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How Apple, FDA Are Steering Mobile Health

Both Apple and federal regulators are increasingly scrutinizing the ever growing number of mobile medical applications that download to smartphones and tablets. Will Apple have more healthcare-related news on Wednesday?

Maureen Kingsley

Mobile medical applications (MMAs) have been hitting the market with increasing frequency ever since they first came onto the scene in the late 1990s

These apps represent a broad range of functionality, assisting users with everything from obtaining publicly available information about prescription drugs and looking up medical-office billing codes to measuring blood-oxygen saturation and displaying blood-glucose levels. Users include medical students, healthcare providers, healthcare patients, and employees in clinical settings. Truly, where modern medicine is concerned, app developers can increasingly say, "There's an app for that."

Needless to say, app "store" operators such as Apple and regulators such as U.S. FDA are now taking more responsiblies when it comes to categorizing MMAs and setting some guidelines for their development, marketing, and use.

Apple, for example, published developer guidelines this summer that begin to address the unique safety, privacy, and regulatory concerns of MMAs. For instance, Section 1.4 of the Safety portion of the guidelines tells developers, "If your app behaves in a way that risks physical harm, we may reject it." Specifically, Section 1.4.1 reads, "Medical apps that could provide inaccurate data or information, or that could be used for diagnosing or treating patients may be reviewed with greater scrutiny. If your medical app has received regulatory clearance, please submit a link to that documentation with your app."

The new guidelines out of Apple make sense, given CEO Tim Cook's excitement over what the high tech giant might be able to accomplish in the healthcare space. There could potentially be more healthcare-related news out of Apple's products announcement event on Wednesday.

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Indeed, for its part, FDA considers some MMAs actual medical devices requiring 510k clearance or even a PMA before they can be made commercially available.

FDA maintains a list of example MMAs requiring regulation. This list includes "mobile apps that transform a mobile platform into a regulated medical device and therefore are mobile medical apps," such as those measuring and displaying the electrical signal produced by the heart; those that use a sensor attached to the mobile platform or tools within the mobile platform itself to record, view, or analyze eye movements for use in the diagnosis of balance disorders; those that use tools within the mobile platform (e.g., a speaker) to produce controlled levels of test tones and signals intended for use in conducting diagnostic hearing evaluations and assisting in the diagnosis of possible otologic disorders, and many more.

The list of MMAs regarded and regulated by FDA as medical devices also includes mobile apps that connect to an existing medical device type for purposes of controlling its operation, function, or energy source, such as apps that act as wireless remote controls or synchronization devices for computed tomography or x-ray machines, and mobile apps that display, transfer, store, or convert patient-specific medical device data from a connected device, such as those that connect to a nursing central station and display medical device data to a physician's mobile platform for review.

Other MMAs, such as those designed to educate or train medical students and/or healthcare providers, and those providing reference information to patients, are not categorized as medical devices and are therefore left alone by FDA. The agency also announced this summer that apps that promote or support general wellness and fitness, such as calorie and exercise trackers, are not subject to FDA oversight.

Maureen Kingsley is a contributor to Qmed

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[Image by Edoddridge - Own work, CC BY-SA 3.0]

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