A formal analysis of ISO/IEEE P11073-20601 standard of medical device communication

This article presents the formal work done for the ISO/IEEE P11073-20601 draft standard for health informatics - personal health device communication - application profile - optimized exchange protocol. ISO/IEEE 11073 family defines standards for device communication between agents (e.g. blood pressure monitors, weighing scales) that collect information about a person and manager (e.g., cell phone, health appliance, or personal computer) for collection, display, and possible later re-transmission. The particular draft standard ISO/IEEE P11073-20601 defines protocols for data exchange between agents and managers. Although such a system in medical use must be extremely reliable under all circumstances, until now a formal analysis has been used only in analyzing draft IEEE P11073-20601 as a part of developing the protocols in this family of standards. We analyzed the protocols both manually and automatically. For the automated analysis of safety properties we applied model-checking techniques, which is feasible since the number of processes is limited, and because we can abstract from most data in the protocols. We used the language Promela and the tool Spin, since this combination has a good reputation in practical applications and it is well documented. The results of our work are now incorporated in this standard.