Software Certification for Distributed, Adaptable Medical Systems: Position Paper on Challenges and Paths Forward

In this position paper, we propose an analysis, architecture and design approach to specify and enforce certifiable behavior as a means for meaningful and economically feasible certification argument construction in the context of distributed, adaptable safety-critical software systems. The main components of our approach are: 1.) methods to identify and separate uncertifiable behavior based on system observables. 2.) Extending interface standards to complement certification activities. 3.) Methods for regulating component interaction. 4.) Methods to dynamically, constrain behavior into localized, certifiable operating regions.