HHS HTI-5 Final Rule Cuts Health IT Requirements With $1.5 Billion in Projected Savings

Key Takeaways

• The Health Data, Technology, and Interoperability (HTI-5) final rule removes 14 certification criteria and revises 7, while preserving privacy and security certification requirements.
• HHS projects more than $1.5 billion in regulatory savings; these estimates do not establish realized savings for payers, providers, or patients.
• Proposed information-blocking changes remain under consideration, including provisions addressing autonomous artificial intelligence (AI) access to electronic health information.

What Changes Under HTI-5

The US Department of Health and Human Services (HHS) announced its HTI-5 final rule on October 26, 2026, reducing health IT certification requirements and projecting more than $1.5 billion in regulatory savings. The rule focuses on developers participating in the Office of the National Coordinator for Health Information Technology (ONC) Health IT Certification Program.¹

Published October 28, the rule generally takes effect December 28, 2026, with specified amendments effective January 1, 2027. Its economic analysis estimates $1.55 billion in present-value savings and $108.1 million in annualized net savings, expressed in 2024 dollars using a 7% discount rate beginning in 2027 and continuing in perpetuity.²

The final rule removes 14 of the program’s 60 certification criteria and revises 7, leaving 39 unchanged. Those retained include criteria adopted or updated under HTI-4 for electronic prior authorization and real-time prescription benefits. ONC describes the changes as targeting established functionality and document-based requirements that can impose unnecessary compliance burdens.³

The final approach is narrower than the December 2025 proposal, which would have eliminated 34 criteria. According to Fierce Healthcare, ONC intends the reduced compliance burden to allow developers to devote more resources to interoperability, automation, and improvements for patients and clinicians.⁴

ONC also narrowed the decision support interventions criterion by removing AI model-card requirements. The American Hospital Association reported that the agency did not finalize proposed removals of privacy and security certification criteria and will consider updates in future rulemaking.⁵

Real-world testing obligations were also reduced. Developers will no longer need to submit annual plans for testing their products in clinical settings, Healthcare Dive reported. Certification remains voluntary, although certain federal, state, and private programs require certified technology.⁶

Interoperability and Information Blocking

ONC describes HTI-5 as establishing a foundation for certification requirements built around Fast Healthcare Interoperability Resources (FHIR) application programming interfaces (APIs). The agency also retained the Insights reporting measure concerning use of FHIR bulk data access.³

However, HTI-5 does not finalize the proposed information-blocking changes. Those proposals included revising definitions of access and use to address autonomous AI systems; public comments remain under consideration.^4,6 Healthcare IT News reported that ONC has not determined whether these changes would be addressed separately or through another rulemaking.⁷

Implications for Managed Care

For payers, the distinction between developer compliance savings and health care spending is central. The federal analysis estimates the time and effort developers would otherwise spend meeting certification requirements; it does not demonstrate lower premiums, vendor prices, or medical spending. Any downstream financial benefit remains unestablished.²

HHS says future proposals will address standards adoption, expanded API uses, potential successor technologies, and targeted certification conditions.¹ For managed care organizations evaluating technology investments, the immediate policy developments are the revised certification framework and retained HTI-4 criteria, alongside unresolved questions about future information-sharing requirements.^1,3

References

1. US Department of Health and Human Services. HHS finalizes HTI-5 deregulatory rule to encourage innovation and reduce health IT certification program compliance costs. Published October 26, 2026. Accessed October 30, 2026. https://www.hhs.gov/press-room/hhs-finalizes-hti-5-deregulatory-rule.html
2. Office of the National Coordinator for Health Information Technology, Department of Health and Human Services. Health data, technology, and interoperability: ONC deregulatory actions to unleash prosperity. Final rule. Federal Register. 2026;91(207):67916-67998. Accessed October 30, 2026. https://www.govinfo.gov/content/pkg/FR-2026-10-28/html/2026-21943.htm
3. Office of the National Coordinator for Health Information Technology. Health Data, Technology, and Interoperability: ONC Deregulatory Actions to Unleash Prosperity (HTI-5) final rule overview. Updated October 27, 2026. Accessed October 30, 2026. https://healthit.gov/resources/health-data-technology-and-interoperability-onc-deregulatory-actions-to-unleash-prosperity-hti-5-final-rule/
4. Landi H. HHS finalizes rule to ease health IT certification requirements but punts info blocking proposals. Fierce Healthcare. Published October 26, 2026. Accessed October 30, 2026. https://www.fiercehealthcare.com/regulatory/hhs-finalizes-hti-5-rule-streamline-onc-health-it-certification-and-cut-compliance-costs
5. American Hospital Association. ONC finalizes certain deregulatory actions related to health data, technology, interoperability. Published October 26, 2026. Accessed October 30, 2026. https://www.aha.org/news/headline/2026-10-26-onc-finalizes-certain-deregulatory-actions-related-health-data-technology-interoperability
6. Vaidya A. ONC cuts health IT certification criteria in HTI-5 final rule. Healthcare Dive. Published October 27, 2026. Accessed October 30, 2026. https://www.healthcaredive.com/news/onc-cuts-health-it-certification-criteria-in-hti-5-final-rule/872876/
7. Fox A. ONC finalizes HTI-5 health IT deregulation rule. Healthcare IT News. Published October 27, 2026. Accessed October 30, 2026. https://www.healthcareitnews.com/news/onc-finalizes-hti-5-health-it-deregulation-rule