COMMUNICATION FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT AND THE COUNCIL A European Health Data Space: harnessing the power of health data for people, patients and innovation
Date: 2022-05-03
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: cross-border cooperation, cross-frontier data flow, data protection, e-Health, exchange of information, health care system, innovation, organisation of health care, personal data, protection of privacy

EN 

  EN 

   EUROPEAN COMMISSION  Strasbourg, 3.5.2022  COM(2022) 196 final  COMMUNICATION FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT AND THE COUNCIL A European Health Data Space: harnessing the power of health data for people, patients and innovation  
 
 
  INTRODUCING THE EUROPEAN HEALTH DATA SPACE:  

Digitalisation is essential for the future of healthcare. The digital transformation is crucial to 
provide  better  healthcare  to  citizens,  to  build  stronger  and  more  resilient  health  systems,  to 
support long-term competitiveness and innovation in the EU’s medical industry, and to help 
the EU recover from the pandemic.  

Data is an indispensable part of today’s world. When used responsibly and in full respect of 
fundamental  rights,  it  can  bring  incredible  benefits  to  every  aspect  of  our  everyday  lives, 
including  our  health.  Member  States’  health  systems  already  generate,  process  and  store  a 
vast  amount  of  data.  Yet  it  often  remains  difficult  for  citizens  to  access  their  health  data 
electronically and for researchers to use it to improve diagnosis and treatments.  

Today, a vast amount of health data is generated every second, providing healthcare services 
and  researchers  with  potential  valuable  insights.  Health  data  reuse  is  estimated  to  be  worth 
around EUR 25-30 billion annually. That figure is expected to reach around EUR 50 billion 
within 10 years1. However, the complexity and divergence of rules, structures and processes 
within  and  across  Member  States  makes  it  difficult  to  easily  access  and  share  health  data. 
This creates barriers to healthcare delivery and innovation, leaving patients unable to benefit 
from  its  potential.  Moreover,  health  systems  are  becoming  the  target  of  cyberattacks. 
Therefore,  the  healthcare  sector  and  relevant  cyber  security  authorities  need  to  consider 
cybersecurity  as  a  key  factor  for  ensuring  the  resilience  and  availability  of  key  healthcare 
services2. 

In essence, today’s EU health sector is rich in data, but poor in making it work for people and 
science. The EU needs to tap into this huge potential to turn the wealth of health data across 
Europe  into  knowledge  at  the  service  of  citizens,  and  to  better  prevent,  diagnose  and  treat 
diseases.  Health  data  can  help  achieve  more  efficient,  higher-quality,  safer  and  more 
personalised care, and help improve healthcare delivery. Health data3 and data science could 
dramatically  transform  public  health  and  revolutionise  healthcare  systems,  enabling  life-
saving healthcare improvements. Health data can also play a crucial role in speeding up the 
development of new medical products and treatments for patients who need them most.  

The COVID-19 pandemic has clearly demonstrated the importance of digital services in the 
health  domain.  It  has  shown  that  up-to-date,  reliable  and  FAIR4  health  data  is  key  in 
providing  an  efficient  public  health  response  to  crisis  and  in  developing  effective 

1 Calculated as a share of the estimated value of data-sharing in the EU. For more information, see the impact 
assessment, Annex 5.  
2 https://www.enisa.europa.eu/topics/critical-information-infrastructures-and-services/health. 
3 Personal information on health status of an individual, or non-personal information related to health, such as 
statistics, anonymous or aggregated data. This includes both medical data (information provided by the patient, 
diagnosis,  doctor  referrals  and  prescriptions,  medical  examination  reports,  laboratory  tests,  radiographs,  data 
acquired or processed in the context of health research or policy making, such as disease registries or data from 
registries  with  side  effects  of  medicinal  products  or  medical  devices  etc.),  administrative  and  financial 
information  about  health  (including  invoices  for  healthcare  services  and  medical  certificates  for  sick  leave 
management etc.), but also determinants of health (social, behavioral, environmental). 
4  FAIR  principles:  findability,  accessibility, 
principles/). 

interoperability,  reusability  (https://www.go-fair.org/fair-

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treatments  and  vaccines.  It  has  also  significantly  accelerated  the  uptake  of  digital  tools, 
such  as  electronic  health  records  (personal  medical  records  or  similar  documents  in  digital 
form), e-prescriptions and digital health applications, as well as the sharing of research data. 
Digital health products and services, including telehealth5, are no longer novelties. They are 
becoming a part of everyday care delivery.  

Harnessing the power of health data through the digital transformation is especially relevant 
when  patients  move  within  or  to  other  EU  countries;  and  when  researchers,  innovators, 
policy-makers  or  regulators  need  critical  data  that  can  enable  the  power  of  science  to  help 
patients. Similarly, sharing health data in border regions where individuals access healthcare 
services across the border much more frequently will be far easier. 

Increased interoperability for health data among healthcare providers could lead to significant 
savings  for patients  and  health systems, given that  around 10% of  medical  images  taken in 
the EU Member States (costing around EUR 14 billion a year) are considered unnecessary6. 
Also,  thanks  to  e-Prescriptions,  errors  in  dispensing  medical  products  could  be  reduced  by 
6%  on  average7  and  up  to  15%8  in  more  digitalised  countries.  It  is  also  estimated  that 
systematic use of MyHealth@EU9 in the cross-border context, could result overall in EUR 
2-3  billion  in  savings  through  the  services  of  electronic  cross-border  prescriptions 
(corresponding to EUR 37-52 million additional dispensations over 10 years)10. 

In  order  to  unleash  the  potential  of  health  data  the  Commission  is  presenting  a  legislative 
proposal to create a European Health Data Space, to empower individuals to take control of 
their own health data and to allow its use for better healthcare delivery, and to enable the EU 
to  make  full  use  of  the  potential  offered  by  a  safe  and  secure  exchange,  use  and  reuse  of 
health data, without the existing obstacles.  

