Laboratory 4.0: on the path to the fourth generation of laboratory medicine

Abstract Laboratory medicine has witnessed three generational paradigm shifts over the past 75 years – from manual work to early automation, from batch processing to patient-oriented selective analysis, and from human perianalytics to Total Laboratory Automation (TLA). Drawing on a personal trajectory spanning half a century of the discipline, this essay argues that a fourth generation, called “Laboratory 4.0”, is not a distant utopia but an expected reality, just like the so-called “Industry 4.0,” which is emerging in other areas of technological development. Three converging forces are driving this transformation: miniaturization (microfluidics, lab-on-a-chip platforms, and painless capillary sampling), decentralization (pervasive diagnostics available at any point and time without a central laboratory as intermediary), and artificial intelligence (from classical decision-support systems to generative large language models). A hybrid model is proposed in which incremental modernization within existing structures (until ∼2035) gives way to genuine decentralization and democratization of diagnostic services (∼2035 to 2045), followed by a fundamental redefinition of the discipline’s role in society from 2045 onwards. Underlying these technical developments is a new epistemic responsibility: as AI transforms raw data into medical knowledge autonomously, laboratory professionals must claim their irreplaceable role as the sole legally and professionally qualified institution responsible for translating laboratory data into medical insight. The future of laboratory medicine is not a swan song, it is an invitation to actively shape the laboratory 4.0.