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 "Can Data from Your Fitbit Transform Medicine?"
Following is an excerpt:
Many runners and fitness fanatics have been quick to embrace wearable wireless tracking devices for measuring physical activity and calories burned. Now, a growing number of physicians are formally studying whether such "wearables" can improve patients' health by spurring people to get moving. …
But adapting consumer gadgets for clinical use poses challenges, from doubts about the reliability of the data to technical hurdles of collecting and analyzing the information. Privacy and security concerns loom large as well. Privacy advocates worry that as Americans upload potentially intimate health information into gadgets and apps, there aren't enough protections to prevent the data from being misused. …
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.