ONC Releases Proposed Rule to Further Cures Act Interoperability Goals

ONC has released a Notice of Proposed Rulemaking (NPRM) for public comment on proposals to implement certain provisions of the 21st Century Cures Act and make several enhancements to the ONC Health IT Certification Program to advance interoperability.

Proposals include:

• Implementing the EHR Reporting Program as a new Condition of Certification for developers of certified health IT under the Program.
• Modifying and expanding exceptions within the information blocking regulations to support health information exchange (HIE).
• Reworking several Certification Program certification criteria for clinical decision support (CDS), patient demographics and observations, electronic case reporting, and application programming interfaces (APIs) 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 data standard in the Certification Program.
• Updating standards and implementation specifications adopted under the Certification Program to advance interoperability, support health IT functionality, and reduce burden and costs.

The ONC rule also proposes new policies that, if finalized, would support greater trust in using predictive decision support interventions (DSIs) in healthcare.

ONC proposed the rule in collaboration with federal partners, including the Agency for Healthcare Research and Quality, FDA, HHS Office for Civil Rights, Department of Veterans Affairs (VA), and Federal Trade Commission (FTC).

The proposals would help users determine whether the predictive DSI is fair, appropriate, valid, effective, and safe while ensuring the tool enables market competition.

Specifically, ONC sought alignment with the FDA’s recent CDS guidance.

“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,” Micky Tripathi, PhD, national coordinator for health information technology, said in a press release.

“We look forward to reviewing public comments on ONC’s proposed rule,” he added.

ONC will host a series of information sessions about the proposed rule in the coming weeks, including an overview session on April 27, 2023.

The proposed rule is on the Office of the Federal Register’s website. The Federal Register will publish the proposed rule on April 18, 2023, when it will be available for public comment for 60 days.

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

• Establishment of Disincentives for Healthcare 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).