Study On Chinese Mobile Medical Applications Regulated Scope

Mobile health can contribute to a more patient-focused healthcare, and supporting the shift towards prevention while at the same time improving the efficiency of the system. The rapid development of mobile smart devices and wireless communication technology have accelerated the adoption and promoted the diversity and quantity of mobile medical applications.However, the characteristics of software and mobile platforms would limit their function leading to a serious security risk while improving the convenience of health management. Therefore, governments started to pay attention to relevant regulation issues while promoting the development of mobile health industry. But as one of the largest emerging markets of mobile medical applications, Chinese existing regulatory system has limited supervision on mobile medical applications.This study mainly focused on the scope of mobile medical applications regulation. It systematically analysed and summarized mobile health-related supervisory documents and developed a method to estimate the possible regulated scope of mobile medical applications. The preliminary determination process of mobile software device and the possible regulatory category were built by this study. At the same time, a risk assessment framework applicable to mobile medical applications was designed. This study will support the authorities to formulate relevant policies and the manufacturers product self-assessment.