mHealth apps for teleconsultation and telemonitoring: the new frontiers of telemedicine and the legal frameworks on medical devices and on the protection of personal data

Abstract

mHealth apps developed for teleconsultation and telemonitoring include software that collect, store and exchange information on the health status of individuals to allow a remote medical examination and a remote monitoring of a patient suffering from a chronic disease. In recent years the phenomenon of mHealth apps has deeply been studied, but uncertainty remains. In the absence of a specific regime for telemedicine, this paper will reconstruct the applicable rules in the European Union and Italian legal systems and investigate whether such a mHealth app should be considered a medical device and what are the requirements deriving from the data protection framework.