Regulating complexity in AI-enabled omics and multi-omics technologies for precision medicine
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.
Fields of Study & Subjects
Artificial Intelligence in Healthcare and Education
Cancer Genomics and Diagnostics
Genomics and Rare Diseases
Publication details
- Journal / source
- npj Digital Medicine
- Publisher
- Springer Science and Business Media LLC
- Volume
- 9
- Issue
- 1
- Publication date
- 17 March 2026
- Language
- EN