although telemedicine may be an interesting option for many healthcare facilities, the lack of 
legal clarity has been repeatedly mentioned in the stakeholders' consultation as an obstacle to 
its wider use.  

The  paramount  objective  in  providing  legal  clarity  in  this  area  is  to  guarantee  that 
telemedicine  develops  in  such  a  manner  that  it  benefits  patient  care  while  ensuring  privacy 
and the highest standards of patient safety.  

The lack of legal clarity – in particular with regard to licensing, accreditation and registration 
of telemedicine services and professionals, liability, reimbursement, jurisdiction – is a major 
challenge  for  telemedicine  and,  in  particular,  for  teleradiology.  Cross  border  provision  of 
telemedicine services also require legal clarification with regard to privacy.  

Only  a  few  Member  States  have  clear  legal  frameworks  enabling  telemedicine.  In  some 
Member States, for a medical act to be legally recognized as such, the physical presence of 
the patient and the health professional in the same place, is required; this is a clear obstacle to 
the use of telemedicine. Moreover, there are often limitations in law or administrative practice 
on reimbursement of telemedicine services.  

Respecting  the  principle  of  subsidiarity,  these  issues  (of  regulation  of  health  services  and 
professions  and  of  reimbursement)  are  primarily  of  Member  State  responsibility,  and  thus 
require  action  at  their  level.  However,  given  the  complexity  of  these  issues  and  their  inter-
relationship  with  aspects  of  Community  law,  Member  States  can  be  supported  by  action  at 
Community  level,  such  as  sharing  of  good  practices  in  order  to  improve  legal  and 
administrative frameworks. 

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Actions 

•  In 2009, the Commission will establish a European platform to support Member States in 
sharing  information  on  current  national  legislative  frameworks  relevant  to  telemedicine 
and proposals for new national regulations. 

•  In 2009, the Commission, in cooperation with Member States, will publish an analysis of 

the Community legal framework applicable to telemedicine services. 

•  By  the  end  of  2011,  Member  States  should  have  assessed  and  adapted  their  national 
regulations  enabling  wider  access  to  telemedicine  services.  Issues  such  as  accreditation, 
liability, reimbursement, privacy and data protection should be addressed. 

The  box  below  provides  an  overview  of  the  main  existing  EU  legislation  applicable  to 
telemedicine services.  

Applicability of EU legislation to telemedicine services 

Telemedicine  is  both  a  health  service  and  an  information  society  service15.  As  such,  it  falls 
under  the  EC  Treaty  (Article  49)  and  existing  EU  secondary  legislation,  in  particular 
Directive 2000/31/EC, referred to hereinafter as the “e-Commerce Directive”.  

The European Court of Justice has stated that neither the special nature of health services nor 
the  way  in  which  they  are  organised  or  financed  removes  them  from  the  ambit  of  the 
fundamental principle of freedom of movement16. This includes the freedom for recipients of 
the  healthcare  service  to  seek  and  receive  medical  treatment  from  another  Member  State, 
regardless of how the service is delivered, i.e. also by telemedicine.  

Directive  98/34/EC  as  amended  by  Directive  98/48/EC  establishes  a  procedure  which 
imposes an obligation on Member States to notify the Commission and each other of all draft 
technical  regulations  concerning  products  and  Information  Society  Services17,  including 
telemedicine, before they are adopted in national law. 

The  e-Commerce  Directive  defines  rules  for  the  provision  of  Information  Society  Services 
both  within  and  between  Member  States.  It  also  applies  to  telemedicine.  For  business-to-
business  (professional-to-professional)  telemedicine  services,  such  as  teleradiology,  the 
country of origin principle applies: the service offered by the professional must comply with 
the rules of the Member State of establishment. In the case of business-to-consumer activities 
(which might be relevant to telemonitoring services) the contractual obligations are exempted 
from  the  country  of  origin  principle:  the  service  might  need  to  comply  with  the  rules  of  the 
recipient’s country.  

Definition  of  medical  acts  is  a  matter  for  the  Member  States.  As  a  general  principle,  the 
classification of specific telemedicine services as medical acts should ensure that these meet 
the same level of requirements as equivalent non-telemedicine services (e.g. teleradiology vs. 

