25 April, 2024
ERS, alongside 36 key stakeholders in the European Union (EU) health community, has welcomed the agreement on the European Health Data Space (EHDS) proposal and produced key recommendations to ensure the EHDS will be implemented in a way that provides added value for patients and European health systems.
ERS, among other signatories of this statement, which are organisations representing patients, professionals, researchers, industry and implementer actors in the healthcare ecosystem at both EU and member state level, welcomed the provisional political agreement on the EHDS reached on 15 March, 2024. ERS also commends the European Parliament’s adoption of this agreement on 24 April, 2024.
Substantial progress was made on key elements of the EHDS. The signatories are happy to see a text that includes stronger wording on stakeholder involvement, a more harmonised approach to opt-out mechanisms, and increased attention to training and capacity building among patients and health professionals. Experience has shown that well-meant policies may fail when they do not reflect the real world that they strive to serve.
A list of key recommendations has been outlined for the implementation phase of the EHDS in the hope that this could address some of the challenges remaining in the draft document. These recommendations are intended to help chart the path forward to a concrete implementation of the EHDS, they are as follows:
- 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 electronic health records (EHRs) in practice.
- Enhance legal clarity and improve definitions.
- Ensure systematic stakeholder involvement throughout the implementation and operation phases.
The political agreement that the EHDS represents is a significant step towards putting the patient at the heart of healthcare and improving data access and sharing. The Council must now vote on the text, and once adopted, ERS looks 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 EU.