Open the Console Prepare evidence for clinical AI review

How do I demonstrate FAVES for a predictive DSI?

FAVES — fair, appropriate, valid, effective, and safe — is the quality bar HTI-1 attaches to predictive DSIs, and you demonstrate it with documented validation, performance measurement across relevant subpopulations, and ongoing monitoring rather than a…

register 09 · Compliance pins· ONC HTI-1
01 ·

Answer.

Healthcare regulation · ONC HTI-1.

FAVES — fair, appropriate, valid, effective, and safe — is the quality bar HTI-1 attaches to predictive DSIs, and you demonstrate it with documented validation, performance measurement across relevant subpopulations, and ongoing monitoring rather than a single declaration. Reproducible, comparable evaluation evidence is the backbone. Planisphere measures the valid/effective/fair-relevant behaviour against a fixed probe set and tracks drift; clinical appropriateness and safety determinations remain the developer's and clinician's responsibility.

Cite-anchor: ONC HTI-1 Final Rule — Predictive Decision Support Intervention certification criterion · 45 CFR 170.315(b)(11); maintenance under 45 CFR 170.402(b)

02 ·

The mark behind the answer.

ONC HTI-1 can require evidence around clinical workflows, ePHI boundaries, change control, or patient-impacting decision…

predictive-DSI transparency · 31 source attributes · FAVES.

→ Full reference for ONC HTI-1

03 ·

More on ONC HTI-1.

Other questions this mark answers.
When did the ONC HTI-1 predictive-DSI requirements take effect? How can an AI tool deployment audit produce one evidence record across HTI-1, §1557, FDA PCCP, and CMS at once?

Try ONC HTI-1 with a free test key.

Start with the free sandbox. Planisphere measures model behaviour and emits a reproducible, sha-pinned record — it does not certify, file, or give legal advice.

Open the Console Prepare evidence for clinical AI review ONC HTI-1 reference
API ·

When ONC HTI-1 asks for proof, hand over records — not assurances.

record the duty · seal the receipt · verify offline

Planisphere records each duty event — an output marked, a disclosure shown, a review made — and seals it into a receipt that verifies offline against our published keys. You send hashes, never content. A record is evidence a third party can check; it is not a certification and not a legal determination.

Open the Console Read the Docs Read the capability briefing

See how a record is checked