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Health authorities start to inspect medical App accuracy

The promise of a full-blown medical analysis/monitoring system always with you is the science fiction dream come true. We're seeing more and more entrants into the medical app market, some of which use the smartphone alone and others which need a physical addon, either elecronic or otherwise.

However, this comes at a price. The traditional medical industry is notrorious for its stringent regulation. It can literally take decades for a new drug to be admitted into general public use. So why should the App market be any different? Don't people's well being - and even, sometimes, lives - depend on the accuracy and timeliness of such systems? There is no reason whatsoever that the fact a given solution is provided in the form of an App means it can magically bypass those same healthcare regulations.

The FDA gets involved

Bloomberg is reporting that uCheck, from Biosense Technologies Private Ltd, hasn't been cleared for general use by the Food and Drug Administration yet is still on sale in the App Store. The App uses separate card strips, to which its users apply a sample, and is then analysed by the iPhones onboard camera in order to measure various health parameters. There are various criticisms of this approach, including the accuracy of the camera itself since the strips, supplied by companies such as Siemens and Bayer, are only designed for direct visual observation - i.e. not an automated process of this kind.

Speaking for the FDA, Synim Rivers said

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 have responded, confirming they intend to work with the FDA in meeting all the necessary regulatory requirements.