“AI-Enabled Tech Faces Dual Hurdles in FDA Regulation, Patent Law”
October 22, 2025In a Bloomberg Law article, Marshall Gerstein Partner and Electrical & Computer Technologies Practice Chair Matt Carey evaluates the challenges that innovators in the healthcare space face when protecting their AI-enabled technologies. While the FDA is modernizing its regulatory framework to ensure patient safety, a significant obstacle arises from the U.S. patent law’s perspective on inventorship and subject matter eligibility.
“Attorneys should understand the intersection of these hurdles, the reasons behind FDA oversight and patent law, the effect of last year’s FDA guidance, and how intellectual property barriers influence protection of AI-enabled technologies,” Matt writes in Bloomberg Law. “There also are ways that innovators can overcome these challenges.”
Read the complete column in Bloomberg Law here.