Some smartphone health apps to be regulated by the FDA

By ACSH Staff — Sep 25, 2013
It seems the time has come to ask not, what can your smartphone do, but rather, what can it NOT do? According to industry analysts, there are now about 17,000 apps that aim to help you stay healthy. Although most of these applications, such as calorie counters or apps that record how far you ve run, pose no harm to consumers

111819231It seems the time has come to ask not, what can your smartphone do, but rather, what can it NOT do? According to industry analysts, there are now about 17,000 apps that aim to help you stay healthy. Although most of these applications, such as calorie counters or apps that record how far you ve run, pose no harm to consumers should they malfunction, some apps turn the smartphone into a medical device, such as a heart monitor or an arm cuff to measure blood pressure. The FDA is now saying that those kinds of apps will be regulated by officials.

Other applications which may be regulated include those that allow users to take pictures of eardrums, perform ultrasounds, monitor irregular heartbeats and measure lung function. The FDA says that 75 such apps have already been approved, 25 within the last year, and they will continue to consider each one on a case by case basis. They estimate that by 2015 about 500 million smartphone users will have used an app in the health category.

According to Dr. Jeffrey Shuren, director of the FDA s medical device center, Mobile apps have the potential to transform healthcare by allowing doctors to diagnose patients with potentially life-threatening conditions outside of traditional healthcare settings, help consumers manage their own health and wellness, and also gain access to useful information whenever and wherever they need it.

ACSH s Ariel Savransky had this perspective. I think that it s important that the FDA is making an effort to impose a level of quality control for certain apps that may affect consumers negatively should they malfunction. And there is clearly a benefit for some to be able to monitor aspects of their health with a click of a button from the comforts of their own homes. However, this is not an excuse to completely dodge in-person medical care, as many conditions still require a visit to your doctor.

ACSH s Dr. Josh Bloom is anxiously awaiting an app that will deliver a non-lethal, but severe electric shock every time he gets too close to a Junior s Cheesecake bakery.