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As defined by Directive 98/34/EC. 
See  notably  Müller  and  Van  Riet  (case  C-385/99)  [2003];  Smits  and  Peerbooms  (case  C-157/99) 
[2001]; Watts (case C-372/04) [2006]. 
Provided that they are not covered by one the exceptions laid down by Directive 98/34/EC as amended 
by Directive 98/48/EC. 

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radiology). This principle ensures that adequately regulated health services are not replaced 
by less regulated telemedicine services and it avoids discrimination between providers of the 
same service which would be incompatible with the e-Commerce Directive. 

Directive  95/46/EC,  on  the  processing  of  personal  data  and  the  protection  of  privacy, 
specifies a number of additional requirements relating to confidentiality and security which 
telemedicine  and  all  other  interactive  on-line  services  have  to  meet  in  order  to  safeguard 
individuals’ rights.  

Directive  2002/58/EC,  concerning  the  processing  of  personal  data  and  the  protection  of 
privacy  in  the  electronic  communications  sector,  lays  down  specific  requirements  on 
providers  of  electronic  communications  services  over  public  communications  networks  to 
ensure confidentiality of communications and security of their networks. 

Directive 2005/36/EC establishes the criteria for a set of regulated professions according to 
which  qualifications  obtained  in  one  Member  State  are  recognised  by  another.  The 
recognition of professional qualifications by the host Member State allows the beneficiary to 
gain access in that Member State to the same profession as that for which he is qualified in 
the home Member State and to pursue it in the host Member State under the same conditions 
as its nationals. 

Telemedicine is also recognised in the proposal for a Directive of the European Parliament 
and of the Council on the application of patients' rights in cross-border healthcare18, which 
addresses patients' cross border mobility including their ability to access to services across 
borders. This proposal is without prejudice to the abovementioned Directives, notably the e-
Commerce Directive and Directive 2005/36/EC. If adopted, the Directive would require the 
Commission  to  take  measures  ensuring  the  interoperability  of  means  for  the  provision  of  e-
health services, including telemedicine (Article 16)19. 

3.3. 

Solving technical issues and facilitating market development 

Although  some  telemedicine  services  have  existed  for  a  long  time  and  most  of  the  ICT  has 
been in place for a while, there are still areas where technical issues need to be addressed.  

Broadband access and the ability of providers to enable full connectivity is a prerequisite for 
the deployment of telemedicine. With broadband for all, telemedicine can eventually become 
a public good, accessible to all. Connectivity with all geographical areas in the EU, including 
rural  and  ultra-peripheral  regions,  is  a  precondition  for  telemedicine  deployment  and  for 
universal access of all individuals to healthcare. The EU's cohesion policy supports both the 
broadband  accessibility  and  the  development  of  content,  services  and  applications  for 
citizens20. 

Interoperability and standardisation in telemonitoring are crucial to allow widespread use of 
the  technologies,  to  enable  them  to  benefit  from  the  single  market21  and  to  contribute  to  its 
completion.  Use  of  existing  standards  and  adoption  of  new  standards  and  standardised 
approaches  to  achieve  interoperability  should  be  supported  by  standards  development 

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COM (2008) 414 final, 2.7.2008 
As stipulated in the proposal in its articles 3,5 and 11 
Regulation (EC) No 1080/2006 of 5 July 2006 
Health Information Network Europe (HINE), 2006 - European eHealth forecast (report) 

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organisations,  with  the  active  participation  of  industry.  Coordinated  community  action  is 
necessary, and indeed has been explicitly called for in the proposal for a Directive on patients' 
rights in cross-border healthcare.  

Trust and confidence in new and innovative technologies and ICT-based services within the 
health sector need to be built through rigorous testing, agreed standards and a widely accepted 
certification  process.  This  applies  particularly  to  telemonitoring  devices.  To  avoid  market 
fragmentation,  concerted  action  is  needed  at  EU  level  to  agree  on  a  common  set  of 
specifications for these telemedicine systems and services. Such concerted action could bring 
together  the  necessary  expertise  and  knowledge  to  ensure  that  good  quality  and  safe  and 
secure  telemedicine  services,  which  are  not  covered  by  existing  legislation,  are  available 
throughout the EU.  

