Hmmm, that spot on your skin doesn’t look good. Is it just a mole, or is it something that you should be concerned about? Maybe you should see a doctor. Or maybe you’re just being overly cautious. What do you do? One of the promises of wearable Health Tech and mobile health devices is that they can help inform consumers and provide more efficient and expedient access to healthcare information. It would be great if you could just take a photo of that spot with your smartphone and find out right away whether it’s skin cancer or nothing to worry about.
The problem is that some companies have tried to deliver on that promise without necessarily having the evidence to back up their conclusions. According to a recent press release by the Federal Trade Commission (FTC), the agency has reached settlements with two marketing companies to stop making unsupported claims about two apps: MelApp and Mole Detective. These apps would instruct the user to take a photo of the mole and they would then report whether the cancer risk was low, medium, or high. The problem is that the companies do not have “competent and reliable scientific evidence” based on clinical testing to support their claims.
When a device steps over the line from reporting data to making a diagnosis based on that data, the product is going to get greater attention from the regulators. The FDA has loosened its requirements for data reporting devices such as fitness bands, but diagnosis requires stringent clinical trials to make sure that there are not too many false positives or false negatives, either one of which could have bad consequences for patients who made decisions based on that information. And it is clear that the FTC is also going to pay close attention to medical claims made by advertisements for Health Tech devices. This is not a replacement for good sense and caution on the part of consumers, but is an important part of protecting people from ineffective or misleading products.