Why It Matters
The Department of Health and Human Services is removing 14 of the 60 health information technology certification criteria under its voluntary certification program, effective Dec. 28, with certain amendments taking effect Jan. 1, 2027. The rule reduces regulatory burdens, gives developers and health care providers flexibility, and supports innovation by removing and revising certification criteria, HHS says.
The rule removes 14 health IT certification criteria, reducing requirements for developers in a program that included 466 developers as of April 1. The Office of the National Coordinator for Health Information Technology (ONC) says the rule aligns with administration goals set out in Executive Orders 14192 and 14267. ONC projects annualized net cost savings of $108.1 million in 2024 dollars, with no new implementation or compliance costs imposed on developers, beginning in 2027.
The Big Picture
The rule narrows a certification framework built through rulemakings beginning with the January 2010 interim final rule and extended through the 2011, 2014, 2015, ONC Cures and HTI-1 final rules, which helped establish the certification requirements now being reduced. HHS cites Executive Order 14192, Unleashing Prosperity Through Deregulation, and Executive Order 14267, Reducing Anti-Competitive Regulatory Barriers, as administration priorities the rule carries out.
As of April 1, 466 developers participated in the ONC Health IT Certification Program, with 601 unique certified products across 693 certificate listings. Approximately 86% of those developers are estimated to be small businesses under the Small Business Administration's $47 million annual receipts threshold. ONC projects annualized net cost savings of $108.1 million in 2024 dollars, discounted at 7%, beginning in 2027 and continuing indefinitely, with a present value of $1.55 billion. ONC estimates that small developers could realize about $93 million in annualized savings.
The rule removes 14 certification criteria spanning clinical, care coordination, clinical quality measures, patient engagement, public health, design and performance, and transport categories, and revises seven others. It also reduces the scope of the Real World Testing Condition and Maintenance of Certification under 45 C.F.R. § 170.405, and revises the Insights Condition under 45 C.F.R. § 170.407 to retain two measures: use of Fast Healthcare Interoperability Resources (FHIR) in applications and FHIR bulk data access.
Effective Jan. 1, 2027, 45 C.F.R. § 170.315 removes and reserves paragraphs (a)(12), (c)(4), (e)(3), and (g)(1), (2), (7) and (9), which contain certification criteria. Some changes build on earlier regulatory actions: the clinical decision support criterion had already expired Jan. 1, 2025, under the HTI-1 final rule, and the real-world testing changes partially codify an enforcement discretion notice in effect since June 30, 2025.
Broader Context
Supporters cited reduced administrative burdens, improved standards-based interoperability, and a "FHIR-forward" approach. Opponents warned that removing certification safeguards without replacement protections could weaken baseline functionality, increase fragmentation, and shift compliance and financial burdens to providers, public health agencies, and rural and safety-net facilities. ONC responded that concerns are likely mitigated by retaining most certification criteria and that it does not anticipate significant increases in overall costs for users because the costs of providing these functions were generally already incorporated into customers' payments.
The final rule removes 14 of the 34 criteria targeted for removal in the proposed rule, leaving 20 proposed removals unfinalized. Among the retained criteria are three public health reporting requirements: transmission to cancer registries, electronic case reporting, and health care surveys. Commenters warned that removing existing reporting requirements before FHIR-based alternatives were operationally ready could disrupt public health reporting. ONC retained these criteria while continuing to evaluate potential future changes.
The Bottom Line
The rule takes effect Dec. 28, with amendatory instructions 7, 10 and 12 effective Jan. 1, 2027. 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. Proposals not addressed in this final rule remain under review and may appear in subsequent rulemakings.
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