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

Published

Author(s)

John J. Garguilo, Sandra I. Martinez, Maria Cherkaoui

Abstract

We present an approach employed to achieve a level of rigor which improves, if not ultimately guarantees - given no optionality, 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 makes 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.
Citation
Biomedical Instrumentation & Technology
Volume
45
Issue
3

Keywords

Conformance Testing, Interoperability, Health care Information Technology, Medical devices, Testable Assertions

Citation

Garguilo, J. , Martinez, S. and Cherkaoui, M. (2011), Helping the Cause of Medical Device Interoperability: A standards-based testing approach based on identifying and obtaining testable assertions, Biomedical Instrumentation & Technology, [online], https://tsapps.nist.gov/publication/get_pdf.cfm?pub_id=907262 (Accessed July 4, 2022)
Created May 2, 2011, Updated February 19, 2017