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Artificial Intelligence Comment Period Digital Health

Jones Day

Medicare's Innovation Center Charts New Direction: Part 2 – Digital Health and AI

Jones Day on

The Center for Medicare and Medicaid Innovation ("CMMI") is set to reshape value-based care. In the second of a three-part series highlighting this new direction, this summary is focused on CMMI's efforts regarding digital...more

MoFo Life Sciences

FDA On Use Of AI/ML In Drug Development: Five Key Takeaways

MoFo Life Sciences on

On Wednesday, May 10, 2023, the Food and Drug Administration (FDA) announced the publication of a new discussion paper titled “Using Artificial Intelligence and Machine Learning in the Development of Drug and Biological...more

Hogan Lovells

FDA M-CERSI AI workshop highlights future FDA comment period on AI in drug development

Hogan Lovells on

The U.S. Food and Drug Administration (FDA) – in collaboration with the University of Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI) – recently hosted a one-day virtual public workshop entitled,...more

Stinson LLP

FDA Proposes Pathway for Artificial Intelligence/Machine Learning Software

Stinson LLP on

Last week, the FDA published a discussion paper outlining a proposed regulatory framework for artificial intelligence/machine learning software as a medical device (AI/ML SaMD)....more

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