Mobile health apps: Are they a regulated medical device?

Mobile health apps: Are they a regulated medical device?

A key driver for mHealth has been the proliferation of mobile health applications (apps). There are two categories of such apps (a) apps for the purpose of prevention, diagnosis and treatment of diseases (medical apps); and (b) apps relevant to lifestyle, fitness and well-being (non-medical apps). This article explores whether these two categories of apps are regulated as a medical device.