COMMISSION STAFF WORKING DOCUMENT on the applicability of the existing EU legal framework to telemedicine services 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
Date: 2012-12-06
Institutions: European Commission
Subjects: consumer protection, data protection, freedom to provide services, health care system, information technology, innovation, judicial proceedings, new technology, telemedicine

EUROPEAN 
COMMISSION 

Brussels, 6.12.2012  
SWD(2012) 414 final 

COMMISSION STAFF WORKING DOCUMENT 

on the applicability of the existing EU legal framework to telemedicine services 

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 

{COM(2012) 736 final} 
{SWD(2012) 413 final} 

EN 

   EN 

 
 
 
 
  
 
COMMISSION STAFF WORKING DOCUMENT 

on the applicability of the existing EU legal framework to telemedicine services 

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 

TABLE OF CONTENTS 

1. 

2. 

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

Legal Framework ......................................................................................................... 6 

2.1. 

Telemedicine as a health care service .......................................................................... 6 

2.1.1.  The Treaty provisions on the freedom to provide services .......................................... 6 

2.1.2.  Directive on the application of patients' rights in cross-border healthcare .................. 6 

2.2. 

Telemedicine as an information society service .......................................................... 7 

3. 

3.1. 

3.2. 

Key legal issues of cross-border telemedicine ........................................................... 10 

Licensing/registration of healthcare professionals performing telemedicine services10 

Conditions for legal processing of health data........................................................... 12 

3.2.1.  General Data Protection rules .................................................................................... 12 

3.2.2.  The data protection reform......................................................................................... 15 

3.2.3.  Other data protection rules ......................................................................................... 15 

3.3. 

3.4. 

Reimbursement .......................................................................................................... 16 

Liability issues and product safety............................................................................. 18 

3.4.1.  Health professional liability ....................................................................................... 19 

3.4.2.  Safety and performance of products and product liability ......................................... 21 

3.5. 

Court litigation/court proceedings ............................................................................. 23 

3.5.1.  Determining the competent jurisdiction..................................................................... 23 

3.5.2.  Determining the applicable law ................................................................................. 25 

4. 

Conclusion ................................................................................................................. 28 

4.1. 

Legal sources concerning information society services............................................. 31 

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4.2. 

4.3. 

4.4. 

4.5. 

Legal sources concerning reimbursement.................................................................. 31 

Legal sources concerning consumer protection ......................................................... 31 

Legal sources concerning data protection .................................................................. 32 

Legal sources concerning medical devices and medicinal products.......................... 32 

1. 

INTRODUCTION 

Telemedicine is defined as "the provision of healthcare services, through the use of ICT, in 
situations where the health professional1 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.  

Health  information  portals,  online  pharmacy,  electronic  health  record  systems,  electronic 
transmission  of  prescriptions  or  referrals  (e-prescription,  e-referrals)  are  not  regarded  as 
telemedicine services for the purpose of this Staff Working Paper. E-prescription is excluded 
as it is an ancillary and independent act, which can also be delivered in a face-to-face meeting 
with a doctor.  

Telemedicine encompasses a wide variety of services such as teleradiology, teleconsultation, 
telemonitoring3,  teleophtalmology,  telesurgery  and  teledermatology,  which  can  therefore  be 
regarded as different forms or ways of delivering telemedicine. 

Telemedicine can help to address major challenges faced by European healthcare systems. For 
example,  telemonitoring  can  improve  the  quality  of  life  of  chronically  ill  patients  through 
self-management solutions and remote monitoring from home, reducing hospitalisation costs 
and saving on unnecessary emergency visits. Additionally, services such as teleradiology and 
teleconsultation can help shortening waiting times, optimising the use of available resources 
and enabling productivity gains.  

Telemedicine  can  also  significantly  improve  access  to  care,  by  delivering  high-quality 
services  to  patients  living  in  remote  or  sparsely  populated  areas  affected  by  shortages  of 
specialised healthcare professionals or by facilitating across border healthcare for the benefit 
of citizens in the EU.4 

1  

2 

3  

4  

The health care professional is here defined as in Article 3f) of Directive 2011/24/EU on the application 
of  patients’  rights  in  cross-border  healthcare:  "means  a  doctor  of  medicine,  a  nurse  responsible  for 
general  care,  a  dental  practitioner,  a  midwife  or  a  pharmacist  within  the  meaning  of  Directive 
2005/36/EC, or another professional exercising activities in the healthcare sector which are restricted 
to a regulated profession as defined in Article 3(1)(a) of Directive 2005/36/EC, or a person considered 
to be a health professional according to the legislation of the Member State of treatment". 
This  definition  of  telemedicine  is  the  one  adopted  by  the  Commission  in  its  Communication  on 
telemedicine  for  the  benefit  of  patients,  healthcare  systems  and  society,  COM(2008)689,  http://eur-
lex.europa.eu/LexUriServ/LexUriServ.do?uri=COM:2008:0689:FIN:EN:PDF 
ISO  technical  specification  13131  addresses  quality  criteria  for  services  and  systems  for  telehealth. 
Some  EU  countries  have  already  adopted  this  technical  specification  as  a  bidding  prerequisite  for 
commissioning telehealth services. 
Telemonitoring  falling  within  the  scope  of  this  SWD  is  telemonitoring  utilised  in  the  context  of  the 
provision of medical care. 
EU  Citizenship  Report  2010  - Dismantling  the obstacles to  EU  citizens’  rights  COM(2010)  603  final 
(see page 9). 

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The  benefits  go  beyond  improving  patient  care  and  healthcare  system  efficiency. 
Telemedicine can also make a significant contribution to the European economy. This sector, 
where European industry – including thousands of small and medium size enterprises (SMEs) 
– is well placed, has been expanding rapidly in the past decade and is expected to continue to 
grow at a fast pace5.  

Member  States  have  long  realised  the  potential  of  telemedicine  and  are  supportive  of  its 
beneficial  deployment.  Nevertheless,  despite  widespread  awareness  of  the  benefits  of 
telemedicine,  its  use  in  the  provision  of  everyday  health  and  care  services  is  still  relatively 
low and one of the reasons identified is the lack of legal clarity6.  

In  its  2008  Communication  on  Telemedicine,  the  European  Commission  announced  the 
publication, in cooperation with the Member States, of an analysis of the EU legal framework 
applicable  to  telemedicine.  Raising  awareness  on  the  rules  and  norms  applicable  to 
telemedicine  was  shown  to  be  a  primary  condition  to  boost  the  wider  deployment  of 
telemedicine services across EU Member States.  

On these grounds, the objective of this Staff Working Paper is to enhance legal clarity for all 
the actors involved in the provision of telemedicine services. This will be done by mapping 
existing EU legislation that applies to cross-border telemedicine services (consistent with the 
title of the SWP)7. In so doing, the paper is expected to contribute to achieving the goals of 
the  Digital  Agenda  for  Europe8,  which  sets  out  to  achieve  widespread  deployment  of 
telemedicine services by 2020. 

The  European  Commission's  2010  EU  Citizenship  Report9  revealed  that  fragmented  legal 
rules on essential aspects of healthcare across the Member States hamper patients exercising 
their right to receive healthcare in other EU Member States, where the quality and delivery of 
care may better respond to their needs, for example through telemedicine solutions. The lack 
of legal clarity also causes concern for healthcare professionals, fuelling distrust in the safety 
of new technolgies. 

Member  States  are  primarily  responsible  for  the  organisation,  financing  and  delivery  of 
healthcare.  This  means  that  they  remain  the  principal  actors  able  to  turn  telemedicine  into 
reality for EU citizens – in full respect of the subsidiarity principle. 

5 

6 

7 

8 

9 

on 

Paper 

Telemedicine, 

The global  market  for  eHealth  is  estimated  to  have  a  potential  value of €60 billion, of  which  Europe 
represents one third, i.e. €20 billion. The combined  global value of the telehome and telehospital market 
in 2011 was estimated at €8.8 billion in 2011, which will climb to €20.7 billion in 2016, according to 
BCC Research study of March 2012. 
Staff  Working 
Commission 
http://ec.europa.eu/information_society/activities/health/docs/policy/telemedicine/telemedecine-
swp_sec-2009-943.pdf  
It is important to underline that EU legislation is for the most part Directives or Regulations. Directives 
must be implemented by Member States in their national law and it is the national law implementing 
Directives that is applicable to EU citizens. Regulations (once they enter into force) have direct effect 
and do not need to be transposed. 
A  Digital  Agenda  for  Europe,  COM(2010)245  final,  http://ec.europa.eu/information_society/digital-
agenda/index_en.htm. (Action 75) 
EU Citizenship Report 2010 – Dismantling the obstacles to EU citizens' rights, COM(2010) 603 final, 
http://ec.europa.eu/justice/citizen/files/com_2010_603_en.pdf. This report identified the main obstacles 
faced by EU citizens in the effective exercise of their rights under EU law. 

SEC(2009)943 

final, 

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Most Member States do not have legal instruments specifically dealing with telemedicine, and 
only  a  few  have  adopted  national  regulations  or  professional  and  ethical  guidelines 
concerning the provision of telemedicine services.  

Moreover, some national legal systems require the physical presence of the patient and health 
professional at the same time and in the same place, for a medical act to be legally valid10.  

As  a  general  rule,  Member  States  should  not  adopt  any  national  law,  which  would  prevent 
service  providers  from  exercising  their  freedom  to  provide  telemedicine  services.  Any 
obstacle  to  the  freedom  to  provide  services  across  borders  is  prohibited,  unless  justified  by 
imperative reasons of public interest for example on the grounds of public health. Hurdles of 
an  administrative  and  reimbursement  nature  might  represent  obstacles  in  this  regard,  and 
Member States should prove that they are justified.  

It is important to underline that telemedicine is not a new medical act and does not intend to 
replace  traditional  methods  of  care  delivery,  such  as  face-to-face  consultations.  It  rather 
represents an innovative way of providing health and care services, which, can complement 
and  potentially  increase  the  quality  and  efficiency  of  traditional  healthcare  delivery.  Such 
potential was recently acknowledged in Directive 2011/24/EU on the application of patients' 
rights  in  cross-border  healthcare11,  due  to  be  transposed  by  25  October  2013,  codifying  the 
European Court of Justice jurisprudence on EU patients' rights to be reimbursed for medical 
treatment in other EU Member States, including through eHealth and telemedicine.  

Recognising  Member  States'  responsibility  for  ensuring  the  widespread  deployment  of 
telemedicine  solutions,  this  Staff  Working  Paper  primarily  aims  to  support  national 
administrations  and  implementing  actors,  by  providing  them  with  clarification  on  how 
telemedicine is affected by current EU legislation.  

