COMMISSION STAFF WORKING DOCUMENT SUBSIDIARITY GRID 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

EN 

  EN 

   EUROPEAN COMMISSION  Strasbourg, 3.5.2022  SWD(2022) 130 final  COMMISSION STAFF WORKING DOCUMENT SUBSIDIARITY GRID 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) 131 final} - {SWD(2022) 132 final}  
 
 
Subsidiarity Grid 

-  As proposed by the Committee of the Regions with guidance in blue  

-  Obviously,  the  answers  to  the  questions  below,  the  explanatory  memorandum 
and  –  if  applicable  –  the  impact  assessment  should  be  consistent.  This  may 
require some iterations.  

-  Please try to stay under 10 pages.  

1.  Can the Union act? What is the legal basis and competence of the Unions’ intended 

action? 

1.1 Which article(s) of the Treaty are used to support the legislative proposal or policy 
initiative? 

The proposal is based on Article 16 and 114 of the Treaty on the Functioning of the European 
Union  (TFEU).  Art.  16  grants  competence  to  the  Union  to  adopt  rules  concerning  the 
protection of individuals with regard to the processing of personal data by Union institutions, 
bodies,  offices  and  agencies,  and  by  the  Member  States  when  carrying  out  activities  which 
fall within the scope of Union law, and the rules relating to the free movement of such data. 
Art.  114  grants  competence  to  the  EU  to  adopt  measures  which  have  as  their  object  the 
establishment and functioning of the internal market. 

1.2  Is  the  Union  competence  represented  by  this  Treaty  article  exclusive,  shared  or 
supporting in nature? 

The  Union  shares  competence  with  the  Member  States  in  the  area  of  the  internal  market 
(Article 114 TFEU) and for data protection (Article 16 TFEU).  

Subsidiarity  does  not  apply  for  policy  areas  where  the  Union  has  exclusive  competence  as 
defined  in  Article  3  TFEU1.  It  is  the  specific  legal  basis  which  determines  whether  the 
proposal falls under the subsidiarity control mechanism. Article 4 TFEU2 sets out the areas 
where competence is shared between the Union and the Member States. Article 6 TFEU3 sets 
out the areas for which the Unions has competence only to support the actions of the Member 
States. 

2.  Subsidiarity Principle: Why should the EU act? 

2.1 Does the proposal fulfil the procedural requirements of Protocol No. 24: 

-  Has there been a wide consultation before proposing the act? 
- 

Is  there  a  detailed  statement  with  qualitative  and,  where  possible,  quantitative 
indicators allowing an appraisal of whether  the action can best be achieved at Union 
level? 

1 https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:12008E003&from=EN  
2 https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:12008E004&from=EN  
3 https://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:12008E006:EN:HTML  
4 https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:12016E/PRO/02&from=EN  

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In preparation of the EHDS proposal, stakeholders have been consulted in various ways. The 
different stakeholder views can be found in great detail in the synopsis report annexed to the 
Impact Assessment SWD (Annex 2). 

A  combined  evaluation  roadmap-inception  impact  assessment  was  published  and  was  open 
for  public  feedback  from  23  December  to  04  February  2021.  In  total,  151  responses  were 
received. 

A  Public  Consultation  was  conducted  from  May-July  2021.  382  valid  responses  were 
received.  Respondents  expressed  support  for  action  at  EU  level  for  accelerating  research  in 
health (89%), promoting individuals’ control over their own health data (88%) and facilitating 
the delivery of healthcare across borders (83%). There was great support for promoting access 
and  sharing  of  health  data  through  a  digital  infrastructure  (72%)  or  an  EU  infrastructure 
(69%). 52% support an EU level certification scheme to promote interoperability. In the area 
of  secondary  use  of  health  data,  a  large  majority  of  respondents  said  an  EU  body  could 
facilitate  access  to  health  data  for  secondary  purposes  (87%).  Mandatory  use  of  technical 
requirements and standards is supported by 67%. 

