Parliament puts final stamp on the European Health Data Space

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On April 24, the European Parliament gave its final endorsement to the regulation on the European Health Data Space (EHDS). The legislation was proposed in May 2022, and constitutes an important pillar of the (developing) European Health Union.

The legislation

The two overarching objectives of the EHDS are:

  • Giving individuals control over their health data, across the EU, and thereby improving healthcare delivery
  • Leveraging health data for policymaking, research, and innovation

As a result, this legislation will have a sizable impact on EHA members:

  • Easier and faster access to patient records, with less bureaucracy
  • Access to high-quality non-identifiable data to support innovative research and improve outcomes in hematology

Find more detailed information about the EHDS on its dedicated page.


After Council endorsement, the legislation will be published and enter into force 20 days later. However, the final text still contains uncertainties that could undermine its use, as explained in this stakeholder statement EHA co-drafted, as well as in this recent BioMed Alliance statement.

EHA will therefore continue to play an active role in the shaping of this legislation during the implementation phase. In fact, the regulation establishes a Stakeholder Forum, that will include HCPs and patients, to enable the exchange of information and promote cooperation with stakeholders regarding the implementation. Depending on the provisions, the implementation will take 2, 4, or even 6 years.

Last Updated on Thursday 25 April 2024.