Objective

farmaec

FARMAKOEKONOMIKA. Modern Pharmacoeconomics and Pharmacoepidemiology

ФАРМАКОЭКОНОМИКА. Современная фармакоэкономика и фармакоэпидемиология

2070-49092070-4933

IRBIS LLC

10.17749/2070-4909/farmakoekonomika.2025.328

farmaec-1240

Research Article

ORIGINAL ARTICLES

ОРИГИНАЛЬНЫЕ ПУБЛИКАЦИИ

Artificial intelligence in healthcare: global implementation, legal regulation, problems and ethical issues

Искусственный интеллект в здравоохранении: мировой опыт внедрения, правовое регулирование, проблемы и этические аспекты

https://orcid.org/0000-0002-0459-0488

Корабельников

Д. И.

Korabelnikov

D. I.

Корабельников Даниил Иванович, к.м.н., доцент

2-я Брестская ул., д. 5, Москва 123056

5 2nd Brestskaya Str., Moscow 123056

lamotkin.an@mail.ru

https://orcid.org/0000-0001-7930-6018

Ламоткин

А. И.

Lamotkin

A. I.

Ламоткин Андрей Игоревич

2-я Брестская ул., д. 5, Москва 123056; ул. Добролюбова, д. 11, Москва 127254

5 2nd Brestskaya Str., Moscow 123056;11 Dobrolyubov Str., Moscow 127254

lamotkin.an@mail.ru

Автономная некоммерческая организация дополнительного профессионального образования «Московский медико-социальный институт им. Ф.П. Гааза»РоссияMoscow Haass Medical and Social InstituteRussian Federation

Автономная некоммерческая организация дополнительного профессионального образования «Московский медико-социальный институт им. Ф.П. Гааза; Федеральное государственное бюджетное учреждение «Центральный научно-исследовательский институт организации и информатизации здравоохранения» Министерства здравоохранения Российской ФедерацииРоссияMoscow Haass Medical and Social Institute; Central Research Institute of Organization and Informatization of HealthcareRussian Federation

2023

11092025

Online First

1240

2023

Корабельников Д.И., Ламоткин А.И.

Korabelnikov D.I., Lamotkin A.I.

This work is licensed under a Creative Commons Attribution 4.0 License.

https://www.pharmacoeconomics.ru/jour/article/view/1240

Objective

Objective: To analyze the legal and ethical aspects of regulating artificial intelligence (AI) in medicine in key jurisdictions (United States, European Union, China, Russia), to identify regulatory gaps, ethical dilemmas and prospects for harmonization of standards.

Material and methods

Material and methods. National and international regulatory documents (GDPR, AI Act, FDA, NMPA), scientific publications, clinical cases and regulatory initiatives (IMDRF, WHO) were reviewed. Methods for comparative legal analysis and systematization of ethical and legal norms were used.

Results

Results. Considerable differences in approaches to AI regulation were identified, including flexibility in the US, the ethical centricity in the EU, centralization in China and an emerging framework in Russia. Key issues were emphasized, such as algorithmic bias, AI transparency, responsibility, and the conflict between innovation and security.

Conclusion

Conclusion. The harmonization of international standards, the introduction of dynamic regulation and the strengthening of interdisciplinary cooperation should be pursued to achieve a balance between innovation and the protection of patients' rights.

Цель

Цель: анализ внедрения, правового регулирования, проблем и этических аспектов искусственного интеллекта (ИИ) в медицине в ключевых регионах (Соединенные Штаты Америки, Европейский союз, Китай, Россия), выявление регуляторных пробелов, этических дилемм и перспектив гармонизации стандартов.

Материалы и методы

Материалы и методы. Проведен обзор международных и национальных нормативных документов (GDPR, AI Act, FDA, NMPA), научных публикаций, клинических примеров и регуляторных инициатив (IMDRF, WHO). Использованы методы сравнительного правового анализа и систематизации этико-правовых норм.

Результаты

Результаты. Выявлены значительные различия в подходах к регулированию ИИ: гибкость в США, этикоцентричность в ЕС, централизация в Китае и формирующаяся база в России. Обозначены ключевые проблемы: предвзятость алгоритмов, прозрачность ИИ, ответственность, конфликт инноваций и безопасности.

Заключение

Заключение. Необходима гармонизация международных стандартов, внедрение динамического регулирования и усиление междисциплинарного сотрудничества для баланса между инновациями и защитой прав пациентов.

искусственный интеллектмедицинское правоправовое регулированиеэтикапредвзятость алгоритмовконфиденциальность данных

artificial intelligencemedical lawlegal regulationethicsalgorithmic biasdata privacy

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