Health IT hyper-enthusiasts, when faced with the prospect of government regulations, react like Pavlov's dogs with the response "regulation of health IT will harm innovation."
Here's a soliloquy of critical questions that need be asked:
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Now, Mr. (or Dr.) Hyper-Enthusiast, you state HIT regulation will harm innovation.
What aspects of regulation, specifically, will harm innovation?
Good manufacturing processes (GMPs)?
Building a safety case for review and inspection?
Pre-market safety/fitness/quality/reliability testing?
Post-marketing surveillance?
What?
Innovations happen before regulatory evaluation, do they not?
What, exactly, are your objections to safety and quality testing of innovations?
Don't innovations need to be tested for safety and quality?
If innovations are not safe, should they not be used on live patients?
How can the industry with its conflicts of interest effectively regulate HIT?
Even if it could, again, how would additional regulatory oversight harm innovation?
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And perhaps this needs to be asked as well:
- Don't you really mean regulation would harm the bottom line?
-- SS