Due  to  its  nature  and  characteristics,  cross-border  telemedicine  falls  within  the  scope  of 
several EU legal instruments. 

The paper follows the key legal steps encountered by a healthcare provider in the provision of 
a  cross-border  telemedicine  act.  It  first  clarifies  licensing  requirements  for  delivering  cross-
border  telemedicine  and  then  the  rules  to  comply  with  for  data  protection,  conditions  and 
rights  for  reimbursement  and  cases  of  liability.  Finally,  it  details  the  EU  legal  provisions 
determining the competent court and the applicable law in case a conflict arises.  

Given the evolving nature of telemedicine technologies, this paper does not intend to cover all 
possible  situations  or  future  developments  of  telemedicine,  but  merely  the  most  frequent  or 
likely scenarios at present. 

It  should  be  noted  that  the  contents  of  this  document  only  represent  the  views  of  the 
Commission services.  

10 

11 

In Poland, the Polish Act on the Professions of Physician and Dentist requires that a diagnosis is made 
only after personally examining the patient. Polish Act on the Professions of Physicians and Dentist of 5 
December 1996.  
Directive  2011/24/EU  on  the  application  of  patients'  rights  in  cross-border  healthcare,  http://eur-
lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2011:088:0045:0065:EN:PDF,  OJ  L  88,  4.4.2011, 
p.45.  

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Lastly, this Staff Working Paper does not prejudge the interpretation that the European Court 
of  Justice,  as  the  final  instance  responsible  for  interpreting  the  Treaty  and  secondary 
legislation, may develop on these matters. 

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2. 

LEGAL FRAMEWORK 

2.1. 

Telemedicine as a health care service 

Relevant provisions 

-Articles 56 and 57 of Treaty on the functioning of the European Union (TFEU) 

-Directive 2011/24/EU on the application of patients' rights in cross-border healthcare 

2.1.1.  The Treaty provisions on the freedom to provide services 

Telemedicine is a service and as such falls under the provisions of the TFEU (i.e. its Article 
56). The European Court of Justice has, on several occasions, stated that health services fall 
within  the  scope  of  the  freedom  to  provide  services  (Article  56  TFEU)12  and  neither  the 
special nature of health services nor the way in which they are organised or financed removes 
them from the ambit of this fundamental freedom13.  

This  includes  the  freedom  for  citizens  to  seek  and  receive  health  and  care  services  from 
another  Member  State,  regardless  of  how  the  service  is  delivered,  i.e.  including  through 
telemedicine.  Finally,  the  Court  expressly  recognised  that  the  freedom  to  provide  services 
applies  to  services,  which  a  provider  supplies  without  moving  from  the  Member  State  in 
which he is established, to recipients in other Member States14.  

Member  States  are,  however,  allowed  to  maintain  or  introduce  restrictions  to  the  free 
movement  of  services,  provided  that  these  are  justified  by  imperative  reasons  of  public 
interest (e.g. public health), do not exceed what is objectively necessary for that purpose and 
that the same result cannot be achieved by less restrictive rules15. 

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

Telemedicine  services  fall  within  the  scope  of  Directive  2011/24/EU  on  the  application  of 
patients'  rights  in  cross-border  healthcare  when  they  are  health  services  provided  by  health 
professionals as defined in that Directive 16.  

Cross-border  telemedicine  services  are  covered  by  the  Directive  as  it  contains  two  express 
references to telemedicine (Article 3(d) and Article 7(7) of the Directive) and its scope covers 
"the  provision  of  healthcare  to  patients,  regardless  of  how  it  is  organised,  delivered  or 
financed" (Article 1(2) of the Directive). 

12 
13 

14 
15 

16 

ECJ judgment of 31 January 1984 in joined cases 286/82 and 26/83 Luisi and Carbone 
See  in  particular  ECJ  judgment  of  28  April  1998,  in  case  C-158/96  Kohll;  ECJ  judgment  of  12  July 
2001  in  case  C-368/98,  Vanbraekel;  ECJ  judgment  of  13  May  2003  in  case  C-385/99,  Müller-Fauré 
and Van Riet; ECJ judgment of 12 July 2001 in case C-157/99, Smits and Peerbooms; ECJ judgment of 
16 May 2006 in case C-372/04, Watts. 
ECJ judgement of 10 May 1995 in case C-384/93 Alpine Investments 
ECJ  judgment  of  02  March  2011  in  case  C-108/91  Ker-Optika,  58  until  76.  ECJ  judgement  of  4 
December  1986  in  case  205/84,  Commission  v  Germany,  paragraphs  27  and  29;  ECJ  judgment  of  26 
February 1991 in case C-180/89, Commission v Italy, paragraphs 17 and 18; and ECJ judgement of 20 
May 1992 in case C-106/91, Ramrath, paragraphs 30 and 31. 
Member States are expected to transpose Directive 2011/24/EU by 25 October 2013. 

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Although  it  does  not  aim  to  solve  all  legal  issues  related  to  the  provision  of  cross-border 
health  services  in  the  EU,  the  Directive  clarifies  patients'  rights  to  be  reimbursed  for  the 
provision of cross-border health services, including cross-border telemedicine services17.  

The key applicable provisions are the following: 

• 

• 

• 

• 

Rights are established to ensure that the essential information on prices, quality and 
safety of care are accessible to the patient to ensure informed decision.  

The  Member  State  of  treatment  (that  in  case  of  telemedicine  is  the  Member  State 
where the service provider is established – see also paragraph 3.1 below) must ensure 
that the healthcare in question is provided in accordance with its legislation (Article 
4(1) of the Directive). 

The  principle  of  non-discrimination  with  regard  to  nationality  is  recognised  and 
applies both to access and to fees charged for medical services (Article 4(3) and (4) 
of the Directive).  

The  Directive  provides  that,  in  principle,  the  Member  State  of  affiliation  of  the 
patient  shall  reimburse  the  costs  of  cross-border  healthcare  if  the  healthcare  in 
question is among the benefits to which the insured person is entitled in the Member 
State of affiliation. 

2.2. 

Telemedicine as an information society service 

Relevant provisions 

-Directive 2000/31/EC on Electronic Commerce, hereinafter the "eCommerce Directive" 

-Directive 98/34/EC hereinafter the "Regulatory Transparency Directive" 

The  eCommerce  Directive18  creates  a  legal  framework  to  ensure  the  free  movement  of 
information society services19. It sets information requirements for information society service 
providers, rules on commercial communications, on contracts concluded by electronic means 
and on the liability of intermediary service providers.  

In order for a telemedicine service to qualify as an information society service, it needs to be a 
“service  normally  provided  for  remuneration,  at  a  distance,  by  electronic  means,  at  the 
individual request of a recipient of service:”20 

17 

18 

19 
20 

It  is  based  on  the  European  Court  of  Justice  rulings  issued  over  a  decade  confirming  the  right  for 
patients  to  be  reimbursed  for  care  received  in  another  Member  State  under  certain  conditions  –  see 
recent Case ECJ ruling of 27 October 2011, C-255-09, Commission v. Portugal 
Directive  200/31/EC  of  8  June  2000  on  certain  legal  aspects  of  information  society  services,  in 
particular electronic commerce, in the Internal Market - OJ L 178, 17. 7. 2000, p. 1. 
Article 2(a) of the e-Commerce Directive andArticle 1(2) of the "Transparency Directive" 
Article 2(a) of the e-Commerce Directive and Article 1(2) of the "Regulatory Transparency Directive" 

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• 

• 

• 

• 

for  remuneration.  "Remuneration"  is  to  be  considered  in  relation  to  the  service  in 
question, regardless of who effectively pays for the telemedicine service; 

at  a  distance.  The  concept  of  "at  a  distance"  means  that  the  service  is  provided 
without  the  parties  being  simultaneously  present.  All  telemedicine  services  are  by 
definition provided at a distance; 

by  electronic  means.  The  service  also  has  to  be  sent  initially  and  received  at  its 
destination  by  means  of  electronic  equipment  for  the  processing  (including  digital 
compression) and storage of data, and entirely transmitted, conveyed and received by 
means of wire, radio, optical means or other electromagnetic means. This means that 
the following health services are not information society services: 

•  services provided in the physical presence of the provider and the recipient, such 
as  medical  examinations  at  a  doctor's  premises,  even  if  using  electronic 
equipment;  

•  services  which  are  not  using  online  telecommunication  services,  such  as  a 
telephone  or  telefax  medical  consultation  or  medical  call-centers  providing 
services through traditional voice telephony; 

at  the  individual  request  of  a  recipient.  Services  falling  under  the  definition  of 
information  society  service  are  those  provided  in  response  to  an  individual  request 
from  the  recipient.  Telemedicine  services  are  usually  provided  at  the  individual 
request of a recipient. Patients being treated by a doctor using telemedicine services 
(e.g. teleradiology), implicitly accept such services and this constitutes the individual 
request. 

Examples of services supplied on individual request can be found in the Vade-mecum to the 
Regulatory Transparency Directive, which include “doctors (computer medicine), etc., access 
to databases, data and file management, consultation, diagnosis etc21.“ 

The main provisions in the eCommerce Directive that apply to cross-border telemedicine are 
the following22: 

• 

• 

21 
22 

The country of origin principle. It provides that the law applicable to an eCommerce 
activity  will  be  the  law  of  the  Member  State  in  which  the  service  provider  is 
established,  i.e.  the  place  in  which  a  service  provider  effectively  pursues  an 
economic activity using a fixed establishment for an indefinite period. The Member 
States may however under certain circumstances and procedural conditions and on a 
case-by-case  basis  take  measures  to  restrict  the  provision  of  a  particular  online 
service from another Member State (Article 3 of the Directive).  

The Directive prohibits Member States from making the taking up and the pursuit of 
the activity of an information society service provider subject to prior authorisation 
or any other requirement having an equivalent effect (Article 4 (1) of the Directive). 

http://ec.europa.eu/enterprise/tris/vade9848/index_en.pdf 
This Staff Working Document does not cover the liability regime of the eCommerce Directive as the 
providers of telemedicine services are not considered "intermediaries" in the meaning of Articles 12-15 
of the Directive. 

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• 

• 

Duty  of  information  of  Information  Society  Service  (ISS)  providers.  They  have  to 
render  easily,  directly  and  permanently  accessible  to  the  recipients  of  the  service  a 
set of information, such as their identity and contact details on their website (Article 
5 of the Directive). Regulated professions have to provide additional information, for 
instance,  their  professional  body  or  registered  institution,  professional  title  and  the 
Member State where it has been granted. 

