FDA regulation of mobile health technologies

摘要

Medicine may stand at the cusp of a mobile transformation. Mobile health, or "mHealth," is the use of portable devices such as smartphones and tablets for medical purposes, including diagnosis, treatment, or support of general health and well-being. Users can interface with mobile devices through software applications ("apps") that typically gather input from interactive questionnaires, separate medical devices connected to the mobile device, or functionalities of the device itself, such as its camera, motion sensor, or microphone. Apps may even process these data with the use of medical algorithms or calculators to generate customized diagnoses and treatment recommendations. Mobile devices make it possible to collect more granular patient data than can be collected from devices that are typically used in hospitals or physicians' offices. The experiences of a single patient can then be measured against large data sets to provide timely recommendations about managing both acute symptoms and chronic conditions.