Assurance Case Considerations For Interoperable Medical Systems

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.