Too Much Freedom?
Want to monitor your blood pressure and sugar level? Eat healthier meals? Screen yourself for depression? Find out if you need glasses? Now you can do it all with apps on your smartphone. In fact, there are 40,000 medical applications available for download on smartphones and tablets — and the market is still in its infancy…Some even replace devices used in hospitals and doctors’ offices, such as glucometers and the high-quality microscopes used by dermatologists to examine skin irregularities.
But so far, the market has been something of an unregulated Wild West; for doctors and patients alike, it is difficult to know which apps actually live up to their health claims or provide accurate information. Last year, the FDA began to lay down the law. The agency released a first draft of guidelines that require mobile apps developers making medical claims to apply for FDA approval for those applications, the same way that new medical devices must be proven safe and effective before they can be sold.
Source: Kaiser Health News.
I really have no idea what to think about this. Regulation on tech markets is annoying to me(since most regulators don’t understand tech at all), but god forbid someone takes an eye exam on their smartphone and then goes driving.
whose life is it any way?
Alex makes a good point. We want out applications to perform like they are supposed to. But we don’t want the FDA deciding what information consumers need and allowed to obtain without a doctor. In-home pregnancy tests were somewhat controversial when first approved. Some doctors thought women had little use for a non-clinical test to verify they were pregnant. After all — the thinking went — women whose test registered a positive reading would need to schedule an appointment with a doctor to verify the test was accurate and begin prenatal care. Thus, a test to verify what women already suspected was useless. I doubt if most women would agree.
There are numerous examples of private entities organized to rule on whether manufacturers’ claims are accurate. Since the FDA is having problems even approving new drugs efficiently, the last thing it needs is this kind of distraction. Especially if it thinks it is going to be giving the last word on healthier meals.
And apps like this have nothing to do with getting a drivers license. That is regulated by state DMVs.
Once again, another case of FDA overreach.
Good for them.
Another unregulated wild west was the securities exchange. Then Billy the Kid came to town, and we all know how that ended.
@Devon, some of us do want that and, given the inefficiency of the market, it may be necessary.