Eye on FDA

A series focused on important FDA and related regulatory developments critical to the life sciences industry.

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Eye on FDA

November 8, 2024

FDA and the Department of Veterans Affairs (VA) announced last week that they plan to develop the first intergovernmental health artificial intelligence (AI) lab. This lab would test health-related AI applications for safety and effectiveness in a virtual lab environment. VA Undersecretary for Health Dr. Shereef Elnahal announced the news during the Veterans Health Administration Innovation Experience conference. The VA serves 9 million veterans—the largest health system in the country. The VA operates 170 medical centers nationwide, meaning that the VA could be well positioned to serve as a base for AI assurance labs across the country.

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Eye on FDA

October 11, 2024

On September 26, 2024, FDA published a compilation of commonly used terms in the digital health, artificial intelligence (AI), and machine learning space and their definitions, available here.1   FDA intends the glossary to be used for general education purposes. The definitions are either directly from, or adapted from, various public sources, including consensus standard organizations and published literature, and FDA includes references to those sources in the glossary.

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