Towards Assurance for Plug & Play Medical Systems

Traditional safety-critical systems are designed and integrated by a systems integrator. The system integrator can asses the safety of the completed system before it is deployed. In medicine, there is a desire to transition from the traditional approach to a new model wherein a user can combine various devices post-hoc to create a new composite system that addresses a specific clinical scenario. Ensuring the safety of these systems is challenging: Safety is a property of systems that arises from the interaction of system components and it’s not possible to asses overall system safety by assessing a single component in isolation. It is unlikely that end-users will have the engineering expertise or resources to perform safety assessments each time they create a new composite system. In this paper we describe a platform-oriented approach to providing assurance for plug & play medical systems as well as an associated assurance argument pattern.