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 article titled "Trackers Put Health Data at Hand."
Following is an excerpt:
The U.S. Food and Drug Administration recently said it won't regulate apps that aren't being marketed to monitor a disease or condition, or to treat or diagnose a patient.
The move is a boon to the industry, but leaves open some regulatory questions, said Bradley Merrill Thompson, an attorney specializing in medical devices at Epstein, Becker & Green P.C. Consumers may use the devices to self-diagnose, which can be risky, he said. For example, a heart-rate device for pregnant women, or an app that helps consumers determine whether a mole may be skin cancer, may cause patients to skip doctor visits.
