Regulations in store for Apple Watch

FDA to set health standards for smartwatch

The Apple Watch is set to come on to the consumer market as early as of March 2015 and the buying public cannot hardly wait. There are so many features that come with this smartwatch that they are just too numerous to mention. One of those features is the heartbeat monitor and pace counter of the Apple Watch. There are also apps that are being developed for the Apple Watch that is supposed to help with the diagnosis and treatment of certain ailments. Because of the Apple Watch being able to do just that, the Food and Drug Administration of the U.S. has announced that they will be setting guidelines for those types of smartwatches. The FDA also says that they will set guidelines for watches that could ‘pose a threat to consumer welfare’.

According to the guidelines, the FDA says that any device that falls under what they call ‘General Wellness’ will not be affected by these new proposals. The FDA says if the device helps with weight management, fitness, self help, or sleep, etic. will not have to adhere or face any kind of FDA panels or guidelines. The new guidelines added that as long as the wearable does not say that they have the same authority as a doctor, they will not be subject to the new FDA guidelines.

These new guidelines by the FDA did say that if the wearable were to help with the diagnosis and treatment of major illnesses and disorders such as autism, obesity, or erectile dysfunction will come under those guidelines and will be monitored by the FDA. At the current time, the Apple Watch falls under the General Wellness guidelines and are in good shape as far as any FDA sanctions and or major regulations. It is being said that the Apple Watch developers and Apple itself met with the FDA about these new rules. With that being said, the future of health diagnosis and help apps for the Apple Watch in the future will have to make sure that they follow these new guidelines set forth by the Food and Drug Administration.

Source: Digitaltrends