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 How are international standards bodies and the U.S. Food and Drug Administration draft guidance on cybersecurity affecting the global manufacture of medical devices?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.