Neuroethics and Regulatory Imperatives for Secure Brain–Machine Interfaces

Brain–Machine Interfaces (BMIs) challenge existing ethical and regulatory frameworks by introducing direct interaction with neural activity—the substrate of identity, agency, and autonomy. As operating systems such as THEMI-OS propose security-first, brain-sovereign architectures, it becomes essential to examine the neuroethical foundations and regulatory pathways that must govern their development and deployment. This companion paper analyzes BMI technology through the lenses of neuroethics, human rights, data protection law, and medical-device regulation. It evaluates risks such as cognitive surveillance, neural coercion, identity misuse, and algorithmic bias, while mapping existing regulatory regimes across jurisdictions. The paper further proposes a practical neuroethical governance framework aligned with minimalist BMI operating systems, emphasizing precaution, proportionality, and reversibility. The aim is to offer a credible, non-alarmist, and policy-relevant contribution to responsible BMI innovation.