FDA Launches First-Ever Probe of Medical App for a Mobile Device

Last year we blogged about the popularity of medical smartphone applications and referred to an investigation showing that the quality of much of the health information available via these apps is questionable.

That’s why although health apps might be fun and even informative, no one should rely solely on them for sound scientific diagnosis or treatment. Last month, the FDA reinforced this idea when it flagged an iPhone app as the first target for establishing regulatory boundaries for mobile medical diagnoses.

As reported by Bloomberg.com, uChek, a smartphone app enabling users to check levels of blood, protein and other substances in their urine, was not approved by the FDA; the feds sent a letter of inquiry to Biosense Technologies, the app’s developer, seeking specific data about how the system works. It was the first such medical device letter directed to a smartphone app developer.

App users, such as people with diabetes who want to check their glucose, dip a test strip in their urine then use the phone’s camera to read the result via a small automated device that generates a value. The test strips are made by Siemens and Bayer, and are approved only for visual, not digital, review. The FDA’s letter, reports Bloomberg, says that the automated reading requires separate approval as a medical device.

As we blogged last year, the proposed FDA standards for mobile device apps that diagnose or treat conditions remain under Congressional review. Proponents of regulation want to set app standards similar to those for other medical devices like heart stents and ultrasound equipment. A spokeswoman for the FDA told Bloomberg that “We intend to finalize the guidance this year. 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.”

The uChek app became available earlier this year. It’s free, but users must purchase the test strips and the $40 automated reader. In its letter to Biosense, the FDA said the company might need to gain approval for the whole system, not just the app.

Depending on how the company responds to the FDA letter, Bloomberg says, the agency might follow up with a stronger warning enumerating specific violations of the law that must be addressed immediately.

If you want to learn more about health and medicine apps for mobile devices, visit iMedicalApps, where health-care professionals assess various products by app type, medical specialty and app name.

Another new resource for assessing the value of medical mobile device apps is Happtique, whose Health App Certification Program (HACP) is meant to advise both providers and consumers on apps that deliver credible content and protect user data.

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