The legal risks of prescribing the AliveCor ECG
With the announcement that the FDA granted 510(k) approval for the AliveCor EKG case for the iPhone 4/4S, the device became available to “licensed U.S. medical professionals and prescribed patients to record, display, store, and transfer single-channel electrocardiogram (ECG) rhythms.”
While this sounds nice, how, exactly, does one become a prescribed patient? Once a doctor prescribes such a device, what are his responsibilities? Does …