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Mobile health “unlikely to face much regulatory scrutiny” in US

The Food and Drug Administration (FDA) might be changing to become “more business-friendly” in how it regulates mobile health, according to an article in the Wall Street Journal.

 

The article features interviews with participants at the Personalized Medicine World Conference.

 

The FDA is one of three bodies with a hand in regulating wireless health in the US, along with the Federal Trade Commission and Federal Communications Commission.

 

Some executives in wireless health gripe about the level of regulation they face and claim it will inhibit the market’s growth. The FDA issued draft guidelines about regulating mobile apps back in July 2011, one of the proposals that have attracted criticism.

 

However, Mavis Yee, a partner at a Silicon Valley law firm called Nixon Peabody, says the agency “has little to no interest in regulating the vast majority of the 40,000 or more mobile-health applications” that are available today.

 

The agency only wants to regulate companies “building wireless accessories for existing medical devices, as well as those that turn a phone or tablet into a clinical medical device”, said Yee.

See on www.mobileworldlive.com