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THE CLINIC

SECTION 12

ISSUE 001

PROJECTIONpolicy6-12mconfidence / high

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.

  1. S01
    Guidances with Digital Health Content

    official regulatory guidance index / dated Live source · verified 2026-07-09 / retrieved 2026-07-09

  2. S02
    Artificial Intelligence-Enabled Medical Devices

    official regulatory database / dated Live source · verified 2026-07-09 / retrieved 2026-07-09

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