This is good as consumers “need to know” and if you read here enough you can hear me rant about all the mHealth devices that only do “one thing” and to have value and make it easier for consumers, having software that can do more than one thing is important. There are many good apps out there today as well and knowing the difference just simply due to the times we live in today with some really good breakthrough technologies makes is difficult at times. We live in world where everyone is marketing every inch of a product or software do we do get overwhelmed and a while back I talked about this fact, it is all around us as well as some flawed data lurking around the web too.
The FDA of course is working on their plans to verify and ensure that both professional and some consumer products do what they say and of course comply with all HIPAA and other standards. I think all of the apps should at least register with the FDA for class one and then the agency can take a look and determine which ones need their expertise for approval and at least this way they have a data base of all that is out there as apps change too with adding new features. With adding new features, a product that perhaps didn’t need approval before may in fact graduate t that category for a simple example. This way the FDA can use some real business intelligence to have a handle on all that is out there since their job is to protect and this would allow for better collaboration too with the FTC and the bonus part here is the fact that if apps have to register (and don’t make this a cost item) we will have less of a glut of mHealth software and better consumer protection.
FDA Mobile Medical Applications NPRM From the FDA–Register All With Categories and Create New Classification for “Clone Apps”
Groups like Continua do their best to ensure standards are met and basically if an app and company were part of the group, all could be submitted in a data base to the FDA to save time and effort with registering too. So if you have acne, these apps are not the cure for you. BD
Marketers who advertised that their smartphone applications could treat acne have agreed to stop making baseless claims in order to settle FTC charges. The mobile applications, commonly referred to as "apps," were sold in Apple's iTunes Store and Google's Android Marketplace. The settlements in two separate cases would bar the marketers from making certain health-related claims without scientific evidence.
"Smartphones make our lives easier in countless ways, but unfortunately when it comes to curing acne, there's no app for that," said FTC Chairman, Jon Leibowitz.
The cases involving mobile apps "AcneApp" and "Acne Pwner" are the first the FTC has brought targeting health claims in the mobile application marketplace.
The settlements would bar the marketers from making acne-treatment claims about their mobile apps and other medical devices, as well as the safety, performance, benefits, or efficacy claims about any device, without competent and reliable scientific evidence. The two marketers of AcneApp would also be barred from misrepresenting research, tests, or studies.
Finally, the settlement orders would require Koby Brown and Gregory W. Pearson, doing business as DermApps, to pay $14,294, and Andrew N. Finkle, doing business as Acne Pwner, to pay $1,700.