TY - GEN
T1 - Modeling and integrating physical environment assumptions in medical cyber-physical system design
AU - Fu, Zhicheng
AU - Guo, Chunhui
AU - Ren, Shangping
AU - Jiang, Yu
AU - Sha, Lui
N1 - Publisher Copyright:
© 2017 IEEE.
PY - 2017/5/11
Y1 - 2017/5/11
N2 - Implicit physical environment assumptions made by safety critical cyber-physical systems, such as medical cyber-physical systems (M-CPS), can lead to catastrophes. Several recent U.S. Food and Drug Administration (FDA) medical device recalls are due to implicit physical environment assumptions. In this paper, we develop a mathematical assumption model and composition rules that allow M-CPS engineers to explicitly and precisely specify assumptions about the physical environment in which the designed M-CPS operates. Algorithms are developed to integrate the mathematical assumption model with system model so that the safety of the system can be not only validated by both medical and engineering professionals but also formally verified by existing formal verification tools. We use an FDA recalled medical ventilator scenario as a case study to show how the mathematical assumption model and its integration in M-CPS design may improve the safety of the ventilator and M-CPS in general.
AB - Implicit physical environment assumptions made by safety critical cyber-physical systems, such as medical cyber-physical systems (M-CPS), can lead to catastrophes. Several recent U.S. Food and Drug Administration (FDA) medical device recalls are due to implicit physical environment assumptions. In this paper, we develop a mathematical assumption model and composition rules that allow M-CPS engineers to explicitly and precisely specify assumptions about the physical environment in which the designed M-CPS operates. Algorithms are developed to integrate the mathematical assumption model with system model so that the safety of the system can be not only validated by both medical and engineering professionals but also formally verified by existing formal verification tools. We use an FDA recalled medical ventilator scenario as a case study to show how the mathematical assumption model and its integration in M-CPS design may improve the safety of the ventilator and M-CPS in general.
UR - http://www.scopus.com/inward/record.url?scp=85020178143&partnerID=8YFLogxK
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U2 - 10.23919/DATE.2017.7927249
DO - 10.23919/DATE.2017.7927249
M3 - Conference contribution
AN - SCOPUS:85020178143
T3 - Proceedings of the 2017 Design, Automation and Test in Europe, DATE 2017
SP - 1615
EP - 1618
BT - Proceedings of the 2017 Design, Automation and Test in Europe, DATE 2017
PB - Institute of Electrical and Electronics Engineers Inc.
T2 - 20th Design, Automation and Test in Europe, DATE 2017
Y2 - 27 March 2017 through 31 March 2017
ER -