Estimated reading time: 3 minutes, 26 seconds

Mobile health (mHealth) applications have the potential to transform healthcare by allowing doctors to diagnose patients with potentially life-threatening conditions outside of the traditional healthcare settings.

These mobile tools also can help people manage their own health and wellness goals, promote healthy living, and access useful information when and where they need it. What's concerning to healthcare practitioners, thought leaders, and regulatory agencies is the fact that these tools are being adopted almost as quickly as they can be developed.

According to the fourth mHealth Developer Economics survey, 500 million smartphone users worldwide will be using one or more health apps by 2015. By 2018, 50% of the more than 3.4 billion smartphone and tablet users will have downloaded mHealth applications. These users include healthcare professionals, consumers, and patients.

In response, the FDA, at the close of 2013 finalized the guidance document on the oversight of mobile applications specific to medicine and healthcare Apps. The document provides examples of mobile apps that are not medical devices, mobile apps that the FDA intends to exercise enforcement discretion, and mobile medical apps that the FDA will regulate. This resource is invaluable for healthcare practitioners whose patients may be seeking their advice about mHealth apps that can help them manage or monitor health status and medical conditions.

FDA mHealth App Watch: Enforcement and Regulation Criteria

The FDA recognizes that "health IT presents tremendous benefits, including greater prevention of medical errors, reductions in unnecessary tests, increased patient engagement, and helping quickly identify and respond to public health threats and emergencies," says Jennifer Rodriguez, a press officer with the FDA.

"However, if health IT products are not designed, implemented or maintained properly, they can pose varying degrees of risk to the patients who use them," she continues. "The diverse and rapidly developing industry of health information technology requires a thoughtful, flexible approach to regulatory oversight."

The FDA uses a risk-based approach* to oversight of medical devices that focuses on device functionality (not specific platforms) and will focus its oversight on those health IT products that pose a greater risk to patients if they don't work as intended.

This is particularly true of subsets of mHealth applications, as follows: the FDA is taking a tailored, risk-based approach that focuses on the small subset of mobile apps that meet the regulatory definition of "device." This includes apps that are intended for use as an accessory to a regulated medical device, or which transform a mobile platform into a regulated medical device. While many mHealth apps carry minimal risk, some can pose a greater risk to patients and those apps will require FDA regulatory review.

For many mobile apps that may meet the regulatory definition of a "device" but pose minimal risk to patients and consumers, the FDA will exercise enforcement discretions and will not be subject to regulatory requirements at the present time. These mobile apps may be intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease.

Also considered in this category are those mobile health and medical applications that help patients/users self-manage their disease or condition without providing specific treatment suggestions; apps that help users organize and track personal health information; apps that provide easy access to health related educational information; and apps that communicate potential medical information to healthcare providers or provide a patient with the ability to interact with their EHR.

The list of mobile medical apps that do require enforcement discretion by the FDA is continually being updated. Additionally, there is an online list of examples of mobile medical apps that have been cleared or approved by the FDA.

To stay informed on mHealth app regulations, healthcare providers and their patients can read "real world" examples and receive consumer updates from the FDA.

Additional information:

Mobile Medical Applications: Guidance for Industry and Drug Administration Staff

USDHHS Mobile Medical Applications

Mobile Medical Apps Guidance News Release of September 2013

Karen M. Rider, M.A. is a freelance writer with special interests in wellness, health psychology, healthcare news and integrative medicine. Karen also writes marketing copy for health and wellness practitioners across a variety of specialties.

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