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Innovating global regulatory frameworks for generative AI in medical devices is an urgent priority
0
Zitationen
16
Autoren
2026
Jahr
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.
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Autoren
Institutionen
- Singapore General Hospital(SG)
- Duke-NUS Medical School(SG)
- University of California, San Francisco(US)
- Stanford University(US)
- SingHealth(SG)
- Fresenius (Germany)(DE)
- Technische Universität Dresden(DE)
- Brigham and Women's Hospital(US)
- Harvard University(US)
- Dana-Farber Cancer Institute(US)
- Dana-Farber Brigham Cancer Center(US)
- Mass General Brigham(US)
- University Hospitals Birmingham NHS Foundation Trust(GB)
- University College Birmingham(GB)
- University of Birmingham(GB)
- National University of Singapore(SG)
- Duke University(US)