5 Provision of healthcare services and medical information using innovative technologies (especially 
information and communication technologies), in situations where the health professional and the patient (or 
two health professionals) are not in the same location. 
6 According to the impact assessment, p. 51. 
7 https://www.hiqa.ie/sites/default/files/2018-05/ePrescribing-An-Intl-Review.pdf.  
8 https://www.hiqa.ie/sites/default/files/2018-05/ePrescribing-An-Intl-Review.pdf. 
9 Cross-border digital infrastructure for the exchange of health data, also known  as the eHealth Digital Service 
Infrastructure (previously referred to as “eHDSI”). 
10 According to the impact assessment, forthcoming, p 51. 

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Figure 1 - Main objectives of the European Health Data Space 

People  are  keen  to  share  their  data,  if  there  is  a  framework  that  merits  their  trust11.  EU 
citizens will be able to access and share their data in real time, while retaining greater control 
over  it.  The  European  Health  Data  Space  will  allow  a  more  effective,  accessible  and 
resilient healthcare and better quality of life, while giving individuals control over their 
health  data  and  unleashing  the  potential  of  the  data  economy.  As  such,  the  European 
Health Data Space will have a significantly positive impact on fundamental rights as regards 
personal  data  protection  and  free  movement.  Properly  articulated  with  the  European  Open 
Science  Cloud  (EOSC)  data  space  and 
life  sciences  data 
infrastructures12,  it will enable researchers, innovators and policy-makers to more effectively 
use the data securely and in a way that safeguards privacy.  

the  relevant  European 

Through  the  Conference  on  the  Future  of  Europe,  citizens  have  explicitly  called  for  the 
creation of a European Health Data Space. As such, the European Health Data Space is a key 
pillar of the strong European Health Union presented by the Commission on 11 November 
2020 to strengthen preparedness and response during health crises and deliver resilient health 
systems. The European Health Union is about protecting everyone’s health – leaving no-one 
behind. It builds on the solidarity that is both the bedrock of the EU and the recipe for success 
in  tackling  COVID-19.  The  European  Health  Data  Space,  which  is  also  one  of  the  actions 
under the European Pillar of Social Rights Action Plan,  will drive this forward –  so that 
the European Health Union can deliver for everyone.  

The European Health Data Space will link data sets and make them accessible, facilitating the 
search for the next game-changing health innovation. It is the first common EU data space 

11 https://ec.europa.eu/health/system/files/2021-02/ms_rules_health-data_en_0.pdf. 
12  The  European  Strategy  Forum  on  Research  Infrastructures,  through  its  strategic  Roadmaps,  facilitated  the 
establishment  of  European  research  infrastructures  dedicated  to  health  research  data,  biobanking  collections, 
medical imaging data, and others. Details available at: https://roadmap2021.esfri.eu/. 

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in  a  specific  area  to  emerge  from  the  EU  strategy  for  data13  and  is  an  integral  part  of  the 
digital transition priority of the European Commission14.  

The  European  Health  Data  Space  builds  on  the  General  Data  Protection  Regulation 
(GDPR)15,  proposed  Data  Governance  Act16,  draft  Data  Act17  and  NIS  Directive18.  As 
horizontal  frameworks,  they  provide  rules  (including  security  measures)  that  apply  to  the 
health sector. But the special sensitivity of health data has been recognised and is addressed 
by  the  current  proposal19.  The  Commission  also  plans  to  adopt  a  proposal  for  a  Cyber 
Resilience  Act  in  2022.  This  Act  would  set  out  the  cybersecurity  requirements  for  digital 
products  and  ancillary  services.  The  security  requirements  set  out  in  the  European  Health 
Data  Space,  notably  as  regards  electronic  health  record  systems,  provide  more  specific 
requirements for the health sector, such as access control. The European Health Data Space 
complements  these  initiatives  and  provides  more  tailor-made  rules  for  the  health  sector, 
where needed. 

Trust is a fundamental enabler for the success of the European Health Data Space. Citizens 
must be  confident that their health data is  adequately  protected. The  European Health Data 
Space  will  provide  a  trustworthy  setting  for  secure  access  to  and  processing  of  a  wide 
range  of  health  data.  Data  protection,  cyber  security,  legality  of  processing  data  and 
personal control of data: these principles share the aim of ensuring that citizens can trust the 
system. They are the building blocks of the European Health Data Space.  

  CHALLENGES IN HARNESSING THE POWER OF HEALTH DATA  

Today,  individuals  face  challenges  in  exercising  their  right  to  control  their  health  data, 
including  accessing  and  transferring  their  data  within  the  same  Member  State  and  across 
borders, despite the relevant rules laid down in the GDPR. Not all Member States have set up 
systems  to  exchange  electronic  health  records  and  there  are  significant  deficiencies  in  the 
interoperability  of  the  systems.  Patient  summaries  and  e-prescription  services  exist  in  two-
thirds of all Member States and are most frequently accessed via an online portal, but only in 
a few Member States can they be sent or received across borders. Furthermore, 11 Member 
States  are  still  using  paper  printouts  for  prescriptions20.  Only  ten  Member  States  support 
access  to  patient  summaries  or e-prescriptions  via MyHealth@EU21 when  data subjects  use 

13  European  Commission.  A  European  data  strategy,  2020.  (https://ec.europa.eu/info/strategy/priorities-2019-
2024/europe-fit-digital-age/european-data-strategy_en).  
14https://ec.europa.eu/info/strategy/priorities-2019-2024/europe-fit-digital-age/shaping-europe-digital-future_en. 
15 https://eur-lex.europa.eu/eli/reg/2016/679/oj.  
16 Proposal for a Regulation on European data governance (Data Governance Act) COM/2020/767, https://eur-
lex.europa.eu /legal-content/EN/TXT/?uri=CELEX%3A52020PC0767. 
17 Proposal for a Regulation on harmonised rules on fair access and use of data (Data Act) COM/2022/68 final. 
18 https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex:32016L1148.  
19 https://tehdas.eu/app/uploads/2021/06/tehdas-why-health-is-a-special-case-for-data-governance-2021-06-
23.pdf. 
20  Thiel,  R.,  Lupiáñez-Villanueva,  F.,  Deimel,  L.,  Gunderson,  L.  and  Sokolyanskaya  A.  (2021).  eHealth, 
Interoperability  of  Health  Data  and  Artificial 
the  EU. 
https://ec.europa.eu/newsroom/dae/redirection/document/79897. 
21 Cross-border digital infrastructure for the exchange of health data, also known as the eHealth Digital Service 
Infrastructure (previously referred to as “eHDSI”), https://eur-lex.europa.eu/legal-content/en/TXT/?uri= 
CELEX%3A32019D1765. 

for  Health  and  Care 

Intelligence 

in 

4 

 
 
                                                 
healthcare  services  of  another  Member  State.  Other  data,  such  as  medical  images  or 
laboratory results, are not exchanged yet22.  

