US lays out rules for health apps

2013-09-24 07:27
The Ledula app is available on the iPhone. (Duncan Alfreds, News24)

The Ledula app is available on the iPhone. (Duncan Alfreds, News24)

Multimedia   ·   User Galleries   ·   News in Pictures Send us your pictures  ·  Send us your stories

Washington - Food and Drug Administration officials say they will begin regulating a new wave of applications and gadgets that work with smartphones to take medical readings and help users monitor their health.

With the rise of the iPhone, Android and other mobile devices has come a flood of applications designed to help people stay healthy.

Industry analysts estimate there are already more than 17 000 medical applications available, ranging from calorie counters to high-tech heart monitors.

The FDA said on Monday that the vast majority of these health care apps don't pose much of a risk to consumers if they malfunction, and will not be federally regulated.

Instead, the agency 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 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, help consumers manage their own health and wellness, and also gain access to useful information whenever and wherever they need it," said Dr. Jeffrey Shuren, director of the FDA's medical device centre.

Most health-related apps are free and perform simple functions, like helping users keep track of their meals or calories burned exercising.

But a growing number of companies are developing more complex apps and attachments that perform tests and functions once reserved for the doctor's office.

These tools allow users to take photos of their eardrums, monitor irregular heartbeats and even measure lung function.

Many of these tools can cost $100 or more. Sales data is not widely reported so it's not yet clear whether patients and their doctors are embracing them.

FDA officials said on 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.

Last year the FDA approved the sale of a $199 heart monitor from AliveCor. The attachment snaps on like a smartphone case with finger electrodes that measure the users' heartbeat.

Hold the device for 30 seconds and it delivers an approximate EKG reading, an essential medical test that checks for problems with the heart's electrical activity. Patients can email the reading to their doctor for analysis.

Other applications in development would allow patients with asthma to measure their lung function by blowing on their phone, rather than using special machines usually found in doctors' offices.

Read more on:    us  |  health  |  technology  |  mobile

Join the conversation! encourages commentary submitted via MyNews24. Contributions of 200 words or more will be considered for publication.

We reserve editorial discretion to decide what will be published.
Read our comments policy for guidelines on contributions. publishes all comments posted on articles provided that they adhere to our Comments Policy. Should you wish to report a comment for editorial review, please do so by clicking the 'Report Comment' button to the right of each comment.

Comment on this story
Comments have been closed for this article.

Inside News24


Book flights

Compare, Book, Fly

Traffic Alerts
There are new stories on the homepage. Click here to see them.


Create Profile

Creating your profile will enable you to submit photos and stories to get published on News24.

Please provide a username for your profile page:

This username must be unique, cannot be edited and will be used in the URL to your profile page across the entire network.


Location Settings

News24 allows you to edit the display of certain components based on a location. If you wish to personalise the page based on your preferences, please select a location for each component and click "Submit" in order for the changes to take affect.

Facebook Sign-In

Hi News addict,

Join the News24 Community to be involved in breaking the news.

Log in with Facebook to comment and personalise news, weather and listings.