Current challenges and the way forwards for regulatory databases of artificial intelligence as a medical device

Journal article : Review

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.

Authors: Ong, AY; Kale, AU; Antoun, J; Hogg, HDJ; Hammond, B

• Publication status: Published
• Peer review status: Peer reviewed
• Publisher: Nature Research
• Journal: npj Digital Medicine
• Volume: 9
• Issue: 1
• Article number: 235
• Publication date: 2026-02-11
• Acceptance date: 2026-01-23
• DOI: 10.1038/s41746-026-02407-w
• EISSN: 2398-6352
• ISSN: 2398-6352
• Language: English
• Keywords: Key (lock); Multidisciplinary approach; Quality (philosophy); Medical device; Big data
• Subtype: Review