Real World Evidence: methodological issues and opportunities from the European Health Data Space

The current Evidence-Based-Medicine (EBM) approach is generally based on data coming from Randomized Clinical Trials or and, epidemiological observational studies. However, the past few years, with the explosion of available data derived from e-technology, a novel aspect regarding EBM arose, the Real-World-Data (RWD). RWD refers to data collected outside traditional studies, such as e-health records, claims data, patient-generated information, registries, etc. This type of information provides invaluable insights into the effectiveness, safety, and value of medical treatments and interventions when applied in real world settings. European Health Data Space (EHDS) is an initiative launched by the European Commission to create a secure and protected platform for exchanging health data across borders within European Union. The powerful combination of RWD within the EHDS serves as a valuable resource, supporting research initiatives. By analyzing diverse RWD sources, researchers generate Real-World Evidence (RWE) broadening medical knowledge. In this comment paper, methodological issues and opportunities of the application of EHDS in member states are discussed. Undoubtedly, EHDS creates a health-specific ecosystem empowering individuals through increased digital access and control their health data, providing a consistent, truthful and proficient set-up for the use of health data for research, innovation, policy-making and regulatory activities.