HHS Finalizes HTI-5 Rule to Cut Health IT Costs
The new regulation streamlines certification requirements for health information technology across the United States.
Updated on Oct. 26, 2026 in Healthcare
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The Department of Health and Human Services has finalized the HTI-5 rule to reduce health IT certification burdens. The measure aims to lower compliance costs for the healthcare industry by simplifying program requirements.
Why it matters
The rule is designed to streamline the health IT certification process and fulfills requirements set by Executive Order 14192. It seeks to reduce regulatory overhead while maintaining essential standards for health information systems.
The final rule removes 14 of 60 existing certification criteria and revises seven others, while retaining 39. HHS projects this will generate $108.1 million in annualized net savings beginning in 2027.
The players
Department of Health and Human Services
This is a United States cabinet-level executive department that provides effective health and human services and fosters sound, sustained advances in the sciences underlying medicine, public health, and social services.
Office of the National Coordinator for Health Information Technology
This entity is a division of the Department of Health and Human Services that coordinates nationwide efforts to implement and use the most advanced health information technology and the electronic exchange of health information.
The details
The regulation removes AI model-card transparency requirements for decision support interventions and adopts deregulatory actions for real-world testing plans. Additionally, the rule includes conforming edits to Application Programming Interface and attestation requirements.
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 move follows a trend of federal agencies attempting to reduce regulatory burdens on health technology firms to accelerate innovation. By pruning legacy certification requirements, HHS aims to reorient the industry toward interoperability without excessive compliance overhead.
For health IT providers and hospital systems, this rule may lower software compliance costs and simplify vendor certification workflows. Patients may eventually see more streamlined digital records access, though future proposals are still needed to fully advance electronic health information sharing.
The takeaway
The federal government is shifting toward a leaner health IT certification framework that prioritizes essential standards over redundant documentation. Organizations should prepare for these shifts as administrative compliance requirements evolve in the coming years.
What happens next
The rule is scheduled for publication in the Federal Register on October 28, 2026, with certain changes becoming effective on January 1, 2027.
Further reading
Learn more about the latest updates in Healthcare.
More information
Access the unpublished HTI-5 final rule via the federal health IT portal.
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