Innovative information models to capture the dynamics of clinical processes: introducing process-oriented traceability in medical informatics specifications as a case study.

"Historia magistra vitae", or at least it tries; in fact, only if recorded and studied from different perspectives, the past can help people to improve their present and build a better future, avoiding mistakes that have already occurred and foreseeing the optimal directions to follow. Traceability, supporting the reconstruction and analysis of what has happened, thus becomes a way to improve safety, quality, efficiency and accuracy in all the sectors in which it is applied, particularly in medicine. The advancement of technical and scientific progress can have a positive contribution, as increasingly accurate and affordable devices are made available for the tracing of care paths. At the same time, however, to create faithful reality descriptions from the heterogeneous information collected, it is essential to study and develop methodologies relating the data to the structure, context and dynamics of the processes that generated them. This work strives to address these issues, with the definition of two theoretical information models describing process-oriented traceability in widely implemented specifications for medical informatics. The first model describes the lifecycle of a biological sample in a diagnostic process, both for clinical routine and research activities: the Specimen Event Tracking Profile is a contribution to the Pathology and Laboratory Medicine (PaLM) Domain of the Integrating the Healthcare Enterprise (IHE) guidelines. The second result is a model describing traceability for a clinical process in general, in the context of openEHR specification.