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 the increasing oversight by the U.S. Food and Drug Administration over mobile health devices.
The article, “New Lifeline For The Poor And Underprivileged Arrives Via Mobile Health,” stated that the White House and a coalition of health groups for mothers are supporting a new initiative called “Text4baby,” which sends free text messages with medical tips and reminders to pregnant women and young mothers. It is probably the most high-profile example of mobile health initiatives, which have been proliferating and drawing Food and Drug Administration scrutiny. The FDA has started working with industry groups to prepare a regulatory framework expected to cover many mobile health devices.
Thompson said companies that are developing mobile devices and wireless networks for the purpose of delivering health care or health-related information should anticipate the FDA will expand its oversight role. “It is health care, and people should not be surprised to see regulation,” he said. But more rules could have a chilling effect on innovation, he added. “I expect FDA will discourage it some. There is a cost to complying with the FDA.”