Base
Rule2023-288572024-01-09

Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and Information Sharing

Health and Human Services Department,

Abstract

This final rule implements the Electronic Health Record (EHR) Reporting Program provision of the 21st Century Cures Act by establishing new Conditions and Maintenance of Certification requirements for health information technology (health IT) developers under the ONC Health IT Certification Program (Program). This final rule also makes several updates to certification criteria and standards recognized by the Program. The Program updates include revised certification criteria for "decision support interventions," "patient demographics and observations," and "electronic case reporting," as well as a new baseline version of the United States Core Data for Interoperability (USCDI) standard to Version 3. Additionally, this final rule provides enhancements to support information sharing under the information blocking regulations. The implementation of these provisions advances interoperability, improves algorithm transparency, and supports the access, exchange, and use of electronic health information (EHI). This final rule also updates numerous technical standards in the Program in additional ways to advance interoperability, enhance health IT certification, and reduce burden and costs for health IT developers and users of health IT.

Action & Dates

Action
Final rule.
Dates
Effective date: This final rule is effective on February 8, 2024.
Effective Date
2024-02-08

CFR References

Topics

Computer technologyHealthHealth careHealth insuranceHealth recordsHospitalsIncorporation by referenceLaboratoriesMedicaidMedicarePrivacyPublic healthReporting and recordkeeping requirements

Document Excerpt

Document Headings Document headings vary by document type but may contain the following: the agency or agencies that issued and signed a document the number of the CFR title and the number of each part the document amends, proposes to amend, or is directly related to the agency docket number / agency internal file number the RIN which identifies each regulatory action listed in the Unified Agenda of Federal Regulatory and Deregulatory Actions See the Document Drafting Handbook for more details. Department of Health and Human Services Office of the Secretary 45 CFR Parts 170, 171 RIN 0955-AA03 AGENCY: Office of the National Coordinator for Health Information Technology (ONC), Department of Health and Human Services (HHS). ACTION: Final rule. SUMMARY: This final rule implements the Electronic Health Record (EHR) Reporting Program provision of the 21st Century Cures Act by establishing new Conditions and Maintenance of Certification requirements for health information technology (health IT) developers under the ONC Health IT Certification Program (Program). This final rule also makes several updates to certification criteria and standards recognized by the Program. The Program updates include revised certification criteria for “decision support interventions,” “patient demographics and observations,” and “electronic case reporting,” as well as a new baseline version of the United States Core Data for Interoperability (USCDI) standard to Version 3. Additionally, this final rule provides enhancements to support information sharing under the information blocking regulations. The implementation of these provisions advances interoperability, improves algorithm transparency, and supports the access, exchange, and use of electronic health information (EHI). This final rule also updates numerous technical standards in the Program in additional ways to advance interoperability, enhance health IT certification, and reduce burden and costs for

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Full Document

Citation: 89 FR 1192