Dependable integrated clinical system architecture with runtime verification

Abstract

Medical devices are essential for the practice of modern medicine, and the standard open-source integrated clinical environment (OpenICE) has been well designed and widely adopted to improve their interoperability. With OpenICE, it is easy to connect individual devices into the integrated clinical system to provide a coherent patient care. In this paper, we present ICERV, the first online verification approach for the OpenICE, to ensure the dependability (mainly for the safety and security) of the integrated system and the involved patient and clinician. The key idea is to customize runtime verification technique to provide a transparent verifying infrastructure to continually intercept the communication commands and messages of those devices, based on which, we can formalize the safety and security requirements as past time linear temporal logic expressions for verifier generation and online formal verification. If any requirements violate, predefined warnings or exception handling actions will be triggered timely to prevent hazards and threats. We have implemented and seamlessly integrated the approach without any changes to the source code of OpenICE nor the code of the upper-level applications or supervision, and the real device is used for evaluation to demonstrate the effectiveness.