Recital 53

Electronic health data used for secondary use can bring great societal benefits. The uptake of real-world data and real-world evidence, including patient-reported outcomes, for evidence-based regulatory and policy purposes as well as for research, health technology assessment and clinical objectives should be encouraged. Real-world data and real-world evidence have the potential to complement health data currently made available. To achieve that goal, it is important that datasets made available for secondary use pursuant to this Regulation be as complete as possible. This Regulation provides the necessary safeguards to mitigate certain risks involved in the achievement of those benefits. The secondary use of electronic health data is based on pseudonymised or anonymised data, in order to preclude the identification of the data subjects.