Stakeholder views were also collected through the study assessing EU Member States rules on 
health  data  in  light  of  the  Regulation  (EU)  2016/679.  During  the  study,  5  workshops  took 
place  with  Ministries  of  Health  representatives  from  most  of  the  Member  States,  experts, 
stakeholder  representatives  and  experts  from  national  data  protection  offices.  A  stakeholder 
survey  was  also  carried  out  to  cross  validate  and  supplement  the  topics  addressed  and 
identified. In total, 543 persons responded to the online survey. Furthermore, 87% consider a 
lack  of  data  portability  drives  up  costs  in  healthcare,  while  84%  consider  a  lack  of  data 
portability slows down time to diagnosis and treatment. 84% are of the view that additional 
measures should be taken at EU level to strengthen patients’ control over their data. 81% of 
respondents suggest the EU should support secondary use of health data through the use of the 
same legal base. 

A study on Health Data, Digital Health and Artificial  Intelligence in  Healthcare, which was 
carried  out  between  September  2020  and  August  2021,  provides  evidence  needed  to  enable 
informed  policy  making  in  the  areas  of  digital  health  products  and  services,  artificial 
intelligence, the governance on the use of health data and the evaluation of Article 14 of the 
Directive 2011/24/EU. The consultation activities included 28 interviews, 9 focus groups and 
2  online  surveys.  The  stakeholders  support  measures  in  a  number  of  areas,  ranging  from 
guidance  on  digital  health  services  and  products  quality,  interoperability,  reimbursement, 
identification  and  authentication,  digital  literacy  and  skills.  On  primary  use,  stakeholders 
support  mandating  national  digital  health  authorities  with  tasks  to  support  cross-border 
provision  of  digital  health  and  access  to  personal  health  data.  In  addition,  they  also  support 
enlargement  of  the  services  of  MyHealth@EU.  On  secondary  use,  there  is  support  for  the 
introduction of a legal and governance framework and structure, building on the establishment 
of Health Data Access  Bodies in a number of Member States, with cooperation at EU level 
through  a  network  or  an  advisory  group.  To  reduce  barriers,  there  would  be  support  for 
specifications and standards.  

Moreover,  the  overall  evaluation  of  the  digital  health  aspects  of  the  Directive  2011/24/EU, 
which is attached as an Annex to the EHDS Staff Working Document (SWD), finds that the 
impact  of  the  Directive  has  been  rather  limited  in  terms  of  interoperability,  and  especially 
secondary use of health data, especially  due to the voluntary nature of the eHealth Network 

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actions  and  limited  competences  on  secondary  use.  However,  the  COVID-19  pandemic  and 
EU Digital COVID Certificates5 shows that a strong legal basis and a common EU approach 
to use of health data for specific purposes, as well as EU efforts to ensure legal, semantic and 
technical  interoperability,  can  significantly  support  the  free  movement  of  people  and  can 
transform  the  EU  into  a  global  standard  setter.  A  study  on  an  infrastructure  and  data 
ecosystem supporting the impact assessment of the European Health Data Space, which was 
carried out between April 2021 and December 2021, aims to present evidence-based insights 
that will support the impact assessment of options for a European digital health infrastructure. 
The  study  identifies,  characterises  and  assesses  options  for  a  digital  infrastructure,  outlines 
cost-effectiveness,  provides  data  on  the  expected  impacts,  both  for  the  primary  and  the 
secondary use of health data. A total of 18 interactive workshops were conducted covering 65 
stakeholders  who  actively  engage  with  health  data  usage.  In  addition,  a  survey  focusing  on 
costs  was  developed,  including  questions  related  to  the  value,  benefits,  impact  and  cost  of 
different options. 

Finally,  the  Impact  Assessment  Study,  which  was  carried  out  between  June  2021  and 
December  2021,  aims  to  present  evidence-based  insights  that  will  support  the  impact 
assessment of options for the EHDS. The study defines and assesses the overall policy options 
for  the  EHDS,  building  upon  the  evidence  gathered  in  the  previous  studies.  The  “public 
consultation  on  overcoming  cross-border  obstacles”  also  illustrates  that  individuals  face 
related obstacles in cross-border regions context.  More details of these studies are provided in 
the Annex in the SWD. 

The explanatory memorandum of the proposal and the impact assessment contain sections on 
the  principle  of  subsidiarity  that  include  qualitative  indicators  allowing  an  appraisal 
demonstrating that the action can best be achieved at Union level.  

