patmedfarПациентоориентированная медицина и фармацияPatient-Oriented Medicine and Pharmacy2949-1924LLC Izdatelstvo OKI10.37489/2949-1924-0005patmedfar-11Research ArticleМЕДИЦИНСКАЯ КИБЕРНЕТИКАMEDICAL CYBERNETICSРегулирование искусственного интеллекта в медицинеRegulation of artificial intelligence in medicinehttps://orcid.org/0000-0001-7309-2215КошечкинК. А.KoshechkinK. A.

Кошечкин Константин Александрович — д. фарм. н., проф. кафедры информационных и интернет-технологий, Институт цифровой медицины

Москва

Koshechkin Konstantin A. — Doctor of Pharmaceutical Sciences, Prof. of the Department of Information and Internet Technologies, Institute of Digital Medicine

Moscow

koshechkin_k_a@staff.sechenov.ruФГАОУ ВО Первый Московский государственный медицинский университет им. И. М. Сеченова Минздрава России (Сеченовский Университет)РоссияFederal State Autonomous Educational Institution of Higher Education First Moscow State Medical University named after Sechenov of the Ministry of Health of Russia (Sechenov University)Russian Federation202321022023113240Copyright © Кошечкин К.А., 20232023Кошечкин К.А.Koshechkin K.A.Данная работа распространяется под лицензией Creative Commons Attribution 4.0.This work is licensed under a Creative Commons Attribution 4.0 License.https://www.pomph.ru/jour/article/view/11

Изучение регулирования искусственного интеллекта (ИИ) в здравоохранении включает краткий обзор текущего состояния использования ИИ в здравоохранении и его потенциальных преимуществ и рисков. В статье приведены текущие правила, которые существуют для ИИ в здравоохранении, включая любые соответствующие законы, руководящие принципы, и лучшие практики, включая информацию о регулирующих органах, таких как FDA и HIPAA. Приведены этические соображения, возникающие при использовании ИИ в здравоохранении, такие как конфиденциальность пациентов и безопасность данных, предвзятость в алгоритмах и прозрачность в принятии решений. Приведены примеры ИИ в здравоохранении, которые иллюстрируют проблемы и возможности, предоставляемые технологией, включая как успешные, так и неудачные внедрения. Описаны будущие разработки в области ИИ и здравоохранения, включая новые технологии и тенденции, а также прогнозы того, как правила могут развиваться в ответ на эти события. Подведены итоги и представлены рекомендации по решению регуляторных проблем, связанных с ИИ в здравоохранении.

A study on the regulation of artificial intelligence (AI) in healthcare, includes a brief overview of the current state of use of AI in healthcare and its potential benefits and risks. The article summarizes the current regulations that exist for AI in healthcare, including any relevant laws, guidelines, and best practices, including information on regulatory bodies such as the FDA and HIPAA. The ethical considerations arising from the use of AI in healthcare, such as patient confidentiality and data security, bias in algorithms, and transparency in decision making, are given. Examples of AI in healthcare are given that illustrate the challenges and opportunities provided by the technology, including both successful and unsuccessful implementations. Future developments in AI and healthcare are described, including emerging technologies and trends, and predictions of how rules might evolve in response to these developments. Summarize and provide recommendations for addressing regulatory challenges related to AI in healthcare.

