lexgenLex GeneticaLex Genetica3034-16393034-1647МГЮА10.17803/lexgen-2025-4-2-63-75lexgen-71Research ArticleLex Genetica: вопросы этики и философииLex Genetica: Questions of Ethics and PhilosophyЭтические аспекты создания и применения медицинских изделий на основе наноробототехники: правовые и деонтологические проблемыEthical Aspects of Creation and Application of Medical Devices Based on Nanorobotics: Legal and Deontological IssuesБегишевИ. Р.BegishevI. R.

Ильдар Р. Бегишев, доктор юридических наук, доцент, заслуженный юрист Республики Татарстан, главный научный сотрудник Научно-исследовательского института цифровых технологий и права 

Казань 

Ildar R. Begishev, Doctor of Science (Law), Associate Professor, Honored Lawyer of the Republic of Tatarstan, Chief Research Associate, Research Institute of Digital Technologies and Law

Kazan 

begishev@mail.ruШутоваА. А.ShutovaA. A.

Альбина А. Шутова, кандидат юридических наук, старший научный сотрудник Научно-исследовательского института цифровых технологий и права

Казань 

Albina A. Shutova, Candidate of Science (Law), Senior Researcher, Research Institute of Digital Technologies and Law

Kazan 

ГуляеваП. С.GulyaevaP. S.

Полина С. Гуляева, младший научный сотрудник Научно-исследовательского института цифровых технологий и права

Казань 

Polina S. Gulyaeva, Junior Researcher, Research Institute of Digital Technologies and Law 

Kazan 

Казанский инновационный университет имени В.Г. ТимирясоваРоссияKazan Innovation University named af ter V.G. TimiryasovRussian Federation202503082025426375Copyright © Бегишев И.Р., Шутова А.А., Гуляева П.С., 20252025Бегишев И.Р., Шутова А.А., Гуляева П.С.Begishev I.R., Shutova A.A., Gulyaeva P.S.Данная работа распространяется под лицензией Creative Commons Attribution 4.0.This work is licensed under a Creative Commons Attribution 4.0 License.https://lexgen.msal.ru/jour/article/view/71

Статья посвящена комплексному анализу этических аспектов создания, применения и утилизации медицинских изделий на основе наноробототехники. Авторы выявляют и систематизируют ключевые правовые и деонтологические проблемы, возникающие на стыке стремительного технологического прогресса в области наномедицины, что создает опасный регуляторный вакуум.Основное внимание уделено разработке системы фундаментальных этических принципов, регулирующих деятельность всех вовлеченных сторон на протяжении жизненного цикла наноробототехнических систем. Для производителей сформулированы следующие принципы: приоритет биосовместимости материалов (на молекулярном и системном уровнях); контроль таргетирования и предсказуемости жизненного цикла устройств; приоритет благополучия пациентов над коммерческими интересами; абсолютный запрет на автономное принятие решений устройствами и ограничение репликации. Для медицинских работников ключевыми принципами являются: получение информированного согласия пациента; непрерывный мониторинг состояния пациента; добровольность применения технологий; профессиональная ответственность за все этапы применения; эмпатия и обязательное наличие соответствующей квалификации. Медицинские организации должны руководствоваться принципами институциональной ответственности (техническое обслуживание, соответствие стандартам), обеспечения качества, сбора и хранения данных, недопущения дискриминации пациентов, отказавшихся от наноробототехники, а также защиты интересов как пациентов, так и медицинского персонала. Отдельно выделены этические принципы утилизации медицинских изделий, включая запрет повторного использования и обязательную экологическую безопасность.Авторы обосновывают необходимость разработки и внедрения специализированного этического кодекса, охватывающего весь жизненный цикл медицинских наноробототехнических систем. Такой кодекс рассматривается как критически важная основа для последующего формирования адекватного законодательного регулирования, способствующего безопасной и ответственной реализации огромного потенциала наноробототехники для трансформации здравоохранения при обеспечении защиты пациентов и общества.

The article presents a comprehensive analysis of the ethical aspects of the creation, use, and disposal of medical devices based on nanorobotic technologies. Serious legal and deontological issues arising due to the insuf ficiency of existing ethical and legal norms to deal with rapid technological progress in nanomedicine reveal a dangerous regulatory vacuum. Therefore, the development of fundamental ethical principles to govern the activities of all parties involved throughout the life cycle of nanorobotic systems becomes an urgent priority. For manufacturers, such principles include prioritizing the biocompatibility of materials at both molecular and system levels, ensuring control over targeting and device lifecycle predictability, prioritizing patient well-being over commercial interests, an absolute ban on autonomous decision-making by devices, and clear limits on permissible replication. For medical professionals, the key principles concern obtaining informed consent, ensuring continuous monitoring of the patient’s condition, voluntary use of technology, professional responsibility at all stages of application, empathy, and the mandatory possession of appropriate qualifications. Medical organizations should be guided by the principles of institutional responsibility, including maintenance and compliance with standards, quality assurance, data collection and storage, non-discrimination against patients who have opted out of nanorobotic treatments, as well as the protection of the interests of both patients and medical staff. Ethical principles applying to the recycling of medical devices include a prohibition of reuse and fulfilling environmental safety requirements. The development and implementation of a specialized code of ethics to cover the entire life cycle of medical nanorobotic systems will provide a necessary foundation for the subsequent development of adequate legislative regulations that release the enormous potential of nanorobotics to transform healthcare while ensuring the protection of patients and society.

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The authors declare that there are no conflicts of interest present.