Presentation (CTI)

OBJECTIVES: The European Health Data Space (EHDS) establishes a framework for secondary use of health data across the EU. However, policy gaps may limit participation by data holders, including providers, industry, registries, and academia. The IHI-IDERHA project aimed to identify barriers and enablers to health data sharing from data holder perspectives, and to develop practical policy recommendations to support secondary use within and beyond the EHDS for clinical, regulatory and HTA decision-making. This work provides a structured, multi-stakeholder policy framework with a specific focus on data holder incentives and risks.
METHODS: A mixed-methods approach that included a stakeholder survey (n=51), a review of EHDS regulatory requirements for data holders, a targeted literature review, and two stakeholder workshops with industry and academic experts was employed. Evidence was triangulated and iteratively validated to inform policy recommendations.
RESULTS: Legal uncertainty and data protection concerns were identified as the primary barriers to data sharing, while interoperability support and standardised legal templates emerged as key enablers. Seven cross-cutting policy gap areas were identified: transparency and public trust; data quality and enrichment; capacity and operational support; legal clarity and process simplification; reputational risk; strategic and commercial risk; and financial incentives and benefit sharing. Key recommendations include strengthening the expertise of health data access bodies (HDABs), particularly in intellectual property, promoting consistent anonymisation approaches, providing targeted infrastructure funding for under-resourced organisations, enabling shared secure processing environments, adopting non-punitive error correction mechanisms, and recognising data sharing as a research output.
CONCLUSIONS: While the EHDS represents a major regulatory step forward, its impact will depend on addressing practical, legal and strategic barriers faced by diverse data holders and enabling trusted cross-border data use. The IHI-IDERHA recommendations offer an implementable, stakeholder-informed roadmap to support consistent and sustainable secondary use of health data for evidence generation in clinical, regulatory, and HTA contexts.