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."
Prostatectomy works best early, researchers say
Patients diagnosed with prostate cancer experience the greatest survival benefit when undergoing radical prostatectomy at a younger age, according to a study from the Harvard School of Public Health.
DexCom teams up with NASCAR for diabetes awareness
Continuous glucose monitoring systems maker DexCom Inc. (NSDQ:DXCM) is sponsoring diabetic NASCAR driver Ryan Reed and the American Diabetes Assn.’s Drive to Stop Diabetes.
Diagnostics lobby slams White House budget proposal
The American Assn. for Clinical Chemistry warned that Medicare reimbursement cuts proposed by the Obama Administration would cut reimbursements for laboratory services by 20% over the next 10 years.