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FDA Proposes Health App Guidelines

The FDA is seeking public input on proposed guidelines for certain mobile medical applications.

The mobile medical applications, or apps, are specific to medicine or healthcare and are designed for use on smartphones and other mobile computing devices. They include a variety of functions, ranging from monitoring calorie intake, to helping people maintain a healthy weight, to allowing doctors to view a patient’s radiology images. Research studies predict that 500 million smartphone users worldwide will be using a healthcare application by 2015.

The agency’s draft guidance defines a small subset of apps that impact or may impact the performance or functionality of currently regulated medical devices. This subset includes mobile medical apps that:

  • Are used as an accessory to medical devices already regulated by the FDA, including apps that allow healthcare professionals to make specific diagnoses by viewing a medical image from a picture archiving and communication system (PACS) on a smartphone or a mobile tablet.
  • Transform a mobile communications device into a regulated medical device by using attachments, sensors or other devices, including apps that turn smartphones into ECG machines to detect abnormal heart rhythms or determine if a patient is experiencing a heart attack.

The FDA says it is not trying to discourage the development of new apps, but instead focus on a select group of applications whose misuse it feels may endanger patients.

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Source: FDA, July 19, 2011


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