The FDA Loosened Clinical AI. The Replayable Record Is the Condition It Set.

The Food and Drug Administration's 6 January 2026 guidance loosens oversight of clinical artificial intelligence on one condition: a clinician must be able to independently review the basis of every recommendation. That condition is an engineering requirement for a replayable, attributable record, which is exactly what the Open Audit Record provides.Originally published at https://mickai.co.uk/articles/fda-loosened-clinical-ai-the-replayable-record-is-the-condition. Mickai is a Sovereign Intelligence Operating System; the Open Audit Record signs every artificial intelligence action before it executes, post-quantum and offline-verifiable. 101 filed UK patent applications, Mickai LTD (Companies House 17166618).