United StatesONC certification criterion for decision support interventions, 45 CFR 170.315(b)(11), as amended by the HTI-5 final rule
45 CFR § 170.315(b)(11), as amended by 91 FR 67916 ()
An AI sector rules rule binding private bodies.
- Instrument type
- a regulation made under an act
- Obligation class
- Governance
As of .
What it requires
- This criterion binds a health IT developer whose Health IT Module is certified to it, in a program of voluntary certification of health IT.
- Enable a limited set of identified users to select, meaning activate, electronic decision support interventions that are evidence-based decision support interventions using the listed data, or predictive decision support interventions using that data together with Clinical Notes and Assessment and Plan of Treatment data.
- Enable interventions to be configured by a limited set of identified users based on a user's role.
- Enable a user to provide electronic feedback data for evidence-based decision support interventions, and make that feedback data available to a limited set of identified users for export in a computable format.
- Provide interventions to a user while the user is interacting with the technology.
- Update a Health IT Module certified to a revised certification criterion, and provide the update to your customers, in accordance with the dates identified for each revised certification criterion.
These lines are LexLint's reading of the law's text, as of .
What this law does
The rule takes effect on , except for three amendatory instructions that take effect on . The amendments to the decision support interventions criterion in 45 CFR 170.315(b)(11) are made by amendatory instruction 11, which is not one of the three that take effect on . As amended, the criterion requires technology to enable a limited set of identified users to select, that is, to activate, electronic decision support interventions.
The interventions it reaches include evidence-based decision support interventions that use listed data such as problems, medications, and allergies and intolerances. It also reaches predictive decision support interventions that use that listed data as well as Clinical Notes and Assessment and Plan of Treatment data. Before the amendment, the criterion reached predictive decision support interventions that use any data expressed in the standards in 45 CFR 170.213.
The criterion requires technology to enable a limited set of identified users to configure interventions based on a user's role. It requires technology to enable a user to provide electronic feedback data for evidence-based decision support interventions and to make that feedback data available to a limited set of identified users for export in a computable format. Interventions provided to a user must occur when a user is interacting with technology.
A health IT developer with a Health IT Module certified to a revised certification criterion must update the module and provide the update to its customers in accordance with the dates identified for each revised criterion. The criterion is one of the criteria of a program for the voluntary certification of health IT. The rule removes the source attribute support, source attribute access and modification, and intervention risk management requirements in paragraphs (b)(11)(iv), (v) and (vi).
The preamble states that the removal covers the requirements related to model cards. It removes paragraph (b)(11)(ii)(B) and redesignates the electronic feedback paragraph (b)(11)(ii)(C) as paragraph (b)(11)(ii)(B). It removes the reference to drug-drug and drug-allergy contraindication checking from the selection paragraph.
When LexLint raises it
When your app profile says your app makes health care decisions or distributes a software product.