News & Analysis as of

Health Technology Machine Learning

Manatt, Phelps & Phillips, LLP

[Webinar] Future of Health: The Emerging Landscape of Augmented Intelligence in Health Care - May 1st, 12:00 pm - 1:00 pm ET

The use of augmented intelligence (AI) in medicine has been increasingly used to develop cancer prognoses, respond to patient messages, predict adverse clinical events and recommend optimal staffing volumes in radiology,...more

Mintz - Health Care Viewpoints

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

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

Foley & Lardner LLP

“Let’s Talk Compliance”: Hot Topics in Compliance

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Editor’s Note: PYA and Foley & Lardner hosted the 6th Annual “Let’s Talk Compliance” two-day Virtual Conference on January 18 and 19, 2024. Panelists included Foley & Lardner attorneys and PYA experts. The event was hosted by...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

Ankura

A Journey into Eriksonian Psychology for AI Development

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Imagine gathering a team of data scientists, computer scientists, and cognitive psychologists in one room. What would they discuss? The latest statistical model or a new psychological theory? In our case, the discussion...more

Gardner Law

[Hybrid Event] MASTERING TOMORROW'S HEALTHCARE TECH: A CUTTING-EDGE APPROACH TO REGULATORY, COMPLIANCE, AND PRIVACY DEMANDS -...

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FDA law firm Gardner Law and EU-based Fieldfisher discuss regulatory, compliance, and privacy matters relevant to high-tech healthcare products. - - Harnessing AI and Connected Devices in Medical Innovation in an...more

Davis Wright Tremaine LLP

[Webinar] Paths and Pitfalls on the Road to AI in Healthcare - July 18th, 11:00 am - 12:00 pm PT

Artificial intelligence-driven technology is transforming nearly everything that we can see and touch, with great promise for the healthcare industry. This webinar will explore the promise, pitfalls and other key...more

McDermott Will & Emery

Inside the ONC’s Plans to Regulate Health AI: Proposal on Predictive Decision Support Interventions

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The Department of Health and Human Services Office of the National Coordinator for Health Information Technology (ONC) published a notice of proposed rulemaking on April 18, 2023, titled “Health Data, Technology, and...more

Epstein Becker & Green

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

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

Wilson Sonsini Goodrich & Rosati

[Ongoing Program] 2023 Medical Device Digital Health Conference - June 16th, San Francisco, CA

Wilson Sonsini’s 30th Annual Medical Device Digital Health Conference will address topics of critical importance to medical device and digital health companies today, including key healthcare regulatory considerations, the...more

Wilson Sonsini Goodrich & Rosati

[Ongoing Program] MDC 2023 Reception & Dinner Women’s Networking Event & Program - June 15th, Menlo Park, CA

Wilson Sonsini’s 30th Annual Medical Device Digital Health Conference will address topics of critical importance to medical device and digital health companies today, including key healthcare regulatory considerations, the...more

Holland & Knight LLP

ONC Proposes Updates to Information Blocking Regulations

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The U.S. Department of Health and Human Services' (HHS) Office of the National Coordinator for Health Information Technology (ONC) on April 11, 2023, released a Notice of Proposed Rule Making called the Health Data,...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

Hogan Lovells

Evolution of FDA regulation of AI-based technology

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Hogan Lovells partners Kelliann H. Payne and John J. Smith, M.D., J.D. recently joined Richard Frank, MD, PhD, Chief Medical Officer, Siemens Healthineers, and other industry leaders in person and virtually at the Health Care...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

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

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