Medicine · OMB M-25-21/22
OMB M-25-21/22 for clinical AI workflows
OMB M-25-21/22 in clinical AI workflows: what compliance requires, who asks for evidence, and the records to keep.
01 / The rule
What OMB M-25-21/22 requires
Federal agencies using (M-25-21) or buying (M-25-22) AI, and through contracts the vendors that supply it; National Security Systems are excluded from both.
- 01Govern AI through a Chief AI Officer, governance board, compliance plan and annual use case inventory (M-25-21).
- 02Meet seven minimum practices for each high-impact AI use by 2026-04-03, or stop using it (M-25-21).
- 03Write contract terms that bind vendors to M-25-21 high-impact practices (M-25-22).
- 04Secure contractual rights to test and monitor delivered AI with agency-held data (M-25-22).
- 05Bar vendors from training on non-public agency data and protect against vendor lock-in (M-25-22).
02 / In this sector
In a clinical AI workflow
Together they cover the federal AI lifecycle: choosing and contracting for AI, then testing, assessing and monitoring it in use. Vendors feel M-25-21 indirectly through M-25-22 clauses.
Clinical committees and health system AI governance.
HHS §1557 · HIPAA · FDA PCCP.
03 / Records
Records to keep
- 01AI use case inventory and high-impact determinations
- 02Impact assessments, pre-deployment tests and monitoring records
- 03AI contract clauses on data, portability, testing and M-25-21 compliance
- 04Independent evaluation results on agency-held datasets
Optional evidence · where Planisphere fits
Keep a record anyone can check
When your team meets a duty, Planisphere can seal the event it reports as a receipt.
A disclosure shown, a review signed, a model change approved: the event your system reports.
The event becomes a sealed receipt, dated and attributed to whoever is signed in.
Paste the receipt into Verify. No account or key.
A record supports your compliance evidence process. It is not a legal finding or a certification. Systems that call Planisphere's gate API can also hold or refuse an action before it runs.
SOURCES
Go back to the source
Office of Management and Budget
Office of Management and Budget
Federal Register via GovInfo
RELATED
Related: OMB M-25-21/22: the full guide · OMB M-25-21/22 for defense · OMB M-25-21/22 for law · OMB M-25-21/22 for education