Advertisement

Assurance Case Considerations for Interoperable Medical Systems

  • Yi ZhangEmail author
  • Brian Larson
  • John Hatcliff
Conference paper
Part of the Lecture Notes in Computer Science book series (LNCS, volume 11094)

Abstract

Modern medical devices are increasingly developed by composing a variety of interoperable elements such as medical devices, services, and platform infrastructures. In many scenarios, multi-vendor consortia are organized to support the development and deployment of interoperable medical systems, in which safety-critical element implementations, risk management results, and safety assurance are reused across organizational boundaries. This reality calls for an assurance case approach that supports interfacing, refinement, and composition of distributed, component-level claims and evidences to construct system-level assurance argumentation. We present a collection of objectives and top-level safety claims towards the development of such an approach for interoperable systems built using medical application platforms.

Keywords

Assurance case Interoperable medical system Ecosystem 

References

  1. 1.
    ASTM: F-2761: 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)Google Scholar
  2. 2.
    Denney, E., Pai, G.: Towards a formal basis for modular safety cases. In: Koornneef, F., van Gulijk, C. (eds.) SAFECOMP 2015. LNCS, vol. 9337, pp. 328–343. Springer, Cham (2015).  https://doi.org/10.1007/978-3-319-24255-2_24CrossRefGoogle Scholar
  3. 3.
    Gorski, J., Jarzebowicz, A., Miler, J.: Validation of services supporting healthcare standards conformance. Metrol. Meas. Syst. 19(2), 269–284 (2012)CrossRefGoogle Scholar
  4. 4.
    Hatcliff, J., et al.: Rationale and architecture principles for medical application platforms. In: Proceedings of the 2012 International Conference on Cyberphysical Systems, pp. 3–12 (2012)Google Scholar
  5. 5.
    Hawkins, R., Kelly, T., Habli, I.: Developing assurance cases for D-MILS systems. In: International Workshop on MILS: Architecture and Assurance for Secure Systems (2015)Google Scholar
  6. 6.
  7. 7.
    Kelly, T.: Concepts and principles of compositional safety case construction. Contract Research Report for QinetiQ COMSA/2001/1/1 34 (2001)Google Scholar
  8. 8.
    Kelly, T.: Using software architecture techniques to support the modular certification of safety-critical systems. In: Proceedings of the 11th Australian Workshop on Safety Critical Systems and Software, vol. 69, pp. 53–65 (2006)Google Scholar
  9. 9.
    Kim, Y.J., Procter, S., Hatcliff, J., Ranganath, V.P., Robby: ecosphere principles for medical application platforms. In: IEEE International Conference on Healthcare Informatics (ICHI) (2015)Google Scholar
  10. 10.
    King, A., et al.: An open test bed for medical device integration and coordination. In: Proceedings of the 31st International Conference on Software Engineering, pp. 141–151 (2009).  https://doi.org/10.1109/ICSE-COMPANION.2009.5070972
  11. 11.
    MDPnP Program: OpenICE - open-source integrated clinical environment (2015). https://www.openice.info/
  12. 12.
    Sljivo, I., Gallina, B., Carlson, J., Hansson, H.: Generation of safety case argument-fragments from safety contracts. In: Bondavalli, A., Di Giandomenico, F. (eds.) SAFECOMP 2014. LNCS, vol. 8666, pp. 170–185. Springer, Cham (2014).  https://doi.org/10.1007/978-3-319-10506-2_12CrossRefGoogle Scholar

Copyright information

© This is a U.S. government work and its text is not subject to copyright protection in the United States; however, its text may be subject to foreign copyright protection 2018

Authors and Affiliations

  1. 1.U.S. Food and Drug AdministrationSilver SpringUSA
  2. 2.Kansas State UniversityManhattanUSA

Personalised recommendations