Europe's independent ethics advisors have released a major statement calling for a systemic overhaul of how the European Union regulates the convergence of neurotechnology and artificial intelligence. The European Group on Ethics in Science and New Technologies (EGE) argues that current regulatory approaches focused on individual devices and data privacy are insufficient to address the broader societal risks posed by interconnected neuro-AI infrastructures.

What Exactly Is Neuro-AI and Why Should You Care?

Neurotechnology and artificial intelligence are increasingly merging in ways that create powerful new capabilities but also new risks. Neurodata, which includes information about brain activity and neural patterns, can now be collected, combined, and reused to train AI models and applications across different contexts. This convergence opens doors to breakthroughs in healthcare, rehabilitation, and scientific research. However, it also raises urgent questions about fundamental rights, democratic accountability, and whether individuals can maintain control over how their brain data is used.

The EGE's new statement, titled "Governing Neuro-AI: Towards an Infrastructure Approach," represents a significant shift in thinking about AI regulation in Europe. Rather than treating neuro-AI as a collection of individual devices or privacy concerns, the experts are urging policymakers to view these systems as interconnected infrastructures through which neurodata flows, gets processed, and is reused to create, deploy, and manage AI-powered neurotechnology applications.

How Should Europe Regulate Brain-AI Systems? Five Key Recommendations

• Robust Neurodata Protection: Define and reinforce protections for neurodata and neurodata-derived inferences under existing EU data protection law to ensure brain data receives appropriate safeguards.
• Responsible Technology Development: Ensure the possible development of Brain Foundation Models and related neuro-AI infrastructures while maintaining ethical standards and public oversight.
• Strong Individual Rights: Protect individuals against disproportionate control and manipulation where neurodata and neurodata-derived inferences are used in consequential contexts like employment or criminal justice.
• Enhanced Governance Capacity: Build European public-interest governance capacity specifically designed for neuro-AI infrastructures to ensure democratic oversight and accountability.
• Comprehensive Regulatory Assessment: Conduct a targeted fitness check of the existing EU regulatory framework to identify gaps and determine what new rules are needed for neuro-AI systems.

Why Is This Different from the EU AI Act?

The EU AI Act, which entered into force in 2024, established a risk-based framework for regulating artificial intelligence systems. However, the EGE's statement suggests that this framework may not adequately address the unique challenges posed by the convergence of neurotechnology and AI. The ethics experts are calling for a more targeted approach that recognizes neuro-AI as a distinct category requiring specialized governance.

The shift from device-level regulation to infrastructure-level governance reflects a growing recognition among European policymakers that AI systems operate within complex, interconnected ecosystems. A single neurotechnology device might collect brain data that flows into multiple AI systems, each using that data for different purposes. Traditional privacy-focused regulation struggles to address these systemic risks because it treats each component in isolation.

What Does This Mean for European Technological Sovereignty?

The EGE's statement also addresses questions of European technological sovereignty and public-interest infrastructures. This reflects broader European concerns about maintaining strategic autonomy in critical technologies rather than becoming dependent on non-European companies and systems. By calling for robust European governance capacity for neuro-AI, the experts are essentially arguing that Europe needs to develop its own institutional expertise and regulatory infrastructure to manage these emerging technologies.

The statement comes from the European Group on Ethics in Science and New Technologies, an independent, multidisciplinary body of experts that provides ethical advice to the European Commission. The EGE is part of the Ethics Advice Mechanism (EthAM), which offers high-quality, independent guidance on all aspects of EU legislation and policies where ethical, societal, and fundamental rights issues intersect with scientific and technological development.

The timing of this statement is significant. As neurotechnology research accelerates across Europe and globally, policymakers face mounting pressure to establish clear rules before these systems become deeply embedded in healthcare systems, workplaces, and other critical institutions. The EGE's call for a comprehensive fitness check of existing EU frameworks suggests that Europe's current regulatory toolkit may need substantial updates to address the neuro-AI challenge effectively.