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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 ....

United States , Sarah Blankstein , Greg Levine , Digital Health Software Precertification Program , Cert Program , International Medical Device , Caption Health , Digital Health Initiative , Caption Health Inc , Non Binding Guidance , Kellie Combs , Im Kellie Combs , Digital Health , Predetermined Change Control , Predetermined Change Control Plan , Change Control Plan , Proposed Framework , Regulators Forum , Product Life Cycle , Good Machine Learning Practices , Change Control , Predetermined Change , Control Plan , Patient Engagement Advisory , Total Product Life Cycle , Action Plan ,

2 Major Digital Health Trends Driven By COVID-19


2 Major Digital Health Trends Driven By COVID-19
By
Megan Baca, Kellie Combs and Christine Moundas
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Primary area of interest ....

United States , Megan Baca , Eric Wicklund , William Ognibene , Michael Purcell , Gideon Palte , Christine Moundas , Stephen Hahn , Sarah Blankstein , Perelman School Of Medicine , Health Insurance Portability , Ropes Gray , Centers For Medicare , Radiological Health , Big Data In Medical Research , Medicaid Services , Health Information Exchange , Children Health Insurance Program , Drug Administration , Portfolio Media Inc , Digital Health Center , Health Information Technology , World Evidence In Drug Development , University Of Pennsylvania , Aetion Inc , Device Software ,