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FDA Seeks To Provide Standards For Mobile Health Applications. The number of “mobile health” apps available to consumers is impressive – over 40,000 are available for download in iTunes and Android app stores combined.  Of these, the vast majority have been developed without any clinical evidence and in a review of the FDA 501(k) medical devices database, only about 100 have actually received certification by the FDA. In a recent study published in the Journal of Cancer Education, the authors reviewed mobile applications related to oncology and found that there was “a paucity of medical accuracy and relevance of a majority of apps directed at general users”. You don’t have to be an expert to realize that doesn’t sound good. Essentially, the study found the apps they tested to be critically lacking in the area of medical accuracy.

When a Mobile App Crosses Over to Medical Device

The FDA is now stepping in to provide guidance to application developers  intended for use in performing a medical device function, such as providing disease diagnosis or disease prevention recommendations. These types of apps will now be considered a medical device, regardless of the platform on which they are run.  The FDA already regulates previously-classified medical devices to make sure they pose no medical risks to users. An example of a recently approved regulated mobile app is the AliveCor Heart Monitor – a portable ECG device that captures and records heart rhythms. These insights can be useful for the early diagnosis of arrhythmias, post ablation follow up or long-term Afib remote monitoring.  Wireless glucose monitoring systems and wireless blood pressure wrist monitors are also examples of regulated mobile devices.AliveCor Heart MonitorThe AliveCor Heart Monitor is a cleared by the FDA for sale in the USA to record, display, store, and transfer single-channel electrocardiogram (ECG) rhythms.

When It’s Still a Mobile Health App

Health apps that fall outside of the FDA guidance include some psychiatric apps, reminder apps for pregnancy or smoking cessation, GPS-enabled asthma management apps, some physical therapy apps that use video and games for motivation, some drug interaction apps where a user enters which herb and drug they would like to take concurrently and preventative screening apps from established medical sources (e.g. hospitals).

Why It Matters

The common standards that the FDA has introduced for medical app developers will help to transform healthcare via improved access, cost and quality of care. Both consumers and medical professionals alike can now have confidence that a new mHealth application has regulatory purview and thus has been developed with a clinical lens. The University of California, San Francisco is taking the same approach as drug manufacturers. They’re conducting clinical trials on a mobile device in current development to reduce risk and improve pregnancy outcomes. Likewise, NASA is developing a highly promising app that will fall under these new guidelines. It acts as a scanner packed with sensors that enables anyone to conduct sophisticated physical exams in a snap.

What Healthcare Marketers Should Do

If you are a healthcare marketer, the first thing you should do is familiarize yourself with the FDA’s Mobile Medical Application Guidance by checking out the document here. We suggest you create your own curated “App store” that can contain lists of apps which your physicians or healthcare professionals have researched and can recommend. This can provide value to your consumers and it positions your physicians and hospital brand as credible experts in mHealth. And any medical app destination you create should be promoted across any of your current mobile efforts. Unsure on where to begin? Primacy can help you put the pieces together. Just give us a call.