2.2 Does the explanatory memorandum (and any impact assessment) accompanying the 
Commission’s  proposal  contain  an  adequate  justification  regarding  the  conformity 
with the principle of subsidiarity? 

The  current  proposal  aims  to  harmonise  the  data  flows  in  order  to  support  data  subjects  to 
benefit  from  protection  and  free  movement  of  health  data,  especially  personal  data.  The 
proposal does not aim to regulate how the healthcare is being provided nor the digital health 
services that are being provided by the Member States. 
According  to  the  evaluation  of  the  digital  aspects  of  the  Directive  2011/24/EU,  the  current 
situation of fragmentation, differences and barriers to access and use of personal health data 
shows  that  action  by  Member  States  alone  is  not  sufficient  and  may  hamper  the  rapid 
development and deployment of digital health products and services including AI based ones. 
According  to  the  above  mentioned  study  on  Regulation  (EU)  2016/679  implementation  in 
health  sector,  despite  the  fact  that  the  Regulation  (EU)  2016/679  provides  extensive  rights 
concerning individuals’  access  to  and transmission of their data, including health data, their 
practical implementation is frustrated by low interoperability in the healthcare sector, which 
has  been  addressed  so  far  mainly  through  soft  law  instruments.  Such  differences  in  local, 
regional and national standards and specifications can also prevent producers of digital health 
services and products to enter new markets, where they need to adapt to new standards. This 
legislative proposal is thus designed to complement the rights and safeguards provided in the 
Regulation (EU) 2016/679 in order to achieve in practice its goals. 

5 EUR-Lex - 32021R0953 - EN - EUR-Lex (europa.eu) 

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The same study shows that the extensive use of national derogations under the article 9(4) of 
the Regulation (EU) 2016/679 created fragmentation and difficulties for accessing data, both 
at  national  level  and  between  Member  States,  impacting  on  the  possibility  of  researchers, 
innovators, policy makers and regulators to carry out their tasks at an EU level or to carry out 
research or innovation, with negative effects on the European economy. 
As shown in the impact assessment, the evaluation of Article 14 of the Directive 2011/24/EU 
shows,  the  approaches  taken  so  far,  consisting  of  low  intensity/soft  instruments,  such  as 
guidelines  and  recommendations  aimed  to  support  interoperability,  have  not  produced  the 
desired  results.  Access  by  individuals  to  and  control  of  their  electronic  health  data  is  still 
limited,  and  there  are  significant  deficiencies  in  the  interoperability  of  information  systems 
used  in  the  health  domain.  Moreover,  national  approaches  in  addressing  the  problems  have 
only limited scope and do not fully address the EU-wide issue: the cross-border exchange of 
health data is currently still very limited, which is partly explained by the significant diversity 
in standards applied to health data in different Member States. In many Member States, there 
are substantial national, regional and local challenges to interoperability and data portability, 
hampering continuity of care and efficient healthcare systems. Even if health data is available 
in electronic format, it does not commonly follow the individual when they use services of a 
different healthcare provider. The EHDS proposal will address these challenges at EU level, 
providing mechanisms for improving interoperability solutions used at national, regional and 
local levels and reinforcing the rights of individuals. 
Therefore,  EU-wide  action  in  the  content  and  form  indicated  is  required  to  promote  cross-
border flow of personal health data, foster a genuine internal market for personal health data 
and digital health products and services. 
In  addition,  evidence  from  the  public  consultation  shows,  there  is  support  for  being  able  to 
transmit  data  from  mHealth  into  the  EHR  systems  (77%)  and  for  the  introduction  of  a 
certification scheme to  assess interoperability of  digital  health products and services (52%). 
The COVID-19 pandemic and EU Digital COVID Certificates shows that a strong legal basis 
and a common EU approach.  
The current situation of fragmentation, differences and barriers to access and use health data, 
shows  that  action  by  Member  States  alone  is  not  sufficient  and  may  hamper  the  rapid 
development and deployment of digital health products and services and of AI. Furthermore, 
the  analysis  on  the  impacts  of  different  policy  options,  including  economic,  social  and 
environmental, international impacts as well as impacts on fundamental rights, single market, 
competitiveness  and  SMEs  show  in  both  qualitative  and  quantitative  terms  that  the  Union 
objectives in question can be better achieved at Union level. 

