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Software Gains New Status as a Product Under Strict Liability Law

A recent lawsuit involving an AI chatbot represents another indication of a possible shift in how courts will approach software under traditional strict products liability principles. Traditionally, courts have been hesitant...more

FDA Draft Guidance on Artificial Intelligence-Enabled Device Software Functions

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

FDA Releases Draft Guidance on Evaluating the Risk and Credibility of AI Used in Establishing Drug and Device Safety,...

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

Electric Vehicle Risks: New Focus of Regulators

The use of electric vehicles (EVs) and micromobility devices (EMDs), e.g., electric scooters, electric bikes, and hoverboards, is on the rise and the accompanying potential risks of EVs and EMDs have become a new area of...more

AI Trends For 2024 - AI: Product Or Service? Product Liability In The Age Of AI

Courts are increasingly being asked: is AI a product or a service? AI companies currently operate within an undefined products liability space. As companies continue to innovate with AI, courts must grapple with complicated...more

AI Trends For 2023 - Budgeting For The Future Of AI

In 2020, Congress passed the National Artificial Intelligence Initiative Act (NAIIA) to strengthen Artificial Intelligence (AI) advances and innovations across multiple sectors by providing investments to National AI Research...more

AI Trends For 2023 - AI Diagnostic Tools And Cybersecurity Risk

Cybersecurity is a key risk factor for emerging applications of artificial intelligence to medical devices. Products failing to address security risks may leave themselves vulnerable to cyberattacks. Bad actors target...more

AI Trends For 2023 - FDA Regulatory

In September 2022, the U.S. Food & Drug Administration (FDA) released its Clinical Decision Support (CDS) Software Guidance and the final report on the Software Pre-Certification Pilot Program....more

U.S. DOT Revamps Federal Guidance on Automated Vehicle Development and Rollout

Updating and building on guidance issued one year ago, the U.S. Department of Transportation published a new federal guidance document entitled Preparing for the Future of Transportation: Automated Vehicles 3.0 (“AV 3.0”)....more

Is Your Company Ready For Artificial Intelligence?

“The rise of powerful AI will be either the best or the worst thing ever to happen to humanity. We do not know which.” –Stephen Hawking Artificial Intelligence (AI) and autonomous technology will shape the future, affect...more

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