The European Health Data Space Regulation is a reality
The European Health Data Space (EHDS) Regulation has made it to the EU’s Official Journal, almost three years after the initial proposal was published.
This crucial step in the EU’s digital health strategy is much-needed to improve access to and use of health data across the European Union, thereby enhancing diagnosis and treatments, and bolstering research and innovation.
Key benefits
- For patients: gives them control over their health data and easy access to medical records across the EU (primary use).
- For research and policy: enables the reuse of health data for research, innovation, and policymaking (secondary use), in a privacy-preserving way.
Impact on healthcare
The EHDS will ensure that patients can get the care they need, regardless of where they are in the EU. This means improved decision-making by clinicians, and enhanced continuity of care for patients. In addition, it will increase efficiency and reduce the administrative burden faced by health professionals.
At the same time, researchers and policymakers will get access to non-identifiable health data to improve health outcomes and to create targeted policies, respectively. How will this work in practice? National and European metadata catalogues will be created, and researchers will be able to file applications to obtain access to the data sets they need.
What’s next?
Application of the legislation will be gradual. A key milestone is foreseen for March 2029, when the first categories of data become available for primary and secondary use. In the meantime, the European Commission will adopt over 20 implementing acts with input from stakeholders (including EHA) and Member States.
Find out more
For more information on the benefits, impact, and implementation of the EHDS, visit our European Health Data Space legislation page.
Back