# Do Specialized Medical LLMs Demand a Radically New Approach Under the EU’s Medical Device Regulation?

## TL;DR

This paper discusses whether specialized medical LLMs require a new regulatory approach under EU rules.

## Contribution

The paper analyzes the need for a novel regulatory framework for medical LLMs based on lessons from multi-use technologies.

## Key findings

- Existing multi-use technologies offer lessons for regulating specialized medical LLMs.
- A 'backward-walking logic' may be necessary to manage risks from medical LLMs.
- Regulators and providers must define clear roles in overseeing these technologies.

## 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.