Wall Street Journal: "ObamaCare’s Electronic-Records Debacle"

This WSJ Op-Ed could have been entitled "President Sucker:  Led Down the Garden Path by The Healthcare IT Industry."

It is entitled "ObamaCare’s Electronic-Records Debacle", as below.  First, though:

On Feb. 18, 2009 the WSJ published the following Letter to the Editor authored by me (http://www.wsj.com/articles/SB123492035330205101):

Digitizing Medical Records May Help, but It's Complex

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

The UK's National Programme for Health IT in the NHS (NPfIT) has since died. (See my Sept. 22, 2011 post "NPfIT Programme goes PfffT" at http://hcrenewal.blogspot.com/2011/09/npfit-programme-going-pffft.html.)  Also see my Dec. 7, 2008 post "Open Letter to President Barack Obama on Healthcare Information Technology" warning of many issues at http://hcrenewal.blogspot.com/2008/12/open-letter-to-president-barack-obama.html.

Now, the WSJ, to which I and other colleagues have been speaking about the realities of healthcare information technology for years but which has seemed reluctant to publish what would amount to a stinging corporate rebuke, has published this Op-Ed by a surgeon, Jeffrey A. Singer:

http://www.wsj.com/articles/jeffrey-a-singer-obamacares-electronic-records-debacle-1424133213

ObamaCare’s Electronic-Records Debacle
The rule raises health-care costs even as it means doctors see fewer patients while providing worse care.

By Jeffrey A. Singer
Feb. 16, 2015 7:33 p.m. ET

The debate over ObamaCare has obscured another important example of government meddling in medicine. Starting this year, physicians like myself who treat Medicare patients must adopt electronic health records, known as EHRs, which are digital versions of a patient’s paper charts. If doctors do not comply, our reimbursement rates will be cut by 1%, rising to a maximum of 5% by the end of the decade.

I am an unwilling participant in this program. In my experience, EHRs harm patients more than they help.

I note that it's not just physicians who are unwilling participants in this medical experiment.  We all are - as patients - in this unregulated experiment. 

As a colleague puts it, with an addendum by me:

"Why are we implementing patient care tools that are not tested for harms, not evaluated for harms, not reported systematically for harms, while the government does not refute the statement that harms are caused by EHRs and admits the true magnitude of harms is unknown?"

The program was inspired by the record-keeping models used by integrated health systems, especially those of the nonprofit consortium Kaiser Permanente and the Department of Veterans Affairs.

Yet even in those environments, these systems cause major problems, e.g.,

http://www.modernhealthcare.com/article/20140620/NEWS/306209940
Complicated, confusing EHRs pose serious patient safety threats [at VA]

By Sabriya Rice
Posted: June 20, 2014 - 8:15 pm ET

Confusing displays, improperly configured software, upgrade glitches and systems failing to speak to one another—those are just a few electronic health record-related events that put patients in danger, according to a new study.

The more complex an EHR system, the more difficult it may be to trace problems, patient safety experts warn. Hospitals planning to add new software or make updates should be strategic about changes and proactively include ways to monitor events.

“Because EHR-related safety concerns have complex socio-technical origins, institutions with longstanding, as well as recent EHR implementations, should build a robust infrastructure to monitor and learn from them,” concluded the report published Friday in the Journal of the American Medical Informatics Association.

Researchers evaluated 100 closed safety investigations reported between August 2009 and May 2013 to the Informatics Patient Safety Office of the Veterans Health Administration.

Among the findings, 74 events resulted from unsafe technology, such as system failures, computer glitches, false alarms or “hidden dependencies,” a term for what happens when a change in one part of a system inadvertently leads to key changes in another part. Another 25 events involved unsafe use of technology such as an input error or a misinterpretation of a display.

The authors of that study admitted the data was very incomplete due to limitations of error recognition, data collection and diffusion, and other factors.

Back to the WSJ:

The federal government mandated in the 2009 stimulus bill that all medical providers that accept Medicare adopt the records by 2015. Bureaucrats and politicians argued that EHRs would facilitate “evidence-based medicine,” thereby improving the quality of care for patients.

This is the "silver bullet theory of IT-enabled transformation" at work.  Add computers and - Presto!  Better care!  After all, how hard can it be to get to the moon in a hot air balloon? 

The moon is "up" and balloons go "up", therefore, why not? All that's required are the right "processes" -- with which the Acme Hot Air Balloon Co. executives can accomplish anything -- and ignoring those pessimistic scientists, engineers and other experts who speak of vacuum of space and radiation and all those esoteric "gotchas" that are bad for business! (See my 2008 Powerpoint presentation to the IEEE Medical Technology Policy Committee on these issues entitled "To The Moon In A Hot Air Balloon: Why Is Clinical IT Difficult?" at this link.)

But for all the talk of “evidence-based medicine,” the federal government barely bothered to study electronic health records before nationalizing the program. The Department of Health and Human Services initiated a five-year pilot program in 2008 to encourage physicians in 12 cities and states to use electronic health records. One year later, the stimulus required EHRs nationwide. By moving forward without sufficient evidence, lawmakers ignored the possibility that what worked for Kaiser or the VA might not work as well for Dr. Jones.

Not only that, the government and industry are hell-bent on avoiding any meaningful quality regulation (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).

Even more critically, they didn't bother to seriously study harms.  Leave that to the independent ECRI Institute, whose findings were alarming (see http://hcrenewal.blogspot.com/2013/02/peering-underneath-icebergs-water-level.html).  The ECRI Institute has not followed up on this study that I am aware; being recipients of government money, as I understand it, to study the problems may have impaired their independence and softened their tone.)

Which is exactly what is happening today. Electronic health records are contributing to two major problems: lower quality of care and higher costs.

The former is evident in the attention-dividing nature of electronic health records. They force me to physically turn my attention away from patients and toward a computer screen—a shift from individual care to IT compliance. This is more than a mere nuisance; it is an impediment to providing personal medical attention.

As someone who formally entered the field in 1992 via postdoc in Medical Informatics at Yale School of Medicine, I can state emphatically that the whole concept of direct physician data entry was an experiment.  In medical informatics, we were exploring ways to avoid the known detriments of direct physician entry via creative applications of information technology.

That experiment has been a clear failure, at least as diffused into the commercial health IT sector in 2015.  However few in my field are willing to admit this due to, in large part, avoidance of dealing with the unpleasant consequences of that admission.  (One pioneer, Clement McDonald now at NIH, has admitted this.  See my Oct. 29, 2014 post "The tragedy of electronic medical records" (http://hcrenewal.blogspot.com/2014/10/the-tragedy-of-electronic-medical.html.)

Doctors now regularly field patient complaints about this unfortunate reality. The problem is so widespread that the American Medical Association—a prominent supporter of the electronic-health-record program—felt compelled to defend EHRs in a 2013 report [now supplanted - see below - ed.], implying that any negative experiences were the fault of bedside manner rather than the program.

AMA has changed its tone.

I think the author of this Op-Ed may have missed the Jan. 21, 2015 letter to HHS from multiple medical societies or submitted this Op-Ed prior to that date. 

A group of 37 medical societies led by the American Medical Association sent a letter to Health and Human Services last month saying the certification program is headed in the wrong direction, and that today's electronic records systems are cumbersome, decrease efficiency and, most importantly, can present safety problems for patients. 

