Washington
Regarding the Sunday Oct. 25, 2009 story in the Washington
Post "Electronic
medical records not seen as a cure-all" by staff writer Alexi Mostrous, I have a number of observations.
(Not including the observation that Mr. Mostrous
probably deserves an award for being the first major newspaper reporter to
broach this topic in a serious and balanced manner.)
First, I believe healthcare IT can live up to all the predictions made about
its benefits - but only if done well. There is massive complexity behind
those two words "done well", and that is HIT's
key stumbling block in 2009. I believe we are only in the adolescent stage of
knowing how to "do health IT well."
Second, I should point out that the intended consequences of health IT
include, among many other things, the following "hiding in plain
sight" (i.e., not often verbalized) intended consequences:
- The improvement of medicine ... in the context of protection
of patient rights established over centuries of development of modern
medicine.
- The improvement of IT itself through cross disciplinary
collaboration between IT and medicine, of the science of IT (computer
science), the social aspects of computerization ("sociotechnical
issues"), and improvement of the our
understanding of the intersection of medicine and computers.
Instead, we largely have the opposite. Patients' rights are trampled, and
hostility and territoriality has arisen between clinicians (including medical informaticists) and IT, groups that rarely if ever
interacted in hospitals ten or twenty years ago.
Of concern, when scientific study sections evaluate NIH grant proposals calling
for testing of new IT that involves patients, patient protections and informed
consent processes are a paramount concern since such activities are considered research.
Yet, in implementing large clinical IT system in a hospital with new features,
there are no formal regulations, and I'm not sure there's even IRB involvement
in most cases. Patients do not get the chance to give informed consent to the
use of these IT devices mediating their care. Why the difference?
The unintended results of computerization efforts have also included
suppression of research on sociotechnical issues and
on informatics, which must include study of the downsides of HIT, and of the
failures in addition to the study of the successes. That is scientific fact -
there is no room for debate, no room for spin on the need for careful study
of the downsides of any mission critical domain. One would think there to
be a vibrant literature on these issues, Yet searches on massive biomedical
databases such as PubMed on, say, "cerner electronic health record" (or other vendors as
well) are disappointing to say the least. Further, my own website on HIT
difficulties remains nearly
unique (PPT) after ten years online. That is not bragging; it is a
disturbing finding to me - symptomatic of an industry that somehow has managed
to avoid serious scrutiny.
In a field with downsides, there are:
1) those who know about the problems but fail to speak,
2) those who see the problems but fail to act, and
3) those who see, know and speak/write/research the problems.
That said, now on to the Washington Post article.
In "Electronic
medical records not seen as a cure-all" the Washington Post observes:
... bipartisan enthusiasm has
obscured questions about the effectiveness of health information technology
products, critics say. Interviews with more than two dozen doctors, academics,
patients and computer programmers suggest that computer systems can increase
errors, add hours to doctors' workloads and compromise patient care.
I would include the bipartisan enthusiasm under the subject header of
"irrational exuberance", which itself falls under the header of
"lack of domain knowledge." That itself is a consequence of both
failure to study the issues, and suppression of those issues by those with an
interest in doing so.
… health IT's
effectiveness is unclear.
The literature is indeed conflicting, and the need for rigorous scientific
study has never been more essential considering the commitment of tens of
billions of dollars towards health IT. The time for story telling, marketing
based on opinion, name calling, leap-of-faith extrapolations of light year
dimensions, and other forms of pseudoscience and non-science are over. The time
for objective study is now.
The Senate Finance Committee has amassed a thick file of
testimony alleging serious computer flaws from doctors, patients and engineers
unhappy with current systems.
Being the ranking member of that committee, Sen. Grassley has a fiduciary
responsibility to protect Medicare and Medicaid patients (and one might argue,
to protect all patients since those programs often serve as models for private
insurers). In that regard, the investigation he has initiated is part of his
responsibility as a ranking member of Congress. Politics aside (and there are
those who will resort to ad hominem "political witch hunt"
arguments), he would have been negligent if he had not initiated an inquiry.
Sen. Grassley has taken on the pharma industry and
the government's Food and Drug Administration itself, such as in this recent
article "FDA
fails to follow up on unproven drugs" where he concluded from a GAO
study he ordered that "FDA has fallen far short of where it should be for
patient safety." He seems quite serious about medical safety.
If only others in Congress had done their job similarly regarding national
finance, we might now not be in the worst economic crisis since '29 with many
major industries failing.
David Blumenthal, the head of health technology at the
Department of Health and Human Services, acknowledged that the systems had
flaws. "But the critical question is whether, on balance, care is better
than before," he said. "I think the answer is yes."
This sounds uncomfortably like how a pharmaceutical company might respond to
doubts about drug effectiveness and safety. In reality it's really irrelevant
what he "thinks." Where's the data? Is this a political statement, a
personal belief, or a statement backed up by scientific fact that is not cast
into doubt by other research results? Our own National Research Council, Joint
Commission, and other international organizations have written about their
doubts and concerns about HIT [as that IT is designed and implemented in 2009].
