Smartphone healthcare apps: New rules

smartphone healthcare app vein clinicFood and Drug Administration officials say they will begin regulating a new wave of health applications and gadgets that work with smartphones to take medical readings and help users monitor their health.

What apps already exist?

With the continuing popularity of iPhones, Androids and other mobile devices, there has been a corresponding tsunami of applications designed to help people stay healthy. In fact, industry analysts estimate there are already more than 17,000 medical applications available, ranging from calorie counters to high-tech heart monitors.In fact, Dr. Reynolds uses an iPhone app, which has been cleared by the FDA, to record, display, store and transfer single-channel electrocardiogram (ECG) rhythms.

Are there any risks involved?

Last Monday, the FDA said that the vast majority of these healthcare apps don’t pose much of a risk to consumers if they malfunction, and will not be federally regulated. Instead, the FDA will focus on a handful of apps that turn smartphones into devices, like a heart monitor, or medical attachments that plug into smartphones, like arm cuffs that measure your blood pressure.

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

What information can be tracked?

Most health-related apps are both free and perform simple functions, like helping users keep track of their meals or calories burned while exercising. However, now a growing number of companies are developing more complex apps and attachments that perform tests and functions once reserved for the doctor’s office.

FDA officials said Monday they have already approved 75 of these “mobile medical applications,” including 25 in the last year. Agency officials estimate that 500 million smartphone users worldwide will use some type of health app by 2015.

However, there is still no app that can determine whether or not you have venous insufficiency (vein disease) and how extensive your medical condition may be. For that, you should schedule a free consultation with Dr. Neal Reynolds of The Vein Clinic.

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