On 11 February 2025, the European Parliament and the Council adopted Regulation (EU) 2025/327 on the European Health Data Space (EHDS), marking a turning point in the management and use of medical data across the European Union. Published in the Official Journal of the European Union on 5 March 2025, the regulation entered into force on 26 March 2025, establishing a common framework for the use and exchange of electronic health data throughout the EU.¹
Objectives of the EHDS Regulation
The EHDS Regulation aims to improve individual access to their own electronic health data and enhance control over it, while also facilitating the reuse of data in the public interest, including for scientific research and policy-making.
By promoting a dedicated health data environment, the regulation supports a single market for digital health services and products, setting out a harmonised legal and technical framework for Electronic Health Record (EHR) systems.
Benefits for Citizens and Healthcare Professionals
For patients, EHDS provides fast and free access to their own electronic health
data, enabling easy sharing of medical information with healthcare providers, including at a
cross-border level. Patients will have increased control over their data, being able to
add personal information, restrict access to certain parts of their record, and
see who accessed their data.²
Healthcare professionals will benefit from faster and easier access to patients’ medical records, which can be consulted across different countries and by different healthcare providers. This interoperability will significantly reduce administrative burden and improve the quality of medical care.
The implementation of Regulation (EU) 2025/327 brings both significant opportunities and challenges for Romania. To fully benefit from the European Health Data Space, authorities must urgently begin developing and implementing a robust, interoperable, and secure digital infrastructure capable of effectively supporting the electronic exchange of medical data. At the same time, patients and medical staff must be supported in developing advanced digital skills, thus ensuring that the transition to the new era of digital health will be both efficient and sustainable for the entire Romanian healthcare system.
1 www.health.ec.europa.eu
2 Idem 1