IDERHA: Unlocking Health Data for Better Public Health Decision-Making

Abstract Issue/problem The European Health Union aims to strengthen health crisis preparedness, ensure equitable access to care, and promote prevention and aftercare across EU member states. Central to this vision is the European Health Data Space (EHDS), designed to enable secure, cross-border access to high-quality health data. While often focusing on the technical requirements of such data infrastructures, policy and governance around data collection, storage and use is equally important for an efficient implementation. Description of the problem Launched in 2023, IDERHA (Integration of Heterogeneous Data and Evidence towards Regulatory and HTA Acceptance) is addressing these challenges. IDERHA builds a federated health data infrastructure across Europe, supporting secondary data use through extended interoperability standards and robust data governance. It further develops AI/ML tools for early lung cancer detection. IDERHA has a strong focus on identifying policy gaps and developing policy recommendations on data access and use and on the acceptance of RWD/RWE in regulatory and HTA decision making. Results The IDERHA project aims to build a data infrastructure and a policy/governance framework aligning to the EHDS, trying to prepare member states for the EHDS implementation. Policy engagement within the project supports the development of governance frameworks ensuring ethical, secure, and transparent data use. So far, the work on policy recommendations has shown trust, transparency and incentives to be critical in all aspects of data sharing and use and that the use of RWD/RWE in regulatory processes is fragmented and diverse. Building on this, IDERHA is working on the development of different policy recommendations and the work in progress will be presented at the conference. Key messages • Federated health data infrastructures are key to enabling ethical and effective RWE use in public health. • Strong policy and governance frameworks are essential to align digital innovation with public health goals.