Regulatory Focus™ > News Articles > Mobile Medical Device Applications: The New Snake Oil?

Mobile Medical Device Applications: The New Snake Oil?

Posted 13 November 2012 | By

Once, charlatans peddled snake oil medicines as cure-alls. Now, there's an app for that.

The New England Center for Investigative Reporting notes that US regulators are increasingly becoming aware of mobile medical applications sold and made available online that promise to do everything from cure acne with light to reduce the effects of tinnitus.

The problem: Nearly all applications claiming to be able to cure a patient are blatantly lying, say experts. The motivation for such sales is unclear-perhaps profit or ignorance-but the effect on patients can be disastrous.

The fraudulent applications typically take advantage of the smartphones' physical attributes-vibrations, light and sound-to trick unsuspecting users into believing that the applications somehow modify or use the device to treat or cure their ailments. Still others dispense incorrect information, possibly leading patients to inaccurate and potentially dangerous courses of self-treatment or non-treatment. A patient might, for example, believe that a mobile application is helping to cure a condition and put off treatment, exacerbating the eventual harm caused. Others apps could direct a patient to a specific, self-administered treatment without making note of contra-indications for medication, causing the user to experience an adverse reaction.

Alarmingly, such applications seem likely to become more common as more people around the globe acquire smartphones capable of using healthcare applications, reports NECIR.

Another problem, writes NECIR, is that while the digital applications may not meet the standards of the US Food and Drug Administration (FDA), in most cases the apps still meet the standards of the application web stores, such as those maintained by Apple and Google. This means regulators are largely playing a cat-and-mouse game with scammers who can harm or swindle users before regulators can take action.

For now, at least, the Federal Trade Commission (FTC) is taking the lead on regulating the devices, taking down applications it believes are misleadingly or fraudulently marketed. In September, FTC released guidance regarding the marketing of mobile device applications, explaining that it will exercise its enforcement powers if developers aren't truthful in the distribution of the application or fail to back up claims using "competent and reliable evidence."

Fines for violations, though, have been small. In two cases where companies settled claims made against them by FTC, fines were less than $15,000 in both cases.

Read more:

NECIR - Many health apps are based on flimsy science at best, and they often do not work

Regulatory Focus - As Mobile Applications Cross Over Into FDA Regulatory Territory, New Frictions Emerge

Regulatory Focus - Experts Examine Regulation of Health-Related Mobile Apps, Software and Social Media

Regulatory Focus - Proposed Legislation Calls for FDA to Form Office Dedicated to Mobile Apps

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