HHS Cuts 14 Health IT Certification Requirements
Software developers and health providers will see reduced compliance burdens and lower costs starting in 2027.
Updated on Oct. 26, 2026 in Healthcare
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The Department of Health and Human Services finalized the HTI-5 rule, which cuts 14 health IT certification requirements to streamline compliance. These changes for developers and providers take effect January 1, 2027.
Why it matters
By removing these criteria and revising others, the rule aims to reduce administrative overhead and lower compliance costs across the healthcare sector. This move follows Executive Order 14192 to minimize regulatory burdens.
The final rule removes 14 of 60 existing certification criteria and revises seven others, while retaining 39. These updates are projected to generate $1.55 billion in present-value regulatory savings and $108.1 million in annualized net savings starting in 2027.
The players
Department of Health and Human Services
The federal executive department responsible for establishing national health policy and enforcing regulatory standards for health information technology.
Office of the National Coordinator for Health Information Technology
The agency within HHS that oversees health IT infrastructure, interoperability standards, and the certification programs for health record systems.
The details
The rule simplifies the certification program by removing AI model-card transparency requirements for decision support interventions and streamlining real-world testing plans. It also makes conforming edits to APIs and attestation requirements while adopting the Standards Version Advancement Process. Notably, the final rule does not change federal information blocking regulations.
Timeline
December 2025: ONC issued the initial HTI-5 proposal.
April 29, 2025: Enforcement discretion issued for Insights reporting requirements.
October 28, 2026: Rule scheduled for publication in the Federal Register.
January 1, 2027: Effective date for certain rule changes.
Market Landscape
This rule marks a shift in the federal regulatory cycle as the government moves from expanding data requirements to pruning existing mandates. It follows the directive of Executive Order 14192 to streamline health IT compliance programs.
Healthcare operators and IT vendors should review the 14 removed criteria to identify immediate reductions in administrative documentation. Internal compliance teams must also prepare for the January 1, 2027, effective date to adjust workflows for the remaining 39 retained requirements.
The takeaway
Operators should re-evaluate their IT compliance budgets to capture the projected $108.1 million in annualized savings. Monitor the upcoming Federal Register publication on October 28, 2026, for specific guidance on transition periods for the seven revised certification criteria.
Further reading
Learn more about the latest policy shifts in Healthcare.
More information
View the complete details and requirements in the Access the unpublished HTI-5 final rule.
Live Poll
Should the government reduce regulatory requirements for health technology developers?
