FDA Offers Guidelines on Medical Apps

Want to know how a medication might affect your breast milk? Whether your medication should be taken on an empty stomach or after a meal? Got a question about a disability, aging, mental health?

There’s an app for all that—all of that…and a whole lot more.

Just four years ago, nobody knew what an “app” was, and Smartphones were only for those willing to adopt new and unfamiliar technology. Today, nearly everyone has access to a phone or tablet that runs all manner of applications, from games (Angry Birds, anyone?) to life-saving medical advice. The Apple iPhone App Store boasts more than 350,000 apps.

Today, the Food and Drug Administration (FDA) announced that it is proposing guidelines that outline the small number of mobile apps the agency plans to oversee—medical apps that could present a risk to patients if the apps don’t work as intended. Some of the new mobile apps are designed to help consumers manage their own health and wellness—like the National Institutes of Health’s LactMed app, which gives nursing mothers information about the effects of medicines on breast milk and nursing infants. Other apps are aimed at helping health care providers improve and facilitate patient care—like the Radiation Emergency Medical Management (REMM) app, which gives health care providers guidance on diagnosing and treating radiation injuries. There are even apps to aid diagnosis of rashes and heart irregularities.

Which apps may be subject to FDA oversight?

  • Apps 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.
  • Apps that 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 FDA policy advisor Bakul Patel: “There are advantages to using medical apps, but consumers and health care professionals should have a balanced awareness of the benefits and risks.”

To read a draft of the FDA proposal, click here:  Draft Guidance for Industry and FDA

In the meanwhile, everyone should remember that apps are just as fallible as all other software. Your health is top priority. If you have questions about anything that could affect your health or the health of your loved ones, consult a medical professional…not your phone.

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