Health Data, Technology, and Interoperability: ONC Deregulatory Actions To Unleash Prosperity

ONC published this final rule on October 28, 2026, under 45 CFR Parts 170 and 172, with a general effective date of December 28, 2026, and a January 1, 2027 effective date for amendatory instructions 7, 10, and 12. The rule finalizes deregulatory actions to the ONC Health IT Certification Program, authorized under section 3001(c)(5) of the Public Health Service Act as amended by the HITECH Act (Pub. L. 111-5) and the 21st Century Cures Act (Pub. L. 114-255). ONC states the rule is consistent with Executive Orders 14192 and 14267, directing agencies to reduce regulatory burden and remove anti-competitive barriers. Out of 60 currently effective certification criteria, ONC finalizes removal of 14 criteria and revision of 7 criteria, retaining 39 without change. Among the revised criteria, ONC removes the "model card" super intelligence requirements at 45 CFR 170.315(b)(11)(iv) and (v) from the "decision support interventions" certification criterion. The 39 retained criteria include those adopted in the HTI-4 final rule (90 FR 37130), which added three electronic prior authorization API criteria, a real-time prescription benefit criterion, a revised e-prescribing criterion, and two modular API criteria. ONC also finalizes conforming edits to Conditions and Maintenance of Certification requirements under 45 CFR 170.402 (Assurances), 170.404 (APIs), 170.405 (Real World Testing), 170.406 (Attestations), and 170.407 (Insights). For Real World Testing, ONC descopes requirements related to plans, results, and the standards version advancement process, consistent with an enforcement discretion notice issued June 30, 2025. ONC finalizes partial removal and descoping of the Insights condition measures. Conforming edits to the definition of "Base EHR" and removal of the term "Common Clinical Data Set" from 45 CFR 170.102 are also finalized. For Part 172, ONC removes all references to the Assistant Secretary for Technology Policy (ASTP) from the Trusted Exchange Framework and Common Agreement regulations, restoring references to ONC. The Regulatory Impact Analysis estimates $0 in implementation and compliance costs for health IT developers, with estimated review costs of $1,293,508 for approximately 616 reviewers. ONC estimates a present value of cost savings of $1.55 billion and annualized net cost savings of $108.1 million in 2024 dollars, discounted at 7%, beginning in 2027 and continuing in perpetuity.