The Department of Health and Human Services (HHS) and the Office of the National Coordinator for Health Information Technology (ONC) made significant reductions in the number of annual reporting measures and certification criteria for health IT developers.

The changes to certification, finalized in the Health Data, Technology, and Interoperability: ONC Deregulatory Actions to Unleash Prosperity (HTI-5) Final Rule, are intended to promote improved information access and cut regulatory overhead.

The Final Rule removed 14 criteria for certification while revising seven additional criteria. The Final Rule also made significant cuts to the number of metrics health IT developers have been required to report to ONC annually as a condition of maintaining their product certification (known as the Insights Condition of Maintenance Program).

Most of the criteria cut utilized legacy standards, such as Consolidated Clinical Document Architecture (C-CDA), that did not align with ONC’s desire to see Fast Healthcare Interoperability Resources(FHIR)-enabled information access. ONC indicated that they anticipate over $1.5 billion in savings from this reduced regulatory burden.

The HTI-5 proposed rule had originally proposed the reduction of 34 certification criteria. ONC indicated that some of those criteria have been selected to remain in the certification program because use of legacy standards were still being utilized in some healthcare sectors, and they wanted more time to transition to FHIR.

Other criteria, including use of Bulk FHIR, were maintained through 2030 to allow the standards to mature. The rational was consistent with HIMSS public comments on the proposed rule, which pointed out potential gaps in care, safety and access that could emerge from a transition timeline that wasn’t consistent with industry and provider readiness.

While applauding federal efforts to cut unnecessary regulatory overhead, HIMSS emphasizes the importance of safeguarding core interoperability foundations, data security and clinical workflow safety.

HIMSS also raised concerns about a proposal to change the definitions of “use” and “access” of health information in the proposed rule. Those changes would result in health information sources being declared to be information blocking if they didn’t comply with artificial intelligence (AI-related requests).

HIMSS was concerned that such a potential increase in the scope and volume of health information requests could overwhelm the current infrastructure and resources available. ONC did not finalize this proposal in the Final Rule. They did indicate that information blocking and other proposals that were not included in the Final Rule may be open to additional public comment or adopted in future rulemaking.

HIMSS continues to advocate for policy solutions that advance digital health maturity while reducing administrative friction. Additional resources on the HTI-5 rule will be available on himss.org in the coming days.

For questions or further discussion regarding these insights, please contact Alana Lerer, senior manager of government relations at alana.lerer@himss.org.