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Machine Learning Regulatory Requirements Regulatory Oversight

Morgan Lewis - As Prescribed

Key Takeaways from the AI Trends in Medical Devices Panel at the 2025 FDLI Annual Conference

Ariel Seeley served on the panel titled AI Trends in Medical Devices: Global Developments, FDA Policies, and Software as a Medical Device at the 2025 Food and Drug Law Institute (FDLI) Annual Conference. The panel provided an...more

Arnall Golden Gregory LLP

FDA in the “Computer Age” — AI Adoption Accelerates as Staffing Shrinks

Neil Young once sang of adapting to a world ruled by data and digital minds in “Computer Age.” Today, that vision feels increasingly real as the Food and Drug Administration turns to artificial intelligence (“AI”) in the face...more

Morgan Lewis - As Prescribed

FDA’s AI-Assisted Review: The Next Stage of Regulated Product Evaluation

On June 2, 2025, FDA announced the launch of Elsa, a generative AI tool designed to “help employees—from scientific reviewers to investigators—work more efficiently.” Per FDA, the tool “modernizes agency functions and...more

IR Global

Recursive Artificial Intelligence: Can the Law Keep Up?

IR Global on

While Artificial Intelligence (AI) has emerged as groundbreaking and significantly impacting various sectors and enhancing quality of life, the chasm between technological advancements and the law is growing by the...more

Gardner Law

FDA Goes All In on AI: What It Means for Your Submissions

Gardner Law on

The FDA is moving quickly to bring artificial intelligence (AI) into the heart of its regulatory review process. On May 8, 2025, the agency announced the successful completion of its first AI-assisted scientific review—and...more

Alston & Bird

5 Things to Think About When Using AI

Alston & Bird on

What Happened? As the Trump Administration’s deregulatory, pro-innovation approach to emerging technology moves forward, the use of artificial intelligence has taken center stage, and it is clear that the Administration...more

Loeb & Loeb LLP

FDA Unleashes AI to Review Product Applications

Loeb & Loeb LLP on

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

Troutman Pepper Locke

Evolving AI Legislation: Federal Policies, Task Forces, and Proposed Laws — The Good Bot Podcast

Troutman Pepper Locke on

Join Troutman Pepper Locke Partner Brett Mason for a podcast series analyzing the intersection of artificial intelligence (AI), health care, and the law. In this episode of The Good Bot, Brett Mason and Emma Trivax delve...more

Carlton Fields

NAIC Big Data Working Group Continues Building a Regulatory Structure

Carlton Fields on

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

Mayer Brown

US NAIC Spring 2025 National Meeting Highlights: Innovation, Cybersecurity, and Technology (H) Committee

Mayer Brown on

On March 26, 2025, the Innovation, Cybersecurity, and Technology (H) Committee (“H Committee”) met at the Spring 2025 US National Meeting of the National Association of Insurance Commissioners (“NAIC”). The meeting covered...more

A&O Shearman

European Commission draft guidelines on AI system definition under EU AI Act

A&O Shearman on

The European Commission (EC) has published draft guidelines on the definition of an AI system to explain the practical application of the legal concept, as anchored in the EU AI Act. The EC aims to assist providers and other...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

Troutman Pepper Locke on

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

Skadden, Arps, Slate, Meagher & Flom LLP

What Companies Can Do To Protect Against Cyberattacks … and the Litigation That Often Follows

Cyber threats continue to grow as a result of increased digitization, widespread use of cloud computing, advanced connectivity and artificial intelligence (AI), requiring boards of directors across all sectors to focus more...more

Mayer Brown

Biden Administration Issues First-Ever National Security Memorandum on Artificial Intelligence

Mayer Brown on

On October 24, 2024, President Biden issued the first-ever National Security Memorandum (NSM) on artificial intelligence (AI), fulfilling another directive (subsection 4.8) set forth in the Administration’s Executive Order on...more

Cooley LLP

[Webinar] AI Talks: AI + Regulatory - November 13th, 12:00 pm - 1:00 pm EDT

Cooley LLP on

This session of Cooley’s AI Talks will cover ways to navigate the US, European Union, and UK regulatory and legislative risks of AI, including strategies for engaging with policymaking bodies and analyzing the business...more

White & Case LLP

AI Watch: Global regulatory tracker - United Kingdom

White & Case LLP on

The UK prioritizes a flexible framework over comprehensive regulation and emphasizes sector-specific laws. Laws/Regulations directly regulating AI (the “AI Regulations”) The UK government's AI Regulation White Paper of...more

White & Case LLP

AI Watch: Global regulatory tracker - Czech Republic

White & Case LLP on

The successful implementation of the EU AI Act into national law is the primary focus for the Czech Republic, with its National AI Strategy being the main policy document. Laws/Regulations directly regulating AI (the “AI...more

White & Case LLP

AI Watch: Global regulatory tracker - South Korea

White & Case LLP on

South Korea's AI Act to act as a consolidated body of law governing AI once approved by the National Assembly. Laws/Regulations directly regulating AI (the “AI Regulations”) While there are no specific laws, statutory...more

White & Case LLP

AI Watch: Global regulatory tracker - Nigeria

White & Case LLP on

Nigeria's draft National AI Policy underway and will pave the way for a comprehensive national AI strategy. Laws/Regulations directly regulating AI (the “AI Regulations”) There is currently no specific law or...more

White & Case LLP

AI Watch: Global regulatory tracker - Norway

White & Case LLP on

Position paper informs Norwegian approach to AI, with sector-specific legislative amendments to regulate developments in AI. Laws/Regulations directly regulating AI (the “AI Regulations”) Currently, there are no...more

White & Case LLP

AI Watch: Global regulatory tracker - United States

White & Case LLP on

The US relies on existing federal laws and guidelines to regulate AI but aims to introduce AI legislation and a federal regulation authority. Laws/Regulations directly regulating AI (the “AI Regulations”) Currently,...more

White & Case LLP

AI Watch: Global regulatory tracker - Japan

White & Case LLP on

Japan adopts a soft law approach to AI governance but lawmakers advance proposal for a hard law approach to generative AI foundation models. Laws/Regulations directly regulating AI (“AI Regulations”) Japan currently...more

Perkins Coie

Today’s Most Disruptive Technologies Spotlight on Multimodal AI

Perkins Coie on

Welcome back to Today’s Most Disruptive Technologies! We turn from quantum computing to a spotlight on multimodal AI. Artificial intelligence (AI) continues to dominate the news and the markets and while some of us are still...more

Foley & Lardner LLP

Navigating the Regulatory Landscape of AI: Insights from Bret Waters, Natasha Allen, and Louis Lehot

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Share on Twitter Print Share by Email Share Back to top In a recent webinar co-hosted by 4thly and Foley & Lardner LLP, lawyers Natasha Allen and Louis Lehot engaged in a thought-provoking discussion with 4thly’s Bret Waters...more

DarrowEverett LLP

Prove It or Lose It: New York City Cracks Down on AI Hiring Software

DarrowEverett LLP on

Artificial Intelligence (“AI”) programs have gained notoriety by injecting ease into otherwise burdensome and difficult daily tasks. However, as with most innovative advancements, AI has also drawn concern from skeptics...more

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