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Understanding ONC’s Health AI Transparency and Risk Management Regulatory Framework
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INTRODUCTION
The Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and Information Sharing (HTI-1) final rule, issued by the US Department of Health and Human Services (HHS) Office of the National Coordinator for Health Information Technology (ONC), went into effect on March 11, 2024, and establishes a new regulatory framework for certain artificial intelligence (AI) and machine learning technologies that support decision-making in health care. Compliance is required beginning December 31, 2024.
This Special Report provides an overview of the final rule’s algorithmic transparency and risk management requirements and the types of technologies that may...
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