On January 21, 2025, the Council of the EU adopted the European Health Data Space Regulation (the “EHDS Regulation”). The EHDS Regulation aims at making cross-border exchange and access to EU health data easier, improving individuals’ control over their personal electronic health data and enabling the reuse of certain health data for research and innovation purposes.

Background

On May 3, 2022, the European Commission unveiled its proposal for a regulation establishing a European Health Data Space. This initiative is part of the Commission’s European Strategy for Data that was released in 2020.

Key Takeaways

• The new rules under the EHDS Regulation seek to provide individuals with faster and easier access to their electronic health data, regardless of whether they are in their home country or another EU member state. Moreover, individuals will have greater control over how their health data is used. To facilitate this, EU countries must establish a dedicated digital health authority to oversee the implementation of these provisions.
• The EHDS Regulation aims to open new doors for researchers and policymakers by granting access to specific types of anonymized, secure health data.
• Digitalization of health data currently varies significantly between EU member states, often creating barriers to cross-border data sharing. The EHDS Regulation seeks to address this challenge by mandating that all electronic health record systems align with the European electronic health record exchange format, ensuring interoperability across the EU.

The provisions of the EHDS Regulation will become applicable between two and six years after the entry into force of the Regulation. As a regulation, the EHDS Regulation will apply directly in all EU Member States.

The EHDS Regulation is now awaiting formal signature by the Council of the EU and the European Parliament. It will come into effect 20 days after its publication in the Official Journal of the EU.

Read the text of the EHDS Regulation and the Council’s Press Release.