2023-07229: Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and Information Sharing

Summary

This proposed rule would implement 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 proposed rule would also make several updates to certification criteria and implementation specifications recognized by the Program, including a revised certification criterion for decision support and revised certification criteria for patient demographics and observations and electronic case reporting. This proposed rule would establish a new baseline version of the United States Core Data for Interoperability (USCDI). Additionally, this proposed rule would provide enhancements to support information sharing under the information blocking regulations. The implementation of these provisions would advance interoperability, improve transparency, and support the access, exchange, and use of electronic health information. The proposed rule would also update the Program in additional ways to advance interoperability, enhance health IT certification, and reduce burden and costs.

The agency’s own summary, as published.

What this changes

Amends 2 parts of the Code of Federal Regulations — the standing rules this notice rewrites.

• 45 CFR 170 Health Information Technology Standards, Implementation Specifications, and Certification Criteria and Certification Programs for Health Information Technology
• 45 CFR 171 Information Blocking