искусственный интеллектрегулирование искусственного интеллектаэтика применения искусственного интеллектабиомедицинская этикаискусственный интеллект в медицинеartificial intelligenceregulation of artificial intelligenceethics of the use of artificial intelligencebiomedical ethicsartificial intelligence in medicineРабота выполнялась без спонсорской поддержки.The work was carried out without sponsorship.ReferencesFartushnyi EN et al. Стратификация узловых образований щитовидной железы по категориям Eu-TIRADS с использованием трансферного обучения свёрточных нейронных сетей // Клиническая и экспериментальная тиреоидология. 2022;18 (2):17-26.Fartushnyi EN et al. Стратификация узловых образований щитовидной железы по категориям Eu-TIRADS с использованием трансферного обучения свёрточных нейронных сетей // Клиническая и экспериментальная тиреоидология. 2022;18 (2):17-26.Lebedev G et al. Technology of supporting medical decision-making using evidence-based medicine and artificial intelligence // Procedia Computer Science. 2020;176.Lebedev G et al. Technology of supporting medical decision-making using evidence-based medicine and artificial intelligence // Procedia Computer Science. 2020;176.Schneider P et al. Rethinking drug design in the artificial intelligence era // Nat. Rev. Drug Discov. 2019 195. Nature Publishing Group. 2019;19 (5):353-64.Schneider P et al. Rethinking drug design in the artificial intelligence era // Nat. Rev. Drug Discov. 2019 195. Nature Publishing Group. 2019;19 (5):353-64.Обзор Российских систем искусственного интеллекта для здравоохранения [Electronic resource]. URL: https://webiomed.ru/blog/obzorrossiiskikh-sistem-iskusstvennogo-intellekta-dliazdravookhraneniia/ (accessed: 23.01.2023).Обзор Российских систем искусственного интеллекта для здравоохранения [Electronic resource]. URL: https://webiomed.ru/blog/obzorrossiiskikh-sistem-iskusstvennogo-intellekta-dliazdravookhraneniia/ (accessed: 23.01.2023).Бирюков П. Н. Деятельность США в сфере использования искусственного интеллекта. Вестник Воронежского государственного университета. Серия: Право. 2019;3 (38):324-34.Бирюков П. Н. Деятельность США в сфере использования искусственного интеллекта. Вестник Воронежского государственного университета. Серия: Право. 2019;3 (38):324-34.UHF Next Step in Care [Electronic resource]. URL: https://www.nextstepincare.org/next_step_in_care_guides/215/HIPAA/russian (accessed: 23.01.2023).UHF Next Step in Care [Electronic resource]. URL: https://www.nextstepincare.org/next_step_in_care_guides/215/HIPAA/russian (accessed: 23.01.2023).Текст GDPR на русском с комментариями и ссылками | GDPR-Text.com [Electronic resource]. URL: https://gdpr-text.com/ru/ (accessed: 23.01.2023).Текст GDPR на русском с комментариями и ссылками | GDPR-Text.com [Electronic resource]. URL: https://gdpr-text.com/ru/ (accessed: 23.01.2023).The Regulation of Medical Devices with Artificial Intelligence | Centre for Law, Technology and Society | University of Ottawa [Electronic resource]. URL: https://techlaw.uottawa.ca/aisociety/events/regulating-medical-devices (accessed: 23.01.2023).The Regulation of Medical Devices with Artificial Intelligence | Centre for Law, Technology and Society | University of Ottawa [Electronic resource]. URL: https://techlaw.uottawa.ca/aisociety/events/regulating-medical-devices (accessed: 23.01.2023).Positioning Australia as a leader in digital economy regulation-Artificial Intelligence and Automated Decision making. 18 MAR 2022. Government of Australia. ISBN: 978-1-925365-05-4.Positioning Australia as a leader in digital economy regulation-Artificial Intelligence and Automated Decision making. 18 MAR 2022. Government of Australia. ISBN: 978-1-925365-05-4.Software and AI as a Medical Device Change Programme — Roadmap | GOV. UK [Electronic resource]. URL: https://www.gov.uk/government/publications/software-and-ai-as-a-medicaldevice-change-programme/software-and-ai-asa-medical-device-change-programme-roadmap (accessed: 23.01.2023).Software and AI as a Medical Device Change Programme — Roadmap | GOV. UK [Electronic resource]. URL: https://www.gov.uk/government/publications/software-and-ai-as-a-medicaldevice-change-programme/software-and-ai-asa-medical-device-change-programme-roadmap (accessed: 23.01.2023).Ota N et al. A Concept for a Japanese Regulatory Framework for Emerging Medical Devices with Frequently Modified Behavior. Clin. Transl. Sci. Wiley-Blackwell, 2020;13 (5):877.Ota N et al. A Concept for a Japanese Regulatory Framework for Emerging Medical Devices with Frequently Modified Behavior. Clin. Transl. Sci. Wiley-Blackwell, 2020;13 (5):877.China SFDA Approval and Registration for Medical Devices, SFDA Registration Agent service [Electronic resource]. URL: http://www.sfda.com/ (accessed: 23.01.2023).China SFDA Approval and Registration for Medical Devices, SFDA Registration Agent service [Electronic resource]. URL: http://www.sfda.com/ (accessed: 23.01.2023).Digital Health Laws and Regulations Report 2022-2023 India [Electronic resource]. URL: https://iclg.com/practice-areas/digital-healthlaws-and-regulations/india (accessed: 23.01.2023).Digital Health Laws and Regulations Report 2022-2023 India [Electronic resource]. URL: https://iclg.com/practice-areas/digital-healthlaws-and-regulations/india (accessed: 23.01.2023).Donnelly DL, Donnelly D. First Do No Harm: Legal Principles Regulating the Future of Artificial Intelligence in Health Care in South Africa. Potchefstroom Electron. Law J. North West University. 