Abstract
Medical Cyber Physical Systems of Systems (MCPSoS) refer to a set of systems that flexibly collaborate at runtime in order to render higher level functionality. Most systems in a MCPSoS offer a generic piece of functionality so that they can contribute to many totally different collaboration scenarios. Consequently, it is unknown at design time which systems will how collaborate at runtime. This unpredictability leads to new challenges for the assurance of safety, because established approaches always build on the assumption that systems and their environments are completely known. We believe that the safety research community has to pull together in order to tackle the challenge of unpredictability and that this requires an appropriate taxonomy in order to establish a common understanding of the challenge and related solutions. To this end, we propose enhancements based on a widely accepted taxonomy for dependable computing with respect to the system-of-systems aspect. Further, we will use the taxonomy to reflect on the new challenge of unpredictability and related solutions from the state-of-the-art, namely, safety contracts and dynamic risk assessment. Finally, we motivate an integration of the safety contracts and dynamic risk assessment and present some ideas on this integration. Throughout the paper, we use a real-world example to exemplify our proposed taxonomy and our thoughts.
Keywords
This is a preview of subscription content, log in via an institution.
Buying options
Tax calculation will be finalised at checkout
Purchases are for personal use only
Learn about institutional subscriptionsReferences
Arney, D., et al.: Toward patient safety in closed-loop medical device systems. In: Proceedings of the 1st ACM/IEEE International Conference on Cyber-Physical Systems - ICCPS 2010, p. 139. ACM Press, New York (2010)
Avizienis, A., et al.: Basic concepts and taxonomy of dependable and secure computing. IEEE Trans. Dependable Secur. Comput. 1(1), 11–33 (2004)
Bondavalli, A., et al.: Cyber-Physical Systems of Systems: Foundations – A Conceptual Model and Some Derivations: the AMADEOS Legacy. Springer, Heidelberg (2016)
Brief, E.: Top 10 Health Technology Hazards for Top 10 Health Technology Hazards for 2017 (2016)
Goldman, J.M.: Getting connected to save lives. Biomed. Instrum. Technol. 39(3), 174 (2005)
Goldman, J.M.: Medical devices and medical systems - essential safety requirements for equipment comprising the patient-centric integrated clinical environment (ICE) - Part 1: general requirements and conceptual model (2009)
Heckemann, K., Gesell, M., Pfister, T., Berns, K., Schneider, K., Trapp, M.: Safe automotive software. In: König, A., Dengel, A., Hinkelmann, K., Kise, K., Howlett, R.J., Jain, L.C. (eds.) KES 2011. LNCS, vol. 6884, pp. 167–176. Springer, Heidelberg (2011). doi:10.1007/978-3-642-23866-6_18
Kaiser, B., et al.: Contract-based design of embedded systems integrating nominal behavior and safety. Complex Syst. Inform. Model. Q. 4, 66–91 (2015)
Kim, C., et al.: A framework for the safe interoperability of medical devices in the presence of network failures. In: Proceedings of the 1st ACM/IEEE International Conference on Cyber-Physical Systems - ICCPS 2010, p. 149. ACM Press, New York (2010)
King, A.L., et al.: Towards assurance for plug & play medical systems. In: Koornneef, F., van Gulijk, C. (eds.) SAFECOMP 2014. LNCS, vol. 9337, pp. 228–242. Springer, Cham (2015). doi:10.1007/978-3-319-24255-2_17
Kurd, Z., Kelly, T., McDermid, J., Calinescu, R., Kwiatkowska, M.: Establishing a framework for dynamic risk management in ‘intelligent’ aero-engine control. In: Buth, B., Rabe, G., Seyfarth, T. (eds.) SAFECOMP 2009. LNCS, vol. 5775, pp. 326–341. Springer, Heidelberg (2009). doi:10.1007/978-3-642-04468-7_26
Machin, M., et al.: SMOF: a safety monitoring framework for autonomous systems. IEEE Trans. Syst. Man Cybern. Syst. 99, 1–14 (2016)
Maddox, R.R., et al.: Continuous Respiratory Monitoring and a “Smart” Infusion System Improve Safety of Patient-Controlled Analgesia in the Postoperative Period. Agency for Healthcare Research and Quality (US), Rockville (2008)
Maier, M.W.: Architecting principles for systems-of-systems. Syst. Eng. 1(4), 267–284 (1998)
Nielsen, C.B., et al.: Systems of systems engineering: basic concepts, model-based techniques, and research directions. ACM Comput. Surv. 48(2), 1–41 (2015)
Pajic, M., et al.: Model-driven safety analysis of closed-loop medical systems. IEEE Trans. Ind. Inform. 10(1), 3–16 (2012)
Schneider, D.: Conditional safety certification for open adaptive systems. (Ph.D. theses in Experimental Software Engineering). Fraunhofer Verlag (26 March 2014), Kaiserslautern (2014)
Schneider, D., Trapp, M.: Conditional safety certification of open adaptive systems. ACM Trans. Auton. Adapt. Syst. 8(2), 1–20 (2013)
Sokolsky, O., et al.: Challenges and research directions in medical cyber-physical systems. Proc. IEEE 100(1), 75–90 (2012)
Stevens, N., et al.: Smart alarms: multivariate medical alarm integration for post CABG surgery patients. In: Proceedings of the 2nd ACM SIGHIT Symposium on International Health Informatics - IHI 2012, p. 533. ACM Press, New York (2012)
Sujan, M.A., et al.: Safety cases for medical devices and health information technology: involving health-care organisations in the assurance of safety. Health Inform. J. 19(3), 165–182 (2013)
Williams, C.K., et al.: Application of the IV medication harm index to assess the nature of harm averted by “Smart” infusion safety systems. J. Patient Saf. 2(3), 132–139 (2006)
BS EN 61508-1: 2010 BSI Standards Publication Functional safety of electrical/electronic/programmable electronic safety-related systems Part 1 : General requirements (2010)
Infusion Pump Improvement Initiative. https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/GeneralHospitalDevicesandSupplies/InfusionPumps/ucm202501.htm
Acknowledgements
The ongoing research that led to this paper is funded by the Brazilian National Research Council (CNPq) under grant CSF 201715/2014-7.
Author information
Authors and Affiliations
Corresponding author
Editor information
Editors and Affiliations
Rights and permissions
Copyright information
© 2017 Springer International Publishing AG
About this paper
Cite this paper
Leite, F.L., Adler, R., Feth, P. (2017). Safety Assurance for Autonomous and Collaborative Medical Cyber-Physical Systems. In: Tonetta, S., Schoitsch, E., Bitsch, F. (eds) Computer Safety, Reliability, and Security . SAFECOMP 2017. Lecture Notes in Computer Science(), vol 10489. Springer, Cham. https://doi.org/10.1007/978-3-319-66284-8_20
Download citation
DOI: https://doi.org/10.1007/978-3-319-66284-8_20
Published:
Publisher Name: Springer, Cham
Print ISBN: 978-3-319-66283-1
Online ISBN: 978-3-319-66284-8
eBook Packages: Computer ScienceComputer Science (R0)