On 5 March 2025, the European Union officially published the European Health Data Space (EHDS) Regulation (Regulation (EU) 2025/327), marking a significant step towards a unified framework for electronic health data across member states.  The Regulation establishes a harmonised legal and technical framework for Electronic Health Records (EHR) systems, fostering data interoperability. Specifically, an EU dataset catalogue connecting the national dataset catalogues - namely HealthData@EU - will be established, meaning that health data will be processed applying common standards (e.g. format and storage) across member states.

So, this initiative aims to revolutionise the accessibility, control, and use of health data, bringing substantial benefits to patients, health professionals, researchers and regulators.

Individuals will have enhanced rights and control over their health data, including free, fast access to their EHR, the ability to add personal health information, restrict access to specific parts or individuals, and easily share records with professionals across the EU (primary use of data). Security and privacy are ensured by default through the application of the GDPR Regulation, with the option to allow secondary use of their electronic health data.

For health professionals, this means faster and easier access to patients’ health records across different healthcare providers and countries, reducing the administrative burden and fastening the time to care delivery.

For the research community, the EHDS introduces a robust legal framework for the secondary use of health data. This will enable researchers, public institutions, or industry to access large-scale, high-quality health data, crucial to streamline the development of life-saving treatments and ensuring better access to healthcare.

Regulators will also benefit from the EHDS through improved access to comprehensive health data, facilitating evidence-based policy-making and regulatory activities.

Altogether, the innovations introduced by the Regulation are expected to have a significant impact on research and regulatory decisions in the field of rare diseases or other small and vulnerable populations, such as paediatric patients. With a large amount of high-quality health data available, researchers will be able to conduct robust clinical studies, improve diseases understanding, accelerate drug development, and enhance patient care.

Implementation Timeline

While the EHDS Regulation enters into force on 26 March 2025, its impact will be gradual rather than immediate. Some features may be adopted voluntarily by member states, but most obligations will take effect four years after the regulation enters into force.

Key timelines:

• By March 2029: Key provisions will apply, including the exchange of priority health data categories (such as Patient Summaries and ePrescriptions) across all EU member states. Rules on secondary data use will also commence for most data categories (e.g. data from EHR).
• By March 2031: The exchange of additional health data categories (including medical images, lab results, and hospital discharge reports) is expected to be operational EU-wide. Secondary use rules will extend to remaining data categories, such as genomic data.

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