Helping the Cause of Medical Device Interoperability: A standards-based testing approach based on identifying and obtaining testable assertions

We present a black-box messaging test approach employed to achieve a level of rigor which improves, if not assures (given no optionality and fully constrained), correct data exchange. In particular, verifying that physiological information derived and communicated via messaging from a source medical device (e.g., an infusion pump) or healthcare information system, to another medical device (e.g., a patient monitor) or healthcare information system which consumes or make use of the data is syntactically and semantically correct. Our approach for developing a test system to validate messages is based on constraining identified and recognized specifications. The test system validation performed uses codified assertions derived from the specifications and constraints placed upon those specifications. To first show conformance which subsequently enables interoperability, these assertions, which are atomic requirements traceable by clause to the base specifications, are employed by our medical device test tools to rigorously enforce standards to facilitate safe and effective plug-and-play information exchange.