Skip to main content

2017 | Supplement | Buchkapitel

Safety Assurance for Autonomous and Collaborative Medical Cyber-Physical Systems

verfasst von : Fabio L. Leite Jr., Rasmus Adler, Patrik Feth

Erschienen in: Computer Safety, Reliability, and Security

Verlag: Springer International Publishing

Aktivieren Sie unsere intelligente Suche um passende Fachinhalte oder Patente zu finden.

search-config
loading …

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.

Sie haben noch keine Lizenz? Dann Informieren Sie sich jetzt über unsere Produkte:

Springer Professional "Wirtschaft+Technik"

Online-Abonnement

Mit Springer Professional "Wirtschaft+Technik" erhalten Sie Zugriff auf:

  • über 102.000 Bücher
  • über 537 Zeitschriften

aus folgenden Fachgebieten:

  • Automobil + Motoren
  • Bauwesen + Immobilien
  • Business IT + Informatik
  • Elektrotechnik + Elektronik
  • Energie + Nachhaltigkeit
  • Finance + Banking
  • Management + Führung
  • Marketing + Vertrieb
  • Maschinenbau + Werkstoffe
  • Versicherung + Risiko

Jetzt Wissensvorsprung sichern!

Springer Professional "Technik"

Online-Abonnement

Mit Springer Professional "Technik" erhalten Sie Zugriff auf:

  • über 67.000 Bücher
  • über 390 Zeitschriften

aus folgenden Fachgebieten:

  • Automobil + Motoren
  • Bauwesen + Immobilien
  • Business IT + Informatik
  • Elektrotechnik + Elektronik
  • Energie + Nachhaltigkeit
  • Maschinenbau + Werkstoffe




 

Jetzt Wissensvorsprung sichern!

Springer Professional "Wirtschaft"

Online-Abonnement

Mit Springer Professional "Wirtschaft" erhalten Sie Zugriff auf:

  • über 67.000 Bücher
  • über 340 Zeitschriften

aus folgenden Fachgebieten:

  • Bauwesen + Immobilien
  • Business IT + Informatik
  • Finance + Banking
  • Management + Führung
  • Marketing + Vertrieb
  • Versicherung + Risiko




Jetzt Wissensvorsprung sichern!

Literatur
1.
Zurück zum Zitat 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) 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)
2.
Zurück zum Zitat Avizienis, A., et al.: Basic concepts and taxonomy of dependable and secure computing. IEEE Trans. Dependable Secur. Comput. 1(1), 11–33 (2004)CrossRef Avizienis, A., et al.: Basic concepts and taxonomy of dependable and secure computing. IEEE Trans. Dependable Secur. Comput. 1(1), 11–33 (2004)CrossRef
3.
Zurück zum Zitat Bondavalli, A., et al.: Cyber-Physical Systems of Systems: Foundations – A Conceptual Model and Some Derivations: the AMADEOS Legacy. Springer, Heidelberg (2016) Bondavalli, A., et al.: Cyber-Physical Systems of Systems: Foundations – A Conceptual Model and Some Derivations: the AMADEOS Legacy. Springer, Heidelberg (2016)
4.
Zurück zum Zitat Brief, E.: Top 10 Health Technology Hazards for Top 10 Health Technology Hazards for 2017 (2016) Brief, E.: Top 10 Health Technology Hazards for Top 10 Health Technology Hazards for 2017 (2016)
5.
Zurück zum Zitat Goldman, J.M.: Getting connected to save lives. Biomed. Instrum. Technol. 39(3), 174 (2005) Goldman, J.M.: Getting connected to save lives. Biomed. Instrum. Technol. 39(3), 174 (2005)
6.
Zurück zum Zitat 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) 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)
7.
Zurück zum Zitat 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 CrossRef 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 CrossRef
8.
Zurück zum Zitat Kaiser, B., et al.: Contract-based design of embedded systems integrating nominal behavior and safety. Complex Syst. Inform. Model. Q. 4, 66–91 (2015) Kaiser, B., et al.: Contract-based design of embedded systems integrating nominal behavior and safety. Complex Syst. Inform. Model. Q. 4, 66–91 (2015)
9.
Zurück zum Zitat 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) 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)
10.
11.
Zurück zum Zitat 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 CrossRef 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 CrossRef
12.
Zurück zum Zitat Machin, M., et al.: SMOF: a safety monitoring framework for autonomous systems. IEEE Trans. Syst. Man Cybern. Syst. 99, 1–14 (2016)CrossRef Machin, M., et al.: SMOF: a safety monitoring framework for autonomous systems. IEEE Trans. Syst. Man Cybern. Syst. 99, 1–14 (2016)CrossRef
13.
Zurück zum Zitat 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) 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)
15.
Zurück zum Zitat 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)CrossRef 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)CrossRef
16.
Zurück zum Zitat Pajic, M., et al.: Model-driven safety analysis of closed-loop medical systems. IEEE Trans. Ind. Inform. 10(1), 3–16 (2012)CrossRef Pajic, M., et al.: Model-driven safety analysis of closed-loop medical systems. IEEE Trans. Ind. Inform. 10(1), 3–16 (2012)CrossRef
17.
Zurück zum Zitat 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.: Conditional safety certification for open adaptive systems. (Ph.D. theses in Experimental Software Engineering). Fraunhofer Verlag (26 March 2014), Kaiserslautern (2014)
18.
Zurück zum Zitat Schneider, D., Trapp, M.: Conditional safety certification of open adaptive systems. ACM Trans. Auton. Adapt. Syst. 8(2), 1–20 (2013)CrossRef Schneider, D., Trapp, M.: Conditional safety certification of open adaptive systems. ACM Trans. Auton. Adapt. Syst. 8(2), 1–20 (2013)CrossRef
19.
Zurück zum Zitat Sokolsky, O., et al.: Challenges and research directions in medical cyber-physical systems. Proc. IEEE 100(1), 75–90 (2012)CrossRef Sokolsky, O., et al.: Challenges and research directions in medical cyber-physical systems. Proc. IEEE 100(1), 75–90 (2012)CrossRef
20.
Zurück zum Zitat 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) 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)
21.
Zurück zum Zitat 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)CrossRef 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)CrossRef
22.
Zurück zum Zitat 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)CrossRef 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)CrossRef
23.
Zurück zum Zitat BS EN 61508-1: 2010 BSI Standards Publication Functional safety of electrical/electronic/programmable electronic safety-related systems Part 1 : General requirements (2010) BS EN 61508-1: 2010 BSI Standards Publication Functional safety of electrical/electronic/programmable electronic safety-related systems Part 1 : General requirements (2010)
Metadaten
Titel
Safety Assurance for Autonomous and Collaborative Medical Cyber-Physical Systems
verfasst von
Fabio L. Leite Jr.
Rasmus Adler
Patrik Feth
Copyright-Jahr
2017
DOI
https://doi.org/10.1007/978-3-319-66284-8_20