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Medicine · SSDF SP 800-218

SSDF SP 800-218 for clinical AI workflows

SSDF SP 800-218 in clinical AI workflows: what compliance requires, who asks for evidence, and the records to keep.

Legal forceVoluntary framework; no government-wide attestation since Jan 2026
Applies from3 Feb 2022
SectorMedicine
Checked21 Oct 2026

01 / The rule

What SSDF SP 800-218 requires

Software producers of all kinds, and in particular vendors whose software is used by US federal agencies.

  1. 01Define security requirements, roles, training and toolchains for software development (PO).
  2. 02Protect code, releases and provenance data from tampering and unauthorized access (PS).
  3. 03Design securely, review and test code, and configure software secure by default (PW).
  4. 04Identify, analyze and fix vulnerabilities and their root causes after release (RV).
  5. 05Apply practices on a risk basis and document how each is met.

02 / In this sector

In a clinical AI workflow

SP 800-218A (July 2024) is an SSDF community profile for generative AI and dual-use foundation models; it adds tasks such as protecting training data and model weights and tracking model provenance.

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. 01Secure development policy mapped to SSDF practices
  2. 02Code review, testing and scanning results per release
  3. 03SBOM and provenance records
  4. 04Vulnerability intake, triage and remediation records

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

Go back to the source

RELATED

Related: SSDF SP 800-218: the full guide · SSDF SP 800-218 for defense · SSDF SP 800-218 for law · SSDF SP 800-218 for education