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Digital Health Life Sciences

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

Hogan Lovells on

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

Husch Blackwell LLP

Structuring the Right Deals for Growth in Life Sciences

Husch Blackwell LLP on

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

Orrick, Herrington & Sutcliffe LLP

Telehealth Transformation: Innovating Mental Health Care Life Sciences Snapshot – Q1 2025

Q4 2024 marked the conclusion of a turnaround year for life sciences venture investment. After two consecutive years of declining activity and macroeconomic uncertainty, the dust has settled, and investment is back on 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On January 6, 2025, the FDA released draft guidance on using artificial intelligence (AI) in regulatory decision-making for drugs and biological products. The draft guidance – the first of its kind from the agency – aims to...more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

A&O Shearman on

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

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

Morgan Lewis on

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

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

Bradley Arant Boult Cummings LLP

Update: Telehealth “Cliff” Looming at End of 2024

As 2024 comes to a close, the telehealth space continues to be uncharted territory. When the COVID-19 pandemic began, the ability to deliver telehealth expanded as providers sought to provide quality care unrestricted by...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

Ropes & Gray LLP on

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

Jones Day

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

Jones Day on

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

Maynard Nexsen

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

Maynard Nexsen on

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

McDermott Will & Emery

Trending in Telehealth: October 21 – 28, 2024

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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

Epstein Becker & Green

Advancements of Artificial Intelligence in Health Care – One Year After White House Executive Order – Diagnosing Health Care

Epstein Becker & Green on

One year ago, on October 30, 2023, President Joe Biden signed an executive order laying the groundwork both for how federal agencies should responsibly incorporate artificial intelligence (AI) within their workflows and how...more

Maynard Nexsen

Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 212: Fujifilm’s Investment in North Carolina with...

Maynard Nexsen on

Recorded at NC Life Sciences Organization’s Annual Meeting, Heather and Matthew welcome back Christine Vannais from Fujifilm and her new colleague, Laurie Braxton. They dive into Fujifilm’s billion-dollar expansion in North...more

McDermott Will & Emery

Trending in Telehealth: September 30 – October 7, 2024

McDermott Will & Emery on

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

McDermott Will & Emery

Trending in Telehealth: September 17 – 30, 2024

McDermott Will & Emery on

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

Maynard Nexsen

Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 208: Extended Reality Technology and the ThinkReality...

Maynard Nexsen on

Recorded at NC Life Sciences Organization’s Annual Meeting, Heather and Lauren are joined by Mattney Beck of Lenovo, a well-known multinational technology company, to discuss their innovations in XR or Extended Reality...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

Troutman Pepper Locke

AI in the Operating Room: Liability Issues for Device Makers — 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 Mason is joined by Partner Eric Rumanek and...more

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