EHR utopian dreams have taken some pronounced hits in recent years.
In
recent months, the hyper-enthusiasts and their government allies have
had to eat significant dirt, and scale back their grandiose but risible -
to those who actually have the expertise and competence to understand
the true challenges of computerization in medicine, and think critically
- plans.
(At this point I'll give them the benefit of the doubt and not call the utopians and hyper-enthusiasts corrupt, just stupid.)
USA Today published this article today outlining the retreat:
Government backs down on some requirements for digital medical records
May 26, 2015
Government regulators are backing
down from many of their toughest requirements for doctors' and hospitals' use
of digital medical records, just as Congress is stepping up its oversight of
issues with the costly technology.
They
needed to back down because the technology, vastly over-hyped and
over-sold as to capabilities, and vastly undersold as to the expertise
required for proper design and implementation, has impaired the practice
of medicine significantly - and caused patient harms:
... Now the Department of Health and
Human Services is proposing a series of revisions to its rules that would give
doctors, hospitals and tech companies more time to meet electronic record
requirements and would address a variety of other complaints from health care
professionals.
"The problem is we're in the
EHR 1.0 stage. They're not good yet," says Terry Fairbanks, a physician
who directs MedStar's National Center for Human Factors in Healthcare. The
federal government "missed a critical step. They spent billions of dollars
to finance the implementation of flawed software."
The
"EHR 1.0" stage? The actual problem is that an industry that's existed
regulation-free for decades now was believed, against the advice of the
iconoclasts, myself included, when it spoke of this
experimental technology as if it were advanced and perfected.
Our leaders all the way up to the last two Presidents were suckered by this industry. In Feb. 2009 I wrote:
http://www.wsj.com/articles/SB123492035330205101
Dear WSJ:
You
observe that the true political goal is socialized medicine facilitated
by health care information technology. You note that the public is
being deceived, as the rules behind this takeover were stealthily
inserted in the stimulus bill.
I have a different view
on who is deceiving whom. In fact, it is the government that has been
deceived by the HIT industry and its pundits. Stated directly, the
administration is deluded about the true difficulty of making
large-scale health IT work. The beneficiaries will largely be the IT
industry and IT management consultants.
For £12.7
billion the U.K., which already has socialized medicine, still does not
have a working national HIT system, but instead has a major IT quagmire,
some of it caused by U.S. HIT vendors.
HIT (with a few exceptions) is largely a disaster. I'm far more concerned about a mega-expensive IT misadventure than an IT-empowered takeover of medicine.
The
stimulus bill, to its credit, recognizes the need for research on
improving HIT. However this is a tool to facilitate clinical care, not a
cybernetic miracle to revolutionize medicine. The government has bought the IT magic bullet exuberance hook, line and sinker.
I can only hope patients get something worthwhile for the $20 billion.
Scot Silverstein, M.D.
Faculty, Biomedical Informatics
Drexel University Institute for Healthcare Informatics
Philadelphia
Nobody was listening.
Back to USA Today:
... William McDade, a Chicago
anesthesiologist, checks the medical records of patient Jacob Isham. McDade has
moved into electronic medical records but isn't convinced they improve
record-keeping, and meanwhile they're expensive and they take time away from
patients.
These digitized records remain the
bane of many doctor and patient relationships, as physicians stare at computer
screens during consultations.And there's the issue of time. University of
Chicago Medicine anesthesiologist William McDade, who has switched from paper
to electronic records, says that while EHRs put information at doctors'
fingertips, those doctors must take extra time to enter data, and some systems
are not intuitive.
The model of physicians as data-entry clerks was experimental
from the start, especially in busy inpatient settings and critical care
areas. I opine that particular experiment is a failure. Paper is far
faster, followed by transcription by those without clinical
obligations. That's expensive, of course; but reality is a harsh
master.
Praveen Arla of Bullitt County
Family Practitioners in Kentucky says even though he's "one of the most
tech-savvy people you're ever going to meet," his practice has struggled
mightily with its system. It cost hundreds of thousands of dollars to put into
place, he says, and it doesn't even connect with other systems in hospitals and
elsewhere.
Physicians should
not have to be "tech-savvy". Software, as I've written before, needs to
be physician-savvy. As much of it is written without clinical
leadership, we have the results outlined in USA Today.
... The federal government
"should've really looked at this more closely when EMRs were implemented.
Now, you have a patchwork of EMR systems. There's zero communication between
EMR systems," he says. "I am really glad they're trying to look back
and slow this down."
I repeatedly called for a slowdown or moratorium of national EHR rollout on this blog. See 2008 and 2009 posts
here and
here for example. My calls were due to the prevalence of bad health IT (BHIT), hopelessly
deficient if not
deranged
talent management practices (especially when compared to clinical
medicine) in the health IT industry, and complete lack of regulation,
validation and quality control of these potentially harmful medical
devices.
I also called the HITECH stimulus act 'social policy malpractice.' See my Sept. 2012 post "
At Risk in the Computerized Hospital: The HITECH Act as Social Policy Malpractice, and Passivity of Medical Professional".
