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Should Mobile Health Apps Be Regulated By FDA?

App developers and mobile device makers better pay close attention because the FDA says it's looking for "greater regulatory clarity."

With the growing popularity of tablets and smartphones--and the explosion of E-health record products for clinicians and patients--we're seeing lots of useful, innovative mobile health tools hit the market. Will the threat of increased fedetal regulation stifle this rush of innovation? That's a question a lot of developers are probably asking themselves as they hear the latest news from the FDA.

Until fairly recently, most mobile health apps have been geared to consumers, including those who want handy access to information online about a health topic of interest--or to track details about their own health and wellness. But a growing number of mobile health apps are also aimed at patients with chronic conditions, measuring parameters like blood glucose, blood pressure, and the like.

These readings are often compiled for the consumer's own informal tracking, but sometimes they're shared with doctors or other clinical third parties.

Increasingly sophisticated applications allow the data to be transmitted to clinicians for more intensive monitoring. Such monitoring allows caregivers to provide invaluable preventative advice when a patient is showing early signs of trouble.

As these apps become increasingly more sophisticated--some can send data to patients' health records or help clinicians make diagnoses or treatment decisions--experts worry that some devices and applications may do more harm than good, especially if they don't meet basic standards of reliability, safety, and security.

These considerations have prompted the Food and Drug Administration to take a closer look at mobile health devices and applications. To date, the FDA hasn't gotten too deep into making rules or enforcing regulations as they relate to mobile health app development. But that's likely to change soon.

What does the FDA have in mind?

"The rapid development and use of mobile apps for medical purposes has signaled the need for greater regulatory clarity for manufacturers developing these technologies," said a FDA spokeswoman in an email exchange with InformationWeek Healthcare.

"In the near future, we plan to provide draft guidance for public comment prior to finalizing, which will provide clarity for manufacturers as they continue to develop innovative, health-related mobile apps," she said.

12 Innovative Mobile Healthcare Apps
(click image for larger view)
Slideshow: 12 Innovative Mobile Healthcare Apps
"The use of mobile medical apps by health care professionals to diagnose and treat patients is helping to make patient-focused health care a reality and these innovative tools could one day also help patients more effectively manage their health," she said.

It's expected that if the FDA begins regulating mobile health apps, they'd likely fall under FDA 501 (k) rules for medical devices.

Within the FDA, medical device data systems (MDDS) are defined as hardware or software products that transfer, store, convert formats, and display medical device data. An MDDS does not modify the data or modify the display of the data, and it does not by itself control the functions or parameters of any other medical device. MDDS are not intended to be used for active patient monitoring.

Examples of MDDS include:

-- Software that stores patient data such as blood pressure readings for review at a later time.

-- Software that converts digital data generated by a pulse oximeter into a format that can be printed.

-- Software that displays a previously stored electrocardiogram for a particular patient.

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