Research reveals the legal problems that arise due to the rapid pace of development of additive technologies (3D printing) in biomedicine (bioprinting). The purpose of the research is to analyze the legislation that defines the legal regime of additive technologies, identify the main gaps in regulation, carry out a comparative legal study, which allows to formulate recommendations to improve Russian legislation. Special strategies are used as an object of comparative research; they contribute to fix the priority development of 3D printing. The employed methods are as follows: the method of analysis of legal regulation, comparative legal and formal legal. Results. Attention is paid to the main trends and risks of progress in this direction, which are reflected in decentralization of production; improving its efficiency and reducing waste; reduction of development time and their introduction into mass production with a simultaneous rise in quality of the finished product; expanding the population's access to material goods; minimizing the state control. Particular attention is paid to the legal assessment of the applicability of bioprinting in transplantology, the manufacture of implants, surgical planning, and the use of printed organs for experiments. Conclusions: when adjusting the legal framework, institutional readiness should be taken into account - the ability of the entire Russian healthcare system to use additive technologies properly (which will require significant changes in healthcare legislation). An independent direction is the use of bioprinting in the testing of drugs. 3D printing creates small organ-like structures (they are called organoids) on which experiments can be carried out for the screening of pharmaceuticals. This will require changes in the legal regime for the circulation of medicines, as well as the main functions of the state regulator (the Russian Ministry of Health and Roszdravnadzor). It is noted that additive technologies make it possible to manufacture medicines, but world experience indicates a cautious attitude towards this type of production. Research argues for the need to follow a risk-based approach in the legal regulation of bioprinting, as well as to introduce the general approach of Hospital Exemption (pharmaceutical exclusion) used in the countries of the European Union, as well as some other countries aimed at the development of regenerative medicine.

The article is devoted to the emerging threats to human rights in the context of the development of biomedical technologies, as well as to the identification of social risks requiring legal resolution in this area. It suggests a human rights model for regulating innovative methods of diagnosis and treatment. The purpose of the article is to analyze legislation in the field of modern biomedicine, genetic engineering, and related innovative technologies. A comparative legal study applied in the work made it possible to substantiate a framework model for regulating modern biomedicine. The main task of such a model is to identify risks affecting fundamental human and civil rights and freedoms. With this approach, the details of regulation are the subject of bylaws or the corresponding prescriptions of professional medical organizations. Methods . The basis of this research was formed by such research methods as analysis of legal regulation, formal legal and comparative legal methods. The main results of the study are to determine the legal links between modern biomedical technologies and the concept of personalized medicine. In fact, the lack of interaction of new advances in biomedicine with the basic provisions of medical care has been revealed. The article proves the need to impose restrictions on the alleged popularization of innovative technologies by persons without medical education, using them for dubious social purposes. The risks of developing updated eugenics have been outlined. The tendency of relativism in consolidating the principles of mutual relations between a person, state, and society has been identified. Conclusions. The development of biomedicine requires an adequate response from the Russian legislation, which does not yet take into account most of its achievements. This creates certain risks for human and civil rights and freedoms. The article substantiates the introduction of bans on the most ethically questionable technologies and experiments. It is proposed to expand the powers of professional medical organizations (including the transfer of some of the regulatory powers to them).

Introduction. Russian civil legislation takes into account innovations in information exchange by fixing the concept of digital rights, while giving them an exclusively private legal understanding. The modern doctrine proceeds from the fact that development of digital technologies has also significantly influenced the concept of fundamental human rights. Continuation of this vision is the emergence of digital rights in the public sphere. This actualizes the analysis of their possible limitations in order to counter terrorism. Theoretical analysis. The research reveals the consequences of the transfer of a significant amount of social relations to digital format. At the same time, while the general discourse of discussions stems from the principle of “normative equivalence” between “offline” and “online” (which does not require fundamental changes in law), the experience of the spread of digital technologies shows that it increasingly faces systemic failures. The authors indicate the difficulties with the definition of digital rights and their regulatory consolidation (by analyzing the regulations of the European Union). Empirical analysis. Based on the identified characteristics of digital communications, the paper presents the models for countering terrorist threats in modern cyberspace. The features of the legislative support of the Chinese model of the “Golden Shield”, based on the principles of digital sovereignty (in particular, the Law of the People’s Republic of China “On Data Security”), are shown. The authors highlight the features of imposing restrictions on the right to digital communication for persons suspected of involvement in terrorist activities (in particular, on the basis of the Anti-Terrorism and Border Security Act adopted in 2019 in the UK) and consider other foreign experience in countering terrorist threats in the digital sphere. Results. The necessity of taking into account the technological features of information exchange in the digital space is demonstrated. This has a significant impact on the emergence of new measures to counter terrorism. Foreign experience testifies to the expansion of the list of operational and search measures, the list of elements of crimes of a terrorist nature.

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