EU greenlights European Health Data Space as new regulation officially published, stakeholders urge swift and effective implementation

Just weeks after adoption by the EU council, the European Health Data Space (EHDS) has officially been published, setting the stage for a unified digital health data system across the EU. In response, a coalition of 39 European health stakeholders has called for effective stakeholder engagement and capacity building during the implementation phase of the regulation.

The European Health Data Space (EHDS) Regulation has been officially published in the Official Journal of the European Union, marking a major milestone in the EU’s push for a secure and interoperable health data ecosystem. The final text of Regulation (EU) 2025/327 was released on March 5, 2025, and will come into force on March 26, 2025. Implementation will be phased, with many key provisons applying from March 26, 2029, giving Member States and stakeholders the necessary time to adapt policies, infrastructure, and systems to meet the regulation’s requirements.

The EHDS builds on existing data protection frameworks, particularly Regulation (EU) 2016/679 (GDPR), and introduces rules for both the primary and secondary use of electronic health data. The regulation ensures that patients retain control over their health data while establishing standards for electronic health record (EHR) systems. A key feature of the EHDS is its cross-border infrastructure, which enables personal electronic health data to be accessed securely across the EU. This means citizens will have immediate access to their health data, and healthcare professionals will be able to compliantly retrieve patient records as needed.

Beyond patient care, the EHDS introduces a framework for secondary data use, allowing health data to be used for research, innovation, and policymaking under strictly regulated conditions.

Effective implementation of the EHDS

As widely recognized, meeting the requirements of the EHDS Regulation will require extensive collaboration across the EU to ensure successful implementation. The Joint Action Towards the European Health Data Space (TEHDAS2), launched as a follow-up to the original TEHDAS project, plays a crucial role in preparing Member States by developing governance structures, technical frameworks, and trust-building mechanisms to ensure EHDS is practical and legally binding.

TEHDAS2 is also working to align policies, establish data-sharing frameworks, and provide guidance on governance, interoperability, and ethical considerations. Recently, four draft guidelines on interoperability, governance, and secure health data handling were released for public consultation.

Stakeholder Call for Action

Coinciding with the EHDS publication, 39 EU health organizations, including RWE4Decisions, the GetReal Institute, EFPIA, and MedTech Europe, issued a joint statement urging policymakers to ensure meaningful stakeholder involvement in shaping the new health data ecosystem.

They emphasize that a collaborative approach, involving citizens, civil society, healthcare professionals, scientists, academia, healthcare providers, payers, industry, and patient representatives, is essential for fostering trust, promoting adoption, and ensuring the EHDS is credible, interoperable, and effective. To succeed, implementation must minimize bureaucracy, prevent fragmented legal interpretations, and avoid excessive burdens on healthcare providers. They stress the need for meaningful stakeholder engagement, including payers, and outline three key recommendations to guide EHDS implementation.

1. Functioning of the Stakeholder Forum

The Stakeholder Forum must be established early, well-resourced, and inclusive, representing patients, healthcare professionals, researchers, and industry from across the EU. It should meet 4–6 times annually at a minimum, operate transparently by publishing key recommendations, and prioritize use cases and KPIs for monitoring progress. Clear communication with the EHDS Board is essential for transparency and accountability.

2. Capacity building and funding

To ensure all stakeholders can engage effectively, investment in training and education in, digital literacy, data governance and information sharing is crucial. Sustainable EU-level funding should support compliance, equitable access, and initiatives like EU4Health to maintain EHDS adoption across Member States.

3. Transparency of the EHDS Board

The EHDS Board must operate with clear transparency measures, including public consultation on its principles, open publication of meeting agendas and minutes, and consideration of webcasts for greater accessibility. Drawing on best practices from EU agencies such as the EMA and EFSA, the Board should ensure stakeholder perspectives are integrated into EHDS implementation, reinforcing trust and accountability.

Next steps

With the EHDS now legally binding, Member States must begin adapting policies and infrastructure to comply with its requirements. Stakeholder engagement, clear governance, and adequate funding will be critical to ensuring the EHDS achieves its full potential.

As the EU moves toward a more integrated health data ecosystem, the EHDS has the potential to enhance patient care, drive medical innovation, and improve public health outcomes. However, its success will depend on continued collaboration between policymakers, industry leaders, healthcare professionals, and patients to overcome implementation challenges and maximize its impact.