Is regulatory science ready for artificial intelligence?

Abstract 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), regulat...

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Main Authors: Thomas Hartung, Maurice Whelan, Weida Tong, Robert M. Califf
Format: Article
Language:English
Published: Nature Portfolio 2025-04-01
Series:npj Digital Medicine
Online Access:https://doi.org/10.1038/s41746-025-01596-0
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author Thomas Hartung
Maurice Whelan
Weida Tong
Robert M. Califf
author_facet Thomas Hartung
Maurice Whelan
Weida Tong
Robert M. Califf
author_sort Thomas Hartung
collection DOAJ
description Abstract 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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spelling doaj-art-73f9bcd7d0da4e9f98ee141e8ecdb9d12025-08-20T02:12:02ZengNature Portfolionpj Digital Medicine2398-63522025-04-01811510.1038/s41746-025-01596-0Is regulatory science ready for artificial intelligence?Thomas Hartung0Maurice Whelan1Weida Tong2Robert M. Califf3Johns Hopkins University, Bloomberg School of Public Health and Whiting School of EngineeringEuropean Commission, Joint Research Center (JRC)National Center for Toxicological Research, US Food and Drug AdministrationOffice of Commissioner, US Food and Drug AdministrationAbstract 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.https://doi.org/10.1038/s41746-025-01596-0
spellingShingle Thomas Hartung
Maurice Whelan
Weida Tong
Robert M. Califf
Is regulatory science ready for artificial intelligence?
npj Digital Medicine
title Is regulatory science ready for artificial intelligence?
title_full Is regulatory science ready for artificial intelligence?
title_fullStr Is regulatory science ready for artificial intelligence?
title_full_unstemmed Is regulatory science ready for artificial intelligence?
title_short Is regulatory science ready for artificial intelligence?
title_sort is regulatory science ready for artificial intelligence
url https://doi.org/10.1038/s41746-025-01596-0
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