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
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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)

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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

Prepare evidence for ONC HTI-1 review.

First evidence record within 21 days of access · re-runs in a single business day. Planisphere measures model behaviour and emits a reproducible, sha-pinned record — it does not certify, file, or give legal advice.