The ongoing negotiations on the latest text of the European Health Data Space (EHDS) regulation have prompted 35 major health stakeholder organizations, representing patients, health professionals, researchers, and industrial actors across the EU and its Member States, to express concerns about various fundamental issues. 

These include the lack of clear definitions, coherence with existing legal frameworks, and uncertainty about governance . Despite a strong desire for the EHDS to succeed in enhancing healthcare efficiency, outcomes, and supporting research and innovation, these critical concerns remain unaddressed. 

EU institutions are currently fast-tracking negotiations to finalize the EHDS before the end of the political term. The group is urging the EU institutions to collaborate closely with healthcare experts and take the necessary time to develop an EHDS that maximizes digital health’s potential to deliver high-quality healthcare for all in the EU.

35 large health stakeholder organisations representing patients, health professionals, researchers and  industrial actors in the healthcare ecosystem at both European Union (EU) and Member State level are expressing their shared concerns about the latest negotiations on the proposed Regulation on the European Health Data Space (EHDS). The EHDS is currently being negotiated at speed by EU institutions to get it ‘over the line’ before the end of this political term. 

There is a real desire by the health stakeholder community for this proposed legislation to be a  success. The potential benefits offered by a well-functioning EHDS would be significant. The EHDS is  intended to make the functioning of European health systems more efficient, contribute to better  health outcomes, and support public health and health research and innovation activities in the EU. 

However, despite repeated calls by health stakeholder organisations from across the European  healthcare ecosystem (on general recommendations for legislating the EHDS, on the challenges of  implementing an effective opt-out / opt-in mechanism in the EHDS, and on raising alarm bells to  address significant legislative shortcomings and uncertainties in the EHDS), the following ten fundamental issues have not been addressed satisfactorily in the legislative positions that form the  bases for the interinstitutional negotiations (trilogues) between Council, the European Parliament and  the European Commission. 

• The EHDS must set forth clearer and more coherent definitions(e.g. on ‘electronic health data’,  ‘data holder’, ‘electronic health record system’). 
• The EHDS must clarify its interaction with other applicable legal frameworks (including GDPR,  Data Governance Act, Data Act, Medical Devices Regulation). 
• The EHDS must harmonise rules, reduce legal fragmentation and ensure that the regulation can  be implemented consistently across the EU.
• The EHDS must specify the scope of electronic health data categories for secondary use. ⬥ The EHDS should avoid any opt-in and only incorporate an opt-out mechanism as long as it  does not lead to inconsistent implementation, increased health data disparities and excessive  administrative burdens. The relevant legal bases under the GDPR should be leveraged and  applied in a harmonised way across Member States.
• The EHDS should safeguard and incentivise health research and innovation activities that are  performed in line with the existing regulatory frameworks.
• The EHDS should leverage existing health data infrastructures, set up by health institutions and  stakeholders, to allow continuity and build on existing expertise.
• The EHDS should avoid excessive data localisation and international health data transfer  restrictions that go beyond the requirements of the GDPR’s framework.
• The EHDS should involve all relevant health stakeholders from the outset of the  implementation process and include them in its governance at both EU and Member State level. ⬥ The EHDS must provide adequate resources and incentives to facilitate its successful implementation. It should be accompanied by policies promoting digital health skills and tools for health professionals, patients and citizens. 

The European healthcare ecosystem is concerned that the draft text of the EHDS does not provide the  necessary degree of legal certainty and consistency with the existing regulatory frameworks. Recently  incorporated or amended key provisions should be carefully considered to avoid unintended negative  consequences. A robust health data governance framework is essential for ensuring privacy and  security to build and maintain public trust in the EHDS. Therefore, we call on the EU institutions to  leverage the expertise of the healthcare ecosystem and take the necessary time to create the EHDS that makes the most of the potential of digital health to provide high-quality healthcare for all in the EU.