COMMUNICATION FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT, THE COUNCIL, THE EUROPEAN ECONOMIC AND SOCIAL COMMITTEE AND THE COMMITTEE OF THE REGIONS on enabling the digital transformation of health and care in the Digital Single Market; empowering citizens and building a healthier society
Date: 2018-04-25
Institutions: Directorate-General for Communications Networks, Content and Technology, European Commission
Subjects: cross-frontier data flow, data protection, digital single market, digitisation, disclosure of information, e-Health, exchange of information, organisation of health care, personal data, technical specification

EN 

  EN 

   EUROPEAN COMMISSION  Brussels, 25.4.2018 COM(2018) 233 final  COMMUNICATION FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT, THE COUNCIL, THE EUROPEAN ECONOMIC AND SOCIAL COMMITTEE AND THE COMMITTEE OF THE REGIONS on enabling the digital transformation of health and care in the Digital Single Market; empowering citizens and building a healthier society {SWD(2018) 126 final}  
 
 
1.   POLICY CONTEXT: HEALTH AND CARE IN A DIGITISING WORLD 

The recent report on the State of Health in the EU1 concluded that only by fundamentally 
rethinking our  health and care systems2  can  we ensure that they remain fit-for-purpose. 
This  means  systems  which  aim  to  continue  to  promote  health,  prevent  disease  and 
provide patient-centred care that meets  citizens'  needs.  Health and care systems require 
reforms  and  innovative  solutions  to  become  more  resilient,  accessible  and  effective  in 
providing quality care to European citizens3.  

Europe's  health  and  care  systems  face  serious  challenges.  These  are  ageing,  multi-
morbidity4,  health  workforce  shortages,  and  the  rising  burden  of  preventable  non-
communicable diseases caused by risk factors such as tobacco, alcohol, and obesity, and 
other  diseases  including  neuro-degenerative  and  rare  diseases.  We  are  also  seeing  a 
growing threat from infectious diseases due to increased resistance to antibiotics and new 
or  re-emerging  pathogens5.  Public  spending  on  health  and  long-term  care  is  steadily 
rising in EU Member States and is expected to continue to do so6. 

Digital  solutions  for  health  and  care  can  increase  the  well-being  of  millions  of  citizens 
and  radically  change  the  way  health  and  care  services  are  delivered  to  patients,  if 
designed purposefully and implemented in a cost-effective way. Digitisation can support 
the  continuity  of  care  across  borders,  an  important  aspect  for  those  who  spend  time 
abroad for business or leisure purposes. Digitisation can also help to promote health and 
prevent disease, including in the work place. It can support the reform of health systems 
and their transition to new care models, centred on people’s needs and enable a shift from 
hospital-centred  systems  to  more  community-based  and  integrated  care  structures7. 
Digital  tools  can  translate  scientific  knowledge  into  helping  citizens  remain  in  good 
health,  thus  helping  to  ensure  that  they  do  not  turn  into  patients.  They  also  have  the 
potential  to  enable  a  better  use  of  health  data  in  research  and  innovation  to  support 
personalised healthcare, better health interventions and more effective health and social 
care systems.  

Data is a key enabler for digital transformation. Health data may be available in various 
forms;  it  is  not  managed  in  the  same  way  in  all  EU  Member  States  or  within  national 
health  systems.  It  is  often  not  even  available  to  the  patients  themselves  or  to  public 
authorities, medical professionals or researchers to help them develop and deliver better 
diagnosis, treatment or personalised care. Even where it exists, health data often depends 
on technologies that are not interoperable, thus hindering its wide use.  

1 State of Health in the EU "Companion Report 2017", https://ec.europa.eu/health/state  
2  The  term  "health  and  care  systems"  implies  a  broader  notion  than  "health  systems"  or  "healthcare 

systems", notably encompassing public health and social care. 

3  Communication  from  the  Commission  "On  effective,  accessible  and  resilient  health  systems", 

COM(2014) 215 final 

4 Multiple chronic conditions or illnesses 
5http://reports.weforum.org/global-risks-2016/global-disease-
outbreaks/?doing_wp_cron=1516386480.4622519016265869140625  
6 Joint Report by the Commission services and the Economic Policy Committee on Health Care and Long-
term  Care  Systems  and  Fiscal  Sustainability,  European  Commission  and  Economic  Policy  Committee, 
October  2016,  https://ec.europa.eu/info/publications/economy-finance/joint-report-health-care-and-long-
term-care-systems-fiscal-sustainability-0_en 

7  Ministerial  Statement,  Organisation  for  Economic  Co-Operation  and  Development  Health  Ministerial 
2017, 

health 
Meeting, 
http://www.oecd.org/health/ministerial/ministerial-statement-2017.pdf  &   
WHO global strategy on people-centred and integrated health services, World Health Organisation, 2015 

generation 

reforms", 

"The 

next 

of 

1 

 
 
                                                 
Because  of  this,  health  systems  lack  key  information  to  optimise  their  services,  and 
providers find it hard to build economies of scale to offer efficient digital health and care 
solutions8 and to support cross-border use of health services. As a result, citizens cannot 
yet  fully  benefit  from  the  digital  single  market  in  this  area.  Market  fragmentation  and 
lack of interoperability across health systems stand in the way of an integrated approach 
to disease prevention, care and cure better geared to people's needs.  

The EU is developing strong approaches in high performance computing, data analytics 
and  artificial  intelligence,  which  can  help  design  and  test  new  healthcare  products9, 
provide  faster  diagnosis  and  better  treatments.  But  succeding  in  these  endeavours 
depends  on  the  availability  of  vast  amounts  of  high  quality  data  and  appropriate 
regulatory frameworks that will safeguard the rights of the individual and society as well 
as stimulating innovation. As the report on the State of Health in the EU concluded, the 
use of patient-centred health data is still under-developed across the EU10.  

