Experimental legal regimes in the field of medical activity and personalized medical information: a decrease in the level of protection or additional guarantees?

Abstract

The article examines the problem of ensuring the protection of personalized medical information in the context of the introduction of experimental legal regimes in the field of digital innovation. The work presents the view of researchers and provides a detailed author’s analysis of the terms used in the designated area: «special legal regime», «legal experiment», «digital innovation». A statistical analysis of initiative proposals for introducing experimental legal regimes in the Russian Federation was carried out. The author examined the key provisions of the programs of experimental legal regimes in the field of medical activity and compared their content with the requirements of general regulation. As a result of the study, the author came to the conclusion that despite the fact that the protection of personalized medical information is not the main task of the introduced experimental legal regimes, in many ways, within the framework of their regulations, this task is solved more consistently than within the framework of general legislation. At the same time, a number of provisions of experimental legal regimes create risks of unauthorized access to protected information, which requires the development of additional guarantees of patients’ rights.