Abstract:Clinical pathways are disseminated as visual flowcharts where spatial topology, arrow direction, colour coding, and font weight encode critical triage logic that remains inaccessible to computational systems. We present PathWISE, a five-phase pipeline combining four LLM-based agents with a deterministic depth-first search auditor and a Java compiler critic, transforming these non-computable artefacts into validated, executable HL7 Clinical Quality Language (CQL) libraries deployable as FHIR CDS Hooks services. Purpose-built agents extract flowchart structure into a typed directed graph, perform deterministic path enumeration, conduct a structured semantic audit of every node's computability, generate terminology-constrained CQL definitions verified by the official Java CQL-to-ELM compiler, and produce routing logic covering 100% of enumerated patient journeys. Demonstrated across five UK NHS cancer pathways (colorectal, lung, skin, upper GI, and breast), PathWISE audits up to 183 nodes (182 under the Hybrid configuration), identifies 544 structured governance findings across four issue categories, achieves 100% syntactic compilation success, with UNCOMPUTABLE nodes receiving false placeholders that preserve compilability while surfacing governance gaps for clinical review, and produces zero hallucinated terminology codes for dictionary-covered concepts. Critically, PathWISE confines non-deterministic LLM inference to knowledge extraction while deterministic graph mathematics and a standard compiler underpin every verification step.




Abstract:Machine learning (ML) models are becoming integral in healthcare technologies, presenting a critical need for formal assurance to validate their safety, fairness, robustness, and trustworthiness. These models are inherently prone to errors, potentially posing serious risks to patient health and could even cause irreparable harm. Traditional software assurance techniques rely on fixed code and do not directly apply to ML models since these algorithms are adaptable and learn from curated datasets through a training process. However, adapting established principles, such as boundary testing using synthetic test data can effectively bridge this gap. To this end, we present a novel technique called Mix-Up Boundary Analysis (MUBA) that facilitates evaluating image classifiers in terms of prediction fairness. We evaluated MUBA for two important medical imaging tasks -- brain tumour classification and breast cancer classification -- and achieved promising results. This research aims to showcase the importance of adapting traditional assurance principles for assessing ML models to enhance the safety and reliability of healthcare technologies. To facilitate future research, we plan to publicly release our code for MUBA.