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 subjects. However the abbreviated last rule introduced on Dec. 11 contained solely TEFCA-related gadgets.
In an e-mail response to a request for extra data, an ASTP spokesman stated that the scope of the HTI-2 proposed rule and the variety of public feedback acquired made it impracticable to finalize the rule in its entirety in a well timed method. “So we (ASTP) centered on a selected set of proposals we may finalize and publish within the Federal Register to be conscious of the general public feedback. Feedback acquired in response to different proposals from the proposed rule are past the scope of this last rule and are nonetheless being reviewed and regarded for functions of issuing subsequent last guidelines, together with one other potential last rule earlier than the tip of this administration. events also needs to look out for the publication of the 2024 Fall Unified Agenda within the very close to future.”
In fact, it’s an open query whether or not new management at HHS within the subsequent administration will take a special method to knowledge requirements, regulation, and TEFCA.
The HTI-2 last rule finalizes sure Trusted Change Framework and Widespread 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 assist 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 Info 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 Last 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 way through which it fulfills a request for entry, alternate, or use of digital well being data to solely by way of TEFCA won’t be thought-about data blocking when the observe follows sure situations.
