ONC Finalizes a Subset of Health IT Regulatory Proposals

The HHS Office of the National Coordinator for Health IT (ONC) released the Health Data, Technology, and Interoperability (HTI-5) final rule Oct. 27. In the rule, ONC finalized previous proposals to reduce certification-related burdens for EHR developers, including elimination of AI model card (“nutrition label” style) transparency requirements for certain decision support functions within EHRs.

ACR® submitted comments about the HTI-5 proposed rule in March. The College recommended ONC promote AI transparency through alternative mechanisms if the certification requirements were eliminated. ONC acknowledged the comments and said it may consider their reinstatement or the adoption of similar requirements in future rulemaking.

The agency also recommended interested EHR users request model information directly from vendors. While FDA-regulated radiology AI devices are outside the scope of EHR certification and are not impacted by this final rule, ACR provides AI device transparency information to the radiology community on the AI Central website, administered by the ACR Data Science Institute®.

ONC did not address information blocking requirements in the HTI-5 final rule despite proposing several major changes in its proposed rule. The agency indicated it plans to cover any unaddressed proposals in future rulemaking.

For more information about information blocking regulations, visit the ACR resource page.

For more information about ONC regulations, contact Michael Peters, ACR Senior Director, Government Affairs, and Lindsay Robbins, ACR Regulatory Policy Specialist.