Thursday, February 28, 2013

Arguments with Pavlov's Dogs: Health IT Regulation Will "Harm Innovation"? How, exactly?


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

4 comments:

Steve Lucas said...

This link from Fox News shows some of the money spent and interrelationships of those inside and outside government in determining our healthcare systems winners and losers:


http://health.foxnews.mobi/quickPage.html?page=31737&content=89770762&pageNum=-1

Many names will be familiar to HCR readers.

Steve Lucas

Anonymous said...

Innovation in the EHR market couldn't get any worse. User interfaces are generally terrible(DOS-like; no offense to DOS). A software quality officer at a REAL, non-healthcare, software company would have a seizure if they were given the task to "fix" a typical EHR user interface. Where to start???

So much is upside down in health care; perhaps regulation will help!

InformaticsMD said...

Steve Lucas said...

This link from Fox News shows some of the money spent and interrelationships of those inside and outside government in determining our healthcare systems winners and losers:


http://health.foxnews.mobi/quickPage.html?page=31737&content=89770762&pageNum=-1


From that article:

In the meantime, there are enough new industries who have engaged in the Obama Gold Rush that when this movie is over it's unclear what will be left at the end of the rainbow.

My answer:

Lawsuits.

What's strange is I try my darndest to educate on the clinical (and legal) risks of too-rapid HIT design and deployment, but many just don't listen.

What can I say?

-- SS

InformaticsMD said...

Anonymous said...

So much is upside down in health care; perhaps regulation will help!

We are living Orwell, when "innovation is experimentation", injury and death by HIT is "anecdote", and issues in HIT do not involve "ethics" but merely "tradeoffs."

-- SS