Final Guidance on Mobile Medical Apps

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Recently, there has been a reported surge in smartphone ownership, in the UK 51% of the population owning a smartphone[1] [2], while in the US data show that about 95 million Americans used their mobile phones either as healthcare tools or to find health information. A recent research found that there are approximately 43,000 medical applications available online only in the iTunes store, and over 8,000 in the Google Play store, numbers that are growing by 150 percent per year [3]. Statistics have demonstrated that on average, users check their smartphones every 6.5 minutes and each person has approximately 41 applications (apps) on the phone [4]. The industry experts predict an increase by 25% a year for mobile health apps, estimating that almost 500 million patients and healthcare providers will use a mobile health app within the next two years [5]. Apps can record dietary information, identify pills, perform medical calculations, keep track of physical activity, screen for diseases, manage doctor’s appointments, and transmit recorded data to the healthcare provider, help quitting smoking or substance abuse, among many other functions. There is a smartphone app for nearly everything and everyone and a recent trend in convergence between devices and apps used by clinicians and those used by patients. A study on nearly 43,700 purported health or medical apps available on Apple's iTunes app store, found that only 54% of them were “genuine” healthcare apps, and 69% of those were targeting patients while the rest of 31% were built for use by clinicians [6]. Smartphones have become an “indispensible” source of healthcare information for approximately 38% of surveyed users, which are considering that their devices are “essential” for ...

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