FDA Guidance Regulates Mobile Medical Apps, Exempts Mobile Health and Wellness Apps
Deven McGraw, Project HealthDesign Regulatory and Assurance Advisory Group, Center for Democracy & Technology
On July 21, the U.S. Food and Drug Administration (FDA) issued guidance on how the agency intends to regulate certain mobile medical applications. The guidance does not establish legally enforceable rules but instead reflects the FDA’s current thinking on a topic and serves as a set of recommendations.
Congress has already granted the FDA authority to regulate medical devices. The agency has previously said that it considers health IT a medical device, and the agency seems to be moving toward greater enforcement of device regulations in other components of health IT, such as electronic health records. In February, the FDA released a final regulation governing medical device data systems (MDDS). The July 2011 guidance on mobile medical apps is the most recent FDA activity in this area.
What Qualifies as a Mobile Medical App?
The FDA tries to make clear that the guidance applies only to a subset of mobile health-related apps the agency is calling mobile medical apps. A mobile medical app is one that:
- Is used as an accessory to an FDA-regulated medical device (e.g., an app that enables a health care professional to view medical images on an iPad and make a diagnosis);
- Transforms a mobile platform into a regulated medical device (e.g., an app that turns a smartphone into an electrocardiography machine to determine if a patient is having a heart attack).
The “intended use” of an app is what determines whether it qualifies as a mobile medical app. To determine intended use, the FDA will look at factors such as the packaging and the manufacturer’s ads and claims about the app.
What Qualifies as a Mobile Health or Wellness App?
The FDA tries to clarify that the guidance does not apply to "mobile apps that are solely used to log, record, track, evaluate, or make decisions or suggestions related to developing or maintaining general health and wellness." Examples of health and wellness apps are provided in the guidance, and include dietary tracking logs, appointment reminders, dietary suggestions based on a calorie counter, posture suggestions, exercise suggestions, etc. In contrast, a mobile medical app is one that is intended for "curing, treating, seeking treatment for, mitigating, or diagnosing a specific disease, disorder, patient state, or any specific, identifiable health condition."
The Gray Area Between Medical Apps and Health/Wellness Apps
The FDA tries to draw clear lines here and offers more examples of mobile medical apps in the guidance (see appendix A). However, the distinction between mobile medical apps and health/wellness apps is not as clear as the guidance presumes and seems to be based on the medical model of health. Today, medical conditions are significantly improved — and even prevented — by healthy behaviors, and providers might prescribe or at least recommend particular diet or exercise protocols as part of medical treatment. Many mobile health applications in development and in active use today fall in this gray area between medical and health/wellness. For example, the current Project HealthDesign teams are testing the impact of the use of consumer-facing health applications on health outcomes for individuals with chronic conditions.
Apps that Qualify as Medical Devices
In the guidance, the FDA acknowledges other classes of mobile apps that don’t qualify as mobile medical apps but might fit within the medical device definition; these other classes of mobile apps (e.g., apps that allow individuals to self-manage their diseases or conditions) would then be subject to FDA regulation. These apps are not covered by this FDA guidance; the agency does, however, intend to monitor the performance of these apps and “determine whether additional or different actions are necessary to protect public health” (see footnote 13 of the guidance).
Mobile medical apps will be expected to meet the device regulatory requirements associated with the risk classification for the app. In brief, the FDA will place more stringent requirements on devices that the agency believes pose a potential high risk for patients; the lowest level of device regulation, reserved for devices that pose minimum risk for morbidity or mortality, involves more general controls. For apps that are clearly not mobile medical apps — or that fall into the gray area between medical apps and health/wellness apps — the FDA recommends that manufacturers voluntarily follow the FDA’s Quality Systems regulations in the design and development of their apps.
Assessing the Guidance
In general, the FDA appears to be striking the right balance with this guidance, focusing on apps that are clearly used in medical treatment and taking a “sit-back-and-wait” approach for health/wellness apps that have implications for treatment. My chief concern about this guidance, however, is the lack of clarity about what is a mobile medical app — which could be subject to regulation as a device — and what is just a health/wellness app. This lack of clarity could be a significant obstacle to innovation in the mobile app space — an area where innovation should be actively encouraged. Some of the most exciting developments in health employ mobile apps to actively engage patients in activities that promote health or that enable them to manage health conditions in more effective and less costly ways.
At a minimum, the FDA should provide more examples of the types of apps that are not considered mobile medical apps, and the agency should select some examples that fall into the gray area — apps that focus on wellness but are intended to improve or mitigate a patient’s medical condition. The agency could also provide an efficient and transparent process for updating this list of examples to try to keep reasonably apace with technological developments. Perhaps a common sense litmus test could distinguish which health apps should be more closely regulated by the FDA: If the consequences of an app malfunction would be significant, it falls into the bucket of what FDA is trying to (and arguably should) more stringently regulate.
Submitting Feedback to the FDA
The FDA has also requested feedback on the regulations; submit your comments to FDA by October 19, 2011.