Healthcare delivery and innovation are hampered by widely varying digital health solutions 
(often  incompatible  with  each  other,  between  Member  States  and  sometimes  even  within 
Member  States),  fragmented  standards  and  specifications,  and  various 
legal  and 
administrative  rules.  Due  to  different  standards  and  limited  interoperability,  industry  faces 
barriers and additional costs both nationally and when entering the markets of other Member 
States. Moreover, due to implementation of the GDPR in a fragmented manner in this area, it 
is more difficult to carry out cross-border studies. 

Current challenges in using health data 

People  cannot  always  easily  access  their  health  data  electronically,  and  if  they  want  to 
consult doctors in more than one hospital or medical centre, they often cannot share the data 
with  other  health  professionals.  Today,  a  patient’s  health  data  is  often  still  recorded  on 
paper,  untraceable  and  scattered  across  various  places  (hospitals,  general  practitioners’ 
venues, medical centres, etc.).  

The situation becomes even more difficult when crossing national borders. If a patient visits a 
doctor  in  another  country,  their  medical  information  (including  diagnostic  images)  is  often 
not accessible, which can lead to delays and errors in diagnosis or treatment. In most cases, 
doctors  cannot  see  the  patient’s  health  data  if  they  have  undergone  health  interventions  in 
another  country.  Continuity  of  care  and  rapid  access  to  personal  electronic  health  data  is 
even  more  important  for  residents  in  border  regions,  crossing  the  border  frequently  to 
receive healthcare. 

The  open  public  consultation23  for  the  European  Health  Data  Space  proposal  showed  that 
88%  of  respondents  think  it  should  promote  citizens’  control  over  their  own  health  data, 
including  access  to  health  data  and  transmission  of  their  health  data  in  electronic  format. 
84% of  respondents  say that citizens should have the right to  transmit one’s health data  in 
electronic  format  to  another  professional  or  entity  of  their  choice  and  82%  feel  that  they 
should  have  the  right  to  request  public  healthcare  providers  to  share  their  health  data 
electronically  with  other  healthcare  providers/entities  of  their  choice.  83%  of  respondents 
say that the European Health Data Space should facilitate delivery of healthcare for citizens 
across borders.  

Researchers and industry, along with policy-makers and innovators, face important obstacles 
in  accessing  the  data  they  need  to  develop  new  products,  to  take  informed  decisions  or  to 
monitor  the  side  effects  of  medicinal  products  over  the  long  term,  based  on  real-world 
evidence, with impact  on patient  safety.  In many cases, consent24 is  the only way to  access 
data for research, policy-making and regulatory purposes. It is very costly and cumbersome 
for researchers to get consent from every patient to use the patient’s data in their research. 

22 https://ec.europa.eu/health/ehealth-digital-health-and-care/electronic-cross-border-health-services_en. 
23 https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/12663-A-European-Health-Data-
Space/public-consultation_en. 
24 https://tehdas.eu/app/uploads/2021/09/tehdas-summary-of-results-case-studies-on-barriers-to-sharing-health-
data-2021-09-28.pdf.  

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Even  when  the  patient  consents,  data  holders  are  sometimes  reluctant  to  provide  data  for 
reasons other than data protection and prefer to keep the health data for their activities. The 
current regulatory fragmentation between Member States hampers research and innovation 
by small players, as well as cross-border research. 

89% of respondents in the public consultation believe that the European Health Data Space 
should support and accelerate research in health. 

The digital health industry faces problems when placing new products and services on the 
market, given the fragmentation of standards and specifications for storing and sharing data. 
This  often  forces  healthcare  providers  to  adopt  new  standards  that  erect  barriers  to  new 
entrants. There is a variety of different standards and specifications of various organisations. 
Therefore, many producers of digital health products and providers of digital health services 
cannot  market  their  products  and  services  in  other  Member  States  without  incurring 
additional costs to adapt them to the national standards. Moreover, industry has difficulties to 
access health data for secondary use, which impacts on their innovation capacity.  

Researchers and innovators still face challenges in accessing critical data that can boost the 
faster  translation  of  research  results  into  benefits  for  patients,  despite  substantial  progress 
through  the  establishment  of  European  Research  Infrastructures25.  These  have  led,  for 
example,  to  the  creation  of  the  European  COVID-19  Data  Platform26.  Fragmented  and 
divergent legal and administrative rules, frameworks, processes, standards and infrastructure 
for  reusing  health  data  restrict  researchers  and  innovators’  access  to  health  data.  They  also 
limit the availability of innovative health products and service. 

For policy-makers and regulators, the limited use of health data puts limits on making more 
efficient  and  effective  healthcare  and  public  health  policy,  which  is  crucial  particularly  for 
effective health crisis management. This was very evident during the COVID-19 pandemic, 
when the European Centre for Disease Prevention and Control and the European Medicines 
Agency  struggled  to  obtain  rapid  access  to  data  and  evidence  for  decisions  and  scientific 
guidance on the response to the pandemic.  

25  The  European  Strategy  Forum  on  Research  Infrastructures,  through  its  strategic  Roadmaps,  facilitated  the 
establishment  of  European  research  infrastructures  dedicated  to  health  research  data,  biobanking  collections, 
medical imaging data, and others. Details available at: ESFRI Roadmap 2021. 
26 COVID-19 Data Portal - accelerating scientific research through data (covid19dataportal.org). 

