Is regulatory science ready for artificial intelligence?

npj Digital Medicine. 2025;8(1):1-5. doi: 10.1038/s41746-025-01596-0

Trust is key in AI for regulatory science, but its definition is debated. If AI models use different features yet perform similarly, which should be trusted? If scientific theories must be testable, how critical is explainability? At the Global Summit on Regulatory Science (GSRS24), regulators agreed that successful AI adoption requires ongoing dialogue, adaptability, and AI-trained personnel to harness its potential for regulatory responsibilities in the evolving 21st-century landscape.

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