2022:25 (1):1-43.Donnelly DL, Donnelly D. First Do No Harm: Legal Principles Regulating the Future of Artificial Intelligence in Health Care in South Africa. Potchefstroom Electron. Law J. North West University. 2022:25 (1):1-43.HSA Guidance on Life Cycle Approach for AI-based Devices: Regulatory Basics | RegDesk [Electronic resource]. URL: https://www.regdesk.co/hsaguidance-on-life-cycle-approach-for-ai-based-devices-regulatory-basics/ (accessed: 23.01.2023).HSA Guidance on Life Cycle Approach for AI-based Devices: Regulatory Basics | RegDesk [Electronic resource]. URL: https://www.regdesk.co/hsaguidance-on-life-cycle-approach-for-ai-based-devices-regulatory-basics/ (accessed: 23.01.2023).Lim K; et al. Trends in the Approval and Quality Management of Artificial Intelligence Medical Devices in the Republic of Korea. Diagnostics. Multidisciplinary Digital Publishing Institute, 2022;12 (2):355.Lim K; et al. Trends in the Approval and Quality Management of Artificial Intelligence Medical Devices in the Republic of Korea. Diagnostics. Multidisciplinary Digital Publishing Institute, 2022;12 (2):355.Нормативное регулирование искусственного интеллекта в медицине [Electronic resource]. URL: https://celsus.ai/blog/normativnoe-regulirovanie-iskusstvennogo-intellekta-v-medicine/ (accessed: 23.01.2023).Нормативное регулирование искусственного интеллекта в медицине [Electronic resource]. URL: https://celsus.ai/blog/normativnoe-regulirovanie-iskusstvennogo-intellekta-v-medicine/ (accessed: 23.01.2023).Нормативно-правовое регулирование искусственного интеллекта в здравоохранении России [Electronic resource]. URL: https://webiomed.ru/blog/normativno-pravovoeregulirovanie-iskusstvennogo-intellekta-vzdravookhranenii-rossii/ (accessed: 23.01.2023).Нормативно-правовое регулирование искусственного интеллекта в здравоохранении России [Electronic resource]. URL: https://webiomed.ru/blog/normativno-pravovoeregulirovanie-iskusstvennogo-intellekta-vzdravookhranenii-rossii/ (accessed: 23.01.2023).Guidance on Artificial Intelligence (AI) and Machine Learning (ML) technologies based Medical Devices Version Number: 1.0.Guidance on Artificial Intelligence (AI) and Machine Learning (ML) technologies based Medical Devices Version Number: 1.0.Medical Device Registration in U. A. E. [Electronic resource]. URL: https://www.themamed.com/en/medical-device-registration-u-a-e / (accessed: 24.01.2023).Medical Device Registration in U. A. E. [Electronic resource]. URL: https://www.themamed.com/en/medical-device-registration-u-a-e / (accessed: 24.01.2023).Artificial Intelligence Comparative Guide — Turkey [Electronic resource]. URL: https://www.mondaq.com/turkey/technology/1059772/artificial-intelligence-comparative-guide (accessed: 24.01.2023).Artificial Intelligence Comparative Guide — Turkey [Electronic resource]. URL: https://www.mondaq.com/turkey/technology/1059772/artificial-intelligence-comparative-guide (accessed: 24.01.2023).The Israel Innovation Authority in Action | Israel Innovation [Electronic resource]. URL: https://innovationisrael.org.il/en/reportchapter/israel-innovation-authority-action (accessed: 24.01.2023).The Israel Innovation Authority in Action | Israel Innovation [Electronic resource]. URL: https://innovationisrael.org.il/en/reportchapter/israel-innovation-authority-action (accessed: 24.01.2023).Wang C et al. Privacy Protection in Using Artificial Intelligence for Healthcare: Chinese Regulation in Comparative Perspective. Healthc. Multidisciplinary Digital Publishing Institute, 2022;10 (10):1878.Wang C et al. Privacy Protection in Using Artificial Intelligence for Healthcare: Chinese Regulation in Comparative Perspective. Healthc. Multidisciplinary Digital Publishing Institute, 2022;10 (10):1878.What Do We Do About the Biases in AI? [Electronic resource]. URL: https://hbr.org/2019/10/what-do-we-do-about-the-biases-in-ai (accessed: 24.01.2023).What Do We Do About the Biases in AI? [Electronic resource]. URL: https://hbr.org/2019/10/what-do-we-do-about-the-biases-in-ai (accessed: 24.01.2023).Habli I, Lawton T, Porter Z. Artificial intelligence in health care: accountability and safety. Bull. World Health Organ. World Health Organization, 2020;98 (4):251.Habli I, Lawton T, Porter Z. Artificial intelligence in health care: accountability