2.3 Based  on  the  answers  to  the  questions  below,  can  the  objectives  of  the  proposed 
action be achieved sufficiently by the Member States acting alone (necessity for EU 
action)? 

The  fragmentation  of  standards,  specifications  for  electronic  health  records  hampers 
manufacturers to enter other markets and impact on the free flow of data.  
The  extensive  use  of  facultative  specification  clauses  under  the  GDPR  at  national  level 
created fragmentation  and difficulties for accessing data, both  at  national level  and between 
Member States, impacting on the possibility of  researchers, policy makers and regulators to 
carry  out  their  tasks  or  to  do  research  or  innovation,  with  negative  effects  on  the  European 
economy.  
Additionally, lack of EU action would hamper the free movement  of data and consequently 
hamper citizens’ right  under the Treaty and  GDPR  on data portability.  Member States have 

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the ability to structure their systems according their needs. This proposal aims is to ensure that 
citizens  could  carry  their  data  and  this  data  can  be  easily  accessible  for  research.  Data 
organization  and  governance  could  vary  sometimes  depending  on  the  Member  State  (e.g. 
federal states may have different structures in place). This proposal will not dismantle these 
structures.  
There  are  several  funds  that  would  be  provided  to  aid  the  implementation  of  the  planned 
measures.  There  was  a  detailed  analysis  in  the  impact  assessment  of  the  different  possible 
options in pursuing the Union objectives indicate the content and form of Union action. The 
options  were  chosen  are  the  ones  that  are  necessary  and  proportionate  to  achiever  the  set 
goals.    

(a)  Are  there  significant/appreciable  transnational/cross-border  aspects  to  the  problems 

being tackled? Have these been quantified? 

Different  interoperability  standards  for  electronic  health  record  systems  impact  on  free 
movement of such goods and of healthcare services.  
The  extensive  use  of  facultative  specification  clauses  under  the  GDPR  at  national  level 
created fragmentation  and difficulties for accessing data, both  at  national level  and between 
Member States, impacting on the possibility of  researchers, policy makers  and regulators to 
carry  out  their  tasks  or  to  do  research  or  innovation,  with  negative  effects  on  the  European 
economy.  Lack  of  EU  actions  would  detrimentally  impact  the  free  flow  of  health  data,  free 
movement of goods, and hamper cross-healthcare services.   

(b) Would  national  action  or  the  absence  of  the  EU  level  action  conflict  with  core 
objectives of the Treaty6 or significantly damage the interests of other Member States? 

National actions erect obstacles to trade that this legislative proposal aims to eliminate hence 
for  example  the  requirements  on  harmonization  of  the  rules  on  electronic  health  records. 
Additionally, lack of EU action would hamper the free movement  of data and consequently 
hamper citizens’ right under the Treaty and GDRP on data portability. Moreover, use of data 
for secondary use (e.g. development of products including AI) are hampered by diversity of 
national rules.    

(c)  To what extent do Member States have the ability or possibility to enact  appropriate 

measures? 

Member States have the ability to structure their systems according their needs.  

(d) How  does  the  problem  and  its  causes  (e.g.  negative  externalities,  spill-over  effects) 

vary across the national, regional and local levels of the EU? 

Data organization and governance could vary sometimes depending on the Member State (e.g. 
federal states may have different structures in place).  
In addition, manufacturers of digital health services and products face barriers and additional 
costs  such  as  variable  standards  or  obligations  when  entering  the  markets  of  other  Member 
States, hampering their competitiveness. 

-  Researchers, innovators, policy-makers and regulators face barriers impeding access to health 
data with different rules and obligations applicable to the reuse of health data. Also, there are 

6 https://europa.eu/european-union/about-eu/eu-in-brief_en  

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divergent rules and frameworks preventing data holders from easily releasing health data for 
reuse. 
Finally, the wide variety of GDPR legal  bases  applied by  different  data  holders in  different 
Member States has made cross-country studies very challenging, as data re-users must comply 
with different requirements in each jurisdiction. 

(e)  Is the problem widespread across the EU or limited to a few Member States? 