I covered that Jan. 21, 2015 letter at http://hcrenewal.blogspot.com/2015/01/meaningful-use-not-so-meaningul.html. 

Apparently our poor bedside manner is a national crisis, judging by how my fellow physicians feel about the EHR program. A 2014 survey by the industry group Medical Economics discovered that 67% of doctors are “dissatisfied with [EHR] functionality.” Three of four physicians said electronic health records “do not save them time,” according to Deloitte. Doctors reported spending—or more accurately, wasting—an average of 48 minutes each day dealing with this system.

Nurses are having similar experiences.  I've written previously about substantial problems nurses at Affinity Medical Center, Ohio (http://www.affinitymedicalcenter.com/) and other organizations are having with EHRs, and how hospital executives were ignoring their complaints.  The complaints have been made openly, I believe, in large part due to the protection afforded by nurses' unions.

See for example my July 2013 post "RNs Say Sutter’s New Electronic System Causing Serious Disruptions to Safe Patient Care at East Bay Hospitals" at http://hcrenewal.blogspot.com/2013/07/rns-say-sutters-new-electronic-system.html (there are links there to still more examples), and my June 2013 post  "Affinity RNs Call for Halt to Flawed Electronic Medical Records System Scheduled to Go Live Friday" at http://hcrenewal.blogspot.com/2013/06/affinity-rns-call-for-halt-to-flawed.html, along with links therein to other similar situations.

Particularly see my July 2013 post "How's this for patient rights? Affinity Medical Center manager: file a safety complaint, and I'll plaster it to your head!" at http://hcrenewal.blogspot.com/2013/07/hows-this-for-patient-rights-affinity.html, where a judge had to intervene in a situation of apparent employee harassment for complaints about patient safety risks.  Also see my post about an open letter to the Chief Nursing Officer (CNO) dated August 15, 2013, at http://hcrenewal.blogspot.com/2013/11/another-survey-on-ehrs-affinity-medical.html.

That plays into the issue of higher costs. The Deloitte survey also found that three of four physicians think electronic health records “increase costs.” There are three reasons. First, physicians can no longer see as many patients as they once did. Doctors must then charge higher prices for the fewer patients they see. This is also true for EHRs’ high implementation costs—the second culprit. A November report from the Agency for Healthcare Research and Quality found that the average five-physician primary-care practice would spend $162,000 to implement the system, followed by $85,000 in first-year maintenance costs. Like any business, physicians pass these costs along to their customers—patients.

Then there’s the third cause: Small private practices often find it difficult to pay such sums, so they increasingly turn to hospitals for relief. In recent years, hospitals have purchased swaths of independent and physician-owned practices, which accounted for two-thirds of medical practices a decade ago but only half today. Two studies in the Journal of the American Medical Association and one in Health Affairs published in 2014 found that, in the words of the latter, this “vertical integration” leads to “higher hospital prices and spending.”

I do not enjoy the fact that this occurred to my own personal physicians who are now employees of a hospital against which I am substitute plaintiff for my deceased mother, whose injuries were EHR-related.  See "On EHR Warnings: Sure, The Experts Think You Shouldn't Ride A Bicycle Into The Eye Of A Hurricane, But We Have Our Own Theory" at
http://hcrenewal.blogspot.com/2013/09/on-ehr-warnings-sure-experts-think-you.html, actually penned in 2011.

Proponents of electronic health records nonetheless claim that EHRs decrease record-keeping errors and increase efficiency. My own experience again indicates otherwise and is corroborated by research.

The EHR system assumes that the patient in front of me is the “average patient.” When I’m in the treatment room, I must fill out a template to demonstrate to the federal government that I made “meaningful use” of the system. This rigidity inhibits my ability to tailor my questions and treatment to my patient’s actual medical needs. It promotes tunnel vision in which physicians become so focused on complying with the EHR work sheet that they surrender a degree of critical thinking and medical investigation.

"Critical thinking always, or your patient's dead" - Victor P. Satinsky MD, heart surgery pioneer, Hahenemann Hospital.

Distractions to the doctor-patient interaction are unwelcome and damn well better have a very high payback - which the experiment with health IT is showing is simply not there at the stage of development of this commercial technology in 2015.

Not surprisingly, a recent study in Perspectives in Health Information Management found that electronic health records encourage errors that can “endanger patient safety or decrease the quality of care.” America saw a real-life example during the recent Ebola crisis, when “patient zero” in Dallas, Thomas Eric Duncan, received a delayed diagnosis due in part to problems with EHRs.

That event could have led to catastrophe, but such errors are daily occurrences in hospitals all across the country.  See the many posts on this blog of EHR risks under the index link http://hcrenewal.blogspot.com/search/label/glitch.

Congress has devoted scant attention to this issue, instead focusing on the larger ObamaCare debate. But ending the mandatory electronic-health-record program should be a plank in the Republican Party’s health-care agenda. For all the good intentions of the politicians who passed them, electronic health records have harmed my practice and my patients.

Dr. Singer practices general surgery in Phoenix and is an adjunct scholar at the Cato Institute.

I would change that to "... ending the mandatory electronic-health-record program should be a plank in the government's health-care agenda."

Finally, of the author's adjunct affiliation, it seems bad health IT affects physicians all across the political spectrum.

-- SS

Citizen's Council for Health Freedom: "The Truth about Electronic Health Records"

The Citizen's Council for Health Freedom (CCHF) is an independent 501(c)3 non-profit organization with a mission "to protect health care choices and patient privacy" (www.cchfreedom.org/about.php).

Its president, Twila Brase, wrote this piece about Electronic Health Records in the CCHF newsletter of June 18, 2014, observing some "inconvenient truths" and highlighting one of the most asinine statements I've ever seen about computers made by (of course) a venture capital official who happened to play a significant role in formulating the Affordable Care Act a.k.a. "Obamacare":

http://healthenews.cchfreedom.org/newsletter.php/148

The Truth about Electronic Health Records

Propaganda only works for so long. Pretty soon truth catches up to it. This is exactly what's happening with electronic health records.

If you're a doctor you know how bad the government-mandated electronic health record (EHR) is. But if you're a patient, you may not realize that EHRs are endangering your life and jeopardizing medical excellence.

The EHR is nothing like what Big Government, Big Data, and Big Health said it would be. They promised convenience, coordinated care, fewer medical errors, more efficient medical practice, and portable medical records. They never meant it and it hasn't happened. These data systems were created for billing, data collection and government control of doctors, not patient care.

From all I have seen over the years, I must agree with the last two sentences above. The pioneers who explored this technology back to the 1950's warned against the nightmare that exists today, but I don't think they believed we would ever get to where we are in 2014.

Further, while Politico did not explicitly mention risk to life and limb caused by these systems, Twila Brase did.  "EHRs are endangering your life" is the elephant in the living room that the industry and its well-captured (and perhaps lubricated?) "regulators" simply will not address in a serious manner.

It has been my belief this reflects self-serving willful blindness, gross negligence and/or pecuniary motives, but I also believe that a fundamental malevolence on the part of people and organizations who know better increasingly needs to be considered as a contributor to the recklessness in the health IT sector.  These are experimental technologies of admittedly (by the regulators) definite but unknown risk, due to impediments to that knowledge.  Demanding their rapid diffusion under threat of penalty while knowing about the risks, and the uncertainty about magnitude, certainly does not reflect a benevolent disposition.

