Innovating global regulatory frameworks for generative AI in medical devices is an urgent priority
Year: 2026
Type: review
Abstract: The integration of generative AI (GenAI) and large language models (LLMs) in healthcare presents both unprecedented opportunities and challenges, necessitating innovative regulatory approaches. In this perspective, we discuss the risks of GenAI and LLM-based medical devices, the limitations of current medical device regulation frameworks when applied to GenAI or LLMs, and advocate for global collaboration in regulatory science research through engaging multidisciplinary expertise and focusing on the needs of diverse populations.
Source: npj Digital Medicine
Institutions: Singapore General Hospital, Duke-NUS Medical School, University of California, San Francisco, Stanford Medicine, Stanford University, National University of Singapore, SingHealth, Else Kröner Fresenius Center for Digital Health, Technische Universität Dresden, Brigham and Women's Hospital, Harvard University, Dana-Farber Cancer Institute, Dana-Farber Brigham Cancer Center, Mass General Brigham, University Hospitals Birmingham NHS Foundation Trust, University of Birmingham, Duke University, SingHealth Duke-NUS Academic Medical Centre
Language: English
Subfield: Health Informatics
Field: Medicine
Domain: Health Sciences
Open Access status: gold
Estimated APC paid: $4,090
OpenAlex ID: W7138919120