The convergence of (multi-)omics and artificial intelligence is transforming precision medicine by enabling data-driven diagnostics, treatment prediction, and patient stratification. Yet, regulatory frameworks lag behind this innovation. This commentary discusses emerging issues around data integrity, algorithm transparency, validation and real-world evidence integration, highlighting gaps between device and pharmaceutical regulations. Drawing on examples of regulatory-approved AI-enabled (multi-)omics tools in the EU and US, we explore evolving regulatory pathways shaping the clinical adoption of next-generation tools for precision medicine.
Welzel et al. (Tue,) studied this question.