What Happened?
If you're using software to manage patient records or coordinate care, then the federal rules your health IT vendor has to meet are getting shorter from Dec. 28. The Department of Health and Human Services has finalized a rule removing 14 of the 60 standards that health IT products have to meet in order to be certified at the federal level. That's according to a Legis1 review of the final rule published Oct. 28.
The Office of the National Coordinator for Health Information Technology (ONC) runs the ONC Health IT Certification Program, which had 466 participating developers as of April 1. The rule also revises seven other criteria and narrows the scope of two of the criteria (Real World Testing and Maintenance of Certification).
Why Does it Matter to Me?
ONC projects the changes will generate $108.1m in annualized net cost savings from 2027 onwards with no new compliance costs for developers. The present value of those savings at a 7% discount rate is $1.55bn.
About 400 of the 466 developers in the program are estimated to be small businesses, defined as companies with less than $47 million in annual receipts. Small developers are projected to capture about $93 million of the $108.1 million in annual savings, roughly 86 percent of the total.
ONC says it does not anticipate significant increases in overall costs for users, because the costs of providing these functions were generally already built into customers' payments.
Both Sides, Now
Supporters of the rule cited reduced administrative burdens, improved standards-based interoperability, and a "FHIR-forward" approach, with FHIR standing for Fast Healthcare Interoperability Resources. Opponents warned that dropping certification safeguards could weaken baseline software functions, fragment patient information during care transitions, and burden rural and safety-net facilities that already lag in electronic reporting.
An ONC Health IT Research & Analysis report found that more than eight in 10 hospitals experienced at least one challenge with electronic public-health reporting in 2024, with small, rural, and critical-access hospitals less engaged than larger facilities.
HHS cited two executive orders, *Unleashing Prosperity Through Deregulation* and *Reducing Anti-Competitive Regulatory Barriers*, as administration priorities the rule carries out.
What Happens Next?
The final rule addresses only 14 of the 34 criteria ONC had originally proposed removing, leaving 20 proposed removals unfinalized and under review for potential future rulemakings. ONC kept three public health reporting requirements, covering cancer registries, electronic case reporting, and health care surveys, while it continues to evaluate potential future changes to them.
Remaining Insights Condition reporting obligations phase in over several years: FHIR application-use metrics begin July 2027, U.S. Core Implementation Guide version stratification begins July 2028, and FHIR bulk data access metrics begin July 2029.
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