Smartphones have transformed the lives of over one billion people worldwide — and that's a conservative estimate. As increasing numbers of tech start-ups are emerging to leverage the power of these devices for health-related services, regulatory bodies have their work cut out for them determining where their authority begins and ends.

Recently, the Food and Drug Administration (FDA) and Federal Trade Commission (FTC) have stepped forward with uniquely different approaches to the influx of health IT software hitting the market.

In February, the FDA issued new guidance for mobile medical apps which effectively distances the agency from closely monitoring the booming market. Instead, they will only regulate the mobile apps that, "are intended to be used as an accessory to a regulated medical device," or "transform a mobile platform into a regulated medical device."
That definition applies to FDA approved products from companies like McKesson, Airstrip, and ZOLL; companies already grounded in health care. It does not apply to the onslaught of applications that offer non-diagnostic, healthy-living statistics.

Meanwhile, the FTC has taken an altogether different tack on mobile medical apps; stepping up in its efforts to take action against companies making false statements about the capabilities of their software. Three app manufacturers have already been singled out this year by the FTC for making unsubstantiated claims.

Two of those companies, Mole Detective and MelApp, proposed to detect melanoma through automated diagnosis of skin lesions. The third was an app claiming to permanently improve a child's focus, memory, attention, behavior, and school performance called ifocus.

For the time being it appears that the FDA will regulate mobile medical apps based on their safety for clinical applications, while the FTC will concentrate on ensuring that "lifestyle" apps resist making unsubstantiated claims about their benefits.

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