USA Today then calls out issues of reliability, safety and liability.
Of course, there's always a straddle-the-fence defender of EHRs, with a "
EHRs have problems, BUT..." refrain, even when almost 40 medical societies have complained about safety and usability issues
(http://hcrenewal.blogspot.com/2015/01/meaningful-use-not-so-meaningul.html):
... Physician
Robert Wachter, author of The Digital Doctor, is a proponent of,EHRs,
but sounded several cautionary notes in his book about the problems. At the
University of California San Francisco, where he chairs the department of
medicine, a teenage patient nearly died of a grand mal seizure after getting 39
times the dose of an antibiotic because of an EHR-related issue. But Wachter
says he believes patients are safer with EHRs than they were with paper.
Wachter's book to my belief omitted known cases of
EHR fatality - in my view a milquetoast, spineless approach to EHR risk at best.
(I'm trying to be kind and objective, but such spinelessness of others about EHRs put my mother in her grave,
http://hcrenewal.blogspot.com/2011/06/my-mother-passed-away.html.)
Further,
the belief that EHRs are safer than paper are not the views in my mind
of a critical-thinking scientist, as the true rates of EHR-related harms
is unknown, yet the incidences of mass "glitches" affecting potentially
thousands of patients at a time and impossible with paper are
well-known.
See my April 9, 2014 post "
FDA on health IT
risk: "We don't know
the magnitude of the risk, and what we do know is the tip of the
iceberg, but health IT is of 'sufficiently low risk' that we don't need
to regulate it" (
http://hcrenewal.blogspot.com/2014/04/fda-on-health-it-risk-reckless-or.html), especially points #1 through 4, and the query link
http://hcrenewal.blogspot.com/search/label/glitch.
5/27/2015 addendum:
The author of this USA Today article Jayne O'Donnell informed me that
the following appeared in the print edition, but not the electronic
version:
But Wachter and
Sally Murphy, former chief nursing officer at HHS' health information
technology agency, say they both believe patients are safer with EHRs
than they were with paper.
"Is there broad proof that electronic health records have impacted quality? No, " says Murphy, "But you just have to pay attention to the unintended consequences and continue to study them."
First,
that response seems the classic salesman's tactic of redirection, to
deflect from fully answering to the cruel reality of the evidence. The
second part of the response strikes me as a non-sequitur, in fact.
Second,
Murphy and Wachter both seem unable to grasp that the myriad en masse
risks to potentially large numbers of patients these systems in their
current state cause, impossible with paper (as, for instance, in the
many posts at the link above), combined with the lack of evidence about
(mass-hyped) "quality improvements", could make patients
less safe under electronic enterprise command-and-control systems, which in hospitals is what these systems really are.
Try getting thousands of prescriptions wrong, for instance (see
http://hcrenewal.blogspot.com/2011/11/lifespan-rhode-island-yet-another.html), or stealing hundreds of thousands of paper records (see for example
http://hcrenewal.blogspot.com/2012/06/more-electronic-medical-record-breaches.html).
Compare to well-staffed paper systems led by health information management professionals (
not IT geeks), especially those supplemented with document imaging systems.
This type of statement - "EHRs are bad today,
BUT they're
still better than paper" - strikes me as reflecting, I'm sad to say,
limited imagination, limited critical thinking, Pollyanna attitudes, and
unfettered faith in computers.
Third, Murphy's somewhat disconnected response "
But you just have to pay attention to the unintended consequences and continue to study them" is a bit surprising considering the statement made by the same ONC office just a few years ago:
Contrast to former ONC Chair David Blumenthal, see second quote at my April 27, 2015 essay "
Pollyanna Rhetoric, Proximate Futures and Realist's Primer on Health IT Realities in 2015" at
http://hcrenewal.blogspot.com/2015/04/pollyanna-statements-proximate-futures.html from an
April 30, 2010 article entitled
"Blumenthal: Evidence of adverse events with EMRs "anecdotal and fragmented":
... The [ONC] committee [investigating FDA reports
of HIT endangement] said that nothing it had found would give them any
pause that a policy of introducing EMR's [rapidly and on a national scale - ed.] could impede patient safety." (David Blumenthal, former head of ONC at HHS, http://www.massdevice.com/news/blumenthal-evidence-adverse-events-with-emrs-anecdotal-and-fragmented)
Sadly
and tragically, my mother was seriously injured by EHR-related
medication reconciliation failure and abrupt cessation of a heart rhythm
medication just weeks after Blumenthal said he was unconcerned about
risk and that we should go full steam ahead. That misadventure began on
May 19, 2010 to be exact.
It is my belief HHS and ONC still do not take risk
seriously and would revert to a Pollyanna stance in a heartbeat without the
pressures of the iconoclasts.
Back to the USA Today article:
... Some
proponents of EHRs say the government has been thwarting efforts to improve
them.