Actions 

•  By  the  end  of  2010,  the  Commission  invites  industry  and  international  standardisation 
bodies to issue a proposal on the interoperability of telemonitoring systems, including both 
existing and new standards. 

•  By  the  end  of  2011,  the  Commission,  in  cooperation  with  Member  States,  will  issue  a 
policy  strategy  paper  on  how  to  ensure  interoperability,  quality  and  security  of 
telemonitoring systems based on existing or emerging standards at European level. 

4. 

CONCLUSIONS  

The societal and economic benefits from wider use of telemedicine are potentially huge. Yet, 
at the present moment, they are far from being fully appreciated or achieved.  

Now is the time for telemedicine to enhance patients’ lives and to offer new tools to health 
professionals.  Telemedicine  can  help  addressing  the  major  challenges  to  healthcare  systems 
and offer major opportunities for the European industry.  

The  Commission  will  give  its  full  support  to  ideas  and  initiatives  to  turn  this  goal  into  a 
reality and is ready to work with Member States and all stakeholders to achieve this objective. 
It  proposes  a  concrete  set  of  actions  for  this  specific  area.  Other  issues  not  specifically 
targeted  in  this  communication,  such  as  the  availability  of  broadband  for  all  and  consistent 
attention  to  the  implementation  of  measures  aimed  at  ensuring  respect  for  the  right  to 
protection  of  personal  data,  are  also  instrumental  in  the  full  beneficial  deployment  of 
telemedicine. 

However, the onus for making this initiative a success rests mainly with Member States. It is 
they who bear the responsibility for the organisation, provision and funding of their healthcare 
systems. Telemedicine will only realise its full potential if Member States engage actively in 
integrating it into their health systems.  

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ANNEX  

THREE LEVELS OF ACTIONS FOR THE YEARS AHEAD 

Actions at the level of Member States 

(1)  Member States are urged to assess their needs and priorities in telemedicine by the end 
of  2009.  These  priorities  should  form  part  of  the  national  health  strategies  to  be 
presented and discussed at the 2010 eHealth Ministerial Conference. 

(2) 

By  the  end  of  2011,  Member  States  should  have  assessed  and  adapted  their  national 
telemedicine  services.  Issues  such  as 
regulations  enabling  wider  access 
accreditation,  liability,  reimbursement,  privacy  and  data  protection  should  be 
addressed. 

to 

Member States' actions to be supported at EU level 

(3) 

(4) 

(5) 

(6) 

In 2009, the Commission will establish a European platform to support Member States 
in  sharing  information  on  current  national  legislative  frameworks  relevant  to 
telemedicine and proposals for new national regulations. 

In 2009, the Commission, in cooperation with Member States, will publish an analysis 
of the Community legal framework applicable to telemedicine services. 

By the end of 2010, the Commission invites industry and international standardisation 
bodies to issue a proposal on the interoperability of telemonitoring systems, including 
both existing and new standards. 

By the end of 2011, the Commission, in cooperation with Member States, will issue a 
policy  strategy  paper  on  how  to  ensure  interoperability,  quality  and  security  of 
telemonitoring systems based on existing or emerging standards at European level. 

Actions to be undertaken by the Commission  

(7) 

(8) 

(9) 

In  2010,  the  Commission,  via  its  Competitiveness  and  Innovation  Programme,  will 
support  a  large-scale  telemonitoring  pilot  project.  This  will  include  a  network  of 
procurers and payers of healthcare services. 

The Commission will support the development, by 2011, of guidelines for consistent 
assessment  of  the  impact  of  telemedicine  services,  including  effectiveness  and  cost-
effectiveness.  This  will  be  based  on  the  work  of  experts  in  the  field,  Commission-
supported studies, large-scale pilot schemes and relevant research projects.  

The Commission will continue to contribute to European collaboration between health 
professionals  and  patients  in  key  areas  with  the  potential  for  greater  application  of 
telemedicine,  in  order  to  make  specific  recommendations  on  how  to  improve 
confidence  in  and  acceptance  of  telemedicine,  also  taking  into  account  ethical  and 
privacy related aspects.  

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(10)  The  Commission  will  support  the  collection  of  good  practice  on  deployment  of 

telemedicine services in the different Member States. 

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