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Ballard Spahr LLP

FDA Issues Guidance on AI for Medical Devices

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The Food and Drug Administration (FDA) issued final guidance Monday that explains how medical device manufacturers can use a Predetermined Change Control Plan (PCCP) to update AI-enabled device software functions (AI-DSFs)...more

Epstein Becker & Green

The AI Doctor Is Out? How California’s AB 489 Could Limit AI Development in Healthcare

Epstein Becker & Green on

California’s Assembly Bill 489 (“AB 489”) signals more than just a tweak to existing healthcare law—it’s a glimpse into how the next generation of regulation may shape the future of AI development and deployment in...more

Holland & Knight LLP

Podcast - Regulating AI in Healthcare: The Road Ahead

Holland & Knight LLP on

In this episode of "Counsel That Cares," Public Policy & Regulation attorney John Vaughan, Healthcare attorney Dan Silverboard and Public Affairs Advisor Sarah Starling Crossan discuss the rapidly evolving landscape of...more

Hogan Lovells

AI wellness or regulated medical device? A lawyer's guide to navigating FDA rules—and what could change next

Hogan Lovells on

As FDA medical device lawyers advising AI and digital health companies, Hogan Lovells lawyers have had a front-row seat to an increasingly common scenario: software platforms and mobile apps that launch with the best of...more

Epstein Becker & Green

HealthBench: Exploring Its Implications and Future in Health Care

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As we noted in our previous blog post, HealthBench, an open-source benchmark developed by OpenAI, measures model performance across realistic health care conversations, providing a comprehensive assessment of both...more

Epstein Becker & Green

[Webinar] Shaping the Future of Artificial Intelligence (AI) Within Life Sciences - September 30th, 9:00 am - 10:15 am ET

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Amy Dow and Brad Thompson, Members of the Firm, speak on “Shaping the Future of Artificial Intelligence (AI) Within Life Sciences,” a virtual program co-hosted by Simmons & Simmons and Epstein Becker Green. On both sides of...more

Butler Snow LLP

Looking Beyond the Pandemic – AI and Digital Health Kick into Warp Speed

Butler Snow LLP on

What This Means for the FDA and the Industry - The COVID-19 pandemic has spurred the development of digital health products utilizing artificial intelligence (AI) and machine learning (ML). When the pandemic passes, there...more

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