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Transparency Healthcare Risk Management

Gardner Law

Why Compliance Audits Are Non-Negotiable

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In today’s heightened enforcement environment, compliance auditing isn’t just a best practice—it’s a necessity. Federal and state laws and industry guidance, including the Office of Inspector General (OIG) Compliance Program...more

Ropes & Gray LLP

The Biden Administration’s Swan Song on Digital Health: Two FDA Guidances on Artificial Intelligence and FDA’s Defense of its...

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In the waning days of the Biden administration, the FDA released a flood of new guidance documents and other agency actions, including several important items related to digital health. On January 7, FDA published two new...more

Knobbe Martens

FDA Issues Draft Guidance for the Use of Artificial Intelligence (AI) in Medical Devices and Drug Development

Knobbe Martens on

The Food and Drug Administration (FDA) has recently issued two draft guidance documents aimed at providing recommendations for the use of AI in medical devices and drug and biological product development.These guidance...more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FDA Issues Artificial Intelligence-Enabled Device Software Functions Draft Guidance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The US Food and Drug Administration (FDA) recently issued its draft guidance, Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations on January 7, 2025....more

Foley & Lardner LLP

The Intersection of Agentic AI and Emerging Legal Frameworks

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The evolution of artificial intelligence (AI) has introduced systems capable of making autonomous decisions, known as agentic AI. While generative AI essentially “creates” – providing content such as text, images, etc. –...more

A&O Shearman

Zooming in on AI - #9: Understanding California's New AI Legislation

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California Governor Gavin Newsom recently passed several AI-related bills, which address the application of AI across several industries and clarify key definitions regarding AI. Below, we provide an overview addressing some...more

Foley & Lardner LLP

Decoding California’s Recent Flurry of AI Laws

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California Governor Gavin Newsom recently faced a wave of AI-related legislation, with 38 bills reaching his desk. Despite rejecting the much-debated SB-1047, Governor Newsom signed more than a dozen other AI-focused bills...more

Foley & Lardner LLP

Leveraging Risk Management Frameworks for AI Solutions in Health Care

Foley & Lardner LLP on

As recently described by The New England Journal of Medicine, the liability risks associated with using artificial intelligence (AI) in a health care setting are substantial and have caused consternation among sector...more

Gardner Law

Transatlantic Legal-Regulatory Update: Live from the Heart of Silicon Valley

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US and EU Life Sciences Law firms Fieldfisher & Gardner Law recently held a CLE event in Silicon Valley covering Healthcare Compliance, Data Privacy and Regulatory hot topics for MedTech and Pharma companies. Discussion...more

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