Mobile Medical Apps: To Be or Not to Be (Wellness or Medical)? That is the Question
The size of the mobile medical app market is massive. One report shows in 2017 the global market was $2.4 billion, with a forecast of $11 billion by 2025. The Apple App Store alone has more than 45,000 health apps. We believe that the COVID-19 crisis will accelerate that growth as the world has now become acclimated to the use of mobile technology for the provision and facilitation of health care and wellness.
For years, FDA and industry grappled with the extent to which the Food and Drug Administration (FDA) would exercise regulatory enforcement over what we will call “health apps” largely intended for mobile devices. Very broadly, if the app provided general information—even to a sub-set of the population to which the user belonged—the agency would not regulate those devices. However, if the app provided user-specific information for the treatment or diagnosis of disease, then it would be subject to regulation if it could pose a risk of harm to the “patient.”
In September 2019, the FDA issued a series of guidance related to software and mobile medical apps. These included a policy for general wellness low risk devices and a specific policy for mobile medical applications.
Thus, there was a framework in which there were well-understood general principles about the regulation—or not—of health apps. The regulatory analysis required an assessment of whether or not the software in question fit the statutory definition of a medical device. If it did, then an analysis was required about whether the app-device was in a class of devices over which FDA would exercise regulatory discretion. If it was by definition a medical device, the next step in the analysis is whether the device was one “whose functionality could pose a risk” to patient safety if it did not operate as intended. If the app-device did pose such a risk, then it was regulated as a medical device.
Then came COVID-19. The world changed. The regulatory framework did not.
Many tens of millions of people were staying home. They could not visit their doctors. The stress of not leaving home (for work, fun, family, friends or health) and fear of the pandemic posed physical and mental health issues.
The COVID-19 world created opportunities for developers of apps for people to use in their homes. The tech world responded to that need and that opportunity. At the end of March 2020, due to the crisis the FDA published a statement of how it would treat mobile apps in the COVID-19 world. It was not much different than in the pre-COVID world.
The pandemic crisis resulted in some boundary shifting as consumers wanted and mobile medical app developers sought to provide apps to suit the new and growing need. FDA saw fit to re-state highlights from its 2019 guidance related to “software functions that are not regulated as medical devices, including some that may be useful in the response to COVID-19.”
Thus, FDA identified examples of products not to be considered medical devices: software providing COVID-19 general information that is not intended for the diagnosis or cure of a specific individual is not to be considered a regulated medical device. Still, even if the software filters for individual patient characteristics, if it is for general information and not for diagnosis or cure of an individual, it is not considered a medical device. Of course, the converse is true—if intended for care and treatment of an individual, or to facilitate or replace a provider’s assessment, then it is to be considered a medical device. Videoconferencing with one’s doctor, does not mean that the software to do so is regulatable as a medical device.
FDA also identified software functions useful in COVID-19 that may meet the statutory definition of a medical device, but over which it does not intend to enforce regulatory requirements. These include the use of patient characteristics to provide treatment recommendations from established authorities, the use of common signs and symptoms to provide a list of possible medical conditions and advise on when to consult a provider or appropriate health care facility or to initiate a call to a pre-determined provider or emergency alerts to first responders.
Developers of higher risk medical device software or devices were encouraged to follow the Emergency Use Authorization process.
The mobile medical app arena is one to which the FDA can be expected to pay particular attention in the months and years to come. The established medical device industry is well-familiar with the principles discussed above. It is the newcomers to this industry or the snake-oil salesman types that especially need to be wary, and follow the analysis required by the FDA as to whether their particular app-device is one in which the FDA regulatory requirements must be followed.