The  organisation  and  delivery  of  health  and  social  care  are  the  responsibility  of  the 
Member  States.  In  some  Member  States,  particularly  those  with  (federal)  regional 
systems,  regional  authorities  are  responsible  for  financing  and  providing  healthcare. 
Nevertheless, in accordance with the Treaty on the Functioning of the European Union11, 
the  Commission  can  promote  public  health  and  the  prevention  of  disease  and  support 
cooperation between the Member States, for example, to improve the complementarity of 
their  health  services  cross-border.  The  Commission  can  also  take  action  to  stimulate 
innovation,  economic  growth  and  the  development  of  the  Single  Market  in  close 
coordination with Member States. 

Health  and  care  authorities  across  Europe  face  common  challenges,  which  can  be  best 
addressed  jointly.  To  this  end,  the  Commission  has  been  working  with  the  Member 
States, regional authorities and other stakeholders to tap into the potential of innovative 
solutions, such as digital technologies and data analytics, and in doing so assist Member 
States  in  pursuing  the  reforms  of  their  health  and  care  systems.  The  Commission 
provides  its  support  through  funding  and  actions  that  promote  policy  cooperation  and 
exchange of good practice. 

EU funding supports research and innovation in digital health and care solutions, notably 
through the Horizon 2020 programme. It also supports the building of infrastructure for 
cross-border  exchange  of  patient  summaries  and  electronic  prescriptions,  with  funding 
from the Connecting Europe Facility programme12.  

The  Directive  on  patients'  rights  in  cross-border  healthcare13  established  the  eHealth 
network to advance the interoperability of eHealth solutions. EU legislation on medical 

8  Commission  Staff  Working  Document  "A  Digital  Single  Market  Strategy  for  Europe  -  Analysis  and 
Evidence", SWD(2015) 100 final, Section 5.6 Digitisation in Basic Sectors; eHealth and eCare, pages 79-
81 

9 Drugs, devices, advanced therapy medicinal products etc.  
10 See page 37 of the "State of Health in the EU "Companion Report 2017", referred above.  
11 Article 168, Treaty on the Functioning of the European Union 
12  eHealth  actions  are  financed  from  the  telecommunications  sector  of  the  Connecting  Europe  Facility 

under the annual work programmes. 

13 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, OJ L 88 of 4.4.2011 

2 

 
                                                 
devices14,  data  protection15,  electronic  identification16  and  security  of  network  and 
information systems17 offers a range of opportunities to facilitate the responsible use of 
digital technologies in health and care.  

Cooperation structures have also been developed; for example, the European Innovation 
Partnership  on  Active  and  Healthy  Ageing18,  the  Active  and  Assisted  Living  Joint 
Programme19,  and  public-private  partnerships  such  as  the  Innovative  Medicines 
Initiative20  and  the  Electronic  Components  and  Systems  for  European  Leadership21. 
Regional  and  national  smart  specialisation  strategies  also  play  a  central  role  in  the 
development of stronger regional ecosystems around the healthcare domain. Since 2004, 
two eHealth Action Plans22 have provided a framework for policy action for the Member 
States  and  the  Commission,  and  the  eHealth  Stakeholders  Group23  has  played  an 
important role.  

2.   NEED FOR FURTHER EU ACTION 

To  date,  the  uptake  of  digital  solutions  for  health  and  care  remains  slow  and  varies 
greatly  across  Member  States  and  regions.  Further  action  at  EU  level  is  crucial  to 
accelerate  the  meaningful  use  of  digital  solutions  in  public  health  and  healthcare  in 
Europe.  In  its  mid-term  review  on  the  implementation  of  the  digital  single  market 
strategy24 the Commission set out its intention to take further action in three areas: 

  citizens' secure access to and sharing of health data across borders; 

  better data to advance research, disease prevention and personalised health and 

care; 

  digital tools for citizen empowerment and person-centred care. 

14 Regulation (EU) 2017/745 of the European Parliament  and of the Council of 5 April 2017 on medical 
devices, OJ L 117 of 5.5.2017; Regulation (EU) 2017/746 of the European Parliament and of the Council 
of 5 April 2017 on in vitro diagnostic medical devices, OJ L 117 of 5.05 2017 

15  Regulation  (EU)  2016/679  of  the  European  Parliament  and  of  the  Council  of  27  April  2016  on  the 
protection of natural persons with regard to the processing of personal data and on the free movement of 
such data, and repealing Directive 95/46/EC, OJ L 119/1 of 4.05.2016 

16  Regulation  (EU)  No  910/2014  of  the  European  Parliament  and  of  the  Council  of  23  July  2014  on 
electronic identification and trust services for electronic transactions in the internal market and repealing 
Directive 1999/93/EC, OJ L 257 of 28.8.2014 

17  Directive  (EU)  2016/1148  of  the  European  Parliament  and  of  the  Council  of  6  July  2016  concerning 
measures for a high common level of security of network and information systems across the Union, OJ 
L 194 of 19.7.2016 

18 https://ec.europa.eu/eip/ageing/home_en  
19 http://www.aal-europe.eu/ 
20 Council Regulation (EU) No 557/2014 of 6 May 2014 establishing the Innovative Medicines Initiative 2 

