ONC proposes updates to Health IT Certification Program

This week, the Department of Health and Human Services’ Office of the National Coordinator (“ONC”) for Health Information Technology released a proposed rule on April 12, 2023. The proposed provisions under the rule can be broken up into two categories: (1) updates to the Health IT certification standards required under the ONC Certification Program and (2) modifications to the ONC’s information blocking provisions. While our subject matter experts here at 1upHealth are still actively reading through the proposed regulation, there are two notable changes that would impact not only Health IT that is seeking certification under the ONC’s Certification, but would also impact health plans required to maintain certain APIs under the CMS interoperability regulations. 

The first is the proposed amendment to the regulation dictating the required data elements in United States Core Data for Interoperability (“USCDI”). Today, the required data elements are just those outlined in version 1, however, the promised amendment would expand the requirements to include the data elements outlined in USCDI version 3.  The transition to USDCI version 3, which is proposed to go into effect on January 1, 2025, not only adds new data classes, but also adds additional data elements to existing classes, with a goal of not only improving reporting and public health initiatives, but to also provide a more holistic view of the patient by incorporating data elements pertaining to social determinants of health (“SDOH”), mental health, and more expansive patient demographic information. The regulation being amended as part of this ONC proposed rule is the very same regulation that is referenced in the CMS interoperability regulation for the content and vocabulary standards required for Patient Access, and come 2026, the Payer to Payer on FHIR Exchange and Provider Access APIs, respectively,  thus similarly expanding a payer’s requirement under the CMS interoperability regulation to exchange data that meets the data elements outlined USCDI version 3, as well.   

Similarly, the proposed regulation also suggests an amendment to the regulation that outlines the Application Programming Interface Standards, another regulation that is incorporated by reference under the CMS interoperability regulation. The proposed amendment would replace the current FHIR US Core Implementation Guide, STU 3.1.1, with v5.0.1 effective as of January 1, 2025. This proposal, much like the foregoing, would also require health plans subject to the CMS interoperability regulations to ensure all APIs subject to such regulatory requirements are similarly updated to reflect the implementation specifications in v5.0.1 to remain compliant. 

As we continue to unpack this proposed regulation, we keep you all apprised of relevant updates – stay tuned for more information! 

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