An “App” a Day Will NOT Keep the FDA Away: The Rise of Mobile Medical Applications


The number of mobile applications (apps) available to consumers on their iPhones, Androids, and iPads is astonishing. As of January 2013, there were more than 775,000 different apps available to iPhone and iPad users.  It comes as no surprise that the healthcare industry is experiencing a similar mobile revolution.


Both patients and health care professionals alike increasingly rely on mobile apps for their healthcare needs.  It is estimated that 81 percent of physicians are utilizing mobile medical apps in their practices.  These technological advances also allow patients more control over their healthcare. In addition to shopping, banking, playing games and connecting to social media, developers are introducing apps that allow patients to transform their smartphones and tablets into sophisticated medical tools. There are apps that allow users to detect skin cancer, view radiological images, check glucose levels, monitor heart rates and even monitor and control pacemakers.


It is undeniable that patient controlled healthcare is a major part of the shifting future of the healthcare industry.  It is estimated that there are as many as 40,000 medical apps currently on the market for smartphones and tablets, and the market is continuing to grow at feverish pace.  By 2015, it is estimated that the users of mobile medical apps will exceed 500,000,000.  


Medical apps are unique from other apps in the sense users are relying on them for important information to ensure their safety and welfare.  Although users may grow irritated when their Angry Birds game malfunctions, it is not the end of the world.  Whereas the same may not be true for a medical app that wirelessly monitors a patient’s pacemaker.  For this reason, the emergence of mobile medical devices gives rise to an exciting new wave of legal and regulatory issues.


One legal question that often arises is whether these health and wellness apps are subject to FDA regulation as medical devices.  In July 2011, the FDA provided some answers with the release of its draft guidance setting forth a proposal for regulating mobile apps.  According to the draft guidance, the FDA plans to regulate only a subset of apps that both meet the definition of a medical device and (1) are used as an accessory to a “regulated medical device” or (2) transform a mobile platform into a “regulated medical device.” 


Despite these efforts to bring clarity to the market, the regulatory requirements pertaining to medical apps remain unclear.  Most notably, many app developers seek further guidance as to whether their products are subject to FDA regulation and, if so, the requirements for compliance.  Many of these looming questions will likely be addressed over the course of the next few months. The House Energy and Commerce Committee recently sent questions to FDA Commissioner Margaret Hamburg, M.D., seeking clarification of the agency’s regulation of the mobile medical device industry.  Specifically, the committee is seeking information regarding the (1) timeline for the release of the final regulatory guideline, (2) impact of medical device tax, and (3) number of medical apps that are currently subject to FDA oversight. Additionally, the FDA recently announced its priority list of medical device guidance documents for 2013, which includes final guidance on medical apps as an “A List” priority.


The increased attention from Congress and the FDA is likely to spawn extensive changes to the regulatory framework for the medical app market over the coming year.  In the meantime, medical app manufacturers should make every effort to possess a strong understanding of the current regulatory and legal issues associated with the development of mobile medical apps as well as begin to develop compliance strategy to adapt to the evolving regulatory structure.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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