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Figure 2 - Problems in controlling, using and sharing health data 

Over half of Member States do not have specific legislation on reusing electronic health data 
for  research,  policy-making  or  regulatory  purposes  for  instance,  and  rely  on  the  general 
provisions  of  the  GDPR,  often  using  consent  for  processing  health  data27.  This  situation 
results in limited health data reuse. Not all Member States have a competent body for health 
data  access,  but  where  such  a  body  exists,  the  number  of  requests  to  use  health  data  for 
research  or  policy-making  projects  is  rapidly  increasing,28  showing  the  interest  in  such  a 
system and suppressed demand.  

There  is  evidently  a  need  for  a  regulatory  framework  that  directly  addresses  the  rights  of 
individuals,  reduces  fragmentation  in  the  digital  single  market  and  enables  researchers, 
innovators and policy-makers to more effectively use the data securely.   

EU-wide  action  is  necessary  and  appropriate  therefore,  to  promote  the  free,  cross-border 
flows of personal health data and to foster a genuine internal market for personal health data 
and digital health products and services. In short, it will help deal with problems that would 
otherwise persist.  

27 Hansen J. et al, Assessment of the EU Member States’ rules on health data in the linght of GDPR, available at 
https://ec.europa.eu/health/system/files/2021-02/ms_rules_health-data_en_0.pdf. 
28 According to the impact assessment accompanying the proposal (p 15), forthcoming. 

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  THE CONCEPT OF A EUROPEAN HEALTH DATA SPACE  

Trust as the foundation of the European Health Data Space 

Stakeholder  consultations,  and  particularly  the  open  public  consultation29,  have  shown  that 
strengthening trust in the sharing of health data and ensuring security and privacy are key for 
citizens, and they must be the cornerstone of the European Health Data Space.  

Unleashing the benefits of science and research requires structural solutions at EU level. And 
to  strengthen  trust  in  the  sharing  of  health  data,  security  and  privacy  are  fundamental 
principles of the European Health Data Space. Accordingly, the European Health Data Space 
includes clear provisions on how data has to be kept secure. 

Concretely,  the  European  Health  Data  Space  builds  on  strong  data  protection  and 
cybersecurity elements. The proposal introduces security criteria for electronic health record 
systems, in addition to interoperability. It builds upon the possibility offered by the GDPR to 
put forward an EU law supporting the use of health data for diagnosis and treatment, but also 
for  research,  statistics  or  for  public  interest,  such  as  protecting  against  serious  cross-border 
threats  to  health  or  ensuring  high  standards  of  quality  and  safety  of  healthcare  and  of 
medicinal products or medical devices. Moreover, in the context of the European Health Data 
Space,  processing  electronic  health  data  for  secondary  use  is  only  possible  in  secure 
processing  environments,  which  need  to  comply  with  very  high  standards  of  privacy  and 
cybersecurity and no personal data can be downloaded from such environments. 

Boosting primary and secondary use of health data 

The European Health Data Space is a health specific ecosystem comprised of rules, common 
standards and practices, infrastructures and a governance framework that aims at:  

a)  empowering  individuals  through  increased  digital  access  to  and  control  of  their 

electronic personal health data and support to their free movement;  

b)  Fostering  a  genuine  single  market  for  electronic  health  record  systems,  relevant 

medical devices and high risk AI systems 

c)  providing a consistent, trustworthy and efficient  set-up for the use of health data for 

research, innovation, policy-making and regulatory activities.  

The  development  of  a  truly  common  European  Health  Data  Space  will  require  actions  at 
national and EU level, along with strong cooperation between public and private stakeholders 
(for  example,  national  digital  health  bodies,  public  health  institutes,  data  protection 
authorities, healthcare providers, health professionals, academic and research institutions, and 
patient associations).  

29 https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/12663-A-European-Health-Data-
Space/public-consultation_en. 

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Figure 3 – Primary and secondary uses of electronic health records  

This  is  where  the  two  distinct  uses  of  health  data  supported  by  the  European  Health  Data 
Space - primary and secondary use - come into play.  

The primary use of electronic health data supports the use of data for better healthcare at 
national and cross-border level. Medical data is typically stored in electronic health records, 
containing segments of a patient’s medical history (centrally or involving various healthcare 
providers). The European Health Data Space will allow people to access their health data and 
make their data available to a health professional of their choice, including when abroad and 
in  the  language  of  the  health  professional.  Thus,  the  patient  can  get  a  better  diagnosis  and 
treatment with fewer medical errors and avoid unnecessary diagnostics. 

The European Health Data Space will integrate three main product markets for primary use of 
health data: 

1)  electronic health records; 
2)  other health and medical software products (for example, medical imaging software, 
e-prescribing software, medical diagnosis software and telemedicine); and 
3)  wellness  apps  (with  a  voluntary  labelling  scheme  informing  consumers  about 
interoperability with electronic health records).30 

Key aspects of European Health Data Space: Primary use of health data 

  Patients will have their electronic health data available via access points established by 
Member  States.  A  cross-border  digital  infrastructure  for  primary  use  will  connect 
Member States and allow patients to share their health data  

  Patients  will  be  empowered  to  control  and  share  their  electronic  health  data  with  a 

healthcare provider of their choice.  

  Member  States  will  be  required  to  make  priority  categories  of  data  available  in  a 
common  European  electronic  health  record  exchange  format,  such  as  patient 
summaries,  e-prescriptions,  e-dispensations,  medical 
image  reports, 
laboratory results and discharge reports. 

images  and 

30  It  is  estimated  that  the  European  Health  Data  Space  will  produce  a  faster  growth  of  the  digital  health  and 
wellness applications markets, expected at 20-30% and 15-20% per year, respectively. 

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  Where personal health data has not been collected electronically prior to the application 
of this Regulation, Member States may decide not to convert it into an electronic format. 
  Health professionals  will be able to access electronic health records and should update 

the electronic health data of the patients they treat.  

  To  support  data  being  shared  between  healthcare  providers,  mandatory  requirements 
for interoperability, security, safety and privacy will be introduced, as well as mandatory 
self-certification of electronic health records covering interoperability and security.  
  All  Member  States  will  be  required  to  participate  in  cross-border  digital 
for  healthcare  delivery 

exchange  of  health  data 

the 

infrastructure 
for 
(MyHealth@EU)31. 

