The HTI-2 rule proposed by the Under Secretary for Technology Policy had several ambitious components related to public health, imaging interoperability, USCDI version 4, updated minimum standards code sets, big data, prior authorization, API capabilities, and other topics. But the abbreviated final rule announced on December 11 contained only elements related to TEFCA.
In an email response to a request for more information, an ASTP spokesperson said the scope of the HTI-2 proposed rule and the number of public comments received made it impracticable to finalize the rule in its entirety in a timely manner. “So we (ASTP) focused on a specific set of proposals that we could finalize and publish in the Federal Register to respond to public comments. Comments received in response to other proposals for the proposed rule are beyond the scope of this final rule and are still being reviewed and considered for purposes of issuing subsequent final rules, including another possible final rule before the end of this Administration. “Stakeholders should also be on the lookout for the release of the Fall 2024 Unified Agenda in the very near future.”
Of course, it remains an open question whether new HHS leadership in the next administration will take a different approach to data standards, regulation, and TEFCA.
He HTI-2 Final Rule finalizes certain proposals related to the Trusted Exchange Framework and the Common Agreement of the proposed rule. Amends the information blocking regulations by including definitions related to the TEFCA Manner Exception. It also implements provisions to support reliability, privacy, security and trust within TEFCA.
The standard establishes the processes associated with the qualifications necessary for an entity to receive and maintain designation as a Qualified Health Information Network (QHIN). The final provisions also establish procedures governing QHIN incorporation and QHIN designation, suspension, termination, and administrative appeals to ASTP/ONC. It also codified the requirements related to QHIN certification for TEFCA adoption.
The HTI-2 Final Rule makes no changes to the TEFCA Manner Exception and adopts the TEFCA-related definitions as proposed. This means that an actor’s practice of limiting how it complies with a request to access, share, or use electronic health information solely through TEFCA will not be considered information blocking when the practice follows certain conditions.
