News & Analysis as of

Life Sciences Pharmaceutical Industry Digital Health

Jones Day

Medicare's Innovation Center Charts New Direction: Part 3 – Drugs, Devices, and Data

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The Center for Medicare and Medicaid Innovation ("CMMI") is set to reshape value-based care. In the third of a three-part series highlighting this new direction, this summary is focused on CMMI's efforts regarding drugs,...more

Wilson Sonsini Goodrich & Rosati

The Life Sciences Report – June 2025

This latest edition features articles on succeeding in the current life sciences funding market, strategic and legal considerations in digital health combinations, the corporate practice of medicine and guidance for...more

A&O Shearman

New German government: Key plans for the Life Sciences and Healthcare sector

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Following the election in February, the party leaderships of CDU, CSU and SPD have agreed on a coalition agreement titled “Responsibility for Germany”. The 146-page document also sets out aspects regarding the healthcare and...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On January 6, 2025, the FDA released draft guidance on using artificial intelligence (AI) in regulatory decision-making for drugs and biological products. The draft guidance – the first of its kind from the agency – aims to...more

A&O Shearman

Key regulatory changes impacting the healthcare industry in the EU and Germany in 2025

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The regulatory frameworks in the life sciences and healthcare sector keep evolving rapidly and dynamically. Several important legislative reforms have been adopted over the last years, which are set to impact players in the...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

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

McDermott Will & Schulte

Trending in Telehealth: October 21 – 28, 2024

Trending in Telehealth highlights state legislative and regulatory developments that impact the healthcare providers, telehealth and digital health companies, pharmacists, and technology companies that deliver and facilitate...more

Holland & Knight LLP

FDA Warning Letter Marks Significant Shift in Enforcement of Laboratory Developed Tests

Holland & Knight LLP on

The U.S. Food and Drug Administration's (FDA) March 21, 2024, warning letter to Agena Bioscience Inc. (Agena), a genetic diagnostic test developer, generated a lot of immediate commentary among regulatory lawyers and...more

Sheppard Mullin Richter & Hampton LLP

FDA Revisits and Updates Guidance on Addressing Misinformation – Ten Years Later

On July 8, the U.S. Food and Drug Administration (“FDA”) announced its updated guidance, “Addressing Misinformation About Medical Devices and Prescription Drugs: Questions and Answers,” which provides recommendations and...more

McDermott Will & Schulte

Trending in Telehealth: May 14 – May 20, 2024

Trending in Telehealth highlights state legislative and regulatory developments that impact the healthcare providers, telehealth and digital health companies, pharmacists and technology companies that deliver and facilitate...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

McDermott Will & Schulte

FDA Clears First OTC Continuous Glucose Monitor

On March 5, 2024, the US Food and Drug Administration (FDA) granted clearance to market the first over-the-counter (OTC) continuous glucose monitor (CGM). Dexcom’s Stelo Glucose Biosensor System (Stelo) is an integrated CGM...more

Knobbe Martens

DarioHealth Acquires Digital Health Company Twill for $22.4 Million

Knobbe Martens on

(February 22, 2024) Dario health announced on February 21, 2024 that it has acquired digital health company Twill. DarioHealth Corp. is a leading digital health company, shaping how people with chronic conditions manage their...more

ArentFox Schiff

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

ArentFox Schiff on

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

Fenwick & West Life Sciences Group

In 2024, the Digital Health Revolution Continues

Digital health is showing signs of life despite financial markets that seem determined to bring some of 2023’s volatility into the new year. Stocks are up and down, and bond yields are climbing. Inflation is proving stubborn,...more

Alston & Bird

Health Care Week in Review: Biden Administration Issued Final Rule on Fees for IDR Process Under NSA; W&M Democrats Release Report...

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Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...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

Trending in Telehealth: November 8 – 14, 2023

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Trending in Telehealth highlights state legislative and regulatory developments that impact the healthcare providers, telehealth and digital health companies, pharmacists and technology companies that deliver and facilitate...more

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