Kevin Fu, PhD
FDA, Silver Spring, Maryland

Kevin Fu is Acting Director of Medical Device Cybersecurity at U.S. FDA’s Center for Devices and Radiological Health (CDRH) and Program Director for Cybersecurity, Digital Health Center of Excellence (DHCoE). Fu is also Associate Professor of EECS at the University of Michigan where he directs the Security and Privacy Research Group (SPQR.eecs.umich.edu). He is most known for the original 2008 cybersecurity research paper showing vulnerabilities in an implantable cardiac defibrillator by sending specially crafted radio waves to induce uncontrolled ventricular fibrillation via an unintended wireless control channel. https://www.secure-medicine.org/hubfs/public/publications/icd-study.pdf The prescient research led to over a decade of revolutionary improvements at medical device manufacturers, global regulators, and international healthcare safety standards bodies just as ransomware and other malicious software began to disrupt clinical workflow at hospitals worldwide.

Kevin was recognized as an IEEE Fellow, Sloan Research Fellow, MIT Technology Review TR35 Innovator of the Year, Fed100 Award recipient, and recipient of an IEEE Security and Privacy Test of Time Award. Fu has testified in the U.S. House and Senate on matters of information security and has written commissioned work on trustworthy medical device software for the U.S. National Academy of Medicine. He co-chaired the AAMI cybersecurity working group to create the first FDA-recognized standards to improve the security of medical device manufacturing. He founded the Archimedes Center for Healthcare and Device Security (secure-medicine.org). He is a founding member of the N95decon.org team for emergency reuse decontamination of N95 masks during PPE shortages. Fu served as a member of the U.S. NIST Information Security and Privacy Advisory Board and federal science advisory groups. Eleven years ago, Fu served as a visiting scientist at the U.S. Food & Drug Administration. Fu received his B.S., M.Eng., and Ph.D. from MIT. He earned a certificate of artisanal bread making from the French Culinary Institute and is an intermediate level salsa dancer.