Commercial  communications.  The  ISS  provider  has  to  comply  with  some  specific 
requirements when using commercial communications for the promotion of  eHealth 
services or products (Articles 6 and 7), for instance, ensuring they are "clearly" and 
"unambiguously" identifiable as such23. Member States must ensure that members of 
regulated  professions  may  use  commercial  communications  online,  subject  to 
compliance  with  such  professional  rules  governing  the  independence,  honour  and 
dignity of the profession.24 

According  to  the  Regulatory  Transparency  Directive25,  Member  States  wishing  to  adopt  a 
regulation on telemedicine services as information society services will have to notify it to the 
Commission and to other Member States before adoption26.  

23 

24  

25 
26 

The  rules  on  unsolicited  commercial  communications  were  complemented  by  new  rules  in  Directive 
2002/58 of 12 July 2002 , recently amended by Directive 2009/136. 
The Services Directive complements the rules on online commercial communication set out in the E-
commerce  Directive.  According  to  Article  24(1)  of  Directive  2006/123  of  12  December  2006  on 
services  in  the  internal  market  (OJ  L  376/36,  27.12.2006),  Member  States  shall  remove  all  total 
prohibitions on commercial communications by the regulated professions. 
Directive 98/34/EC of 20 July 1998, OJ L 204, 21.0, 21.7.1998. 
This  requirement  seeks  to  verify  that  the  future  regulation  will  not  create  obstacles  to  the  free 
movement of information society services and to the freedom of establishment (of information society 
service providers) within the internal market. 

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3. 

KEY LEGAL ISSUES OF CROSS-BORDER TELEMEDICINE 

In  order  to  provide  telemedicine  cross-border  within  the  EU,  healthcare  professionals  first 
have to look for the responses to the following questions: 

– 

– 

– 

– 

– 

Licensing: Does the telemedicine provider also need to be licensed/registered in the 
Member State of the patient? 

Data Protection: What are the conditions for the legitimate processing of personal 
data related to health?  

Reimbursement: Will the cross-border telemedicine service be reimbursed? 

Liability: What is the liability regime applicable in case damage arises? 

Relevant jurisdiction and applicable law in case of damage: What are the relevant 
jurisdiction and the law applicable in case damage arises? 

3.1. 

Licensing/registration  of  healthcare  professionals  performing  telemedicine 
services 

Relevant provisions 

-Articles 56 and 57 of TFEU 

-Directive 2011/24/EU on the application of patients' rights in cross-border healthcare 

- Directive 2000/31/EC on electronic Commerce, hereinafter "the eCommerce Directive".  

In  most  Member  States,  the  competence  to  accredit  professionals  wishing  to  deliver  health 
services  is  delegated  to  an  appointed  licensing  or  registration  body.  Upon  being 
licensed/registered,  the  health  professional  will  have  to  abide  by  the  rules  and  regulations 
established  by  the  licensing  authority  (the  professional  body)  and  be  subject  to  disciplinary 
sanctions  in  case  of  non-observance27.  It  is  also  up  to  each  Member  State  to  decide  which 
healthcare  professionals  are  entitled 
the  kind  of 
recognition/accredition they need to do so. 

to  deliver  health  services  and 

When  healthcare  services  are  provided  by  means  of  telemedicine,  i.e.  without  the  actual 
movement of either the healthcare professional (i.e. the telemedicine provider) or the service 
recipient  (i.e.  patient  or  another  healthcare  professional),  some  questions  regarding  the 
licensing/registration of health professionals arise in cross-border scenarios. 

It is assumed that the telemedicine provider healthcare professional already complies with the 
authorization  and  registration  requirements  of  his  or  her  Member  State  of  establishment. 

27 

EN 

For an overview of Member States' accreditation mechanisms, see the 'Study on the Legal Framework 
onwards, 
for 
http://ec.europa.eu/information_society/activities/health/docs/studies/legal-fw-interop/ehealth-legal-
fmwk-final-report.pdf  

Interoperable 

Europe', 

eHealth 

page 

35 

in 

11 

   EN 

 
 
                                                 
Directive  2005/36/EC28    on  the  recognition  of  professional  qualifications  does  not  apply  to 
healthcare professionals providing cross-border telemedicine. This is clearly stated in Article 
5(2) of the Directive, which sets that the Directive is only applicable to situations where the 
service provider actually moves to the territory of a host Member State to pursue a regulated 
profession.  As  indicated  above,  telemedicine  services  are  provided  without  the  actual 
movement of the telemedicine provider health care professional. 

As  already  mentioned,  Directive  2011/24/EU  requires  that  cross-border  healthcare  is  to  be 
provided in accordance with the legislation of the Member State of treatment (Article 4(1) of 
the Directive). In the case of telemedicine, the Member State of treatment is expressly defined 
as  that  of  the  service  provider's  Member  State  of  establishment  (Article  4(1)(a)  of  the 
Directive)29. 

The  applicability  of  the  service  provider's  Member  State  of  establishment  legislation  is  also 
enshrined  in  the  eCommerce  Directive30.  In  other  words,  if  the  service  provider  (here  the 
healthcare professional) complies with the legislation applicable to the taking up and exercise 
of an information society service in his Member State of establishment, he will in principle be 
free  to  provide  its  services  in  other  Member  States  (Article  3(1)  and  3(2)  of  Directive 
2000/31/EC). This is known as the 'country-of-origin principle'.  

Case study 

In January 2014, an innovative eye care centre in Country A explores the opportunity to 
invest  in  a  state-of-the-art  teleophtalmology  system,  capable  of  providing  services  at 
distance  nationally  and  across  borders.  Healthcare  professionals  in  the  centre  are 
particularly  interested  in  expanding  their  services  to  patients  living  in  border  regions  in 
Country B and Country C, offering them the comfort of remote eye care from home. 

Prior to purchasing the necessary equipment, the healthcare professionals from Country A 
seek relevant information concerning the conditions they need to comply with in order to 
be entitled to treat patients in other EU Member States and, if applicable, the requirements 
for professional recognition of their credentials.  

It should first of all be noted that the professionals from Country A will continue exercising 
their  activity  there  and  will  propose  health  services  in  Country  B  and  Country  C  from 
Country  A,  without  physically  moving  to  either  of  those  countries.  The  provisions  of 
Directive  2005/36  on  the  recognition  of  professional  qualifications  are  therefore  not 
applicable. 

However,  Article  4(1)  of  Directive  2011/24/EU  applies.  It  provides  that  cross-border 
healthcare be provided in accordance with the legislation of the Member State of treatment, 
which  in  the  case  of  telemedicine  is  that  of  the  service  provider's  Member  State  of 
establishment. 

This  means  that  the  healthcare  professionals  of  Country  A  should  only  comply  with  the 

28 

29 

30 

Directive  2005/36/EC  of  the  European  Parliament  and  of  the  Council  of  7  September  2005  on  the 
recognition of professional qualifications, OJ 30.09.2005 L 255/22. This Directive only covers health 
professionals that fall within the category of the regulated professions.  
As  expressly  defined  by  Article  3d):  "In  the  case  of  telemedicine,  healthcare  is  considered  to  be 
provided in the Member State where the healthcare provider is established". 
As  stated  in  Directive  2011/24/EU  on  the  application  of  patients'  rights  in  cross-border  healthcare 
(Article 2(e)), this Directive does not prejudice to the application of the eCommerce Directive. 

EN 

12 

   EN 

 
                                                 
existing accreditation and legal requirements existing in Country A to perform telemedicine. 

As  the  telemedicine  services  at  stake  fall  within  the  definition  of  an  information  society 
service,  the  healthcare  professionals  from  Country  A  would  also  have  to  comply  with  the 
national  provisions  applicable  in  Country  A  for  the  provision  of  an  information  society 
service.  

3.2. 

Conditions for legal processing of health data  

Relevant provisions 

- Article 16(1) TFEU, Article 8 of the EU Charter of Fundamental Rights and Article 8 of the 
European Convention on Human Rights (“ECHR”) 

-  Directive  95/46/EC  on  the  protection  of  individuals  with  regard  to  the  processing  of 
personal data and on the free movement of such data 

-  Directive  2002/58/EC  concerning  the  processing  of  personal  data  and  the  protection  of 
privacy in the electronic communications sector  

- Directive 2011/24/EU on the application of patients' rights in cross-border healthcare 

A  significant  aspect  of  the  cross-border  provision  of  telemedicine  services  provided  by  a 
healthcare  professional  is  the  legitimate  processing  of  personal  data  and  the  respect  for  the 
fundamental  right  to  the  protection  of  personal  data.  Telemedicine  by  its  nature  involves 
personal data processing through the generation and/or transmission of personal data related 
to health. 

Since the entry into force of the Treaty on the Functioning of the EU (TFEU), the EU Charter 
of Fundamental Rights has become legally binding, and Article 8 of the Charter guaranteeing 
the  fundamental  right  to  the  protection  of  personal  data  is  now  enshrined  in  Article  16(1) 
TFEU.  

3.2.1.  General Data Protection rules 
Directive 95/46/EC31 is the general EU law on the protection of personal data, which sets the 
rights of data subjects and establishes criteria for the legitimacy of processing personal data, 
including "personal data on health"32. Directive 95/46/EC is currently under review33 with the 
aim  to  modernise  and  clarify  the  EU  legal  system  for  the  protection  of  personal  data, 
strengthen  individuals'  rights,  while  at  the  same  time  reducing  administrative  formalities  to 
ensure a free flow of personal data within the EU and beyond. 

31 

32 

33  

OJ L 281, 23.11.1995, p. 31. It is currently under revision, see 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  
Directive 95/46/EC has been elaborated on the European Standards EN 14484:2003 “Health informatics 
– International transfer of personal health data covered by the EU data protection directive – High level 
security policy” and EN 14485:2003 “Health informatics – Guidance for handling personal health data 
in  international  applications  in  the  context  of  the  EU  data  protection  directive”.  These  standards  are 
currently under revision. 
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 (General Data Protection Regulation), COM(2012) 
11, http://ec.europa.eu/justice/data-protection/document/review2012/com_2012_11_en.pdf 

EN 

13 

   EN 

 
                                                 
As  regard  to  its  scope  of  application,  Directive  95/46/EC  establishes  that  "personal  data" 
means  any  information  related  to  an  identified  or  identifiable  natural  person  (the  "data 
subject"; Article 2 a) of the Directive). An identifiable person is one who can be identified, 
directly or indirectly, in particular by reference to an identification number or to one or more 
factors specific to his physical, physiological, mental, economic, cultural or social identity34 
This includes the processing of sound and image data. 

