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Medicine · EAR

EAR for clinical AI workflows

EAR in clinical AI workflows: what compliance requires, who asks for evidence, and the records to keep.

Legal forceBinding law
SectorMedicine
Checked21 Oct 2026

01 / The rule

What EAR requires

Anyone exporting, reexporting or transferring items subject to the EAR (commodities, software, technology), including releases of technology to foreign persons in the US.

  1. 01Classify items (ECCN or EAR99) and determine licence requirements by destination, end user and end use.
  2. 02Obtain BIS licences or use a valid licence exception before exporting controlled items or technology.
  3. 03Treat release of controlled technology or source code to foreign persons as a deemed export.
  4. 04Screen parties against the Entity List and other restricted-party lists.
  5. 05Apply advanced computing controls and due diligence for AI chips and data-center items.
  6. 06Keep export records for five years.

02 / In this sector

In a clinical AI workflow

Controls advanced AI chips and related technology; ECCN 4E091 (closed model weights above a training-compute threshold) remains in the CFR text but BIS stopped enforcing it in May 2025 and plans formal rescission; published (open) model weights and software are generally not subject to the EAR.

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. 01Item classification records (ECCN determinations)
  2. 02Licences, licence exception determinations and conditions
  3. 03Restricted-party screening logs
  4. 04Export transaction records kept five years

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: EAR: the full guide · EAR for defense · EAR for law · EAR for education