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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

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AI Drug Development: FDA Releases Draft Guidance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On January 6, 2025, the U.S. Food and Drug Administration (FDA) released draft guidance titled Considerations for the Use of Artificial Intelligence To Support Regulatory Decision-Making for Drug and Biological Products...more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

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

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

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

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

Smart & Biggar

Health Canada paving the way for more AI/ML medical devices

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Since 2018, Health Canada has undertaken an initiative to adapt its regulatory approach to better support digital health technologies, specifically medical devices. Key focus areas include artificial intelligence, software as...more

Sheppard Mullin Richter & Hampton LLP

FDA Joins Other Regulators in Focus on AI and Machine Learning

The Food and Drug Administration recently sought comments on the role of transparency for artificial intelligence and machine learning-enabled medical devices. The FDA invited comments in follow up to a recent workshop on the...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

Jones Day

Vital Signs: Digital Health Law Update | Summer 2021

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NOTE FROM THE EDITORS - The "dog days of summer" certainly provide a welcome, if brief, break in the extremely rapid pace of statutory, regulatory, and various other policy and industry efforts applicable to digital health....more

Lowenstein Sandler LLP

A Look Ahead: US FDA And Medical Device Regulations In 2021

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The pandemic year of 2020 presented FDA with many enormous challenges, including how to use emergency authorizations to approve diagnostic tests, personal protective equipment, and therapies, how to conduct remote...more

Morgan Lewis

Three Considerations for AI Healthcare Application Developers and Users

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The applications of artificial intelligence (AI) are seemingly innumerable with benefits reportedly as prolific as the technology behind them, including in the healthcare space. To keep pace, the US Food and Drug...more

Jones Day

Vital Signs Digital Health Law Update | Winter 2021

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Note from the Editors - Digital technologies have transformed almost every aspect of the health care and life sciences industry—from electronic health records and telemedicine, to diagnostics and therapeutics augmented by...more

Akin Gump Strauss Hauer & Feld LLP

MedTech Update 2020: Legal and Regulatory Issues to Watch For in the Medical Technology Industry in the New Year

Medical device and diagnostics companies and laboratories should anticipate significant legal, regulatory and market changes in 2020 that will have a lasting impact on the industry. From revisions to how the government...more

Morgan Lewis

FDA Issues Proposal on Oversight of Artificial Intelligence and Machine Learning Software

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The Food and Drug Administration’s recent discussion paper suggests a new regulatory approach for evaluating postmarket changes to artificial intelligence and machine learning software devices, but further clarity is needed...more

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