Director, Regulatory and Policy Affairs Division, Office of Policy

0955-AA10 202510 The Regulatory Plan and the Unified Agenda of Federal Regulatory and Deregulatory Actions 0955 Office of the National Coordinator for Health Information Technology ONC 0900 Department of Health and Human Services HHS Health Data, Technology, and Interoperability: Application Programming Interfaces and Information Blocking

The proposed rule would seek to advance interoperability through proposals for standards adoption; the certification of health IT to support expanded uses of application programming interfaces (APIs); and enhancements to the conditions of certification. Additionally, the rule would update the information blocking regulations to support information sharing and improved patient health outcomes.

]]> Economically Significant First Time Published in The Unified Agenda Proposed Rule Stage Undetermined Undetermined Regulatory 45 CFR 170 45 CFR 171 42 U.S.C. 300jj–11 42 U.S.C. 300jj–14 42 U.S.C. 300jj-52 5 U.S.C. 552 P.L 114-255 Yes

The Make America Healthy Again initiative, as established by Executive Orders 14212 Establishing the President’s Make America Healthy Again Commission and 14221 Making America Healthy Again by Empowering Patients with Clear, Accurate, and Actionable Healthcare Pricing Information, aims to combat chronic disease and enhance price transparency. Executive Order 14267, Reducing Anti-Competitive Regulatory Barriers, further promotes market competition and lowering health care costs. The HTI-6 Proposed Rule is needed to further enhance the access, exchange, and use of electronic health information (EHI) by patients, providers, and third parties - empowering them to address chronic disease, increase market competition, and lower health care costs. Specifically, proposals in the rule would advance interoperability and EHI sharing through: standards adoption; the certification of health IT to support expanded uses of application programming interfaces (APIs) and potential successor technologies; targeted conditions of certification; and revised information blocking regulations.

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The provisions would be implemented under the authority of the Public Health Service Act, as amended by the HITECH Act and the 21st Century Cures Act.

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ONC will consider different options to improve interoperability and access to electronic health information so that the benefits to providers, patients, and payers are maximized and the economic burden to health IT developers, providers, and other stakeholders is minimized.

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The majority of costs for this proposed rule would be incurred by health IT developers in terms of meeting new requirements and continual compliance with the condition and maintenance of certification requirements. We expect that through implementation and compliance with the regulations, the market (particularly patients, payers, and providers) will benefit greatly from increased interoperability and access to electronic heath information. We have not yet quantified the costs and benefits of this proposed rule.

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At this time, ASTP/ONC has not been able to identify any substantial risks that would undermine likely proposals in the proposed rule.

]]> NPRM 11/00/2026 Undetermined Businesses Undetermined No No No No Michael Lipinski Director, Regulatory and Policy Affairs Division, Office of Policy 0955 Office of the National Coordinator for Health Information Technology ONC 202 690-7151 michael.lipinski@hhs.gov Mail Stop: 7033A, 330 C Street SW, Washington DC 20201