  A pilot project will support patients having access to their data on a mobile device in the 

language of the country of destination. 

  To facilitate the implementation,  transitional  periods will apply  for  certain  obligations 
including  the  registration  of  health  data,  access  of  health  professionals  to  data,  making 
data  available  in  the  European  format,  the  participation  in  the  cross  border  digital 
infrastructure,  self-certification  of  electronic  health  record  systems,  as  well  as  the 
voluntary label for wellness applications. 

  Member States will have to set up a digital health authority to ensure that the additional 

rights for individuals are properly implemented. 

The secondary use  of electronic health data takes place when  health data  is  processed  to 
inform  and  assess  public  health  policies  or  to  conduct  research.  This  can  enhance  patient 
safety  and  boost  the  development  of  new  medicines  and  medical  devices,  as  well  as 
personalised  medicine  and  products  relying  on  artificial  intelligence.  In  the  context  of 
European Health Data Space, the results of such research are made public in aggregated form 
duly preserving data privacy.  

Key aspects of European Health Data Space: Secondary use of health data 

  The European Health Data Space sets out a common EU framework allowing for use of 
health  data  for  research,  innovation,  public  health,  policy-making,  regulatory  activities 
and personalised medicine. It will draw on the creation of a new and decentralised EU-
infrastructure  for  secondary  use  of  health data  (HealthData@EU)  that  will  connect 
health data access bodies which should be set up in all Member States. 

  Those who wish to re-use health data will need to apply for a permit from a health data 
access body. The data permit sets out how the data may be used and for what purpose.  
  The  data  can  only  be  accessed  and  processed  in  closed  secure  environments  to  be 

provided by the health data access bodies with clear standards for cyber security. 

  Only anonymous data can be extracted by the user who applied for the permit from the 
secure processing environment. Where researchers, companies or public institutions need 
access to personal electronic health data they can only access it in pseudonymised form, 
i.e.  data  offering  information  about  the  disease,  symptoms  and  medication,  without 

31  Ten  Member  States  already  support  their  patients  in  sharing  data  with  foreign  health  professionals  in 
professionals’ own language and all Member States are set to join these  data exchanges. A pilot project under 
EU4Health will support patients’ access to their data in their own language.   

10 

 
 
                                                 
 

revealing to the user the identity of the individual. It is forbidden for the user to attempt to 
re-identify the data subjects. 
It  will  be  forbidden  to  use  the  data  to  take  decisions  detrimental  to  individuals,  to 
increase  insurance  premiums,  to  market  health  products  towards  health  professionals  or 
patients or to design harmful products or services. 

  Health  data  access  bodies  will  have  to  ensure  transparency:  information  will  be 
published  about  data  access  applications.  In  addition,  data  users  must  make  public  the 
results of their  electronic health data uses  and inform  the health data access  bodies of 
any significant findings relevant for the health of individuals. 

  For simple cases, users can directly request data from a single health data provider as long 

as the same safeguards for privacy and security are ensured.  

  Researchers and innovators from third countries can access data for secondary use under 

the same conditions and requirements as those from inside the EU. 

  All Member States will be required to participate in the EU-infrastructure for secondary 
use (HealthData@EU) to facilitate cross-border studies. This infrastructure will be piloted 
in a EU4Health project starting in 202232.  

A common governance 

The proposal will also reinforce the existing governance at national and EU level as regards 
health data. It builds upon the current cooperation for primary use of data, within the eHealth 
Network,  which  proved  very  intensive33,  but  also  effective  during  COVID-19  pandemic, 
managing  to  build,  in  a  record  time,  two  EU-wide  infrastructures  (EU  Digital  COVID 
Certificate and contact tracing and warning apps) 34.  

EU governance mechanism 

  A  new  European  Health  Data  Space  Board  chaired  by  the  Commission  will  be  created, 
composed of the representatives of digital health authorities and health data access bodies 
from all the Member States, and observers, depending on area of work. 
It  will  contribute  to  the  consistent  application  of  the  Regulation  throughout  the  EU,  to 
coordinate and exchange best practices and will cooperate with other bodies at EU level. 
  Member  States  will  cooperate  at  EU  level  to  ensure  the  smooth  functioning  of  the  two 

 

cross-border digital infrastructures (primary and secondary).  

   THE EUROPEAN HEALTH DATA SPACE WORKING IN SYNERGY WITH 

OTHER HEALTH POLICY PRIORITIES   

The  European  Health  Data  Space  will  become  a  powerful  instrument  for  sharing  data  to 
support tailor-made prevention and treatment protocols and expertise across borders. Pooling 
large volumes of data is a prerequisite for refining our knowledge on how to address diseases.  

32  https://ec.europa.eu/info/funding-tenders/opportunities/portal/screen/opportunities/topic-details/eu4h-2021-pj-
06. 
33 Over 400 on-line meetings of the eHealth Network and its subgroups have been organised since March 2020.  
34 https://ec.europa.eu/health/ehealth-digital-health-and-care/ehealth-and-covid-19_en. 

11 

 
 
                                                 
The  European  Health  Data  Space  will  boost  the  work  under  Europe’s  Beating  Cancer 
Plan35  and  facilitate  research  and  evidence  gathering  under  the  Horizon  Europe  Cancer 
Mission36.  Pooling  and  sharing  knowledge,  experience  and  data  helps  develop  practical 
solutions to benefit cancer patients – and, indeed, everyone in the EU.  

The European Health Data Space will open up innovative approaches to cancer registration, 
with  potential  alternatives  to  gather  timely,  geo-localised  information  on  various  types  of 
cancers. This could provide a real-time state of play of cancers across the EU. At the same 
time,  it  could  identify  trends,  disparities  and  inequalities  between  Member  States  and 
regions.  Importantly,  this  could  make  it  easier  to  spot  the  challenges  and  specific  areas  of 
action needing investment and other action at EU, national and regional level.  

With  better  telemedicine  and  remote  monitoring  tools  in  the  European  Health  Data  Space, 
we  can  make  the  most  of  virtual  medical  consultations,  training  and  continuous  education. 
This will help pool expertise for diagnosis and treatment, building on the European Reference 
Networks  model37.  It  will  also  make  cancer  screening  and  care  more  targeted,  more 
effective and accessible.  

