Development of Legal Regulation of the Use of Mobile Medical Technologies (mHealth) in the Law of International Integration Associations: European Union Experience

Abstract

The paper examines the experience of legal regulation of the use of mobile medical technologies (MMT, mHealth) in the largest regional integration association — the European Union (EU). It is noted that digital healthcare is a multifaceted concept that includes various aspects of public health and the digital environment surrounding it. Digitalization of healthcare covers medical processes, including software to support the work of doctors (including telemedicine technologies), tools for managing a medical institution, remote interaction with patients and monitoring such interaction; big data analytics for drug development, clinical research management, patient population studies; additional patient-oriented tools and including applications related to the determination of physical condition and the course of treatment, as well as compliance with the medication regimen. The paper provides a detailed overview of the main EU documents in the relevant field, illustrates the impact of judicial practice on the development of regulation in the field of mobile medical technologies, and analyzes the mechanisms of selfregulation in this area using the example of specific court cases. It is emphasized that while self-regulation on the part of the applications store can set developers of mobile healthcare applications in the right direction by converting the provisions of Regulation 2016/679 (GDPR) into technical requirements for preliminary approval, compliance with privacy provisions is facilitated by increased awareness of both application users and developers, as well as brokers of medical data about the risks to the observance of fundamental human rights. from the side of mobile healthcare applications. In conclusion, the authors formulated the key problems and ways to improve EU regulatory framework in the field of mobile medical technologies, recommended the use of EU best practices in the development of MMT regulatory regulation in the Russian Federation and integration associations with its participation.