Adapting a System-Theoretic Hazard Analysis Method for the Analysis of an eHealth Interoperability Conformance Profile.

Interoperability between heterogenous (health) IT systems relies on standards, which are communicated to system vendors in the form of so-called conformance profiles. Clinical information systems are often subjected to mandatory conformance testing and certification prior to being admitted into the health information exchange (HIE). The requirements specified in conformance profiles are therefore instrumental for ensuring the correctness and safety of the emerging HIE network. How can we ensure the quality and safety of conformance requirements themselves? We have adapted a system-theoretic hazard analysis method (STPA) for this purpose and applied it to an industrial case study in British Columbia, the Clinical Data eXchange (CDX) system. Our results indicate that the method is effective in detecting missing and erroneous constraints.