Real-World Evidence (RWE)
Also known as: RWE
Evidence about a clinical AI tool's performance drawn from routine clinical use rather than a controlled study.
Real-world evidence (RWE) is evidence about how a clinical AI tool actually performs, drawn from routine clinical use in a live health system setting, as opposed to a controlled research or validation study.
RWE is used alongside pre-market validation studies to monitor a tool after deployment, since real clinical settings introduce variability, such as different equipment, patient populations, and workflows, that a controlled study may not fully capture.