Joint Undertaking, OJ L 169 of 7.6.2014 

21  Council  Regulation  (EU)  No  561/2014  of  6  May  2014  establishing  the  Electronic  Components  and 

Systems for European Leadership Joint Undertaking, OJ L 169 of 7.6.2014 

22 COM(2004) 356 final  &  COM(2012) 736 final 
23 http://ec.europa.eu/transparency/regexpert/index.cfm?do=groupDetail.groupDetail&groupID=2769 
24 COM(2017) 228 final 

3 

 
 
                                                 
For  this  purpose,  the  Commission  carried  out  a  public  consultation25.  The  responses  to 
the  consultation  largely  recognised  the  need  for  further  work,  identifying  important 
challenges  that  prevent  digital  health  and  care  solutions  from  being  adopted  across  the 
EU  and  underserve  people's  needs.  These  refer  to  areas  such  as  access  to  health  data, 
diversity  of  Electronic  Health  Records,  lack  of  technical  interoperability  and  access  to 
digital health services. The consultation also identified concerns specific to the electronic 
sharing of data, namely the risk of privacy breaches, cybersecurity risks and the quality 
and reliability of data.  

On the scope of future EU actions, respondents gave priority to:  

 

the  development  of  EU-wide  standards  for  data  quality,  reliability  and 
cybersecurity;  

  EU-wide standardisation of electronic health records; and  

  better interoperability through open exchange formats.  

On  8  December  2017,  the  Council  adopted  Conclusions26,  inviting  Member  States  and 
the Commission to work together on a range of issues and seize the potential of digital 
technologies  in  health  and  care.  The  Conclusions  also  call  specifically  for  the 
implementation  in  the  health  sector  of  existing  EU  legislation  on  the  protection  of 
personal data, electronic identification and information security.  

The present Communication sets out  how the EU can  help meet the objectives of these 
Council  Conclusions.  It  proposes  to  build  the  necessary  cooperation  and  infrastructure 
across the EU and in doing so help Member States to fulfil their political commitment in 
these areas. The proposed actions also support the Commission's commitment to deliver 
on the Sustainable Development Goals on healthy lives and well-being for all at all ages27 
and the principles of the European Pillar of Social Rights28.  

The  vision  outlined  in  this  Communication  is  to  promote  health,  prevent  and  control 
disease, help address patients' unmet needs and make it easier for citizens to have equal 
access to high quality care  through the meaningful use of digital innovations. It will also 
strengthen  the  resilience  and  sustainability  of  Europe’s  health  and  care  systems.  By 
helping to maximise the potential of the digital internal market with a wider deployment 
of  digital  products  and  services  in  health  and  care,  the  proposed  actions  also  aim  to 
stimulate growth and promote the European industry in the domain. 

25  Public  Consultation  on  Transformation  of  Health  and  Care  in  the  Digital  Single  Market,  carried  out 
(https://ec.europa.eu/info/consultations/public-consultation-

and  October 

July 

between 
transformation-health-and-care-digital-single-market_en) 

2017 

26 Council conclusions 2017/C 440/05 on Health in the Digital Society — making progress in data-driven 

innovation in the field of health, OJ C 440 of 21.12.2017 

27 COM(2016) 739 final and https://www.un.org/sustainabledevelopment/health/ 
28 COM/2017/0250 final 

4 

 
 
 
                                                 
3.   CITIZENS' SECURE ACCESS TO AND SHARING OF HEALTH DATA 

Citizens  have  the  right  to  access  and  share  their  health  data.  When  it  enters  into 
application on 25 May 2018, the General Data Protection Regulation29 will put citizens in 
control  of  the  use  of  their  personal  data  including  health  data.  The  public  consultation 
confirmed that a majority of respondents would like to have more access to their health 
data.  They  would  also  like  to  share  the  data  for  their  treatment  or  for  research,  if 
appropriate guarantees are in place. Technology should ensure that this is the case with 
infrastructure that is built in conformity with data protection rules. 

However, at present, many citizens in Europe have limited electronic access to data about 
their own health. The data is often untraceable and scattered in different places. This may 
impact  adversely  on  diagnosis,  treatment  and  follow-up;  for  example,  when  a  person  is 
abroad and their medical information is not accessible. Moreover, incompatible formats 
and standards in electronic health record systems continue to be used across the EU. 

In essence, citizens should have secure access, anywhere in the EU, to a comprehensive 
electronic record of their health data. Citizens should remain in control of and be able to 
share their health data securely with authorised parties (for medical treatment, preventive 
services,  research  or  for  any  other  purpose  they  deem  appropriate).  This  should  be 
irrespective  of  where  the  data  is  located  and  in  line  with  data  protection  legislation. 
Unauthorised access should be prevented. 

Current  efforts  to  exchange  patient  data  across  borders  in  the  EU  rely  on  the  voluntary 
cooperation of health authorities to connect to the eHealth digital service infrastructure30, 
which is supported by the  Connecting Europe Facility (Broadband and Information and 
Communication Technologies) programme and uses the guidelines agreed by the eHealth 
network31 for the governance, establishment and operation of the eHealth digital service 
infrastructure32.  

Currently, this exchange is limited to patient summaries and ePrescriptions, and does not 
cover  electronic  health  records.  These  two  use  cases  of  patient  data  exchanges  are 
planned  to  start  in  2018  between  8  -  9  Member  States,  with  around  22  Member  States 
expected to join the exchange by 2020.  

Therefore, as the system is now moving into the operational phase, the Commission sees 
a  need  to  gradually  extend  these  two  use  cases  to  also  cover  the  interoperability  of 
Member  states'  electronic  health  record  systems  by  supporting  the  development  and 
adoption  of  a  European  electronic  health  record  exchange  format.  There  is  also  a  clear 
case to develop further effective methods for enabling the use of medical information for 
public  health  and  research  and  to  develop  common  identification  and  authentication 
measures,  as  laid  down  in  Article  14(2)  of  Directive  2011/24/EU.  Such  changes  will 
require  reviewing  the  management  and  functioning  of  the  eHealth  network  to  ensure 
appropriate governance of the eHealth digital service infrastructure and its financial basis. 

