Clinical Decision Support Remains Regulatory Gray Area

Until the Food and Drug Administration provides further clarification on what types of applications would be viewed as clinical decision support, this software category will remain a regulatory gray area leaving developers unclear as to how to market these products. That is the consensus of stakeholders who met May 14 as part of a public meeting on a risk-based health IT regulatory framework proposed by federal agencies.

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Comments (1)
Call it "Big Brother" if you want. FDA doesn't belong in this conversation, purely legislative. If I understood correctly you wish to collect data on healthcare with the ability to identify a individual. Too many opportunities for misuse. Remember the saying "Cash Is KING" well information runs a close second.
Posted by Michael E | Saturday, May 17 2014 at 6:45PM ET
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