Question · ONC HTI-1
How can an AI tool deployment audit produce one evidence record across HTI-1, §1557, FDA PCCP, and CMS at once?
HTI-1 updated the ONC certification program: it replaced the old clinical decision support criterion with the decision support interventions criterion, added algorithm transparency and risk management duties for predictive models, moved the baseline to USCDI v3, and revised information blocking rules.
01 / The answer
The short answer
A single, well-documented evaluation can feed several of these regimes, but it cannot replace their separate duties, which fall on different parties. Validity and fairness results across demographic groups can support a certified developer's HTI-1 source attributes, a covered entity's §1557 mitigation efforts and a device maker's PCCP acceptance criteria. Repeated measurements over time support HTI-1's ongoing review and PCCP performance monitoring. Medicare Advantage rules need something different: case records showing each coverage decision rested on the individual patient's history and clinician review, not only a model's output.
02 / The rule
What ONC HTI-1 requires
HTI-1 updated the ONC certification program: it replaced the old clinical decision support criterion with the decision support interventions criterion, added algorithm transparency and risk management duties for predictive models, moved the baseline to USCDI v3, and revised information blocking rules. It was the first US federal rule to require transparency about AI and other predictive models embedded in EHRs.
- 01Certify to the decision support interventions criterion (45 CFR 170.315(b)(11)), which replaced the clinical decision support criterion (a)(9).
- 02Provide users source attribute information for supplied predictive and evidence-based decision support tools.
- 03Apply intervention risk management practices to supplied predictive DSIs and publish summary information about them.
- 04Review and update source attributes and risk practices on an ongoing basis from January 1, 2025.
03 / Records
Records to keep
- 01Certification to 170.315(b)(11) listed on the Certified Health IT Product List
- 02Source attribute records for each supplied DSI
- 03Intervention risk management documentation and public summary
- 04Records of ongoing attribute review and updates
Optional evidence · where Planisphere fits
Keep a record anyone can check
When your team meets a duty, Planisphere can seal the event it reports as a receipt.
A disclosure shown, a review signed, a model change approved: the event your system reports.
The event becomes a sealed receipt, dated and attributed to whoever is signed in.
Paste the receipt into Verify. No account or key.
A record supports your compliance evidence process. It is not a legal finding or a certification. Systems that call Planisphere's gate API can also hold or refuse an action before it runs.
SOURCES
Go back to the source
Federal Register (ASTP/ONC)
Federal Register (CMS/ONC)
RELATED
Related: ONC HTI-1: the full guide · When did the ONC HTI-1 predictive-DSI requirements take effect? · How do I demonstrate FAVES for a predictive DSI?