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FDA’s Plan for AI/Ml-Based Software As Medical Devices: Progress and Concerns

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U.S. Food and Drug Administration (FDA) has acknowledged the prevalence of Artificial Intelligence/Machine Learning (AI/ML)-Based Software as Medical Devices (SaMDs) and has been taking steps towards advancing its regulatory oversight.

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FDA’s Plan for AI/Ml-Based Software As Medical Devices: Progress and Concerns

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A former lead engineer at the NASA Jet Propulsion Laboratory, Dr. Nguyen focuses her practice on domestic and international patent prosecution. She is a founder and co-leader of the firm’s Life Sciences Data Analytics patent group. She applies her experience also from her doctoral studies and her work as a former research scholar to provide portfolio management and counseling, IP due diligence, and freedom-to-operate analyses. Dr. Nguyen also has experience drafting briefs and inter partes reviews (IPRs), analyzing prior art and patent infringement, working with experts, and handling disputes before the U.S. International Trade Commission (ITC) and the federal courts. Her clients include large domestic and international companies, early-stage startups, and universities.Dr. Nguyen’s knowledge spans a wide range of technology areas, including electronic devices, medical devices and health systems, semiconductor materials and fabrication, computer/device hardware, memory, optoelectronics, optics, nanotechnology, microelectromechanical systems (MEMs), electronic packaging, augmented/virtual reality systems, autonomous vehicles, smart glass, mechanical assemblies, and consumer products. Her experience also encompasses telecommunications and networks, integrated circuits and digital designs, quantum computing, computer software, and digital cameras.Prior to joining Morrison & Foerster, Dr. Nguyen was a lead engineer at the NASA Jet Propulsion Laboratory and a hardware engineer at Hewlett-Packard. She also worked as a research scholar at the Center for Quantum Devices, Georgia Tech Computer Aid Design Lab, and Berkeley Wireless Research Center, where her research involved collaborating with several companies and laboratories such as Raytheon, Cree, IBM, Intel, BAE Systems, Lockheed Martin, Sandia National Labs, U.S. Army Night Vision Labs, Naval Research Lab, Aerospace Corporation, Argonne National Lab, Lawrence Livermore National Lab, Los Alamos National Lab, L3 Communications, Boeing, General Electric, FLIR, Teledyne, and Rockwell Automation.Dr. Nguyen received her J.D. from Loyola Law School. She also received her Ph.D. in electrical engineering from Northwestern University, where she focused her studies on semiconductor materials and optoelectronic devices. She received her M.S. in computer science from the Georgia Institute of Technology, where she focused her studies on computer-aided design and quantum computing. Jean also received her B.S. degree in computer engineering from the University of Wisconsin at Madison with emphasis on integrated circuits and digital designs. She has authored over 40 technical publications, 50 conference proceedings, and three book chapters. She also holds three patents.Dr. Nguyen has served on several committees with the Los Angeles Intellectual Property Law Association (LAIPLA). She is registered to practice in California and before the United States Patent and Trademark Office.