The FDA has warned mobile health app and device developers claiming to diagnose traumatic brain injuries:
to mobile health app and devices developers that claim to diagnose traumatic brain injuries , lengthening the body of evidence that the mHealth market is riddled with flaws.The FDA strictly regulates tech that diagnoses TBIs, which affect 3 million people annually and cause 50,000 deaths each year,
There's little evidence supporting the effectiveness of diagnostic mHealth apps. For example, out of the hundreds of thousands of mHealth apps on the market, the effectiveness of only 22 have beenAnd health apps are known to overshare user data, raising privacy concerns.
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