natszdravНациональное здравоохранениеNational Health Care (Russia)2713-069X2713-0703Federal State Autonomous Educational Institution of Higher Education I.M. Sechenov First Moscow State Medical University of the Ministry of Health of the Russian Federation (Sechenov University)10.47093/2713-069X.2024.5.2.25-35natszdrav-372Research ArticleИНФОРМАТИЗАЦИЯ ЗДРАВООХРАНЕНИЯINFORMATIZATION OF HEALTHCAREВозможности больших данных в фармакоэпидемиологии, проблемы использования, юридическое регулированиеThe possibilities of big data in pharmacoepidemiology, problems of use, legal regulationhttps://orcid.org/0000-0002-4293-3285ОрловаН. В.OrlovaN. V.

Орлова Наталья Васильевна – д-р мед. наук, профессор кафедры факультетской терапии педиатрического факультета

ул. Островитянова, д. 1, г. Москва, 117513

Natalya V. Orlova – Dr. of Sci. (Medicine), Professor, Department of Faculty Therapy, Faculty of Pediatrics

Ostrovityanova str., 1, Moscow, 117513

vrach315@yandex.ruhttps://orcid.org/0000-0001-8452-5522СуворовГ. Н.SuvorovG. N.

Суворов Георгий Николаевич – канд. юрид. наук, доцент кафедры госпитальной эпидемиологии, медицинской паразитологии и тропических болезней; заместитель директора по науке и сетевому взаимодействию

ул. Баррикадная, д. 2/1, стр. 1, г. Москва, 125993

Тверской бульвар, д. 13, стр. 1, г. Москва, 123104

Georgy N. Suvorov – Cand. of Sci. (Jurid.), Associate Professor, epartment of Hospital Epidemiology, Medical Parasitology and Tropical Diseases; Deputy Director for Science and Network Interaction

Barricadnaya str., 2/1, building 1, Moscow, 125993

Tverskoy Boulevard, 13/1, Moscow, 123104

https://orcid.org/0000-0001-8124-109XКарселадзеН. Д.KarseladzeN. D.

Карселадзе Наталья Джимшеровна – канд. мед. наук, врач-терапевт

ст. 1а, Московская область, 142014

Natalia D. Karseladze – Cand. of Sci. (Medicine), therapist

1а, Moscow region, 142014

https://orcid.org/0009-0007-2537-8658ЯкушевЮ. Ю.YakushevYu. Yu.

Якушев Юрий Юрьевич – студент 6-го курса

ул. Островитянова, д. 1, г. Москва, 117513

Yuri Yu. Yakushev – 6th year student

Ostrovityanova str., 1, Moscow, 117513

https://orcid.org/0000-0001-9033-5223ГололобоваТ. В.GololobovaT. V.

Гололобова Татьяна Викторовна – д-р мед. наук, доцент, заведующая кафедрой госпитальной эпидемиологии, медицинской паразитологии и тропических болезней; заместитель директора по научной работе

ул. Баррикадная, д. 2/1, стр. 1, г. Москва, 125993

Волоколамское шоссе, д. 75, к. 1, г. Москва, 125424

Tatyana V. Gololobova – Dr. of Sci. (Medicine), Associate Professor, Head of the Department of Hospital Epidemiology, Medical Parasitology and Tropical Diseases; Deputy Director for Scientific Work

Barricadnaya str., 2/1, building 1, Moscow, 125993

Volokolamsk highway, 75/1, Moscow, 125424

ФГАОУ ВО «Российский национальный исследовательский медицинский университет им. Н.И. Пирогова» Министерства здравоохранения Российской ФедерацииРоссияN.I. Pirogov Russian National Research Medical UniversityRussian FederationФГБОУ ДПО «Российская медицинская академия непрерывного профессионального образования» Министерства здравоохранения Российской Федерации; ФГАНУ «Центр социологических исследований»РоссияRussian Medical Academy of Continuing Professional Education; Center for Sociological ResearchRussian FederationМедицинский центр DMEMED аэропорта Домодедово имени М.В. ЛомоносоваРоссияMedical Center DMEMED, M.V. Lomonosov Airport DomodedovoRussian FederationФГБОУ ДПО «Российская медицинская академия непрерывного профессионального образования» Министерства здравоохранения Российской Федерации; ФГУП «Государственный научно-исследовательский институт биологического приборостроения» ФМБА РоссииРоссияRussian Medical Academy of Continuing Professional Education; State Scientific Research Institute of Biological Instrumentation FMBA of RussiaRussian Federation202421102024522535Copyright © Орлова Н.В., Суворов Г.Н., Карселадзе Н.Д., Якушев Ю.Ю., Гололобова Т.В., 20242024Орлова Н.В., Суворов Г.Н., Карселадзе Н.Д., Якушев Ю.Ю., Гололобова Т.В.Orlova N.V., Suvorov G.N., Karseladze N.D., Yakushev Y.Y., Gololobova T.V.Данная работа распространяется под лицензией Creative Commons Attribution 4.0.This work is licensed under a Creative Commons Attribution 4.0 License.https://www.natszdrav.ru/jour/article/view/372

Рост цифровизации в медицине значительно расширил возможности использования больших данных в фармакоэпидемиологии. Использование больших данных позволяет сократить расходы на клинические исследования, увеличить скорость набора и расширить выборку, дает возможность оценить действие лекарственных препаратов у беременных и эффективность при редких заболеваниях. Проанализированы базы данных PubMed, Scopus, Web of Science и Google Scholar за 12 лет, с 2012 по 2023 год, документы Организации Объединенных Наций, Всемирной организации здравоохранения, федеральные законы Российской Федерации в области использования искусственного интеллекта, защиты конфиденциальной информации, проведения клинических исследований. Поиск осуществлялся по ключевым словам: «большие данные», «регистры», «фармакоэпидемиология», «персональные данные», «правовое регулирование», «методы защиты». В статье приведены примеры использования больших данных в здравоохранении, включающих от 25 до 50 млн человек. Анализ литературных данных выявил однотипные проблемы: отсутствие единообразия внесения информации, неполная информация, ограничение доступности. В обзоре определены проблемы защиты конфиденциальности информации. Рассмотрены механизмы стандартизации информации, хранения, обработки данных. Представлена международная и российская законодательные базы, регламентирующие проведение клинических исследований с использованием больших данных.

The growth of digitalization in medicine has significantly expanded the possibilities of using big data in pharmacoepidemiology. The use of big data makes it possible to reduce the cost of clinical research, increase the speed of recruitment and expand the sample, makes it possible to evaluate the effect of drugs in pregnant women and effectiveness in rare diseases. The databases PubMed, Scopus, Web of Science and Google Scholar for 12 years from 2012 to 2023, United Nations documents, World Health Organization, Federal laws of the Russian Federation in the field of artificial intelligence, protection of confidential information, and clinical research were analyzed. The search was carried out by keywords: «big data», «registers», «pharmacoepidemiology», «personal data», «legal regulation», «protection methods». The article provides examples of the use of big data in healthcare, including from 25 to 50 million people. The analysis of the literature data revealed the same type of problems – the lack of uniformity in the introduction of information, incomplete information, limited availability. The review identifies the problems of protecting the confidentiality of information. The mechanisms of information standardization, storage, and data processing are considered. The international and Russian legislative framework regulating the conduct of clinical trials using big data is presented.

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