FDA Proposes Regulating Mobile Health “Apps”

August 1, 2011

FDA Proposes Regulating Mobile Health “Apps”

It is estimated that there are currently more than 17,000 medical applications available for a Smart-phone, tablet computer or personal digital assistant. These apps can range from calorie counters to programs that let doctors view medical scans on their phones.

The FDA is proposing to regulate some of those applications, specifically any app that helps to diagnose, treat or prevent a disease or medical condition. Some examples, a medical app. that allows a Doctor to view medical images on their iPad and make a diagnosis, or an app that transforms their smart-phone into an electrocardiography, (ECG), machine that can detect abnormal heart rhythms to determine if a patient is experiencing a heart attack.

“The use of mobile medical applications by health care professionals is revolutionizing health care,” said Dr. Bakul Patel, an FDA policy advisor in the Center for Devices and Radiological Health. “But inaccurate information can present a significant health risk to patients.”

There are advantages to using medical apps, but consumers and health care professionals should have a balanced awareness of the benefits and risks,” Patel says. Apps can give consumers valuable health information in seconds and are opening innovative ways for technology to improve health care, Patel says. However, the small group of mobile medical apps FDA proposes to oversee present a potential risk—these apps may impact how a currently regulated medical device (such as an ultrasound) performs, he adds. “We want to hear from as many consumers, advocacy groups, health care professionals, and software creators and distributors as possible to help us finalize the proposed guidelines,” Patel says.


Publisher: Salient News