The possibilities of big data in pharmacoepidemiology, problems of use, legal regulation

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.

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