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Medicine · ISO/IEC 42001

ISO/IEC 42001 for clinical AI workflows

ISO/IEC 42001 in clinical AI workflows: what compliance requires, who asks for evidence, and the records to keep.

Legal forceVoluntary standard; certifiable by accredited bodies
Applies from18 Dec 2023
SectorMedicine
Checked21 Oct 2026

01 / The rule

What ISO/IEC 42001 requires

Any organization that provides or uses products or services that use AI systems, regardless of size, type or nature, if it chooses to adopt or certify.

  1. 01Define the AIMS scope, the organization's role toward AI (e.g. provider, user) and relevant interested parties.
  2. 02Top management sets an AI policy, AI objectives and assigns roles and responsibilities.
  3. 03Run AI risk assessments, AI risk treatment and AI system impact assessments, and record a Statement of Applicability.
  4. 04Plan, operate and control AI processes, applying the Annex A controls selected in risk treatment.
  5. 05Monitor, measure and evaluate AIMS performance through internal audits and management reviews.
  6. 06Correct nonconformities and continually improve the AIMS.

02 / In this sector

In a clinical AI workflow

AI-specific. It is a governance system for how an organization develops, provides or uses AI systems, not a technical test of any one model.

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. 01AI policy and documented AIMS scope
  2. 02AI risk assessment, risk treatment plan and Statement of Applicability
  3. 03AI system impact assessment records
  4. 04Internal audit reports, management review minutes and certification audit report

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

PRIMARY
ISO/IEC 42001:2023 catalogue entry

International Organization for Standardization

RELATED

Related: ISO/IEC 42001: the full guide · ISO/IEC 42001 for defense · ISO/IEC 42001 for law · ISO/IEC 42001 for education