For more on the above points see my April 9, 2014 post "FDA on health IT risk: reckless, or another GM-like political coverup?" (http://hcrenewal.blogspot.com/2014/04/fda-on-health-it-risk-reckless-or.html) and its 11 points and hyperlinks.  This post and its linked brethren represents an indictment of sorts against the health IT hyperenthusiast culture and the unprecedented regulatory accommodation enjoyed by this sector.

Arthur Allen at POLITICO Pro eHealth (http://www.politico.com/story/2014/06/health-care-electronic-records-107881.html) says government-imposed EHRs are:

• Driving doctors to distraction 

• Igniting nurse protests

• Crushing hospitals under debt

"In short," he writes, "the current generation of electronic health records has about as many fans in medicine as Barack Obama at a tea party convention."

I guess that's  Politco's way of saying "not very many at all."

Doctors forced to use these EHRs say:

• "They slow us down and distract us from taking care of patients."

• "We're basically key-punch operators, transcriptionists having to input the data ourselves. It has essentially tripled the time to complete a medical record."

• "That's why I'm retiring."

• "Before I took notes, wrote what I wanted to say. Now I write and I click. If you just click, the person who reads the record gets no idea of what the patient was going through, your thought process."

• "Anything that in a normal world would take at most two clicks, here it takes four or five."

In fact, doctors and nurses forced to use this technology say far worse (e.g., see my posts on candid clinician feedback at http://hcrenewal.blogspot.com/2010/01/honest-physician-survey-on-ehrs.html , http://hcrenewal.blogspot.com/2013/11/another-survey-on-ehrs-affinity-medical.html , http://hcrenewal.blogspot.com/2014/02/ehrs-real-story-sobering-assessment.html , and http://hcrenewal.blogspot.com/2013/07/candid-nurse-opinions-on-ehrs-at.html).

Proponents falsely promised privacy. The real goal of Big Government, Big Data and Big Health was NO privacy. Data is valued as a tool of control and a means to profit. And today, 2.2 million entities today have legal access to your medical records without your consent because of the so-called HIPAA "privacy rule" and the 2009 HITECH Act. In addition, untold numbers of computer thieves, identity thieves and hackers have illegal access.

Not only that, but our data is sold in, in essence, data broker "back alleys" (e.g., see "Health IT Vendors Trafficking in Patient Data?" at http://hcrenewal.blogspot.com/2009/10/health-it-vendors-trafficking-in.html ).

Worse, the phenomenon of mismanagement of the "sales" is international in scope (e.g., see "NHS slammed for MAJOR data blunders as scale of patient info sell-off is revealed" at http://www.theregister.co.uk/2014/06/17/nhs_blamed_for_major_data_blunders_with_sale_of_patient_info_to_private_outfits/).

Every doctor and hospital must use EHRs by January 1, 2015 or face financial penalties. This was part of Obama's 2009 Recovery Act, and the foundation of Obamacare. The sheer cost of the mandate has forced many doctors to shut down private clinics and become health system employees, susceptible to being told by outsiders how to practice medicine.

Regarding "crushing hospitals under debt", the EHR "mania" has led medical centers such as the University of Arizona Health System, about to undergo the stresses of mass immigration of South American children no less, to sink $30 million into the red in large part in trying to fix EHR bugs (see my June 2, 2014 post "In Fixing Those 9,553 EHR "Issues", Southern Arizona’s Largest Health Network is $28.5 Million In The Red" at http://hcrenewal.blogspot.com/2014/06/in-fixing-those-9553-ehr-issues.html).

As another example of madness, the mania -- plus bad health IT -- led a  medical system based in Rhode Island to spend $100 million to replace Siemens health IT that caused thousands of potentially harmful prescription errors (http://hcrenewal.blogspot.com/2011/11/lifespan-rhode-island-yet-another.html) with Epic, and in doing so, eroding the cash flow and bond rating of the state's largest health system (http://www.modernhealthcare.com/article/20140606/NEWS/306069948).

Next Ms. Brase reveals a stunning fact about one of the architects of that 2009 Economic Recovery Act:

The arrogance of some EHR supporters is unpardonable. Bob Kocher helped write Obamacare, was trained as a doctor and is employed as a Venrock venture capitalist in health IT, but his credentials are those of a bureaucrat and profiteer (http://www.venrock.com/teammember/bob-kocher/).

Unpardonable arrogance indeed. 

In other words, a speculator and profiteer in the health IT sector helped in the formulation of laws that pushed the technology onto physicians, nurses and hospitals with CMS penalties for non-adopters of "certified" systems.   It would be interesting to know just how far such a potential conflict of interest went in the crafting of the ACA and HITECH itself.

Beyond that issue, this venture cap issues the following perverse statement, as cited by Politico and CCHF:

Per Politico pro eHealth, he says, "The reason so many [computers] are inefficient is that doctors are inefficient. If they redesigned their workflows, computers would work better."

Readers of this blog are familiar with perversity in health IT, but that statement is literally stunning.  It would make for a funny Saturday Night Live or Rowan and Martin's Laugh-In (to us 60's folks) skit if the topic were not so serious.

If they [doctors] redesigned their workflows, computers would work better?

Where, exactly, is the evidence for that assertion?   Exactly how should doctors "redesign" their workflows, considering the poorly bounded, conflicted, highly variable, uncertain, and high-tempo nature of the field? [1]

How can one even have a well-defined and unvarying "workflow" in such a domain that would "make computers work better?"

Answer:  it's impossible.

(Perhaps patients should adjust the unpredictable nature of their illnesses and symptoms to make the computers work better, too?)

What Dr. Kocher seems to turn on its head is the recognition that: 

"The reason so many [computers in healthcare] are inefficient is that they are grossly misdesigned for a domain like medicine.  They are unfit for purpose.  If they [the IT companies] redesigned their entire process in HIT production (from conception, design, implementation, marketing, and support) to be consistent with the needs of the field of clinical medicine and of clinicians, computers would work better." - Silverstein

The reality is that if the healthcare IT industry actually fired its ossified business-IT-oriented leaders (since business computing and clinical computing are two highly different fields, e.g., see http://hcrenewal.blogspot.com/2008/06/business-v-clinical-computing.html), or relegated them to managing accounting systems, and embraced the teaching of 50+ years of Medical Informatics in building good health IT (see definitions of good and bad health IT at http://cci.drexel.edu/faculty/ssilverstein/cases/), then we might actually get significant value and better safety from the technology.

Mr. Kocher, that's an idea to consider. 

As I wrote at that 2008 post on business v. clinical computing:

... The prevalent belief in MIS [management information systems a.k.a. business computing] seems to be that medicine is another area of transactional business subject to conventional modeling by generalists, to be followed by "business process re-engineering" and traditional information systems development processes and methodologies.

However, the belief that one could employ conventional business-oriented "analysis" in the clinical world always seemed to me to be oversimplistic, overoptimistic, and in fact not infrequently harmful to medical practice as a result of the simplistic assumptions. It is a belief that does not perform well even in the conventional business world where significant cost overruns, project difficulties, and project failures are commonplace, let alone in the unforgiving environments of medicine.

