Neurotechnologies under the EU AI Act: Where law meets science

Just as the neurorights debate fires up globally, the EU Artificial Intelligence Act adds a new flavor to the regulatory soup of neurotechnologies in the EU.

Briefly, the AI Act applies when an AI system, either on its own or as a part of a product, is placed on the market in the EU, irrespective of where the provider — manufacturer — may be based, or when it is used by a deployer in the EU. It also applies to any provider or deployer, regardless of their place of establishment, if the output produced by the relevant AI system is intended to be used in the EU.

These obligations are in addition to existing legislation operators may already be subject to, such as the EU Medical Device Regulation and the General Data Protection Regulation.

Exceptions nonetheless exist, such as when an AI system or model is developed and used for the sole purpose of scientific research, pre-market research and testing — excluding testing in real world conditions — systems developed exclusively for military, defense or national security purposes, and personal or nonprofessional uses.

What is an AI system?

An AI system under the act is "a machine-based system that is designed to operate with varying levels of autonomy and that may exhibit adaptiveness after deployment, and that, for explicit or implicit objectives, infers, from the input it receives, how to generate outputs such as predictions, content, recommendations, or decisions that can influence physical or virtual environments."