Framework to Assist Healthcare Delivery Organisations and Medical Device Manufacturers Establish Security Assurance for Networked Medical Devices

This paper introduces an assurance framework for networked medical device development. This work is being conducted to address the everincreasing concerns of medical device security with a specific focus on medical devices to be incorporated into IT networks. The framework utilises a Process Assessment Model and a Process Reference Model to address system development lifecycle processes, security assurance processes and a focused risk management process. There is currently no governance for the development of secure medical devices in place and so, this work sets out to resolve this problem by increasing the awareness of medical device security risks, threats and vulnerabilities among Medical Device Manufacturers, IT vendors and Healthcare Delivery Organisations.