Bradley Merrill Thompson Quoted in “Wanted: A Watchdog for the Mobile Medical App Explosion”Reuters June 5, 2014
Bradley Merrill Thompson, a Member of the Firm in the Health Care and Life Sciences practice, was quoted in an article titled "Wanted: A Watchdog for the Mobile Medical App Explosion."
Following is an excerpt:
According to an IMSHealth report from October 2013, more than 43,000 health-related apps are available on the U.S. iTunes store, and 33,500 on Google Play. Bradley Merrill Thompson, a health-care-focused attorney with Washington D.C.-based Epstein, Becker & Green, speculates that hundreds of unregulated mobile "medical devices" - anything with a specific medical application - populate Apple's store.
Reuters found several dozen applications on the App Store and Google Play that fall into the FDA's definition of a medical device. …
The FDA has cracked down on a small number of mobile medical apps in recent years. …
Thompson, who runs the mHealth Regulatory Coalition, an organization that counts Samsung and Qualcomm among its members, is pushing the FDA to distinguish between products it will not regulate and those it considers mobile medical devices.
In September 2013, the FDA clarified that it will focus on apps that seek to replace a doctor's visit or perform clinical tests, though it gave no examples.