The Draft Text of the European Health Data Space (EHDS) in Trilogues Sparks Deep Concerns in the European Healthcare Ecosystem
This Press Release, jointly issued by 35 large European health stakeholder organisations including Cancer Patients Europe and representing patients, health professionals, researchers, and industry actors, expresses deep concerns regarding the draft EHDS Regulation text in trilogue negotiations in February 2024. Despite the community’s desire for the legislation to succeed and prior stakeholder calls for amendments, the statement identifies ten fundamental unresolved issues including unclear definitions, fragmented interaction with existing legal frameworks (GDPR, Data Act, MDR), lack of harmonisation across Member States, problematic opt-in/opt-out mechanisms, excessive data localisation, insufficient stakeholder involvement in governance, and inadequate implementation resources. The signatories call on EU institutions to leverage healthcare ecosystem expertise and take the necessary time to create a robust EHDS.