Kevin Fu is Associate Professor of EECS at the University of Michigan where he directs the Security and Privacy Research Group (SPQR.eecs.umich.edu). During 2021, Fu is also Acting Director of Medical Device Cybersecurity at FDA’s Center for Devices and Radiological Health (CDRH) and Program Director for Cybersecurity, Digital Health Center of Excellence (DHCoE). He is most known for the original 2008 cybersecurity research paper (opens new window) showing vulnerabilities in an implantable cardiac defibrillator by sending specially crafted radio waves to induce uncontrolled ventricular fibrillation via an unintended wireless control channel. 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.
Today, it would be difficult to find medical device technology that does not critically depend on computer software. Network connectivity and wireless communication has transformed the delivery of patient care. The technology often enables patients to lead more normal and healthy lives. However, medical devices that rely on software (e.g., drug infusion pumps, linear accelerators, pacemakers) also inherit the pesky cybersecurity risks endemic to computing. What’s special about medical devices and cybersecurity? What’s hype and what’s real? What can history teach us? How are international standards bodies and regulatory cybersecurity requirements changing the global manufacture of medical devices? This talk will provide a glimpse into the risks, benefits, and regulatory issues for medical device cybersecurity and innovation of trustworthy medical device software.