Earlier today, the FDA released its final guidance for developers of mobile medical applications. The FDA is focusing on regulating potentially harmful apps instead of policing applications that pose minimal risk to consumers. These more harmful apps include those which are using mobile technology to make a specific diagnosis and those which transform mobile devices into a regulated medical device – for example, an app that can turn your phone into a ECG to track heart risks. There are currently thousands of mobile applications currently on the market, with only about 100 that have been approved by the FDA.
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With the FDA focusing on mobile applications that work as or with regulated medical devices, telehealth services are likely to be affected. Gaining approval by the FDA will likely be a difficult, stringent process. However, it also will increase the safety and security of telehealth and can lead to better care.
With this relaxed oversight on health apps that are not related to regulated medical devices, do you think we will see an increase in the number of apps available?