European Health Data Space (EHDS)

The European Health Data Space will establish a common framework for the use and exchange of electronic health data across the EU. It will:

  • Empower patients to access, control and share their health data across borders to receive care (primary use)
  • Enable the secure reuse of non-identifiable health data for research, innovation, policy-making, and regulatory activities (secondary use)

While the legislative text has been finalized and published (in 2025), the work is far from finished. We’re currently in the implementation phase, where the more practical and technical details are being decided. EHA represents hematologists through its advocacy at the EU level.

The legislation will become applicable in March 2029.

Primary use of health data 

Primary use is defined as the processing of health data solely for the provision of healthcare. Patients can exercise the following rights over their health data: 

  • Fast and free access 
  • Sharing and portability 
  • Obtaining information regarding access 
  • Restricting access 
  • Requesting rectification

Secondary use of health data  

Secondary use is defined as the processing of health data for purposes other than the provision of healthcare. 

Permitted purposes 

  • Policymaking, regulatory activities, statistics, and public interest activities, which are reserved for public sector bodies and EU institutions, bodies, and agencies. 
  • Education and teaching. 
  • Scientific research (strictly with the aim of benefitting end-users). 
  • Improvement of delivery of care and treatment optimization.

Prohibited purposes 

  • Developing harmful products or services.  
  • Advertising or marketing activities. 
  • Taking decisions with detrimental legal, social, or economic effects (insurance, loans, employment).

Access to non-identifiable health data 

Access to health data requires a data permit, subject to strict criteria. For instance: 

  • The requested data must be necessary, adequate, and proportionate 
  • The applicant must have a qualification linked to the intended purposes of data use and have appropriate expertise 
  • The applicant must put safeguards in place to prevent misuse of the data

When a permit is granted, the researcher or company will receive access to the sought anonymized or pseudonymized health data. In order to receive data in pseudonymized format, an additional justification is necessary.

Patient rights

Patients can: 

  • Opt out at any time (reversible) 
  • Get insights into who has access to their data and for which purpose 
  • Access information on the outcomes derived from the project in which their health data was used

Member states’ discretion 

The legislation leaves room for member states to: 

  • Circumvent the patient opt-out, but only under strict conditions 
  • Implement stricter safeguards for sensitive categories of data (e.g. genetic, genomic data), which could include an opt-in

Find out more  

For more information regarding the EHDS, you can contact the European Affairs team.

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