Bradley Merrill Thompson, a Member of the Firm in the Health Care and Life Sciences practice, in the Washington, DC, office, was quoted in “An Active Fall Anticipated for mHealth Regulatory Policymaking.”
Following is an excerpt:
Specifically, the FDA says it plans to regulate mobile applications that are used to control medical devices or are used to display, store, analyze or transmit patient information from those devices. It also plans to regulate apps that transform mobile devices such as laptops, tablets and cell phones into medical devices, and those that analyze patient data in order to provide diagnosis and recommend treatments.
However, attorney Bradley Merrill Thompson, who oversees the industry mHealth Regulatory Coalition, says while the guidance is a good start it still leaves a lot of “gray zone” in terms of what devices and applications will come under the FDA’s purview.
“One of the general concerns that we have is that the drive to divide all health information technology including mobile apps into three neat buckets is doomed to be outdated fairly soon,” he warns. “So I would like to see FDA come up with a broader, more conceptual approach that reflects an understanding that much of the software will be interconnected [in its report to Congress].”