European health stakeholder organizations voice concerns over European Health Data Space regulation

In a press release, European health stakeholders have expressed concerns over the forthcoming EHDS regulation negotiations, urging EU institutions to prioritize expertise and time allocation to ensure safe and beneficial digital health, while safeguarding privacy and trust.

A group of 35 European health stakeholder organizations have collectively expressed concerns regarding the ongoing trilogue negotiations on the proposed Regulation for the European Health Data Space (EHDS). These organizations, including the GetReal Institute and European Federation of Pharmaceutical Industries and Associations (EFPIA), represent patients and researchers, as well as healthcare and industry professionals, across the EU and Member States. The EHDS, currently under rapid negotiation by EU lawmakers, aims to streamline European health systems, enhance health outcomes, and bolster public health and research activities within the EU.

Despite a collective need for the legislation’s success, the stakeholders have highlighted ten fundamental issues that remain inadequately addressed in the current legislative  discussions:

• Clarity and coherence: Stakeholders emphasize the necessity for clearer definitions within the EHDS, particularly regarding terms such as ‘electronic health data’ and ‘data holder.’
• Interaction with legal frameworks: The interaction of the EHDS with other relevant legal frameworks, such as the GDPR, Data Governance Act, Data Act, and Medical Devices Regulation, needs clarification.
• Harmonization and consistency: Stakeholders advocate for harmonized rules to reduce legal fragmentation and ensure consistent implementation across the EU.
• Scope of data categories: The EHDS must specify the scope of electronic health data categories for secondary use.
• Opt-in mechanism: The EHDS should avoid opt-in mechanisms and instead utilize an opt-out approach to ensure consistent implementation, reduce disparities in health data access, and minimize administrative burdens. It is crucial to apply the GDPR’s legal foundations uniformly across all Member States.
• Support for research and innovation: Emphasis is placed on safeguarding and incentivizing health research and innovation activities within existing regulatory frameworks.
• Utilization of existing infrastructures: Leveraging existing health data infrastructures, set up by health institutions and stakeholders, is advised to ensure continuity and expertise utilization.
• Data localization and transfer: Concerns are raised regarding excessive data localization and international data transfer restrictions.
• Stakeholder involvement: Stakeholders stress the importance of involving relevant health stakeholders in both EU and Member State governance from the outset of implementation.
• Resource allocation: The EHDS must allocate sufficient resources and offer incentives to ensure its effective implementation. This should be complemented by policies that promote the development of digital health skills and tools for healthcare professionals, patients, and citizens.

In light of these concerns, the stakeholders have urged EU institutions to utilize expertise from the healthcare ecosystem and allocate sufficient time to develop an EHDS that optimizes the benefits of digital health while maintaining privacy, security, and public trust.