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.
By Alex. W. Karasik, Brian L. Johnsrud, and George J. Schaller
Duane Morris Takeaways: On October 13, 2025, California Governor Gavin Newsom, issued a written statement declining to sign Senate Bill 7 – called the “No Robo Bosses” Act (the “Act”). While the Act aimed to restrict when and how employers could use automated decision-making systems and artificial intelligence, Governor Newsom rejected the proposed legislation in terms of the Act’s broad drafting and unfocused notification requirements. Governor Newsom’s statement reflects an initial rebuttal to a wave of pending AI regulations as states wrestle with suitable AI guidance. Given the pro-employee tendencies of Governor Newsom and California regulators generally, this outcome is a mild surprise. Employers nonetheless should expect continued scrutiny of AI regulations before enactment.
This legislative activity surely sets the stage for what many believe is the next wave of class action litigation.
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.
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.
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.