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Jones Day

Vital Signs: Digital Health Law Update | Spring 2025

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Welcome to Vital Signs, a curated compilation of the latest legal and regulatory developments in digital health....more

Arnall Golden Gregory LLP

Healthcare Authority Newsletter - April 2025 #5

News Briefs - March Healthcare Data Breaches Declined 46% to Lowest Since 2022 - Healthcare data breaches appear to be on the decline for now. The HIPAA Journal reported just 58 breaches in March -- the lowest total for the...more

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

Rothwell, Figg, Ernst & Manbeck, P.C.

From Algorithms to Approvals: Navigating AI in Drug and Biological Product Regulation

On January 6, 2025, the FDA released draft guidance on using artificial intelligence (AI) in regulatory decision-making for drugs and biological products. The draft guidance – the first of its kind from the agency – aims to...more

Ropes & Gray LLP

The Biden Administration’s Swan Song on Digital Health: Two FDA Guidances on Artificial Intelligence and FDA’s Defense of its...

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In the waning days of the Biden administration, the FDA released a flood of new guidance documents and other agency actions, including several important items related to digital health. On January 7, FDA published two new...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

Morgan Lewis

Healthcare and Life Sciences: Key Insights and Considerations for Stakeholders in 2025

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This report compiles several important developments that shaped the healthcare and life sciences industries in 2024 and spotlights key areas to watch in 2025. Each section addresses either an industry sector within healthcare...more

American Conference Institute (ACI)

[Event] 2nd Annual Life Sciences AI Summit - February 20th - 21st, New York, NY

Gain firsthand insights from leading in-house experts on the transformative power of AI in the life sciences at ACI's 2nd Annual Life Sciences AI Summit. Discover strategies to navigate the complex legal and regulatory...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 | Fall-Winter 2024

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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 present a timely discussion about increasing litigation and...more

Jones Day

Inaugural Meeting for FDA's Digital Health Advisory Committee to Focus on GenAI-enabled Medical Devices

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The U.S. Food and Drug Administration's ("FDA") new advisory committee on digital health is set to examine its approach for evaluating and regulating the safety and effectiveness of medical devices utilizing generative...more

Orrick, Herrington & Sutcliffe LLP

The EU AI Act: Key Takeaways for Life Sciences and Digital Health Companies

This update is part of our EU AI Act Essentials Series. The European AI Act is a landmark piece of legislation that establishes the first major comprehensive framework for regulating the use of artificial intelligence,...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

McGuireWoods LLP

[Event] 20th Annual Healthcare Private Equity and Finance Conference - May 8th - 9th, Chicago, IL

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Mark your calendar for the 2024 McGuireWoods Healthcare Private Equity and Finance Conference, and help us celebrate 20 years of bringing healthcare industry leaders together. This premier two-day healthcare...more

ArentFox Schiff

Top Legal Considerations for the GCs and CFOs in the Life Sciences Industry in 2024

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The top legal issues in 2024 for the life sciences field reflect the complex and changing legal landscape that the industry is navigating, encompassing drug pricing, regulatory challenges, and broader societal and governance...more

McDermott Will & Schulte

European Health & Life Sciences Symposium 2023 | Key Takeaways

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200+ leading individuals in healthcare, life sciences and private equity gathered at the Shangri-La Hotel in Paris for the European Health & Life Sciences Symposium 2023 to enjoy a day packed with fireside chats, in-depth...more

McDermott Will & Schulte

[Event] HPE Europe 2023 - September 21st, London, United Kingdom

HPE Europe is back! Join the biggest names in healthcare, life sciences and private equity for an unforgettable day of thought-provoking discussions, cutting-edge insights and valuable networking opportunities at the...more

King & Spalding

Pharma Investment Trend Report: What We’re Watching in 2023

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2022 was a big year for the pharmaceutical and biotechnology sectors. Novel technologies emerged at a rapid clip. The Food and Drug Administration (“FDA” or the “Agency”) approved over forty novel drugs and biologics and...more

Fenwick & West Life Sciences Group

Big Tech Continues Foray Into Healthcare, Opening New Opportunities for Digital Health Startups

As the financial markets continue to struggle, digital health companies are conserving resources, slowing hiring and minding their burn rate given the uncertainty around the current economic slowdown and whether the economy...more

American Conference Institute (ACI)

[Event] Drug & Medical Device Litigation - December 7th - 8th, New York, NY

The premier event for drug and medical device product liability lawyers to gain essential winning litigation strategies. ACI’s 26th Annual Flagship Conference on Drug and Medical Device Litigation is returning to New York...more

Knobbe Martens

UCLA Biodesign Launches Study to Help Advance MedTech and Digital Health Innovation Forward Into a New Decade

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What does it require to bring a transformational innovation to patients? To address this question, the UCLA Biodesign Hub for MedTech and Digital Health has launched an industry-wide study to uncover the cost and time to...more

Morgan Lewis - Tech & Sourcing

Important Considerations When Tech Service Providers and Life Science Companies Collaborate in the Digital Health Space

When negotiating a digital health collaboration agreement between a tech company and a life sciences company, whether for the development of artificial intelligence or other software, the provision of data hosting and...more

MoFo Life Sciences

Recent Digital Health-Related FDA Announcements

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The U.S. Food and Drug Administration (FDA) is showing its dedication to the advancement of digital health technology with two recent announcements: a new Digital Health Center of Excellence and an update on its Software...more

Hogan Lovells

[Virtual Event] AI – A brave new world? - December 1st, 11:00 am - 12:15 pm EST

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Life Sciences and Health Care Horizons virtual event series - The fast pace of innovation in the life sciences and health care industry has reached an all-time high in 2020 as the industry grapples with the new reality of...more

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