Medicine · ONC HTI-1
ONC HTI-1 for clinical AI workflows
ONC HTI-1 in clinical AI workflows: what compliance requires, who asks for evidence, and the records to keep.
01 / The rule
What ONC HTI-1 requires
Developers of health IT certified under the ONC Health IT Certification Program, plus actors subject to the information blocking rules (developers, health information networks and exchanges, and health care providers).
- 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.
- 05Support USCDI version 3 as the baseline data standard for certified modules.
- 06Comply with revised information blocking definitions and exceptions in 45 CFR part 171.
02 / In this sector
In a clinical AI workflow
HTI-1 defines 'predictive decision support intervention' to cover models that learn from training data, which includes machine-learning and generative AI features in certified EHRs. It requires those tools to come with disclosed development, validation, fairness and monitoring details.
Clinical committees and health system AI governance.
HHS §1557 · HIPAA · FDA PCCP.
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 · ONC HTI-1 for defense · ONC HTI-1 for law · ONC HTI-1 for education