Wednesday, April 21, 2010

Will iPhone Apps Have to be FDA-Approved as Medical Devices?

... if you're a radiologist, it seems some do:

“We did a stroke trial ... and compared performance of radiologists reading on the iPhone to the standard clinical reading work station and the performance was identical,” said Mitchell. “They performed just as well in this tough diagnostic task.

“That’s a really good indicator that this could be quite useful for diagnosing all sorts of things that aren’t as tough,” he added.

Mitchell said it’s currently being tested on the new iPad, which has a larger screen to view the images.

The application for iPhone and other mobile devices has been licensed as a medical device in Canada, said Philippe Laroche, a spokesman for Health Canada.

It’s still awaiting approval from the US Food and Drug Administration and CE Mark in Europe.
Now, the next blockbuster: the FDA-approval iPhone app!

-Wes

6 comments:

The Notwithstanding Blog said...

Is FDA approval mandatory for software like this? I would imagine that if mobile apps need to be FDA-approved for clinical use, then virtually every EMR out there is being used illegally.

I would guess (hope?) that they sought regulatory approval as a precaution and not out of requirement.

Rogue Medic said...

One of the proposed methods of decreasing door to balloon time is sending the 12 lead to the cardiologist's phone. This could end up being very frustrating, entertaining, silly, and counterproductive.

Would each phone and software upgrade also need FDA approval for each app? The non-Apple market is very diverse, with dozens of phones that might be able to produce comparable displays.

After a couple of years they will either realize that this is silly, or they will embrace it with the fanaticism of the minions of Satan formerly known as JCAHO.

Jared Houck said...

I'm not sure why they are seeking FDA approval, unless is to simply say that they are FDA approved in their marketing information. Stand alone software usually isn't considered a "medical device".

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/ClassifyYourDevice/ucm051512.htm

drew said...

I had a conversation about the large amount of medical smartphone applications with my CEO, a former cardiologist, and their use throughout the healthcare industry. We concluded that for these programs to be useful there would have to be some sort of government oversight akin to the FAA to regulate which applications are used in hospitals across the nation. Otherwise there a hundred different apps that do the same thing.

The Notwithstanding Blog said...

Is it a bad thing if there are a hundred different apps doing the same thing? I think of that scenario and see the foundations of a market in which appmakers compete on the basis of price and quality. As long as none of them are patently unsafe (a condition that I find hard to imagine), it would allow different hospitals to choose the ones that best suit their needs, instead of being limited to those deemed worthy by the FDA.

drew said...

There needs to be an agreement on compatibility for apps that share basic information, like patient's info, so doctors from different medical facilities can sync up without interference. You're right though, government regulation is taking it too far, but maybe some industry standards should be applied.