Enabling Effective Secondary Use of Health Data in Europe: Specific Recommendations for a Potential Opt-Out Mechanism for the EHDS
This Position Paper, co-signed by Cancer Patients Europe and multiple European health stakeholder organisations, addresses proposals for an opt-out mechanism for citizens to withdraw their data from secondary use under the European Health Data Space (EHDS) Regulation. While supporting the European Commission’s original approach without opt-out to ensure representative datasets, the signatories provide six specific recommendations for implementation if an opt-out is ultimately included: EU-wide applicability with limited national derogation, minimal burden on healthcare professionals, capability for consistent implementation across all 27 Member States, routine monitoring to avoid bias, well-defined scope limitations for registries and clinical trials, and necessary investment in transparency and infrastructure. The statement calls for a full impact assessment and strong stakeholder representation in EHDS governance.