Abstract
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.
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Notes
- 1.
Through out this section we adopt a formal notation that might lead some readers to believe that when we use the term “model” we are explicitly refering to formal models (i.e., ones that could be analyzed by a model-checker). This is not the case. We are using “model” in a very general sense and a model could range from an informal “mental model” to an executable model that could be simulated to a formal model that could be analyzed by a model-checker.
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Acknowledgements
This research was supported in part by NSF CNS-1035715, NSF CPS 1239324, NIH 1U01EB012470-01, and DGIST Research and Development Program of the Ministry of Science, ICT and Future Planning of Korea (CPS Global Center).
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King, A.L. et al. (2015). Towards Assurance for Plug & Play Medical Systems. In: Koornneef, F., van Gulijk, C. (eds) Computer Safety, Reliability, and Security. SAFECOMP 2014. Lecture Notes in Computer Science(), vol 9337. Springer, Cham. https://doi.org/10.1007/978-3-319-24255-2_17
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