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Update December 2024

Hello Public Health Laboratory Community!

You may have heard that ASTP released two final rules in December: HTI-2 and HTI-3.

The final HTI-2 and HTI-3 contain only a subset of the components that were in the proposed rule that was released in July for comment. The final rules do not contain the components that were relevant to public health data exchange; those sections are still under review.

We expect that ASTP will be releasing the components of the proposed HTI-2 in subsequent rules (HTI-3, HTI-4, etc.) over the next weeks and months. ASTP is still reviewing comments received on many sections of the HTI-2 draft, including APHL's comments. The final HTI-2 and HTI-3 rules represent the sections of the proposed rule that ASTP could finalize before the end of the year.

The HTI-2 final rule clarifies exceptions to information blocking; updates privacy and security requirements for IT certification; and updates the minimum qualifications that an entity must meet to qualify as a QHIN.

The HTI-3 final rule is focused on information blocking exceptions. It clarifies that how and when individuals can request that information not be shared. It also clarifies an exception for reproductive care.

APHL will continue to coordinate with ASTP and to monitor the Federal Register for informatics policy updates that affect the public health community.

Here are links to HTI-2 and HTI-3 in the Federal Register and ASTP's FAQ sheets:

HTI-2 Proposed Rule Overview (FAQ)

·       HTI-3 Final Rule: Protecting Care Access (FAQ)

Federal Register :: Health Data, Technology, and Interoperability: Trusted Exchange Framework and Common Agreement (TEFCA) (HTI-2 Full Rule)  

Federal Register :: Health Data, Technology, and Interoperability: Protecting Care Access (HTI-3 Full Rule)

Overview

Hello Public Health Community,

...

It is anticipated that ASTP ONC will release the final HTI-2 rule in or around March 2025.

HTI-2 Summary

HTI-2 will touch on many aspects of healthcare IT. Key proposals include the following:

...

APHL Recommendations

APHL submitted more than ten pages of comments, compiled from conversations with staff, SMEs, and member laboratories. Key takeaways include:

...

View file
nameAPHL HTI-2 Comment Letter 1.pdf

Next Steps

Thank you to all the APHL members and partners who contributed their thoughts, concerns, and expertise while we reviewed the proposed rule and developed the organization’s comments. We believe that by speaking with one voice, we can amplify our message. APHL will continue to monitor ONC’s activities, and we will let you know when the final rule is released. At that time, we will help our laboratories and their partners understand the requirements and navigate the changes that will be needed.