Thursday, August 30, 2012

A Tacit Admission That National Health IT is a Gargantuan Experiment

In my post yesterday "The Scientific Justification for Meaningul Use, Stage 2" I wrote:

There's no truly robust evidence of generalizable benefit, no randomized trials, there's significant evidence to the contrary, there's risk to safety that this disruptive technology causes in its present state (but the magnitude is unknown, see quotes from 2012 IOM study here) that MU and "certification" do not address, there's a plethora of hair-raising defect reports from the only seller that reports such things, but CMS justifies the program [starting at p. 18 in the Final Rule for Meaningful Use Stage 2 at this link - ed.] with the line:

"Evidence [on benefits] is limited ... Nonetheless, we believe there are substantial benefits that can be obtained by eligible hospitals and EPs ... There is evidence to support the cost-saving benefits anticipated from wider adoption of EHRs."

I am deeply impressed by the level of rigorous science here.  We are truly in a golden age of science.  [That is obviously satirical - ed.]

The Final Rule for MU Stage 2, via the admissions made by it regarding limited evidence, is in fact a tacit admission that the whole national health IT enterprise is a huge experiment (involving human subjects, obviously).  It is likely the most forthright admission we will get from this government on that issue.

With neither explicit patient informed consent nor a formal regulatory process to validate safety, but merely based on a "we believe" justification from the government, hospitals and practices are leaving themselves wide open to liability in the situation of patient injury or death caused by, or promoted by, this technology.

(Parenthetically, I note that I've already seen a claim in a legal brief that "certification" implies safety and a legal indemnification, and that the federal HITECH act - that as in this report merely provides statutory authority to the incentive program - pre-empts common-law i.e., state litigation over health IT.  The judge dismissed the claims.)

-- SS

Aug. 30, 2012 addendum:

A commenter pointed out that experiments on minors without consent might constitute an even more egregious action, subject to even more stringent laws (and perhaps penalties, I add) than on adults.   I cannot confirm that, but it is an interesting observation.  If you are an attorney, please comment, anonymously or otherwise.

-- SS


Anonymous said...

HIM$$ duped the Congress with ambiguous descriptions of certification by its subsidiary, at the time, CCHIT.

It is no wonder that the lawmakers and others are of the erroneous impression that certification meant that the CPOE devices were approved as being safe and efficacious.

What a sham. What an experiment.

The babies used in these experiments are unconsented minors. There are special laws that apply.

Wonder when the plaintiffs' bar will catch on to that one.

InformaticsMD said...

Anonymous August 30, 2012 11:08:00 AM EDT wrote:

The babies used in these experiments are unconsented minors. There are special laws that apply. Wonder when the plaintiffs' bar will catch on to that one.

As numerous members of that Bar read this blog, they probably already have caught on.

-- SS