Do Medical Device Data Systems Pose a Risk to Patients? FDA Says No

If a recent guidance document is any indication of the future, the FDA is getting out of the business of regulating health information technology. The FDA June 20 in a draft guidance proposed to exempt medical device data systems from any kind of regulation, because they pose little risk to patients. What this means for developers of health IT products and investors is a much lower regulatory burden to getting their devices on the market, so they can spend their resources elsewhere.

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