That's laughable. A review
of Australian computer scientist/informtics expert Jon Patrick's
analysis of the Cerner ED EHR product, for example, gives insight into
just how crappy this industry and its products are, and government was
certainly not the cause. See:
Patrick, J. A Study of a Health
Enterprise Information System. School of Information Technologies,
University of Sydney. Technical Report TR673, 2011 at
http://sydney.edu.au/engineering/it/~hitru/index.php?option=com_content&task=view&id=91&Itemid=146.
... In addition to extending the
deadline for implementing EHR requirements, a series of HHS proposed rules
extends the time doctors, hospitals and tech companies have to meet EHR
requirements, cuts how much data doctors and hospitals have to collect and
reduces how many patients have to access to their own electronic records from
5% of all their patients to just one person.
"That is a slap in the face to
patient rights and all the advocates because we worked so hard and for so long
to ensure patients could access their data," says patient advocate Regina
Holliday.
Holliday became an electronic records advocate
after her husband died of kidney cancer in 2009 at age 39. His care was
adversely affected because hospitals weren't reading his earlier EHRs and she
had trouble getting access to the records.
I
met Regina Holliday in Australia during my 2012 keynote presentation to
the Health Informatics Society of Australia on health IT trust (
http://hcrenewal.blogspot.com/2012/08/my-presentation-to-health-informatics.html). As I recently mentioned to her, it's even worse that the requirements for a
tamper-proof audit trail are also being relaxed.
Without
a complete and secure audit trail, electronic records can be altered
without detection by hospitals, e.g., after a medical misadventure, to
their advantage. This represents a massive conflict of interest is a
violation of patient's rights to a secure and unaltered record in the
event of a mishap, in my opinion.
The
2014 Edition EHR CERTIFICATION CRITERIA, 45 CFR 170.314 spells out in great detail specs for such an audit trail (see page 7 at
http://www.healthit.gov/sites/default/files/meaningfulusetablesseries2_110112.pdf), but compliance has been 'conveniently' relaxed, after hospital and industry lobbying I'm sure.
(The certified electronic health record technology definition proposed by CMS would continue to include
the “Base EHR” definition found in the “2015
Edition Health IT Certification Criteria” in addition to CMS’ own
objectives and criteria. This definition
does not include mandatory tamper resistant audit trails. The audit trail requirement is
not proposed to be included in the 2015 definition of “Base EHR." Neither is this criterion found in CMS’ own definition of CEHRT; rather
it is “
strongly recommended” that providers ensure the audit log
function is enabled at all times when the CEHRT
is in use, since the audit log function helps ensure protection of
patient information and mitigate risks in the event of any potential
breach.)
"Strongly recommended" in this industry in my opinion equates to "safely ignore" if it impacts margins.
... EHRs "have made our lives
harder" without improving safety, says Jean Ross, co-president of National
Nurses United. Last year, the nurses' union called on the Food and Drug
Administration "to enact much tougher oversight and public
protections" on EHR use.
Meanwhile, the medical industry is
urging HHS to give them even more time and flexibility to improve their
systems.
"The level of federal
involvement and prescriptiveness now is unhealthy," says Wachter, who
chairs the UCSF department of medicine. "It has skewed the marketplace so
vendors are spending too much time meeting federal regulations rather than
innovating."
Here's
Wachter again, in essence, kissing the industry's ass. Government EHR
regulation is still minimal, and prior to MU was nearly non-existent.
Where was the "innovation" (more properly, quality, usability, efficacy
and safety) then, I ask?
...
Sen. Lamar Alexander, R-Tenn., chairman of the Senate health committee,
and Sen. Patty Murray, D-Wash., announced a bipartisan electronic
health records working group late last month to help doctors and
hospitals improve quality, safety and privacy and facilitate electronic
record exchange among health care providers and different EHR vendors.
"It's
a great idea, it holds promise, but it's not working the way it is
supposed to," Alexander said of EHRs at a recent committee hearing
At a Senate appropriations subcommittee meeting last month, Alexander told HHS Secretary Sylvia Burwell that he wanted EHR issues at the top of his committee and HHS' priority list to be addressed through regulation or legislation.
I
have spoken to the Senator's healthcare staff, who are aware of my
Drexel website and my writings on this blog. They were stunned by the
reality of health IT, and I hope they have relayed my concerns and
writings to the senator and that this contributed to his mandate.
... Minnesota lawmakers became the
latest state this week to allow health care providers to opt out of using EHRs.
But MedStar's Fairbanks says doctors would welcome well-designed, intuitive
EHRs that made their jobs easier instead of more difficult — and that would
improve safety for patients, too.
It
is my view that under current approaches to health IT, in terms of
talent management, leadership, product conception, design, construction,
implementation, maintenance (e.g., correction of reported bugs),
regulation, and other factors, that dream is simply impossible.
The entire EHR experiment needs serious re-thinking, by people with the appropriate expertise to know what they're doing.
I
note that excludes just about the entire business-IT leadership of this
country, who, lacking actual clinical experience, are one major source
of today's problems.
 |
| Today, Pinky, we're going to roll out national health IT ... tomorrow, we TAKE OVER THE WORLD! |
-- SS
