Regulating complexity in AI-enabled omics and multi-omics technologies for precision medicine.
expert_opinion · Level V
Where this comes from
- Record sourced from PubMed, PMID 41845005.
- Also identified by DOI 10.1038/s41746-026-02553-1 and PMC identifier 13022003.
- Licence recorded as CC BY-NC-ND.
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Abstract
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.