"Processing of personal data" means any operation or set of operations, which is performed 
upon  personal  data,  whether  or  not  by  automatic  means,  such  as  collection,  recording, 
organization,  storage,  adaptation  or  alteration,  retrieval,  consultation,  use,  disclosure  by 
transmission,  dissemination  or  otherwise  making  available,  alignment  or  combination, 
blocking,  erasure  or  destruction  (Article  2  b)  of  the  Directive).  This  may  include  the 
processing of sound and image data. 

Data protection rules are applicable not only when the data controller is established within the 
EU,  but,  whenever  the  data  controller  uses  equipment  situated  within  the  EU  in  order  to 
process  data  (Article  4  of  the  Directive).  Data  controllers  from  outside  the  EU,  processing 
data in the EU, are therefore obliged to follow European data protection rules in such cases.  

Special protection for personal data related to health  

According  to  Directive  95/46/EC  the  processing  of  personal  data  related  to  health  is 
prohibited unless certain conditions are fulfilled (Article 8 of the Directive). According to the 
European  Court  of  Justice,  the  notion  of  "data  concerning  health"  must  be  given  a  wide 
interpretation, so as to include information concerning all aspects, both physical and mental, 
of an individual's health35. The Article 29 Data Protection Working Party36 provided further 
interpretation of this concept   by recommending that health data should cover: 

• 

• 

any personal data closely linked to the health status of a person only, such as genetic 
data or data on consumption of medicinal products, alcohol or drugs. 

any other data contained in the medical documentation concerning the treatment of a 
patient – including administrative data (social security number, date of admission to 
hospital,  etc.).  Any data that is not relevant for the treatment of the patient, should 
not be included in the medical file37.  

Derogation  from  the  prohibition  of  processing  health  data  is  granted  under  very  specific 
circumstances.  Limited  exemptions  to  this  prohibition  principle  are  laid  down  in  the 
Directive,  in  particular  if  processing  is  required  for  specified  medical  and  healthcare 
purposes. The general prohibition of processing such personal data does not apply where: 

• 

34 

35 
36 
37 

the data subject has given his explicit consent to the processing; 

on 

Data 

Party 

Further  clarifications  and  examples  can  be  found  in  “Opinion  4/2007  (WP  136)  of  the  Article  29 
Working 
data” 
of 
(http://ec.europa.eu/justice_home/fsj/privacy/docs/wpdocs/2007/wp136_en.pdf ). 
European Court of Justice, Judgment of 6 November 2003, Case C-101/01 - Bodil Lindqvist, 50 and 51. 
This group was created by Article 29 of Directive 95/46/EC. 
See Article 29 Data Protection Working Party working document on Electronic Health Records of 15 
February 2007.  

Protection 

personal 

concept 

the 

on 

EN 

14 

   EN 

 
                                                 
• 

• 

processing is necessary to protect the vital interests of the data subject or of another 
person where the data subject is physically or legally incapable of giving his consent; 

where  processing  of  the  data  is  required  for  the  purposes  of  preventive  medicine, 
medical diagnosis, the provision of care or treatment or  the  management of health-
care  services,  and  where  those  data  are  processed  by  a  health  professional  subject 
under national law or rules established by national competent bodies to the obligation 
of professional secrecy or by another person also subject to an equivalent obligation 
of secrecy (Article 8(3) of the Directive). 

Member  States  are  allowed  to  derogate  further  from  the  prohibition  of  processing  sensitive 
categories of data, for reasons of substantial public interest in areas such as public health and 
social security (Article 8(4) of the Directive). Any such measure must be proportionate, i.e. 
there must not be other less infringing measures available. 

General principles for the processing of personal data 

The processing of personal data related to health must comply with the following general data 
protection principles established by legislation. Some of the key principles are outlined in the 
following summarised table: 

Personal data must: 

Data controllers must: 

– 

– 

– 

only  be  collected  for  specific, 
explicit  and  legitimate  purposes 
and  not  be  kept  for  longer  than 
necessary (Article 6(1)(b)). Further 
processing  of  data  for  historical, 
statistical  or  scientific  purposes 
as 
shall 
that 
incompatible 
Member States provide appropriate 
safeguards; 

considered 

provided 

not 

be 

be  limited  to  the  relevant  data  for 
the  specific  purposes 
they  are 
intended to fulfil, e.g. by obtaining 
appropriate  contractual  or  other 
commitments  from  the  entities  in 
the third countries (Article 6(1)(c)) 

to 

only  be 
third 
transferred 
countries  outside  the  EU/EEA  if 
they  guarantee  an  “adequate”  level 
of  protection38.  Where  a  non-EU 
an 
country  does  not 

ensure 

– 

– 

– 

provide  certain  information  to  data 
subjects  on  the  identity  of  the 
controller  and  recipients  of  data, 
the purposes of the processing, and 
the  existence  of  a  right  of  access 
(Articles 10 and 11) 

allow  data  subjects  access  to  their 
personal data  

data 

personal 

technical 
implement  appropriate 
to 
and  organisational  measures 
protect 
against 
accidental  or  unlawful  destruction 
or  unauthorised  disclosure.  Such 
measures  shall  ensure  a  level  of 
security  appropriate  to  the  risks 
represented  by  the  processing  and 
the  nature  of 
to  be 
protected (Article 17) 

the  data 

– 

under  specific  conditions,  comply 
with European data protection rules 

38 

The Council and the European Parliament have given the Commission the power to determine, on the 
basis  of  Article  25(6)  of  Directive  95/46/EC  whether  a  third  country  ensures  an  adequate  level  of 
protection  by  reason  of  its  domestic  law  or  of  the  international  commitments  it  has  entered  into.  
See  Commission  decisions  on  the  adequacy  of  the  protection  of  personal  data  in  third  countries:  
http://ec.europa.eu/justice/policies/privacy/thridcountries/index_en.htm  

EN 

15 

   EN 

 
                                                 
adequate  level  of  protection,  the 
transfer  of  personal  data  is  only 
allowed  under  certain  conditions 
(Article 26).  

even  when  they  are  based  outside 
the EU (Article 4).  

Case study 

Patient X, affiliated to the Country A social security system, suffers from chronic gall 
bladder  problems.  The  treating  healthcare  provider  in  Country  A  puts  the  patient  in 
touch with a surgical centre of excellence specialising in digestive systems in Country 
B.  A  well-renowned  healthcare  professional  based  in  Country  B  would  be  able  to 
operate  on  Patient  X  through  telesurgery.  A  series  of  medical  tests  and  important 
health-related patient data are requested by the Country B based operating doctor. The 
key  sensitive  medical  information  is  therefore  to  be  transferred  electronically  across 
borders  between  Country  A  and  Country  B.  The  health  data  first  have  to  be  processed 
according to the law of Country A as the data controller is a healthcare provider from that 
country.  The  latter  will  have  to  ensure  that  the  processing  was  legitimate  according  to 
Article  8  of  the  Data  Protection  Directive  95/46/EC  and  the  Country  A  law  transposing 
the Data Protection Directive.  

Once  the  health  data  of  the  patient  are  transferred  to  Country  B,  any  further  processing 
must  comply  with  the  law  of  that  Country  (e.g.  legitimate  grounds  for  processing, 
information to data subject, access to data, security requirements, etc.). 

3.2.2.  The data protection reform 

EU pilot projects such as EpSOS have shown that current practices regarding the assessment 
of  lawfulness,  proportionality  and  required  level  of  security  for  such  health  data  vary  a  lot 
across the Union, due to the margins of manover left to the discretion of Member States when 
implementing Directive 95/46/EC. It has shown that this is one of the many factors limiting 
innovation in the eHealth sector. 

By  providing  one  single  set  of  rules  and  for  a  consistency  mechanism  involving  the  data 
protection  authorities  in  charge  of  ensuring  a  consistent  application  of  the  Regulation,  the 
proposed Data Protection Regulation presented by the Commission on 25 January 2012 will 
facilitate the cross border exchange of health data while preserving a high level of protection.   

3.2.3.  Other data protection rules 
Directive  2002/58/EC  (as  lastly  amended  by  Directive  2009/13639)  lays  down  specific 
the  provision  of  publicly  available  electronic 
requirements 
communications  services  in  public  communications  networks    to  ensure  confidentiality  of 
communications  and  security  of  their  networks.  One  important  obligation  is  their  duty  to 
notify personal data breaches to the competent national authority.40  

in  connection  with 

According to the Directive on the application of patients' rights in cross-border healthcare the 
Member State of treatment must ensure that the fundamental right to privacy with respect to 

39 
40 

OJ L 201, 31.7.2002, p. 37. and OJ L 88, 4.4.2011, p. 45–65 
See Articles 5 and 4(3) of Directive 2002/58/EC 

EN 

16 

   EN 

 
 
                                                 
the  processing  of  personal  data  is  protected  in  conformity  with  national  measures 
implementing  Union  provisions  on  the  protection  of  personal  data,  in  particular  Directives 
95/46/EC and 2002/58/EC.  

This means that these rules should also be respected with regard to patients' medical invoices 
and health records. 

Patients  who  have 
through 
telemedicine)  are  entitled  to  a  written  or  electronic  medical  record  of  such  treatment,  and 
access to at least a copy of this (See Articles 4(f) and 5(d) of Directive 2011/24/EU). 

received  cross-border  healthcare 

(including 

treatment 

3.3. 

Reimbursement  

Relevant provisions 

- Directive 2011/24/EU on the application of patients' rights in cross-border healthcare 

When  providing  cross-border  telemedicine  services,  it  is  essential  to  determine  whether  the 
patient being treated is entitled to reimbursement for the services received.  

EU  legal  provisions  come  into  play  in  cases  of  cross-border  provision  of  telemedicine 
services.  Two  different  and  alternative  mechanisms  for  reimbursement  of  cross-border 
healthcare are in place at EU level: 

• 

• 

Regulation  (EC)  No  883/2004  on  the  coordination  of  social  security  systems41. 
However, this is not applicable to telemedicine services as it expressly requires the 
physical  presence  of  the  patient  in  the  Member  State  of  treatment  (the  one  of  the 
healthcare provider);42  

the other mechanism is provided for in the Directive on the application of patients' 
rights in cross-border healthcare43, which covers telemedicine within its scope. 

The Directive on the application of patients' rights in cross-border healthcare sets as a general 
rule  that  the  Member  State  of  affiliation  shall  ensure  that  the  costs  incurred  by  any  insured 
person  receiving  cross-border  healthcare  are  reimbursed,  if  the  healthcare  in  question  is 
among the benefits to which the insured person is entitled in the Member State of affiliation 
(Article 7(1) of the Directive).  

The Directive makes it clear that cross-border healthcare services using eHealth services44 are 
also to be reimbursed (Recital 26 of the Directive).  

