THE CLINIC
SECTION 12
ISSUE 001
AI Device Change Passports
Projection: every adaptive medical device will carry a machine-readable change passport: approved modifications, training-data shifts, evaluation results, version lineage, and rollback conditions. Before an update reaches patients, a hospital could compare it with the exact configuration that earned validation—and reject silent replacement wearing familiar software’s name.
Why this idea is here
What the evidence establishes.
FDA guidance now addresses predetermined change-control plans and lifecycle management; its device list links authorizations to public regulatory records.
Source ledger
Read the sources.
- S01Guidances with Digital Health Content
official regulatory guidance index / dated Live source · verified 2026-07-09 / retrieved 2026-07-09
- S02Artificial Intelligence-Enabled Medical Devices
official regulatory database / dated Live source · verified 2026-07-09 / retrieved 2026-07-09