European Health Data Space: A Step Forward for Digital Health in Europe
In April 2024, the European Parliament adopted the Regulation on the European Health Data Space (EHDS), a legislative act designed to transform access to, governance of, and reuse of health data within the European Union.
The Regulation entered into force on 26 March 2025, marking the beginning of a gradual transition phase and introducing concrete obligations for both public and private healthcare providers.
What Are the Objectives of the EHDS Regulation?
The Regulation benefits not only patients, but also healthcare professionals, researchers, policymakers and all stakeholders in the health sector. It is built around three main objectives:
- Strengthening healthcare delivery by guaranteeing citizens direct, secure and controlled access to their health data, while facilitating data sharing among healthcare professionals across the EU.
- Regulating the reuse of health data through strict authorisation mechanisms for secondary uses such as research, innovation and the improvement of health policies.
- Promoting data fluidity and interoperability through the creation of a single market for electronic health records, ensuring that health data are accessible, readable and shareable throughout the European Union, thereby facilitating patient mobility and continuity of care across borders.
What Benefits Does the EHDS Regulation Offer to Healthcare Providers?
By improving access to health data, the Regulation enhances care coordination and helps reduce unnecessary duplication of medical examinations.
The technical interoperability requirements imposed on health information systems facilitate exchanges between healthcare establishments, while also increasing operational efficiency.
In addition, the structured framework for the secondary use of health data opens up new opportunities for research and innovation projects.
What Should Healthcare Stakeholders in Belgium Prepare For?
The EHDS introduces numerous obligations. The following key aspects deserve particular attention:
Secure Access to and Exchange of Health Data
Healthcare providers will be required to ensure that patients have free, direct and secure access to their electronic health data in a European standardised format (EEHRxF). They must also guarantee continuity of cross‑border care through interoperable, certified and technically reliable systems.
Regulated Reuse of Health Data (Secondary Uses)
Providers will be required to make certain data available in pseudonymised form for purposes such as research, innovation or public health, subject to prior authorisation procedures imposed by the competent authorities. This topic will be addressed in more detail in a separate publication.
Adaptation of Information Systems
Electronic health record systems will need to be updated or replaced to meet the Regulation’s requirements on interoperability, security and certification.
Close attention will also need to be paid to the technical specifications to be published by the European Commission.
Compliance with Other European Regulatory Instruments
Data processing activities must remain compliant not only with the General Data Protection Regulation (GDPR), but also with other applicable European instruments, such as the Data Governance Act, the Data Act and the NIS2 Directive.
New Rights for Patients
Patients will benefit from expanded rights, including the right to rectify their data, to restrict certain uses, and to lodge complaints with the competent authority.
Healthcare providers will therefore need to implement appropriate internal procedures to handle such requests effectively.
Our advice:
The EHDS Regulation represents a major advancement in digital health, but it also requires significant changes to practices and systems. It is therefore essential for healthcare institutions and providers to anticipate the different phases of implementation of the Regulation.
To assess your needs, adapt your governance framework or obtain tailored advice, do not hesitate to contact us.
