johnbwilliams wrote on Wednesday, December 22, 2010:
The U.S. FDA is seeking to regulate EHR systems. Making the implementation of MU Clinicial Decision Support a separate project but pluggable into OpenEMR as a standalone certified module will help OpenEMR avoid FDA regulation if it comes to pass.
tmccormi wrote on Wednesday, December 22, 2010:
John,
Please provide a reference link to what you are talking about. what would the Food and Drug Administration have to do with Clinical Desc Rules?
-Tony
johnbwilliams wrote on Wednesday, December 22, 2010:
http://www.nytimes.com/2010/12/14/business/14records.html?_r=1
FDA’s regulatory purview includes “devices” that provide clinical decision intelligence. Native clinical decision support could cause OpenEMR to be considered a medical device by the FDA.
tmccormi wrote on Wednesday, December 22, 2010:
And every other Certified EMR on the market … I can’t imagine that very high end vendors would put up with that.
-Tony