mHealth will remain uncharted territory until FDA finalizes app rules

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Truth in advertising has never been more important than it is for the mHealth industry. Just look at a recent probe by the New England Center for Investigative Reporting that found that consumers are being bamboozled by hucksters selling mobile health apps that purport to cure everything from acne to alcoholism.

The stakes are incredibly high. As the center's report states, nearly 247 million mobile phone users are expected to download health apps in 2012, according to research2guidance, a global market research firm. Another estimate predicts that figure to more than double to 500 million smartphone users with medical apps on their devices by 2015.

Direct-to-consumer marketing is a slippery slope, especially when a company is making medical claims about their product. Having previously worked for one of the world's largest medical device manufacturers, I've seen firsthand the meticulous scrutiny and vetting processes that companies must go through with the U.S. Food and Drug Administration, which regulates labeling and marketing for these products.    

However, in the New England Center for Investigative Reporting's survey of 1,500 health apps that cost money and have been available since June 2011, the center found that more than 20 percent claim to treat or cure medical problems, many of which do not follow established medical guidelines and have not been clinically tested. Both the iTunes store and the Google Play store are "riddled with health apps that experts say do not work and in some cases could even endanger people," the article stated.

I'm not a lawyer but it seems to me that these claims are blatant violations of the Federal Trade Commission Act, which states that advertising must be truthful and non-deceptive, and that advertisers must have evidence to back up their claims. According to the FTC's Deception Policy Statement, an ad is deceptive if it contains a statement, or omits information, that is "likely to mislead consumers acting reasonably under the circumstances."

While the FTC pursued the government's only cases against health-app developers last year, shutting down two acne apps that made "false or misleading" claims about their cell phone light treatment, the agency has not pursued any other app developers for making dubious medical claims. As a general rule, the FTC regulates advertising for foods, over-the-counter drugs, dietary supplements, medical devices, and cosmetics, while the FDA handles most matters related to prescription drug advertising and labeling.

The problem right now is that mHealth apps are in limbo from a regulatory perspective. Currently, the FDA is drafting final regulations detailing what types of health apps would need agency approval before they can be marketed in the U.S. The FDA is expected to publish its rules by the end of the year.

Unfortunately, until those FDA regulations are finalized, it will be a Wild West of mHealth claims and marketing tactics by app developers. - Greg