Saturday, May 25, 2013

FDA Targets Its First Medical App

FDA Targets Its First Medical App:
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.