FDA to regulate Mobile Apps with Highest Risk

FDA LogoHealth care can be delivered with better quality and less cost through mobile technologies, but unfortunately, the scope and uncertainty of proposed FDA rules is impeding progress and adoption of these new technologies.

On 7/19/2011 the FDA announced that it is seeking public comment on proposed regulatory oversight of the mobile medical (mHealth) apps that pose the greatest risk to patients when they don’t work right. Its aim is to “strike a fine balance between promoting innovation and assuring safety and effectiveness.”

According to the news release, some 500 million smartphone users will be using mHealth apps worldwide by 2015. The new rules will apply to those apps that:

  • are used as an accessory to a regulated medical device; or
  • transform a mobile platform into a regulated medical device.

Intended Use

The intended use of a mobile app (as shown by labeling, advertising, or manufacturer statements) determines whether it meets the definition of a “device.” When the intended use is for the “diagnosis of disease or other conditions, or the cure, mitigation, treatment, or prevention of disease, or is intended to affect the structure or any function of the body of man,” the mobile app is treated as a regulated device.

The Draft Guidance for Industry and FDA Staff provides details about how mobile medical apps will be regulated. It gives examples of what would be considered a regulated medical device and what would not.

Examples of Regulated Medical Apps

I had concerns with the FDA’s very first example of a regulated device. It was a light emitting diode (LED) included on a mobile platform with a software app to make the LED operate. If the manufacturer advertises it as illuminating objects generally, then neither the app nor the mobile platform would be considered regulated medical devices. But if the manufacturer says it can also be used as a light source to examine patients, then the mobile app would meet the definition of a regulated device.

Another example is mobile apps that are extensions of a medical device, connecting to the device for purposes of controlling the device or displaying, storing, analyzing, or transmitting patient-specific medical device data. That seems to include a smartphone used to transmit data captured from a blood pressure cuff, glucose meter or similar device. I understand why the glucose meter might be regulated, but why regulate the smartphone app?

Also regulated would be any app that uses a built-in accelerometer to collect motion information for monitoring things like sleep apnea or general physical activity. Does that include keeping track of grandma to know if she’s getting her exercise or even moving around the household? ‘Not clear.

Although I didn’t go through all 29 pages of the FDA’s draft guidance, I generally found the document confusing enough to cause many manufacturers to avoid describing medical uses of included features. That seems counterproductive, in my opinion, since we should be promoting the use of these features.

Examples of Unregulated Medical Apps

The Draft Guidance lists several apps that will NOT be regulated, including reference apps like Epocrates or Physicians’ Desk Reference, electronic medical records, billing & administration apps, and generic tools such as an iPhone magnifying app or LED light marketed not sold for medical purposes.

Are we Regulating the Right Things?

Rather than regulate the smartphone or mobile app as it connects to a medical device to transmit patient data to a remote service, shouldn’t we be encouraging that? And isn’t it more important to regulate the network connection? I contend that NETWORK RELIABILITY is a far bigger issue when calls with medical sensor data don’t get through. A smartphone that communicates vital statistics can be lifesaving, but a missed medical alert can be life threatening.

Apparently I’m not alone in my concern over the confusing rules and how they might slow innovation. A new mHealth Regulatory Coalition was established to work with the FDA on the issues and has already published a white paper with questions on the Scope of FDA Regulation.

While you can reply with comments below, we encourage you to comment directly to the FDA using the information in their press release and to watch some of their education materials such as those listed below.

FDA’s Home Use Medical Device Initiative

Promoting Patient Safety with Home Use Devices

Home Use Medical Devices: New Risks