Medical Device Communication: A Standards- based Conformance Testing Approach

NIST researchers are collaborating with medical device experts to facilitate the development and adoption of standards for medical device communications throughout the healthcare enterprise as well as integrating it into the electronic health record. We have developed test tools and corresponding electronic representation of an international standard's information model that provides several important capabilities leading toward device interoperability. We describe a conformance testing approach which allows users to abstractly define devices via device profiles and implementation conformance statements. This information and tooling is subsequently used to provide syntactic and semantic validation of medical device messages according to medical device communication standard ISO/IEEE 11073.