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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FDA Draft Guidance on Artificial Intelligence-Enabled Device Software Functions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FDA Issues Artificial Intelligence-Enabled Device Software Functions Draft Guidance

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The US Food and Drug Administration (FDA) recently issued its draft guidance, Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations on January 7, 2025....more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

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Last week, the U.S. Food and Drug Administration (FDA) issued two significant draft guidance documents concerning the use of artificial intelligence (AI) in medical devices and in drug and biological product development....more

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

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FDA Issues Draft Guidance on AI-Enabled Medical Devices

The FDA has shared draft guidance on the design and development of AI-enabled medical devices and marketing submissions for those devices.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

Harris Beach Murtha PLLC

Key Considerations for Selling AI Software to the Government

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The federal government is the biggest purchaser in America and that extends to the SaaS space. On September 24, 2024, the Office of Management and Budget (OMB) released Memorandum M-24-18, offering updated guidelines for the...more

Foley & Lardner LLP

NIST’s AI Risk Management Framework Helps Businesses Address AI Risk

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As we previously discussed, earlier this year the National Institute of Standards and Technology (NIST) launched the Trustworthy and Responsible AI Resource Center. Included in the AI Resource Center is NIST’s AI Risk...more

Ankura

5 Best Practices for Third Party Risk Management

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Organizations are becoming increasingly reliant on external parties to manage parts of their business. The centralized knowledge, expertise, and economies of scale that third parties provide enables organizations to focus...more

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