New Rules Could Improve Health App Innovation
The United States Food and Drug Administration (FDA) has released guidelines on how it is going to regulate the plethora of new health-related smartphone applications.
In recent years developers, doctors and crowdsourcing competitions have created thousands of applications to help people improve their health and stay healthy. They include apps to monitor heart health, count calories and measure lung function.
“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 center.
The FDA has now said that most of these apps pose a negligible threat to health and will not be regulated. However, it will turn its attention to apps that turn smart phones into medical devices.
Guidelines
These applications form a minority of the estimated 17,000 health-related mobile apps that are out there, but the agency believe they are the ones that are most likely to put patient safety at risk.
The new guidelines will cover medical apps that:
- are intended to be used as an accessory to a regulated medical device
- transform a mobile platform into a regulated medical device
FDA officials have already approved 75 of these “mobile medical applications,” including 25 in the last year.
Clarity
The move is good news for developers as there is now clarity about what will and will not be regulated. Previously, there have been complaints that a lack of guidelines has scared away potential investors.
The FDA believes that come 2015, 500 million smartphone users will have some type of health app.
Add your Comment
[LOGIN FIRST] if you're already a member.fields are required.