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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

Morrison & Foerster LLP

European Digital Compliance: Key Digital Regulation & Compliance Developments - February 2025

To help organizations stay on top of the main developments in European digital compliance, Morrison Foerster’s European Digital Regulatory Compliance team reports on some of the main topical digital regulatory and compliance...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FDA Issues Draft Guidance for the Use of Artificial Intelligence (AI) in Medical Devices and Drug Development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The Food and Drug Administration (FDA) has recently issued two draft guidance documents aimed at providing recommendations for the use of AI in medical devices and drug and biological product development.These guidance...more

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FDA Draft Guidance on Artificial Intelligence-Enabled Device Software Functions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FDA Issues Artificial Intelligence-Enabled Device Software Functions Draft Guidance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The US Food and Drug Administration (FDA) recently issued its draft guidance, Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations on January 7, 2025....more

Foley & Lardner LLP

BIS Finalizes Rule Prohibiting Connected Vehicle Imports Linked to China and Russia: Key Compliance Requirements Announced

Foley & Lardner LLP on

The U.S. Department of Commerce’s Bureau of Industry and Security (BIS) has promulgated a Final Rule prohibiting the import and sale of connected vehicles and related components linked to the People’s Republic of China (PRC)...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FDA Issues Draft Guidance on AI-Enabled Medical Devices

The FDA has shared draft guidance on the design and development of AI-enabled medical devices and marketing submissions for those devices.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

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

HaystackID

Rising HSR Transactions Highlight M&A Recovery and Emerging Challenges

HaystackID on

The intersection of economic indicators and Hart-Scott-Rodino (HSR) transaction trends provides a detailed view of the evolving mergers and acquisitions (M&A) environment. These insights are essential for professionals...more

Skadden, Arps, Slate, Meagher & Flom LLP

Privacy & Cybersecurity Update - December 2019

In this month's edition of our Privacy & Cybersecurity Update, we take a look at guidance on artificial intelligence released by the U.K. Information Commissioner's Office and the Turing Institute, as well as guidance...more

Mitratech Holdings, Inc

For the CCPA, New AG Regulations Are a “How-To” Manual

Yes, the California Consumer Privacy Act is really happening. As the clock ticks down toward the January 1, 2020 effective dateof the California Consumer Privacy Act, many businesses are coming to grips with the fact that the...more

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