FDA Guidance – One Giant Leap for mHealth

The freshly released FDA Guidance on Mobile Medical Apps is being widely praised as a green light for mobile app manufactures everywhere.  As demanded by the public and promised by the FDA, the guidelines do very little to hinder the innovation of mHealth.  FDA regulated mobile medical apps are limited to mobile apps “whose functionality could pose a risk to a patient’s safety if it does not function correctly,” which, in turn, amounts to diagnostic and pseudo-medical device applications:

– Apps that are an extension of 1+ medical devices that connects to control display, storage, analyzing or transmitting patient-specific medical device data
– Apps that transform the mobile platform into a regulated medical device by using attachments, display screens, or sensors
– Apps that become a regulated medical device by performing patient-specific analysis and providing patient-specific diagnosis, or treatment recommendations.

The FDA’s current and extended regulations on mobile medical devices and mobile medical apps assures patients and providers that patient information is secure, while easing the industry’s assumption that mHealth would be stonewalled by strict FDA regulations.

Mobile app manufactures are breathing a little easier, and are likely working at full force to create patient-and-provider-friendly apps. The FDA guidelines leave a lot of leeway for the industry’s mHealth innovation to grow, prosper, and facilitate the new wave of patient engagement and patient health care.

The following are non-regulated mHealth apps:

– Apps that help patient self-manage medical information/conditions/treatments
– Apps that provide simple tools to track health information
– Apps that provide easy access to information relating to conditions/treatments
– Apps that document/communicate potential medical conditions to providers
– Apps that automate tasks for health care providers
– Apps that enable doctors/patients to interact with EHR systems

While most of the Health IT population is pleased with the non-restrictive guidelines, there are of course some items that are open to interpretation and loosely described, such as the definition of an app “manufacture,” as well was where some apps fall in the categories outlined in the guide.  During an open mic, hosted by mHIMSS, much of the discussion revolved around the FDA’s desire for the Health IT industry to take the guidelines listed and merge, innovate, and develop new mobile applications.

In a press release, Jeffrey Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health stated, “…The FDA’s tailored policy protects patients while encouraging innovation.” While there may be kinks to work out, all in all, it looks like the FDA isn’t foe, but is indeed a friend to mHealth.

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