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Friday, September 27, 2013

Is That Health App Approved?

Reliability of gyno, and all medical information, has evolved rapidly over the recent years. We used to rely on physicians advice, most wasn't written down, little was studied and that that was studied was often considered to be a propitiatory secret. The often recounted "The Secret of the Chamberlens" story of forceps invention, that was kept a family secret for generations. But that was the middle ages, and we have progressed. Most of our parents will tell us that in their youth they let their docs make decisions, because they had information access. Now even the most esoteric of studies are often out there on the web, and often before they are even published. And now the decision making part of applying that medical information has landed in the public domain through the tens of thousands of medical apps out there. Many of these are literally fun and informative, some really are to just help the doctor, and here is where "approval for apps" comes into the story. This week the Food and Drug Administration announced that it will regulate only a small portion of the mobile health applications, they are only interested in regulating a narrowly defined stet of software programs that run on smartphones and tablets and perform the same functions as medical devices.
Agency officials said their goal is to oversee apps that function like medical devices, performing ultrasounds, for example, and that could potentially pose risks to patients. In the case of an ultrasound device, the wrongly applied energy levels are potentially dangerous, thus this would come under regulation. An app to explain the ultrasound, whether used to recommend treatment, would then not come under the regulation. Tens of thousands of health apps have sprung up in recent years, including apps that count steps or calories for fitness and weight loss, but agency officials said they would not regulate those types of apps.So buyer be ware, if your app says the calorie count of a slice of bread is deceptively low...remember, this calorie count is a reflection of the info the app owners set down, not necessarily conforming to any particular regulations or scrutiny. Some apps have already gotten the agency’s stamp of approval, and that should be labeled somewhere in the app information. For instance the app that turns a phone paired with a special case into a portable electrocardiogram (EKG) machine. Others make a phone double as an ultrasound device or a tool for measuring a person’s glucose levels. It's confusing, I say gab with your gyno to get advice on what apps to use. 

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