Over the course of the last few years, more than 1000 new health apps have hit the market. Many are to empower people in taking more control over their own healthcare or to span the communications gap between patients and their health providers. But are all of them worthwhile? Are all of them safe? After all, anyone can create and sell apps; no medical knowledge or experience is required. The FDA has now issued guidelines to help us make that distinction.
The Food and Drug Administration (FDA) appreciates the extent of mobile health apps that are currently available as well as the torrent that will be released to the market along with the potential benefits and risks that they pose to the public.
The FDA is currently turning its attention to health apps that regulate medical devices or function alongside. Reminders for exercise or exercise measurements and calorie counters are not within their scope.
“In general, if a mobile app is intended for use in performing a medical device function (i.e., for diagnosis of disease or other conditions, or the cure, mitigation, treatment, or prevention of disease) it is a medical device, regardless of the platform on which it is run.”
Illustrations of this would be apps that display data from a medical device or one that controls a device like an app that controls inflation of a blood pressure cuff.
- Mobile Platform- this is a computing platform and is typically handheld as smart phones, tablets and other portable computers, iPads.
- Mobile Application (Mobile App)- software that runs on the mobile platform with or without wireless connections
- Mobile Medical Application (Mobile Medical App)- meant to be medical device accessory or one that modifies a mobile platform into a medical device.
In other words, if the mobile app is used to diagnose a medical condition, cure, treat or prevent disease, it is considered a medical device. The platform that it is run on is irrelevant in terms of the definition.
By seeking out the FDA approved label on devices (which it is now required to have ), you can feel comfortable that it is less likely to be a danger to use. Reports of any adverse effects are required to be reported and also the corrections that have been made. Further information on this can be obtained by viewing “Device Advice: Recalls, Corrections, and Removals” at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/PostmarketRequirements/R ecallsCorrectionsAndRemovals/default.htm.
Additional information is available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/default.htm, under “Overview of Medical Device Regulation”
The FDA has several resources and publications online that describe various regulatory requirements in detail. FDA’s “Device Advice” website (http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/default.htm) and online courses at “CDRH Learn” (http://www.fda.gov/Training/CDRHLearn/default.htm) are a good place to start.
Well, I hope this has helped you to seek out your options. Health apps are here to help us and by performing due diligence, you can get wonderful assistance for your personalized healthcare.
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See you at the next post!