Legal Master Thesis: Navigating the Evolving EU Neurotechnology Landscape: A Multi-Regulatory Analysis
Year: 2025
Type: dissertation
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.
Author: Gonzalez Alfaro, Tania Alejandra
Institution: Management Center Innsbruck
Language: English
Subfield: Law
Field: Social Sciences
Domain: Social Sciences
Open Access status: green
OpenAlex ID: W7117239355
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