My fear is that many in business computing may lack the mental flexibility and capability to understand issues like that, that conflict directly with their linear-flow, business-oriented worldview.

In other words, Mr. Kocher wants doctors to practice according to the computer systems he helped impose, not the doctor's patients. We must never let his agenda for medical practice prevail. State legislatures must act now to restore patient privacy rights and use Tenth Amendment powers to undo the EHR mandate.

Exactly.  It's certainly the simple way to big profits, and injured and dead patients be damned.  Building good health IT is far more resource intensive.

Working to sustain an ethical patient-doctor relationship,

Twila Brase
President and Co-founder

Thank heaven someone is working towards those ends.

Notes:

[1]  Per Medical Informatics researchers Nemeth and Cook's "Hiding in plain sight: What Koppel et al. tell us about healthcare IT", Journal of Biomedical Informatics 38 (2005) 262–263 available at http://www.ctlab.org/documents/Hiding%20in%20plain%20sight.pdf) 

Drudge Report, Oct. 10, 2013, 9 AM EST: All that needs to be said about government, computing and healthcare

Per Drudge Report. Oct. 10, 2013, 9 AM EST:

From the same people who brought us HITECH, the stimulus bill for rapid rollout of commercial electronic medical records, order entry, results reporting and other components of enterprise clinical "command and control" software for hospitals through which every transaction of care must pass.

More IT malpractice.  The Drudge links, as they appear on the page:

Obamacare website cost more than FACEBOOK, TWITTER, LINKEDIN, INSTAGRAM...
'How can we tax people for not buying a product from a website that doesn't work?'
Major insurers, Dem allies repeatedly warned Obama admin...
REPORT: WH knew site might not be ready...
POLL: Just 1 in 10 report success...
DNC head says site designed for 50,000 max...
Once you get in, you can't get out...
Crazzzzzzzy code...
'It looks like nobody tested it'...
WASHPOST: Not code, but 'outdated, costly, buggy technology'...
CARNEY: 'I Don’t Know' If Obama Has Tried Website...
Hawaii forced to relaunch after zero sign-ups...

I won't comment any further; I don't think I need to.

Drudge Report, Oct. 10, 2013, 9 AM EST.  Click to enlarge.

Of course, the Anecdotalists [1] and Denialists [2] will probably say this is all a "glitch" and that things will be great in ver. 2.0.

Fools all.

Oh, and the cost, via Drudge, per the linked story.  A mere:

$634,320,919

-- SS

[1]  See "Health IT: On Anecdotalism and Totalitarianism" at  http://hcrenewal.blogspot.com/2010/09/health-it-on-anecdotalism-and.html)

[2]  See "The Denialists' Deck of Cards: An Illustrated Taxonomy of Rhetoric Used to Frustrate Consumer Protection Efforts" by Chris Jay Hoofnagle, available at http://papers.ssrn.com/sol3/papers.cfm?abstract_id=962462)

Oct. 10, 2013 addendum:

Also see "Analysis: IT experts question architecture of Obamacare website" at http://uk.reuters.com/article/2013/10/05/us-usa-healthcare-technology-analysis-idUKBRE99407T20131005.  If the allegations here are even partially true, every programmer and manager who ever worked on this system should be summarily fired and never permitted to touch another computer involved in healthcare - ever.

-- SS

EMR Defects That Injure and Kill, and Litigation: A Hospital Is Paying a Huge Hourly Rate for This?

At my Oct. 2011 post "A Diary of EHR-Initiated Tragedy" I wrote that:

... I've realized that these past posts, when integrated for an upcoming investigation, tell a story that is probably not uncommon in hospitals today. They form a sort of Diary of EHR-Initiated Tragedy.

Sadly, this Diary was my account of my own mother's EHR-related injuries.

There is a new chapter brewing.

In the latest objections to the Complaint against the hospital and its agents, the retained defense attorney proffered this argument:

(ii) Plaintiff's Software Design Defect Claims are Preempted by the Federal HITECH Act.

• To the extent Plaintiff attempts to bring a common law product liability claims against defendant hospital for required use of EMR software, such a claim is barred due to Federal Preemption of this area with the passage of the Health Information Technology for Economic and Clinical Health (HITECH) Act. 42 U.S.S. 201, 300 et seq.

• Specifically, the design, manufacture, specification, certification and sale of EMR in the United States is a highly regulated industry under the jurisdiction of the Department of Health and Human Services (HHS). The HHS draws its statutory authority to design and certify EMR as safe and effective under the HITECH act as amended. Id. [See note below - ed.]

• The Supremacy Clause of the United States Constitution, article VI, clause 2, preempts and state law that conflicts with the exercise of federal power. Fid. Fed. Sav. & Loan Ass'n v. de la Cuesta, 458 U.S. 141m 102 S. Ct. 3014 (1982). "Pre-emption may be either express or implied, and 'is compelled whether Congress' command is explicitly stated in the statute's language or implicitly contained in its structure and purpose." Matter of Cajun Elec. Power Co-Op., Inc., 109 F.3d 248, 254 (5th Cir. 1997) citing Jones v. Rath Packing Co., 430 U.S. 519, 525 (1977).

• In this case, to impose common law liability upon defendant hospital for using certified EHR technology, which was in compliance with federal law and regulations for Health Information Technology, would directly conflict with Congress' statutory scheme for fostering and promoting the implementation and use of EHR.

In other words, the HITECH Act gives hospitals free license to implement clinical information technology poorly with impunity, based on cases in banks, power companies and meat-packing plants, and HHS certification means HHS has found HIT is safe and effective.

[Note]: On "... The HHS draws its statutory authority to design and certify EMR as safe and effective under the HITECH act as amended." HHS does not design or certify EMRs. Is that assertion just made up out of thin air?

Regarding "to the extent Plaintiff attempts to bring a common law product liability claims against defendant hospital for required use of EMR software", that's just made up. There is no requirement for the use of EMR software.

On HIT "certification" implying safety and effectiveness, not exactly. "Certification" is entirely irrelevant. I had previously written here that:

"Certification" of health IT is not validation of safety, usability, efficacy, etc., but a pre-flight checklist of features, interoperability, security and the like. The certifiers admit this explicitly. See the CCHIT web pages for example. ("CCHIT Certified®, an independently developed certification that includes a rigorous inspection of an EHR’s integrated functionality, interoperability and security.")

Health IT "certification" is not like Underwriters Laboratories (UL) certification of appliances. ("Independent, not-for-profit product safety testing and certification organization ... With more than a 116-year proven track record, UL has been defining safety from the public adoption of electricity to new breakthroughs that help protect our future. UL employees are committed to safeguarding people, places and products in new and innovative ways for today’s borderless world.")

