The #HTI2 Final Rule just dropped. At 156 pages, this is light reading for a December final rule from the Assistant Secretary for Thwarting PTO.
You can read the final text PDF of Health Data, Technology, and Interoperability: Trusted Exchange Framework and Common Agreement (TEFCA) here, and on Monday 12/16, here.
The key question for anyone who read the original war and peace version would be, where did over 1000 pages go? The answer provided by ASTP is rather simple: "Comments received in response to other proposals from the HTI-2 Proposed Rule are beyond the scope of this final rule, are still being reviewed and considered, and may be the subject of subsequent final rules..."
So, next year ... maybe.
The key changes are:
- Complete EHR and EHR Module terms have been removed from #HTI2
- They finalized the TEFCA Manner Exception in subpart D of part 171 with no revisions.
- They added 45 CFR part 172 which codifies provisions related to TEFCA
Changes to 170.315 (certification criteria) in #HTI2 are minimal, see https://public-inspection.federalregister.gov/2024-29163.pdf#page=126
Changes to Section 171 add a severability clause and reference definitions from Section 172 (new), see https://public-inspection.federalregister.gov/2024-29163.pdf#page=129
The final 27 pages of HTI-2 add section 172 TRUSTED EXCHANGE FRAMEWORK AND COMMON AGREEMENT to regulation. These regulations apply to QHINs in the main, not Health IT providers that are NOT QHINs, and so I'm not going to cover them in detail, but I will cover one topic, delegation. ASTP is permitted under #HTI2 to delegate some of its responsibilities to the RCE (@sequoiaproject). See https://public-inspection.federalregister.gov/2024-29163.pdf#page=139
These include:
Subpart C—QHIN Onboarding and Designation Processes
172.300 Applicability.
172.301 Submission of QHIN application.
172.302 Review of QHIN application.
172.303 QHIN approval and Onboarding.
172.304 QHIN Designation.
172.305 Withdrawal of QHIN application.
172.306 Denial of QHIN application.
172.307 Re-application.
Subpart D—Suspension
172.400 Applicability.
172.401 QHIN suspensions.
172.402 Selective suspension of exchange between QHINs.
Subpart E—Termination
172.501 QHIN self-termination.
172.503 Termination by mutual agreement.
So, like I said, a light rulemaking from ASTP this Christmas. Sounds like they have more work to do to earn the appelation: Assistant Secretary for Thwarting PTO.
Merry Christmas to all!
