Health data

Health data is featured in many EU strategic and legislative discussions, as well as in funding initiatives.  

With hematology at the forefront of medical innovation, health data is a key topic in our interaction with policymakers, regulators, and other stakeholders.  

In order to improve access to innovative therapies, support hematology research, and advance personalized medicine, we participate in collaborative health data and eHealth initiatives.  

A major target of our advocacy has been the European Health Data Space regulation, published in 2025.  

European Health Data Space legislation  

Main aims of the EHDS 

  • Give citizens access and control and share their data across EU borders 
  • Create strict rules for the reuse of non-identifiable health data for research, innovation, and policy-making 

Which should result in: 

  • Better diagnosis and treatment  
  • Informed policy and regulatory approaches 
  • Data-driven research and innovation

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—reserved for public sector bodies and EU institutions, bodies, and agencies. 
  • Education and teaching. 
  • Scientific research (strictly with the aim of benefiting 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.

Patients’ say 

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

Implementation 

The regulation establishes a Stakeholder Forum, in order to: 

  • Enable the exchange of information 
  • Promote cooperation with stakeholders on the implementation of the legislation

Find out more  

For more information regarding the EHDS, you can contact Tamara Almeida at t.almeida@ehaweb.org 

EHA Strategy on Health Data 

Given the importance of health data for hematology, EHA’s Board approved a strategy in April 2022 that features eight complementary goals: 

  1. Need for sustainable, representative, high-quality data structures and data sources to facilitate research and education and allow timely regulatory and improved clinical decision making 
  2. Transparent, inclusive, and ethical use of novel analytical tooling for evidence generation 
  3. Promotion of FAIR data principles (Findability, Accessibility, Interoperability, and Reuse) 
  4. Implementation of Personalized Medicine 
  5. Harmonization of real-world data (RWD) 
  6. Align with, link into and influence, where possible, strategic European initiatives on health data 
  7. Empowerment of patients in data generation, sharing, analysis, and ownership
  8. Support for existing, centralized data repositories of strategic importance to EHA/hematology for long-term sustainability

    Health Data Steering Group  

Our work on health data is guided by the Health Data Steering Group (HDSG), which includes a patient representative. The HDSG is tasked with:  

  • Advising the EHA Board on health data matters relevant to hematology practice, research, and education  
  • Overseeing the implementation of the strategy  
  • Advising on interpretation of the strategy (including within the context of European Affairs work)  

 

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