The European Health Data Space will open new opportunities for health data to make a vital 
contribution  to  innovation and research  in  medicines and  treatments, thereby promoting  the 
development  of  new  therapies  and  medicinal  products.  This  will  help  meet  the  aims  of  the 
Pharmaceutical Strategy for Europe38 and the mandate of the European Health Emergency 
Preparedness and Response Authority (HERA).  

Moreover,  the  European  Health  Data  Space  will  make  continuity  of  care  across  EU  a 
reality. By enabling patients to share their health data (including vaccination data) with health 
professionals, in  the  professional’s own language, it will  support better  decision-making on 
treatment and care across the EU. It will also avoid unnecessary and costly repetitions of tests 
and other medical procedures. 

The  European  Health  Data  Space  recognises  the  long-standing  qualification  of  medical 
device software under the Medical Devices Regulation and the In Vitro Diagnostic Medical 
Devices Regulation39.  Where manufacturers  can state that  a medical  device  is  interoperable 
with  electronic  health  record  systems,  they  will  need  to  comply  with  the  essential 
requirements on interoperability, implemented by the self-certification scheme for electronic 
health record systems. 

5. BENEFITS OF A EUROPEAN HEALTH DATA SPACE  

The  European  Health  Data  Space  will  benefit  individuals,  health  professionals,  healthcare 
providers, researchers, regulators and policy-makers. 

35 https://ec.europa.eu/health/system/files/2021-02/eu_cancer-plan_en_0.pdf.  
36 https://ec.europa.eu/info/research-and-innovation/funding/funding-opportunities/funding-programmes-and-
open-calls/horizon-europe/eu-missions-horizon-europe/cancer_en.  
37 ERN CPMS - (ern-net.eu). 
38 https://ec.europa.eu/health/medicinal-products/pharmaceutical-strategy-europe_en.  
39 Regulations (EU) 2017/745 and (EU) 2017/746 respectively. 

12 

 
 
                                                 
Figure 4. Benefits for users of European Health Data Space 

Individuals will have greater control over their health data. If they wish, they will be able to 
provide  their  data  to  a  healthcare  professional  of  their  choice  rapidly  and  in  an  easy, 
transparent, common format. This will reduce the number of unnecessary tests and costs, and 
increase  healthcare  safety.  The  ability  to  access,  analyse,  and  share  health  data  will  make 
healthcare  more  efficient,  support  better  medical  decisions  and,  therefore,  improve  health 
outcomes.  The  European  Health  Data  Space  will  help  attain  the  Commission’s  vision  for 
EU’s  digital  transformation  by  2030,  the  Digital  Compass40  aim  of  providing  100%  of 
citizens  with  access  to  their  medical  records  and  the  Declaration  of  Digital  Principles41.  It 
will  build  on  the  Commission  proposal  for  a  European  Digital  Identity  Framework  and 
Wallet  enabling  citizens  to  have  trustworthy  cross-border  access  to  their  health  data  from 
mobile devices. 

The European Health Data Space will respect the principle of non-discrimination, addressing 
the rights and needs of persons with disabilities (i.e. access to information, freedom to choose 
between  in  person  or  digital  services)  as  well  as  those  of  rare  diseases  patients.  The  vast 
majority of people living with a rare disease are willing to share their health data to advance 
care  and  research.42  The  European  Health  Data  Space  will  unleash  the  potential  for  better 
cross-border access  to  such data and will support the development  of treatments  and health 
services for rare disease patients. The examples of the European Reference Networks and its 
Clinical  Patient  Management  Systems43  show  that  patients  located  anywhere  in  a  Member 
State can benefit from advice on the diagnosis and treatment of their rare diseases from the 
best specialists in the EU, using virtual consultation panels. 

The European Health Data Space, together with the GDPR, will give people the right to: 

40 https://ec.europa.eu/info/strategy/priorities-2019-2024/europe-fit-digital-age/europes-digital-decade-digital-
targets-2030_en. 
41 https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/13017-Declaration-of-Digital-
Principles-the-%E2%80%98European-way%E2%80%99-for-the-digital-society_en.  
42 https://ojrd.biomedcentral.com/track/pdf/10.1186/s13023-019-1123-4.pdf.  
43 https://ec.europa.eu/health/european-reference-networks/work-erns_en.  

13 

 
 
 
                                                 
-  access  their  health  data  in  electronic  form  immediately,  free  of  charge  and  in  an  easily 
readable,  accessible  and  commonly  used  format.  Data  can  be  accessed  using  patient 
portals, on computers or smart phones, depending on how the Member States make available 
this information at national level. For people with disabilities to be able to enjoy their rights, 
the access must be accessible in line with the requirements of the European Accessibility Act 
(Directive 2019/882); 

- share their data in electronic form with other health professionals when going to another 
hospital, without hindrance from previous healthcare providers or manufacturers; 

- add data to their electronic health record for themselves or for people who trust them, such 
as their children;  

- request changes to erroneous data online; 

- restrict access to their electronic health data or part of the data; in cases of vital interest, 
where  their  life  is  at  stake,  such  data  may  however  be  made  available  with  additional 
restrictions; 

- easily obtain information on which professional(s) accessed their data; 

Member  States  are  required  to  designate  digital  health  authorities  that  will  have  a 
fundamental role in enforcing the above-mentioned rights. 

Health  professionals’  work  will  be  made  easier  and  more  effective  with  more  efficient 
access  to  health  data  of  their  patients.  Member  States  should  support  professionals  in  this 
endeavour.  However,  adapting  legal  frameworks  to  secure  the  right  safeguards  and  ethical 
standards is only a first step. Comprehensive monitoring to assess the true impact of digital 
technologies  on  patient  care  and  health  outcomes  is  also  needed.  Training  health 
professionals to use digital technologies is another precondition.   

