FDA Targets Its First Medical App

credit: slowburn? / Foter.com / CC BY-NC-SA

In 2011, the Food and Drug Agency released proposed guidelines for the regulation of mobile medical apps—health programs for devices like the iPad and iPhone. At the time, there were about 200 million such apps in use, but the FDA said its rules would only pertain to a small segment of the market: apps that, say, controlled blood pressure cuffs or insulin pumps, or that were intended to be used to make clinical decision.

Two years later, those rules still aren't finalized. But the agency has begun questioning one medical app maker. Via Bloomberg News:

An iPhone application that lets users check levels of blood, protein and other substances in their urine is the first target of U.S. regulators seeking boundaries in a burgeoning industry for medical diagnosis on-the-go.

Biosense Technologies Private Ltd.'s uChek system isn't cleared by the Food and Drug Administration and the agency said it wants to know why not, in a first-of-its-kind letter to a maker of a mobile-device application. The app relies on users, such as diabetics checking their glucose, to dip test strips in urine and use the smartphone's camera to allow the system to processes and generate automated results.

One of the big worries with this sort of target was that it could stifle innovation. App makers are going to be less inclined to build medical apps if they're also going to have to deal with a lot of burdensome FDA compliance issues. And uChek, the app in question, seems like it has the potential to be a fairly innovative and useful tool for a lot of people. Basically, the app lets users perform a urinalysis at home. Mashable explained how the app works, and the problems it solves, after Biosense's founder introduced the tech at a TED talk last February:

There are a couple of problems with those commercially available [urinalysis] test strips: They're hard for you to examine on your own, and they consist of 10 confusingly colored pads that intentionally change color a couple of times after you dip them in urine.

What's more, to get a proper read on them, doctors and hospitals have to buy one of six expensive urine-analysis machines — all of which are incompatible with anything but their own brand of urine strips.

Uchek reads the color of those strips the way other apps read barcodes or QR codes. The app asks you to take a couple of shots of the strips at intervals of a few minutes. It then delivers the chemical composition of your pee, what that means, and how it is changing over time.

So, it's an app that provides valuable health status information, without leaving home, and without an expensive medical professional or expensive medical equipment. This seems like the sort of beneficial, efficient health care innovation that we would generally want to encourage. But adding a new layer of FDA regulation is likely to have the opposite effect. 

Comments

[Gilbert Martin]

The app creators should sue the FDA on the grounds that it is exceeding the boundary of it's legitmate authority.

The apps are merely providing information. They are not drugs, actual medical devices (such are artificial hips,etc.). Why should the FDA have any say in the matter to begin with?

[BigFire]

Or as the end quote for the Nanny of the Motht video points out, somewhere someone is having fun, and we can't have that.

[Bubba Jones]

I actually side with the FDA on this one. There are some pretty basic guidelines for medical devices to ensure they are reliable and accurate, especially when they are targeted for consumers. For all we know this device yields dangerously erroneous results if the phone has the wrong protective cover on it.

These are diagnostic devices used to monitor patient health and inform medical decisions. It's important that the results meet spec.

[AlmightyJB]

And? If I'm using an app I downloaded then I'm obviously willing to take that risk. No one is forcing people to use it.

[nilecroc]

Fuck off slaver.

[Contrarian P]

See my response to mtopper below.

More specifically for you "For all we know this device yields dangerously erroneous results"...such as what? What urinalysis results would be dangerous? Do you have any idea what you're talking about? And until there is actual data demonstrating a potential harm from a cover (which is likely garbage anyway, since most phone covers leave the camera lens exposed), why are we even having this discussion?

[Nikki makes the sign of a tsp]

This seems like the sort of beneficial, efficient health care innovation that we would generally want to encourage.

We? Yes. FDA? Not so much.

[Ray]

At the time, there were about 200 million such apps available

Umm, that might be a few orders of magnitude off...

[Peter Suderman]

Updated to say "in use" rather than "available."

[AlmightyJB]

"to get a proper read on them, doctors and hospitals have to buy one of six expensive urine-analysis machines ? all of which are incompatible with anything but their own brand of urine strips."

Hmmm...I wonder who sicced the FDA on them?

[mtopper]

I agree with Bubba Jones. Just because its an "internet gadget" doesnt mean it gives accurate medical information. What if the system erroneously told a person their blood sugar was fine and they relied on that to make a decision not to seek treatment. The FDA is responsible for preventing that failure. I say they need to set up a system whereby they can evaluate the possible impact of these apps.

[AlmightyJB]

"they relied on that to make a decision"

That's that persons choice.

"The FDA is responsible for preventing that failure"

No they are not. You are responsible for your well being.

[Contrarian P]

And if the person using the product understands that it's not a physician nor a clinical laboratory? Can you point to a single case of someone being harmed through the use of these apps? Until there's a problem, why are we busy trying to come up with solutions? Isn't it more likely that people would use the apps to monitor their health and if they saw something they thought was wrong, it would make them more likely to seek medical attention? It sounds to me that this is more a case of urinalysis device manufacturers who want to keep their cash flow brisk. If I, as a physician, could look at your urine results that you brought from home and prescribe you the appropriate treatment, it would cut down on testing costs and wait time considerably.