Moskva, Russian Federation
Russian Federation
Introduction. The rapid development of neurotechnologies and brain–computer interfaces expand opportunities for diagnosis, treatment, rehabilitation, and restoration of communication while creating new ethical, legal, and organisational risks related to cognitive liberty, personal autonomy, mental privacy, neural data security, and interventions affecting nervous system functions. International documents establish general principles for the responsible development of neurotechnologies; however, mechanisms for their practical implementation, including risk classification, ethics review, audit, monitoring, and allocation of responsibility, remain heterogeneous. Aim. To conduct a comparative analysis of international ethical and regulatory approaches to the development and application of neurotechnologies and to substantiate the conceptual architecture of the project «Code of Ethics for the Development and Application of Neurotechnologies and Interfaces» (Neurocodex) version 1.0 as the basis of the national lifecycle management system for neurotechnologies and brain–computer interfaces. A normative and conceptual analysis of the Neurocodex and its comparison with international documents, as well as scientific publications on neuroethics, neuro-law, protection of neurodata and regulation of brain–computer interfaces has been carried out. The analysis demonstrated that the Neurocode integrates the principles of human rights and dignity, cognitive liberty, personal autonomy, mental privacy, transparency, fairness, and non-discrimination with mechanisms of risk-based classification, independent ethics review, clinical and cybersecurity requirements, accountability, monitoring, and long-term stewardship. The proposed four-tier risk classification takes into account technology invasiveness, the nature of effects on the nervous system, reversibility of consequences, sensitivity of neural data, algorithmic autonomy, and context of use. Conclusion. Neurocode version 1.0 may be regarded as a conceptual foundation for a national ethical system for the responsible development and use of neurotechnologies, enabling a transition from general principles to procedures for risk assessment, independent review, audit, monitoring, and long-term stewardship. Its further development requires interdisciplinary testing, formalisation of risk-level criteria, measurable compliance indicators, and harmonisation with current legislation
neurocodex, neurotechnology, brain–computer interface, neuroethics, neuropravity, neurodata, cognitive freedom, mental privacy, ethical expertise, risk-based regulation
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