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FRE 702 for clinical AI workflows

FRE 702 in clinical AI workflows: what compliance requires, who asks for evidence, and the records to keep.

Legal forceBinding in federal court proceedings
Applies from1 Dec 2023
SectorMedicine
Checked21 Oct 2026

01 / The rule

What FRE 702 requires

Parties offering expert testimony in federal court, and the judges who decide whether to admit it.

  1. 01Show the court, more likely than not, that each Rule 702 requirement is met; weight arguments do not substitute for this showing.
  2. 02Base the opinion on sufficient facts or data.
  3. 03Use reliable principles and methods, including known or potential error rates where available.
  4. 04Show the opinion reflects a reliable application of the method to the case facts, without overstating certainty.

02 / In this sector

In a clinical AI workflow

When an expert relies on an AI or machine-learning tool, the court can ask whether the tool's method is reliable and was reliably applied: validation, error rates, data and reproducibility. A proposed Rule 707 to extend these factors to machine output offered without an expert was not recommended for approval in May 2026 and remains under study.

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. 01Expert report describing data, method, and error rate
  2. 02Validation studies or benchmarks for any AI tool relied on
  3. 03Versioned inputs, settings and outputs allowing reproduction
  4. 04Record of limits and uncertainty stated in the opinion

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
Federal Rules of Evidence (December 1, 2025 edition)

Administrative Office of the U.S. Courts

PRIMARY

RELATED

Related: FRE 702: the full guide · FRE 702 for defense · FRE 702 for law · FRE 702 for education