Ethical Risks and Governance of Consumer Electroencephalography-Based Neurotechnology: Qualitative Interview Study With Expert Stakeholders

Background Consumer electroencephalography (EEG)-based neurotechnologies are rapidly expanding across commercial digital health delivery networks and wellness markets. Positioned at the intersection of non-medical self-monitoring and clinical applications, these consumer devices introduce complex challenges for device governance and digital bioethics regarding product claims, data privacy, evidential substantiation, and user protection. Objective This qualitative study examined expert stakeholder perspectives on the ethical, regulatory, and data governance challenges of consumer EEG neurotechnology, focusing on the allocation of responsibility across product lifecycles. Methods We conducted semi-structured interviews with 19 expert stakeholders spanning research, clinical practice, engineering, industry, ethics, law, and regulatory policy across North America, Europe, and Latin America. Interview data were systematically analysed using reflexive thematic analysis to examine how governance challenges, evidence burdens, and responsibilities are conceptualized across the neurotechnology ecosystem. Results Five interrelated themes emerged: (1) Regulatory Category Boundaries and Oversight; (2) Evidential Credibility and Claims-Related Harm; (3) Neurodata Privacy, Security, and Inference; (4) Layered Governance and Explicit Accountability; and (5) Participation, Global Equity, and Contextual Responsiveness. Participants identified major friction in applying traditional medical oversight to nonmedical digital health uses, linked unverified claims to user vulnerability, and expressed concern over downstream neurodata processing. A connecting synthesis demonstrates that oversight responsibilities span multiple actors and development stages rather than resting on a single regulatory mechanism. Conclusions Effective governance of consumer EEG digital health devices requires explicit allocation of duties for claims substantiation, data practices, and user safety, backed by inclusive stakeholder participation and contextual responsiveness.