Reference · Healthcare
ONC HTI-1 Decision Support Interventions, Explained
45 CFR 170.315(b)(11) — Decision support interventions; HTI-5 proposed
ONC's HTI-1 final rule replaced the older clinical decision support criterion with a decision support interventions criterion that reaches predictive models. Certified health IT developers had to meet it by 31 December 2024; it has been in the certification program since 1 January 2025. The criterion binds developers, but its source attributes are what a provider or payer needs to know what its predictive tools do.
Who it applies to
Developers of certified health IT, through the ONC Health IT Certification Program. Deploying organizations are not certified under it, but they configure the interventions, receive the source attributes, and carry their own duties under HIPAA, Section 1557, and state law.
The six sub-paragraphs
- (i) Interaction: identified users can interact with interventions based on patient data.
- (ii) Configuration and feedback: users can configure interventions, record and export feedback, and select interventions across transitions of care.
- (iii) Selection of evidence-based and predictive interventions using USCDI data.
- (iv) Source attributes: citation, developer, funding, dates, and whether race, ethnicity, language, sexual orientation, gender identity, sex, date of birth, social determinants, or health status are used; for predictive interventions, also intended use and populations, cautioned uses and risks, development data and representativeness, fairness process, external validation, performance, maintenance, and update schedule.
- (v) Access and modification of source attributes in plain language.
- (vi) Intervention risk management for predictive interventions: risk analysis, mitigation, and governance, with a public summary.
HTI-5, the proposal
ONC's HTI-5 proposed rule would remove a large share of the certification criteria, narrow the decision support criterion, and remove the source-attribute requirements. The comment period closed on 27 February 2026. It is a proposal; no obligation changes until a final rule is published.
Control mapping
What a reviewer expects to be able to see.
| Obligation | What the system must do | Evidence a reviewer expects |
|---|---|---|
| Predictive intervention inventory | Know which predictive interventions are enabled | The enabled set, from the certified health IT and from traffic |
| Source attributes | Keep the developer's attributes on file and reachable by clinicians | Attributes per tool with a completeness check |
| Configuration and feedback | Control configuration changes and record feedback | Change history and feedback exports |
| Intervention risk management | Mirror the developer's practices for the interventions in use | Risk analysis, mitigations, governance owner |
Key dates
- 31 December 2024Developer deadline to update to the DSI criterion.
- 1 January 2025DSI criterion in the certification program.
- 1 January 2026Insights Condition reporting by certified developers begins.
- 27 February 2026HTI-5 proposed rule comment period closes.
Primary sources
Common gaps
Where deployers most often lose the thread.
- Source attributes nobody has read. The developer made them available. Nobody in the organization can say, for a given tool, whether external validation exists.
- A predictive tool switched on by a vendor update. Configuration changed; the inventory did not.
- Waiting for HTI-5. A proposal is not a rule. The source attributes exist today and the 1557 determination needs them today.
In practice
Last reviewed September 5, 2026. This reference summarises publicly available regulatory guidance and is provided for general information. It is not legal advice. Obligations depend on an institution's charter, registration status, size, and activities. Verify against the primary sources cited above and consult counsel before relying on any summary here.