29  Regulation  (EU)  2016/679  of  the  European  Parliament  and  of  the  Council  of  27  April  2016  on  the 
protection of natural persons with regard to the processing of personal data and on the free movement of 
such data, and repealing Directive 95/46/EC, OJ L 119/1 of 4.05.2016, particularly Article 15 (right of 
access) and Article 20 (right to data portability) 

30 https://ec.europa.eu/cefdigital/wiki/display/CEFDSIS/eHealth+2.0  
31 https://ec.europa.eu/health/ehealth/policy/network/guidance_ehealthgenericservices_en  
32 https://ec.europa.eu/health//sites/health/files/ehealth/docs/ev_20151123_co01_en.pdf  

5 

 
                                                 
It  will  also  necessitate,  in  agreement  with  the  eHealth  network,  extending  the  current 
scope of the eHealth digital service infrastructure itself. 

Developing  specifications  for  a  European  electronic  health  record  exchange  format 
should  be  based  on  open  standards  and  build  on  appropriate  technical  expertise,  taking 
into account the potential use of data for research and other purposes. Additionally, the 
Commission  intends  to  monitor  the  cross-border  interoperability  of  electronic  health 
record systems and, once in place, the adoption of the European electronic health record 
exchange format across the EU. 

Moreover, the Commission intends to identify incentives for adopting the open European 
electronic  health  record  exchange  format  widely  across  the  EU  and  explore  other 
measures to tackle any practices that result in the lack of interoperability, thus hindering 
the  digital  single  market  in  this  area.  The  Commission  also  plans  to  encourage 
approaches  already  developed  in  some  Member  States  and  regions  to  establish 
interoperable systems.  

The  Commission  will  monitor  the  implementation  of  the  General  Data  Protection 
Regulation and the Regulation on electronic identification and trust services for electronic 
transactions in the internal market33 with regard to health. The recently proposed rules on 
certification for cybersecurity requirements34  may, once adopted, also be factored in the 
system.  Here,  account  should  be  taken  of  emerging  technologies  such  as  blockchain, 
innovative  identity  management  mechanisms,  and  certification  mechanism  for  secure 
solutions  in  line  with  the  cybersecurity  Communication35  and  the  provisions  of  the 
General  Data  Protection  Regulation,  in  particular,  on  security,  data  breach  and 
notification requirements36. 

The Commission  intends to mobilise funding from the Connecting Europe Facility and 
Horizon  2020  programmes  for  the  European  electronic  health  record  exchange  format 
and  the  further  development  of  the  eHealth  digital  service  infrastructure.  Health 
authorities can explore a targeted use of EU financing instruments, such as the European 
Structural and Investment Funds and the European Fund for Strategic Investments, for the 
deployment of interoperable electronic health records at national and regional level which 
enable  citizens  (and  authorised  third  parties)  to  access  their  personal  health  data. 
Additional  funding  for  this  might  also  be  considered  under  the  next  EU  multi-annual 
financial framework.  

The Commission will: 

  Review  Commission  Implementing  Decision  2011/89037    pursuant  to  Article  14 
of the Directive on patients’ rights in cross-border healthcare38, in order to clarify 

33  Regulation  (EU)  No  910/2014  of  the  European  Parliament  and  of  the  Council  of  23  July  2014  on 
electronic  identification  and  trust  services  for  electronic  transactions  in  the  internal  market  and 
repealing Directive 1999/93/EC, OJ L 257 of 28.8.2014 

34 COM(2017)477, https://ec.europa.eu/info/law/better-regulation/initiatives/com-2017-477_en 
35 Joint Communication to the European Parliament and the Council Resilience, Deterrence and Defence: 

Building strong cybersecurity for the EU, JOIN/2017/0450 final 

36  General  Data  Protection  Regulation  Article  32  on  security  requirements;  Articles  33  and  34  on  data 

breach and notification requirements 

37 Commission Implementing Decision of 22 December 2011 providing the rules for the establishment, the 
management  and  the  functioning  of  the  network  of  national  responsible  authorities  on  eHealth.  OJ  L 
344, 28.12.2011, p. 48–50 

6 

 
 
                                                 
the role of the eHealth Network in the governance of the eHealth digital service 
infrastructure  and  its  operational  requirements,  as  well  as  to  improve  the 
interoperability of patient data and access by the citizen.  

  Adopt  a  Commission  recommendation  on  the  technical  specifications  for  a 
European  electronic  health 
format,  while  monitoring 
record  exchange 
implementation of relevant EU legislation and considering other measures in the 
future  if  needed.  Such  specifications  should  also  address  citizens'  access  to 
electronic health records and aspects related to the implementation of appropriate 
data protection safeguards and security of patient health data in compliance with 
the General Data Protection Regulation.  

  Further support the eHealth Digital Service Infrastructure to enable new services 
for people, such as exchange of electronic health records using the specifications 
of the European electronic health record exchange format, and the use of the data 
for public health and research. 

  Mobilise funds from the Connecting Europe Facility (Broadband and Information 
and  Communication  Technologies)  and  Horizon  2020  programmes  within  the 
current  envelopes,  and  consider  further  support  from  the  next  multi-annual 
financial framework, to encourage further collaboration between Member States 
and between regions on the cross-border exchange of health data and its possible 
expansion (notably to full electronic health records and other new services).  

