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mHealth Trials Are Happening, Without the Clinic
Healthcare regulators are becoming technology regulators
If an adverse event happens, that free market could contract suddenly, and some of it could even go underground. Ironically, recent changes in the way technology gets distributed could make it easier for the FDA or other agencies to take action, but also to encourage that underground.
Windows 8, now shipping, has joined Apple's iOS and Google's Android in a new model of software distribution. These platforms' app stores make it easy for centralized control to be exercised over what apps run on these devices. If an app is shown to be the cause of an adverse event, we may witness the spectacle of the FDA ordering the removal of that app from the app store, and that would be that.
But would consumers try to jailbreak their phones to run banned healthcare apps? Stranger things have happened.
Now you may be shaking your head at this point, given that most healthcare apps are read-only or accept only a limited amount of input. If a patient or caregiver incorrectly enters a blood pressure or blood sugar reading into an app, the problem lies with them, and not with the app.
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Comments are moderated. Please be patient.
Wayne Caswell (12/5/2012 at 8:48 AM)
Will the consumer medical device and app be more accurate or helpful than the average general practitioner, or the mediocre one, or the top-notch one? Will low prices extend availability to more people and justify trade offs? Who gets to decide: consumers, medical practitioners, health institutions, insurers, employers, or regulators, and what will influence their decision? What might be the role of advertising? This is a relatively new and fast growing area with lots of unanswered questions. So, what may trigger government regulators to seek answers?