OHSIRIS: A Federated Data Space for Interoperable Biomedical Research

OHSIRIS aims to implement a federated and interoperable data space to enable secure and scalable reuse of real-world health data for biomedical research. The project adopts a protocol-driven approach, where research questions are translated into standardized analytical workflows executed across multiple institutions using the OMOP Common Data Model. A federated architecture ensures that data remain at the source, while only aggregated results are shared, supporting compliance with data protection regulations. The framework was validated through three use cases: a multicenter study on lung cancer risk factors, a cost-effectiveness analysis of respiratory syncytial virus immunization, and an antimicrobial use monitoring study. Results demonstrate the feasibility of executing reproducible and comparable analyses across sites using standardized methods and outputs. OHSIRIS provides a practical implementation of a governed health data space aligned with European initiatives, supporting interoperable, privacy-preserving, and collaborative biomedical research.