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Before an AI tool is allowed to influence care at a hospital, it would run invisibly alongside clinicians for months so its real-world performance at that site is known first.
Shadow deployment (the model runs on live data but its outputs are hidden and compared with clinicians and outcomes) is standard practice at a few pioneering centres but not required. The proposal makes a pre-specified silent trial (minimum case numbers, pre-declared performance thresholds, subgroup analysis, comparison with local clinicians) a condition of go-live at each site, reported to the registry, as the AI equivalent of laboratory method verification before a new assay is used.
Shares A standard for monitoring AI performance drift with pause thresholds, How medical AI devices are evaluated: limitations and recommendations from an analysis of FDA approvals, AI that is built but not validated or deployed.
Shares A standard for monitoring AI performance drift with pause thresholds, How medical AI devices are evaluated: limitations and recommendations from an analysis of FDA approvals, AI that is built but not validated or deployed.
Shares How medical AI devices are evaluated: limitations and recommendations from an analysis of FDA approvals, AI that is built but not validated or deployed.
Shares How medical AI devices are evaluated: limitations and recommendations from an analysis of FDA approvals, AI that is built but not validated or deployed.
Shares How medical AI devices are evaluated: limitations and recommendations from an analysis of FDA approvals, AI that is built but not validated or deployed.
Shares How medical AI devices are evaluated: limitations and recommendations from an analysis of FDA approvals, AI that is built but not validated or deployed.
Shares How medical AI devices are evaluated: limitations and recommendations from an analysis of FDA approvals, AI that is built but not validated or deployed.
Shares How medical AI devices are evaluated: limitations and recommendations from an analysis of FDA approvals, AI that is built but not validated or deployed.