An Argumentative Approach to Assessing Safety in Medical Device Software Using Defeasible Logic Programming

Abstract

Modern health-care technology depends to a large extent on software deployed in medical devices, which brings several well-known benefits but also poses new hazards to patient safety. As a consequence, assessing safety and reliability in software in medical devices turns out to be a critical issue. In this paper we outline a method for safety assessment of medical devices based on Defeasible Logic Programming (DeLP), which provides an argumentative framework for reasoning with uncertain and incomplete knowledge.We contend that argumentation theory as defined in DeLP can be used to integrate and contrast different evidences for assessing the approval and commercialization of medical devices, aiming at increasing transparency to all the stakeholders involved in their certification. The outlined framework is validated by modeling the infamous Therac-25 accident.