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Machine Learning Regulatory Requirements

King & Spalding

FDA Announces Completion of AI-Assisted Scientific Review Pilot and Deployment of Agency-Wide AI-Assisted Review

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On May 8, 2025, the Food and Drug Administration (FDA) announced the completion of its generative artificial intelligence (AI) pilot program for scientific reviewers. FDA Commissioner Marty Makary was quoted in the...more

Hogan Lovells

FDA advances AI-powered review of medical product applications

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If the initiative proceeds as planned, it will mark a pivotal shift in the regulatory landscape, introducing both efficiencies and novel questions related to the reliability and validity of the AI reviews, as well as...more

McDermott Will & Emery

European Health & Life Sciences Symposium 2025 - Investment Opportunities in TechBio and Pharma Services

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In April 2025, McDermott once again hosted its 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

Wilson Sonsini Goodrich & Rosati

All Eyes on AI: Regulatory, Litigation, and Transactional Developments – Q1 2025

The firm is pleased to distribute the Q1 2025 edition of All Eyes on AI: Regulatory, Litigation, and Transactional Developments, which closely follows the evolving regulatory landscape for artificial intelligence (AI) in the...more

Pillsbury - Global Sourcing Practice

Legal Definitions of AI: Considerations and Common Threads

By now, we all know what AI is. Some of us use ChatGPT as our search engine, confidant, secretary, travel agent, and much more. Others, at least, are acutely aware that AI exists, because everyone else is talking about it,...more

BCLP

HK Releases Guideline Concerning Generative AI

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On 15 April 2025, the Hong Kong Government’s Digital Policy Office published the Hong Kong Generative Artificial Intelligence Technical and Application Guideline (“Guideline”), which aims to provide operational guidance for...more

Holtzman Vogel Baran Torchinsky & Josefiak

Early Returns Podcast - Oliver Roberts: AI and the Law, and an Education

Jan Baran speaks with Artificial Intelligence (AI) legal expert. lawyer and teacher, Oliver Roberts, to speak about AI, its birth, its forms, and how people have historically used and are currently using the ever-changing...more

Farella Braun + Martel LLP

Copyright Office Weighs in on Use of Copryighted Works for LLM Training

A day before the firing of the head of the U.S. Copyright Office, the third installment of the office's series of reports on copyright issues and AI was released. The 113-page document covers a lot of ground, not the least of...more

DLA Piper

Becoming the World’s Leading AI Continent: The Commission’s “AI Continent Action Plan”

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The European Commission has shortly published its “AI Continent Action Plan” and, doing so, set itself no less a task than winning the global race for AI leadership and making Europe the leading AI continent. This shall be...more

BakerHostetler

AI Audit Best Practices for Building User and Global Trust

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Artificial intelligence (AI) as a field encapsulates machine learning, deep learning and generative AI. As the impact of these technologies continues to grow, industry leaders and regulators have been grappling with how to...more

DLA Piper

For Your AIs Only: Agentic AI Steps Out of the Shadows

DLA Piper on

Agentic AI can independently act and adapt to changing environments without relying on existing data patterns like GenAI. Agentic AI promises more goal-oriented autonomous systems, ideal for matters involving complex...more

McDermott Will & Emery

Quit Monkeying Around: FDA Offers Faster Approval Times in Bid to Phase Out Animal Testing

On April 10, 2025, the US Food and Drug Administration (FDA) announced its intent to phase out the use of animal testing in the development of certain drugs and biologics. To help bring this “paradigm shift in drug...more

Hogan Lovells

FDA animal testing phaseout urges AI-based trial alternatives, organoids, other “NAMs”

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The U.S. Food and Drug Administration (FDA) recently announced it plans to phase out animal testing in the development of monoclonal antibody therapies and other drugs and biological products “with more effective,...more

Jones Day

OMB Directs Agencies to Accelerate AI Adoption and Devise Governance Strategy

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The Office of Management and Budget releases highly anticipated guidance to federal agencies on the use and deployment of artificial intelligence and how to manage its risks....more

MoFo Life Sciences

Patent-Eligibility Considerations & Prosecution Strategies for AI-Based Life Sciences Patent Applications

MoFo Life Sciences on

This post is part of MoFo’s 2025 Intersection of AI and Life Sciences blog series. In this blog series, we explore how artificial intelligence is revolutionizing research, innovation, and patient care in the life sciences....more

Ropes & Gray LLP

Adversarial Machine Learning in Focus: Novel Risks, Straightforward Legal Approaches

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The Artificial Intelligence and Machine Learning (“AI/ML”) risk environment is in flux. One reason is that regulators are shifting from AI safety to AI innovation approaches, as a recent DataPhiles post examined. Another is...more

Skadden, Arps, Slate, Meagher & Flom LLP

Key Themes From the 2025 IAPP Global Privacy Summit

On April 23 and 24, 2025, regulators, industry leaders and data privacy leaders from across the globe convened in Washington, D.C. for the 2025 International Association of Privacy Professionals (IAPP) Global Privacy Summit....more

Carlton Fields

States Build the Next Mile of Artificial Intelligence Regulation

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Since the start of 2025, the following states have added to the roadwork on artificial intelligence regulation in insurance by implementing the NAIC’s model bulletin on the use of AI systems by insurers...more

Carlton Fields

NAIC Big Data Working Group Continues Building a Regulatory Structure

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During the NAIC Spring National Meeting, the Big Data and Artificial Intelligence (H) Working Group reviewed its blueprint to build an overarching regulatory edifice to oversee insurers’ use of artificial intelligence...more

Thomas Fox - Compliance Evangelist

Compliance Tip Of the Day: Using AI to Transform Whistleblower Response

Welcome to “Compliance Tip of the Day,” the podcast where we bring you daily insights and practical advice on navigating the ever-evolving landscape of compliance and regulatory requirements. Whether you’re a seasoned...more

Orrick, Herrington & Sutcliffe LLP

EU Commission Clarifies Definition of AI Systems

The European Commission published guidelines that clarify the definition of AI systems under the AI Act, analyzing each component of the definition of AI system, providing examples and specifying which systems should be...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

Mitchell, Williams, Selig, Gates & Woodyard,...

Artificial Intelligence/Generative AI's Environmental and Human Effects: April 22nd U.S. GAO Report

The United States Government Accountability Office (“GAO”) released on April 22nd a report titled: Artificial Intelligence: Generative AI's Environmental and Human Effects (“Report”). See GAO-25-107172....more

K2 Integrity

A Collaborative Approach to Customer Risk Assessment

K2 Integrity on

Unlock a New Era of Customer Risk Assessment - Legacy customer risk rating (CRR) models—built on static KYC data and subjective judgment—are no longer sufficient in a world of dynamic threats and tightening regulatory...more

Ropes & Gray LLP

Regulatory Landscape for AI-enabled MedTech in APAC

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Regulation of artificial intelligence (AI) in Asia Pacific remains nascent, mostly governed by existing regulatory frameworks designed for other technologies and products. It’s a work in progress. AI techniques – machine...more

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