With improved interoperability, health professionals will be able to access a patient’s medical 
history, thus increasing the evidence base for decisions on treatment and diagnosis. This will 
make  healthcare  systems  more  efficient  and  reduce  costs,  because  health  professionals  will 
spend less time copying data from  multiple sources in  multiple formats,  and will  no longer 
redo the same tests. The take-up of more advanced digital technologies needs to be promoted, 
involving and training the potential users.  

Digital technologies can provide solutions to problems that health workers encounter in their 
routine tasks. Digital technologies can make daily workflows easier, reducing administrative 
burden and freeing up time for more patient-focused care. Above all, they can add value in 
clinical  practice,  helping  achieve  better  health  outcomes  for  patients.  However,  providing 
tools alone will not bring about a successful digital transformation. Health professionals need 
to be involved in the digital transformation and in co-designing digital health solutions.  

Healthcare providers will perform fewer unnecessary tests, with positive effects for patients 
and  healthcare  expenditure.  Optimising  the  use  of  health  data  has  the  potential  to  bring 
significant benefits and improve the effectiveness of healthcare systems. The health services 
sector represents approximately 10% of the EU’s GDP (2019) and includes both public and 

14 

 
 
private  providers44.  It  is  a  fundamental  ecosystem  for  both  the  wellbeing  of  Europeans  and 
the economy of the EU. With the right tools and solutions in place, it can be more efficient 
without  hampering  the  performance  of  healthcare  systems.  One  such  solution  is  to  avoid 
repeating  unnecessary  tests  by  strengthening  interoperability  to  support  data  exchange 
between  healthcare  providers  within  countries  and  across  borders.  The  Organisation  for 
Economic Co-operation and Development estimates that automatic data-sharing, among other 
things, can lead to direct financial savings of as much as 15% of hospital expenditure45. This 
comes  from  avoiding  costs  of  capturing  data  from  paper  and  reducing  errors  when 
transcribing  information.  Telemedicine  is  also  expected  to  make  healthcare  systems  more 
efficient46. A 2018 market study on telemedicine47 considered that its market potential in the 
EU was strong and expected to grow at a compound annual growth rate of 14% in the coming 
years. Overall, the benefits of primary use of health data can be quantified at EUR 5.5 billion 
over 10 years48 including savings for healthcare providers and patients in health costs thanks 
to  an  increased  uptake  of  telemedicine,  faster  deployment  of  cross-border  sharing  of  health 
data and faster growth of the digital health and wellness applications markets. 

Researchers  will  also  benefit  from  a  more  direct  way  of  obtaining  access  to  data  in  the 
context of the European Health Data Space. By obtaining access to data through health data 
access  bodies  they  will  spend  less  time  and  money  to  get  consent  for  various  research 
projects.  This  will  free  up  time  to  do  the  actual  research.  Researchers  will  have  access  to 
large troves of health data, in particular healthcare and real-world evidence (RWE) data, with 
the  higher  data  quality  and  level  of  FAIR-ness49  that  medical  breakthroughs  require. 
Researchers  will  be  able  to  know  what  data  is  available,  where,  and  of  what  quality,  in 
addition to what is already available at European Research Infrastructures. They will be able 
to access the data in a more effective and less expensive way, through a data access body that 
maintains privacy.  

Regulators and policy-makers will have easier access to health data for the benefit of public 
health and the overall functioning of healthcare systems. This will improve health outcomes 
for  patients  and  the  broader  public.  For  instance,  in  a  medium-sized  EU  country, 
renegotiating a reduction of up to 5% on the prices of various medicinal products, based on 
better knowledge of their effects, could equate to EUR 50 million a year in savings50. These 
benefits would lead to better access to healthcare, reduced costs, increased efficiency,  more 
resilient health systems, new research and innovation and better policy-making.  

44 Healthcare expenditure statistics - Statistics Explained (europa.eu). 
45 https://www.oecd.org/health/health-systems/Empowering-Health-Workforce-Digital-Revolution.pdf. 
46 https://www.oecd-ilibrary.org/docserver/8e56ede7-en.pdf?expires=1646391218&id=i d&accname=  
guest&checksum=40DB0F3D91A7741CC0D072D9196F2AEE. 
47 https://ec.europa.eu/health/system/files/2019-08/2018_provision_marketstudy_telemedicine_en_0.pdf. 
48 According to the proposal’s impact assessment, p. 58.  
49 FAIR principles: findability, accessibility, interoperability, reusability (https://www.go-fair.org/fair-
principles/). 
50 According to the proposal’s impact assessment., p. 56. 

15 

 
 
                                                 
The solution for secondary use of health data proposed by the European Health Data Space is 
expected  to  result  in  a  significant  economic  benefit  of  at  least  EUR  5.4  billion  over  the 
next 10 years51. This benefit will come from three key areas: 

  efficiency  gains  in  data  access  as  a  result  of  a  less  costly  access  to  health  data  for 
users, be they researchers, innovators, regulators or policy-makers (EUR 3.4 billion);  
  greater information transparency for policy-makers and regulators (EUR 0.8 billion); 

and  

  better value for patients, healthcare providers and innovators, thanks to further reuse 
of health data. This will be possible with the development of innovative products and 
services in health using data-intensive technologies, such as AI-based systems (EUR 
1.2 billion). 

to  real  world  conditions  (such  as 

Industry will benefit from same standards and specifications for interoperability and security 
across Europe, which will open new markets, including for SMEs. It will benefit from greater 
availability  of  electronic  health  data  through  privacy  preserving  mechanisms  for  citizens 
including  infrastructures  that  are  trustworthy  by  design,  and  the  use  of  anonymisation, 
aggregation  and  synthetic  data.  Industry  will  also  benefit  from  data  that  could  help  them 
develop  new  medicinal  products  or  new  devices  involving  AI.  Combined  with  AI 
technologies  and  access 
through  Testing  and 
Experimentation  Facilities),  this  will  greatly  boost  innovation  and  accelerate  the  discovery, 
development  and  approval  of  new  prevention  approaches  and  treatments.  Industry  will  be 
able  to  use  the  data  for  innovation;  for  developing  products  that  could  improve  people’s 
health; and for producing new and innovative medicinal products  and devices that can help 
provide better, more personalised care. However, it will be forbidden to attempt to re-identify 
the individuals whose data is used. Moreover, the European Health Data Space data cannot be 
used  to  target  individuals  or  health  professionals  to  sell  products  or  health  services,  to 
increase insurance premiums or to develop harmful products. All in all, the European Health 
Data  Space  supports  industry  in  producing  useful  innovations  for  society,  while  keeping 
health data safe.  

