By Jay Anders

Healthcare stands on the precipice of a transformative era, with artificial intelligence (AI) and large language models (LLMs) demonstrating remarkable potential in streamlining clinical documentation, quality measurement, and medical coding. As these technologies mature, forward-thinking healthcare provider organizations are exploring ways to leverage AI to improve data quality, reduce clinician burden, and ultimately enhance patient care. However, recent regulation may present challenges for the health IT companies bringing their AI solutions to the market.

The ONC Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and Information Sharing Final Rule (HTI-1 Final Rule) is an AI disclosure and governance rule that took effect on March 11, 2024. The expansive final rule covers a wide range of topics, from data standards to interoperability quality measures to information sharing and blocking rules. Most importantly for this article, it regulates the application of AI to clinical decision support, referred to as "decision support interventions" (DSIs).

Yet, despite the flurry of regulatory policymaking and legislation, there remains no centralized framework governing artificial intelligence in the U.S.

The HTI-1 Final Rule applies to developers of Certified Electronic Health Record Technology (CEHRT), particularly those who incorporate predictive DSIs into their products. It aims to regulate and enhance the transparency, effectiveness, and safety of predictive DSIs used in healthcare settings, ensuring that these technologies are developed and managed responsibly.

What do we need? Algorithmic transparency! When do we need it? Now!
The rule establishes algorithm transparency and risk management requirements and introduces the agency's "FAVES" principles: Fair, Appropriate, Valid, Effective, and Safe. These principles set key standards for the development, implementation, and evaluation of predictive DSIs in healthcare technology. They also appear in other federal policy guidance, indicating their crucial role in shaping the future of regulatory policy for the agency.

While the HTI-1 Final Rule only applies to EHR companies who sell CEHRT, third-party DSIs integrated into or included as part of these EHR products are subject to the same transparency and risk management requirements as native DSIs. For this reason, practically any company selling predictive decision support technology to CEHRT vendors needs to understand and comply with the rule.

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