Assuring the Safety, Security and Reliability of Medical Device Cyber Physical Systems

Abstract:

Recent years have seen medical devices go from being monolithic to a collection of integrated systems. Modern medical device systems have thus become a distinct class of cyber-physical systems called Medical Cyber Physical Systems (MCPS), featuring complex and close interaction of sophisticated treatment algorithms with the physical aspects of the system, and especially the patient whose safety is of the utmost concern. The goal of this project is to develop a new paradigm for the design and implementation of safe, secure, and reliable MCPS, which includes:

• A compositional development framework for safe and secure MCPS;
• An approach to evidence-based regulatory approval and incremental certification of MCPS;
• Techniques for rigorous evaluation of clinical scenarios, both operational procedures for caregivers and device systems;
• Control-theoretic methods for the design of physiological closed-loop scenarios.

On-going research directions:

• Model-based, safety-assured development of medical devices, concentrating on the generic PCA (GPCA) infusion pump case study. Current efforts concentrate on code generation techniques that aim to combine platform-independent code generation from state-machine models and platform-dependent glue code that accesses low-level services.
• An interoperability platform with timing guarantees that allows us to develop and deploy software for new clinical scenarios as virtual medical devices (VMD), potentially opening a regulatory pathway for the approval of systems of interoperable medical devices.
• Development and safety analysis of physiologically closed-loop clinical scenarios. Current efforts concentrate on the development and evaluation of controllers for blood glucose control.
• Development of network-enabled smart alarm and decision support applications. A generic smart alarm architecture has been developed. Current efforts concentrate on the decision support system for reducing false alarms in post-surgery patients.
• Development and evaluation techniques for assurance cases for MCPS. Using the GPCA effort as the case study, current efforts concentrate on the development of confidence arguments for the assurance case and methods of quantifying uncertainty during assurance case evaluation.