Local validation memo
What it is
The Local validation memo is the artifact that satisfies RUAIH focus area 4 — Monitoring, evaluating and validating — at the control level.
Who signs it
The clinical sponsor and the AI committee jointly.
A document without a signature is a draft. An assessor is checking that someone with authority put their name to it.
What an assessor asks for
A written protocol and a result, on your data, for every tool in the top risk tier.
What goes in it
- The question the validation answers, stated before the data is pulled
- Population, period and inclusion criteria
- Reference standard and how it was established
- Primary and secondary metrics with pre-specified thresholds
- Silent trial design where the tool will influence a clinical decision
- Subgroup analysis
- Result, interpretation, and the go / fix / stop recommendation
- Signatures and date
The most common failure
Treating a silent trial as optional because the vendor’s published AUC is high. Published performance is measured on a development population; your question is whether it holds on yours.
Where this sits
See the RUAIH crosswalk for how this control maps across CHAI’s playbooks and the NIST AI RMF.
Written and reviewed by Neel Chauhan, MD MBA, physician-executive and founder of the Healthcare AI Institute. Last reviewed 2026-07-30.
Specified from the published RUAIH focus areas and the September 2025 Joint Commission and CHAI guidance, plus the failure modes we see most often in practice.
The Institute accepts no vendor sponsorship, holds no vendor equity and takes no referral fees.