HHS Office of Inspector General released on July 10, 2024 a Proposed Rule for Health Data, Technology, and Interoperability: Patient Engagement, Information Sharing, and Public Health Interoperability (HTI-2)

There is a lot to share! Follow Gravely Group and Steve Gravely for a complete breakdown of the proposed rule in our series #HTI2ProposedRule.

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PART 1

HTI-2 proposes several important changes to the Information Blocking Final Rule and builds on changes that began with HTI-1.

i. Revise the definition of #HealthcareProvider to explicitly reference 42USC300jj(3). This was already quite clear and seems like a “belt and suspenders” change, but someone must have raised concerns.

ii. Codify specific practices that would constitute “interference” for Information Blocking purposes. As you know, information blocking is defined as a practice that interferes with the access, use or exchange of EHI. In the Information Blocking Proposed Rule, ONC provided a list of 42 specific practices that would implicate information blocking. ONC stressed that this list was illustrative and offered to help people understand the idea of “practices”. Now, ONC seeks to codify in regulation these specific practices.

Steve Gravely says, “This makes no sense to me and I expect that, once codified, these practices could be interpreted as de facto information blocking violations. I am very concerned about this proposal.”

iii. Modify the #PrivacyException to clean up the definition of “individual”. ONC also wants to expand the current sub-exception that allows a provider to comply with restrictions requested by the individual about their own EHI.

Steve Gravely says, “ONC wants to make it clear that a provider can honor these restrictions, even if it thinks that the restrictions are problematic, and not worry about violating the information blocking rule.”

iv. Modify the #InfeasibilityException to further clarify when this exception can be asserted based on the inability to segment EHI.

v. Modify the Third-party seeking modification Exception to replace “healthcare provider” with “covered entity” for the exclusion.

Steve Gravely says, “This exception, introduced in HTI-1 is very confusing in my opinion and I had hoped that ONC would provide more clarity in HTI-2. It did not.”

Stay tuned for more insights!