The Department of Health and Human Services Office of the National Coordinator for Health Information Technology (ONC) published a notice of proposed rulemaking on April 18, 2023, titled “Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and Information Sharing,” or HTI-1.
HTI-1 includes proposals that would create new transparency and risk management expectations for artificial intelligence (AI) and machine learning (ML) technology that aid decision-making in healthcare. Importantly, ONC’s proposal includes requirements for a broad set of technologies based on algorithms or models that could be used by many types of users, for any purpose, irrespective of the technology’s risk profile and regardless of who developed the algorithm or model. If finalized, ONC’s HTI-1 proposal for AI/ML technologies they define as “Predictive Decision Support Interventions” will significantly impact the development, deployment and use of AI/ML tools in healthcare. As of June 14, 2023, comments on the HTI-1 proposed rule are due on June 20, 2023.