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Software Artificial Intelligence Manufacturers

Orrick, Herrington & Sutcliffe LLP

New EU Directive Modernizes Defective Product Liability to Address New Technologies

The EU Commission has adopted Directive (EU) 2024/2853, which implements a comprehensive overhaul of the 1985 Directive 85/374/EEC on defective product liability (“New PLD”). The new framework, which complements Regulation...more

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

Goodwin

EU Updates its Product Liability Regime: Important Considerations for Providers of AI Systems and Software

Goodwin on

The European Union has significantly overhauled its product liability regime with a new directive concerning liability for defective products (Product Liability Directive). EU member states have until December 9, 2026, to...more

Fenwick & West LLP

The EU Updates its Products Liability Directive to Include AI

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On Dec. 8, the European Union (EU) updated its Product Liability Directive (PLD) to, inter alia, specifically address AI software. This directive must next be “transposed,” or written into law by each of the 27 member states....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

Proskauer Rose LLP

EU's AI Act: Ten Facts for Organisations in the UK and US

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The EU’s AI Act (the “Act”) is the world’s first comprehensive AI law. The Act manages risks posed by certain AI systems and prohibits certain AI-related practices. UK and US organisations should not assume that the Act does...more

HaystackID

[Webcast Transcript] Best Practices for Selecting, Staffing, and Supporting Complex and High-Velocity Legal Document Reviews

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Editor’s Note: In this insightful webcast hosted by HaystackID on April 19, 2023, our expert panel delved into the best practices for selecting, staffing, and supporting complex and high-velocity legal document reviews. The...more

Goodwin

FDA Issues Draft Guidance for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions

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The US Food and Drug Administration (FDA or the Agency) recently issued its draft guidance titled “Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning...more

Knobbe Martens

AI & the FDA

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The use of artificial intelligence (AI) in healthcare has been growing rapidly in recent years, and AI-enabled medical devices are playing a larger role in patient care. Such devices may use machine learning algorithms to...more

Gardner Law

The Evolving FDA Regulatory Landscape of Artificial Intelligence

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As artificial intelligence technology evolves on a seemingly minute-by-minute basis, the U.S. FDA’s regulatory approach continues to evolve in an effort to keep pace. “The promise of artificial intelligence in medicine is...more

Dorsey & Whitney LLP

Biden Administration Restricts U.S. Exports of Advanced Computing and Semiconductor Manufacturing Equipment, Software, and...

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On October 7, 2022, the Biden Administration announced new restrictions on exports to China of advanced integrated circuits (“ICs”), computers and components containing advanced ICs, semiconductor manufacturing equipment, and...more

Robins Kaplan LLP

Financial Daily Dose 12.02.2019 | Top Story: US Restores Metal Tariffs on Argentina and Brazil

Robins Kaplan LLP on

The White House will again slap tariffs on steel and aluminum imports from Argentina and Brazil in an apparent reaction to “massive devaluation” of  currencies in both South American nations....more

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