ECO Joins 35 Other Stakeholder Organisations in Providing Key Recommendations on European Health Data Space Implementation

The signatories of this statement, which are key stakeholder organisations representing patients, health professionals, researchers, industry and implementer actors in the healthcare ecosystem at both European Union (EU) and Member State level, welcome the provisional political agreement on the Regulation for the European Health Data Space (EHDS) reached on 15 March 2024.

Our patients’, healthcare professionals’, researchers’, industry, and multi-stakeholder implementer organisations, have worked together since February 2023 to develop a set of key recommendations for the implementation phase of the EHDS that could address some of the challenges remaining in the draft document. At least eight elements need to be considered. They include preventing fragmentation in interpretation and implementation of the opt-out and opt-in provisions, appropriate information provision to patients, guidance for data holders, clarity on definitions and interaction with other legal frameworks, better interoperability in practice, enhancing public trust and structural stakeholder involvement.

These recommendations are intended to help chart the path forward to a concrete implementation of the EHDS.

Recommendations:

• Address the risk of a fragmented interpretation and implementation of opt-out and opt-in mechanisms.
  • Opt-out mechanisms to the primary and secondary use of data must be implemented in a harmonised manner across Member States to ensure a consistent approach to reduce barriers to cross-border health research.
• Provide clear information to patients.
  • To facilitate patients’ understanding of the functioning of EHDS and to help them make informed decisions on the re-use of their health data, the information provided to patients must be sufficiently clear, concise, and shared in a harmonised manner across EU countries. Standardised EU templates should be developed to inform patients, ensure transparency, and establish clear EU guidelines for inferred data usage.
• Interoperability of EHRs in Practice.
  • The implementation of the EHDS must not add to the already high workload of healthcare professionals. There is a need for sufficient support, guidance, and tools to help healthcare professionals fulfil their additional roles and responsibilities under the EHDS and develop the required digital skills and competences, as well as investment in infrastructure and data as well as digital health literacy in general. Adequate resources and funding should be provided at the EU level to support training initiatives, streamline compliance procedures, and allocate resources efficiently. It is crucial to ensure that resources are properly and uniformly allocated at the national level to avoid discrepancies in implementation speed and capacity among Member States.
• Enhance legal clarity & improve definitions.
  • There is a need for additional guidance and legal clarity on the different definitions and the interplay with other legislations, to prevent a fragmented interpretation and implementation. The interplay between EHDS and other existing legal frameworks, such as the General Data Protection Regulation (GDPR), the Medical Devices Regulation (MDR), the In Vitro Diagnostic Medical Device Regulation (IVDR), Artificial Intelligence Act and the Clinical Trials Regulation (CTR), presents challenges in ensuring coherence and compatibility across different regulatory regimes. This requires a careful assessment of the application of the different regulations, and guidance on their interaction. At the same time, implementation guidance related to the definitions and obligations of data holders and users can help the health community to better fulfil their foreseen roles in EHDS.
• Ensure systematic stakeholder involvement throughout the implementation and operation phases.
  • We welcome the inclusion of new provisions on stakeholder involvement, including the creation of a new Stakeholder Forum. However, the involvement of patients, healthcare professionals, researchers, and industry representatives and implementer for a must be further defined to ensure this involvement in the implementation and governance of EHDS happens in a systematic manner. Establishing mechanisms for ongoing consultation, capacity-building initiatives, and transparent decision-making processes will enhance EHDS governance, foster trust and optimise stakeholder contributions. By empowering stakeholders and leveraging their expertise, policymakers can develop informed, responsive, and inclusive EHDS policies and initiatives, ensuring their success and sustainability.

In conclusion, we believe that the political agreement EHDS represents a significant step forward towards putting the patient at the heart of healthcare and improving proper data access and sharing. We look forward to continuing the dialogue and contributing to an effective implementation and governance of the EHDS to improve healthcare and research, while promoting effective and efficient patient-centric care through interoperability and innovation across the European Union.