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)


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.


Assurance case Interoperable medical system Ecosystem 


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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

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