The research of modern approaches to the system of mHEALTH regulation

Abstract

Actuality. More than 10,000 mHealth applications have been developed recently on Android and iOS platforms. The most popular ones help the users to do fitness (47% of all mHealth applications), to follow the course of illness and treatment (24%), to control lifestyle and stress (17%), and to track diet and nutrition (12%). The aim of the research was to study modern approaches to the regulation of mHealth system. Systematic and logical methods of analysis were used in the investigation. Results of the research. In October 2015, the FDA (USA) issued a special Mobile Health Applications Guide, which divides them into three main groups: Group 1 contains applications that are not medical devices and, accordingly, the FDA does not regulate them. Group 2 includes applications that may be medical products, but have a low risk for the population. For manufacturers of such applications, it is proposed to comply with certain requirements in accordance with the quality system of medical products. Group 3 consists of mobile medical applications that are medical products and are obligatory subjected to the FDA regulatory control. Subsequently, in the United States, it was suggested to introduce into medical practice, medical applications and mobile devices. Thus, the basic principles of their integration were determined. In the EU countries the approach to the regulation of mHealth system is identical to the approach in the United States.