4.   BETTER DATA TO PROMOTE RESEARCH, DISEASE PREVENTION AND PERSONALISED 
HEALTH AND CARE  

Personalised  medicine  is  an  emerging  approach  that  uses  data  generated  by  new 
technologies to better understand the characteristics of an individual and deliver the right 
care to the right person at the right time. New technologies enable a wider use of genomic 
and  other  information  (such  as  molecular  profiling,  diagnostic  imaging,  environmental 
and  lifestyle  data)  to  help  doctors  and  scientists  better  understand  disease  and  how  to 
better predict, prevent, diagnose and treat.  

Several national and regional initiatives already support the pooling of genomic and other 
health data to advance research and personalised medicine. We need to better coordinate 
these  existing  initiatives  to  reach  the  necessary  critical  mass  at  EU  level  and  match 
similar  initiatives  in  other  world  regions.  Significant  breakthroughs  can  be  achieved  by 
linking Europe's fragmented resources through secure cross-border digital infrastructures, 
while  ensuring  full  compliance  with  data  protection  legislation  and  ethical  principles. 
Ensuring  interoperable  standards  for  genomic  and  other  data  is  also  critical  for  an 
effective sharing of datasets.  

Linking  resources  and  using  common  standards  will  improve  the  accessibility,  sharing 
and  use  of  health  data  to  improve  understanding  of  health  and  disease.  This  will  also 
make  it  possible  to  better  anticipate  disease  outbreaks,  speed  up  diagnosis  and  develop 
better  preventive  and  treatment  measures,  and  monitor  the  effectiveness  and  possible 
undesired  effects  of  such  measures.  European  coordinated  action  in  this  field  can  bring 
tangible benefits for citizens and health systems in the EU, making it possible to tackle 
major health challenges such as cancer or brain disease, epidemics of infectious disease, 
or rare diseases (where half the new cases are found in children). Coordinated EU action 

38 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, OJ L 088,  p.45 

7 

 
 
 
 
                                                                                                                                                 
in this area also responds to the Council Conclusions on personalised medicine39, which 
called on the Commission to help achieve the potential of "Big Data".  

The  Commission  intends  to  support  the  pooling  of  the  EU's  data  resources  and  to 
facilitate  their  use  for  research  and  health  policy.  It  will  do  this  in  line  with  data 
protection  requirements,  and  building  on  the  European  High  Performance  Computing 
initiative40 and the European Open Science Cloud41 infrastructure. The aim is to connect 
national  initiatives  with  European  networks  of  scientific  and  clinical  expertise,  such  as 
the  International  Consortium  for  Personalised  Medicine,  the  European  Reference 
Networks,  the  European  Research  Infrastructures,  the  Human  Brain  Project  and  other 
relevant initiatives. This will help European research and industry remain at the forefront, 
bringing  new  personalised  medical  solutions  to  the  market.  Any  initiatives  in  this  area 
should  take  full  account  of  EU  policy  and  technological  developments  in  the  field  of 
cybersecurity, 5G42, the Internet of Things, the European Cloud Initiative43 and EU policy 
on  healthcare  products,  i.e.  pharmaceuticals,  medical  devices,  advanced  therapies  and 
health technology assessments.  

The  Commission  intends  step  up  coordination  between  authorities  across  the  EU  to 
implement  the  secure  exchange  of  genomic  and  other  health  data  in  order  to  advance 
research  and  personalised  medicine.  By  combining  sequenced  genomic  data  and  other 
medical data, physicians and researchers can get a better picture of disease in a particular 
individual and determine the most appropriate treatment for that individual. This should 
be  based  on  a  transparent  system  of  governance,  with  the  aim  of  linking  national  and 
regional banks of "-omics"44 data, biobanks and other registries across the EU. The initial 
goal of this coordination is to provide access to at least 1 million sequenced genomes in 
the  EU  by  202245,  and  then  to  a  larger  prospective  population-based  cohort  (beyond 
sequenced genomes) of at least 10 million people by 2025. This will integrate molecular 
profiling,  diagnostic  imaging,  lifestyle  (in  particular  risk  factors);  microbiological 
genomics and environmental data as well as links to electronic health records. It will also 
build  on  "digital  patient"  predictive  approaches  based  on  computer  modelling, 
simulations  and  artificial  intelligence.  Ultimately,  it  will  help  to  lay  the  foundation  for 
developing  a  reference  map  (atlas)  of  all  human  cells,  with  a  view  to  analyse  human 
tissues  and  organs  by  state-of-the-art  methodologies,  and  to  compare  and  understand 
changes during disease.  

It is paramount to agree on technical specifications for access and exchange of health data 
for research and public health purposes, addressing, for example, health data collection, 
storage,  compression,  processing  and  access  across  the  EU.  This  effort  will  build  upon 
the ongoing work of standardisation bodies, national initiatives and initiatives by health 

39 Personalised Medicine for Patients, Council Conclusions (7 December 2015) 15054/15 
40 http://europa.eu/rapid/press-release_IP-18-64_en.htm  
41 https://ec.europa.eu/research/openscience/index.cfm?pg=open-science-cloud  
42 https://ec.europa.eu/digital-single-market/en/5g-europe-action-plan  
43 European Cloud Initiative - Building a competitive data and knowledge economy in Europe. COM(2016) 

178 final 

44 ‘Omics’ technology is a general term for a broad discipline in science and engineering for analysing the 
interactions  of  biological  information  objects  in  various  ‘omes’  that  include  the  genome,  proteome, 
metabolome,  transcriptome  etc.  Its  main  focus  is  on  developing  technologies  and  tools  for  gathering 
information on various classes of biomolecules and their ligands, and understanding relationships among 
them, including the related regulatory mechanisms. (SWD(2013) 436) 

45 In April 2018, 14 Member States signed a joint declaration on cooperation "Towards access to at least 1 

million sequenced genomes in the European Union by 2022", https://ec.europa.eu/digital-single-
market/en/news/eu-countries-will-cooperate-linking-genomic-databases-across-borders 

8 

 
 
 
 
                                                 
professional  societies,  considering,  among  other  things,  the  link  with  electronic  health 
records.  

