FDA looking into regulation of mobile medical APP’s

Posted on September 7, 2010

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Medical APP’s are heavy movers on the APP store as we can see with the iStethoscope APP. As a result, the FDA has turned their attention to medical APP’s that it deems fill a medical purpose. The FDA wants to regulate these APP’s and that will make development a much longer process. Be prepared if you develop these types of APP’s and make sure you have a lot of insurance! If the FDA is successful in regulating APP’s of this nature, how long until other government agencies find a way to get in the regulation game!

More than three million doctors have downloaded an iPhone app which is replacing the stethoscope in UK hospitals.

The iStethoscope app, created by Peter Bentley at University College London, was originally developed as nothing more than a toy.

But now more than 500 users a day are downloading the free version of the application which experts say has already saved lives.

To use the app the iPhone is pressed against the chest where its built-in microphone is able to pick up on the heart’s beat.

The new app could replace the stethoscope in some hospitals

The user then shakes the iPhone to hear the last eight seconds of recording and see a phonocardiograph display and a spectrogram. The diagrams can then be emailed to a specialist.

‘Everybody is very excited about the potential of the adoption of mobile phone technology into the medical workplace, and rightly so,’ Dr Bentley told the Guardian.

‘Smartphones are incredibly powerful devices packed full of sensors, cameras, high-quality microphones with amazing displays,’ he said.

‘They are capable of saving lives, saving money and improving healthcare in a dramatic fashion – and we carry these massively powerful computers in our pockets.’

Bentley said that future cheap iPhone apps for use by doctors are being held back by out-of-date regulations that prevents smartphones from becoming medical devices.

Dr Bentley said that he could create a mobile ultrasound scanner or an app to measure oxygen levels in the blood but is being held back by the regulations.

A spokesman for the Medicines and Healthcare products Regulatory Agency (MHRA), which looks at how to regulate new technologies, said: This is such a complex area that we are currently looking at every application on a case-by-case basis.

‘We want to ensure that these new technologies are effectively regulated – thereby protecting health and avoiding unnecessary deterrents – while at the same time removing any unnecessary obstacles to manufacturers who wish to exploit new technologies for the benefit of patients.’

The U.S. Food and Drug Administration  is actively watching app stores for apps that it deems fill a medical purpose with an eye toward regulating them, according to Bradley Merrill Thompson, an attorney specializing in health care issues. Thompson said even smartphone apps require FDA approval, just like other medical “devices,” and the determination if an app requires federal approval is strictly the FDA’s call. Apps such as iStethoscope for the iPhone  and Instant Heart Rate for Android may find themselves facing a regulatory process much like other medical devices such as glucose monitors, which could stymie innovation and put the kibosh on plans to use smartphones for health monitoring.

iStethoscope uses the iPhone’s microphone to monitor the user’s heartbeat, while Instant Heart Rate uses the camera on an Android phone to serve the same function. These aren’t the first apps to appear for medical-related purposes, and they won’t be the last, So at what point will the FDA step in and put the clamps down on such apps? According to Thompson, it isn’t clear which apps might trigger FDA scrutiny.

While the iStethoscope app doesn’t make any medical diagnoses from the heartbeats detected, other apps have clearly entered the diagnostic realm. One computer program listens to coughs to determine the underlying cause, and this program can (and probably will) be ported to a smartphone app. We’ve already covered apps that listen to sensors on a patient to track vital signs, and medical researchers are actively working on smartphone apps that analyze blood or saliva samples for monitoring the condition of patients with HIV and malaria.

Some uses of these apps are more involved in the medical process than a simple stethoscope app, but where is the line drawn? In an article written last year, Thompson notes the FDA could even regulate cell phones used for medical purposes. He points out that once a program is committed to computer media, “media with the code written on it is enough of a ‘thing’ for FDA to regulate.”

“The FDA is actively engaged in surveillance of various app stores to see if apps should trigger their involvement. Applications where a smartphone is connected in any way to imaging are under scrutiny, in particular. Any app that is used to transmit images to a medical facility requires FDA approval.”

FDA involvement will complicate the app development process; developers will have to be aware that their app might warrant an FDA approval process, and if so, if it’s worth continuing with the project. As the distribution vehicle for apps, app stores will need to be aware of the implications FDA involvement brings to the process. Some apps may be rejected by the store because of potential federal scrutiny.

Posted in: Mobile Health