The problem of access to health data exists across the whole of the EU.  
Available  evidence  show  that  when  available,  electronic  health  records  are  often  only 
accessible  locally,  or  at  the  regional  level.  Fox  example,  although  electronic  health  records 
exist  in  two-thirds  of  Member  States,  by  the  end  of  2020  only  7  Member  States  offered 
services (Patient Summary and/or ePrescriptions) on the MyHealth@EU platform. Two thirds 
of  countries  detail  measures  for  technical  interoperability  and  exchange  measures  in  their 
legislative  framework  and  18  study  countries  indicate  that  data  sharing  of  EHRs  across 
national borders is permitted by law. But, only 4 Member States have rules to provide digital 
access  to  a  copy  of  the  medical  record/s  for  patients  affiliated  to  their  healthcare  system 
seeking cross-border healthcare in another Member State. 

(f)  Are Member States overstretched in achieving the objectives of the planned measure? 

There  are  several  funds  that  would  be  provided  to  aid  the  implementation  of  the  planned 
measures. The proposal has strong ties with several other actions of the Union in the areas of 
health  and  social  care,  digitisation,  research,  innovation  and  fundamental  rights.  Some 
obligations  will  be  funded  directly  from  the  EU4Health  programme  and  supported  further 
from  the  Digital  Europe  Programme.  In  addition,  the  Member  States  can  also  use  other  EU 
funding  programmes  that  will  complement  EU4Health  such  as  Recovery  and  Resilience 
Facility  (RRF)  and  the  European  Regional  Development  Fund  (ERDF)  that  will  be  able  to 
support the connection of Member States to the European infrastructures. Additionally, where 
physical  connectivity  is  lacking  in  the  health  sector,  Connecting  Europe  Facility  will  also 
contribute  to  the  development  of  projects  of  common  interest  including  in  health.  The 
implementation of the objectives and provisions of this Regulation will be complemented by 
other actions under Digital Europe Programme and Horizon Europe. 

(g) How  do  the  views/preferred  courses  of  action  of  national,  regional  and  local 

authorities differ across the EU? 

There  was  a  detailed  analysis  in  the  impact  assessment  of  the  different  possible  options  in 
pursuing  the  Union  objectives  indicate  the  content  and  form  of  Union  action.  The  options 
were chosen are the ones that are necessary and proportionate to achiever the set goals.    

2.4 Based on the answer to the questions below, can the objectives of the proposed action 
be  better  achieved  at  Union  level  by  reason  of  scale  or  effects  of  that  action  (EU 
added value)? 

(a)  Are there clear benefits from EU level action?  

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Without  EU  action,  the  activities  in  the  area  of  interoperability  will  remain  voluntary  and 
fragmented,  impeding  national  and  cross-border  sharing  of  patients'  data.  Moreover,  the 
access  and  portability  of  data  will  remain  limited  and  their  implementation  impeded  by 
technical  challenges.  On  the  secondary  use  of  data,  the  approach  will  remain  fragmented, 
impacting on the activities of public sector bodies, but also of researchers and industries, as 
well as on the capacity to carry out cross-border research. 

(b) Are there economies of scale? Can the objectives be met more efficiently at EU level 
(larger  benefits  per  unit  cost)?  Will  the  functioning  of  the  internal  market  be 
improved? 

Digital  health  services  and  products  are  advancing  rapidly.  The  internal  market  is 
transforming in the light of new technologies including AI in health. The divergence in rules 
and  standards  prevents  providers  from  building  economies  of  scale  to  offer  efficient  digital 
health and care solutions and to support cross-border use of health services. This slows down 
the  provision  of  digital  health  services  and  makes  their  implementation  more  costly. 
Additionally, there are obstacles to free movement of products (electronic health records) due 
to  the  varied  rules  in  different  Member  States.  Free  movement  of  data  would  boost  up  the 
internal market and allowed new technologies to be developed and deployed. 

(c)  What  are  the  benefits  in  replacing  different  national  policies  and  rules  with  a  more 

homogenous policy approach? 

