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Barbara A. Binzak and William A. Garvin’s article titled, “An Update on mHealth Regulation in the United States,” was recently published in the Journal of Mobile Technology in Medicine (“mHealth is an abbreviation of “mobile health”). The article details the Final Guidance for Industry and FDA Staff on Mobile Medical Applications and provides clarity on why those considering developing mobile medical apps should be careful.

Binzak and Garvin touch on the three levels of regulation of mobile apps that the FDA has established and how the “FDA intends to focus its enforcement efforts on apps that pose the greatest safety risks to patients if they do not function as designed.”