European Health Data Space and Registry: Ongoing Engagement and Next Steps

European Health Data Space (EHDS)

The European health landscape is entering a new phase with the implementation of the European Health Data Space (EHDS) — a major EU initiative designed to enable secure access, sharing, and reuse of health data across Member States.

Adopted as Regulation (EU) 2025/327 of the European Parliament and Council, and published in the EU’s Official Journal on the 5^th of March 2025 and coming into effect twenty days later , the EHDS establishes a common framework for the use of electronic health data, supporting both clinical care (“primary use”) and research, innovation, and policy development (“secondary use”).

This initiative aims to:

• Empower patients with greater control over their health data
• Enable cross-border access to health information
• Facilitate high-quality research and evidence-based decision-making
• Strengthen collaboration across European healthcare systems

The EHDS will be progressively implemented within the next decade , with periodic key milestones to reach fully operational status in all EU Member States and secondary use in third countries and international organisations. .

Our Involvement

As part of our ongoing commitment to advancing clinical research and improving patient outcomes, we are closely following developments related to the European Health Data Space and the implications on disease registries, especially rare disease registries.

The ECFSPR EHDS-Focus Group was established in November 2025 with initial discussions to combine the current knowledge, activity and experience of EU countries in the EHDS and EHDS preparation. Drawing together the questions and objectives of both national and international registries this group is proactively seeking to ensure the needs of Cystic Fibrosis and rare disease registries are considered as we establish how we will align.

In January, we organised a meeting  in Brussels, where key aspects of the EHDS and future registry integration were explored with European stakeholders. These discussions highlighted the importance of:

• Ensuring interoperability and data quality across registries
• Aligning registry infrastructures with upcoming EHDS requirements
• Promoting collaboration between clinical communities, regulators, and policymakers

Looking Ahead

Endeavoring to drive information exchange, further discussion and communication between all countries contributing Cystic Fibrosis and CFSPID data directly or indirectly through national registries to the ECFSPR, the ECFSPR EHDS-Focus Group established the EHDS-Focus Meeting Series. Initiating discussion with the European Commission, Mélodie Bernaux and Owe Langfeldt have accepted the invitation to present and participate in an interactive webinar discussion exploring the impact of the EHDS on the ECFSPR, national CF Registries and international collaborations in preparation for the upcoming changes and challenges in regulation.

We will continue to actively engage in this evolving landscape. Our next opportunity for face to face discussion will take place during our upcoming meeting in Lisbon on June 4th at the 49^th ECFS Conference 2026, where the focus will remain on preparing for the integration of registries within the EHDS framework.

Through these efforts, we aim to contribute to a coordinated European approach that maximises the value of quality, harmonised health data while maintaining the highest standards of data protection, governance, and patient trust.

Conclusion

The European Health Data Space represents a significant step forward for digital health in Europe, offering new opportunities for collaboration, innovation, and improved care. We remain committed to supporting this transition and ensuring that disease registries play a meaningful role in shaping the future of health data use in Europe.