Mobile medical applications are revolutionizing the way that healthcare is delivered across the world. In fact, it is estimated that by 2015, 500 million smart phone users worldwide will be using a health care application (app) on their Smartphone or tablet [1]. Mobile medical applications, or mobile medical apps, can enable a mobile platform to become a heart monitor, a light for diagnosing melanoma, or even a blood glucose meter. The possibilities are endless.

In order to address questions and provide clarity on how mobile medical apps should be regulated, a draft of the guidance was issued by the Food and Drug Administration (FDA) on July 21 [2]. According to the draft, a “mobile medical app” is one that meets the definition of “device” in section 201(h) of the Federal Food, Drug, and Cosmetic Act (FD&C Act); and either:

• Is used as an accessory to a regulated medical device; or
• Transforms a mobile platform into a regulated medical device

The intended use plays an integral role in determining whether or not an app meets the definition of a “device”. Apps that are devices and satisfy one of the two provisions stated above will be subject to regulatory oversight.

It may prove difficult to determine whether an app will be regulated by the FDA due to the vast breadth of applications that are possible in this highly innovative field. The draft of the guidance provides examples of apps that are mobile medical apps (i.e. an app that displays an x-ray to a doctor for diagnosis, or an app that determines a chemotherapy dose based on a patient’s surface area) and examples of apps that are not mobile medical apps (i.e. an app that is an electronic health record, or an app that suggests a workout schedule for a marathon). The FDA encourages dialogue to determine the correct regulatory approach.

As with all medical devices, certain risks are associated with each mobile medical app. The draft document only intends to address the subset of mobile medical apps that present the greatest risk when it malfunctions . Developers of mobile medical apps have the responsibility to identify and mitigate risks wherever possible. A company’s risk management activities should include an evaluation of the technology as well as the platform that it uses. For example, a doctor who uses an app that displays MRI images on an Android phone may be have the risk of misdiagnosis of a patient due to the small screen size, or low contrast ratio of the phone.

The mobile medical app developer, like other device manufacturers, will be required to comply with quality system regulations, labeling requirements, and adverse event reporting . However, for now, platform manufacturers, like Apple or Motorola, are relieved from any regulatory obligation so long as they keep an eye on their marketing claims. Platform manufacturers may be tempted to advertise that their platform has the best compatibility with a new mobile medical app, however such advertising would impact the intended use of their platform, and may make them subject to regulatory oversight [3].

To date, there are a number of manufacturers who have already received clearance on their apps, such as Withings’ automatic blood pressure monitor for the iPhone. For developers of new medical apps, this draft is important to understand and comment on. Since these mobile medical apps are being regulated as medical devices, they are also subject to the same penalties (i.e. non-conformances, fines, criminal conviction) if the regulations are not properly followed. The FDA is hosting a public workshop to discuss the draft on September 12-13,[4] and comments on this draft can be submitted until October 19.

- Sherri Hall

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[1] http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm263340.htm
[2]http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm263280.htm
[3] http://www.ansongroup.com/ansons-initial-assessment-of-fdas-mobile-medical-app-draft-guidance/
[4] http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm267821.htm

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