Safety Analysis of Body Sensor Networks

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This project is a collaboration under the NSF-FDA Scholar-In-Residence (SIR) program. Wireless body sensor networks (BSNs) are an emerging class of cyber-physical system (CPS) that are changing the healthcare paradigm with their ability to provide remote, continuous health and wellness monitoring. BSN technology is rapidly moving from the domain of research prototypes to commercial healthcare applications, with associated safety implications. However, because of a lack of an accepted definition of safety for BSNs and associated techniques for specifying and verifying their safety properties, manufacturers do not have guidelines for how to design BSNs to meet safety specifications, and the FDA (the primary regulatory body for these systems) is handicapped in their ability to evaluate BSNs to determine their suitability for the healthcare market. The regulatory problem is compounded by the nature of BSNs: wireless sensing, computing, and communicating devices operating in a coordinated manner to provide vital information about the physical state of a person. This project explores: (1) the development of a definition of safety properties for BSNs in light of their mobile, cyber-physical nature; (2) the development of a reference model for BSNs (termed the "generic BSN") from which specific BSN designs can be specified and instantiated and which lends itself to analysis techniques for extracting and formally verifying the instantiated design against identified safety properties. These developments will provide manufacturers with the ability to design BSNs to meet safety specifications and will enable the FDA to better evaluate such systems in an objective, repeatable, and systematic manner.