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Software Regulatory Requirements Risk Management

Sheppard Mullin Richter & Hampton LLP

FedRAMP 20x – Major Overhaul Announced to Streamline the Security Authorization Process for Government Cloud Offerings

On March 24, 2025, the Federal Risk and Authorization Management Program (“FedRAMP”) announced a major overhaul of the program, which is being called “FedRAMP 20x.” The FedRAMP 20x announcement stated there are no immediate...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

Warner Norcross + Judd

Lessons from CES 2025: The Legal Side of Product Innovation — What Every Manufacturer and Supplier Needs to Know

Warner Norcross + Judd on

The 2025 Consumer Electronics Show (CES) — one of the world’s most influential tech events — once again showcased groundbreaking innovations that are shaping the future of technology. I was among the over 141,000 attendees of...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...

DLA Piper on

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

Vinson & Elkins LLP

From Cloud to Compliance: Legal Essentials for Building and Operating AI-Ready Data Centers

Vinson & Elkins LLP on

Driven by the demand for AI-ready cloud infrastructure, the market cap for global data center construction, currently valued at more than $250 billion, is set to double in less than ten years, reaching half a trillion dollars...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FDA Draft Guidance on Artificial Intelligence-Enabled Device Software Functions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FDA Issues Artificial Intelligence-Enabled Device Software Functions Draft Guidance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

Hogan Lovells on

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

Foley & Lardner LLP

Foley Automotive Update - January 2025.

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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

DLA Piper

EU: Cyber Resilience Act published in EU Official Journal

DLA Piper on

On 20 November 2024, the EU Cyber Resilience Act (CRA) was published in the Official Journal of the EU, kicking off the phased implementation of the CRA obligations....more

Ankura

Navigating Privacy Compliance Challenges for Startup Success

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Startups face unique challenges that can impact their success and sustainability. Obstacles such as financial constraints (inadequate funding or limited cash flow) and resource constraints often result in small teams having...more

Mayer Brown

Contracting for AI in the Evolving Regulatory Landscape

Mayer Brown on

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

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