PROBLEMS AND SOLUTIONS FOR INTEROPERABILITY OF MEDICAL DEVICES

We analyze pre-standard ENV 13735 of the upcoming ISO/IEEE 11073.2 standard, which standardizes some communication protocols between dynamically interconnected medical devices and ANSI/HL7 that deals with the inter-interoperability across the care-sector. These standards are currently under development, which gives us an opportunity to influence its contents using our results. The approach we use is to make formal models of the protocols, and to analyze them using the model- checking tool Spin. Both standards give raise to similar problems from a safety point of view. Our analysis revealed several omissions, inconsistencies and other types of errors in the protocols and their descriptions. We discuss possible sources of these problems, and propose some solutions.