Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and Information Sharing (HTI-1) Proposed Rule

ONC's HTI-1 proposed rule seeks to implement provisions of the 21st Century Cures Act and make updates to the ONC Health IT Certification Program (Certification Program) with new and updated standards, implementation specifications, and certification criteria. Implementation of the proposed rule’s provisions will advance interoperability, improve transparency, and support the access, exchange, and use of electronic health information.

Key provisions of the proposed rule include:

• Implementing the Electronic Health Record Reporting Program as new Condition and Maintenance of Certification requirements (Insights Condition) for developers of certified health information technology (health IT) under the Certification Program. 
• Modifying and expanding exceptions in the information blocking regulations to support information sharing and certainty for regulated actors. 
• Revising several Certification Program certification criteria, including existing criteria for clinical decision support (CDS), patient demographics and observations, electronic case reporting, and application programming interfaces for patient and population services.  
• Raising the baseline version of the United States Core Data for Interoperability (USCDI) from Version 1 to Version 3. 
• Updating standards adopted under the Certification Program to advance interoperability, support enhanced health IT functionality, and reduce burden and costs.  

In collaboration with federal partners, including the Agency for Healthcare Research and Quality (AHRQ), Food and Drug Administration (FDA), HHS Office for Civil Rights (OCR), U.S. Department of Veterans Affairs (VA), and the Federal Trade Commission (FTC), the HTI-1 proposed rule also proposes new policies that, if finalized, would promote greater trust in the predictive decision support interventions (DSIs) used in healthcare. These proposals would help enable users to determine whether the predictive DSI is fair, appropriate, valid, effective, and safe, and enable market competition and align with the FDA’s recent guidance on CDS. 

The HTI-1 proposed rule published in the Federal Register on April 18, 2023 and was available for public comment until June 20, 2023 at 11:59 pm ET.