HHS Proposes New Rule to Further Implement the 21st Century Cures Act

ONC Seeks Public Comment by June 20, 2023

The U.S. Department of Health and Human Services' (HHS) Office of the National Coordinator for Health Information Technology (ONC) today released a Notice of Proposed Rulemaking (NPRM) for public comment on proposals to implement certain provisions of the 21st Century Cures Act (Cures Act) and make several enhancements to the ONC Health IT Certification Program (Certification Program) to advance interoperability, improve transparency, and support the access, exchange, and use of electronic health information.

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, we sought alignment with the FDA’s recent guidance on CDS.

“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 information technology. “We look forward to reviewing public comments on ONC’s proposed rule.”

ONC will be hosting a series of information sessions about the proposed rule in the coming weeks, including an overview session on April 27, 2023. More information can be found at healthit.gov/proposedrule and via ONC’s Twitter account, @ONC_HealthIT.

The proposed rule is on display at the Office of the Federal Register’s website. It will publish in the Federal Register on April 18, 2023, at which point it will be available for public comment for 60 days. ONC will provide a public comment template in the coming days for commenters to use, if they so choose, when submitting their comments. To be assured consideration, written or electronic comments must be received via the Federal Register and no later than 11:59 p.m. ET on June 20, 2023.

In addition to this proposed rule, ONC is developing two other proposed rules, which are listed in the Fall 2022 Unified Agenda of Regulatory and Deregulatory Actions and the Regulatory Plan:

• Establishment of Disincentives for Health Care Providers who Have Committed Information Blocking (https://www.reginfo.gov/public/do/eAgendaViewRule?pubId=202210&RIN=0955-AA05).
• Patient Engagement, Information Sharing, and Public Health Interoperability (https://www.reginfo.gov/public/do/eAgendaViewRule?pubId=202210&RIN=0955-AA06).

For more information, resources, and educational events on ONCs regulatory programs, please visit healthit.gov/proposedrule.