News & Analysis as of

Artificial Intelligence Healthcare Medical Devices

Smart & Biggar

CDA update: new five-year strategic plan and position statement on using AI in health technology assessments

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On April 15, 2025, Canada’s Drug Agency (CDA) released its new five-year strategic plan, Insight to Impact 2025-2030. Formerly the Canadian Agency for Drugs and Technologies in Health (CADTH), this is the CDA’s first...more

Loeb & Loeb LLP

FDA Unleashes AI to Review Product Applications

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The U.S. Food and Drug Administration (FDA) has been ahead of the curve for a number of years on emerging issues and opportunities for the agency and regulated industry arising from the advent and evolution of artificial...more

White & Case LLP

AI’s Expanded Role in the Life Sciences Regulatory Review Process: Key Developments in U.S. and EU

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Overview - - The U.S. Food and Drug Administration (FDA) announced that it aims to increase the agency’s use of artificial intelligence (AI) across its centers to accelerate scientific reviews by June 30, 2025. - The...more

Gardner Law

AI in Healthcare: Navigating Legal, Ethical, and Regulatory Frontiers

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On March 22, 2025, Gardner Law, PLLC proudly co-hosted a thought-provoking continuing legal education (CLE) event with the Mitchell Hamline School of Law Health Law Institute, titled “AI in Healthcare: Adapting to...more

Butler Snow LLP

Junk Science: What Courts are Seeing and How It Affects Us: A Judge’s Eye View

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Trial lawyers, especially defense lawyers in the pharmaceutical and medical device arena, strive to ensure that “junk science” stays out of the courtroom. Unfortunately, that is often wishful thinking. When I spoke with an...more

MoFo Life Sciences

AI Agent as a Service in Medtech: Key Considerations for Commercial Contracts

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Artificial intelligence (AI) is transforming the medical technology (“medtech”) and healthcare industries through the integration of advanced AI agents. Unlike traditional AI systems that perform discrete, predefined tasks,...more

Hutchison PLLC

Building a Business at the Intersection of Neurodata and Innovation With Rob Cooley

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What if the key to understanding and improving brain health lies in a breakthrough approach to neurodata? For Rob Cooley, founder and CEO of Nuream, unlocking the potential of brainwave data has the power to transform...more

McDonnell Boehnen Hulbert & Berghoff LLP

AI News Roundup – Reinforcement learning pioneers win Turing Award, McDonald’s brings AI to the fast-food restaurant, “cheating”...

To help you stay on top of the latest news, our AI practice group has compiled a roundup of the developments we are following....more

Gardner Law

AI Regulation and Legal Trends in the U.S and Abroad

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The Evolving Role of AI/ML in Healthcare - The use of artificial intelligence/machine learning (AI/ML) in healthcare is evolving rapidly and introducing new challenges. Not only are medical devices using AI for diagnostics,...more

Spilman Thomas & Battle, PLLC

Decoded - Technology Law Insights, V 6, Issue 2, February 2025

Welcome to our second issue of 2025 of Decoded - our technology law insights e-newsletter. For those of you with an interest in the Corporate Transparency Act, Brienne Marco and Joe Unger report that the recent injunction...more

McDermott Will & Emery

FDA Reveals AI Development Cheat Sheet in Highly Anticipated Draft Guidances

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Early in the new year, the US Food and Drug Administration (FDA) released two anticipated draft guidance documents focused on artificial intelligence (AI): Artificial Intelligence-Enabled Device Software Functions: Lifecycle...more

Troutman Pepper Locke

2025 SCOPE Conference Emphasizes AI and Better Technologies to Improve Patient Outcomes

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The 2025 SCOPE Conference (Summit for Clinical Ops Executives), held last week in Orlando, FL, brought together more than 4,500 industry leaders, innovators, and experts in the clinical operations field. ...more

Arnall Golden Gregory LLP

Healthcare Authority Newsletter - January 2025 #4

News Briefs - 80 Percent of Health Organizations Hit with Cyberattack - More than 80 percent of healthcare organizations detected a cyberattack on their technology infrastructure within the past year, according to a survey by...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

Hogan Lovells

JPM 2025 recap: Panelists discuss life sciences growth strategies, policy uncertainties, and promising regulatory opportunities

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In the wake of the 2024 U.S. elections, stakeholders in the life sciences and health care industry are intensely focused on the policy implications for global financial markets, investment strategies, and M&A opportunities....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

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

Dickinson Wright

Part 3: Key Takeaways from Claim Examples in the 2024 AI Patent Eligibility Guidance

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This is the third post in a 3-part series. Below, we describe Example 49 which focuses on using AI to assist with a medical treatment....more

Knobbe Martens

FDA Issues Draft Guidance for the Use of Artificial Intelligence (AI) in Medical Devices and Drug Development

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The Food and Drug Administration (FDA) has recently issued two draft guidance documents aimed at providing recommendations for the use of AI in medical devices and drug and biological product development.These guidance...more

BakerHostetler

Healthcare Industry Team 2024 Year in Review

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As we begin a year that will once again be transformative for the industry, we are excited to present our comprehensive 2024 year-in-review, highlighting all that has happened and the trends that will shape 2025. ...more

Skadden, Arps, Slate, Meagher & Flom LLP

Drug Pricing and Health Care Fraud Remain Key Issues

Key Points - - It remains to be seen what priorities Robert F. Kennedy Jr. and Marty Makary might set if confirmed as HHS secretary and FDA commissioner, respectively. - The Trump administration will likely focus on drug...more

Nelson Mullins Riley & Scarborough LLP

Bipartisan House Task Force Report Outlines Key Areas of AI Focus for Health Care

As the New Year begins, questions surrounding how recent election results will impact technology regulation across industries loom large. It’s hardly a bold prediction that artificial intelligence (“AI”) and the regulation...more

DLA Piper

FDA Issues Artificial Intelligence-Enabled Device Software Functions Draft Guidance

DLA Piper on

The US Food and Drug Administration (FDA) recently issued its draft guidance, Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations on January 7, 2025....more

Gardner Law

Breaking the Ice: FDA-focused firm leader sees benefits in AI

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Artificial intelligence already is positively affecting health, according to Mark Gardner, MBA, Esq., Founder and Managing Partner, Gardner Law, which represents clients subject to Food and Drug Administration regulations. ...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

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