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Vital Signs Digital Health Law Update | Summer 2023 - Healthcare

We bring you Vital Signs, a curated, one-stop resource on the most notable digital health law updates from our U.S. and global contributors. In Industry Insights.

FDA s New Guidance Proposes Flexible Use Of AI In Medical Devices - Healthcare

FDA Issues Draft Guidance Related to Marketing Submissions for AI/ML-Enabled DSFs, and Final Guidance Describing the FDA s Adoption of Section 524B Ensuring Cybersecurity of Devices | Wilson Sonsini Goodrich & Rosati

Podcast: Non-Binding Guidance: FDA Regulatory Developments In AI And Machine Learning - Food, Drugs, Healthcare, Life Sciences

This installation of Ropes & Gray s podcast series Non-binding Guidance focuses on FDA regulatory developments in the area of artificial intelligence ( AI ) and machine learning. AI and machine learning represent a rapidly growing frontier in digital health, with applications ranging from medical device software used for diagnostic and triaging applications to drug candidate selection to clinical trial design and interpretation. In this episode, FDA regulatory attorneys Kellie Combs, Greg Levine, and Sarah Blankstein explore the development and uptake of these technologies in response to the ongoing COVID-19 pandemic, FDA s current regulatory landscape for these technologies, recent steps FDA has taken to update its regulatory approach to these tools in

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