Recorded on March 31, 2022 by the Stanford Center for Artificial Intelligence in Medicine and Imaging for our AI Legal Office Hours launch. Through the generous support of Fenwick & West LLP, the AIMI Center provides the Stanford AI community complimentary legal consultations with a qualified corporate or intellectual property attorney. Learn more at aimi.stanford.edu/resources/o...
Abstract:
This talk will survey FDA's public positions on and involvement with AI/ML as it relates to medical device regulation, including software as a medical device (SaMD). We will discuss the eight major efforts/programs FDA has undergone regarding AI/ML medical device regulation, starting with the AI Discussion Paper released in April of 2019.
Speaker:
Zach Harnad, JD, MS, MA, is an attorney at Fenwick & West LLP, where he advises on a broad variety of intellectual property matters, with a focus on technology transactions and commercial matters, for clients in the technology, artificial intelligence (AI) / machine learning (ML), digital health, and life sciences industries. He also counsels clients on technology, IP, contracts, and open source aspects of venture financings and mergers and acquisitions. Zach is a graduate of Stanford Law and is an AIMI Associate Fellow.