Human in the Loop
Also called: HITL, clinician oversight
A design where a person reviews or approves model output before it affects care, which is the basis for most regulatory exemptions in clinical software.
Human in the loop describes an architecture where model output passes through human review. It is the reason ambient documentation and most clinical reference tools are not regulated as devices: the clinician is the safeguard.
Where This Gets Misread
The safeguard is only as good as the review, and review quality is inversely related to volume and time pressure ... the exact conditions these tools are deployed to relieve. A human in the loop who approves ninety-eight percent of drafts without substantive edits is a rubber stamp with a job title, and the regulatory logic does not account for that.