Do Specialized Medical LLMs Demand a Radically New Approach Under the EU's Medical Device Regulation
Document Type
Article
Publication Date
2025
Abstract
We examine the arguments made by Onitiu and colleagues concerning the need to adopt a “backward-walking logic” to manage the risks arising from the use of Large Language Models (LLMs) adapted for a medical purpose. We examine what lessons can be learned from existing multi-use technologies and applied to specialized LLMs, notwithstanding their novelty, and explore the appropriate respective roles of device providers and regulators within the ecosystem of technological oversight.
Recommended Citation
Smith, Hannah Louise and W. Nicholson Price II. "Do Specialized Medical LLMs Demand a Radically New Approach Under the EU’s Medical Device Regulation?" Journal of Law, Medicine & Ethics 53, no. 3 (2025): 465-466.
Included in
Artificial Intelligence and Robotics Commons, Health Law and Policy Commons, Medical Jurisprudence Commons
Comments
© The Author(s), 2025. Published by Cambridge University Press on behalf of American Society of Law, Medicine & Ethics. This is an Open Access article, distributed under the terms of the Creative Commons Attribution licence (http://creativecommons.org/licenses/by/4.0), which permits unrestricted re-use, distribution and reproduction, provided the original article is properly cited.