2020 № 7 Issues of regulation of handling of medical products in the mar kets
The work outlines some of the provisions of the Project of the Commission of the Eurasian Economic Union: “On Amending the Rules for Registration and Examination of the Safety, Quality and Efficiency of Medical Devices”, provides an analysis of the prospects of the Project, its impact on the efficiency of circulation of medical devices in the territories of the countries of the Eurasian Economic Union. Based on the results of the analysis, conclusions are drawn on the applicability and significance of the considered provisions of the Project. The aim of the work is to analyze the main provisions of the Project of the Commission of the Eurasian Economic Union: “On Amending the Rules for Registration and Examination of the Safety, Quality and Efficiency of Medical Devices” and the possibilities of their practical application. The following methods were used in the work, namely, general scientific: analysis and synthesis, systemic, profile-economic: marketing, controlling methods. The scientific novelty of the work lies in the generalization, analysis of the materials considered and in the formation of proposals for certain areas of the Project and conclusions on the development of integration in the medical industry of the countries of the Eurasian Economic Union, according to the results of the analysis.
2020 № 7 Possibility of transboundary transfer of health-personal
In the article, the authors analyze the possibility of cross-border transfer of personal data related to health, separately considering
the possibility of such a transfer within the EAEU. The authors pay special attention to the analysis of the correlation of the concepts of medical confidentiality and personal data related to the state of health, the peculiarities of regulating the cross-border transfer of this information according to Russian legislation, as well as the consideration of the Unified State Information System in the field of health care created in the Russian Federation (hereinafter – the Unified State Health Insurance System, a unified system). The authors also consider the possibility of using a single system for cross-border data transfer, indicate the main risks of such use, and also determine the set of necessary additions for Russian legislation in order to use the EGISP in cross-border data transfer. Separately, the authors analyze the possibility of transferring personal data related to the state of health in the framework of the Eurasian Economic Union, which is often discussed within the EAEU digital agenda. The authors analyzed the permissibility of such transfer under the EAEU as a whole, the proposals put forward in its support, namely the adoption of a separate agreement about the delivery of health care by participating countries of the EAEU any citizens of member States of the Union, the adoption of the act on transfer of personal data about the health of the citizens of the EAEU member States and the creation of a single digital platform for the provision of such transfer (including, subject to the establishment
of safety requirements the transfer of such data and penalties for violation of these requirements), as well as the identification of
specially authorized state bodies in each of the EAEU countries in order to ensure responsibility for the transfer of this category of data.