Tuesday, February 24, 2015

Mobile Health App Scams

The U.S. Food and Drug Administration has released guidelines for mobile health apps, and soon will have enforcement power to eliminate scams such as this one.

Smartphone and tablet users should be wary of mobile health apps whether they are on iOS or Android. The potential marketplace is enormous globally.  Euro regulators will also be surveying offerings from vendors as well.

If you’re worried about melanoma, head to the doctor — not the app store. On Monday, the Federal Trade Commission announced it has cracked down on two companies that charged customers up to $4.99 for apps that claimed to help them detect early signs of melanoma.

You get the idea. According to the FTC, the app makers had no evidence to provide support for their apps’ claims that they could assist consumers detect melanoma, which is a form of skin cancer.
The Mole Detective app first appeared in 2012 and was marketed by a U.S. company while MelApp appeared in 2011 from a U.K. firm. The apps sold from $1.99 to $4.99 in the Apple and Google app stores.
A search of Apple’s app store shows both apps have now disappeared, and a search for “melanoma” turned up no results.
The scheme is so far-fetched that the best way to explain it is through these pictures from the FTC, which show how the apps — named MelApp and Mole Detective — claimed to use smartphone cameras to assess skin conditions:

FTC to regulate sales of mhealth apps

In an announcement Monday, the FTC states marketers of MelApp and Mole Detective acted deceptively in claiming the apps can detect melanoma symptoms based on photographs a consumer uploads to the app. Two of the four companies involved with the apps have agreed to stop making unsupported and unsubstantiated claims.
"Truth in advertising laws apply in the mobile marketplace," said Jessica Rich, director of the FTC's Bureau of Consumer Protection, in the announcement. "App developers and marketers must have scientific evidence to support any health or disease claims that they make for their apps."

The settlement with New Consumer Solutions prohibits the vendor from claiming an app can detect or diagnose melanoma unless the claim is supported by "competent and reliable scientific evidence in the form of human clinical testing of the device." It prohibits the company from making misleading or unsubstantiated health claims about a product or service, and includes a $3,930 fine. The FTC is pursuing a litigated judgment against non-settling defendants Lasarow and his company.
In regard to MelApp, marketing began online in 2011 by Health Discovery, which sold the app for $1.99. The FTC settlement bars the company from the same stipulations cited for New Consumer Solutions. The settlement prohibits Health Discovery from making any other misleading or unsubstantiated claims about a device's health benefits or efficacy, and includes a fine of $17,963.

The FTC decisions were split votes, with a dissenting vote issued by Commissioner Maureen Ohlhausen in both cases.
For more information:
- read the FTC announcement
- read the commissioners' statement in favor of the decision
- read the dissenting commissioner statement

Potential buyers must be aware of scams in mobile health apps.  General health information apps have no regulatory oversite. However remote monitoring and wearable technology will require  certification by the FDA, FTC and other agencies as yet unknown.

The mhealth industry has to deal with  Blurred Lines during this relatively early period of development.

Before the Federal Trade Commission or Food and Drug Administration tackle another mobile health technology investigation, the two federal agencies--both of which are charged with protecting consumers--need to huddle up in a conference room, lock the door and not come out until they produce a clear map of what they're responsible for when it comes to oversight and regulating such tools.
Why? Because right now it's getting quite difficult to figure out who's keeping on eye on the shallow end of the mobile health technology pool and who's watching the deep end. And anyone who's had a pool or spent time at a public pool know that a lack of supervision at either end can lead to potential disaster.

the FTC describes itself as working "for consumers to prevent fraudulent, deceptive, and unfair business practices and to provide information to help spot, stop, and avoid them." The FDA, for its part, describes its focus as being "responsible for protecting the public health by assuring the safety, efficacy and security of human and veterinary drugs, biological products, medical devices, our nation's food supply, cosmetics, and products that emit radiation."

That may be all well and good, but it really doesn't answer the big question: Is the FTC going to be the one and only lifeguard when it comes to the mHealth technology pool. Additionally, what role, if at all, will the FDA play as more mHealth cases come to light?
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