The changes to the health IT certification criteria aim to free health IT developers from regulatory burdens and save $1.5 billion.
Regulators say that reducing the certification program’s criteria will allow health IT developers to dedicate resources to other aspects of technology development, such as improving user experience.
The final rule advances the Trump administration’s deregulatory agenda. Since 2025, the administration has slashed regulations across the healthcare industry, including rescinding Biden-era directives on health AI and previously mandatory processes for agency rulemaking. Previously, HTI-4 added and updated health IT certification criteria for electronic prior authorization, electronic prescribing and real-time prescription benefit checks, also in an effort to ease administrative burdens.
But the HTI-5 final rule does not go as far as the ONC's proposed HTI-5 rule released in December 2025 indicated.The proposed rule suggested removing 34 criteria from the ONC Health IT Certification Program, but the final rule only cut 14. The final rule also pares down the real-world testing requirement for developers, a condition for maintaining certification. Health IT developers will no longer have to submit annual plans for testing their tools in clinical settings.
The final rule also punts the ONC's decision on information-blocking proposals to a future date. Information blocking refers to actions that obstruct the exchange of health information, which is prohibited except in certain cases. While the agency proposed clarifying certain definitions and exceptions related to the information blocking rule — including revising the definitions of “access” and “use” to include autonomous AI systems — the proposals and comments submitted by the industry remain under consideration.
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