FDA Struggles With Regulation of Mobile Health

From: Bloomberg/BNA

By Dana A. Elfin

Dec. 10 — The regulation of mobile medical applications is likely to remain an open question for the foreseeable future, according to speakers at a Food and Drug Law Institute (FDLI) conference in Washington.

As so-called mhealth apps continue to proliferate and the technologies behind them continue to advance, “it’ll be quite a few years before we have a handle on this technology and how it’s going to be regulated by the FDA, if at all,” Jeffrey K. Shapiro, of Hyman Phelps & McNamara P.C. in Washington, said Dec. 10.

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