I’m not an iPhone user, but amazed by the huge number of unique medical applications designed for iPhone. The iphone have various applications that that can assist someone with medical diagnostics or healthcare maintenance, keep track of medical information, and can even communicate with a physician. I wonder if the iPhone will be considered as a medical device. According to the FDA, “a medical device is an implementation, product, apparatus or other component or accessory, which is used in the diagnosis, cure, mitigation, treatment, prevention of disease or affects any structure of the body.” That could actually include information technologies and performance technologies since it’s something that is performed on the patient, touches the patient or is performed between physician and patient. Since the FDA has jurisdiction over any device that diagnoses, treats or prevents a disease, the FDA could possibly consider iPhones to be wireless medical devices in the future. Today, iPhone doesn’t meet that definition as a standalone device. But, I would like to know what do you think? Should the FDA have some regulatory jurisdiction over healthcare application developed for the iPhone?
While being an iPhone onwer myself, I too am amazed at all the applications that are available....a lot are even free of charge. I think having healthcare apps can be a good thing in that it allows patients to become more involved in their health. As for now, one can simply get information of symptoms, diseases, drugs, etc off the iPhone. Because it is not being directly used in the diagnosis or treatment, as for now the iPhone, in my opinion, would not be considered a medical device. It is instead being used to confirm a disease and to point the patient in the direction of proper treatment. While the iPhone is not quite at the state of being a medical device...who knows what the future holds. The fact that they are trying to develop a glucose tester that fits into the iPhone, makes it seem as though in the near future it could be considered a medical device.
ReplyDeletethank you for a great post. Vinanza Grape
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