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Medicine · FIPS 140-3

FIPS 140-3 for clinical AI workflows

FIPS 140-3 in clinical AI workflows: what compliance requires, who asks for evidence, and the records to keep.

Legal forceMandatory for federal agencies using cryptography to protect sensitive information; binding on vendors through procurement
Applies from22 Sep 2019
SectorMedicine
Checked21 Oct 2026

01 / The rule

What FIPS 140-3 requires

Federal agencies and the vendors whose cryptographic modules they buy; validated jointly by NIST and Canada's Cyber Centre through the CMVP.

  1. 01Use cryptographic modules validated under the CMVP to protect sensitive federal information.
  2. 02Have modules tested by an accredited lab against ISO/IEC 19790 and 24759 as modified by SP 800-140x.
  3. 03Meet requirements for the chosen security level (1 to 4), covering interfaces, roles, self-tests, key management and physical security.
  4. 04Use only approved security functions and keep modules in their validated configuration.

02 / In this sector

In a clinical AI workflow

Applies to AI systems as to any system: encryption of model weights, training data and inference traffic in federal settings must use validated modules.

Usually asked by

Clinical committees and health system AI governance.

Named alongside

HHS §1557 · HIPAA · FDA PCCP.

Sector pagePlanisphere for medicine

03 / Records

Records to keep

  1. 01CMVP certificate numbers for each module used
  2. 02Module security policy and approved-mode configuration
  3. 03System inventory mapping data flows to validated modules

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.

01 · Your teamRecord the event

A disclosure shown, a review signed, a model change approved: the event your system reports.

02 · PlanisphereSeal it

The event becomes a sealed receipt, dated and attributed to whoever is signed in.

03 · AnyoneCheck it

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

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RELATED

Related: FIPS 140-3: the full guide · FIPS 140-3 for defense · FIPS 140-3 for law · FIPS 140-3 for education