COMMISSION STAFF WORKING DOCUMENT EXECUTIVE SUMMARY OF THE IMPACT ASSESSMENT REPORT Accompanying the document PROPOSAL FOR A REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on the European Health Data Space
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, patient's rights, personal data, protection of privacy, public health

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   EUROPEAN COMMISSION  Strasbourg, 3.5.2022  SWD(2022) 132 final  COMMISSION STAFF WORKING DOCUMENT  EXECUTIVE SUMMARY OF THE IMPACT ASSESSMENT REPORT  Accompanying the document PROPOSAL FOR A REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on the European Health Data Space {COM(2022) 197 final} - {SEC(2022) 196 final} - {SWD(2022) 130 final} - {SWD(2022) 131 final}  
 
 
A.  Need for action 
What is the problem and why is it a problem at EU level? 

The evaluation of the digital aspects of the Cross Border Healthcare Directive (2011/24/EU) (CBHD) 
shows low effectiveness of the current voluntary system. The main problems are that individuals have 
limited  control  over  their  health  data  at  national  and  cross-border  level,  digital  health  solution 
producers  face  barriers  when  entering  other  Member  States’  markets  and  individuals  cannot  benefit 
from innovative treatments due to limited access to health data by researchers, innovators and policy 
makers. 

What should be achieved? 

Ensure  that  individuals  have  control  over  their  own  health  data  (nationally  and  cross-border)  can 
benefit from  a  range  of  health-related  products  and  services  and  that  researchers,  innovators,  policy-
makers and regulators can make the most of the available health data. 

What is the value added of action at EU level (subsidiarity)? 

Despite possibilities offered by GDPR, fragmentation persist at Member States level, when accessing 
health data. Moreover, the access and portability provisions of the GDPR do not fully meet the needs of 
the  health  sector.  This  hampers  interoperability,  data  access  and  sharing,  provision  of  digital  health 
services  and  products  in  the  internal  market,  as  well  as  research,  innovation  and  policy-making, 
including responses to health crises. 

B.  Solutions 
What are the various options to achieve the objectives? Is there a preferred option or not? If not, 
why? 

Option  1:  Intervention  with  low  intensity:  It  relies  on  a  reinforced  cooperation  mechanism  and 
voluntary instruments that would cover digital health products and services and reuse of health data. It 
would be supported by improved governance and digital infrastructure. 

Option 2 and 2+: Intervention with medium intensity: It would strengthen the rights of citizens to 
control  digitally  their  health  data  and  provide  an  EU  framework  for  re-use  of  health  data.  The 
governance  would  rely  on  national  bodies  (for  primary  and  secondary  use  of  data)  that  would 
implement  the  policies  nationally  and,  at  EU  level,  would  support  the  development  of  appropriate 
requirements.  A  digital  infrastructure  would  support  cross  border  sharing  and  re-use  of  health  data. 
Implementation  would  be  supported  by  certification  and  labels,  thus  ensuring  transparency  for 
authorities, procurers and users.  

Option 3 and 3+: Intervention with high intensity:  It would go beyond Option 2 by  assigning the 
definition of EU level requirements and access to cross country health data to an existing or new EU 
body and would extend the coverage of certification. 

The  preferred  option  is  Option  2,  with  elements  of  2+  ensuring  a  certification  of  electronic  health 
records,  data  intermediation  services  comprising  electronic  health  records  and  medical  devices  that 
feed data into EHRs, as well as a voluntary label for wellness apps. This would ensure the best balance 
between effectiveness and efficiency in reaching the objectives. Option 1 would improve the baseline 
marginally, as it remains voluntary. Option 3 would also be effective, but would have higher costs, may 
impact more on SMEs and may be less feasible politically.  

What are different stakeholders' views? Who supports which option?  

There was consensus overall among stakeholders that the EHDS should promote citizens’ control over 
their own health data, including access to health data and transmission of their health data in electronic 
format  and  facilitating  cross-border  healthcare  provision.  Researchers  and  regulators  are  concerned 
about  the  current  fragmented  procedures  for  health  data  reuse  and  welcome  EU  action.  Industry 

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representatives  support  common  EU  interoperability  requirements,  but  stressed  the  need  for  a 
proportionate  approach.  A  third-party  certification  scheme  has  more  support  than  authorisation  or 
labelling,  but  support  varies  between  stakeholders.  National  representatives  support  the  rollout  of 
MyHealth@EU  and  the  creation  of  a  network  of  Health  Data  Access  Bodies,  but  warned  about  the 
need to respect national specificities. 

