Only 1 in 1000 mHealth Apps Have been Regulated by FDA

Dec. 5, 2014
A trio of health law experts have advocated for more regulation and oversight of the mobile health (mHealth) application industry, saying that only 100 of 100,000 mHealth apps have been cleared by the Food and Drug Administration (FDA).

A trio of health law experts have advocated for more regulation and oversight of the mobile health (mHealth) application industry, saying that only 100 of 100,000 mHealth apps have been cleared by the Food and Drug Administration (FDA).

The researchers, led by Nathan Cortez, the Southern Methodist University (SMU) Dedman School of Law associate dean of research, argue that an under-regulated mHealth industry would create a "Wild West" market. They say that additional FDA funding and technical expertise on how to regulate mHealth products is necessary.

“Most consumers take mobile health app claims at face value, and think that because they’re available through a trusted retailer like the iTunes Store, they must have been reviewed by the FDA, which isn’t usually the case,” Cortez said in a statement.

The mHealth app industry is booming, the researchers note, citing a study that predicts revenue from these apps will earn $26 billion in 2017. This makes it necessary, they argue, for it to be regulated. Many of the products, Cortez said, cannot fulfill the promises they allege and others make errors that could harm patients. He cites several examples in the research, including Sanofi Aventis’ 2012 recall of a diabetes app that miscalculated insulin dosages.

“The conventional wisdom is that FDA regulation will stifle innovation, and that’s a very short-term way to think about this,” Cortez said. “Most Silicon Valley firms aren’t used to much federal regulation, and Internet technologies have been subject to very little federal oversight.”

Read the source article at SMU Dedman School of Law

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