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:
Implementation of regulatory provisions related to TEFCA, including requirements for Qualified Health Information Networks (QHINs)
Administrative updates to the ONC Health IT Certification Program
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:
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