FDA's Guidance On Medical Device Data Needs Improvement

Law360, New York (July 14, 2016, 11:48 AM EDT) -- Mary Nold Larimore

Kimberly C. Metzger A patient with an implantable wireless medical device needs access to the data the device collects. Ordinarily, she would get this information from her doctor, because when the device collects data and sends it to the manufacturer, it is the doctor who can log on to the manufacturer’s website to obtain it. The patient, however, can no longer afford deductibles or co-pays, and has been forced to drastically cut back on doctor visits. She contacts the manufacturer directly to obtain this data — and is told the manufacturer can only disclose it to her doctor....

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