They are derived from electronic health records (EHRs), claims and billing activities, product and disease registries, etc.
Results from analysis on aggregated RWD can inform the design of clinical study protocols or advance post-approval research.
RWE is defined by FDA as "clinical evidence regarding the usage and potential benefits or risks of a medical product derived from analysis of RWD".
[4] In 2018, the EMA published a discussion paper on the use of patient disease registries for regulatory purposes (methodological and operational considerations).
The use of real-world data from electronic health records and digital health-monitoring devices is also given as an example of general Post-Market Clinical Followup (PMCF) information for medical devices in the guideline "MDCG 2022-21 Guidance on Periodic Safety Update Report (PSUR) according to Regulation (EU) 2017/745 (MDR)" from December 2022.