Summary
Finalizes changes to ONC Health IT Certification Program requirements, including removal of decision-support source-attribute transparency and predictive intervention risk-management requirements in 45 CFR 170.315(b)(11)(iv)–(vi), and related maintenance requirements. The rule generally takes effect December 28, 2026; specified amendments take effect January 1, 2027.
Healthcare Implications
Changes certification requirements for developers supplying predictive decision support and the information available through certified health IT. Developers and health systems should plan for the transition while following requirements still in effect. The rule does not remove separate applicable nondiscrimination duties or constitute FDA authorization of an AI product.