"Highly regulated industry?" I guess that's why the Institute of Medicine just completed a report that concluded that health IT safety is unacceptable, that regulation is lacking, and that the health IT industry best get its act together voluntarily, or FDA will have to step in:

... the push [by the Administration] is occurring so far without any agency really ‘watch dogging’ the safety of health IT — the software, hardware and systems that record and manage patients’ health information. These expensive devices by and large have not gone through any regulatory checks for safety in the way that food, drugs and other medical technology must; most of that oversight is handled by the FDA. But at the moment, no one is required to report instances of harm caused by health information devices and no government agency currently monitors their safety.... The current state of safety and health IT is not acceptable; specific actions are required to improve the safety of health IT. The first eight recommendations are intended to create conditions and incentives to encourage substantial industry-driven change without formal regulation. However, because the private sector to date has not taken sufficient action on its own, the committee believes a follow-up recommendation is needed to formally regulate health IT. If the actions recommended to the private and public sectors are not effective as determined by the Secretary of HHS, the Secretary should direct the FDA to exercise all authorities to regulate health IT.

As to the assertion that "to impose common law liability upon defendant hospital for using certified EHR technology, which was in compliance with federal law and regulations for Health Information Technology, would directly conflict with Congress' statutory scheme for fostering and promoting the implementation and use of EHR", let's repeat:
There are no federal laws and regulations for Health Information Technology.

The technology is unregulated. I could design an EMR tonight and put it up for sale tomorrow. It might not qualify for federal incentives if it were not "certified" by an ONC-Authorized Testing and Certification Body (ONC-ATCB), but if I could find a buyer willing to use it, there are no laws or regulations preventing that. From the ONC FAQ here:

... In order to qualify for Medicare and Medicaid EHR incentive payments, providers must use EHR technology that has been certified by an Office of the National Coordinator for Health Information Technology-Authorized Testing and Certification Body (ONC-ATCB, or ATCB). The temporary certification program provides assurances that the EHR technology adopted by health care providers is technically capable of supporting their efforts to achieve meaningful use.

As to imposition of such a common law liability "conflicting with a Congressional scheme for promoting EHR's", that is simply irrelevant.

I note the assertion is also defamatory towards Congress, implying Congress is fine with hospitals deploying health IT with reckless abandon, and should be permitted to do so with legal impunity for the sake of their "scheme."
There's also a claim made that the defendant hospital is not on the hook for EHR defects in their installed systems, because they "don't sell or manufacture the product."

They do, however, modify, customize, maintain, and test it for proper functioning in situ (the latter if they are acting responsibly, especially since the technology is experimental and not tested/approved by FDA, not even undergoing "fast track" 510(k) approval). It should also be noted that the latter 510(k) process does not confer freedom from user liability even when it is obtained.

Even to my non-legally-trained mind, I believe the duties that hospitals owe patients include these, especially with a non-FDA approved experimental technology known to cause risk, injury and death but at a magnitude that is not known:

• The duty to make a reasonable inspection of equipment it uses in the treatment of patients and remedy any defects discoverable by such inspection.

• The duty to provide equipment reasonably suited for the use intended.

Finally, as it turns out, the ED EHR in question was not "certified" when my mother became injured. It was not "certified" until many months later.

Additionally, the hospital in question made its buy decision and did its implementation several years before HITECH (enacted as part of the American Recovery and Reinvestment Act of 2009) was even a twinkle in the Administration's eye.

If I were paying handsomely for legal counsel such as outlined above, I'd cringe.

Sadly, while legal obstructionism continues (as I am finding is common regarding health IT-related litigation), more patients are being injured and killed.

-- SS

Senator Stephen H. Martin of Virginia: proposed limitations on use, storage, sharing, & processing of electronic medical record data

Here's a politician who certainly seems concerned with the privacy and confidentiality and flawed-analysis downsides of electronic health records -  Senator Stephen H. Martin of Virginia:

---

SB 1275 Medical data in an electronic or digital format; limitations on use, storage, sharing, & processing.

SUMMARY AS INTRODUCED:

Medical data. Prohibits any person that regularly stores medical data in an electronic or digital format from (i) participating in the establishment or implementation of the Nationwide Health Information Network; (ii) performing any analytic or statistical processing with regard to any medical records from multiple patients for purposes of medical diagnosis or treatment, including population health management; or (iii) processing medical data at a facility within the Commonwealth in any instance where a majority of the patients whose medical data is being processed do not reside in the Commonwealth. A database at which medical data is regularly stored in an electronic or digital format shall not store or maintain in a manner that is accessible by the operator or any other person, in an electronic or digital format, at any one time, medical data regarding more than 10,000 patients. 

Of note, the bill also counters the coercive aspects of the HITECH bill, stealthily sneaked into the Economic Recovery Act (ARRA) without so much as a peep of public comment, thanks to the Health IT lobby (as described by Robert O'Harrow Jr. in the WaPo in May 2009, see here):

The measure provides that any health care provider shall not be subject to any penalty, sanction, or other adverse action resulting from its failure or refusal to implement an online computerized medical record system. A patient's consent to the sharing of his health care information shall be presumed not to grant consent to the electronic or digital storing or transmission of the information to any person other than for health care coverage purposes. Finally, the measure prohibits the Commonwealth from authorizing the establishment or operation of a health information exchange.

The proposal seems authoritarian in terms of use of aggregated, de-identified medical data for public health purposes.  In the current environment, however, of health IT hyper-exuberance, misuse of medical data (e.g., putting it up for sale as at link, link) and repeated major security breaches, perhaps a return to sanity requires putting the brakes on - hard - and performing a 'system reset.'

It's clear the hyperenthusiasts will not like this proposed legislation.

-- SS

The HIT Scam

Worth a read -

The HIT Scam By Greg Scandlen

Notable in the piece are these observations:

 ... even the editors of the Washington Post have come to agree the whole [national health IT] project was a fiasco — but only after we wasted $27 billion of taxpayer money.

Yet, those who are enriching themselves on the $27 billion are just happy as clams over the program. John Hoyt, the Executive Vice President of the Healthcare Information and Management Systems Society (HIMSS) was quoted in a recent Health Change Bulletin as saying −

This data suggests that the HITECH portion of the 2009 stimulus law is achieving its intended result of encouraging increased implementation and meaningful use of electronic health records among hospitals. Facilities…are laying the groundwork for interoperability to occur. Stage 6 and Stage 7 hospitals are fully prepared for provider-to-provider or facility-to-facility interoperability, as well as increasing the provider or facility’s ability to provide electronic health data reporting to public health and immunization registries to support population health review and syndromic surveillance.

There, aren’t you greatly reassured? By the way, the New York Times piece cited above reported that –

RAND’s 2005 report was paid for by a group of companies, including General Electric and Cerner Corporation, that have profited by developing and selling electronic records systems to hospitals and physician practices. Cerner’s revenue has nearly tripled since the report was released, to a projected $3 billion in 2013, from $1 billion in 2005.

No doubt the companies that paid for the RAND study are also members of HIMSS. And General Electric certainly has what might be called a “special” relationship with President Obama.

I've been writing on similar issues for more than a decade.

It's well past the time when the same rigor that applies to pharma and medical devices be applied to the health IT sector.  And the marketing hype, along with bad health IT, abolished.

-- SS 

HITECH and Experimental Airplanes

This from a commenter, who has been deeply involved in major governmental health IT initiatives in another land, who wishes to remain anonymous:

The whole HITECH initiative really is getting like the equivalent of loading up a brand new airplane with paying travelers before debugging the software or even putting a model in the wind tunnel, and doing so without FAA approval.

