Inside the ONC’s Plans to Regulate Health AI: Proposal on Predictive Decision Support Interventions

Lexology June 14, 2023
McDermott Will & Emery

OVERVIEW

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...

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