and safety. Bull. World Health Organ. World Health Organization, 2020;98 (4):251.Study: Google AI can outdo the experts in finding breast cancer | Fierce Healthcare [Electronic resource]. URL: https://www.fiercehealthcare.com/tech/study-finds-google-ai-can-detect-breastcancer-as-well-as-doctors-and-sometimes-better (accessed: 24.01.2023).Study: Google AI can outdo the experts in finding breast cancer | Fierce Healthcare [Electronic resource]. URL: https://www.fiercehealthcare.com/tech/study-finds-google-ai-can-detect-breastcancer-as-well-as-doctors-and-sometimes-better (accessed: 24.01.2023).Wang J. Fast Identification of Possible Drug Treatment of Coronavirus Disease-19 (COVID-19) through Computational Drug Repurposing Study. J. Chem. Inf. Model. 2020;60 (6):3277-86.Wang J. Fast Identification of Possible Drug Treatment of Coronavirus Disease-19 (COVID-19) through Computational Drug Repurposing Study. J. Chem. Inf. Model. 2020;60 (6):3277-86.Yeh MCH. et al. Artificial Intelligence — Based Prediction of Lung Cancer Risk Using Nonimaging Electronic Medical Records: Deep Learning Approach. J. Med. Internet Res. JMIR Publications Inc., 2021;23 (8).Yeh MCH. et al. Artificial Intelligence — Based Prediction of Lung Cancer Risk Using Nonimaging Electronic Medical Records: Deep Learning Approach. J. Med. Internet Res. JMIR Publications Inc., 2021;23 (8).HCA Healthcare hospitals recognized among U. S. 100 Top Hospitals, 15 Top Health Systems by Fortune / IBM Watson Health | HCA Healthcare Today [Electronic resource]. URL: https://hcahealthcaretoday.com/2021/05/12/hca-healthcare-hospitals-recognized-among-u-s-100-tophospitals-15-top-health-systems-by-fortune-ibmwatson-health/ (accessed: 24.01.2023).HCA Healthcare hospitals recognized among U. S. 100 Top Hospitals, 15 Top Health Systems by Fortune / IBM Watson Health | HCA Healthcare Today [Electronic resource]. URL: https://hcahealthcaretoday.com/2021/05/12/hca-healthcare-hospitals-recognized-among-u-s-100-tophospitals-15-top-health-systems-by-fortune-ibmwatson-health/ (accessed: 24.01.2023).Biofourmis expands AI-enabled virtual care to monitor complex chronic conditions | Fierce Healthcare [Electronic resource]. URL: https://www.fiercehealthcare.com/health-tech/biofourmis-expands-ai-enabled-virtual-care-complex-chronic-conditions (accessed: 24.01.2023).Biofourmis expands AI-enabled virtual care to monitor complex chronic conditions | Fierce Healthcare [Electronic resource]. URL: https://www.fiercehealthcare.com/health-tech/biofourmis-expands-ai-enabled-virtual-care-complex-chronic-conditions (accessed: 24.01.2023).Esteva A et al. Dermatologist-level classification of skin cancer with deep neural networks. Nature. Nature Publishing Group, 2017;542 (7639):115-8.Esteva A et al. Dermatologist-level classification of skin cancer with deep neural networks. Nature. Nature Publishing Group, 2017;542 (7639):115-8.Study finds gender and skin-type bias in commercial artificial-intelligence systems | MIT News | Massachusetts Institute of Technology [Electronic resource]. URL: https://news.mit.edu/2018/study-finds-gender-skintype-bias-artificial-intelligence-systems-0212 (accessed: 24.01.2023).Study finds gender and skin-type bias in commercial artificial-intelligence systems | MIT News | Massachusetts Institute of Technology [Electronic resource]. URL: https://news.mit.edu/2018/study-finds-gender-skintype-bias-artificial-intelligence-systems-0212 (accessed: 24.01.2023).Inclusive Intelligence: Artificial Intelligence in the Service of Science, Work, and the Public Good [Electronic resource]. URL: https://vcresearch.berkeley.edu/sites/default/files/inline-files/Inclusive%20Intelligence%20Signature%20Initiative%20October%202019.pdf (accessed: 24.01.2023).Inclusive Intelligence: Artificial Intelligence in the Service of Science, Work, and the Public Good [Electronic resource]. URL: https://vcresearch.berkeley.edu/sites/default/files/inline-files/Inclusive%20Intelligence%20Signature%20Initiative%20October%202019.pdf (accessed: 24.01.2023).FTC warns health apps must notify users about data breaches or face fines | Fierce Healthcare [Electronic resource]. URL: https://www.fiercehealthcare.com/digital-health/ftc-warnshealth-apps-must-notify-users-about-data-breaches-or-face-fines (accessed: 24.01.2023).FTC warns health apps must notify users about data breaches or face fines | Fierce Healthcare [Electronic resource]. URL: https://www.fiercehealthcare.com/digital-health/ftc-warnshealth-apps-must-notify-users-about-data-breaches-or-face-fines (accessed: 24.01.2023).Bak M et al. You Can't Have AI Both Ways: Balancing Health Data Privacy and Access Fairly. Front. Genet. Frontiers Media S. A., 2022;13:1490.Bak M et al. You Can't Have AI Both Ways: Balancing Health Data Privacy and Access Fairly. Front. Genet. Frontiers Media S. A., 2022;13:1490.

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