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Keynote: Kevin Fu

The Cutting Edge of Medical Device Security and Privacy

Today it would be difficult to find a medical device that does not critically rely on computer software in its function, manufacture, or use in clinical decision making. Despite the lessons learned by the radiation accidents of the Therac-25 twenty years ago, medical devices that rely on software (e.g., drug infusion pumps, linear accelerators for radiation) continue to injure or kill patients in preventable ways. Why is it so hard to create trustworthy software for medical devices? Devices are not isolated devices. They are systems of systems. And software plays a significant role for control of these critical systems that can significantly affect patient safety, either positively or negatively, depending on its trustworthiness. Failure to meaningfully specify requirements, complacency, and lack of care for human factors further erode trustworthiness. The lack of trustworthy medical device software leads to shortfalls in properties such as safety, effectiveness, dependability, reliability, security, and privacy. Good systems engineering and the adoption of modern software engineering techniques can address many of the risks of medical device software---leading to devices that help patients lead more normal, healthy lives.