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.