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Software Risk Management Artificial Intelligence

Holland & Knight LLP

A Regulatory Assessment of AI Performance Guarantees

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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

Robinson+Cole Data Privacy + Security Insider

AppLovin & Its AI: A Lesson in Accuracy

Last week, we explored a recent data breach class action and the litigation risk of such lawsuits. Companies need to be aware of litigation risk not only arising from data breaches, but also from shareholder class actions...more

EDRM - Electronic Discovery Reference Model

New Battle of the Bots: ChatGPT 4.5 Challenges Reigning Champ ChatGPT 4o

Two AI heavyweights step into the ring: ChatGPT 4o, the reigning champion of fluency and speed, and the new challenger, ChatGPT 4.5, boasting an upgraded intellect and sharper wit. But which one is truly the best? To find...more

Robinson+Cole Data Privacy + Security Insider

Privacy Tip #434 – Use of GenAI Tools Escaping Corporate Policies

According to a new LayerX report, most users are logging into GenAI tools through personal accounts that are not supported or tracked by an organization’s single sign on policy. These logins to AI SaaS applications are...more

EDRM - Electronic Discovery Reference Model

Bar Battle of the Bots – Part One

The legal world is watching AI with both excitement and skepticism. Can today’s most advanced reasoning models think like a lawyer? Can they dissect complex fact patterns, apply legal principles, and construct a persuasive...more

U.S. Legal Support

How to Choose the Right Trial Technology Partner

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In 2025, technology holds a well-established place in the legal profession. And even though there are headlines about emerging tech itself being on trial, the pros of Artificial Intelligence (AI), Machine Learning (ML), and...more

Fenwick & West LLP

CLE Takeaways: Strategic Considerations at the Intersection of Games, IP, & AI

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As artificial intelligence transforms gaming, developers and publishers need a clear, strategic approach to incorporating AI into their pipelines. Success requires balancing innovation with thoughtful risk management while...more

Jackson Lewis P.C.

The Importance of Being Erroneous: Are AI Mistakes a Feature, Not a Bug?

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No one intentionally sets out to make a mistake. Yet, it has long been recognized by some of our greatest innovators from Thomas Edison to Albert Einstein to Henry Ford that making mistakes (and learning from them) is the key...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

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

Harris Beach Murtha PLLC

Have a SaaS Contract in Place? You May Need an AI Addendum

Virtually every business has signed an agreement with a software as a service (“SaaS”) provider at one time or another. And now, virtually every SaaS provider (it seems, at least) is coming out with an AI-related feature or...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

Morrison & Foerster LLP - Government...

Biden’s Final Cybersecurity Order Proposes Significant Changes, All to Be Implemented by the Incoming Administration

Citing the threats posed by foreign adversaries and criminal organizations, and seeking enhanced accountability for companies that provide software and cloud services to the federal government, the Biden administration has...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.

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

Sheppard Mullin Richter & Hampton LLP

Governmental Practice Cybersecurity and Data Protection: 2024 Recap & 2025 Forecast Alert

To kick off the New Year (and as is now tradition, since we put out a similar Recap & Forecast last year), Sheppard Mullin’s Governmental Practice Cybersecurity & Data Protection Team has prepared a cybersecurity-focused 2024...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

McDermott+

FDA Issues Final Guidance on Predetermined Change Control Plans for AI-Enabled Devices

McDermott+ on

On December 3, 2024, the US Food and Drug Administration (FDA) published final guidance titled, Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software...more

Lowenstein Sandler LLP

Key Considerations When Adopting Artificial Intelligence as a CFTC-Regulated Firm

Lowenstein Sandler LLP on

On December 5, 2024, the U.S. Commodities Futures Trading Commission (CFTC) staff (Staff) issued a staff advisory (Advisory) on the use of artificial intelligence (AI) by market participants in CFTC-regulated markets.1 Staff...more

Goodwin

Texas AG Reaches First-of-its-Kind Settlement With Healthcare AI Company Over Hallucination Rate Claims

Goodwin on

In a recent settlement, the Texas attorney general resolved allegations that Pieces Technologies, Inc. (Pieces), a healthcare generative AI company, misrepresented the hallucination rate of its generative AI product to...more

Mayer Brown

Applying the Enterprise Risk Mindset to Navigate Cybersecurity Threats - New Risk Mindset Series

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Financial institutions and securities market participants continue to face escalating cyber threats – in frequency, volume, and severity. The many reasons for the escalating risk include: Financial services companies are...more

Goodwin

Four Steps to Maximize AI Innovation in Medtech

Goodwin on

Investment in artificial intelligence (AI) is rising fast. The International Data Corporation projects global spending on AI R&D will reach $632 billion by 2028, more than twice the expected total for 2024....more

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