Verification and validation of knowledge-based clinical decision support systems - a practical approach : A descriptive case study at Cambio CDS

Abstract: The use of clinical decision support (CDS) systems has grown progressively during the past decades. CDS systems are associated with improved patient safety and outcomes, better prescription and diagnosing practices by clinicians and lower healthcare costs. Quality assurance of these systems is critical, given the potentially severe consequences of any errors. Yet, after several decades of research, there is still no consensual or standardized approach to their verification and validation (V&V). This project is a descriptive and exploratory case study aiming to provide a practical description of how Cambio CDS, a market-leading developer of CDS services, conducts its V&V process. Qualitative methods including semi-structured interviews and coding-based textual data analysis were used to elicit the description of the V&V approaches used by the company. The results showed that the company’s V&V methodology is strongly influenced by the company’s model-driven development approach, a strong focus and leveraging of domain knowledge and good testing practices with a focus on automation and test-driven development. A few suggestions for future directions were discussed.