C.  Impacts of the preferred option 
What are the benefits of the preferred option (if any, otherwise of main ones)? 

The  preferred  option  would  ensure  that  citizens  are  able  to  access  and  transmit  digitally  their  health 
data and enable access to it, irrespective of healthcare provider and data source. MyHealth@EU would 
become mandatory and individuals could exchange their health data cross-border in a foreign language. 
Mandatory  requirements  and  certification  (for  electronic  health  records,  data  intermediation  services 
providing  EHRs  and  medical  devices  feeding  information  into  EHRs),  and  a  voluntary  label  for 
wellness  apps  would  ensure  transparency  for  users  and  procurers  and  reduce  cross-border  market 
barriers  for  manufacturers.  Researchers,  innovators,  policy-makers  and  regulators  would  be  able  to 
have  access  to  quality  data  for  their  work  in  a  secure  way,  with  a  trusted  governance  and  at  lower 
prices.  The total  economic  benefits  of  this  option  are  expected  to  be  above  EUR  11  billion,  over  10 
years. 

What are the costs of the preferred option (if any; otherwise of main ones)? 

The  main  costs  stem  from  the  deployment  of  the  digital  infrastructure  supporting  the  EHDS.  This 
includes  completing  the  coverage  of  MyHealth@EU  and  the  full  rollout  of  the  necessary  digital 
infrastructure connecting Health Data Access Bodies, research infrastructures and EU bodies. Actions 
on promoting interoperability through mandatory certification and voluntary labels are also expected to 
trigger costs. The overall costs for the preferred option are expected to be between EUR 0.7-2.5 billion 
above the baseline over 10 years. 

What are the impacts on small and medium-sized enterprises (SMEs)? 

SMEs would have to comply with mandatory requirements on interoperability, security for electronic 
health records and some medical devices that feed information into EHRs. Producers of wellness apps 
could  elect  to  ensure  transparency  for  users  through  voluntary  labels.  While  these  measures  may 
increase the burden on SMEs, common requirements across EU will increase the chances to be selected 
in  procurements  or  reimbursement  schema  and  will  reduce  the  entry  barriers  to  the  markets  of  other 
Member States, partially or totally offsetting such costs. The common network of Health Data Access 
Bodies would facilitate the access of SMEs to health data, for research and innovation purposes. The 
preferred option is expected to lower the barriers for SMEs to reuse quality health data, contributing to 
their competitiveness. 

Will there be significant impacts on national budgets and administrations?  

The rollout of digital infrastructures for use and reuse of health data and the set up of health data access 
bodies  are  expected  to  impact  national  budgets  and  administrations.  The  preferred  option  allows 
Member States to choose their organisational arrangements, building on Data Governance Act. Parts of 
the  costs  will  be  offset  through  fees  charged  by  Health  Data  Access  Bodies.  The  setting  up  of  data 
access bodies is expected to lower the costs to access data for regulators and policy makers and would 
increase  transparency  concerning  medicinal  products,  allowing  additional  savings.  Digitalisation  can 
also  reduce  unnecessary  tests  and  ensure  transparency  in  spending,  allowing  savings  to  the  health 
budget. EU funds will provide support for digitalisation. 

Will there be other significant impacts? 

Citizens would be able to enforce their rights to access and transmit digitally their health data to user-
selected third parties from the health/social sector, without hindrance from manufacturers or healthcare 
providers.  Participation  in  MyHealth@EU  within  a  certain  timeframe  would  reduce  disparities  when 

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accessing healthcare services in the cross-border context. The preferred option defines a common EU 
framework for accessing health data for  research, innovation policy making, regulatory purposes and 
personalised medicine, building on GDPR, with a trusted governance and high security. It can reduce 
costs to access health data, with a higher level of transparency, accountability and security for citizens. 
The analysis of health data may lead to new medical discoveries. 

Proportionality? 

The  initiative  is  limited  to  aspects  that  Member  States  cannot  achieve  satisfactorily  on  their  own,  as 
shown by the evaluation of Article 14 of the CBHD. The preferred option is proportionate, given the 
medium intensity of the proposal and the expected benefits for citizens and industry. 

D. Follow up 
When will the policy be reviewed? 

The  Commission  will  review  the  monitoring  indicators  periodically  and  evaluate  the  impacts  of  the 
legislative act after 7 years.  

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