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Dentons

Ep. 58 – Addressing Potential Discrimination in Patient Care Decision Support Tools

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Effective May 1, 2025, the Section 1557 regulations require covered healthcare providers to take reasonable steps by May 1, 2025, to identify and mitigate the risk of discrimination when they use AI and other emergency...more

McDonnell Boehnen Hulbert & Berghoff LLP

AI News Roundup – Pew poll reveals AI pessimism among American public, AI-assisted treatment found to reduce Parkinson’s symptoms,...

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To help you stay on top of the latest news, our AI practice group has compiled a roundup of the developments we are following....more

Fenwick & West LLP

Healthtech Patents: What Alivecor v. Apple Means for AI-Powered Innovation

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A major Federal Circuit ruling just sent a clear message to AI-driven healthtech companies: AI alone won’t get you a patent....more

McDermott Will & Emery

Section 1557 Patient Care Decision Support Tools, Anti-Discrimination Compliance: 12 Things to Consider

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In April 2024, the US Department of Health and Human Services (HHS) issued a final rule reinterpreting Section 1557 of the Affordable Care Act, which prohibits discrimination on the basis of race, color, national origin, sex,...more

EDRM - Electronic Discovery Reference Model

Dario Amodei’s Essay on AI, ‘Machines of Loving Grace,’ Is Like a Breath of Fresh Air

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While almost everyone is panicking about a potential robot apocalypse, Dario Amodei, the CEO and co-founder of Anthropic (“Claude”), is explaining how AI might compress 100 years of medical progress into a decade, cure mental...more

Robinson+Cole Health Law Diagnosis

Forecasting the Integration of AI into Health Care Compliance Programs

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Health care entities maintain compliance programs in order to comply with the myriad changing laws and regulations that apply to the health care industry. Although laws and regulations specific to the use of artificial...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

Alston & Bird

Biden Executive Order on Artificial Intelligence Highlights Breadth, Challenges, and More Activity to Come

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On October 30, 2023, President Joe Biden signed the Executive Order on the Safe, Secure, and Trustworthy Development and Use of Artificial Intelligence (EO). The wide-ranging EO covers many sectors of the economy and...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

McDermott Will & Emery

Reviewing Key Principles from FDA's Artificial Intelligence White Paper

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In April 2019, the US Food and Drug Administration (FDA) issued a white paper, “Proposed Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device,”...more

Orrick, Herrington & Sutcliffe LLP

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

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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

Akin Gump Strauss Hauer & Feld LLP

FDA’s AI White Paper: To Be or Not to Be, That is the Question

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• FDA has released a white paper outlining a potential regulatory framework for software as a medical device (SaMD) that leverages artificial intelligence (AI) or machine learning (ML). • The white paper distinguishes three...more

Hogan Lovells

An intelligent approach for regulating medical device AI

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From analysis of medical imaging such as echocardiograms, computed tomography (CT), endoscopy, and skin photographs, to tissue histology and physiological data such as electrocardiograms (ECG), these technologies have...more

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