Clinical trials have long been considered the gold standard for high-quality evidence of drug and device safety and efficacy. However, data captured in EHRs during routine healthcare interactions can offer rich insight into product performance in real-world settings. These insights can be used to improve patient care, enhance product safety and effectiveness, and expand access to innovative therapies.

The US Food and Drug Administration also supports using real-world evidence derived from real-world data for regulatory decision-making but stipulates that data must be fit for purpose.

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