Webinar: FDA Oversight of AI and Machine Learning in Medical Devices

Duane Morris will host the third session of its Wearable Webinars Series, Product Liability and IP Strategies for Wearables, on Tuesday, November 4, 2025, 12:00 p.m. to 12:30 p.m. Eastern.

REGISTER

Agatha Liu, Ph.D., will cover how wearables with diagnostic, monitoring or therapeutic claims fall under the FDA’s software as a medical device framework, including predetermined change control plans, good machine learning practices and real-world performance monitoring of adaptive algorithms.

Takeaways from R.I.S.E. AI Conference

This week at the University of Notre Dame’s inaugural R.I.S.E. AI Conference in South Bend, Indiana, partner Alex W. Karasik of the Duane Morris Class Action Defense Group was a panelist at the highly anticipated session, “Challenges and Opportunities for Responsible Adoption of AI.”  The conference, which had over 300 attendees from 16 countries, produced excellent dialogues on how cutting-edge technologies can both solve and create problems, including class action litigation.

Read more at the Duane Morris Class Action Defense Blog.

First Consumer-Facing AI Governance Rules Enacted in U.S.

As an important development in U.S. AI regulation, California enacted its automated decisionmaking technology (ADMT) rules in September 2025. These are the first enacted, broadly scoped, consumer-facing AI governance rules in the country. They offer opt-out rights and logic disclosures for AI-driven significant decisions affecting consumers. The rules took effect on October 1, 2025, with compliance required by January 1, 2027, for covered businesses that use ADMT in significant decisions before that date. Read the full Alert on the Duane Morris website.

Updated Artificial Intelligence Regulations for California Employers

With artificial intelligence developing at breakneck speed, California employment regulations are following right behind. Updated regulations issued by the California Civil Rights Council address the use of artificial intelligence, machine learning, algorithms, statistics and other automated-decision systems (ADS) used to make employment-based decisions. The updated rules, which took effect October 1, 2025, amend existing regulations, Cal. Code Regs., tit. 2, and are designed to protect against potential employment discrimination. The regulations apply to all employers with at least five employees working anywhere and at least one located within California. Read the full Alert on the Duane Morris website.

Artificial Intelligence Errors for Construction Contractors

In a recent Commercial Construction Renovation article, Duane Morris attorneys Robert H. Bell and Michael Ferri write:

Artificial intelligence (“AI”) is rapidly making its way into the construction bidding process. Contractors now use AI-powered estimating software to perform quantity takeoffs and analyze costs with unprecedented speed. According to the drafting and engineering software giant Autodesk, estimating teams are increasingly using AI and automation, particularly for quantity takeoffs, cost forecasting, and speeding up bid creation. Yet as digital tools become routine, legal rules governing bids still rely on traditional principles. This raises a pressing question: if an AI tool makes a costly error in a bid, will the legal system treat that mistake any differently than a human error? Courts are only beginning to grapple with AI-related mishaps, but early indications suggest AI errors will be handled much like any other bidding mistake. In other words, contractors will likely be held responsible for errors made by their AI tools, just as they are responsible for the mistakes of human estimators or means and methods under their control.

“Responsible Use of AI in Healthcare” Guidance

On September 17, 2025, the Joint Commission and Coalition for Health AI issued a joint guidance document entitled “Responsible Use of AI in Healthcare” to help providers implement AI while mitigating the risks of its use. The guidance provides seven elements that constitute responsible AI use in healthcare and discusses how provider organizations can implement them. Read the full Alert on the Duane Morris website.

Northern District of California Allows CIPA Claims Against AI Pizza Ordering Assistant to Proceed

On August 11, 2025, Judge Susan Illston of the Northern District of California denied a motion to dismiss in Taylor v. ConverseNow Technologies, Inc. (Case No. 25-cv-00990-SI), allowing claims under California’s Invasion of Privacy Act (CIPA) Sections 631 and 632 to move forward against an AI voice assistant provider. ConverseNow provides artificial intelligence voice assistant technology that restaurants, including Domino’s, use to answer phone calls, process orders and capture customer information. The plaintiff alleged that when she placed a pizza order by phone, her call was intercepted and routed through ConverseNow’s servers, where her name, address and credit card details were recorded without her knowledge or consent. Read the full Alert on the Duane Morris website.

How Are Courts Approaching Copyrighted Materials and Artificial Intelligence?

Two groundbreaking decisions from the Northern District of California—Kadrey v. Meta Platforms, Inc. and Bartz v. Anthropic PBC—shed light on how courts are approaching the use of copyrighted materials in training large language models (LLMs). Both cases involved authors alleging copyright infringement based on the use of their books to train generative AI models, and both courts held that use of the copyrighted materials to train the AI models was transformative. The court in Anthropic held, however, that copying pirated books constitutes copyright infringement and the transformative nature of the use did not rescue such infringement. Conversely, the Meta court held that copying from pirate sites to train AI is fair use, but only because the plaintiffs failed to submit evidence of market harm, which the court believed to be the most relevant factor. As such, while use of copyrighted works to train AI may be fair use, copying works without permission carries the risk of infringement. Read the full Alert on the Duane Morris website.

The Convergence of Artificial Intelligence & Crypto

This article, authored by Duane Morris partner Agatha Liu, was originally published by the California Lawyers AssociationThis article has been reprinted with permission.

The nation is well positioned to further develop artificial intelligence (AI) and promote its application, while the government renews its interest in cryptocurrency (crypto) as a significant part of digital assets. Both AI application and crypto hold huge potential to advance collective prosperity, yet they are rooted in complex, disruptive technologies that pose significant challenges for policymakers. Traditionally, the two fields have followed separate trajectories, but their convergence is increasingly evident.

Read the full article on the Duane Morris website.

© 2009- Duane Morris LLP. Duane Morris is a registered service mark of Duane Morris LLP.

The opinions expressed on this blog are those of the author and are not to be construed as legal advice.

Proudly powered by WordPress