What’s In the ONC’s New Proposed Rule Under the 21st Century Cures Act?

On April 11^th, the Office of the National Coordinator for Health Information Technology (ONC) released a new proposed rule titled, “Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and Information Sharing,” to further deliver on the interoperability goals laid out in the 21^st Century Cures Act. The proposals in the rule seek to improve the connectivity and exchange of health information and promote equity, innovation and transparency in healthcare. 

Key provisions of the proposed rule 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.

What’s Notable: New info-blocking condition for TEFCA

The proposed rule also includes the first real update to the ONC’s Anti-Information Blocking Rule, which went into effect last year. Most notably, it provides new information-blocking flexibilities for organizations that participate in TEFCA.  Under the new proposal, a TEFCA participant that fulfills a data-sharing request from another TEFCA participant through the framework wouldn’t be required to offer that data in any alternative manner. In other words, an information-blocking actor can prioritize using TEFCA to transmit data over other feasible ways – an exception that the ONC says furthers both the goals of TEFCA adoption and interoperability. 

Want to dive deeper? The proposed rule can be accessed here, and will be officially published on the Federal Register on April 18, 2023, when it will be available for public comment for 60 days. To be assured consideration, written or electronic comments must be received via the Federal Register no later than 11:59 p.m. ET on June 20, 2023.