The possibilities of big data in pharmacoepidemiology, problems of use, legal regulation
https://doi.org/10.47093/2713-069X.2024.5.2.25-35
Abstract
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.
About the Authors
N. V. Orlova
N.I. Pirogov Russian National Research Medical University
Russian Federation
Russian Federation
Natalya V. Orlova – Dr. of Sci. (Medicine), Professor, Department of Faculty Therapy, Faculty of Pediatrics
Ostrovityanova str., 1, Moscow, 117513
G. N. Suvorov
Russian Medical Academy of Continuing Professional Education; Center for Sociological Research
Russian Federation
Russian Federation
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
N. D. Karseladze
Medical Center DMEMED, M.V. Lomonosov Airport Domodedovo
Russian Federation
Russian Federation
Natalia D. Karseladze – Cand. of Sci. (Medicine), therapist
1а, Moscow region, 142014
Yu. Yu. Yakushev
N.I. Pirogov Russian National Research Medical University
Russian Federation
Russian Federation
Yuri Yu. Yakushev – 6th year student
Ostrovityanova str., 1, Moscow, 117513
T. V. Gololobova
Russian Medical Academy of Continuing Professional Education; State Scientific Research Institute of Biological Instrumentation FMBA of Russia
Russian Federation
Russian Federation
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
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Review
For citations:
Orlova N.V., Suvorov G.N., Karseladze N.D., Yakushev Yu.Yu., Gololobova T.V. The possibilities of big data in pharmacoepidemiology, problems of use, legal regulation. National Health Care (Russia). 2024;5(2):25-35. (In Russ.) https://doi.org/10.47093/2713-069X.2024.5.2.25-35
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