AIMI Legal Office Hours: Virtual Launch & Talk by Zach Harned on "FDA, AI/ML and Medical Devices"
Event Details:
Location
AIMI Legal AI Office Hours is a new program supported by Fenwick & West for the Stanford AIMI community; the virtual launch event is open to all.
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.