Health Data
The EAU Policy Office is a leading stakeholder voice contributing to the development of the European Health Data Space, in particular what it means for the secondary use of data for research.
The European Health Data Space (EHDS) implementation will have an impact on how real world evidence along with clinical trial data can be used to guide research and clinical decision making for better patient outcomes.
Topic Leads: Phil Cornford and Vasileios Sakalis
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.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. This involves a cross-border infrastructure called HealthData@EU, and 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 this important for urology and the EAU?
The EHDS is being implemented while the EAU is developing the UroEvidenceHub – a platform driving the use of Big Data for real-world evidence to inform clinical decision making and improve 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?
At the EAU, we are 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 raised a number of questions with the European Commission and other actors in the implementation on the involvement of medical professionals and societies.
The EAU has been working with a large number of actors in the EU healthcare space to author joint recommendations, such as around the involvement of different stakeholders in the EHDS Stakeholder Forum. It is critical that stakeholder engagement for the EHDS is inclusive 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
The EAU provided its response to the Commission’s call for evidence on AI: EAU response to the AI in science call for evidence - Uroweb