0955-AA06 202210 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 Patient Engagement, Information Sharing, and Public Health Interoperability

The rulemaking builds on policies adopted in the 21st Century Cures Act: Interoperability, Information Blocking, and the ONC Health IT Certification final rule (85 FR 25642) and included in the Health Information Technology: ONC Health IT Certification Program Updates, Health Information Network Attestation Process for the Trusted Exchange Framework and Common Agreement, and Enhancements to Support Information Sharing proposed rule (0955-AA03). The rulemaking advances electronic health information sharing through proposals for: standards adoption; the certification of health IT to support expanded uses of application programming interfaces (APIs), such as electronic prior authorization, patient engagement, and interoperable public health exchange; and supporting patient engagement and other information sharing principles under the information blocking regulations.

]]> Other Significant First Time Published in The Unified Agenda Proposed Rule Stage Undetermined No 45 CFR 170 45 CFR 171 42 U.S.C. 300jj–11 42 U.S.C. 300jj–14 42 U.S.C. 300jj–19a 42 U.S.C. 300jj-52 5 U.S.C. 552 Pub. L. 114-255 Yes

The rulemaking builds on policies adopted in the 21st Century Cures Act: Interoperability, Information Blocking, and the ONC Health IT Certification final rule (85 FR 25642) and included in the Health Information Technology: ONC Health IT Certification Program Updates, Health Information Network Attestation Process for the Trusted Exchange Framework and Common Agreement, and Enhancements to Support Information Sharing proposed rule (0955-AA03). The rulemaking is needed to advance electronic health information sharing through proposals for: standards adoption; the certification of health IT to support expanded uses of application programming interfaces (APIs), such as electronic prior authorization, patient engagement, and interoperable public health exchange; and supporting patient engagement and other information sharing principles under the information blocking regulations.

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The regulatory proposals 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 electronic health information interoperability and sharing 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. We also expect that implementation of new standards for interoperability and information sharing requirements may account for some costs. We expect that through implementation and compliance with the regulations, the market (particularly patients, payers, and providers) will benefit greatly from improved interoperability and the access, exchange, and use of electronic heath information.

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At this time, ONC has not been able to identify any substantial risks that would undermine likely proposals in the proposed rule. ONC will continue to consider and deliberate regarding any potential risks and will be sure to identify them for stakeholders and seek comment from stakeholders during the comment period for the proposed rule.

]]> NPRM 11/00/2023 Undetermined Businesses Undetermined No No No No Michael Lipinski Director, Regulatory and Policy Affairs Division/ Office of Policy 0955 Assistant Secretary for Technology Policy and Office of the National Coordinator for Health Information Technology ASTP/ONC 202 690-7151 michael.lipinski@hhs.gov Mail Stop: 7033A, 330 C Street SW, Washington DC 20201