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ONC Issues Guidance on Final Health Data Rule

Oct 29, 2026

Office of the National Coordinator for Health Information Technology (ONC)

On October 26, 2026, HHS finalized the Health Data, Technology, and Interoperability: ONC Deregulatory Actions to Unleash Prosperity (HTI-5) Final Rule.  The rule reduces burden on health IT developers by streamlining the ONC Health IT Certification Program (Certification Program), removing and revising requirements to directly reduce compliance-related costs and support innovation in alignment with Executive Order 14192.

HTI-5 At a glance

  • Of the 60 certification criteria in the Certification Program, HTI-5 removes 14 and revises seven.  ONC retained and made no changes to the remaining 39 criteria, including the new and revised criteria adopted in the HTI-4 final rule.
  • The final rule makes conforming edits to the Assurances, Application Programming Interfaces, and Attestations Conditions and Maintenance of Certification requirements.
  • The Real World Testing Condition and Maintenance of Certification requirements are descoped through deregulatory actions related to real world testing plans, real world testing results, and the use of the Standards Version Advancement Process (SVAP).
  • The Insights Condition and Maintenance of Certification reporting requirements are reduced to align with the enforcement discretion ONC issued on April 29, 2025.
  • HTI-5 resets the Certification Program’s regulatory scope and establishes a foundation on which ONC may build additional FHIR®-based API requirements in future rulemaking.  The rule describes this approach as supporting emerging interoperability solutions that combine FHIR with newer standards, consistent with the Cures Act’s reference to successor technology and standards in the API Condition of Certification.

Certification criteria removed or revised

HTI-5 reduces or removes certain long-standing, functionality-oriented and document-based certification criteria—capabilities that are already well established in health IT products on the market or that impede innovation.

Certification criterion Reference Action Timing
Clinical decision support § 170.315(a)(9) Remove Effective date of final rule
Family health history § 170.315(a)(12) Remove Effective January 1, 2027
Transitions of care § 170.315(b)(1) Revise Effective January 1, 2030
Clinical information reconciliation and incorporation § 170.315(b)(2) Revise Effective date of final rule
Security tags – summary of care – send § 170.315(b)(7) Remove Effective date of final rule
Security tags – summary of care – receive § 170.315(b)(8) Remove Effective date of final rule
Care plan § 170.315(b)(9) Remove Effective date of final rule
Decision support interventions § 170.315(b)(11) Revise Effective date of final rule
Clinical quality measures — report § 170.315(c)(3) Revise Effective date of final rule
Clinical quality measures — filter § 170.315(c)(4) Remove Effective January 1, 2027
View, download, and transmit to 3rd party § 170.315(e)(1) Revise Effective date of final rule
Patient health information capture § 170.315(e)(3) Remove Effective January 1, 2027
Transmission to public health agencies — antimicrobial use and resistance reporting § 170.315(f)(6) Revise Effective date of final rule
Automated numerator recording § 170.315(g)(1) Remove Effective January 1, 2027
Automated measure calculation § 170.315(g)(2) Remove Effective January 1, 2027
Safety-enhanced design § 170.315(g)(3) Revise Effective date of final rule
Consolidated CDA creation performance § 170.315(g)(6) Remove Effective date of final rule
Application access — patient selection § 170.315(g)(7) Remove Effective January 1, 2027
Application access — all data request § 170.315(g)(9) Remove Effective January 1, 2027
Direct Project § 170.315(h)(1) Remove Effective date of final rule
Direct Project, Edge Protocol, and XDR/XDM § 170.315(h)(2) Remove Effective date of final rule

HTI-5 Final Rule Resources

For Certification Program upcoming deadlines and events, please visit the ONC Program Resources page.  To submit questions or comments to ONC please use our Inquiry Portal.