Advancement of New Regulations by HHS for Transparency and Interoperability in AI

he healthcare domain. 

This regulatory initiative, named the Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and Information Sharing (HTI-1), is carefully crafted to enact crucial stipulations specified in the 21st Century Cures Act. It particularly focuses on certifying health IT and addressing challenges related to information blocking.

As a vital element within the ONC Health IT Certification Program, the HTI-1 regulation integrates a range of standards, implementation specifications, and certification criteria specifically customized for electronic health record (EHR) software entities and developers of health IT. Steven Posnack, the Deputy National Coordinator for Health IT at ONC, stressed the alignment of these regulatory initiatives with a broader strategy, encompassing prior measures related to information blocking introduced in October.

Key Aspects of HTI-1 Rule

• Nationwide Mandates: The HTI-1 rule establishes nationwide mandates to enhance transparency regarding the use of artificial intelligence (AI) and algorithms in health IT.
• Credibility and Openness: The initiative focuses on instilling credibility and openness in predictive algorithms, with a particular emphasis on those associated with clinical decision support (CDS) and decision support interventions (DSIs).
• AI/ML Technology Categorization: The rule classifies AI/ML technologies as “predictive decision support interventions,” significantly influencing the development, deployment, and utilization of AI/ML tools in the healthcare sector.

While the regulations do not directly target developers of AI and machine learning, they indirectly influence this cohort by imposing requirements on developers of certified health IT. Developers are anticipated to adhere to the decision support intervention requirements by the conclusion of 2024. The HTI-1 rule seeks to foster responsible AI use by granting clinical users access to crucial information about the algorithms underpinning their decision-making processes.

Acknowledging industry apprehensions regarding compliance timelines, ONC has adjusted the implementation schedule to accommodate varied requirements over time. The HTI-1 rule introduces novel transparency requirements related to algorithms within a one-year timeframe. By the close of 2024, health IT developers are expected to update their certified health IT to align with these transparency requirements.

The HTI-1 rule also confronts issues related to health disparities, equity, and patient safety. It mandates that algorithms refrain from contributing to health disparities and necessitates access to supporting evidence for impartial decision-making within clinical decision support tools. Additionally, new reporting metrics geared towards interoperability are introduced for certified health IT technology.

Taking a forward-looking stance, the finalized rule propels the United States Core Data for Interoperability (USCDI) Version 3 (v3) as the new baseline standard within the ONC Health IT certification program, commencing January 1, 2026. This move is perceived as a stride towards advancing more accurate and comprehensive patient characteristics data, aiming to foster equity, diminish disparities, and enhance public health data interoperability.

The regulation’s extensive purview extends to the revision of information blocking definitions and exceptions, the introduction of a new exception for secure information exchange, and the imposition of interoperability-focused reporting metrics for certified health IT technology.