There are storm clouds on the horizon for makers of borderline mobile medical apps (MMAs) that reside in the FDA’s “regulatory discretion” zone. There is a growing number of groups voicing concern about the safety and usefulness of these apps. This latest concern is published in the New England Journal of Medicine and is authored by Nathan Cortez, J.D., I. Glenn Cohen and Aaron S. Kesselheim, M.P.H.
The authors are proposing a separate process for these apps, because:
“I do think mHealth apps are becoming more ambitious–trying to do more–and it’s important for FDA to ensure that these products are relatively safe and work as claimed,” Cortez told FierceMobileHealthcare. “The FDA’s 510(k) process should provide some gatekeeping for new products, but that process doesn’t always work well. That said, I think the agency has done a good job of identifying riskier mHealth products that should be cleared before being marketed.”
As was recently reported, the FTC is extremely concerned with the amount of personal health data that is being siphoned off through common mHealth apps. What is being done with that data is unclear, but the worst case scenario is often vocalized:
“Information about consumers’ most intimate health conditions is going to be sold to the highest bidder,” Jeffrey Chester, executive director of the Center for Digital Democracy, told the Washington Post in May. “Employers might get access to it, insurers might get access to it, or mortgage lenders–which could lead to a vast array of negative discriminatory practices.”
Dr. Iltifat Husain worries about apps such as “Instant Blood Pressure” that purports to tell someone their blood pressure using only the iPhone camera. There is no evidence that the app works and Dr. Husain worries that relying on this information could get innocent patients into trouble, and into his emergency room.
You’ll hear much same complaint from Eric Topol, a medical doctor and director of the Scripps Translational Science Institute. “These apps have no validated data compared with accepted reference standards and therefore are quite concerning,” he says.
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Source: Fierce Mobile Healthcare