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Software Artificial Intelligence Regulatory Requirements

Hogan Lovells

AI Health Law & Policy: Complying with FDA GMP rules for AI-enabled diagnostic devices

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The U.S. Food and Drug Administration (FDA) recently issued a Warning Letter citing a failure to obtain marketing authorization via a premarket approval (PMA) or 510(k) clearance as well as Good Manufacturing Practice (GMP)...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

Holland & Knight LLP

A Regulatory Assessment of AI Performance Guarantees

Holland & Knight LLP on

With the warranty industry evolving in the U.S., companies seeking to modernize conventional warranties by leveraging advanced technologies such as artificial intelligence (AI) are faced with unique regulatory questions and...more

DLA Piper

How Many Neurons Must a System Compute Before You Can Call It AI? Unpicking the Guidelines on the AI Act’s Definition of...

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Bob Dylan famously asked, “How many roads must a man walk down, before you can call him a man?”. The power of the question is that there is no answer – and comparing the tribulations of one person’s journey through life to...more

MoFo Life Sciences

FDA Draft Guidance on Artificial Intelligence-Enabled Device Software Functions

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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

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FDA Issues Artificial Intelligence-Enabled Device Software Functions Draft Guidance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The US Food and Drug Administration (FDA) recently issued its draft guidance, Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations on January 7, 2025....more

Venable LLP

AI On the Prize: Decoding FDA's Latest Guidance

Venable LLP on

Last week, the U.S. Food and Drug Administration (FDA) issued two significant draft guidance documents concerning the use of artificial intelligence (AI) in medical devices and in drug and biological product development....more

Hogan Lovells

New guidance on AI-enabled device software functions clarifies information FDA expects in marketing applications

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On January 7, 2024, the U.S. Food and Drug Administration (FDA) published the draft guidance “Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations,” which...more

Pillsbury - Internet & Social Media Law Blog

The Importance of Opting In: Pitfalls of AI Enablement Without Client Buy-In

Imagine you’re an associate at a consulting firm. You’re surprised to see a new “AI Assist” button appear in your email application one morning. Without any training or guidance from your firm’s IT department, you decide to...more

Fox Rothschild LLP

Investments in Chinese Technology Companies Limited by New US Outbound Investment Rule

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U.S. investors interested in investing in advanced Chinese technology companies may now be constrained by the U.S. Government’s first-ever outbound investment rule (Final Rule) which took effect on Jan. 2, 2025. The Final...more

King & Spalding

FDA Releases Draft Guidance on Submission Recommendations for AI-Enabled Device Software Functions

King & Spalding on

On January 7, 2025, FDA published a draft guidance titled “Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations.” The draft guidance was long-anticipated; it...more

Foley & Lardner LLP

Foley Automotive Update - January 2025.

Foley & Lardner LLP on

Foley & Lardner announced the 2024 installment of its Auto Trends series—A Year in Review: Updates, Trends and the Road Ahead. This series delves deep into the transformative forces shaping the automotive world by providing...more

Orrick, Herrington & Sutcliffe LLP

FDA Issues Draft Guidance on AI-Enabled Medical Devices

The FDA has shared draft guidance on the design and development of AI-enabled medical devices and marketing submissions for those devices. The Importance of Engaging Early Sponsors of AI-enabled devices should engage with the...more

Husch Blackwell LLP

State AI Update: December 30, 2024

Husch Blackwell LLP on

Welcome to the second edition of Byte Back AI, a weekly newsletter providing updates on proposed state AI bills and regulations, an AI bill tracker chart, summaries of important AI hearings, and special features....more

Spilman Thomas & Battle, PLLC

Decoded - Technology Law Insights, V 5, Issue 10, December 2024

Happy Holidays and welcome to our year-end issue of Decoded. We hope you enjoyed reading our technology law insights e-newsletter this year. We are already planning for 2025. ...more

Jones Day

Radical Changes to Europe's Product Liability Rules Adopted

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Dramatic changes to EU product liability rules are expected to drive an increase in litigation....more

DLA Piper

Navigating AI Liability Risks

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Our webinar explored liability that can be incurred from the creation use or deployment of AI systems and raised some important questions around the current and future regulatory landscape applicable to AI and liability. We...more

Alston & Bird

What to Tell Your C-Suite About the EU AI Act

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Our Privacy, Cyber & Data Strategy Team highlights 11 common questions your company’s senior executives may have about the European Union’s Artificial Intelligence Act and how you can answer them....more

Reveal

AI in eDiscovery: Highlights from the ACEDS Benelux Chapter Event

Reveal on

On May 30, 2024, the Benelux Chapter of the Association of Certified eDiscovery Specialists (ACEDS) hosted a highly anticipated event in collaboration with Reveal and Houthoff in Amsterdam. This exclusive gathering brought...more

White & Case LLP

Newly passed Colorado AI Act will impose obligations on developers and deployers of high-risk AI systems

White & Case LLP on

The Colorado Artificial Intelligence Act will impose mounting obligations on developers and deployers of high-risk AI systems in an effort to protect consumers from discriminatory consequential decisions by such systems....more

Epstein Becker & Green

FDA Oversight of AI Software Developed by Health Care Providers

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Introduction - Hardly a day goes by when we don’t see some media report of health care providers experimenting with machine learning, and more recently with generative AI, in the context of patient care. The allure is...more

DarrowEverett LLP

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

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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

Jones Day

Generative Artificial Intelligence and the Requirements of Open Source Software Licenses

Jones Day on

Recently filed litigation against Microsoft Corporation, GitHub, Inc., and various OpenAI entities ("Defendants") highlights new challenges that generative artificial intelligence ("AI") presents and risks associated with...more

Mayer Brown

Contracting for AI in the Evolving Regulatory Landscape

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Across industries, companies are actively pursuing and seeking to scale existing implementation of artificial intelligence (AI) solutions to increase revenue, cut costs, develop new product offerings and retain or gain a...more

Morgan Lewis - Tech & Sourcing

Important Considerations When Tech Service Providers and Life Science Companies Collaborate in the Digital Health Space

When negotiating a digital health collaboration agreement between a tech company and a life sciences company, whether for the development of artificial intelligence or other software, the provision of data hosting and...more

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