Government Regulatory Bodies Send Mixed Messages on Mobile Health IT

The US Food and Drug Administration (FDA) has adopted a hands-off approach to regulating mobile health devices—a technology that has proliferated rapidly in the last few years. In light of these emerging apps, the Healthcare Information and Management Systems Society (HIMSS) is calling on the FDA to create a new category as part of its proposed regulations for mobile devices.

In a letter to the FDA, HIMSS proposed that the FDA add a category that would cover “pharmacy, diagnostics and procedural health IT functions, with areas of focus including medication management, radiology, labs, and surgery,” Government Health IT reported. The FDA currently recognizes three categories of health information technology: administrative health IT functions, health management health IT functions, and medical device health IT functions.

In April, the FDA released a framework clarifying that health IT products, such as mobile devices, are not the same as medical devices and therefore will not be subject to high regulatory scrutiny,

FDA officials have publically noted the difficulty they’ve faced in keeping up with the pace of mobile apps. In a roundtable discussion on mobile health in June, Bakul Patel, senior policy adviser for FDA’s Center for Devices and Radiological Health, said “The whole mobile app world has its own ecosystem where things live, die and sort of recycle again…and it’s mostly consumer driven. The end-of-life cycles [are] so short compared to any other products we’ve ever seen,” PBS News Hour reported.


FTC Warns Against Mobile Devices and Data Safety

While the FDA will limit oversight over mobile devices, the Federal Trade Commission (FTC), however, recently expressed concern about the ways in which smartphone and mobile applications gather data from users, including sensitive health data. An FTC report in May confirmed that much of the data apps and smartphones collect is eventually sold to third party entities that use it for marketing and other tasks.

In a roundtable discussion hosted by the publication The Hill, FTC commissioner Julie Brill told Reuters that app developers should give consumers more tools and “robust choice mechanisms” before any sensitive data is collected and stored.

“We don’t know where that information ultimately goes,” Brill said. “It makes consumers uncomfortable.” She also noted that she’s has put pressure on Congress to pass laws prohibiting the collection of personal information under false pretenses, according to Reuters.


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