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


Richard Handford

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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.

The vast majority of apps do not fall into this category. They relate to diet, exercise trackers, reference tools for doctors and consumers, or means for mobile access to patient records, for instance.

However, it should be noted that the FDA has yet to publish its final proposals in this area, despite the long lag since the publication of the earlier draft guidelines.

Yee also mentions a bill put before Congress by Mike Honda, the Congressman who represents Silicon Valley. The Honda bill would create a new division within the FDA called the Office of Wireless Health.

This is the kind of intervention that some in the industry do not like but Yee says the bill would also include support for entrepreneurs and investors in the form of loans and prizes that might be more to their taste.

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