ONC Proposal Implements Cures Acts Provisions, Enhances Certification Program

In a newly proposed rule, the Office of the National Coordinator for Health Information Technology (ONC) seeks to implement provisions of the 21st Century Cures Act and make enhancements to the ONC Health IT Certification Program. The rule also seeks to promote greater trust in predictive clinical decision support using artificial intelligence.

Proposals include:

• Implementing the Electronic Health Record Reporting Program as a new Condition of Certification for developers of certified health information technology (health IT) under the program.
• Modifying and expanding exceptions in the information blocking regulations to support information sharing.
• 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.
• Adopting the United States Core Data for Interoperability (USCDI) Version 3 as a standard within the Certification Program and establishing an expiration date for USCDI Version 1 as an adopted standard within the Certification Program.
• Updating standards and implementation specifications adopted under the Certification Program to advance interoperability, support enhanced health IT functionality, and reduce burden and costs.

Further, in collaboration with federal partners, including the Agency for Healthcare Research and Quality, Food and Drug Administration (FDA), HHS Office for Civil Rights, and U.S. Department of Veterans Affairs (VA), and the Federal Trade Commission (FTC), the ONC rule 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. Specifically, ONC sought alignment with the FDA’s recent guidance on clinical decision support.

“In addition to fulfilling important statutory obligations of the 21st Century Cures Act, implementing these provisions is critical to advancing interoperability, promoting health equity, and supporting expansion of appropriate access, exchange, and use of electronic health information,” said Micky Tripathi, Ph.D., national coordinator for health IT, in a statement. “We look forward to reviewing public comments on ONC’s proposed rule.”

In the coming weeks, ONC will host several information sessions on the proposed rule and seeks public comment by June 20, 2023.