41 

42 
43 

44 

Regulation (EC) No 883/2004 of the European Parliament and of the Council of 29 April 2004 on the 
coordination of social security systems - OJ L 166, 30.4.2004, p. 1. 
See Article 20 of Regulation (EC) No 883/2004 
See  Article  3  (d)  of  Directive  2011/24/EU  on  the  application  of  patients'  rights  in  cross-border 
healthcare. 
e-Health tools or solutions include products, systems and services that go beyond simply Internet-based 
applications.  They  include  tools  for  both  health  authorities  and  professionals  as  well  as  personalised 
health  systems  for  patients  and  citizens.  Examples  include  health  information  networks,  electronic 
health  records,  telemedicine  services,  personal  wearable  and  portable  communicable  systems,  health 
portals,  and  many  other  information  and  communication  technology-based  tools  assisting  prevention, 
diagnosis, treatment, health monitoring, and lifestyle management. 

EN 

17 

   EN 

 
                                                 
It also provides that the Member State of affiliation may impose on an insured person seeking 
reimbursement of the costs of cross-border healthcare, including healthcare received through 
the  use  of  telemedicine,  the  same  conditions,  criteria  of  eligibility  and  regulatory  and 
administrative formalities as it would impose if this healthcare were provided on its territory 
(Article 7(7) of the Directive). 

Therefore  a  patient  receiving  a  telemedicine  service  from  a  healthcare  provider  located  in 
another  Member  State  should,  in  principle,  be  reimbursed  for  the  costs  incurred.  However, 
such reimbursement shall only take place provided that the telemedicine service falls within 
the  range  of  healthcare  services  to  which  citizens  are  entitled  in  the  Member  State  of 
affiliation45. 

The service will be reimbursed up to the same level as a telemedicine service in the Member 
State  of  affiliation.  In  the  case  of  health  systems  which  do  not  operate  on  the  basis  of 
reimbursement directly to the patient and do not therefore have reimbursement tariffs which 
they  use  within  their  own  system,  the  patient  is  entitled  to  be  reimbursed  up  to  the  amount 
paid for that service by the institution responsible for meeting the costs of healthcare. Member 
States  will  also  have  to  have  a  transparent  mechanism  for  the  calculation  of  costs  of  cross-
border healthcare that are to be reimbursed to the insured person. 

Reimbursement of cross-border healthcare, cannot, as a rule, be subject to prior authorisation 
(Article  7(8)  of  the  Directive).  However,  Member  States  may  introduce  a  system  of  prior 
authorisation only for certains types of healthcare and under strict conditions (Article 8(2) of 
Directive); such as planning requirements and the use of highly specialised and cost-intensive 
medical  infrastructure  or  medical  equipment.  Such  a  system  should  be  restricted  to  what  is 
necessary and proportionate to the objective to be achieved. Member States should notify to 
the  European  Commission  of  the  set-up  of  a  prior  authorisation  system  and  make  publicly 
available which healthcare is subject to such system. 

The  Directive  also  limits  the  conditions  under  which  the  Member  State  of  affiliation  may 
refuse to grant prior authorisation to an insured person (Article 8(6) of the Directive).  

Case study 

Further to an acute admission for decompensated heart failure on January 1, 2014, patient 
X  from  Country  A  is  referred  by  his  secondary  care  provider  in  Country  A  to  telehealth 
services offered to patients who suffer heart failure by a hospital in Country B. Patient X 
would  benefit  from  this  type  of  supporting  technology,  as  it  would  encourage  better  self-
management of his condition and adherence to the prescribed medications.  

Though telehealth services of this kind are recognised as valid medical acts in Country A, 
no facilities are available locally to offer the service. This is due to a shortage of nursing 
staff  at  the  Country  A  hospital  where  Patient  X  was  initially  treated.  Other  Country  A-
based healthcare centres providing same telehealth services operate at the local level only, 
and thus have no capacity to include Patient X in their schemes.  

After meeting the indicated specialist doctor in Country B, the patient requests to have the 

45 

As previously mentioned, Member States have the primary responsibility to define their health policy 
and  the  organisation  and delivery  of health services.  This includes  the  competence  to  decide whether 
telemedicine  can  be  reimbursed,  what  telemedicine  acts  to  reimburse,  as  well  as  the  level  of 
reimbursement.  

EN 

18 

   EN 

 
                                                 
necessary equipment installed at home. In order to do so, patient X is faced with upfront 
out-of-pocket  costs  directly  requested  by  the  treating  centre  in  Country  B.  Prior  to 
concluding  the  agreement,  patient  X  therefore  seeks  information  concerning  his 
entitlement  to  reimbursement  and  the  applicable  conditions  attached  from  his  social 
security scheme. 

According to Directive 2011/24/EU, patients are entlitled to be reimbursed by their Member 
State of affiliation, for the healthcare received in another EU Member State, if the healthcare 
in question is among the benefits to which the insured person is entitled in his home country.  

If  these  conditions  are  met,  Patient  X  should  therefore  have  his  costs  related  to  the 
telemedicine service in Country B reimbursed by his healthcare system46. 

3.4. 

Liability issues and product safety 

Relevant provisions 

-  Directive  85/374/EEC  on  liability  for  defective  products  as  amended  by  Directive 
1999/34/EC, hereinafter "the defective products Directive" 

-  Directive  2011/24/EU  on  the  application  of  patients'  rights  in  cross-border  healthcare, 
hereinafter "the cross-border healthcare Directive" 

- Directive 90/385/EEC on active implantable medical devices and Directive 93/42/EEC on 
medical devices and Directive 98/79/EC on in vitro diagnostic medical devices  

-  Regulation  593/2008  on  the  law  applicable  to  contractual  obligations  (Rome  I)  and 
Regulation 864/2007 on the law applicable to non-contractual obligations (Rome II) 

When  damage  occurs  in  the  provision  of  a  cross-border  telemedicine  act,  it  is  first  of  all 
necessary  to  determine  who  should  be  held  liable.  This  may  prove  complex,  due  to  the 
potentially large number of actors involved (e.g. nurses, health informaticians, doctors, etc.). 
Several types of liability might also come into play depending on the source of the problem.  

Liability can be of a professional nature (medical) or of a defective product.  

Also,  depending  on  the  existence  or  not  of  a  contractual  relationship  between  the  damaged 
person  and  the  person  responsible  for  the  damage,  a  case  of  contractual  liability  or  tort 
liability could arise47. 

EU legislation only harmonises rules related to liability for defective products. EU legislation 
determines, however, which law is applicable to the liability of the different actors involved. 
Indeed,  the  law  applicable  will  determine  the  basis  and  extent  of  liability,  the  level  of 
compensation  and  the  nature  and  assessment  of  damage/problem.  For  more  details  on  the 
determination of the law applicable see Section 3.5.2. 

46 

47 

However,  Member  States  can  set-up  a  prior  authorisation  system  for  a specific healthcare  act  in very 
limited cases enshrined in the Directive. It must be notified to the Commission, and information on such 
a system should be made publicly available.  
Vicarious liability could also come into play, i.e. when a person is held responsible for another person's 
damage. 

EN 

19 

   EN 

 
 
                                                                                                                                                         
The newly adopted Directive on Consumer Rights48 (which repeals Directive 97/7/EC on the 
protection  of  consumers  in  respect  of  distance  contracts  as  of  13  June  2014)  expressly 
excludes healthcare from its scope. It is thus not covered by this paper.  

3.4.1.  Health professional liability 

Medical liability is regulated at the Member State level and the complexity and diversity in 
liability rules in the Member States regarding the provision of healthcare are considerable.  

Most  of  the  Member  States  apply  their  general  liability  regime  in  case  of  medical  errors  or 
negligence in providing healthcare. A few of them, however, have introduced specific liability 
rules to increase protection for patients49. Medical liability can take various forms, depending 
on the provisions existing at Member State level. One must distinguish between the following 
types of liability regime: 

• 

• 

• 

contractual or delictual liability; 

criminal, civil or administrative liability; 

faultless liability (also known as "strict liability") or liability with fault.  

Nevertheless,  the  Directive  on  the  application  of  patients'  rights  in  cross-border  healthcare 
contains some provisions, which are helpful to shed some light on the cross-border liability 
for healthcare services, albeit not solving the issue completely. 

The  legislation  of  the  Member  State  of  treatment  should  apply  as  a  rule  to  the  provision  of 
cross-border  telemedicine  services  to  patients  (Article  4(1)  of  the  Directive).  For 
telemedicine,  the  Member  State  of  treatment  is  the  Member  State  in  which  the  service 
provider is established (Article 3(d) of the Directive). 

Member States have the duty to put in place systems of professional liability insurance or a 
guarantee  or  similar  arrangement  that  is  equivalent  or  essentially  comparable  as  regards  its 
purpose  and  which  is  appropriate  to  the  nature  and  the  extent  of  the  risk  for  treatment 
provided  on  their  territory,  including  cross-border  healthcare  (Article  4(2)(d)  of  the 
Directive).  

Transparent  complaint  procedures  for  the  patient  suffering  harm  from  the  services  they 
receive must be in place, in accordance with the legislation of the Member State of treatment 
(Article 4(2)(c) of the Directive).  

The determination of responsibilities between several healthcare professionals involved in the 
provision of a telemedicine act (e.g. a second opinion doctor) should be facilitated by the duty 
of  the  Member  State  of  treatment  to  ensure  that  cross-border  patients  receive  a  written  or 
electronic  medical  record  of  the  treatment  received  (Article  4(2)(f)  of  the  Directive).  The 

48  

49 

Directive  2011/83/EC  on  consumers 
lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2011:304:0064:0088:EN:PDF 
For  an  overview  of  Member  States  liability  rules  relating  to  damages  rising  from  the  provision  of 
healthcare, see 'Study on the Legal Framework for Interoperable eHealth in Europe', page 41 onwards, 
http://ec.europa.eu/information_society/activities/health/docs/studies/legal-fw-interop/ehealth-legal-
fmwk-final-report.pdf 

rights,  OJ  L  304,  22.11.2011,  p.  64,  http://eur-

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written account of the treatment, which could constitute evidence in Court, should detail how 
and by whom the patient was treated. 

Patients planning to receive healthcare in another Member State should receive the following 
relevant information (Articles 4 and 6 of the Directive): 

• 

• 

from  the  national  contact  point  of  the  Member  State  of  treatment,  upon  request, 
relevant information on the standards and guidelines on quality and safety50; 

from  healthcare  providers,  relevant  information  to  help  individual  patients  to  make 
an informed choice: 

•  on treatment options;  

•  on  the  availability,  quality  and  safety  of  the  healthcare  they  provide  in  the 

Member State of treatment; 

•  clear  invoices  and  clear  information  on  prices,  on  the  healthcare  professional's 
authorisation  or  registration  status,  their  insurance  cover  or  other  means  of 
personal or collective protection with regard to professional liability.  

