With an estimated 100,000 health and fitness apps available on the two leading smartphone platforms, iOS and Android, it seems there is an app for everything – from tracking your bowel movements, to practising your pimple-popping technique.
However, a number of apps are starting to raise the ire of government regulators. Brain-training juggernaut Lumosity was recently fined US$2 million (A$2.7 million) for making unfounded claims that its app could improve work performance and delay the onset of Alzheimer’s.
“Ultimeyes”, a vision-training app touted to “turn back the clock on your vision” and reduce the need for glasses and contact lenses, was fined US$150,000 for misrepresenting scientific research and ordered to stop making deceptive marketing claims.
“MelApp” claimed to be able to assess melanoma on the basis of a photograph of the mole and some other inputted information, analysed using “patent protect, highly sophisticated mathematical algorithms and image pattern recognition technology”. The US Federal Trade Commission (FTC) found its claims lacked scientific evidence, leading to a hefty fine and strict instructions regarding future marketing.
To date, authorities have primarily pursued rogue health apps from a consumer rights perspective, on the basis of misleading advertising – that is, the apps claiming to do something when, in fact, they may be ineffective – rather than from a medical-safety perspective.
In the US, the Food and Drug Authority (FDA) is traditionally responsible for approving medical devices. However, apps that essentially allow a smartphone to become a medical device present a grey area. The FDA has issued guidelines, but compliance is primarily voluntary. Only a minuscule percentage of apps available in the Apple and Google Play stores have FDA approval.
Most apps that present themselves as substitute medical devices offer fine-print disclaimers, such as “not FDA cleared” and “for entertainment purposes”. This information is buried in the expandable description of the app on the app store, which most users will never read.