If there is rigorous, systematic research weighing pro's and con's to back this
assertion, I wish it would be published.
For his statement is really saying "we don't really know how many systems
have flaws, we know some do, and we don't really know the full extent of the
impact of those flaws, but because there can be some benefits, let's spend $50+
billion before we know the extent of the problems and fix them." We do not know with any reasonable degree of
certainty the incidence of adverse clinical events and unintended consequences
(such as clinician distraction from having to find workarounds to flaws)
attributable to HIT. I point out
research from Harvard forty years ago, when Harvard informatics pioneer Dr. Octo Barnett published the "Ten Commandments of
HIT." Two of those commandments were:
... 8. Thou
shall be concerned with realities of the cost and projected benefit of the
computer system [i.e., ROI - ed.]
…10. Be optimistic about the future, supportive of good work that is being
done, passionate in your commitment, but always guided by a fundamental
skepticism.
The full set is in this
post. Somewhere in the past 40 years, the rigorous ROI evaluations (which
also must include systematic evaluations of risk, as any businessperson knows)
and the fundamental skepticism seem to have gotten lost.
Over the next two months, Blumenthal will finalize the
definition of "meaningful use," the standard that hospitals
and physicians will have to reach before qualifying for health IT stimulus
funds.
This is an example of putting the cart before the horse, and is a
semantically-based, self contained logical fallacy of sorts. If a health IT
system is harmful, the term "meaningful use" is itself Orwellian. If
we don't know if HIT is beneficial, or have doubts, then such as term
presupposes that health IT is inherently beneficial. A better term would have
been "good faith use" - use based on
the faith or hope that health IT will have an overall positive effect.
The term "meaningful use" jumps the gun and is more a political
slogan than a "meaningful term."
"If you look at other high-risk industries, like drug
regulation or aviation, there's a requirement to report problems," said
David C. Classen, an associate professor of medicine
at the
This is obvious, the reasons for it are obvious, and the reasons why health IT
needs a requirement for problems reporting (one aspect of post-marketing
surveillance, the "Phase IV" study as it is known in pharma) is obvious. Yet in 2009, no such requirement exists
(see my post "Our
Policy Is To Always Have Unabashed Faith In The
Computer" for more on why we need reporting requirements.) Why do
these requirements simply not exist in HIT?
"It's been a complete nightmare," said Steve Chabala, an emergency room physician at St. Mary Mercy
Hospital in
The industry in the past has called such physicians "luddites",
"resistant to change", "stubborn" etc. However, argumentum ad
hominem is a fallacious mode of argument that has no place in a scientific
field such as biomedicine. There also seems to be quite a lot of such concerns
expressed by a large number of physicians, nurses, etc., and dismissing their
concerns with a wave of the hand is cavalier in the extreme - again, these are first
principles, without room for argument or debate. Let's study the issues
rigorously and scientifically before resorting to ad hominem.
Other doctors spoke of cluttered screens, unresponsive
vendors and illogical displays. "It's a huge safety issue," said
Christine Sinsky, an internist in
See my eight part series on mission hostile clinical IT here for examples of what
Dr. Sinsky is referring to.
She emphasized that electronic records have improved her
practice. "We wouldn't want to go back," she said. "But EHRs are still in need of significant improvement."
Yes, not cancellation, but improvement. And, quite importantly, before
tens of billions of dollars are spent. Hospitals and physician offices are not
an IT development laboratory, since the users of these facilities
(patients) have very special rights and the clinicians, very special
obligations and responsibilities.
Legal experts say it is impossible to know how often health
IT mishaps occur. Electronic medical records are not classified as medical
devices, so hospitals are not required to report problems.
That after decades of HIT development, sales and implementation we cannot know
with certainty how often mishaps occur is, quite simply, a scandal of major
proportions. Quoting an old House of God law, #10:
"if you don't take a temperature, you can't find a fever."
Another applicable aphorism seen on another discussion board: "you can
only be so negligent or craven before the only remaining rationale is that you
intended the result."
"Doctors who report problems can lose their jobs,"
Hoffman said.
I've taken risks with my own career in criticizing health IT, as have my
colleagues. Hoffman is not exaggerating.
"Hospitals don't have any incentive to do so [speak out
about problems with HIT] and may be in breach of contract if they do."
Imagine the outcry if the same prevailed regarding drugs or medical devices.
The cemeteries would be lined with people whose epitaph could read "we
bury our mistakes."
While orange-shirted vendor employees "ran around with
no idea how to work their own equipment," the internist said, doctors
struggled to keep chronically ill patients alive. "I didn't go through all
my training to have my ability to take care of patients destroyed by devices
that are an impediment to medical care."
This gets to issues I first raised in this website on HIT difficulties: who are
these IT personnel, and what are their qualifications,
exactly, to be working in mission critical medical environments? How is their
competence evaluated?
I think these are questions that need to be answered.