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Artificial Intelligence Clinical Trials

McDermott Will & Emery

European Health & Life Sciences Symposium 2025: Key Takeaways

In April 2025, we were proud to host the annual European Health & Life Sciences Symposium at the Shangri-La hotel in Paris. Attended by some 300 delegates from across the industry, participants including investors,...more

Hogan Lovells

AI Health Law & Policy: FDA’s rapidly evolving regulatory paradigms

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Artificial intelligence has become one of the most transformative forces in health care, reshaping everything from drug discovery to diagnostics. For pharmaceutical and medical device companies, AI-driven solutions present...more

Holland & Knight LLP

Two Days, Two Hearings: NIH and FDA Nominees Go Before the HELP Committee

Holland & Knight LLP on

Dr. Jayanta (Jay) Bhattacharya, nominated to be Director of the National Institutes of Health (NIH), and Dr. Martin Makary, nominated to be the Commissioner of the U.S. Food and Drug Administration (FDA), appeared before the...more

Troutman Pepper Locke

A Model’s Credibility Is in the Details: FDA Draft Guidance on the Use of AI Models in Drug and Biological Product Development

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In January, the U.S. Food and Drug Administration (FDA) issued its first guidance on the use of artificial intelligence (AI) models in drug development and in regulatory submissions titled, “Considerations for the Use of...more

Foley & Lardner LLP

Unlocking the Future of Medicine: The Role of AI in Drug Discovery

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Since 1995, Nature Medicine has been chronicling advances in medical technology and health care. To mark the journal’s 30th anniversary, each month an issue of critical importance for the future of medicine will be...more

Akin Gump Strauss Hauer & Feld LLP

Akin Intelligence - November/December 2024

Welcome to the November-December edition of Akin Intelligence. As the end of 2024 approached, the European Union (EU) sustained progress on guidance and supporting materials for its AI Act and international AI Safety...more

Sheppard Mullin Richter & Hampton LLP

2025 Top-of-Mind Issues for Life Sciences Companies

DTC Telehealth Platforms - Arrangements involving telemedicine and direct-to-consumer (“DTC”) business services are expected to be a source of major regulatory scrutiny. In 2024, such arrangements were the focus of proposed...more

Hogan Lovells

International AI Regulatory Contrast: Evolving frameworks in the EU, UK, and US

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In the EU, the AI Act has been approved, carrying significant implications for medical device, technology, and pharmaceutical firms. In the US, there is no comprehensive federal AI legislation, but at least 45 states have...more

DLA Piper

Key Takeaways from FDA’s Draft Guidance on Use of AI in Drug and Biological Life Cycle

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The US Food and Drug Administration (FDA) recently issued its draft guidance, Considerations for the Use of Artificial Intelligence to Support Regulatory Decision-Making for Drug and Biological Products, on January 6, 2025. ...more

Hogan Lovells

FDA unveils long-awaited guidance on AI use to support drug and biologic development

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The U.S. Food and Drug Administration (FDA) recently published its long-awaited draft guidance on considerations for the use of artificial intelligence (AI) to support regulatory decision-making for drug and biologics, which...more

Hogan Lovells

Life Sciences Law Update - Key developments for pharma and medical device companies in EU and Germany, France, UK, Italy and Spain...

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Pharma: Launch of Shortages Monitoring Platform, several Changes re Clinical Trial Management in EU Countries; Devices: Resolution on the need to revise the MDR and IVDR published; Compliance: CSRD still not implemented in...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

Hogan Lovells

FDA’s evolving regulatory framework for AI use in drug & device clinical trials and research

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U.S. Food and Drug Administration (FDA) Commissioner Robert Califf, M.D., and other senior FDA officials recently published a “Special Communication” in JAMA describing FDA’s concerns with the use of AI in medical product...more

Alston & Bird

Health Care Week in Review: CMS Releases Advance Notice of MA and Part D Payment Methodologies and Senate Finance Chair Identifies...

Alston & Bird on

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

Hogan Lovells

JPM2025: Regulation of artificial intelligence: Navigating a new frontier in health care

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Artificial intelligence (AI) is transforming the health care landscape, from diagnostics to drug development and clinical trials. As AI technologies rapidly evolve, global regulators face the complex task of regulating AI to...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

Knobbe Martens

FDA Provides Perspective on Goals and Challenges for Regulation of Artificial Intelligence in Medical Devices, Drug Design, and...

Knobbe Martens on

A recent article authored by Haider J. Warraich, MD; Troy Tazbaz; and Robert M. Califf, MD in the Journal of the American Medical Association, reviews the history of artificial intelligence (AI) regulation by the U.S. Food...more

Akin Gump Strauss Hauer & Feld LLP

National Institutes of Health Develops AI Algorithm to Identify Potential Volunteers for Clinical Trials

Researchers from the National Institutes of Health (NIH) have developed an algorithm that harnesses AI to help accelerate the process of matching potential volunteers for relevant clinical research trials. The algorithm,...more

Health Care Compliance Association (HCCA)

In This Month’s E-News: September 2024

Report on Research Compliance 21, no. 9 (September, 2024) - Based on their review of public data on ClinicalTrials.gov, a bipartisan quartet of U.S. representatives has asked the Food and Drug Administration (FDA) to...more

DLA Piper

FemTech and the use of AI

DLA Piper on

Due to an exponential growth in the investment in female health and wellbeing, Forbes and Dealroom reported that 2023 saw 1.14 billion USD raised collectively across 120 deals in ‘FemTech’. ...more

Foley & Lardner LLP

Artificial Intelligence: Is the Health Care Sector Ready for the Rollout?

Foley & Lardner LLP on

On July 17, 2024, Foley & Lardner LLP hosted the Boston Health Care AI & Technology Investor Summit with Endeavor Venture Funds, bringing together hundreds of attendees in person and virtually to discuss issues surrounding...more

Foley & Lardner LLP

Challenges in AI-Enabled Biomarker Discovery

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Patient biomarkers are now used in personalized medicine to predict disease progression, minimize side effects, and maximize therapeutic benefits in the treatment of disease. In oncology, the use of biomarkers has increased...more

McDermott Will & Emery

Real-World Data Back in the Spotlight at FDA

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On July 25, 2024, the US Food and Drug Administration (FDA) announced the release of a final version of its Real-World Data: Assessing Electronic Health Records and Medical Claims Data to Support Regulatory Decision-Making...more

Proskauer - Health Care Law Brief

OIG Reports that Clinical Trials Lack Diverse Subjects: What Role Can Artificial Intelligence Play?

As the largest public funder of biomedical research in the world, the National Institutes of Health (“NIH”) annually funds over $38 billion in extramural research, including about $6 billion for clinical trials. On May 28,...more

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