European Health Data Space Regulation

On February 11, 2025, the European Parliament and the Council of the European Union (“EU”) adopted Regulation (EU) 2025/327, establishing the European Health Data Space (“EHDS”). This regulation (“EHDS Regulation”), which came into force on March 25, 2025, amends Directive 2011/24/EU and Regulation (EU) 2024/2847 and has the objective of revolutionizing health data access and sharing across Europe.

The EHDS aims to be a cornerstone of a cohesive and robust European Health Union, addressing the critical need for a unified and resilient health data infrastructure, as underscored by the COVID-19 pandemic. By enhancing access to and control over personal electronic health data, it optimizes healthcare delivery and facilitates data sharing for research and public health purposes, while ensuring data protection and interoperability across Member States.

EHDS Regulation: Key provisions

Primary and secondary use of health data

The EHDS Regulation establishes requirements for both the primary and secondary use of health data.

For primary use, it provides a uniform legal framework for using electronic health record systems across the EU. This facilitates access to electronic health data in different EU countries, which is vital in medical emergencies requiring quick access to accurate information. This interoperability ensures better continuity of care, enabling healthcare professionals to have a comprehensive overview of a patient’s medical history, regardless of where the treatment was initially provided.

The EHDS Regulation’s main innovation lies in the governance of the secondary use of health data to promote health research, innovation, policy-making, and regulatory activities. Having access to large volumes of anonymized or pseudonymized health data can accelerate the discovery of new therapies and improve existing diagnoses and treatments. Researchers, companies, or institutions must obtain permission from a health data access body to access this data, which will be granted only for specific purposes within secure and closed environments, without revealing individuals’ identities.

Secondary use of data is prohibited for commercial purposes, including advertising, insurance application evaluations, loan conditions, and employment decisions.

HealthData@EU

The EHDS Regulation introduces the HealthData@EU platform to facilitate the crossborder exchange of electronic health data for secondary use. This infrastructure aims to accelerate secondary use while increasing legal certainty and respecting individuals’ privacy.

To ensure the sensitivity of personal electronic health data is respected, the EHDS Regulation includes robust safeguards for data protection, security, confidentiality, and ethical use. This regulation is crucial for protecting patients’ personal data and complying with the General Data Protection Regulation. Harmonizing data protection standards among Member States builds trust, allowing patients and healthcare professionals to share information securely, while also enabling interested entities to use data for secondary purposes appropriately and carefully.

Challenges and phased implementation

Despite its benefits, the EHDS Regulation faces significant practical challenges. Its implementation must be phased due to the substantial investments required in technological infrastructure and the training of healthcare professionals and researchers.

Also, harmonizing standards and ensuring interoperability between multiple national health systems is a complex undertaking, requiring close collaboration among Member States’ health authorities. Therefore, although the EHDS Regulation came into force on March 25, 2025, it will be implemented incrementally over several phases from 2027 to 2034.

Conclusion

The EHDS Regulation has the potential to transform how health data is accessed, managed, and used within the EU. It aims to create a secure and interoperable health data space, bringing substantial benefits to healthcare, research, and innovation.