By Jessica Tym / mHealthWatch
Though consumers are spending a lot of money on mHealth products, or the use of mobile devices for medical and health purposes, and the industry is expected to grow from $2.4 billion to 26 billion in 2017, Nathan Cortez, law professor and associate dean of research at Southern Methodist University law school, outlines of Voxxi the potential dangers of such medical apps in a New England Journal of Medicine article.
Because people can purchase the apps from trusted retailers like iTunes Store, they think they have been reviewed by the FDA. Cortez says this is not the case and that out of the hundred thousand mHealth apps, only about 100 have been approved by the FDA and it’s largely an unregulated business.
For example, a 2011 rheumatoid arthritis app by Pfizer calculated a score for how severe your rheumatoid arthritis was and it was not accurate. People may have seen treatment decisions made based on erroneous calculations.
A 2012 diabetes app by Sanofi Aventis was recalled because it miscalculated insulin dosages.
Cortez argues that FDA is not “aggressively pursuing products” and the FDA needs “additional funding and in-house technical expertise to oversee the ongoing flood of mHealth products.”
Congress has considered but not passed several bills intended to give the FDA more power to regulate the mHealth industry, including the idea of a new federal Office of Wireless Health Technology.
“With the kind of crazy innovations over the last several decades, I think the FDA needs some updated statutory authority from Congress to be more sensitive with these technologies,” Cortez added.