Mobile Applications and Ecosystems in Healthcare: Legal Aspects
Abstract
Over past decade healthcare sector has undergone a qualitative transformation. Digitalization of healthcare is one of the most important global development trends, aimed at making medicine more accessible to the population and improving the speed and quality of medical care. In healthcare the following advanced digital solutions are in active use: telemedicine services, mobile applications, big data processing technologies, machine learning and artificial intelligence systems. In view of their usability, individual approach, accessibility, and informativeness, the use of mobile applications has become an integral part of human life in modern society. Mobile applications are in demand in medical organizations for diagnostics, decision support and remote patient monitoring. Despite the obvious advantages, the widespread use of mobile applications, including for medical purposes, raises questions of personal data protection, mobile applications definition and legal regime clarification, as well as regulatory control. Mobile health apps accumulate large amounts of data, passively collected by automatic means and voluntarily provided by users. In the absence of preliminary control of mobile applications for compliance with legal requirements, as well as for adopted measures ensuring the confidentiality and security of data, there are substantiated risks of violation of user rights, leakage of personal data, and discrimination against users by employers and insurance companies. The article examines certain aspects of the legal regime of mobile health applications, as well as the specifics of protecting the personal data they accumulate. The need to establish a legal definition of the concepts of “mobile application” and “mobile medical application”, subject to preliminary regulatory control, is affirmed. Based on a analysis of the legislation of the Russian Federation and certain foreign countries, the authors formulated a series of recommendations aimed at improving the effectiveness of protecting users of mobile applications used for medical purposes, in the context of rapidly evolving digital transformation.
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