If anyone attempted that in aviation, no one and I mean NO ONE would board the plane including the crew and Captain, so why is it OK in healthcare?  Is it just because the avoidable disasters are one body at a time in Health vs. 200-400 at once in air travel?

The answer to the last question?

Yes.

-- SS

House Ways And Means, and Energy and Commerce, Note EHRs Not What They Were Made Out To Be, Calls For HITECH Moratorium

I have called numerous times for a moratorium on ambitious national health IT programs.  See 2008 and 2009 posts here and here for example.  My calls are due to the prevalence of bad health IT (BHIT) in 2012, 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 in its present form 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".)

Congress is starting to catch on:

Letter from House Ways and Means, and Energy & Commerce, to Secretary Sebelius of HHS.  Click here to download.

The letter to HHS secretary Sebelius is from Congressmen Dave Camp (Chairman, Ways and Means), Wally Herger (Chariman, Ways and Means Subcommittee on Health), Fred Upton (Chairman, Energy and Commerce) and Joe Pitts (Chairman, Energy and Commerce Subcommittee on Health).

In the letter the following is noted:

Dear Secretary Sebelius:

We are writing to express serious concerns about the final Electronic Health Record (EHR) Stage 2 Meaningful Use rules recently issued by HHS and ONC.  We believe the Stage 2 rules are, in some respects, weaker than the proposed Stage 1 regulation released in 2009.  The results will be a less efficient system that squanders taxpayer dollars and does little, if anything, to improve outcomes for Medicare.

The letter then notes that the "Stage 2 rules ask less of providers and do less for program efficiency" and that the Stage 2 rules fail to achieve comprehensive interoperability in the face of
warnings that:

..".failure to set a date for certain interoperable standards would put as much as $35 billion in Medicare and taxpayer funds in the hands of providrrs who purchase and use EHR systems that are not interoperable."

They note the Stage 2 rules fail to achieve interoperability in a timely manner and that "more than four and a half years and two final MU rules later, it is safe to say that we are no closer to interoperability in spite of the nearly $10 billion spent."

A major reason for this, I believe, is regulatory capture by the IT industry as I outlined in my somewhat rhetorically-entitled posts "Health IT Vendor EPIC Caught Red-Handed: Ghostwriting And Using Customers as Stealth Lobbyists - Did ONC Ignore This?" and "Was EPIC successful in watering down the Meaningful Use Stage 2 Final Rule?"

The House letter also notes:

It is highly counterproductive for providers to have purchased EHR systems that "cannot talk with one another" and cannot perform basic functions because of the insufficient standards set by your agency.

One of the critical "basic functions" is the note search capability upon which the vendors used their influence during the "public comments" period to have written out of existence, as in the above posts.  The influence became apparent due to serious public comment editing mistakes by customers.  One wonders what other episodes of vendor influence did not make it into the public spotlight.

The house committee members also note:

Perhaps not surprisingly, your EHR inventive program appears to be doing more harm than good.  A recent analysis of Medicare data by the New York Times explains the costly consequences.

Unfortunately, the letter did not spotlight the excellent analysis done by the Center for Public Integrity and published before the NYT article ("Cracking the Codes" by Fred Schulte et al.)

Finally, the letter calls for HHS to:

... Immediately suspend the distribution of incentive payments until your agency promulgates universal interoperable standards.  Such a move would also require a commensurate delay of penalties for providers who choose not to integrate HIT into their practice"  and to "significantly increase what's expected of Meaningful Users."

It is unfortunate the letter seems to make the assumption that health IT in its present form, and the industry in its present state of anarchy, can produce good health IT (GHIT) that is safe and effective.  (As I've written, we need ease-of-use, reliability and safety - basic "operability" - before interoperability.)  Perhaps the congresspeople need to read my recent post "Honesty and Good Sense on Electronic Medical Records From Down Under".

Financial issues are one major concern, but patient harm and death due to the disruptive influences of BHIT are, in fact in many respects more important.

Finally, to those who would suggest a political angle to this letter (I note comments on sites such as on the Histalk blog that the authors are Republicans), I note that ONC was started in 2004 by George W. Bush, and that health IT has always had broad bi-partisan support.

Reality in healthcare is more often than not apolitical, and injured and dead patients really don't care much about ideology.

-- SS

At Risk in the Computerized Hospital: The HITECH Act as Social Policy Malpractice, and Passivity of Medical Professionals

I am revisiting the issue of HITECH in light of recent reports on health IT drawbacks and/or failure to achieve long-claimed advantages.

The HITECH Act, a multi-billion dollar EHR incentive/penalty measure inserted into the 2009 American Recovery and Reinvestment Act legislation (ARRA or 'economic recovery' act), is proving to be an example of what should be called "Social Policy Malpractice."

The HITECH Act was largely a consequence of intense industry lobbying on behalf of the IT industry (as in the Washington Post at "The Machinery Behind Health-Care Reform: How an Industry Lobby Scored a Swift, Unexpected Victory by Channeling Billions to Electronic Records", May 16, 2009).

It is in fact not based on science or reliable evidence, and has led to increased patient endangerment and a worsening national debt picture.

The recent revelations of reports from diverse sources including but not by any means limited to the following indicate that HITECH and its expenditures of billions of dollars on experimental, unregulated, unproven technology represents social policy malpractice:
 

• ABC News (Your Medical Records May Not Be Private: ABC News Investigation" - privacy of electronic health data is very poor, in ways that paper would and could never have permitted);

• The Center for Public Integrity "Growth of electronic medical records eases path to inflated bills", on how EHRs lead to increased, not decreased healthcare costs;

• Experts at Penn and Harvard -"A Major Glitch for Digitized Health-Care Records" - savings from EHRs are illusory;

• Budget reports - in view of the deficit spending reported by OMB and others that is causing national debt to spiral out of control, jeopardizing the economic well being of the United States, and with upcoding as a side-effect and no cost savings, HITECH is an unaffordable extravagance. 

• Recent revelations of outright EHR-induced mass chaos largely due to outspoken clinicians who've had enough - "Contra Costa County health doctors air complaints about county's new $45 million computer system", "Lake County (IL) Health Department - Depression era soup lines at the clinic";

• Abuses of NPRM Public Comment periods on followup health IT incentive regulations via industry ghostwriting (stealth lobbying), reducing EHR effectiveness while further enriching the industry - "Health IT Vendor EPIC Caught Red-Handed: Ghostwriting And Using Customers as Stealth Lobbyists - Did ONC Ignore This?";

Of course, I'd already cited these reports in past posts but they bear repeating:

• The IOM report on HIT safety ("There's risk, but we don't even know the magnitude because there are major systemic impediments to diffusion of that information"), http://hcrenewal.blogspot.com/2011/11/iom-report-on-health-it-safety-nix-fda.html;

• FDA (known injuries and deaths are likely the "tip of the iceberg" because of the impediments, and EHRs are medical devices that should fall under the FD&C Act, but FDA has largely refrained from enforcing our regulatory requirements with respect to HIT devices because they're a political hot potato - Jeff Shuren MD JD, CDRH), http://hcrenewal.blogspot.com/2011/04/fda-decides-regulating-implantable.html;

• NIST (health IT usability is poor, major remediation is needed) - http://hcrenewal.blogspot.com/2011/10/nist-on-ehr-mission-hostile-user.html

I'd called for a moratorium on ambitious EHR plans for similar reasons as far back as 2008, at posts here and here.

