Bloomberg reports the U.S. Food and Drug Administration is launching a first of its kind inquiry into medical diagnosis apps starting with the ‘uChek’ urine analysis app from Biosense Technologies. The free app, which is currently still on the App Store, requires users to purchase a kit containing urine test strips that can be visually analyzed with the iPhone’s camera. The problem, according to a letter sent to Biosense from the FDA, is the fact that the test strips have only been cleared for “direct visual reading” and not automated analysis from an application:
Please note that though the types of urinalysis dipsticks you reference for use with your application are cleared, they are only cleared when interpreted by direct visual reading. Since your app allows a mobile phone to analyze the dipsticks, the phone and device as a whole functions as an automated strip reader. When these dipsticks are read by an automated strip reader, the dipsticks require new clearance as part of the test system. Therefore, any company intending to promote their device for use in analyzing, reading, and/or interpreting these dipsticks need to obtain clearance for the entire urinalysis test system (i.e., the strip reader and the test strips, as used together).
While Biosense plans to work with the FDA to resolve the issue, Bloomberg notes that this is only the start of a broader crack down on apps that claim to diagnose medical conditions:
As noted by PatentlyApple, Apple has filed a patent report today that details a new diagnostic tool that works through iTunes. The tool uses in-depth change logs that details firmware updates, physical conditions that surround the device during the events, the location of the device, and more. iTunes could be set to find corruption in the change log to let the user, and possibly a support Genius, know of what needs to be changed.
The log may be generated periodically (e.g., every 5 milliseconds, every 30 minutes, every 5 hours, after every reset, or at any other time based or event based or environment based event occurs). Each generated log may be stored on the Apple device or uploaded to a remote entity, and each log may be retained or overwritten by a more recently generated log depending on available storage space and/or processing capabilities, for example.
So what about privacy? The log will contain only information that will aid Apple in helping you, and will be without any personal information. As we’d imagine, each time you connect a device, like an iPhone, to iTunes it will pull the log. Like any patent, this might not actually be used. But hey, anything to save a trip to the Genius Bar right? Could this possibly tie in with this morning’s report regarding a web based tool?