Are you feeling under the weather? Have some questions about your new prescription? There’s an app for that. With today’s technology there is an app for everything. There are over 425,000 apps on the market and a good number of those are health related. But how do you know which ones to trust?
The Food and Drug Administration (FDA) is currently proposing guidelines to oversee a small number of medical apps. They are focusing on those apps that could potentially pose a risk to patients if they are working improperly. Currently the FDA is only focusing on what they are calling “mobile medical apps” which can be “used as an accessory to a regulated medical device” or those apps that “transform a mobile platform into a regulated medical device.” The FDA will not be regulating medical reference apps, wellness trackers (such as calorie counters), medical office functions, or electronic health record systems.
The FDA has already approved a few apps that are mainly used by professionals in the health care industry; including apps that are designed to view x-rays and other medical images.
According to FDA policy advisor Bakul Patel, “the FDA is proposing to oversee 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.”
The proposed guidelines can be found here: http://www.regulations.gov/#!documentDetail;D=FDA-2011-D-0530-0001 Consumers are welcome to share their thoughts on the website until October 19.