FDA called out in study of smartphone apps for melanoma
Fresh data have emerged in the ongoing debate over the regulation of medical apps for smartphones and mobile devices. Researchers questioned the accuracy of four apps for evaluating skin lesions in a study, generating some troubling results and pointing out that such apps have gone unregulated.
Last year ended without expected guidance from the FDA on which medical apps would require the agency's stamp. And the researchers shed light how three apps with automated systems for evaluating images of melanomas misdiagnosed skin lesions as benign 30% or more of the time. Think the FDA should regulate mobile apps for diagnosing cancer?
As the U.S. researchers noted in JAMA Dermatology, smartphone app stores have thousands of downloadable items for everything from counting calories to making important calls on health status. The mobile health app industry raked in about $718 million globally in 2011, as consumers integrated information from their iPhones and other prized devices into healthcare decisions.
"Some examples include applications that are intended to aid users in learning about adverse effects of medications, to track their caloric intake and expenditure to manage weight loss, and to log their menstrual cycles to monitor fertility," the authors of the study wrote.
"Although such applications have the potential to improve patient awareness and physician-patient communication, applications that provide any type of medical advice might result in harm to the patient if that advice is incorrect or misleading."
Their study included 60 images of melanomas and 128 images of benign lesions. The most accurate of the 4 apps didn't use algorithms to automatically make calls on whether the lesions were serious health threats. Rather, patients upload images for real expert physicians to evaluate remotely.
The bottom line from the study was that unregulated medical apps with questionable (or even shoddy) accuracy could place patients at risk, especially when consumers take the advice of the tech tools without consulting a doctor. Even apps with disclaimers are ripe for misuse.