The European Health Data Space Regulation (EHDS)
The European Health Data Space Regulation (2025/327) came into force on 26 March 2025. The EHDS is a common framework and data infrastructure supporting data sharing for ‘primary’ purposes (healthcare purposes) and ‘secondary’ purposes (research, evidence-based policy making, and regulatory decisions).
By March 2029, EU citizens will be able to access and use electronic patient summaries, electronic prescriptions and electronic dispensations in all EU member states and by 2031, electronic imaging and medical results and discharge reports should follow. The cross-border infrastructure implementing this is called MyHealth@EU
By March 2029, the secondary use of electronic health data should also be operational and implemented. This involves a cross-border infrastructure called HealthData@EU. This involves the creation of metadata catalogues by all EU member states for a large number of health data categories (such as electronic health records, registry data, clinical trial data, population health records and reimbursement data). The data should be made available by a broad range of actors in the healthcare space and requests for access can be made to research de-identified data under secure processing environments, in order to protect the safety and confidentiality of data.
Why is it important for urology and the EAU?
The EHDS is being implemented at a time when the EAU is developing the UroEvidenceHub and driving the use of Real World Evidence and Big Data to inform clinical decision making and better outcomes for patients. The data made available from the EHDS is therefore a potential source of knowledge for urological research, particularly for research questions where there is much to learn outside of a controlled clinical trial environment. The data gathered in the UroEvidenceHub can also be a source of multi-disciplinary discovery.
What has the EAU been doing to contribute to the development of the EHDS?
We have been raising the voice of clinicians and urological patients in the debate around the new law. There are many questions that are still unanswered about how the rules will be enforced and it is important that the views of healthcare professionals are heard. We have been raising a number of questions with the European Commission and other actors in the implementation on the involvement of medical professionals and societies in particular.
We have been working with a large number of actors in the EU healthcare space to raise our recommendations in a joint manner – the last of our joint recommendations is around the involvement of stakeholders in the EHDS Stakeholder Forum. For the EHDS it is critical that the stakeholder engagement is correct and effective. Read our most recent statement here:
Previous statements from the EHDS informal stakeholder group can be found here:
- Stakeholder coalition calls for legislative refinement of the EHDS - Cancer Patients Europe
- European Health Data Space (EHDS) in trilogues sparks deep concerns in the European healthcare ecosystem - Uroweb
- Joint Statement: health organisations define EHDS' opt out required for life saving research - Uroweb
- 7 recommendations for the European Health Data Space to improve patient outcomes, empower EU citizens, and strengthen health systems - Uroweb
- The European Commission website on the European Health Data Space can be found here: European Health Data Space Regulation (EHDS) - European Commission