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HTI-2

HTI-2

Owned by Melanie Kourbage
Last updated: Jan 06, 2025
4 min read

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,

As many of you know, ONC released a proposed rule in July known as Health Data, Technology, and Interoperability (HTI-2): Patient Engagement, Information Sharing, and Public Health Interoperability. The new HTI-2 Proposed Rule includes new and revised standards and certification criteria in the ONC Health IT Certification Program. This rule will have an impact on public health data exchange and the IT systems that public health and our partners use. APHL is committed to representing our members and the interests of the public health laboratory community on policy proposals such as HTI-2. Our Informatics team therefore worked with other program areas within APHL, with our member labs, and with partner NGOs like CSTE and JPHIT to review the proposed rule, assess its impact, and develop consensus recommendations.

The detailed feedback that APHL submitted on every aspect of the proposed rule is attached to this posting. In addition, APHL was a contributing author on the comments submitted by the Joint Public Health Taskforce (JPHIT).

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:

  • ONC will update the USCDI standard to v4, with v3 expiring in January 2028.

  • Newer versions of minimum standard code sets will be the baseline for Health IT certification. These new standards include updated HL7 implementation guides for immunizations, syndromic surveillance, ELR (LOI/LRI), eCR, cancer reporting, birth reporting, and antimicrobial resistance. For health IT to be certified, it must support bidirectional exchange of these data flows.

  • ONC will adopt the HL7 FHIR Bulk v2 implementation guide.

  • Other key proposals would affect electronic prior authorization requests for payers, information blocking, and APIs for exchanging information across patient, provider, and payer.

For more information on HTI-2, see the following links

APHL Recommendations

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

  • APHL recommends a phased approach and incremental rollout for all proposed changes. We emphasized that public health will need investment and support to meet these goals and the timeline, in terms of funding, technical assistance, shared services, and education.

  • Clarification is needed to specify that health authorities can meet criteria through intermediary platforms like AIMS, and that these centralized shared services can become certified on behalf of the health authority. Shared services can include vocabulary mapping; a shared public health API toolkit; decision support; or rule-based and use case-based routing and reuse of data feeds, among other services.

  • APHL asked for ONC to clarify that public health can continue to operate with legacy systems after 2028, replacing them with certified health IT as warranted by the system’s IT lifecycle.

  • Importantly, the proposed rule recommends a transition to the LRI implementation guide for ELR reporting. APHL asked for clarification on the timeline for this transition.

  • APHL pointed out that 157+ senders use the NAACR HL7 251 message to send cancer reporting data via AIMS, but HTI-2 mandates the Cancer FHIR implementation guide. APHL recommended that the V2.5.1 based NAACCR standard should be supported in the final rule alongside the Cancer FHIR IG.

  • Similarly, APHL recommended that the final rule should allow multiple eCR implementation guides (e.g., CDA), not just FHIR, given how much progress the community has made in generating eCR CDA from EHRs in the last few years.

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.