FDA Issues Guidance on Medical Device Data Systems

FDAs regulatory oversight of health IT products is focused on the devices that pose higher risk to patients, says Patel, who argues that this FDA guidance will encourage greater innovation in the development and maturation of these systems.

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Comments (1)
The FDA should implement regulation controls similar to that of HIPAA/HITECH for security and privacy controls. No network is 100% secure and therefore any (IP)device that transmits data over a network system poses a high risk in the event of a breach. I agree with Mr. Thompson, a sloppy way to regulate.
Posted by Gary J | Monday, June 23 2014 at 9:51AM ET
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