HTD Hot Takes: HTI-2 Edition

The biggest things to know about ONC's new rule

On July 10 the Office of the National Coordinator released their newest proposed rule affecting health IT developers and the broader healthcare ecosystem - the Health Data, Technology, and Interoperability: Patient Engagement, Information Sharing, and Public Health Interoperability (HTI-2) Proposed Rule.

HTI-2 represents an update to the certification program originally established in the HITECH Act and subsequently updated in the Cures Act Final Rule and 2023’s HTI-1 Rule. For those unfamiliar with the history of the ONC’s certification program, including criteria and those most affected, check out The EHR Labyrinth for extensive detail. 

There are already quite a few summarizations of the rule out there (thank you Claude), but here are the major points to know:

• The rule enhances several existing certified health IT functionalities with newer versions

  • Updates US Core Data for Interoperability (USCDI) from version 3 to 4

    • Full changes listed here, but this is largely an iterative update

  • Better filters in bulk data export to improve performance

  • Granular scopes via SMART 2.2 to give patients and providers more control over application permissions

  • System-to-system authorization for all FHIR APIs to ensure backend applications can use them

  • User-Access Brands and Endpoints to allow for better discoverability of FHIR endpoints

  • Broader data reconciliation capabilities to allow providers to pull more outside information into the chart

  • E-prescribing updates and revisions to move to new standards, ensure transmission of discrete signetur data, and require additional transactions around real-time benefit checking and prior authorization

  • Inclusion of imaging links in APIs and transitions of care

• The rule adds a variety of cutting-edge FHIR capabilities to certified health technology

  • Standardized API for Public Health Data Exchange to tailor the general bulk FHIR API to public health needs

  • SMART Health Cards, primarily for sharing immunizations and labs for public health purposes

  • UDAP Dynamic Client Registration to allow for programmatic registration of applications instead of the manual processes needed today

  • FHIR Subscriptions for notifying applications and reducing the need to poll APIs

  • CDS Hooks for deeper workflow integration of clinical decision support applications

• The rule adds criteria (summarized here) for public health software developers, who were previously not included in the program 

  • Immunization registries

  • Syndromic surveillance registries

  • Reportable laboratory results registries

  • Cancer registry reporting registries

  • Electronic case reporting registries 

  • Antimicrobial use and resistance registries 

  • Birth reporting registries

  • Prescription Drug Monitoring Programs (PDMP) 

• The rule adds criteria for categories of payer software developers, who were previously not included in the program (Note: this is something we help with at HTD)

  • Patient Access APIs

  • Formulary APIs

  • Provider Directory APIs

  • Provider Access APIs

  • Payer-to-Payer APIs

  • Prior Authorization APIs

• The rule formally defines key concepts, relationships, and procedures that the ONC has in relation to the Trusted Exchange Framework and Common Agreement  (TEFCA)

This is quite a lot to process, so click the link to find our biggest takeaways for developers, providers, patients, and other stakeholders on the HTD blog.