The Future of Healthcare Data Exchange: Analyzing the HTI-2 Final Rule and TEFCA Framework

Introduction

The Department of Health and Human Services (HHS) has taken another significant step forward in advancing nationwide health information exchange with the release of the Health Data, Technology, and Interoperability: Patient Engagement, Information Sharing, and Public Health Interoperability final rule (HTI-2). This rule, published in December 2024, represents a focused effort to establish clear regulatory frameworks around the Trusted Exchange Framework and Common Agreement (TEFCA) while also implementing select administrative updates to existing health IT certification criteria.

The HTI-2 final rule specifically addresses three key areas:

1. Implementation of regulatory provisions related to TEFCA, including requirements for Qualified Health Information Networks (QHINs)

2. Administrative updates to the ONC Health IT Certification Program

3. Modifications to information blocking regulations specifically related to TEFCA

This essay provides a comprehensive analysis of the final rule, examining its implications for healthcare organizations, technology vendors, and ultimately patient care. We'll explore how these regulations aim to advance interoperability while establishing governance frameworks that promote security, privacy, and trust in health information exchange.

TEFCA Framework and Regulatory Implementation

The centerpiece of the HTI-2 final rule is the establishment of regulatory provisions around TEFCA implementation. TEFCA represents a critical initiative to create a universal floor for interoperability across the country through a network-of-networks approach. The final rule codifies key aspects of TEFCA governance while maintaining flexibility for the framework to evolve.

QHIN Requirements and Governance

The rule establishes comprehensive requirements for organizations seeking to become QHINs, which serve as the backbone entities facilitating health information exchange under TEFCA. Key qualification requirements include:

Ownership and Control Requirements:

• Must be a U.S. Entity subject to U.S. jurisdiction

• Cannot be under foreign control

• Directors, officers, executives and 5%+ owners cannot be on restricted lists

• Must maintain principal place of business in the U.S.

Technical Exchange Capabilities:

• Ability to exchange information between multiple unaffiliated organizations

• Capability to exchange all Required Information as defined in the framework

• Must be actively exchanging information for at least one Exchange Purpose

• Ability to receive and respond to transactions from other QHINs

• Technical capacity to support high transaction volumes

Organizational Requirements: