Many embedded systems are intended for use in complex and highly concurrent processes with multiple human agents. In these cases, the requirements for the system depend critically on the details of the process. If certification is to be useful for such systems, it must take the details of the process into account. In this paper, we describe some current research involving the formal definition and analysis of complex medical processes. We discuss the ways in which this work may provide a basis for a more complete understanding of the behavior of medical devices in the context of the processes in which they are used, and thus for certification methods for sophisticated embedded systems.
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