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

McDermott Will & Emery
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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...

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