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Artificial Intelligence Digital Health

Husch Blackwell LLP

Hospice Insights Podcast - But Wait: Things to Consider Before Adopting AI Tools In Your Hospice

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Husch Blackwell’s Meg Pekarske is joined by colleague Kathleen Snyder, who has extensive experience in digital health and has been busy advising health care providers on how to safely implement artificial intelligence (AI)...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

Wilson Sonsini Goodrich & Rosati

Utah Enacts Mental Health Chatbot Law

On March 25, 2025, Utah Governor Spencer Cox signed HB 452, which establishes new rules for the use of artificial intelligence (AI) mental health chatbots accessible to any “Utah user,” defined as, “an individual located in...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

Husch Blackwell LLP

Structuring the Right Deals for Growth in Life Sciences

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Innovation in life sciences isn’t just about scientific breakthroughs—it’s about making the right business decisions. Whether a company is developing AI-driven diagnostics, biotech therapies, connected medical devices, or...more

Arnall Golden Gregory LLP

Healthcare Authority Newsletter - February 2025 #3

News Briefs - Proposed Budget Cuts Could Greatly Impact Healthcare Sector - House Republicans unveiled a budget resolution that asks the Energy and Commerce Committee, which oversees Medicare and Medicaid, to find $880...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On January 6, 2025, the FDA released draft guidance on using artificial intelligence (AI) in regulatory decision-making for drugs and biological products. The draft guidance – the first of its kind from the agency – aims to...more

Morgan Lewis

How New Executive Orders May Affect FDA’s Medical Device Operations

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Several executive orders recently signed by US President Donald Trump may have significant implications for the US Food and Drug Administration (FDA) and its regulatory oversight for medical device and digital health...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

Arnall Golden Gregory LLP

Healthcare Authority Newsletter - January 2025 #2

News Briefs - Hospitals Urged to Check for Accuracy as AI Use Increases -About 65 percent, or 1,696, of U.S. hospitals surveyed reported using artificial intelligence or predictive models integrated with their electronic...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

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

Fenwick & West LLP

2024 Digital Health Recap: Early-Stage Momentum and 'Goliath' Moves

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As we kick off 2025, it's worth reflecting on the forces that shaped digital health in 2024. From early-stage innovation capturing investor attention to mega funds like a16z and General Catalyst driving dealmaking, the year...more

Akin Gump Strauss Hauer & Feld LLP

FDA Publishes a Wide Range of Guidances in the Final Days of the Biden Administration

On January 6 and 7, 2025, the FDA announced, by our count, 31 draft or final guidances, on a wide range of topics. Historically, an incoming administration will impose a temporary freeze on the issuance of guidances and...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

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

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

Fenwick & West LLP

Key Takeaways from Digital Health Counsel 2024 AI Summit

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Walking away from Digital Health Counsel 2024 AI Summit, the stunning impact that AI and data-powered innovation are making on healthcare is undeniable. Organized by Ogden Murphy Wallace and sponsored by Fenwick, the summit...more

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