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White House releases “America’s AI Action Plan”

On July 23, 2025, the White House released “Winning the Race: America’s AI Action Plan,” a document outlining nonbinding policy goals for federal regulation and support of artificial intelligence (AI). The action plan mirrors...more

Real-World Data Back in the Spotlight at FDA

On July 25, 2024, the US Food and Drug Administration (FDA) announced the release of a final version of its Real-World Data: Assessing Electronic Health Records and Medical Claims Data to Support Regulatory Decision-Making...more

Landmark Executive Order on AI: What Does It Mean for Healthcare?

On October 30, 2023, the White House released a long-awaited Executive Order (EO) on the “Safe, Secure, and Trustworthy Development and Use of Artificial Intelligence.” The EO acknowledges the transformative potential of AI...more

FDA Issues Draft Predetermined Change Control Plan for Machine-Learning-Enabled Device Software Functions

On April 3, 2023, the US Food and Drug Administration (FDA) published its draft guidance, Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning...more

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