Development and piloting of a software tool to facilitate proactive hazard and risk analysis of Health Information Technology

Abstract

Health Information Technology (HIT) is now widely promoted as a means for improving patient safety. The technology could also, under certain conditions, pose hazards to patient safety. However, current definitions of hazards are generic and hard to interpret, particularly for large HIT in complex socio-technical settings, i.e. involving interacting clinical, organisational and technological factors. In this paper, we develop a new conceptualisation for the notion of hazards and implement this conceptualisation in a tool-supported methodology called the Safety Modelling, Assurance and Reporting Toolset (SMART). SMART aims to support clinicians and engineers in performing hazard identification and risk analysis and producing a safety case for HIT. Through a pilot study, we used and examined SMART for developing a safety case for electronic prescribing in three acute hospitals. Our results demonstrate the ability of SMART to ensure that the safety evidence is generated based on explicit traceability between the clinical models and HIT functionality. They also highlight challenges concerning identifying hazards in a consistent way, with clear impact on patient safety in order to facilitate clinically-meaningful risk analysis.

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