Error Type Refinement for Assurance of Families of Platform-Based Systems

Conference paper
Part of the Lecture Notes in Computer Science book series (LNCS, volume 9338)


Medical Application Platforms (MAPs) are an emerging paradigm for developing interoperable medical systems. Existing assurance-related concepts for conventional medical devices including hazard analyses, risk management processes, and assurance cases need to be enhanced and reworked to deal with notions of interoperability, reuse, and compositionality in MAPs.

In this paper, we present the motivation for a framework for defining and refining error types associated with interoperable systems and its relevance to safety standards development activities. This framework forms the starting point for the analysis and documentation of faults, propagations of errors related to those faults, and their associated hazards and mitigation strategies—all of which need to be addressed in risk management activities and assurance cases for these systems.


Interoperable medical systems Hazard analyses Faults Errors Reusable components and assurance 


  1. 1.
    Arlat, J., Aguera, M., Amat, L., Crouzet, Y., Fabre, J.C., Laprie, J.C., Martins, E., Powell, D.: Fault injection for dependability validation: a methodology and some applications. IEEE Trans. Softw. Eng. 16(2), 166–182 (1990)CrossRefGoogle Scholar
  2. 2.
    Arney, D., Pajic, M., Goldman, J.M., Lee, I., Mangharam, R., Sokolsky, O.: Toward patient safety in closed-loop medical device systems. In: Proceedings of the 1st ACM/IEEE International Conference on Cyber-Physical Systems, pp. 139–148. ACM (2010)Google Scholar
  3. 3.
    ASTM International: ASTM F2761 - Medical Devices and Medical Systems - Essential safety requirements for equipment comprising the patient-centric integrated clinical environment (ICE) (2009).
  4. 4.
    Avižienis, A., Laprie, J.C., Randell, B., Landwehr, C.: Basic concepts and taxonomy of dependable and secure computing. IEEE Trans. Dependable Secure Comput. 1(1), 11–33 (2004)CrossRefGoogle Scholar
  5. 5.
    Ericson II, C.A.: Hazard Analysis Techniques for System Safety. Wiley, New York (2005)CrossRefGoogle Scholar
  6. 6.
    Hatcliff, J., King, A., Lee, I., MacDonald, A., Fernando, A., Robkin, M., Vasserman, E., Weininger, S., Goldman, J.M.: Rationale and architecture principles for medical application platforms. In: 2012 IEEE/ACM Third International Conference on Cyber-Physical Systems (ICCPS), pp. 3–12. IEEE (2012)Google Scholar
  7. 7.
    Hicks, R.W., Sikirica, V., Nelson, W., Schein, J.R., Cousins, D.D.: Medication errors involving patient-controlled analgesia. Am. J. Health-Syst. Pharm. 65(5), 429–440 (2008)CrossRefGoogle Scholar
  8. 8.
    King, A., Chen, S., Lee, I.: The middleware assurance substrate: enabling strong real-time guarantees in open systems with openflow. In: 17th IEEE Computer Society symposium on Object/component/service-oriented realtime distributed computing (ISORC). IEEE (2014)Google Scholar
  9. 9.
    King, A., Procter, S., Andresen, D., Hatcliff, J., Warren, S., Spees, W., Jetley, R., Jones, P., Weininger, S.: An open test bed for medical device integration and coordination. In: Proceedings of the 31st International Conference on Software Engineering (2009)Google Scholar
  10. 10.
    Procter, S., Hatcliff, J.: An architecturally-integrated, systems-based hazard analysis for medical applications. In: 2014 Twelfth ACM/IEEE International Conference on Formal Methods and Models for Codesign (MEMOCODE), pp. 124–133. IEEE (2014)Google Scholar
  11. 11.
    Procter, S., Hatcliff, J.: Robby: towards an AADL-based definition of app architectures for medical application platforms. In: Proceedings of the International Workshop on Software Engineering in Healthcare. Washington, DC, July 2014Google Scholar
  12. 12.
    SAE AS-2C Architecture Description Language Subcommittee: SAE Architecture Analysis and Design Language (AADL) Annex, vol. 3, Annex E: Error Model Language. Technical report SAE Aerospace, June 2014Google Scholar
  13. 13.
    SAE AS5506B: Architecture Analysis and Design Language (AADL). AS-5506B, SAE International (2004)Google Scholar
  14. 14.
    Wallace, M.: Modular architectural representation and analysis of fault propagation and transformation. Electron. Notes Theor. Comput. Sci. 141(3), 53–71 (2005)MathSciNetCrossRefGoogle Scholar

Copyright information

© Springer International Publishing Switzerland 2015

Authors and Affiliations

  1. 1.Kansas State UniversityManhattanUSA
  2. 2.United States Food and Drug AdministrationSilver SpringUSA
  3. 3.Underwriters LaboratoriesChicagoUSA

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