Bradley Thompson, a Member of the Firm in the Health Care and Life Sciences Practice in the Washington, DC office, was quoted in an article about a Federal Communications Commission (FCC) request that the FDA clarify its regulations on health-related applications on smartphones.
The article, “FCC Urges FDA Clarity On Mobile Apps, Device Approval Process,” stated that companies seeking to commercialize mobile health devices are regulated by both the Food and Drug Administration and the FCC. While most smartphone applications do not trigger FDA oversight, other technologies — particularly applications to help patients manage diabetes — involve data transfers among glucometers, smartphones and physicians that would necessitate FDA clearance or approval.
“These tools are ways to allow people to live independently longer and manage their health to avoid some of the complications, for example, of diabetes,” said Thompson. “We need to figure out a way to encourage this technology.”