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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

Mintz - Health Care Viewpoints

FDA Needs a New Approach to AI/ML-Enabled Medical Devices

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We have been writing about software as a medical device (SaMD) for years, tracking the Food and Drug Administration's (FDA) efforts to keep up with the fast-paced development of digital technology, such as launching the...more

Mintz

EnforceMintz — Artificial Intelligence and False Claims Act Enforcement

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Like most industries, the health care sector is grappling with the uses of artificial intelligence (AI) and what AI means for the future. At the same time, many health care companies already have integrated algorithms and AI...more

Epstein Becker & Green

Unpacking Averages: Understanding the Potential for Bias in a Sepsis Prediction Algorithm, a Case Study

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Would it surprise you if I told you that a popular and well-respected machine learning algorithm developed to predict the onset of sepsis has shown some evidence of racial bias? How can that be, you might ask, for an...more

Alston & Bird

AI Regulation in the U.S.: What’s Coming, and What Companies Need to Do in 2023

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Artificial intelligence (AI) is expanding into more industries (often in surprising ways) and has inevitably caught the attention of federal and state regulators. Our Privacy, Cyber & Data Strategy Team summarizes the...more

MoFo Life Sciences

FDA’S Plan For AI/ML-Based Software As Medical Devices: Progress And Concerns

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U.S. Food and Drug Administration (FDA) has acknowledged the prevalence of Artificial Intelligence/Machine Learning (AI/ML)-Based Software as Medical Devices (SaMDs) and has been taking steps towards advancing its regulatory...more

Orrick, Herrington & Sutcliffe LLP

“Good” and “Safe” Data – Panel Launches Artificial Intelligence Initiative

Orrick, Herrington & Sutcliffe LLP on

On April 25, 2019 Orrick’s Successful Women in IP (SWIP) group and the newly launched AI Cross Practice Initiative joined forces to bring together industry-leading AI experts for a lively panel discussion on the data used to...more

Arnall Golden Gregory LLP

FDA’s Steps Toward a New Review Framework for Medical Devices That Use Artificial Intelligence Algorithms

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On April 2, 2019, the Food and Drug Administration issued a statement by Commissioner Scott Gottlieb on steps toward a new review framework specifically tailored to promote the development of medical devices that use...more

Stinson LLP

FDA Proposes Pathway for Artificial Intelligence/Machine Learning Software

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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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