Perspective calls for global regulatory frameworks for generative AI medical devices
A perspective article says global regulatory frameworks for generative AI medical devices are an urgent priority. It highlights risks, limits of current rules, and the need for multidisciplinary collaboration.
A perspective article said innovating global regulatory frameworks for generative AI in medical devices is an urgent priority. The integration of generative AI and large language models in healthcare presents both unprecedented opportunities and challenges, necessitating innovative regulatory approaches.
The article discusses the risks of GenAI and LLM-based medical devices and the limitations of current medical device regulation frameworks when applied to GenAI or LLMs. It advocates for global collaboration in regulatory science research through engaging multidisciplinary expertise and focusing on the needs of diverse populations.
The article cited Food and Drug Administration, U.S.A. Total product lifecycle considerations for generative AI-enabled devices in 2024, work on ethical and regulatory challenges of large language models in medicine, testing and evaluation of health care applications of large language models, benchmark evaluation of DeepSeek large language models in clinical decision-making, and evaluation and mitigation of the limitations of large language models in clinical decision-making. It also referenced work on a toolbox for surfacing health equity harms and biases in large language models, medical large language models being vulnerable to data-poisoning attacks, and algorithmovigilance.
The article said no datasets were generated or analysed during the current study.