The reception or lack of such information could also have a role to play in the determination 
of possible liability of the actors involved in the provision of a cross-border telemedicine act. 

Case study 

Further  to  a  persistent  cough,  patient  X,  whom  is  affiliated  to  Country  A  social  security 
scheme,  is  asked  by  his  general  practitioner  in  his  Member  State  to  undergo  chest  x-ray 
tests.  However  the  hospital  in  Country  A  where  the  x-rays  were  taken  has  no  lung 
teleradiologist specialist on site to interpret the results. Using electronic means, images are 
thus sent to a teleradiologist established in a hospital in Country B, with whom the Country 
A  hospital  has  a  contractual  relationship  for  the  provision  of  such  type  of  teleradiology 
services. The specialist in Country B is asked to deliver a medical opinion on the x-rays to 
support the medical doctor in Country A in his diagnosis of the patient's conditions.  

The  teleradiologist  in  Country  B  provides  a  consultation  falling  short  of  the  expected 
medical  standard,  resulting  in  an  incorrect  diagnosis.  This  negatively  impacts  on  the 
treatment decision prescribed by the treating doctor in Country A. Besides not addressing 
the patient's cough, the treatment provokes a worsening of the patient's conditions, raising 
an issue of medical negligence.  

The  telemedicine  service  is  provided  across-border  between  two  healthcare  professionals 
located  in  two  different  EU  Member  States,  which  are  bound  by  an  established  contractual 
relationship.  The  patient  only  has  a  contractual  relationship  with  his  healthcare  provider  in 
Country A. There is no contractual relationship between the patient and the teleradiologist in 
Country B. 

50 

Such  information  must  include  information  "on  supervision  and  assessment  of  healthcare  providers, 
information  on  which  healthcare  providers  are  subject  to  these  standards  and  guidelines  and 
information  on  the  accessibility  of  hospitals  for  persons  with  disabilities"-  (Article  4(2)(a)  of  the 
Directive) 

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Liability action against doctor in Country A introduced by patient X in Country A 

As  the  patient  and  his  doctor  have  their  residence  in  Country  A,there  is  no  cross-border 
situation. Therefore, the  Courts of Country A are competent and the law of this country will 
also apply. 

Liability action introduced by patient X against Country B teleradiologist 

As there is no contract binding patient X and the radiologist from country B, patient will have 
the  option  of  suing  in  the  MS  of  domicile  of  the  teleradiologist  (Article  2  of  Brussels  I 
Regulation),  namely  country  B,  or  in  the  patient's  Member  State  of  residence,  which  is  the 
one  where  the  harmful  event  occurred  (Article  5.3  of  Brussels  I  Regulation).  This  means 
either where the negligence took place or where it caused harm, i.e. where it was acted on, 
namely  country  A.  Whereas  the  law  applicable  will  be  the  law  of  the  country  where  the 
damage occurred (Article 4.1 Rome II Regulation). 

3.4.2. 

Safety and performance of products and product liability 

The provision of a telemedicine service is often made possible thanks to the use of a medical 
device51. 

To  the  extent  that  a  telemedicine  system  falls within the definition of  an active implantable 
medical device or of a medical device or of an in vitro diagnostic medical device as laid down 
in  Directive  90/385/EEC  or  Directive  98/79/EC52,  respectively,  the  product  must  be  in 
conformity with the legal requirements set out in those directives. The directives mainly lay 
down the essential requirements on safety and performance of medical devices to ensure the 
protection of the health and safety of patients, users in relation to the use of medical devices53. 

Liability  for  defective  products  is  regulated  at  EU  level  by  Directive  85/374/EEC54,  which 
applies to any product manufactured in or imported into the European market.  

This Directive aims at ensuring a high level of consumer protection against damage caused to 
health or property by a defective product55. It introduces the principle of objective liability or 
faultless  liability  of  the  producer  or  the  importer,  and  if  no  producer  or  importer  can  be 
identified of the supplier.  

51 

52 

53 

54 

55 

Here are some examples of telemedicine products: 
-Patient monitoring devices measuring vital signals such as ECG, heart rate, breathing etc. 
-Telemonitoring devices transmitting data between patients and doctors 
-Components  of  communication  infrastructure  facilitating  the  transfer  of  data  (e.g.  digital  images) 
between health centres. 
Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States 
relating  to  active  implantable  medical  devices,  Official  Journal  L  189  ,  20/07/1990  P.  0017  –  0036; 
Council  Directive  93/42/EEC  of  14  June  1993  concerning  medical  devices,  Official  Journal  L  169  , 
12/07/1993  P.  0001  –  0043;  Directive  98/79/EC  of  27  October  1998  on  in  vitro  diagnostic  medical 
devices, Official Journal L 331 , 07/12/1998 P. 0001 - 0037 
Guidance  on  stand  alone  software  used  in  healthcare  within  the  regulatory  framework  of  medical 
devices 
http://ec.europa.eu/health/medical-
been 
devices/files/meddev/2_1_6_ol_en.pdf . 
Directive  85/374/EEC  on  liability  for  defective  products  as  amended  by  Directive  1999/34/EC  ("the 
defective products Directive") 
Pursuant to Article 6 of the Directive, a product is deemed defective when it does not provide the safety 
which a person is entitled to expect. 

published, 

recently 

has 

see 

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The producer will be held liable and has to pay compensation for damages resulting from a 
defect caused to persons or properties.  

If more than one person is liable for the same damage, joint liability is applicable. This means 
that the injured patient can claim full compensation for the damage from any one of the liable 
persons.  

This  also  means  that  the  injured  person  does  not  have  to  prove  the  existence  of  a  fault  or 
negligence; he needs to prove that damage arose, that a defect in the product exists and that 
there is a causal relationship between defect and damage.  

For instance, if a diabetic patient were to be harmed by a defective medical device providing 
the wrong quantity of insulin in his body, he could sue the producer of such device and would 
have  to  demonstrate  the  harm  to  his  health  and  the  causal  link  with  the  proven  defective 
device. 

The  liability  of  the  producer  can  only  be  excluded  or  reduced  under  certain  circumstances 
enumerated by the Directive (Articles 7 and 8). Moreover, the consumer has three years time 
to introduce an action in court from the moment he becomes aware of the damage, the defect 
and  the  identity  of  the  producer.  Additionally,  the  consumer's  right  to  recover  damages  is 
limited to ten years after the producer has put the product into circulation. 

This  "objective  liability"  scheme  is  of  course  without  prejudice  of  the  rights  the  injured 
patient may have according to the rules of the law of contractual or non contractial liability.  

Case study 

telemonitoring  system.  Due 

Patient  X  is  a  citizen  of  Country  A  and  has  undergone  partial  knee  replacement  in  a 
specialised centre of excellence in Country B. Prior to his return to Country A, the patient 
is  provided  with  a  patient-controlled  analgesia  infusion  pump  and  is  offered  to  receive 
follow-up  consultations  through  the  treating  hospital's  Department  of  Orthopedic 
Surgery's 
to  severe  post-operative  pain,  during  a 
telemonitoring  consultation  session  between  patient  X  in  Country  A  and  his  treating 
doctor in Country B, patient X is prescribed the use of the pump. The patient is expected 
to  be  monitored  for  the  following  24  hours  as  to  ensure  proper  use  of  the  device.  A 
software  defect,  however,  causes  the  preprogrammed  analgesic  ceiling  meant  to  avoid 
intoxication  to  malfunction.  This  results  in  hazardous  respiratory  depression  for  the 
patient,  who  is  urgently  hospitalised.  After  some  research,  the  software  is  proven  to  be 
produced by a producer in Country B. 

Patient X will be able to sue the producer of the defective software on the basis of Directive 
85/374/EECon liability for defective products, which provides for a faultless liability. The 
patient will have to prove the defect and the causal link between the harm caused and the 
defective product. 

The  competent  court  and  the  applicable  law  will  have  to  be  determined  according  to  the 
Regulations  on Brussels I and Rome I, Rome II (see Section  3.5 of this document). If  the 
pump is CE marked as a medical device, the national authorities could decide to withdraw 
the  defective  product  from  the  market  based  on  the  national  provisions  implementing  the 

EN 

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Medical Devices Directive (i.e. Directive 93/42/EEC). 

3.5. 

Court litigation/court proceedings 

Relevant provisions 

-Council  Regulation  (EC)  No  44/2001  of  22  December  2000  on  jurisdiction  and  the 
recognition  and  enforcement  of  judgments  in  civil  and  commercial  matters,  hereinafter 
"Brussels I Regulation" 

-Regulation  (EC)  No  593/2008  of  the  European  Parliament  and  of  the  Council  of  17  June 
2008 on the law applicable to contractual obligations, hereinafter "Rome I Regulation" 

-Regulation  (EC)  No  864/2007  of  the  European  Parliament  and  of  the  Council  of  11  July 
2007 on the law applicable to non-contractual obligations, hereinafter "Rome II Regulation" 

3.5.1.  Determining the competent jurisdiction 

In the exercise and delivery of cross-border telemedicine services, it is essential that the actors 
involved  determine  in  which  Member  State  and  in  particular  before  which  jurisdiction  they 
can sue or be sued, in case problems occur.  

For civil and commercial matters, the rules determining the competent jurisdiction in a cross-
border situation are enshrined in Regulation (EC) No 44/2001.  

Parties can designate which court should be competent to resolve a possible conflict arising 
between them (Article 23 of the Regulation)56.This agreement must be in writing. However, 
with  the  view  to  protect  consumers,  the  possibility  for  such  a  designation  in  the  case  of  a 
consumer/ professional contractual relationship is limited (Article 17 of the Regulation). 

If parties have not contractually defined the court of their choice, as a general rule jurisdiction 
is  to  be  exercised  in  the  Member  State  in  which  the  defendant  is  domiciled,  regardless  of 
his/her nationality57.  

However, in certain circumstances a defendant may be sued in the courts of another Member 
State.  This  is  the  case  for  instance  in  matters  involving  a  contractual  relationship  or  a  non-
contractual relationship (liability for wrongful acts): 

• 

In  matters  involving  a  non-contractual  relationship,  the  competent  courts  are  the 
courts of the place where the harmful event occurred or may occur (Article 5(3) of 
the Regulation). According to case law, this includes the place where either the act 
causing  harm  or  the  direct  damage  occurs;  cases  of  consequential  damage  are 
therefore  not  covered.  In  a  cross-border  telemedicine  scenario,  it  can  be  assumed 
that: 

•  the place where the act causing the damage occurs is located in the Member State 

where the professional is when delivering the service, and; 

56 
57 

This is subject to what is said below in relation to consumer contracts,  
See Article 2 of Regulation 44/2001 

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•  the  place  where  the  damage  arises  is  located  in  the  Member  State  where  the 

patient was when he received the medical advice or treatment.  

