Should the FDA Monitor Health Apps?

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The Food and Drug Administration (FDA) is proposing guidelines to monitor a “small number of mobile apps.”

Before you start wondering whether the feds are going to jump into your pocket along with your ever-present smartphone, it doesn’t look that way yet.

They won’t be in your business for all those apps that do things like track your weight or give you tips on breastfeeding.

Namely, they will be keeping an eye on apps that “could present a risk to patients if the apps don’t work as intended” — those that should be used by health care professionals, like ultrasounds and an application for iPhones and iPads that allow doctors to view medical images and X-rays.

The proposed monitoring would not cover apps that could potentially cause damage if used by lay people like the growing number of CPR or first responder apps. (Developers can, however, elect to register and list and to seek approval or clearance for mobile apps with the FDA.)

Still, parsing the thousands of health-related apps may be a harder job than they first thought: the guidelines were due in March.

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

The FDA says it wants consumers to weigh in on the guidelines during a 90-day public comment period once the guidelines are published in the Federal Register July 21. (You can preview the document online here).

“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.

You can submit comments on the proposal online or in writing to: Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD  20852.

Do you think the FDA should monitor health apps?

Via FDA