National rules governing health data, digital health, services and products is impeding the free 
movement  of  goods  and  services  in  healthcare.  Homogenous  rules  would  ensure  that  these 
products  and  services  as  well  as  data  would  freely  move  within  EU  and providing  concrete 
benefits  to  citizens  and  stakeholders  in  these  sectors.  The  citizens  will  benefit  from  easier 
access  and  sharing  of  their  health  data  while  preserving  the  security  and  confidentiality  of 
such  data.  Health  care  providers  would  benefit  from  easier  and  timely  access  to  relevant 
health  data  from  their  patients  that  would  save  time  dedicated  to  treating  them  instead  of 
collecting  the  necessary  data  to  do  their  work.  For  reusers  of  health  data,  an  homogenous 
framework  across  the  EU  in  the  reuse  of  health  data  will  promote  the  inclusion  of  diverse 
datasets  from  numerous  countries  and  will  increase  the  accuracy  and  the  representability  of 
the results reflecting the diversity of the EU population.  

(d) Do  the  benefits  of  EU-level  action  outweigh  the  loss  of  competence  of  the  Member 
States and the local and regional authorities (beyond the costs and benefits of acting at 
national, regional and local levels)? 

The loss of competence of Member States is outweighed by the benefits for patients, health 
care providers and economic operators. 
This  law  would  ensure  that  health  data  could  move  freely  within  the  EU  for  healthcare 
including telemedicine and other medical  services (primary use)  as well as for research and 
development of products (secondary use). In addition, common rules on digital health would 
eliminate obstacles to trade. These provisions would allow EU citizens to reap the benefits of 
the  advancements  of  new  technologies  including  AI,  new  ways  of  providing  healthcare 
services and would be beneficial to economic operators in these sectors.  

(e)  Will there be improved legal clarity for those having to implement the legislation? 

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The proposed law provides a legal framework and these would be followed by delegated, and 
implementing acts, as well as possibly other specifications under the governance frameworks 
that is established and possible issuing of common standard on how these requirements could 
be technically fulfilled. Consequently, there will be legal clarity and a governance structure to 
further discuss policies.    

3.  Proportionality: How the EU should act 

3.1  Does the explanatory memorandum (and any impact assessment) accompanying the 
Commission’s  proposal  contain  an  adequate 
the 
proportionality of the proposal and a statement allowing appraisal of the compliance 
of the proposal with the principle of proportionality? 

justification  regarding 

The initiative seeks to put in place measures that are necessary to achieve the main objectives. 
The  proposal  creates  an  enabling  framework  that  does  not  go  beyond  what  is  necessary  to 
achieve the objectives.  It addresses  existing barriers to  foster the realisation of the potential 
value  of  electronic  health  data.  It  sets  a  framework  that  reduces  fragmentation  and  legal 
uncertainty. The initiative involves and relies on the work of the national authorities and seeks 
a strong involvement of relevant stakeholders. 

The proposed Regulation will give rise to financial and administrative costs, which are to be 
borne  through  the  allocation  of  resources  at  both  Member  States  and  EU  level.  The  impact 
assessment demonstrates that the preferred policy option brings the best benefits at the least 
cost. The preferred policy option does not exceed what is necessary to achieve the objectives 
of the Treaties. 

3.2 Based  on  the  answers  to  the  questions  below  and  information  available  from  any 
impact assessment, the explanatory memorandum or other sources, is  the proposed 
action an appropriate way to achieve the intended objectives? 

The  proposal  takes  the  form  of  a  new  Regulation  which  is  considered  the  most  suitable 
instrument,  given  the  need  for  a  regulatory  framework  that  directly  addresses  the  rights  of 
natural  persons  and  reduces  fragmentation  in  the  digital  single  market.  In  the  preparing  the 
proposal,  different  national  legal  contexts  that  built  upon  the  GDPR  by  providing  national 
legislation for the primary and the secondary use of health data were carefully analysed. But 
the  conclusions  of  the  impact  assessment  has  shown  that  there  is  a  need  to  go  beyond  the 
national  legislation.  In  order  to  prevent  major  disruption,  but  also  inconsistent  future 
developments, the proposal aims to put forward an initiative that takes into account the main 
common elements of different frameworks while proposing a coherent and homogenous EU 
level framework. 

(a)  Is  the  initiative  limited  to  those  aspects  that  Member  States  cannot  achieve 

satisfactorily on their own, and where the Union can do better? 

