Recently, the Office of the National Coordinator for Health Information Technology (ONC) Department of Health and Human Services (HHS) published a final rule, Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and Information Sharing. The final rule implements the Electronic Health Record (EHR) Reporting Program provision of the 21st Century Cures Act by establishing new Conditions and Maintenance of Certification requirements for health information technology developers under the ONC Health IT Certification Program and makes updates to certification criteria and standards recognized by the Program.
Additionally, the final rule provides enhancements to support information sharing under the information blocking regulations and updates technical standards in the Program to advance interoperability, enhance health IT certification, and reduce burden and costs for health IT developers and users of health IT.
The final rule also promotes the responsible development and use of artificial intelligence through transparency and improves patient care through policies that advance standards-based interoperability and electronic health information (EHI) exchange.
ONC Health IT Certification Program Updates
As noted above, the final rule implements the EHR Reporting Program through new Conditions and Maintenance of Certification requirements for developers of certified health IT, which will provide transparency into the use and benefits of certified health IT. This final rule revises several Program certification criteria, including criteria related to decision support, electronic case reporting, and standards-based application programming interfaces (APIs).
One notable change to the Health IT Certification Program is that ONC will no longer maintain an edition naming convention for the health IT certification criteria. The last new edition was released in 2020, which was an update of the 2015 Edition certification criteria. Without editions, all certification criteria within the Health IT Certification Program are renamed to “ONC Certification Criteria for Health IT.”
Additionally, ONC may now update individual certification criterion through notice and comment rulemaking.
ONC hopes that the adoption of new and revised standards and criteria in this final rule will facilitate interoperability through standardized health information and functionality, which will ultimately lead to better care and health outcomes for patients, all while reducing burden and costs. ONC also hopes that it will make it easier for certified health IT developers to maintain product certification over time.
Information Blocking
The final rule also implements certain provisions of the Cures Act to improve information sharing—and address information blocking—by providing refined definitions of statutory terms and further identifying practices that are reasonable and necessary and, therefore, do not constitute information blocking.
ONC noted that generally, commentors on the draft guidance were supportive of the proposed enhancements and for updating the regulations as time goes on to improve clarity and/or reduce burdens, all while continuing to encourage interoperable access, exchange, and use of electronic health information to the fullest extent allowed.
The final rule became effective on February 8, 2024.