I can’t decide whether to be happy or sad about this story. You may have read some of the reports about smartphone apps that can identify whether that mole is melanoma or not. Well, the FTC is cracking down on them for false or misleading advertising:
The Federal Trade Commission has challenged marketers for deceptively claiming their mobile apps could detect symptoms of melanoma, even in its early stages. In two separate cases, marketers of MelApp and Mole Detective have agreed to settlements that bar them from continuing to make such unsupported claims. The agency is pursuing charges against two additional marketers of Mole Detective who did not agree to settle.
According to the FTC’s complaints, each of the apps instructed users to photograph a mole with a smartphone camera and input other information about the mole. The apps then purported to calculate the mole’s melanoma risk as low, medium, or high. The FTC alleged that the marketers deceptively claimed the apps accurately analyzed melanoma risk and could assess such risk in early stages. The marketers lacked adequate evidence to support such claims, the FTC charged.
“Truth in advertising laws apply in the mobile marketplace,†said Jessica Rich, Director of the FTC’s Bureau of Consumer Protection. “App developers and marketers must have scientific evidence to support any health or disease claims that they make for their apps.â€
The story goes on to list the companies involved. The fines that have been levied ($18,000 and $4,000) may not be enough to deter anybody from anything and it’s far from done deal as whether the FTC will ever be able to collect.
The story does raise some interesting issues, however. Of course these apps are medical devices. I don’t understand how anybody thinks there’s any ambiguity about that. They’re making medical claims.
But there’s not enough in this report to determine whether these apps are actually totally bogus or their developers have done original and creative research. It doesn’t say the claims are false just that they haven’t been proven true which isn’t the same thing. And it’s not entirely clear what they mean by that.
It would also be interesting to know who alerted the FTC to these apps. Was it consumers who felt they’d been mislead or dermatologists who were afraid they were losing business? I can imagine how an app like the ones described could actually increase dermatologists’ business.
Interesting to compare that w/ 23andMe, which had to shut down until the FDA could evaluate claims made from its genetic testing service. The FDA just gave approval to market the Bloom syndrome carrier report, so a direct to consumer test was approved. At some point that is the question, what will the FDA allow to be marketed directly to consumers. The story that someone had a breast removed because of a genetic test result had to have been urban myth.
I’m not positive, but I think one could take the data from your 23andMe test and enter it into programs available online to get health risk assessments similar to what 23andMe had previously provided.
As to whether it is a medical device, if I download photographs of suspicious moles from WebMD and compared them to mine, how is that much different than having a smartphone camera make the comparison? Ostensibly more accurate? Someone is making money from the app? The camera is acting as an intermediary between medical knowledge and myself?
I’m kind of surprised no one has developed a full body imager that compares more recent scans to a baseline to determine if any suspicious growths have appeared. I wouldn’t think it would be THAT difficult to develop.
As a guy who had melanoma several years ago, this is a topic of personal interest. I haven’t looked recently, but the apps I tried a couple years ago were quite underwhelming. Maybe I’m rare, but I already know what to look for – what I would like is an app that can easily track mole changes over time. I need to do some research to see if there’s anything out there that does this, though I think it will be hard for any app to beat my wife.
Ice,
There actually is a full body imager for this, but I haven’t used one yet.