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Holland & Knight LLP

Podcast - Regulating AI in Healthcare: The Road Ahead

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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

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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

Morgan Lewis

Navigating Uncertainty in US FDA’s Center for Devices and Radiological Health Regulation of Medical Devices

Morgan Lewis on

The past six months at the US Department of Health and Human Services and the US Food and Drug Administration’s Center for Devices and Radiological Health have seen a fluctuating workforce size, a slew of new executive...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

Rothwell, Figg, Ernst & Manbeck, P.C.

From Algorithms to Approvals: Navigating AI in Drug and Biological Product Regulation

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On January 6, 2025, the FDA released draft guidance on using artificial intelligence (AI) in regulatory decision-making for drugs and biological products. The draft guidance – the first of its kind from the agency – aims to...more

Morgan Lewis

How New Executive Orders May Affect FDA’s Medical Device Operations

Morgan Lewis on

Several executive orders recently signed by US President Donald Trump may have significant implications for the US Food and Drug Administration (FDA) and its regulatory oversight for medical device and digital health...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

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

Hogan Lovells

Life Sciences and Health Care Horizons - 2018

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Innovation in the life sciences and health care industries is occurring at a dizzying pace. Five years ago, anti-PD-1 antibodies from Merck and BMS had yet to be approved, CAR-T therapies were still in small-scale clinical...more

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