“A smartphone app that rids you of acne. Another that monitors your heart rate 24-7. One that detects skin cancer by looking at your birthmarks. If they sound too good to be true, they may be,” Christina Farr writes for Reuters. “Patients today use a number of apps that purport to track and treat a panoply of ailments, a headache for regulators and patient safety advocates. Now, the advent of wearable devices bristling with sophisticated biotracking sensors is stirring concern in the medical community about misdiagnoses that could have serious consequences for consumers.”
“Some are asking whether Apple and Google should do more to police their fast-growing app marketplaces,” Farr writes. “‘Most of the health apps out there are built by people with zero medical experience,’ said Paris Wallace, chief executive officer of Ovuline, a popular fertility app. Worse, many developers don’t have the resources for legal counsel, Wallace said, and are more likely to make false claims to patients without seeking FDA clearance.”
“The Food and Drug Administration last year published guidelines on the kinds of mobile apps it will supervise. But industry insiders fear the agency may get overwhelmed as apps mushroom,” Farr writes. “This week Apple introduced “Healthkit,” a repository of data for medical apps that opens up new realms for developers to explore. It may also make it easier for those with scant understanding of regulatory protocols to dive into the market… The iPhone maker is the preferred choice for developers. Analytics firm AppAnnie found that Apple generates five times more revenue from downloads of health and fitness apps than Google… One source familiar with the matter said Apple is looking to add a regulatory expert to its growing digital health team, who will be tasked with oversight of the App Store.”
“‘Research has shown that many existing medical apps may be useless. Seventy-five percent of smartphone apps that claim to assess malignancy are wrongly diagnosing at least 30 percent of melanomas as ‘unconcerning,’ researchers from the American Medical Association’s JAMA Dermatology found. A 2012 study by the New England Center for Investigative Reporting revealed that of 1,500 health apps it evaluated, 20 percent claimed to treat or cure medical problems, but only a small percentage of them had been clinically tested” Farr writes. Medical professionals fear patients may defer an in-person checkup because of faulty results. By the time they see a doctor it may be too late. A false negative for cancer, for instance, may prompt a user to put off professional consultation.”
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