MASSDEVICE ON CALL — Mobile app developers are growing increasingly interested in healthcare, creating something of a crisis of regulation.
The FDA last year released guidance on how it plans to regulate healthcare apps, saying generally that it plan to let developers of apps that fit in the gray area between medical technology and harmless health app to determine for themselves when to undergo agency review. The FDA asked developers to use some measure of common sense in making that decision, but the line between mobile app and regulated medical device isn’t always so clear.
Apps that will get more attention include those that are developed as an "accessory" to a regulated device, ones that help healthcare providers view images for analysis and diagnosis and devices that effectively "transform" a mobile device into a medical device, such as smartphone-based heart rhythm monitors.
"But if a mobile app is not intended to do any of those things, the FDA has stated that it intends to exercise discretion," Battelle Human Centric Design director Reade Harpham wrote for MDDI Online. "Examples contained in the guidance document include apps that help patients self-manage their own conditions, track their health information, communicate potential medical conditions to healthcare providers, and so forth. In most cases, these types of apps might not be subject to regulatory enforcement."
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