Key Insights from the HTI-2 Proposed Rule

On July 10, 2024, the Office of the National Coordinator for Health Information Technology (ONC) unveiled the Health Data, Technology, and Interoperability: Patient Engagement, Information Sharing, and Public Health Interoperability (HTI-2) proposed rule. This rule represents a significant step forward in improving healthcare data interoperability and information sharing across the healthcare ecosystem.

Key Provisions of the HTI-2 Rule

The HTI-2 proposed rule builds on the foundational work of the HTI-1 final rule by introducing several new standards and certification criteria aimed at enhancing interoperability among healthcare providers, public health entities, and payers. Key aspects include:

New Certification Criteria:

• Public Health IT Certification: Establishes certification criteria for health IT systems used in public health to ensure they meet specific standards for data exchange and interoperability.
• Payer IT Certification: Introduces certification for health IT systems used by payers, aimed at improving data exchange and compliance with regulatory requirements.

Standards-Based APIs:

• The proposed rule emphasizes the use of standards-based application programming interfaces (APIs) to facilitate seamless data exchange. This includes updates to the United States Core Data for Interoperability (USCDI) standard, which will see an upgrade to version 4, effective January 1, 2028.

Integration with CMS Requirements:

• Aligns with the Centers for Medicare & Medicaid Services (CMS) Interoperability and Prior Authorization final rule, promoting the adoption of electronic prior authorization processes and enhancing the functionality of APIs used for such purposes.

Public Health and Payer Data Systems:

• Developed in collaboration with the Centers for Disease Control and Prevention (CDC) and CMS, the new criteria aim to modernize data systems and improve public health responses, as well as support value-based care delivery.

Technological and Standards Updates

The HTI-2 proposed rule introduces several technological updates, including:

• Enhanced Data Exchange: The capability to exchange clinical images, such as X-rays, and the addition of multi-factor authentication support to bolster security.
• Real-Time Prescription Benefit Tool: A new certification criterion for a real-time prescription benefit tool, which will help providers and patients make more informed medication decisions by comparing drug costs and alternatives.
• Bulk Data Access: Updates to the HL7 FHIR Bulk Data Access implementation specification to support better data exports and application development.

Information Blocking and Privacy Provisions

The rule also addresses information blocking by proposing revisions to current exceptions and introducing a new "Protecting Care Access" exception. This exception is designed to prevent potential legal risks associated with sharing reproductive health information, following the Supreme Court's Dobbs decision in 2022.

TEFCA Governance and Future Planning

The HTI-2 rule includes provisions for new Trusted Exchange Framework and Common Agreement (TEFCA) governance rules. These rules are intended to codify definitions and clarify the application of information blocking regulations to TEFCA participants, further supporting national interoperability goals.

Impact and Next Steps

The HTI-2 proposed rule advances health data interoperability by introducing new certification criteria, API standards, and privacy provisions. . Stakeholders are encouraged to review the draft rule and provide feedback during the 60-day public comment period after its publication in the Federal Register. For more details and to participate in the public comment process, visit healthit.gov/proposedrule.