• 

In  matters  involving  a  contractual  relationship,  one  must  distinguish  between  (1) 
telemedicine  scenarios 
to 
involving  professionals  only, 
professional relationship and (2) telemedicine scenarios involving a professional and 
a patient, i.e. a professional to consumer relationship58: 

i.e.  a  professional 

•  Contract  between  professionals  only:  the  competent  courts  are  the  courts  in  the 
Member State where, under the contract, the services were provided or should be 
provided (Article 5(1)(b) of the Regulation)59.  

•  Professional to consumer contract:  

(a) 

if  the  professional's  activity  is  "directed  to  the  Member  State  of  the 
consumer's  domicile  or  to  several  States  including  that  Member  State", 
the consumer has a choice: he may sue either in the Member State where 
the other party is domiciled or in the Member State where he is himself 
domiciled  (Article  15(1)(c)  in  conjunction  with  Article  16  of  the 
Regulation).  

In  the  rulings  Alpenhof  and  Pammer60,  the  European  Court  of  Justice 
clarified the notion of "directed activities" in the context of the internet. 
To  determine  whether  a  trader's  website  is  ‘directing’  its  activity  to  the 
Member  State  of  the  consumer’s  domicile,  it  should  be  ascertained 
whether, before the conclusion of any contract, it was apparent from the 
website and the trader’s overall activity that he was foreseeing business 
opportunities  in  that  Member  State61.  On  the  other  hand,  "the  mere 
accessibility of the trader’s or the intermediary’s website in the Member 
State in which the consumer is domiciled is insufficient"62.  

In  the  case  the  consumer  is  sued  (e.g.  over  a  dispute  concerning  an 
unpaid  bill),  the  competent  jurisdiction  will  be  the  one  of  the  Member 
State of his domicile. 

58 

59 

60 
61 

62 

According  to  Article  15  of  Regulation  44/2001,  a  consumer  is  defined  as  a  person,  who  concludes  a 
contract "for a purpose which can be regarded as being outside his trade or profession". This is always 
the case for patients. 
For instance, this means that in a cross-border telemedicine scenario between two professionals (e.g. for 
a secondary opinion), in the absence of a court choice clause, the competent court should be the one of 
the Member State where the telemedicine service was delivered according to the contract. 
ECJ Rulings C-144/09 and C-585/08 of 7 December 2010. 
The  Court  also  formulates  a  non-exhaustive  list  of  matters  from  which  it  may  be  concluded  that  the 
trader’s activity is directed to the Member State of the consumer’s domicile: "the international nature 
of the activity, mention of itineraries from other Member States for going to the place where the trader 
is established, use of a language or a currency other than the language or currency generally used in 
the  Member  State  in  which  the  trader  is  established,  mention  of  telephone  numbers  with  an 
international code, outlay of expenditure on an internet referencing service to facilitate access to the 
trader’s site or that of its intermediary by consumers domiciled in other Member States etc."  
This  means  that,  for  instance,  if  a  Belgian  citizen  were  to  contact  on  his  own  initiative  a  Swedish 
healthcare professional providing telemedicine services advertised via a website, and such website was 
only available in Swedish language, the Belgian citizen (who understands Swedish) would not be able 
to sue the Swedish professional in Belgium as the website did not specifically target the Belgian market.  

EN 

25 

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(b) 

if  the  activity  is  not  directed  to  the  Member  State  of  the  consumer's 
domicile, the competent courts are the courts in the Member State where, 
under  the  contract,  the  services  were  provided  or  should  be  provided 
(Article  5(1)(b)  of  the  Regulation.  In  a  cross-border  Telemedicine 
scenario,  and  by  analogy  with  the  case-law  concerning  the  delivery  of 
goods, it could be reasonably assumed that it would be the Member State 
where the patient was when he received the advice or treatment.  

• 

Thus, to sum up, the patient always has the possibility of suing the professional in the 
Member  State  where  the  professional  is  domiciled.  The  alternative  optional 
jurisdictions are likely in very many cases to allow him to sue in the Member State of 
his own domicile if he so chooses. 

3.5.2.  Determining the applicable law  

In case a conflict arises following the provision of a cross-border telemedicine service, after 
identifying  the  competent  jurisdiction,  it  will  be  necessary  to  identify,  which  law  should 
apply.  

As  for  the  determination  of  the  competent  court,  at  EU  level,  existing  rules  on  the 
determination  of  the  applicable  law  in  a  cross-border  situation  only  cover  civil  and 
commercial matters.  

3.5.2.1.  Determining the applicable law in a contractual relationship  

In  situations  resulting  in  a  conflict  of  laws  involving  a  contractual  relation,  the  Rome  I 
Regulation63 shall apply.  

• 

Contract between professionals:  

The general rule is the freedom of choice of the parties, meaning that the applicable law to the 
contract will be the one expressly chosen by the parties.  

In the absence of choice of the applicable law in the contract, the default rule shall apply:  

The contract for the provision of services shall be governed by the law of the Member State 
where the service provider has his habitual residence (Article 4(1)(b) of the Regulation).  

• 

Contract between a professional and a consumer:  

• 

• 

If  the  healthcare  professional  directs  its  activities  to  the  Member  State  where 
the  consumer  has  his  habitual  residence or  to  several  countries  including  that 
country,  the    contract  shall  be  governed  by  the  law  of  the  country  where  the 
consumer has his habitual residence (Article 6 of the Regulation)64.   

If the healthcare professional does not direct its activities to the Member State 
where the patient has his habitual residence, the contract shall be governed by 

63 
64  

OJ L 177, 4.7.2008, p. 6. 
See above the concept of "directing activities" clarified by the ECJ judgment of 7 December 2010 in the 
joined cases C-144/09 Alpenhof and C-585/08 Pammer.  

EN 

26 

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the  law  of  the  Member  State  where  the  service  provider  has  his  habitual 
residence (Article 4(1) b) of the Regulation).  

• 

The  parties  may  nevertheless  choose  a  law  other  than  the  consumer's  law.  If 
they do so, however, the consumer may still not be deprived of the protection 
afforded  to  him  by  the  provisions  of  the  law  of  his  country  that  cannot  be 
derogated from (due to their importance) through agreement. 

3.5.2.2.  Determining the applicable law in a non-contractual relationship  

In  situations  involving  a  conflict  of  laws  regarding  non-contractual  obligations  in  civil  or 
commercial matters, the Rome II Regulation shall apply, which provides the following:  

• 

• 

The law applicable to a non-contractual obligation arising out of a tort/delict shall be 
the law of the country in which the damage occurs (i.e. the Member State where the 
patient  was  when  he  received  the  treatment).  This  is  irrespective  of  the  country  in 
which the event giving rise to the damage occurred (i.e. the Member State where the 
healtcare professional was when he delivered the advice/treatment) and irrespective 
of  the  country  or  countries  in  which  the  indirect  consequences  of  that  event  occur 
(Article 4(1) of the Regulation).  

Under  certain  conditions,  the  parties  may  choose  another  applicable  law  by  an 
agreement entered into after the event giving rise to the damage occurred (Article 14 
of the Regulation).  

3.5.2.3.  Relationship  between  Rome  I  and  II  Regulations  and  Directive  2011/24/EU  on  the 

application of patients' rights in cross-border healthcare 

Cross-border healthcare  shall be  provided  in  accordance with the legislation of the Member 
State  of  treatment  and  the  standards  and  guidelines  on  quality  and  safety  laid  down  by  that 
Member State (Article 4 of Directive 2011/24/EU).  

However,  that  provision  does  not  derogate  from  the  rules  set  out  in  the  Rome  I  and  II 
Regulations  on  applicable  law  (Article  2(q)  of  the  Directive2011/24/EU)  .  Article  4  of  the 
Directive thus only applies to public law issues and states the obvious principle that treatment 
must be carried out in a way that complies with the local law. If the law applicable to civil 
liability is that of a different Member State than the one of the healthcare provider, Article 4 
of the Directive will not displace that law but may have an impact on the way in which it is 
applied.  

For example, if the Member State of treatment is France but the parties have chosen UK law, 
the latter will apply to civil liability between the parties but the standards imposed by French 
law  will  still  be  relevant  in  determining  whether  a  surgeon  has  been  negligent  or  has  not 
complied with local requirements on explaining to a patient the risks attendant on a particular 
operation. This rule operates in a way similar to Article 17 of the Rome II Regulation which 
provides  that  in  assessing  the  conduct  of  the  person  claimed  to  be  liable,  account  shall  be 
taken  of  the  rules  of  safety  and  conduct  in  force  in  the  place  of  the  event  giving  rise  to 
liability. 

Finally, as already mentioned, it should be noted that certain situations can give rise to both, 
contractual  and  non-contractual  liability.  Member  States'  legal  systems  deal  with  such 

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27 

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situations  in  different  ways65.  The  Rome  II  Regulation  does  not  decide  in  favour  of  either 
solution  but  implicitly  accepts  those  national  legal  systems  which  admit  the  concurrent 
pleading  of  claims  in  contract  and  court  by  allowing  the  court  to  apply  the  same  law  to 
contractual and tort claims.  

Case study 

Patient  X  from  Country  A  intends  to  initiate  a  lawsuit  against  his  treating  doctor  in 
Country  B,  after  receiving  a  teleconsultation  for  pulmonary  rehabilitation.  The 
healthcare professional was unable to detect complications in the respiratory condition of 
patient X and failed to provide the appropriate medical treatment. The patient came into 
contact  with  the  Country  B  doctor  after  visiting  his  website,  which  advertises,  among 
others, his teleconsultation services in the language of patient X and accepts payments in 
the  currency  of  that  country.  Despite  concluding  a  telemedicine  contract,  the  parties 
omitted to specify the competent court and applicable law in case of conflict.  

It  is  first  necessary  to  identify  the  court  competent  to  judge  this  case.  In  the  absence  of 
parties' agreement in the case of a consumer-professional relationship, the consumer has a 
choice: he may sue either in the Member State where the other party is domiciled or in the 
Member State where he is himself domiciled (Articles 15(1)(c) and 16 of Regulation (EC) 
No 44/2001). Such a choice exists only if the professional directed his activities  "towards 
the  Member  State  of  the  consumer's  domicile  or  to  several  States  including  that  Member 
State, and the contract falls within the scope of such activities". 

