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Apple, Alphabet and Fitbit test FDA fast track for health apps

The pilot project might spare them from having to certify products.
Jon Fingas, @jonfingas
September 26, 2017
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A few of the tech giants you know are about to get fast-track approval for their digital health efforts. The US Food and Drug Administration has named the companies involved in a recently-instituted "pre-certification" program that determines whether or not they meet baseline quality standards for health software. Apple, Fitbit, Samsung and Alphabet's Verily are among the firms that will help the FDA set the benchmarks and decide just how much information companies need to send if they've been pre-cleared. Depending on how the program fares, companies may get to send less information or even avoid certifying certain apps altogether.

The FDA vows to detail progress as the pilot goes forward, including a workshop slated for January 2018. And yes, it'll accept feedback from both industry groups and the public.

If pre-certification goes forward, it could lead to health apps and features reaching the US sooner than they might if they had to go through a product-focused approval process. That's potentially great for technological progress. With that said, there are concerns: will the standards be high enough that smaller, less scrutinized companies won't abuse them? And what happens if a pre-certified company bungles an app down the line? The pilot project may well settle these questions, but there's no guarantee it will avoid significant problems down the road.

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