FDA may regulate mobile health apps

The U.S. Food and Drug Administration may soon approve or reject mobile health applications. The government agency said on Wednesday that it is proposing to oversee the applications in an effort to ensure the apps perform as advertised and aren’t actually hurting users. “There are advantages to using medical apps, but consumers and health care professionals should have a balanced awareness of the benefits and risks,” FDA policy advisor Bakul Patel said. The administration hopes to approve and reject mobile applications that:

  • Are used as an accessory to an FDA-regulated medical device. For example, an app could enable a health care professional to view medical images on an iPad and make a diagnosis;
  • Transform a mobile platform into a regulated medical device. For example, an app that turns a smartphone into an electrocardiography, or ECG, machine to detect abnormal heart rhythms or determine if a patient is experiencing a heart attack.

“We want to hear from as many consumers, advocacy groups, health care professionals, and software creators and distributors as possible to help us finalize the proposed guidelines,” Patel said. The proposed guidelines will be published on Wednesday.

[Via Gizmodo]

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