The Commission also intends to test specific practical applications of cross-border health 
data  exchange  for  research  and  health  policy  to  improve  treatment,  diagnosis  and 
prevention of diseases, initially focusing on the following pilot areas:  

 

faster  diagnosis  and  better  treatment  of  rare  diseases  for  the  almost  30  million 
people in the EU affected by one of the 5000-8000 life threatening or chronically 
debilitating rare diseases;  

  better  anticipation  of  epidemics  and  EU-wide  identification  of  cross-border 

infectious threats; and  

  use  of  "real  world  data"46  (collected outside  formal  clinical  trials)  by  healthcare 
professionals,  public  authorities  and  industry  to  ensure  that  healthcare  products, 
innovative technologies and therapies meet patient's needs and lead to favourable 
health outcomes.  

These  pilot  actions  will  aim  to  bring  together  appropriate  programmes,  initiatives  and 
actors, both at EU and national level. This includes research programmes, the European 
Surveillance System for infectious disease surveillance47, medical expertise and work of 
the European Reference Networks, the European Platform for Rare Diseases Registration, 
and the global rare diseases information  repository  (Orphanet)  within  the framework of 
the planned European Joint Programme Co-fund on Rare Diseases. The pilot actions will 
be developed with clinical associations, national competent authorities, health technology 
assessment bodies, research infrastructures, industry, the Innovative Medicines Initiative 
and relevant EU agencies48.  

Beyond  these  initial  pilot  areas,  others  may  also  be  considered,  notably  focusing  on 
cancer or neurodegenerative diseases (establishing links with appropriate initiatives such 
as the Human Brain Project).  

These  activities  will  increase  the  quality  of  data,  standardise  data  collection,  promote 
interoperability  of  European  disease  registries  (such  as  the  cancer  and  rare  disease 
registries supported by the Joint Research Centre) and advance the analysis of data using 
of high performance computing and modelling. In this way, a critical mass of usable data 
will  support  vital  knowledge  generation  and  help  improve  prevention,  diagnosis  and 
treatment  of  patients.  Furthermore,  the  Commission  will  explore  with  scientific 
representatives  and  clinical  groups  how  best  to  stimulate  demand  for  data  aggregation, 
addressing incentives and concerns, such as safeguarding data protection compliance, for 
the further processing of health data.  

46  Real  world  data  is  big  data,  referring  specifically  to  any  type  of  data  not  collected  in  a  randomised 
clinical trial. This data can complement randomised clinical trial data to fill the knowledge gap between 
clinical  trials  and  clinical  practice,  provide  new  insights  into  disease  patterns  and  help  improve  the 
safety and effectiveness of health interventions. 

47 Decision 1082/2013/EU on serious cross-border threats to health 
48  Such  as  the  European  Centre  for  Disease  Prevention,  the  European  Food  Safety  Authority  and  the 

European Medicines Agency 

9 

 
 
 
 
 
 
                                                 
Resources  will  be  mobilised  through  the  EU  research  programme  Horizon  202049, 
including  the  Innovative  Medicines  Initiative,  the  third  "Health"  programme50,  and  the 
Connecting  Europe  Facility51  (Broadband  and  Information  and  Communication 
Technologies). Additional support from the Member States will be encouraged to allow 
the  pilots  to  reach  their  full  potential.  Additional  funding  for  this  might  be  considered 
also  under  the  next  EU  multi-annual  financial  framework  to  more  closely  link  existing 
European resources to a world-leading health data and computation infrastructure able to 
effectively support scientific research and personalised medicine.  

The  Commission  will,  while  ensuring  full  compliance  with  data  protection  legislation 
and ethical principles: 
  Set  up  a  mechanism  for  the  voluntary  coordination  of  authorities  and  other 
stakeholders  to  share  data  and  infrastructure  for  prevention  and  personalised 
medicine  research. This includes a European network on genomics, and seeking  to 
link also with ongoing '-omics' and human cell mapping initiatives.  

  Support the development of  technical specifications for  secure access and cross-
border exchange of genomic and other health datasets within the internal market 
for research purposes. This is to facilitate interoperability of relevant registries and 
databases in support of personalised medicine research. 

  Launch pilot actions, pooling data and resources across the EU, to demonstrate the 
benefits  of  advancing  research,  disease  prevention,  personalised  medicine,  health 
technology assessment, as well as clinical and regulatory decision making; and 

  Support all the above by mobilising funds from Horizon 2020 and the Connecting 
Europe  Facility  (Broadband  and  Information  and  Communication  Technologies),) 
within  the  current  envelopes,  and  consider  further  support  from  the  next  multi-
annual financial framework. 

