HHS Establishes Certification Requirements for Artificial Intelligence and Machine Learning Software Developers

Lexology January 17, 2024
Snell & Wilmer LLP

As the impact of artificial intelligence on various sectors of the U.S. economy grew in 2023, so did the involvement of regulators and policymakers. One of the most recent — and substantive — regulatory standards is the 916-page final rule, Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and Information Sharing (the “Rule” aka “HTI-1”), that the U.S. Department of Health and Human Services (“HHS”) issued through its Office of the National Coordinator for Health Information Technology (“ONC”) on December 13, 2023. The Biden administration considers the Rule to be a significant step in advancing the President’s Executive Order on the “Safe, Secure and Trustworthy Development and Use of Artificial Intelligence” of October 30, 2023.

The Rule, which...

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