May 18, 2013
The absence of regulatory standards for mHealth apps has led many to worry that apps with little or no therapeutic value are being promoted by hucksters who aim to take advantage of the public’s interest in health related apps. Now an investigation by the New England Center for Investigative Reporting that was reported in the Washington Post cites a rash of apps in both the iTunes Store and Google Play that are the 21st Century equivalent of snake oil.
The investigation examined 1500 health related apps available for a fee and found that a fifth of them claim to treat or cure disease. Without clear guidance from the FDA on these products (which is due by the end of the year), regulators have been slow to crack down. According to the Post, the FTC has only pursued charges on two mHealth app developers so far. In those cases the apps claimed to treat acne by using light generated by the iPhone. While some forms of light are effective in the treatment of acne, the iPhone does not have the capability to generate light at the brightness or wave length required to produce a therapeutic benefit.
In the absence of FDA guidance, Happtique.com is launching its own certification for health apps. Also over a dozen mHealth apps have been cleared through the FDA’s 510k process that is used for medical devices. Meanwhile, in a regulatory vacuum bad actors continue to have a field day, which is a shame for developers who are creating truly useful mHealth tools that will help to transform health care delivery. Read the Washington Post article here.