From: Medical Device and Diagnostic Industry
The line between consumer a consumer mHealth app and a regulated medical device comes down to what kind of user data is being collected and how it’s being used.
Reade Harpham
When is an app more than an app? mHealth is one of the fastest-growing segments of the digital marketplace, with more than 100,000 health and fitness apps available in the Apple iTunes store alone and tens of millions of downloads each year. The vast majority are consumer-focused apps that are not subject to FDA regulation. But when developers cross the line and start providing medical information or advice, they enter a whole new world of liability and regulation. How do you know when your app has become a medical device? And what steps do mHealth developers need to take to reduce their risks?
The line between a consumer mHealth app and a regulated medical device comes down to what kind of user data you are collecting and whether that data is used to make a medical decision by the user, by the user’s doctor, or by the app itself. The popular LoseIt app, which allows users to track calorie intake and activity levels for weight loss, falls clearly on the consumer side. An app designed to help diabetics track blood sugar levels and determine how much insulin to take is clearly a medical device. But others are not be so clear-cut. Is an app that allows users to input daily blood pressure readings a medical device? If it’s simply a log, probably not. But if it offers advice or diagnosis based on those readings or transmits the information to a doctor to allow them to monitor a patient’s health, it has crossed the line.
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