New Proposed Rule: HTI-2 Aims to Enhance Health IT Certification and Data Interoperability

September 18, 2024

September 18, 2024 – Alexandria, Virginia — On July 10, 2024, the Department of Health and Human Services (HHS) released the Health Data, Technology, and Interoperability (HTI-2) proposed rule. This rule introduces key updates to health information technology (IT) certification and regulations, focusing on improving data exchange across healthcare providers, public health agencies, and payers. As healthcare organizations increasingly rely on seamless information sharing, HTI-2 seeks to ensure greater interoperability and transparency, while supporting value-based care initiatives.

Key Proposals in HTI-2:

  • New Certification Criteria: HTI-2 introduces certification standards for health IT systems used in public health and payer environments. These new criteria aim to streamline data sharing, making it easier for healthcare providers, payers, and public health agencies to exchange important health data more effectively.
  • Adoption of USCDI Version 4: The proposed rule calls for adopting the latest version of the United States Core Data for Interoperability (USCDI v4) by January 2028. This update expands the data elements included in health IT, allowing for more comprehensive patient information, such as health status assessments, laboratory data, treatment goals, physical activity, and substance use. By broadening the scope of data exchanged, this change seeks to improve care quality and reduce health disparities.
  • Bulk Data Enhancements: HTI-2 proposes updates to enhance the performance of bulk data transfers, which are critical for managing large-scale data sharing. These enhancements aim to help health IT developers and healthcare organizations efficiently transfer patient data across systems, supporting faster and more accurate population health management.
  • Electronic Prior Authorization: The rule proposes updates to make prior authorization processes more efficient through electronic health records (EHRs). This change would reduce administrative burdens for healthcare providers, allowing faster approvals for necessary treatments, while ensuring patients receive timely care.
  • Updates to Information Blocking Exceptions: The HTI-2 rule proposes changes to existing exceptions and introduces two new ones. These revisions aim to protect patient privacy and legal rights, especially in sensitive areas like reproductive healthcare. They provide flexibility for healthcare providers in sharing or restricting electronic health information (EHI) under certain conditions.

The HTI-2 proposal is intended to further advance health technology interoperability by building off the HTI-1 rule released late last year. HTI-1 laid the groundwork by establishing foundational standards for health data exchange, and HTI-2 builds on that progress to further improve the flow of information across different systems, including clinical images and multi-factor authentication for security.

Public comments on the HTI-2 proposed rule are being accepted until October 4, 2024. For more information, visit https://www.healthit.gov/topic/laws-regulation-and-policy/health-data-technology-and-interoperability-patient-engagement

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