6. FUNDING NEEDS AND COVERAGE 

Investing  in  digitalisation  is  investing  in  better  healthcare  and  the  resilience  of  our  health 
systems.  The  EU  and  Member  States  need  to  take  this  bold  step,  together.  To  make  the 
European  Health  Data  Space  a  reality,  rapid  progress  in  the  digitalisation  of  healthcare  at 
national level is needed. This includes investments in electronic health records, telemedicine, 
interoperability,  but  also  data  quality,  institutions  and  solutions  for  secondary  use  of  health 
data. At the same time, interoperable EU-wide infrastructures to  enable  cross-border use of 
health data in the EU are also necessary.  

To make the European Health Data Space work, financing needs to cover the costs of:  

1.  deploying  and  operating  infrastructures,  at  national  and  EU  level,  meaning  national 
infrastructures,  as  well  as  support  for  the  EU  gateways  and  additional  EU  services, 
such  as  the  connection  of  Member  States  to  the  infrastructures  supporting  cross-

51 According to the proposal’s impact assessment, p. 58. 

16 

 
 
                                                 
border sharing of patients’ data in a language of the country of destination, supporting 
multi-country research and policy-making projects and compliance with cybersecurity 
and interoperability standards; and 

2.  governance  for  the  European  Health  Data  Space,  meaning  coordination  of  relevant 

bodies, financing joint actions, and supporting for EU level cooperation; 

3.  carrying out actions to support interoperability, protection of personal data, and data 
quality,  meaning  development  and  selection  of  standards  and  specifications  for  data 
sharing,  support  for  Member  States  to  code  data,  support  for  developing  the 
standardisation of new data categories, etc. 

At EU level, EUR 810 million is available to support the European Health Data Space. Over 
EUR  330  million  have  been  earmarked  for  European  Health  Data  Space  activities  and 
infrastructures:  EUR  280  million  under  the  EU4Health  Programme  and  additional  EUR  50 
million under the Digital Europe Programme. Grants will be available to Member States:  

1.  to expand MyHealth@EU to more Member States and new services (patient summaries, 
e-prescriptions and e-dispensations, images, laboratory reports and discharge), including 
also patients’ access to their health data. A pilot project under the 2021 EU4Health work 
programme  will  help  patients  obtain  their  health  data  on  their  smartphones,  in  the 
language of the country of destination;  

2.  to  provide  services  by  health  data  access  bodies  on  secondary  use  of  health  data.  An 
EU4Health  pilot  project  under  the  2021  EU4Health  work  programme  will  support  the 
development of infrastructure for secondary use of health data. 

More  than  EUR  480  million  from  Digital  Europe  Programme,  Connecting  Europe  Facility 
and Horizon Europe can be used by Member States and entities involved in European Health 
Data Space, along with other sectors. Moreover, the Digital Europe Programme will support 
the deployment of infrastructures needed to make health data securely accessible across EU 
borders  and  to  develop  common  data  spaces  (with  over  EUR  140  million  from  the  work 
programmes  2021-2022).  Where  physical  connectivity  is  lacking,  the  Connecting  Europe 
Facility will promote the interconnection of cloud infrastructures in Member States, including 
those that are needed in the European Health Data Space (EUR 130 million). Horizon Europe 
will  continue  to  support  the  needs  of  the  European  Health  Data  Space  through  specific 
research and innovation projects and coordination and support actions focusing on health data 
quality and interoperability and through the research infrastructures (around EUR 210 million 
allocated until 2022). 

In  addition,  Member  States  have  earmarked  EUR  12  billion  under  the  Recovery  and 
Resilience Facility for investments in health, including digital health and the secondary use of 
InvestEU  offer 
health  data.  The  European  Regional  Development  Fund  and 
complementarities  for  additional  investments  in  digital  health  based  on  national  needs.  The 
Commission  will  also  support  Member  States  through  the  Technical  Support  Instrument, 
upon  demand,  on  designing  and  implementing  strategies  and  action  plans  aiming  to  render 
health systems interoperable. 

17 

 
 
 
 
7. CONCLUSION 

As  the  EU  emerges  from  COVID-19  stronger,  more  united  and  better  prepared  for  future 
crises, it has become abundantly clear that, when Europe comes together, cooperates and 
pools resources, giant strides can be achieved.   

The digitalisation of healthcare in Europe is a challenge that requires such unity of purpose 
and  common  effort  in  a  strong  European  Health  Union  that  puts  citizens’  health  first.  The 
European Health Data Space will be a key driver of this.  

The  unprecedented  cooperation  in  digital  health  during  the  COVID-19  crisis  positioned 
Europe as a global standard setter, for instance with regards to EU Digital COVID Certificate 
or  contact  tracing  and  warning  apps.  Europe  must  build  upon  these  achievements  and 
reinforce cooperation with partner countries and international organisations and leadership in 
this area for stronger global health systems. 

We  now  have  an  opportunity  to  shift  another  paradigm  and  create  an  environment  that  is 
conducive to sharing and making data available, built on trust and common principles, and in 
the collective interest of everyone in the EU to truly harness the power of health data.  

This project will be built on the foundations of secure and trustworthy access to data that is 
fully in line with the fundamental values underpinning EU.  

It  is  an  opportunity  to  empower  us  all,  as  individuals,  to  profit  from  stronger  rights  and 
safeguards over our health data. It will be easier to access and share our health data with other 
health professionals, without having to re-do the same tests unnecessarily. At the same time, 
easier  access  to  interoperable  data  of  high  quality  will  also  facilitate  innovation  and  the 
development of new treatments, new vaccines and personalised medicine. 

In short, we have an opportunity to unleash the potential of health data economy.  

The  time  has  come  to  seize  that  opportunity  and  make  the  European  Health  Data  Space  a 
reality. 

18