The Assistant Secretary for Expertise Coverage’s proposed HTI-2 rule had a number of bold elements associated to public well being, imaging interoperability, USCDI Model 4, up to date minimal requirements code units, bulk knowledge, prior authorization, API capabilities and different matters. However the abbreviated last rule introduced on Dec. 11 contained solely TEFCA-related objects.
In an e-mail response to a request for extra data, an ASTP spokesman mentioned that the scope of the HTI-2 proposed rule and the variety of public feedback obtained made it impracticable to finalize the rule in its entirety in a well timed method. “So we (ASTP) targeted on a particular set of proposals we might finalize and publish within the Federal Register to be attentive to the general public feedback. Feedback obtained in response to different proposals from the proposed rule are past the scope of this last rule and are nonetheless being reviewed and thought of for functions of issuing subsequent last guidelines, together with one other potential last rule earlier than the tip of this administration. events must also look out for the publication of the 2024 Fall Unified Agenda within the very close to future.”
After all, it’s an open query whether or not new management at HHS within the subsequent administration will take a unique strategy to knowledge requirements, regulation, and TEFCA.
The HTI-2 last rule finalizes sure Trusted Alternate Framework and Frequent Settlement-related proposals from the proposed rule. It amends the knowledge blocking rules by together with definitions associated to the TEFCA Method Exception. It additionally implements provisions to help the reliability, privateness, safety, and belief inside TEFCA.
The rule establishes the processes related to the {qualifications} needed for an entity to obtain and preserve designation as a Certified Well being Data Community (QHIN). The ultimate provisions additionally set up the procedures governing onboarding of QHINs and designation of QHINs, suspension, termination, and administrative appeals to ASTP/ONC. It additionally codified necessities associated to QHIN attestation for the adoption of TEFCA.
The HTI-2 Ultimate Rule makes no adjustments to the TEFCA Method Exception and adopts the TEFCA-related definitions as proposed. This implies an actor’s observe of limiting the style during which it fulfills a request for entry, alternate, or use of digital well being data to solely through TEFCA is not going to be thought-about data blocking when the observe follows sure circumstances.