According to the European Court of Justice ruling Alpenhof and Pammer, the fact that the 
Country B doctor proposes his services on a website in the language of the consumer as well 
as in his currency, demonstrates that he was directly targeting the patient's country for the 
exercise  of  his  activity.  The  competent  court  will  therefore  be  left  to  the  choice  of  the 
patient, either in Country A or in Country B. 

In  addition,  it  is  necessary  to  identify  the  applicable  law  to  the  case.  As  a  contractual 
relationship exists between the patient from Country A and the doctor from Country B, the 
provisions of Rome I Regulation are applicable. According to Article 6 of the Regulation, in 
the  absence  of  a  law  choice  clause  in  a  contract  concluded  with  a  consumer,  the  law 
applicable should be the one of the country where the consumer has his habitual residence, 
provided that the professional "directs" by any means such activities to that country. It was 
shown  above  that  the  doctor  targeted  the  country  of  the  consumer.  This  means  that  the 
applicable law is the law of Country A and the doctor from Country B will be sued under 
the liability regime of Country A (i.e. the law of the patient). 

Article  4  of  Directive  2011/24/EU  also  applies.  It  provides  that  the  rules  on  safety  and 
quality  of  the  healthcare  treatment  are  governed  by  the  law  of  the  Member  State  of 
treatment,  which  is  expressly  defined  as  the  law  of  the  service  provider's  country  of 
establishment  in  the  case  of  telemedicine.  Therefore,  the  law  of  Country  B  would  as  well 
apply  but  only  as  regards  the  standards  and  guidelines  on  quality  and  safety  of  the 

65 

Some Member States (e.g. Germany and England) allow a victim to base a claim on both contractual 
and delictual liability. Other Member States, notably France, limit  the victim to the contractual claim 
(so-called non cumul rule). 

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28 

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healthcare treatment. 

4. 

CONCLUSION 

This Staff Working Paper provides an overview of the relevant body of EU legislation that is 
applicable to cross-border telemedicine services provided in the EU.  

It  first  underlines  that  a  telemedicine  service  is  both  a  health  service  and  an  information 
society service. Therefore it is covered by the principle of freedom to provide services as well 
as  by  the  provisions  of  the  Directive  on  the  application  of  patients'  rights  in  cross-border 
healthcare and the eCommerce Directive. 

The  document  focuses  on  the  key  legal  issues  related  to  the  provision  of  cross-border 
telemedicine: 
licensing/registration  of  health  professionals  performing  cross-border 
telemedicine  services;  the  conditions  for  legal  processing  of  health  data;  the  right  of 
reimbursement of a cross-border telemedicine act; and finally the determination of potential 
liability, competent jurisdiction, and applicable law. 

MAIN KEY FINDINGS: 

Patients' rights  

The  rights  of  patients  when  receiving  cross-border  healthcare,  including  telemedicine  are 
enshrined  in  Directive  2011/24/EU  on  the  application  of  patients'  rights  in  cross-border 
healthcare. They include the right to: 

receive  treatment  in  another  Member  State  and  be  reimbursed  under  certain 

• 
conditions; 

• 

have access to a written or electronic copy of their health records. 

Licensing/registration of healthcare professionals 

Directive 2011/24/EU on the application of patients' rights in cross-border healthcare requires 
that  cross-border  healthcare  is  to  be  provided  in  accordance  with  the  legislation  of  the 
Member State of treatment. In the case of telemedicine, it expressly defines the Member State 
of treatment as that of the service provider's Member State of establishment.  

Indeed, to provide cross-border telemedicine services, the professional does not need to move. 
Logically,  the  professional  do  not  have  to  have  an  authorization  of  the  Member  State  of 
residence  of  the  patient.  This  is  only  in  the  case  where  he  wants  to  exercise  in  another 
Member  State  that  the  one  of  its  habitual  residence  that  he  may  need  to  request  an 
authorisation. 

Processing of health data  

The  processing  of  personal  data  related  to  health  is  regulated  under  Directive  1995/46  on 
general data protection, currently under review. The Commission proposal for a regulation on 

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29 

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data  protection  will,  inter  alia,  clarify  the  rules  applicable  to  personal  data  related  to  health 
including for the purpose of research.  

Liability  

The liability regime of healthcare professionals varies from one Member State to another. The 
liability regime for defective products is the only liability regime related to the provision of 
telemedicine regulated at European level. 

Reimbursement  

Directive 2011/24/EU on the application of patients' rights in cross-border healthcare provides 
that the costs incurred by the patient for cross-border healthcare, such as telemedicine should 
be reimbursed if the healthcare in question is among the benefits to which the insured person 
(i.e. patient) is entitled in his Member State of affiliation. 

Other issues  

The definition of telemedicine as a medical act varies from one Member State to another. 

Directive 2005/36/EC on the recognition of professional qualifications only covers healthcare 
professionals  that  physically  move  to  another  Member  State  to  practice  their  profession66. 
This is for the most part not the case for the health care professionals providing cross-border 
telemedicine. 

For  each  abovementioned  issue,  a  summary  of  the  applicable  EU  legislation  and  their  main 
provisions is given and illustrated in a case study. 

This  Staff  Working  Paper  underlines  the  importance  of  legal  clarity  in  cultivating  trust  and 
acceptability  of  telemedicine.  Furthermore,  it  is  intended  to  serve  as  guidance  to  Member 
States, raising awareness on what telemedicine is and what they are committing to when they 
adopt it as a type of medical act, or reimbursable health service. 

Finally,  this  paper  shall  serve  as  a  starting  point  for  discussion  with  Member  States  on  the 
opportunity to tackle at EU level remaining legal uncertainties created by divergent national 
regimes such as the issue of medical liability. 

66  

EN 

proposal 

See: 
The 
http://ec.europa.eu/internal_market/qualifications/docs/policy_developments/modernising/COM2011_8
83_en.pdf 

approach. 

Directive 

2005/36 

revise 

keeps 

this 

to 

30 

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ANNEX: LIST OF SECONDARY EU LEGISLATION APPLICABLE TO TELEMEDICINE 

4.1. 

Legal sources concerning information society services 

Directive 98/34/EC of the European Parliament and of the Council of 20 July 1998 amended 
by Directive 98/34/EC laying down a procedure for the provision of information in the field 
of technical standards and regulations and of rules on information society services 

Directive 1999/93/EC on a Community framework for electronic signatures  

Directive  2000/31/EC  of  the  European  Parliament  and  of  the  Council  of  8  June  2000  on 
certain legal aspects of information society services, in particular electronic commerce, in the 
Internal Market ('Directive on electronic commerce')  

4.2. 

Legal sources concerning reimbursement 

Directive 2011/24/EU of the European Parliament and of the Council of 9 March 2011 on the 
application of patients’ rights in cross-border healthcare 

4.3. 

Legal sources concerning consumer protection 

Council of Europe Convention on products liability in regard to personal injury and death of 
27 January 1977  

Directive  1999/34/EC  of  the  European  Parliament  and  of  the  Council  of  10  May  1999 
amending Council Directive 85/374/EEC of 25 July 1985 on the approximation of the laws, 
regulations  and  administrative  provisions  of  the  Member  States  concerning  liability  for 
defective products  

Directive 2011/83/EU of the European Parliament and of the Council of 25 October 2011 on 
consumer  rights,  amending  Council  Directive  93/13/EEC  and  Directive  1999/44/EC  of  the 
European  Parliament  and  of  the  Council  and  repealing  Council  Directive  85/577/EEC  and 
Directive 97/7/EC of the European Parliament and of the Council 

Directive 2001/95/EC of the European Parliament and of the Council of 3 December 2001 on 
general product safety  

RoHS  Directive  2002/95/EC  of  the  European  Parliament  and  of  the  Council  of  27  January 
2003 on the restriction of the use of certain hazardous substances in electrical and electronic 
equipment.  

Directive  2005/29/EC  of  the  European  Parliament  and  of  the  Council  of  11  May  2005 
concerning  unfair  business-to-consumer  commercial  practices  in  the  internal  market  (Unfair 
Commercial Practices Directive). 

Directive 2006/114/EC of the European Parliament and of the Council of 12 December 2006 
concerning  misleading  and  comparative  advertising.  This  directive  applies,  as  regards 

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misleading  advertising  to  business-to-business,  and  in  the  case  of  comparative  advertising 
both to business-to-business and business-to-consumer relationships.  

Directive  2011/83  of  the  European  Parliament  and  of  the  Council  of  25  October  2011  on 
consumer  rights,  amending  Council  Directive  93/13/EEC  and  Directive  1999/44/EC  of  the 
European  Parliament  and  of  the  Council  and  repealing  Council  Directive  85/577/EEC  and 
Directive 97/7/EC of the European Parliament and of the Council 

4.4. 

Legal sources concerning data protection 

Directive 95/46/CE of the European Parliament and of the Council of 25 October 1995 on the 
protection  of  individuals  with  regards  to  the  processing  of  personal  data  and  on  the  free 
movement of such data 

Directive 2009/136/EC of the European Parliament and of the Council of 25 November 2009 
amending  Directive  2002/22/EC  on  universal  service  and  users’  rights  relating  to  electronic 
communications  networks  and  services,  Directive  2002/58/EC  concerning  the  processing  of 
personal  data  and  the  protection  of  privacy  in  the  electronic  communications  sector  and 
Regulation  (EC)  No  2006/2004  on  cooperation  between  national  authorities  responsible  for 
the enforcement of consumer protection laws 

4.5. 

Legal sources concerning medical devices and medicinal products  

Council  Directive  90/385/EEC  of  20  June  1990  on  the  approximation  of  the  laws  of  the 
Member  States  relating  to  Active  Implantable  Medical  Devices  as  amended  by  Directive 
2007/47/EC of 5 September 2007 

Council  Directive  93/42/EEC  of  14  June  1993  concerning  Medical  Devices  as  amended  by 
Directive 2007/47/EC of 5 September 2007 

Directive  98/79/EC  on  In  Vitro  Diagnostic  Medical  Devices  as  amended  by  Directive 
2007/47/EC of 5 September 2007 

Commission Regulation (EU) No 207/2012 of 9 March 2012 on electronic instructions for use 
of medical devices 

Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on 
the Community code relating to medicinal products for human use  

4.6.   Legal sources concerning conflicts of jurisdiction and conflicts of laws 

Council  Regulation  (EC)  No  44/2001  of  22  December  2000  on  jurisdiction  and  the 
recognition and enforcement of judgments in civil and commercial matters (Brussels I) 

Regulation (EC) No 593/2008 of the European Parliament and of the Council of 17 June 2008 
on the law applicable to contractual obligations (Rome I) 

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Regulation (EC) No 864/2007 of the European Parliament and of the Council of 11 July 2007 
on the law applicable to non-contractual obligations (Rome II) 

EN 

33 

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