recommended reading

FDA Will Regulate Some Mobile Medical Apps as Devices

Syda Productions/Shutterstock.com

The Food and Drug Administration plans to apply the same strict regulations to mobile apps as it does to medical devices, such as blood pressure monitors, if those apps perform the same functions as stand-alone or computer based devices.

The FDA has developed a “tailored” approach to regulation of mobile apps that would allow use of some apps without oversight, according to Dr. Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health.  “Some mobile apps carry minimal risks to consumers or patients, but others can carry significant risks if they do not operate correctly,” he said. “The FDA’s tailored policy protects patients while encouraging innovation.”

The FDA said that "if a mobile app is intended for use in performing a medical device function (i.e. for diagnosis of disease or other conditions, or the cure, mitigation, treatment, or prevention of disease), it is a medical device, regardless of the platform on which it is run,” in a guidance document for industry and its staff released Monday.

The agency said its oversight approach to mobile apps “is focused on their functionality, just as we focus on the functionality of conventional devices, with oversight not determined by the platform.”

Bakul Patel,  senior policy advisor to Shuren, said the agency would regulate a mobile medical app that helps measure blood pressure by controlling the inflation and deflation of a blood pressure cuff (a blood pressure monitor), just as it regulates traditional devices that measure blood pressure

But, he said, a mobile app that doctors or patients use to log and track trends with their blood pressure would not be regulated as a device.

 Mobile medical apps that recommend calorie or carbohydrate intakes to people who track what they eat also are also not within the current focus of FDA's regulatory oversight.  “While such mobile apps may have health implications, FDA believes the risks posed by these devices are low and such apps can empower patients to be more engaged in their health care,” the agency said.

The agency said that, based on industry estimates, 500 million smartphone users worldwide will be using a health care application by 2015; by 2018, 50 percent of the more than 3.4 billion smartphone and tablet users will have downloaded mobile health applications. These users include health care professionals, consumers, and patients.

The FDA emphasized it won’t regulate the sale or ordinary use of smartphones and tablets, allaying concerns that the agency would try to regulate all mobile gadgets. The new regulations do not cover mobile electronic health record apps.

Mobile apps, the FDA said, can help people manage their own health and wellness, promote healthy living, and gain access to useful information when and where they need it, and the agency “encourages the development of mobile medical apps that improve health care and provide consumers and health care professionals with valuable health information.”

(Image via Syda Productions/Shutterstock.com)

Join us at Nextgov Prime Oct. 15-16 in Washington for indepth discussions about cloud computing, data security and much more. Registration is free for federal employees.

Threatwatch Alert

Thousands of cyber attacks occur each day

See the latest threats

JOIN THE DISCUSSION

Close [ x ] More from Nextgov
 
 

Thank you for subscribing to newsletters from Nextgov.com.
We think these reports might interest you:

  • It’s Time for the Federal Government to Embrace Wireless and Mobility

    The United States has turned a corner on the adoption of mobile phones, tablets and other smart devices, outpacing traditional desktop and laptop sales by a wide margin. This issue brief discusses the state of wireless and mobility in federal government and outlines why now is the time to embrace these technologies in government.

    Download
  • Featured Content from RSA Conference: Dissed by NIST

    Learn more about the latest draft of the U.S. National Institute of Standards and Technology guidance document on authentication and lifecycle management.

    Download
  • A New Security Architecture for Federal Networks

    Federal government networks are under constant attack, and the number of those attacks is increasing. This issue brief discusses today's threats and a new model for the future.

    Download
  • Going Agile:Revolutionizing Federal Digital Services Delivery

    Here’s one indication that times have changed: Harriet Tubman is going to be the next face of the twenty dollar bill. Another sign of change? The way in which the federal government arrived at that decision.

    Download
  • Software-Defined Networking

    So many demands are being placed on federal information technology networks, which must handle vast amounts of data, accommodate voice and video, and cope with a multitude of highly connected devices while keeping government information secure from cyber threats. This issue brief discusses the state of SDN in the federal government and the path forward.

    Download
  • The New IP: Moving Government Agencies Toward the Network of The Future

    Federal IT managers are looking to modernize legacy network infrastructures that are taxed by growing demands from mobile devices, video, vast amounts of data, and more. This issue brief discusses the federal government network landscape, as well as market, financial force drivers for network modernization.

    Download

When you download a report, your information may be shared with the underwriters of that document.