2026-21943RuleSignificantWallet

ONC Promises to Unleash Prosperity by Rewriting Health-Tech Rules

Published Date: 10/28/2026

Rule

Summary

Starting December 28, 2026, new rules will make health tech easier and less costly for developers and healthcare providers by cutting red tape and updating certification standards. These changes help speed up innovation and improve how health data moves between systems, benefiting patients and the industry alike. Some updates kick in January 1, 2027, so everyone has time to adjust and thrive.

Analyzed Economic Effects

4 provisions identified: 4 benefits, 0 costs, 0 mixed.

Big Cost Savings for Health IT Developers

Starting December 28, 2026, ONC finalized deregulatory actions that reduce certification burdens on health IT developers and estimated a present value of cost savings of $1.55 billion and annualized net cost savings of $108.1 million (2024 dollars) beginning in 2027 and in perpetuity. The rule states there are $0 implementation and compliance costs for developers and that the changes reduce effort and entry barriers for new Certification Program participants.

Specific Certification Criteria Removed or Revised

The final rule finalizes removal of 14 certification criteria and revisions to seven criteria, while retaining 39 certification criteria. These changes remove some functionality-oriented and non-FHIR-based certification requirements, which the rule says will reduce the need to design, test, certify, and maintain certain certified functionalities.

Shift Toward FHIR APIs and Innovation

The rule directs the Certification Program to focus on FHIR-based application programming interfaces (APIs) and finalizes removal or revision of non-FHIR certification criteria to support that shift. The preamble states this change is intended to enable FHIR-based API requirements, encourage newer standards (including Model Context Protocol for LLM context), and allow more innovative interoperability solutions.

More Choices and Less Burden for Providers

The rule states that by removing burdensome Certification Program requirements, providers will have more choices of certified health IT and developers will have more time to support providers' technological needs. The final rule says these deregulatory actions support providers in caring for their patients and increase competition in the certified health IT market.

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Key Dates

Published Date
Rule Effective
10/28/2026
12/28/2026

Department and Agencies

Department
Independent Agency
Agency
Health and Human Services Department
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