 

The path that ethical medical centers and clinicians should take is to delay computerization in 2012 and push for slowdown or retraction of HITECH and its penalties for non-adopters. 

Yet instead, what is usually seen is excuses and cheerleading by healthcare organization leaders, and passive physician and nurse acceptance of deficient information technology.  

This stunning passivity and acceptance by physicians and nurses of a deeply flawed technology of unknown risk seems largely due to physician learned helplessness and the Stockholm Syndrome.  See the posts on "physician learned helplessness" at http://hcrenewal.blogspot.com/2007/10/physicians-learned-helplessness.html (commenting on observations in MedScape written by a lawyer), as well as on the "Stckholm Syndrome"  at http://en.wikipedia.org/wiki/Stockholm_syndrome. 

Per a psychiatrist/informatics specialist Dr. Scott Monteith who has commented on this blog, the compliance of clinicians may also be a manifestation of the inherent human psychopathology reflected in the Milgram Experiment (and elsewhere):

The Milgram experiment on obedience to authority figures was a series of notable social psychology experiments conducted by Yale University psychologist Stanley Milgram, which measured the willingness of study participants to obey an authority figure who instructed them to perform acts that conflicted with their personal conscience. Milgram first described his research in 1963 in an article published in the Journal of Abnormal and Social Psychology, and later discussed his findings in greater depth in his 1974 book, Obedience to Authority: An Experimental View.

As to the consequences of physician "acceptance" of this technology in 2012 in its present condition, physicians are:

• Acting, in effect, 'in loco parentis' for their patients, not in the latter's best interests, who are not even afforded opportunity for informed consent.  This is in violation of long-accepted norms of human subjects experimentation and research such as the Belmont Report, Nuremberg Code and HHS human subject protection regulations at 45 CFR part 46 themselves;

• Giving free provision of their expertise and labor at improvisation and workarounds, in effect providing free alpha and beta testing to an entirely unregulated IT sector;

• Engaging in passive acceptance of the entire liability and their hospital executives' breach of fiduciary responsibility to protect them from same due to Hold Harmless clauses, and breach of Joint Commission safety standards through signing "gag" clauses on defects and harms (see http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=koppel_kreda).

National health IT leaders have proven to be hyperenthusiasts about health IT benefits as well:

... This from Robert Kolodner, former head of the Office of the National Coordinator for Health IT (ONC) at HHS:

Dr. Robert Kolodner, a physician who headed the federal push for electronic medical records in 2007, acknowledged that billing abuse took a backseat to steps likely to entice the medical community to embrace the new technology.

Kolodner said officials were certain the savings achieved by computerizing medicine would be so great that billing abuse, “while needing to be monitored, was not something that should be put as the primary issue at that time.”

In other words, sideline (ignore) health IT-based billing abuse (and safety risks to the live patients subjected to this experimental technology without informed consent) because "we believe" the savings will be greater based on "our faith in the technology."

 

Such individuals contributed materially to the social policy malpractice represented by the HITECH ACT.

Considering all of the above, I call once again for a moratorium on further economic incentives for EHR adoption, and investment in the very measures recommended by the National Research Council in its Jan. 2009 report "Computational Technology for Effective Health Care: Immediate Steps and Strategic Directions" that:

In the long term, success will depend upon accelerating interdisciplinary research in biomedical informatics, computer science, social science, and health care engineering.

This research must be conducted, of course, with full human subjects protections in place.

-- SS

Malpractice Attorney Puts ONC-Authorized Testing and Certification Bodies (ATCBs) at Risk of Litigation?

I am jet-lagged after returning from Sydney, Australia, where I delivered one of the keynote addresses at the Health Informatics Society of Australia annual conference, HIC 2012 (http://www.hisa.org.au/page/hic2012/).

My theme in a talk entitled "Critical Thinking on Building Trusted, Transformative Medical Information:  Improving Health IT as the First Step" was health IT trust and safety.  I was actually invited in 2011 but could not attend; I was helping care for my mother, who was severely injured due to a HIT-related mishap in 2010.  Her death in 2011 allowed me to attend now on re-invitation.

More on my presentation later.

A beautiful view of the Sydney Harbour Bridge and Opera House, taken with a mere Canon SX110IS.  Click to enlarge.

In the meantime, I returned to the U.S. to find that the defense attorney for the hospital where my mother was severely injured, and then died as a result, is once again raising an absurd issue in objections to the medical malpractice Complaint that was refiled within the Statute of Limitations for technical reasons.   The President Judge of the county where the case is filed had dismissed this complaint (among many others) some time ago:

(ii) Plaintiffs Software Design Defect Claims are Preempted by the Federal HITECH Act

... To the extent Plaintiff attempts to bring a common law product liability claim against [name redacted] Hospital for required use of EMR software, such a claim is barred due to Federal Preemption of this area with the passage of the Health Information Technology for Economic and Clinical Health (HITECH) Act. 42 U.S.C. 201, 300, et seq.

Specifically, the design, manufacture, specification, certification and sale of EMR in the United States is a highly regulated industry under the jurisdiction of the Department of Health and Human Services (HHS). The HHS draws its statutory authority to design and certify EMR as safe and effective under the HITECH act as amended. Id.

The Supremacy Clause of the United States Constitution, article VI, clause 2, preempts any state law that conflicts with the exercise of federal power. Fid. Fed. Say. & Loan Ass’n v. de la Cuesta, 458 U.S. 141, 102 S. Ct. 3014 (1982). “Pre-emption may be either express or implied, and ‘is compelled whether Congress’ command is explicitly stated in the statute’s language or implicitly contained in its structure and purpose.” Matter of Calun Elec. Power Co-op., Inc., 109 F.3d 248, 254 (5th Cir. 1997) citing Jones v. Rath Packing Co., 430 U.s. 519, 525 (1977).

In this case, to impose common law liability upon [name redacted] Hospital for using certified EHR technology, which was in compliance with federal law and regulations for Health Information Technology, would directly conflict with Congress’ statutory scheme for fostering and promoting the implementation and use of EHR 

I really don't think Congress intended HIT to maim and kill patients with impunity.  In any case, this assertion was thrown out in its entirety several months ago, but here it is again in a new set of objections.  I find its reappearance remarkable.  I also wonder if the industry is behind it.

As per numerous posts in this blog, such assertions are false - and likely knowingly so in this situation.  (In that case, this would be an even more serious matter.)

For example as I pointed out at my Feb. 2012 post Hospitals and Doctors Use Health IT at Their Own Risk - Even if "Certified", ONC-Authorized Testing and Certification Bodies (ATCB's) answered my questions about safety, legal indemnification etc.  Their work has nothing to do with certifying HIT as safe by their own admission.

Also, as in my April 2011 post FDA Decides Regulating Implantable Defibrillator Medical Devices a "Political Hot Potato"; Demurs and my Nov. 2011 post IOM Report - "Health IT and Patient Safety: Building Safer Systems for Better Care, the HIT industry is unregulated.

