Legal Master Thesis: Navigating the Evolving EU Neurotechnology Landscape: A Multi-Regulatory Analysis

This thesis investigates the fragmented and often ambiguous regulatory landscape governing non-medical brain-computer interfaces (BCIs) and brain data wearables in the European Union, addressing the critical gaps that emerge when these devices operate outside of a medical context. By conducting a detailed analysis of key EU regulations, including the General Data Protection Regulation (GDPR), the AI Act (AIA), the General Product Safety Regulation (GPSR), and the Medical Device Regulation (MDR), this research aims to identify where current frameworks fall short in ensuring consumer privacy and safety. A secondary review of the Radio Equipment Directive (RED), Cyber Resilience Act (CRA), and other relevant standards, further highlights the need for a comprehensive and harmonized approach to address issues of cybersecurity and data integrity. The findings of this research provide a crucial legal and technical framework for regulators, manufacturers, and researchers, offering a path toward harmonized governance that can foster innovation while protecting fundamental rights in the expanding field of consumer neurotechnology.

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Publication Details

Journal
Zenodo (CERN European Organization for Nuclear Research)
Published
2025-10-09
DOI
https://doi.org/10.5281/zenodo.18045355
Primary Topic
Neuroethics, Human Enhancement, Biomedical Innovations
Type
article
Field-Weighted Citation Impact
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article

Legal Master Thesis: Navigating the Evolving EU Neurotechnology Landscape: A Multi-Regulatory Analysis

Tania Alejandra Gonzalez Alfaro
Zenodo (CERN European Organization for Nuclear Research)
Neuroethics, Human Enhancement, Biomedical Innovations
article

Legal Master Thesis: Navigating the Evolving EU Neurotechnology Landscape: A Multi-Regulatory Analysis

Tania Alejandra Gonzalez Alfaro
article en

Abstract

This thesis investigates the fragmented and often ambiguous regulatory landscape governing non-medical brain-computer interfaces (BCIs) and brain data wearables in the European Union, addressing the critical gaps that emerge when these devices operate outside of a medical context. By conducting a detailed analysis of key EU regulations, including the General Data Protection Regulation (GDPR), the AI Act (AIA), the General Product Safety Regulation (GPSR), and the Medical Device Regulation (MDR), this research aims to identify where current frameworks fall short in ensuring consumer privacy and safety. A secondary review of the Radio Equipment Directive (RED), Cyber Resilience Act (CRA), and other relevant standards, further highlights the need for a comprehensive and harmonized approach to address issues of cybersecurity and data integrity. The findings of this research provide a crucial legal and technical framework for regulators, manufacturers, and researchers, offering a path toward harmonized governance that can foster innovation while protecting fundamental rights in the expanding field of consumer neurotechnology.

Zenodo (CERN European Organization for Nuclear Research)
Management Center Innsbruck (AT)
Openalex Percentile: Top 33%
Neuroethics, Human Enhancement, Biomedical Innovations
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