A digital-health team builds an AI-assisted patient-intake feature. In Architecture, the PHI data store and its access layer are declared as explicit assets with handling rules. Development generates the intake flow, and the Quality Gate rejects a logging call that would write PHI to an unsecured sink. The Analyzer records the rejection, the corrective fix, and the engineer who approved it.
When an FDA reviewer or a HIPAA auditor later requests the design history of the intake feature, the team exports the artifact trail — requirement, asset map, generated code, approvals — as a design history file that was assembled continuously, not reconstructed under deadline.
