ONC HTI-1.
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… The evidence record proves: Distinctness — outputs are separable across the cohorts the source attributes name, giving the fairness/FAVES rows a measured backing
Reviewed 2026-07-08
What this is.
Use. predictive-DSI transparency · 31 source attributes · FAVES.
Register. 09 · Compliance controls — one of the 17 registers of the PLANiSPHERE corpus library.
Promise. compliance
ONC HTI-1 can require evidence around clinical workflows, ePHI boundaries, change control, or patient-impacting decisions. A team can use Planisphere's self-serve API to gate actions and retain a measurement record for internal or external compliance review; Planisphere 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?
See it work.
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.
What it requires.
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.
Questions this answers.
The board that carries this.
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 —… Read the related clinical AI workflow product context 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 updatesSibling marks. Compliance controls
For each vertical.
ONC HTI-1 for defense AI workflow
NIST AI RMF · DoW RAI · OMB M-25-21 Open the pageONC HTI-1 for clinical AI workflow
HHS §1557 · HIPAA · FDA PCCP Open the pageONC HTI-1 for legal AI workflow
FRE 702 · ABA Model Rules Open the pageONC HTI-1 for tutor and grader workflow
Title VI · FERPA · §504 / IDEA Open the pageSee the record ONC HTI-1 asks for.
The console shows the evidence; the docs show the endpoints; the briefing shows what the product does and does not claim.