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Digital Health Artificial Intelligence Machine Learning

Hogan Lovells

Life Sciences & Health Care Horizons 2025

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Our 2025 Life Sciences and Health Care Horizons edition is now live! Explore the latest global insights from the U.S., Asia-Pacific, Europe, Latin America, and the Middle East on the key issues and emerging trends shaping the...more

Ropes & Gray LLP

[Podcast] Women @ RopesTalk: Conversation with Jan Sbarbaro, Lyric

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On this episode of Women @ RopesTalk hosted by IP transactions and licensing partner Megan Baca, IP transactions partner Emily Karlberg returns for another engaging conversation, this time with Jan Sbarbaro, the chief legal &...more

Ankura

HLTH 2024: 9 Key Observations Steering Healthcare into 2025

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Every year, 12,000 leaders in the healthcare industry meet at HLTH. This year's conference covered all aspects of the healthcare ecosystem, and here are the nine that we should watch as we enter the new year....more

Orrick, Herrington & Sutcliffe LLP

The Download: A Private Sector Model for Responsible AI in Healthcare & Why Value-Based Care Is Good Business

WHAT WE'RE SEEING - In this Life Sciences & Healthtech edition of The Download, we take on key trends at the intersection of tech and healthcare, continuing the energizing conversation from JPM Healthcare last week. 01 A...more

Foley & Lardner LLP

AI Drug Development: FDA Releases Draft Guidance

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On January 6, 2025, the U.S. Food and Drug Administration (FDA) released draft guidance titled Considerations for the Use of Artificial Intelligence To Support Regulatory Decision-Making for Drug and Biological Products...more

Jones Day

FDA's Digital Health Advisory Committee Discusses Total Product Lifecycle Considerations for GenAI-Enabled Devices

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While generative artificial intelligence ("GenAI") has the potential to fundamentally change health care, it presents unique risks and complexities that challenge the U.S. Food and Drug Administration's ("FDA" or "Agency")...more

Hogan Lovells

FDA’s first Digital Health AdComm meeting mulls promises & perils of Generative AI

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Amid continued rapid development of novel software products that present new opportunities in the health care space, FDA has yet to grant marketing authorization to a medical device incorporating artificial intelligence (AI)...more

Ropes & Gray LLP

FDA Finalizes Guidance on Predetermined Change Control Plans for AI-Enabled Medical Device Software

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On December 4, 2024, the U.S. Food and Drug Administration (“FDA”) released its final guidance for industry on predetermined change control plans (“PCCPs”) for devices that utilize artificial intelligence-enabled software...more

Sheppard Mullin Richter & Hampton LLP

FDA Releases Long-Anticipated Guidance on Predetermined Change Control Plans for Devices That Utilize AI/ML Software

FDA’s primary challenge in regulating AI-enabled device software functions (“AI-DSF”) has been that the self-modifying nature of these functions simply does not fit within the Agency’s long-standing framework for medical...more

Fenwick & West LLP

Upcoming FDA Meeting Focuses on Generative AI in Medical Devices

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The U.S. Food and Drug Administration will focus on “Total Product Lifecycle Considerations for Generative AI-Enabled Devices” during its upcoming Digital Health Advisory Committee meeting on November 20–21. This meeting will...more

Maynard Nexsen

Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 213: AI Transformations in Life Sciences and Beyond with...

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Recorded at NC Life Sciences Organization’s Annual Meeting, Heather and Matthew welcome Igor Jablokov, an entrepreneur, former IBM director, and pioneer of the artificial intelligence industry who has been involved in several...more

Akin Gump Strauss Hauer & Feld LLP

FDA Publishes Digital Health and Artificial Intelligence Glossary

On September 26, 2024, FDA published a compilation of commonly used terms in the digital health, artificial intelligence (AI), and machine learning space and their definitions, available here. FDA intends the glossary to be...more

Jones Day

Vital Signs: Digital Health Law Update | Spring 2024

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Welcome to Vital Signs, a curated compilation of the latest legal and regulatory developments in digital health. Our lead article reports on recent developments in the U.S. Food and Drug Administration's ("FDA") regulatory...more

Troutman Pepper Locke

The FDA's Response to AI Medical Innovation — The Good Bot Podcast

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Join Troutman Pepper Partner Brett Mason for a podcast series analyzing the intersection of artificial intelligence (AI), health care, and the law. In this installment, Brett is joined by Partner Judy O'Grady and Associate...more

White & Case LLP

Digital healthcare in Southeast Asia offers healthy returns

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Rapid digitalization in the health industry is set to drive M&A across the region - Digitalization is reshaping the global healthcare industry as demand for personalized, more accessible care fuels innovative market...more

Troutman Pepper Locke

Introduction to The Good Bot: Decoding AI and Its Integration Into Health Care — The Good Bot Podcast

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Join Troutman Pepper Partner Brett Mason for a podcast series analyzing the intersection of artificial intelligence (AI), health care, and the law. In this introductory episode, Brett is joined by Morgan Hague from...more

Skadden, Arps, Slate, Meagher & Flom LLP

EU and Germany Lay Groundwork for the Use of Medical Data for Research and AI Training

Both the EU and Germany are taking significant steps to accelerate digitalization in the health sector and facilitate the exchange and use of health data for research and innovation purposes. They aim to improve...more

American Conference Institute (ACI)

[Event] 22nd Advanced Summit on Life Sciences - May 29th - 30th, New York, NY

Hosted by American Conference Institute, the 22nd Advanced Summit on Life Sciences Patents returns for another exciting year with curated programming that will provide practical insights on how to maximize your patent term...more

Mintz - Health Care Viewpoints

2023: Another Year Chock Full of Challenges for FDA

At the start of 2022, we reflected on what the Food and Drug Administration (FDA) had accomplished during the preceding 12 months and the challenges that could be ahead for the agency during the impending year, especially...more

Jones Day

Vital Signs: Digital Health Law Update | Fall 2023

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We bring you Vital Signs, a curated, one-stop resource on the most notable digital health law updates from our U.S. and global contributors. In Industry Insights, our lawyers describe the increasingly common regulation of...more

BakerHostetler

FDA Forms Digital Health Advisory Committee to Navigate Emerging Technologies

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The FDA has announced the formation of the Digital Health Advisory Committee, a group dedicated to navigating the complexities of emerging DHTs like AI/ML, augmented reality and more. This development evidences the FDA’s...more

Holland & Knight LLP

Podcast - Artificial Intelligence in Healthcare and How to Comply with HIPAA & State Privacy Laws

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In this episode of "Counsel That Cares," HIPAA and healthcare privacy attorneys Beth Pitman and Shannon Hartsfield dissect the highly publicized Dinerstein v. Google case. They address the implications and concerns of sharing...more

Jones Day

Vital Signs Digital Health Law Update | Summer 2023

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We bring you Vital Signs, a curated, one-stop resource on the most notable digital health law updates from our U.S. and global contributors. In Industry Insights, we take an in-depth look at generative artificial intelligence...more

Fenwick & West Life Sciences Group

Generative AI And Digital Health–What Does the Future Hold?

Artificial intelligence and healthcare are hardly strangers, as machine learning programs have been aiding in the diagnosis of disease, drug discovery, the streamlining of clinical workflows and the analysis of medical data...more

McDermott Will & Emery

[Webinar] AI Risk Management 101 - June 29th, 12:00 pm - 1:00 pm ET

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Healthcare is rapidly changing, with artificial intelligence (AI) and algorithmic models leading the transformation. In recent years, big data and machine learning algorithms have revolutionized our ability to predict...more

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