"Although the vast majority of mHealth products are very low-risk, some apps make promises they can't fulfill, and others make errors that could harm patients," Cortez notes, pointing out that life-threatening technical mistakes are not only possible they also have occurred.
One of several examples cited in the study includes Sanofi Aventis' 2012 recall of a diabetes app that miscalculated insulin dosages.
Several Congressional bills have been proposed to strengthen FDA jurisdiction over mHealth products, with one proposing the creation of a new Office of Wireless Health Technology within the administration, the article notes. Meanwhile, more restrictive bills also have been introduced to keep the FDA from regulating "clinical software" or "applying a complex regulatory framework could inhibit future growth and innovation in this promising market."
"The conventional wisdom is that FDA regulation will stifle innovation, and that's a very short-term way to think about this," Cortez says. "Most Silicon Valley firms aren't used to much federal regulation, and Internet technologies have been subject to very little federal oversight."
If dangerous errors and disproven product benefits are allowed to proliferate, "some very useful products will be undermined by widespread consumer distrust," Cortez contends.
"We're trying to push lawmakers to empower the FDA, not hamstring it," he says. "Clarity will help the industry create products more helpful than harmful."
|Contact: Denise Gee|
Southern Methodist University