Brussels, 22 April 2024 – The EU health community welcomes the agreement on the European Health Data Space (EHDS) proposal and provides key recommendations to ensure the EHDS will be implemented in a way that provides the most added value for patients and European health systems.
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 the 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.
Political negotiators have made substantial progress in the negotiation to agree on the key elements of EHDS. The stakeholder signatories are content to see a text that includes stronger wording on stakeholder involvement, a slightly more harmonised approach to opt-out mechanisms, and increased attention to capacity building in the member states and digital literacy among patients and health professionals. We recognise that the EHDS is an ambitious and innovative policy effort that will be built in a complex environment, and expectations will have to be managed to establish realistic outcomes and timelines. As we move towards the implementation and operation phases, delivering the elements of the EHDS will require EU institutions to involve relevant stakeholders in order to create effective policy tools, instruments, and delegated and implementing acts that will promote harmonised implementation and improve legal clarity. Experience has shown that well-meant policies may fail when they do not reflect the real world that they strive to serve. Therefore, engaging stakeholders in this process is essential to ensure a feasible implementation path forward.
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 the 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
- Provide clear information to patients
- Limit the additional burden on healthcare professionals
- Interoperability of EHRs in Practice
- Enhance legal clarity & improve definitions
- Ensure systematic stakeholder involvement throughout the implementation and operation phases
In conclusion, we believe that the political agreement of 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 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.
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[1] Human genetic, epigenomic, genomic data, other human molecular data, data from wellness applications, data from biobanks and associated databases