The ongoing negotiations surrounding the European Health Data Space (EHDS) regulation have sparked significant concerns among 35 major health stakeholder organisations across the EU and its Member States. Representing patients, health professionals, researchers, and industrial actors, these organisations have voiced apprehensions about various fundamental issues within the latest text.

1. Lack of Clear Definitions: There is uncertainty surrounding the clarity and specificity of definitions within the EHDS regulation, raising concerns about its practical implementation.
2. Coherence with Existing Legal Frameworks: Stakeholders have raised questions about the alignment of the EHDS regulation with existing legal frameworks, emphasising the importance of maintaining coherence to avoid conflicts and ambiguities.
3. Uncertainty about Governance: The EHDS regulation currently lacks clarity regarding governance structures, prompting concerns about accountability, transparency, and effective management of health data.

Despite the shared desire for the EHDS to succeed in enhancing healthcare outcomes and supporting research and innovation, these critical concerns remain unaddressed.

With EU institutions fast-tracking negotiations to finalise the EHDS before the end of the political term, the stakeholder group is urging institutions to take a collaborative approach with healthcare experts. Stay tuned for further developments as negotiations progress and stakeholders continue to advocate for a robust and effective European Health Data Space regulation.