A security assurance framework for networked medical devices

This paper presents work for the development of a framework to assure the security of networked medical devices being incorporated. The paper focuses on one component of the framework, which addresses system development processes, and the assurance of these through the use of a Process Assessment Model with a major focus on the security risk management process. With the inclusion of a set of specific security controls and assurance processes, the purpose is to increase awareness of security vulnerabilities, risks and controls among Medical Device Manufacturers with the aim of increasing the overall security capability of medical devices