How do I scope the ONC HTI-1 audit?

Use the brass 'Prepare evidence for ONC HTI-1 review' button. First evidence record within 21 days of access; re-runs in a single business day.

ONC HTI-1.

Prepare evidence for ONC HTI-1 review

Buyer translation: this reference page maps the mark to a tool, system, control, deployment, or evidence question. predictive-DSI transparency · 31 source attributes · FAVES · ONC HTI-1 can require evidence around clinical workflows, ePHI boundaries, change control, or patient-impacting decisions. Planisphere maps the workflow, runs the harness, and packages the measurement record for internal or external compliance review; it does not certify compliance, perform the HIPAA risk analysis, or replace the safeguard system of record.

Reviewed 2026-07-02

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What this is.

Sixty-nine marks · cite-anchors for every regulatory regime Planisphere maps to · postmark idiom · single distinctive brass glyph per control · universal classifier · pSEO surface

Use. predictive-DSI transparency · 31 source attributes · FAVES.

Source. magnifier over ledger · brass attribute rows.

Register. 09 · Compliance controls — one of the ten registers of the PLANiSPHERE corpus library.

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Promise. compliance

The contract this mark binds — derived, not asserted.

ONC HTI-1 can require evidence around clinical workflows, ePHI boundaries, change control, or patient-impacting decisions. Planisphere maps the workflow, runs the harness, and packages the measurement record for internal or external compliance review; it does not certify compliance, perform the HIPAA risk analysis, or replace the safeguard system of record.

Answers: What evidence can Planisphere prepare for ONC HTI-1 review?

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See it work.

Evidence record you can check — not code you have to trust.

Planisphere measures your tool deployment against ONC HTI-1 and seals the result into a signed, Merkle-rooted evidence record. The grade recomputes on your own hardware; the model state never crosses the boundary.

Prepare evidence for clinical AI review →See how a record is checked

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What it requires.

The obligation this regime imposes — and the honest ceiling. Healthcare regulation

ONC HTI-1 (45 CFR 170.315(b)(11), final 2024-01-09, in effect 2025-01-01) requires certified Health IT Modules to surface 31 source attributes for every Predictive DSI — technology that derives relationships from training data and outputs a prediction, classification, recommendation, evaluation, or analysis. The attributes cover intended use, intended users, the decision-making role, output, the validation cohort, fairness measures, and the FAVES posture (Fair, Appropriate, Valid, Effective, Safe). It creates a standing maintenance duty: under §170.402(b) the developer must keep those attributes current as the model, data, or population shifts.

What the evidence record proves.

Distinctness — outputs are separable across the cohorts the source attributes name, giving the fairness/FAVES rows a measured backing
Drift — re-runs detect when behaviour has moved off the declared baseline, turning the §170.402(b) maintenance duty into a dated, signed delta
Coherence — output is consistent with the intended decision-making role the source attributes declare
Each measured row carries its cite-anchor to §170.315(b)(11) next to a SHA
The record is Merkle-rooted and reproducible bit-exact on the customer's hardware

What this does not prove. Planisphere does not certify a Health IT Module, does not file with ASTP/ONC, and does not read PHI — it attests the measurement underneath the source attributes while the developer remains the declarant and ASTP/ONC the certifier. HTI-2 privacy/security certification and FDA device clearance are out of scope.

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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Questions this answers.

3 high-intent questions buyers search — each on its own page, each pinned to ONC HTI-1.

When did the ONC HTI-1 predictive-DSI requirements take effect? Read the answer → How do I demonstrate FAVES for a predictive DSI? Read the answer → How can an AI tool deployment audit produce one evidence record across HTI-1, §1557, FDA PCCP, and CMS at once? Read the answer →

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The board that carries this.

Related marks, and the surface this one funnels to.

ONC HTI-1 asks for an evidence record: ONC HTI-1 (45 CFR 170.315(b)(11), final 2024-01-09, in effect 2025-01-01) requires certified Health IT Modules to surface 31 source attributes for every Predictive DSI —… The clinical AI workflow produces that record — see how it runs at /medicine.

CMS reg 09 · Medicare/Medicaid coverage · algorithm cannot be the sole basis to deny care DSI Source Attributes reg 09 · the 31 predictive-DSI source attributes as an evidence checklist FDA PCCP reg 09 · Predetermined Change Control Plan · drift-bounded model updates

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