Current challenges and the way forwards for regulatory databases of artificial intelligence as a medical device
Ong, Ariel Yuhan Kale, Aditya U Antoun, Joe Hogg, Henry David Jeffry Hammond, Ben Keane, Pearse A Pearson, Russell Harvey, Hugh Denniston, Alastair K
Ong, Ariel Yuhan
Kale, Aditya U
Antoun, Joe
Hogg, Henry David Jeffry
Hammond, Ben
Keane, Pearse A
Pearson, Russell
Harvey, Hugh
Denniston, Alastair K
Abstract
Effective regulatory oversight is a key step in ensuring that artificial intelligence as a medical device (AIaMD) is safe in real-world clinical settings. In this Perspective, we provide insights from our experience working with international regulatory databases, informed by our recent research and the expertise of the multidisciplinary authorship team. We highlight four key challenges, discuss attempts to circumvent these limitations, and highlight emerging initiatives. Nevertheless, the underlying issue of the quality and availability of input data from regulatory databases remains. We discuss considerations for improving accessibility and transparency, outline key aspects for a next-generation regulatory data ecosystem for AIaMDs, and call on global stakeholders to come together and align efforts to develop a clear roadmap to accelerate safe innovation and improve outcomes for patients worldwide.
MIDER Authors
Affiliations
Moorfields Eye Hospital NHS Foundation Trust; University College London; NIHR Moorfields Biomedical Research; Oxford University Hospitals NHS Foundation Trust; University Hospitals Birmingham NHS Foundation Trust; University of Birmingham; NIHR Birmingham Biomedical Research Centre; Hardian Health; Medicines and Healthcare Products Regulatory Agency; Birmingham Health Partners Centre for Regulatory Science and Innovation
Date
2026-02-11
Type
Article
Collections
Citation
Ong AY, Kale AU, Antoun J, Hogg HDJ, Hammond B, Keane PA, Pearson R, Harvey H, Denniston AK. Current challenges and the way forwards for regulatory databases of artificial intelligence as a medical device. NPJ Digit Med. 2026 Feb 11;9(1):235. doi: 10.1038/s41746-026-02407-w.