Aren't we missing the larger issue? Proper certification of health information systems is going to be expensive, and that is probably unavoidable. Moeover, someone is going to have to bear the burden of that cost. I'm not sure that this question should really be tied to the certification model, though. One issue is primarily technical: How do we determine that this device or system is safe? The other is a business question: Who's going to pay for it?
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