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Manufacturers Cybersecurity Machine Learning

Foley & Lardner LLP

Cybersecurity in the Age of Industry 4.0 - Part 1

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As the manufacturing sector continues to embrace the hyper-connected era of Smart Manufacturing, known as Industry 4.0, more and more organizations are integrating advanced automation, artificial intelligence (AI), the...more

Pillsbury Winthrop Shaw Pittman LLP

The EU’s AI Act: A Review of the World’s First Comprehensive Law on Artificial Intelligence and What This Means for EU and Non-EU...

The agreed text of the AI Act was published on July 12, 2024, essentially starting the clock on the legal deadlines contained in it. Its obligations will apply in tiered phases, with the first key obligations being enforced...more

Troutman Pepper

New FDA Guidance on AI and Medical Products

Troutman Pepper on

n March 15, the U.S. Food and Drug Administration (FDA) published a paper titled “Artificial Intelligence and Medical Products: How CBER, CDER, CDRH, and OCP are Working Together.” This paper describes the FDA’s strategy for...more

K&L Gates LLP

Brussels Regulatory Brief: March 2024

K&L Gates LLP on

Antitrust and Competition - The European Commission Fines Apple EUR 1.8 billion for Abusing Its Dominant Position in the Music Streaming Sector - On 4 March 2024, the European Commission (Commission) fined Apple EUR 1.8...more

Dorsey & Whitney LLP

AI regulation introduced in Europe - setting the way forward for the rest of the world or slowing down the adoption of new tech?

Dorsey & Whitney LLP on

The EU AI Act, which was passed by the European Parliament on 13 March and is set to become law later this year, will probably be the world’s first legislation to introduce a general regulatory framework for artificial...more

Skadden, Arps, Slate, Meagher & Flom LLP

The Informed Board - Winter 2024

The oversight obligations of boards continue to expand. Recent enforcement actions and new laws in areas such as cybersecurity, artificial intelligence and supply chains create new challenges for boards, as we explain in this...more

Foley & Lardner LLP

Top Legal Issues Facing the Manufacturing Sector in 2023

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Agility and resiliency remain essential attributes for manufacturers in 2023. Manufacturers are no longer focused on figuring out when things will return to “normal.” Instead, they are applying lessons learned from the...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

Nutter McClennen & Fish LLP

Code Red: The FDA’s Artificial Intelligence/Machine Learning Action Plan Poses Potential Risks for Medical Device Makers

Q: The FDA’s stance on a regulatory framework for artificial intelligence and machine learning (AI/ML) software as a medical device is continuously evolving. Could you explain the history? A: Artificial intelligence (AI) is...more

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