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Source: DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the Secretary
Final rule.
CFR Part: "45 CFR Parts 170, 171"
RIN Number: "RIN 0955-AA03"
Citation: "89 FR 1192"
Page Number: "1192"
"Rules and Regulations"
Agency: "Office of the National Coordinator for Health Information Technology (ONC), Department of Health and Human Services (HHS)."
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 health IT developers and users of health IT.
DATES:
Effective date: This final rule is effective on February 8, 2024.
Incorporation by reference: The incorporation by reference of certain publications listed in the rule was approved by the Director of the Federal Register as of February 8, 2024.
FOR FURTHER INFORMATION CONTACT:
Michael Lipinski, Office of Policy, Office of the National Coordinator for Health Information Technology, 202-690-7151.
SUPPLEMENTARY INFORMATION:
Table of Contents
I. Executive Summary
A. Purpose of Regulatory Action
1. Statutory Responsibilities and Implementation
2. Administration Executive Orders
3. Federal Coordination
B. Summary of Major Provisions
1. ONC Health IT Certification Program Updates
a. "The ONC Certification Criteria for Health IT" and Discontinuing Year Themed "Editions"
b. New and Revised Standards and Certification Criteria
i. The United States Core Data for Interoperability Version 3 (USCDI v3)
ii. C-CDA Companion Guide Updates
iii. "Minimum Standards" Code Sets Updates
iv. Electronic Case Reporting
v. Decision Support Interventions and Predictive Models
vi. Synchronized...