Regulating Neurotechnologies and AI-Driven Neural Implants in the European Union: Legal and Ethical Challenges

Sammanfattning

This thesis explores the legal, ethical, and human rights challenges posed by emerging neurotechnologies and Artificial Intelligence (AI)-driven neural implants within the European Union. It critically assesses the adequacy of current EU regulatory frameworks, specifically the General Data Protection Regulation, the Artificial Intelligence Act, and the Medical Device Regulation in addressing the unique risks and implications associated with these rapidly advancing technologies. Through an in-depth analysis, the study identifies both overlaps and significant gaps within these frameworks, particularly regarding the protection of mental privacy, autonomy, and integrity. The research further investigates the fundamental human rights implicated by neurotechnological interventions, emphasising the layered protection offered by existing rights to physical and mental integrity, freedom of thought, and expression. However, it finds that current human rights frameworks lack sufficient clarity and specificity to effectively safeguard emerging concerns such as mental autonomy, equitable access, and protection against novel discriminatory practices like ‘neuroprofiling’. Finally, the thesis engages with the evolving concept of neurorights, highlighting scholarly debates on whether such rights should be enshrined as new fundamental rights or integrated through reinterpretation of existing legal instruments. It advocates for the latter approach, urging normative and legal reforms that recalibrate and expand current protections to responsibly address the ethical, legal, and societal challenges posed by neurotechnologies and AI-driven neural implants. Additionally, this thesis also includes brief comparative insights from international and EU Member State practices, such as those in Latin America and the Caribbean, Chile and Spain, to demonstrate how the concept of neurorights, neurodata, and the protection of existing human rights can be addressed in different jurisdictions, providing a broader perspective on such regulations and potential models for legal reforms. The findings underscore the urgent need for proactive, forward-looking regulatory measures that align with technological innovation while upholding human dignity, privacy, and fundamental rights in the EU context.