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The US Food and Drug Administration (FDA) sent a warning to mobile health (mHealth) app and devices developers that claim to diagnose traumatic brain injuries (TBIs), lengthening the body of evidence that the mHealth market is riddled with flaws.
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The FDA strictly regulates tech that diagnoses TBIs, which affect 3 million people annually and cause 50,000 deaths each year, per the Brain Trauma Foundation. But the FDA’s notice suggests issues around unapproved apps and devices misleadingly claiming to assess or diagnose brain conditions, which could cause consumers with serious head injuries to skip out on medical care.
Here’s what it means: This is the latest news that could sway consumers away from unregulated mHealth apps.
- 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 been evaluated in the last decade.
- And health apps are known to overshare user data, raising privacy concerns. For example, 79% of the 24 top-rated mHealth apps shared user data with a total of 55 entities, including app developers, their parent companies, and third parties, according toa recent study. Despite the study’s limited scope, its findings likely apply to the broader mHealth market.
The bigger picture: Providers have an opportunity to fill the gap in the mHealth market with credible products.
Providers — including telemedicine companies and traditional health systems — have an opportunity to leverage their doctor networks to develop superior mHealth apps. Patients may be more trusting and likely to use mHealth apps that are developed and prescribed by doctors. And tying a small user fee to these apps also offers a significant revenue opportunity — there were an estimated 3.7 billion mHealth app downloads globally in 2017, up from 1.7 billion in 2013.
The swelling cost of building an mHealth app from scratch should push providers to invest now. On average, mHealth apps currently take between 15 months and two years to launch and cost around $425,000to develop. That’s up 960% from the $40,000 it cost to develop an mHealth app in 2011. In order to tap into the benefits of mHealth apps before costs become more prohibitive, providers should partner with mHealth app developers or explore developing apps in-house now — or risk losing out.
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