Digital transformation of health systems has created vast collections of real-world health data (RWD), including electronic patient records and insurance claims databases. For health researchers and policymakers, RWD promise several advantages: ready availability, low cost, large number of patients and time points included and diversity in patients and settings. For all its promise, using RWD presents a novel set of challenges. As the data collection methods were designed with purposes other than research in mind, the data might be biased, limited in scope or not readily available to researchers.

Most past initiatives seeking to support the use of RWD are mostly proof of concept studies and fragmented into confined disease areas and specific settings. The European Commission recently launched the European Health Data Space (EHDS) aiming—among other objectives—to make the re-use of RWD easier. In this presentation, we will examine the emerging landscape of using RWD for health research and policymaking.