5.   DIGITAL TOOLS FOR CITIZEN EMPOWERMENT AND FOR PERSON-CENTRED CARE  

The ageing of the population together with the growing burden of chronic conditions and 
multi-morbidity  are  steadily  increasing  demand  for  health  and  care.  This  means  health 
and  social  care  systems  have  to  develop  a  different  approach  to  enable  more  effective 
care delivery and to confront the complexity of different services which patients are now 
expected to navigate. That is why it is widely recognised that health systems need to shift 
from treatment to health promotion and disease prevention, from a focus on disease to a 
focus  on  well-being  and  individuals,  and  from  service  fragmentation  to  the  integration 
and  coordination  of  services  along  the  continuum  of  care.  Member  States  and  regional 

49  Regulation  (EU)  No  1291/2013  of  the  European  Parliament  and  of  the  Council of  11  December  2013 
establishing Horizon 2020 - the Framework Programme for Research and Innovation (2014-2020) and 
repealing Decision No 1982/2006/EC, OJ L 347 of 20.12.2013 

50 Regulation (EU) No 282/2014 of the European Parliament and of the Council of 11 March 2014 on the 
establishment  of  a  third  Programme  for  the  Union's  action  in  the  field  of  health  (2014-2020)  and 
repealing Decision No 1350/2007/EC, OJ L 86 of 21.3.2014 

51  Regulation  (EU)  No  1316/2013  of  the  European  Parliament  and  of  the  Council of  11  December  2013 
establishing  the  Connecting  Europe  Facility,  amending  Regulation  (EU)  No  913/2010  and  repealing 
Regulations (EC) No 680/2007 and (EC) No 67/2010, OJ L 348 of 20.12.2013 

10 

 
 
 
                                                 
authorities  are  already  moving  forward  with  such  reforms  in  order  to  improve  the 
effectiveness, accessibility and resilience of their health systems52.  

To better advance health promotion, prevent disease and deliver integrated services based 
on  people's  needs,  health  systems  have  to  find  innovative  solutions  through  new 
technologies,  products  and  organisational  changes.  Central  to  the  success  of  this 
transformation are:  

 

 

 

the configuration of new care models,  

the  use  of  health  technology  assessment  for  attaining  greater  quality  and 
sustainability of health services53,  

the involvement of multi-disciplinary care teams with new or redesigned roles for 
care professionals,  

 

the integration of promotion and prevention into primary care,  

  a health workforce of sufficient capacity and appropriate skills,  

 

 

the active cooperation between care professionals and patients, and  

the  utilisation  of  digital  solutions,  all  of  which  provide  the necessary  means  for 
delivery of efficient and cost-effective care.  

Person-centred  approaches  to  organising  health  and  care  can  allow  citizens  to  assume 
responsibility  for  their  health,  improve  their  well-being  and  the  quality  of  care  and 
contribute  to  sustainable  health  systems.  By  using  digital  solutions,  such  as  wearables 
and  mHealth54  apps,  citizens  can  actively  engage  in  health  promotion  and  self-
management  of  chronic conditions. This  in  turn  can  help control  the  rising  demand  for 
health and care. Digital tools hold great potential to disseminate scientific knowledge in 
an easily accessible form, so as to help people stay in good health – thus preventing them 
from  turning  into  patients.  Building  on  scientific  information  on  risk  factors,  digital 
solutions  can  be  used  across  all  sectors,  including  in  education,  transport,  and  urban 
policies  to  promote  information  and  awareness campaigns  on  healthy  lifestyles.  Digital 
tools also enable citizens to provide feedback and data about their health to their doctors. 
This can improve the quality of health services and ultimately people's health and well-
being. 

So far, such new care models have typically been deployed on a small scale, but initial 
evidence indicates their benefits  for both  patients  and health and  care systems.  For this 

52 See footnotes 1, 3, 6, 7 and also:  

-  Council  Conclusions:  Towards  modern,  responsive  and  sustainable  health  systems,  OJ  C  202, 
8.7.2011, p. 10–12  &  
- Council Conclusions on the EPC - Commission Joint Report on health care and long-term care in the 
EU, 8 November 2016, http://data.consilium.europa.eu/doc/document/ST-14182-2016-INIT/en/pdf   & 
- Strategic Implementation Plan of the European Innovation Partnership on Active and Healthy Ageing. 
Examples of implementation can be found in the Reference Sites of the partnership.  

53 COM(2018) 51 final 
54  Mobile  Health  (mHealth)  is  a  sub-segment  of  eHealth  and  covers  medical  and  public  health  practice 
supported by mobile devices. It especially includes the use of mobile communication devices for health 
and well-being services and information purposes as well as mobile health applications. See COM(2014) 
219 Green Paper on mobile health (http://ec.europa.eu/newsroom/dae/document.cfm?doc_id=5147) 

11 

 
                                                 
transformation  to  truly  materialise,  there  will  have  to  be  full-scale  deployment  of  new 
care models. Only then will it be possible to  deliver  better  health  outcomes  for people, 
achieve  efficiency gains for health  and care systems,  reduce the risk  of  a digital divide 
and allow equitable and inclusive access to better health services for all segments of the 
population.  

However, this  transformation  is complex and  only  possible  if the  many  different actors 
engage  in  a  joint  effort.  It  requires:  (i)  significant  financial  investment  at  a  time  when 
health  and  social  care  systems  are  under  financial  pressure;  (ii)  commitment  and 
knowledge  of  how  to  ensure  such  an  investment  leads  to  successful  and  cost-effective 
implementation  of  digitally-enabled,  person-centred  care  solutions;  and  (iii)  market 
conditions  that  can  facilitate  economies  of  scale  for  the  suppliers  of  technology  and 
services.  As  these  preconditions  have  not  yet  been  adequately  fulfilled,  the  health  and 
care  sector  in  Europe  has  so  far  been  relatively  slow  in  implementing  and  scaling  up 
innovative solutions for person-centred care.  

