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?

Mobile Health, Telemedicine and Walgreens

Walgreens app makes virtual doctor visits a reality

The service is immediately available to residents of California and Michigan and will be rolled out in other states in the next few years. Illinois residents should be able to use the app by the end of 2015.  Appointments cost $49, most of which goes to physicians. That fee is also not much more than a copay for an in-person doctor's visit through some insurance plans. “Some insurance companies cover telemedicine”, Leider said.

Walgreens is launching a virtual doctor visit feature on its mobile app, the company announced Monday. The nation's largest drugstore chain is teaming up with MDLive, a provider of virtual health services, to connect Walgreens customers with certified doctors via video chat on a smartphone, tablet or computer. 

"Consumers are demanding to do everything through mobile," Parker said. "Everything else they can do through mobile, and now they can do this too."

MDLive stands to gain 2 million people a day through Walgreens' mobile app and website. CEO Randy Parker said the company has 2,000 doctors available.

Last year Walgreens launched a Pharmacy Chat feature on its app to allow users to instant message with pharmacy staff. The company said it averages 9,000 chats a week.

"I think this will become a normal part of health care in three to five years," Leider said. "We have got some real forces that are going to make this very compelling."

He said a shortage of primary care physicians coupled with more people becoming insured through the Affordable Care Act means the market is growing for people who might find telemedicine useful.

Dr. Leider made the bold statement, “"I think this will become a normal part of health care in three to five years," Leider said. "We have got some real forces that are going to make this very compelling."

In October, Deerfield-based Walgreen announced a similar telehealth initiative partnership with health information website WebMD to encourage customers to increase exercise to earn discounts at Walgreens stores. The company said it now awards points on its Balance Rewards loyalty card for logging activities on the WebMD Healthy Target app.

The service is immediately available to residents of California and Michigan and will be rolled out in other states in the next few years. Illinois residents should be able to use the app by the end of 2015, said Dr. Harry Leider, chief medical officer  for Walgreens.  Appointments cost $49, most of which goes to physicians. That fee is also not much more than a copay for an in-person doctor's visit through some insurance plans. “Some insurance companies cover telemedicine”, Leider said.

"Consumers are demanding to do everything through mobile," Parker said. "Everything else they can do through mobile, and now they can do this too."

Chicago Tribune

ehirst@tribpub.com