Zach Harned - FDA, AI/ML, and Medical Devices

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.

[@kevinkawchak]

Great discussion.

[@theamazingmarlbito6293]

Does anyone have the slides?

[@jeffnorris5735]

Agreed -- I would love to have the hyperlinks.