Data

Real-world data studies — RWD/RWE (Real-World Data / Real-World Evidence) — leverage data that has already been collected: care data, data from previous studies or health data warehouses. No procedure is added to the patient pathway: the research bears on the data itself — its quality, linkage, representativeness and the analysis method.

Regulatory frameworks

• WorldwideDeclaration of Helsinki (research on identifiable data and samples) · ICH E6(R3) good practice when the data feeds a regulatory dossier · in the United States: HIPAA rule and IRB committees
• European UnionGDPR — Regulation (EU) 2016/679 (legal basis, minimisation, individual rights) · European Health Data Space (EHDS) — Regulation (EU) 2025/327, in force since March 2025, secondary use rolled out progressively
• FranceLoi Jardé — research not involving the human person (RNIPH) · CNIL reference methodologies (notably MR-004) or CNIL authorisation · Health Data Hub
• BelgiumLaw of 30 July 2018 on the protection of natural persons with regard to the processing of personal data (implementing the GDPR) · Data Protection Authority (APD) · opinion of an accredited ethics committee for retrospective studies on patient data