The Congressional hearings debating the regulatory framework for mobile health devices and apps made me think about how we view mobile health apps and the criteria we use to determine what makes some better than others.
And as we all think in terms of the NCAA college basketball tournament around this time, I thought we would do a mini tournament using mobile health apps.
My take: apps securing 510(k) clearance from the US Food and Drug Administration as medical devices are better because they have had to submit the product to a tougher burden of proof. But there are other things that gives apps merit:
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- The problem it’s trying to solve
- The scale of that problem
- The effectiveness of the app
An app that tackles a costly issue like adherence or patient engagement doesn’t necessarily need a diagnostic purpose. But these apps can have a huge impact on reducing healthcare costs and getting patients to take more responsibility for their care, which improves outcomes.
I wanted to create a list that reflected the diversity of the healthcare and medical apps available. I did not set out to compare similar apps. One of the great things about the NCAA tournament is there are frequently unexpected victories and indeed upsets like Florida Gulf Coast’s victory over Georgetown and LaSalle beating Mississippi. This competition shouldn’t be any different.
Think of a mobile health tool with FDA approval as a top 10 and think of the non FDA approved apps as the underdog.
My matchups are below. I’d welcome your thoughts on which app should win (I’ll publish the results of my matchups in the coming days).
The Mobile Health App Sweet 16:
- Mobile Mim by Mim Software (FDA cleared) vs Smartphone Breathalyzer by Breathometer
- AliveCor (FDA cleared) vs. DrawMD by Visible Health
- MobiUS SP1 System by MobiSante, ultrasound imaging system (FDA cleared) vs. DoctorMole by Mark Shippen
- Diabetes Manager by WellDoc (FDA cleared) vs iTriage by Healthagen
- Welch Allyn iExaminer Adapter app (FDA cleared) vs HemaGo app by NovoNordisk
- Gauss Pixel App by Gauss Surgical (FDA cleared) vs. BurnMedPro by Johns Hopkins Mobile Medicine
- AirStrip ONE by AirStrip Technologies (FDA cleared) vs Lab Counter by ZappyLab
- iHealth Wireless Blood Pressure Monitor by iHealth Lab Inc (FDA cleared) vs. iBlueButton by Humetrix