The  Commission  will  therefore  work  with  relevant  actors  (such  as  Member  States, 
regions,  technology  and  service  providers,  health  and  care  professionals,  civil  society 
organisations,  academia,  investors  and  existing  stakeholder  platforms)  to  support  more 
cooperation across borders and enlarge the deployment of digitally-enabled care models.  

In  particular,  the  Commission  will  encourage  closer  cooperation  between  regional  and 
national  authorities  to  stimulate  the  development  of  the  health  technology  sector.  This 
includes supporting start-ups and small and medium-size enterprises that develop digital 
solutions  for  person-centred  care  and  patient-feedback.  The  cooperation  will  involve 
public  authorities  and  other  stakeholders  committed  to  promoting  shared  or  mutually 
recognised principles for validating and certifying digital solutions for adoption in health 
systems (for instance, mHealth and independent living). 

Addressing  the  demand  side  of  the  digital  transformation  of  health  and  care,  the 
Commission will help Member States and regional authorities develop their capacity to 
engage in this transformation and receive technical assistance. It will do this by building 
on  the  achievements  and  assets  of  existing  programmes  and  EU  initiatives55  and  by 
forging synergies between them in order to deliver a range of actions, which will include: 
(i)  provision  of  knowledge  resources  such  as  guidelines,  tools,  innovative  and  best 
practices  as  well  as  reference  catalogues56;  (ii)  technical  support  for  implementation, 
twinning actions for mutual learning and transfer of innovative practices between regions 
and Member States, large-scale pilots and cross-border innovative procurement projects; 
(iii) development of toolkits with indicators to measure patient-reported outcomes, use of 
digital  technologies  in  health  and  care,  and  evidence  of  impact;  and  (iv)  protocols  to 
tackle the reliability of health information.  

Additionally, it is necessary to facilitate investment opportunities in Member States and 
regions  to  leverage  public  and  private  investment  for  the  large-scale  deployment  of 
digitally-enabled,  integrated  person-centred  care.  This  will  include  actions  to  raise 

55 Such as: the European Innovation Partnership on Active and Healthy Ageing, the European Institute of 
Technology's  Knowledge  and  Innovation Community on  Health,  the  Member  State  Steering  Group  on 
Health  Promotion  and  Prevention  and  Management  of  Non-Communicable  Diseases,  the  EU  Expert 
Group  on  Health  Systems  Performance  Assessment,  the  Active  Assisted  Living  Joint  Programme 
community, as well as the Internet of Things platforms for digital health and care under the Digitising 
European Industry initiative. 

56 Such as the EU catalogue of ICT Standards for public procurers. 

12 

 
                                                 
awareness of financing opportunities  and innovative procurement, promote the strategic 
use of EU financing instruments, increase access to multi-source investment opportunities 
and promote stakeholder collaboration and community building for investments.    

The  Commission  will  support  actions  in  the  fields  described  above  with  funding  from 
Horizon  2020  and  the  third  "Health"  programme.  Also,  the  Structural  Reform  Support 
Service is available to provide technical support to Member States upon their request and 
subject to budget availability. The Commission will also promote synergies in this area 
with the European Structural and Investment Funds and the European Fund for Strategic 
Investments.  Further  funding  might  also  be  considered  under  the  next  EU  multi-annual 
financial framework.  

The Commission will: 

  Support  cooperation  to  stimulate  the  supply  and  uptake  of  digital  health  by 
promoting common principles for validating and certifying health technology.  
  Support  the  exchange  of  innovative  and  best  practices,  capacity  building  and 
technical  assistance  for  health  and  care  authorities  (for  using  open  standards  and 
interoperable  digital  solutions  to    promote  health,  prevent  and  manage  chronic 
conditions, empower  people and centre  care on the person), with  financial support 
from  Horizon  2020,  the  Structural  Reform  Support  Programme57  and  the  third 
"Health"  programme,  within  the  current  budgets,  while  considering  making 
proposals for further support under the next multi-annual financial framework. 

  Raise  awareness  about  innovative  procurement  and  investment  possibilities  for 
digital  transformation  in  public  health  and  healthcare,  mobilising  relevant  EU 
programmes and financial instruments, collaborating with the European Investment 
Bank and investor networks, and considering further support, including possible co-
investment approaches, under the next multi-annual financial framework. 

  Promote  knowledge  and  skills  of  citizens,  patients  and  health  and  care 
professionals  in  using  digital  solutions  in  collaboration  with  health  professional 
organisations and academia. 

6. THE WAY FORWARD 

Innovative digital solutions can boost people's health and quality of life and enable more 
efficient ways of organising and delivering health and care services. For this to happen, 
they must be designed to meet the needs of people and health systems and be thoughtfully 
implemented to suit the local context. Digital technologies should be seen as an integral 
part  of  health  and  care  and  geared  towards  the  wider  objectives  of  health  systems.  The 
actions  put  forward  in  this  Communication  aim  in  particular  to  support  the  Member 
States’ strategies on reforming health systems.  

The  swift  deployment  of  innovative  digital  health  solutions  can  best  be  achieved  by 
working  together  at  EU  level,  sharing  experiences  in  deploying,  measuring  impact  and 
transferring innovation across Member States and regions. The active engagement of all 

57  This  includes  informing  and  encouraging  Member  States  also  to  explore  the  possibilities  of  receiving 
technical  support  from  the  Structural  Reform  Support  Service,  with  regard  to  (i)  the  use  of  digital 
solutions  for  health  systems,  and  (ii)  the  development  of  a  strong  digital  governance  framework  in 
healthcare. 

13 

 
 
 
 
                                                 
parties  is  essential  to  succeed  in  creating  a  “triple  win”  that  benefits  people,  health 
systems and the market.  

14