The FDA defines a medical device as an “instrument, apparatus, implement, machine,” or other object whose intended purpose is, among other things, to diagnose, cure, treat or prevent a disease.
So, would a tool that monitors a diabetic’s blood glucose and automatically sends alerts to report highs and lows count? What about a portable ultrasound device or a tool to check your child’s ear for an infection?
Would your perception of these things change if I said they were all on your iPhone or Galaxy S?
There’s no denying that mHealth will play a huge role in the delivery system over the next several years, especially as the apps mature and we all get more used to them. That’s a large part of the reason that we’ve been covering the trend in this year’s iteration of Connecting the Continuum. But as mHealth begins to move from iTunes and fitness apps to exam rooms in your facilities, questions emerge around how to regulate apps.
As we’ve reported, the FDA last year tried to lift some of the clouds that hung over the mHealth regulatory framework. And earlier this month, the agency issued draft guidance that would free some devices from having to undergo premarket scrutiny.
A group of lawyers writing in the July 24 New England Journal of Medicine, argue for more clarity from regulators on mHealth. “A bewildering array of mHealth products can make it difficult for individual patients or physicians to evaluate their quality or utility,” they write.
Recognizing that patients are downloading apps at a dizzying rate, some hospitals and health systems, like Ochsner Health System in New Orleans, are combing through the vast array of services and trying to help patients make informed decisions. It makes sense. After all, whom do you trust more, your provider or some stranger who left a review on Google Play?
I’m curious what you think. Are your physicians helping to guide patients to mHealth apps? Do you think the FDA and other agencies need to increase scrutiny of the mHealth market?