The time is not far when your doctor will prescribe you a mobile health app in addition to your drug prescription.
Mobile health applications referred to as mHealth apps are dramatically expanding their reach to the point that they are significantly reducing the number of visits to clinics. For the same reason, mHealth has come under the microscope by public and private regulatory groups. With over 60,000 health-based apps currently available right now, the mHealth market is expected to be worth of $26 billion by 2017.
So, how do you regulate mobile apps?
A three day discussion was conducted by FDA on this very topic. In doing so, they mostly talked about what and what not to regulate when it comes to mHealth including devices, apps, app developers etc. For example, tablets and smartphones will not be considered medical devices just because they can run prescription apps, app stores and developers will not be considered medical device manufacturers, and apps will not be forced to seek re-approval for small updates. Moreover, any apps that contribute to Electronic Health Records or act as personal health monitors will not be regulated.
But this doesn’t put apps in the clear. In the last 16 years, the FDA has reviewed about 100 mHealth apps. While their stance toward apps is in developed, the agency has postured toward regulating any apps that do meet their definition of a medical device, or “an instrument, apparatus, implement, machine, contrivance, implant, or in vitro reagent that is intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease in man, or intended to affect the structure or any function of the body.”
But even if mHealth apps are closely regulated and approved by FDA, users/ patients still might suffer from some common problems. Apps may be over-prescribed because they’re well marketed by advertising campaigns, patients may demand them whether or not they’re needed, they may contribute to their own kind of side effect or treatment interactions, they can add to the prescription-burden of patients who already have too many treatments to keep up with, and so on.
- Growing popularity of mHealth in Healthcare (healthitplus.wordpress.com)
- mHealth Apps growing in popularity amongst Physicians & Healthcare Execs (healthitplus.wordpress.com)
- Improved care through mHealth and mobile technology (healthitplus.wordpress.com)
- Will mobile health IT regulation, taxes harm medical innovation? House subcommittee hearings want to know (medcitynews.com)
- FDA and mobile health apps (mypersonalphone.wordpress.com)
- FDA Clarifies Plans for Mobile Health App Regulation (eweek.com)