The FDA Will Only Regulate a Small Portion of Health Apps
Shelly Palmer
The Food and Drug Administration said Monday that it would regulate only a small portion of the rapidly expanding universe of mobile health applications, software programs that run on smartphones and tablets and perform the same functions as medical devices. Agency officials said their goal is to oversee apps that function like medical devices, performing ultrasounds, for example, and that could potentially pose risks to patients. Tens of thousands of health apps have sprung up in recent years, including apps that count steps or calories for fitness and weight loss, but agency officials said they would not regulate those types of apps. Some apps have already gotten the agency’s stamp of approval. One turns a phone paired with a special case into a portable electrocardiogram machine. Others make a phone double as an ultrasound device or a tool for measuring a person’s glucose levels.
