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:
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:
The agency has said it wants stricter rules for apps that directly diagnose or treat conditions, proposing in 2011 to apply similar quality standards as for heart stents, ultrasound machines and other medical devices.
“We intend to finalize the guidance this year,” Synim Rivers, an agency spokeswoman, said yesterday in an e-mail. “The FDA has proposed a regulatory approach that limits its immediate oversight to a specific, small subset of mobile medical applications that are medical devices and present the greatest risk to patient safety if they don’t work as intended.”
Biosense claims that the uChek app allows them to price their system at “a fraction of other semi-automated urinalysis while providing comparable accuracy,” but does warn that “uChek is intended for use only by or on the recommendation of a qualified healthcare professional.”
