Adapting a system-theoretic hazard analysis method for interoperability of information systems in health care

Date

2022-04-25

Authors

Costa Rocha, Oscar Aleixo

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Abstract

The adoption of Health Information Systems (HIS) by primary care clinics and practitioners has become a standard in the healthcare industry. This increase in HIS utilization enables the informatization and automation of many paper-based clinical workflows, such as clinical referrals, through systems interoperability. The healthcare industry defines several interoperability standards and mechanisms to support the exchange of data among HIS. For example, the health authorities, Interior Health and Northern Health, created the CDX system to provide interoperability for HIS across British Columbia using SOAP Web Services and HL7 Clinical Document Architecture (CDA) interoperability standards. The CDX interoperability allows HIS such as Electronic Medical Record (EMR) systems to exchange information with other HIS, such as patients clinical records, clinical notes and laboratory testing results. In addition, to ensure the EMR systems adhere to the CDX specification, these health authorities conduct conformance testing with the EMR vendors to certify the EMR systems. However, conformance testing can only cover a subset of the systems' specifications and a few use cases. Therefore, systems properties that are not closely associated with the systems (i.e. emergent properties) are hard, or even impractical, to assure using only conformance testing. System safety is one of these properties that are particularly significant for EMR systems because it deals with patient safety. A well-known approach for improving systems safety is through hazard analysis. For scenarios where the human factor is an essential part of the system, such as EMR systems, the System-Theoretic Process Analysis (STPA) is more appropriate than traditional hazard analysis techniques. In this work, we perform a hazard analysis using STPA on the CDX conformance profile in order to evaluate and improve the safety of the CDX system interoperability. In addition, we utilize and customize a tool named FASTEN to support and facilitate the analysis. To conclude, our analysis identified a number of new safety-related constraints and improved a few other already specified constraints.

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Keywords

system interoperability, system safety, systems theory, hazard analysis, domain-specific language, health information systems, conformance testing, requirements engineering, STAMP, STPA

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