Have been working in this space for a while - mobile health IT and applications - and just posted on my blog the mHealth Revolution track at the TEPR+ conference last week. The most notable session (and lively) was a speaker from the medical devices branch of the US Federal Drug Administration that regulates and approves medical devices. All of these developments, and more, are raising many questions about just when does a mobile phone become a medical device - when it stores and transmits medical information? Is used to exchange information between a patient and health care provider for diagnostic and/or treatment purposes? Manage a chronic health condition? Read diagnostic tests - the new iPhone MRI app for example? Turning it into a medical lab would certainly raise the same question, and the Glucophone is labeling itself as a medical device. Questions for right now but a call for conversations about where and how these lines are drawn to protect patients and insure quality health care. How and who decides when an application is not merely a consumer product but of 'medical quality?' See for more information - http://tinyurl.com/aoy4xd.
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