Challenges in the regulatory approval of medical cyber-physical systems

Authors:
Oleg Sokolsky;Insup Lee;Mats Heimdahl
Affiliations:
University of Pennsylvania, Philadelphia, PA, USA;University of Pennsylvania, Philadelphia, PA, USA;University of Minnesota, Minneapolis, MN, USA
Venue:
EMSOFT '11 Proceedings of the ninth ACM international conference on Embedded software
Year:
2011

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Abstract

We are considering the challenges that regulators face in approving modern medical devices, which are software intensive and increasingly network enabled. We then consider assurance cases, which offer the means of organizing the evidence into a coherent argument demonstrating the level of assurance provided by a system, and discuss research directions that promise to make construction and evaluation of assurance cases easier and more precise. Finally, we discuss some recent trends that will further complicate the regulatory approval of medical cyber-physical systems.