The abundance of data, digitization and advancements in digital health has created diversities 
among many Member States as Member States adopted varied regulatory measures or lack of 
measures  in  ensuring  citizen’s  rights  and  free  movement.  Lack  of  EU  actions  would 
detrimentally impact the free flow of health data, free movement of goods, and hamper cross-
healthcare services.  

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Member  States  will  continue  to  structure  their  digital  health  services  according  their  needs. 
What  this  proposal  aims  is  to  ensure  that  citizens  could  carry  their  data,  data  can  be  easily 
accessible for research and that electronic health records could be transferred within the EU 
without any obstacles to trade.(cid:13) The options that were chosen are the ones that allow leeway 
to the Member States and regions organized their systems on data and digital health services 
and products and at the same achieve some common rules that would ensure free movement, 
data  portability,  access  to  data  in  order  to  allow  citizens  to  reap  concrete  benefits  of  this 
evolution and economic operators have clear rules on their rights and obligations.   

(b) Is the form of Union action (choice of instrument) justified, as simple as possible, and 
coherent  with  the  satisfactory  achievement  of,  and  ensuring  compliance  with  the 
(framework)  directive, 
objectives  pursued 
recommendation, or alternative regulatory methods such as co-legislation, etc.)? 

(e.g.  choice  between 

regulation, 

This proposal would provide a legal framework in the form of Regulation imposing necessary 
and  proportionate  obligations  in  ensuring  free  movement  of  data,  data  portability  for 
healthcare, access and use of data for research and development of products, free movement 
of  digital  health  as  the  voluntary  measures,  which  is  the  current  regulatory  framework  has 
shown a limited effectiveness in supporting patients’ control over their health data at national 
and  cross-border  level  and  very  low  effectiveness  on  secondary  uses  of  health  data.  In 
addition, the COVID-19 crisis has revealed the need and the high potential for interoperability 
and harmonisation, building upon existing technical expertise at national level. 

(c)  Does  the  Union  action  leave  as  much  scope  for  national  decision  as  possible  while 
achieving  satisfactorily  the  objectives  set?  (e.g.  is  it  possible  to  limit  the  European 
action to minimum standards or use a less stringent policy instrument of approach?) 

The  proposed  Regulation  still  allows  Member  States  to  organize  their  systems  as  regards 
digital  health  services,  data  and  digital  health.  For  the  primary  use  of  health  data,  each  MS 
will be required to  designate a national  digital  health body. For the secondary use of health 
data,  each  MS  would  be  required  to  ensure  that  there  is  a  national  body  entrusted  with 
decision-making  powers  and  tasks  in  relation  to  health  data  access  by  third  parties  for 
secondary  use.  Ms  will  still  be  responsible  for  the  organisation  of  their  healthcare  systems 
(including  for  instance  the  reimbursement  of  healthcare  which  will  still  be  a  national 
competence, etc) 

(d) Does  the  initiative  create  financial  or  administrative  cost  for  the  Union,  national 
governments, regional or local authorities, economic operators or citizens? Are these 
costs commensurate with the objective to be achieved? 

The  proposed  Regulation  will  give  rise  to  financial  and  administrative  costs.  There  are 
important costs for Member States to set up the system but funds will be available to support 
this transition. These costs are necessary to achieve the objectives of the proposal. The Impact 
Assessment demonstrates that the preferred Policy Option brings the best benefits at the least 
cost. The preferred policy option does not exceed what is necessary to achieve the objectives 
of the Treaties.  

(e)  While  respecting  the  Union  law,  have  special  circumstances  applying  in  individual 

Member States been taken into account? 

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Already  some  Member  States  have  existing  governance  bodies  and  infrastructure  in 
collecting, sharing and using data (e.g. in Finland and France). The proposed legal framework 
build  on  those  existing  infrastructures.  It  creates  interoperable  structures  to  allow  them  to 
provide  even  more  benefits  to  research  and  development  of  products  than  they  currently 
provide.  Similarly,  regarding  primary  use  of  data  and  digital  health  services  the  proposed 
Regulation  builds  upon  existing  infrastructure  MyHealth@EU  and  would  simplify  current 
complex  burdens  faced  by  individuals,  provide  simple  ways  for  data  transfers,  building  on 
existing infrastructures and systems.   

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