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The U.S. Food and Drug Administration (FDA) today announced plans to regulate health and medical apps with a set of proposed guidelines. The FDA posted the guidelines, and is encouraging "consumers to weigh-in on the guidelines during a 90-day public comment period."
FDA policy advisor Bakul Patel states, “There are advantages to using medical apps, but consumers and health care professionals should have a balanced awareness of the benefits and risks.” Patel goes on to explain the policy, claiming the FDA is only proposing to regulate a "small group of mobile medical apps" that may "present a potential risk" to consumers.
Primarily, the FDA is going to target mobile medical apps 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
According to Patel, the FDA really wants to hear your opinion regarding this government reach into your App Store options. “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 says.
So, with Washington D.C. now proposing to potentially dictate how apps should be developed and used, do you have something to say about it?