Medicina di laboratorio basata sulle evidenze e health technology assessment: strumenti per il governo e la sostenibilità della diagnostica di laboratorio

Laboratory medicine has progressively evolved from a purely analytical service into a strategic component of clinical decision-making and patient management. In this context, diagnostic tests should be evaluated not only for analytical accuracy, but also for their clinical utility, organizational impact, and contribution to healthcare sustainability. This position paper discusses the integration of Evidence-Based Laboratory Medicine (EBLM) and Health Technology Assessment (HTA) as complementary approaches to support governance, appropriateness, and sustainability of laboratory diagnostics within the Italian National Health Service. The paper reviews the methodological principles of EBLM, including systematic evidence retrieval, critical appraisal of diagnostic studies, and translation of evidence into laboratory practice through validated tools such as QUADAS, GRADE, and STARD. It also examines the role of HTA in the multidimensional evaluation of diagnostic technologies, considering clinical effectiveness, safety, economic impact, organizational implications, ethical aspects, and acceptability. Particular attention is devoted to the concept of diagnostic “claim” and to the “linked evidence” approach, which connects analytical performance with clinical outcomes and healthcare value. An integrated EBLM-HTA framework is proposed as a pragmatic decision-making model to support the introduction, adoption, restriction, or disinvestment of diagnostic tests. The paper also highlights the growing importance of rapid HTA models, real-world evidence, artificial intelligence, and living HTA strategies in laboratory medicine. Despite persistent methodological and cultural challenges, the integration of EBLM and HTA represents a key strategy for improving diagnostic appropriateness, healthcare quality, and sustainability.