On the HIT regulation issue, IOM has itself stated in no uncertain terms that HIT is non-regulated (not "a highly regulated industry") in their report to HHS.  For instance, in the aforementioned 2012 report they state (as one example):

... If the Secretary [of HHS] deems it necessary for the FDA to regulate EHRs and other currently nonregulated health IT products, clear determinations will need to be made about whether all health IT products classify as medical devices for the purposes of regulation. If FDA regulation is deemed necessary, the FDA will need to commit sufficient resources and add capacity and expertise to be effective.

I won't even address the claim that the HITECH Act represents or intended to represent Federal pre-emption of state common law rights.   It's without merit, and actually absurd.

Worst of all, statements in legal dockets that "HHS draws its statutory authority to design and certify EMR as safe and effective under the HITECH Act" (in reality, private non-governmental ONC-Authorized Testing and Certification Bodies or ATCB's are appointed by ONC to "certify" HIT features and functionality to be compliant with "Meaningful Use" guidelines and do not test for safety or efficacy) potentially puts those private ATCB's at risk for being named defendants in lawsuits where HIT was found unsafe and/or ineffective if upheld.

I am sure the ATCB's and ONC would not be happy about that.

-- SS

Debt Ceiling deal could endanger health care law - and it would be beneficial if health IT/HITECH were part of the trimmings

A story about the recent political deal to raise the Debt Ceiling entitled "Deal could endanger health care law" appeared in the Politico (hat tip Drudge Report):

Deal could endanger health care law

By JENNIFER HABERKORN | 8/3/11 11:28 PM EDT

Politico.com

The debt ceiling agreement could jeopardize millions of dollars, and perhaps billions, in initiatives from President Barack Obama’s health care reform law if the super committee can’t come up with required spending cuts.

Many of the pots of money in the law — one of the Democrats’ most prized pieces of legislation — could get trimmed by the debt deal’s sequestration, or triggered cuts. The funds for prevention programs and community health centers, grants to help states set up insurance exchanges and co-ops, and money to help states review insurance rates could be slashed across the board if the panel can’t find enough cuts this fall.

My suggestion:

Put health IT and the HITECH Act (the health IT component that 'somehow' found its way into the fantastically-successful American Recovery and Reinvestment Act of 2009) on the table.

Health IT devices are medical devices that are dangerous, unregulated and unproven (e.g., see 'Reading List' here) in their current state of development and lawless environment.

Cutting HIT funding probably would be beneficial in avoiding waste as well.

Note what just occurred in the UK:

UK NHS pulls the plug on its £11bn IT system

-- SS

Medicare/Medicaid Cuts? Spend Money on Patients - Not Computer Experiments

There has recently been much debate about how to save this country from European-style financial ruin. From "GOP 2012 budget proposal cuts taxes on rich, cuts Medicare in the future", Examiner.com, April 3, 2011:

On Tuesday House Budget Committee Chairman Paul Ryan (R-WI) is expected to release the Republicans’ 2012 budget proposal. Currently Democratic and Republican leaders are trying to negotiate a compromise on the 2011 budget would make some cuts to discretionary spending. Republicans have said they would not be able to propose really significant cuts to lower the deficit until 2012. According to reports, the GOP proposal would dramatically cut taxes on corporations and the rich, while also making significant cuts to Medicare and Medicaid.

I propose the cuts to Medicare and Medicaid, which will directly affect medical care delivery to the elderly and poor, be traded for cutting extravagant expenditures for experimental medical computer technology. This could be accomplished through repeal of HITECH and diversion of those funds to patient care, where it's more urgently needed.

Let scarce taxpayer dollars be spent on the health of human beings, not on machines of uncertain value and risk at their current state of evolution in 2011.

At my Jan. 2011 post "US House of Representatives Proposes to Defund Largest Non-Consented Medical Experiment in U.S. History: HITECH" I had written about H.R.408, the Spending Reduction Act of 2011 Introduced in the House of Representatives:

In a new bill in the House of Representatives, the ‘‘Spending Reduction Act of 2011’’ (link - PDF), it is proposed to cut unobligated funds of, among others, division A of the "American Recovery and Reinvestment Act of 2009":

... Spending Reduction Act of 2011

DIVISION A—APPROPRIATIONS PROVISIONS

... TITLE XIII—HEALTH INFORMATION TECHNOLOGY

Title XIII of the ARRA along with title IV of division B is better known as HITECH:

SEC. 13001. SHORT TITLE; TABLE OF CONTENTS OF TITLE.

(a) SHORT TITLE.—This title (and title IV of division B) may be cited as the ‘‘Health Information Technology for Economic and Clinical Health Act’’ or the ‘‘HITECH Act’’.

I commented that it looked like HITECH was one of a number of spending extravaganzas on the proposed chopping block.

Health IT under the country's current financial condition is indeed an extravagance, especially considering the experimental nature of the technology and the doubts expressed by experts as to its true value in its current state of development (see "An Updated Reading List on Health IT" at my Drexel Univ. Healthcare IT failures site).

This recent revelation should also be considered:

The quality of the technology is likely far, far worse than anyone, including the pessimists, imagined. The HIT problem reports in FDA's MAUDE database (link) are child's play compared to the following.

The unprecedented, recent, detailed analysis of a major American electronic health record system for use in Emergency Departments (of all places) by an Australian health IT expert at the following links is simply astonishing, if not downright frightening. See:

• Analysis of Cerner Problems Defined by ED Directors, http://sydney.edu.au/engineering/it/~hitru/index.php?option=com_content&task=view&id=120&Itemid=116

• A study of an Enterprise Health information System, http://sydney.edu.au/engineering/it/~hitru/index.php?option=com_content&task=view&id=91&Itemid=146

If even a fraction of this analysis is correct, we should simply take those billions of dollars and turn them into cigar wrappers.

Or perhaps coffins.

I will also repeat some of my rationale in my Jan. 2011 post for repeal of HITECH:

• This country cannot afford HITECH at this time. Put simply, we are broke, and the national deficit is ballooning far out of control. The money would be far better spent at this time on care of those who cannot afford that care.
  

• HITECH appeared as if out of nowhere, with little to no input time from stakeholders. This suggests lobbying by those with conflicts of interest to push this bill onto the public, affecting their medical care without informed consent (see my March 2009 post "Draft Patient Rights Statement and Informed Consent on Use of HIT"). The bill includes persuasion along with economic coercion for non-adopting organizations and physicians. ("Adoption" = adherence to government-set standards of "meaningful use" of poorly usable technology.) I disapprove of the stealth process by which HITECH appeared. This is the U.S., not the old USSR.

• Mass social experiments involving major systemic changes to our healthcare delivery system, with exceptional claims being made about IT, need to be backed by exceptional evidence. That evidence is lacking. In fact, the evidence might actually point in the negative direction. See my aforementioned post "An Updated Reading List on Health IT."
  

• The technology is not ready. It is dangerous in unqualified hands, which most every medical center and physician office is in 2011 (i.e., an IT backwater). The field of health IT was somehow transformed from an experimental field into the 'savior of medicine' without the proof of value and safety that would ordinarily be required to move an experimental technology from lab to national rollout. Per the Washington Post, this process appears to have been a highly politicized one, favoring the corporate elites. The Washington Post’s 2009 article on the influential HIT vendor lobby “The Machinery Behind Healthcare Reform” is at this link.

To these I will add a few more reasons to convert HITECH extravagance in time of financial distress and high unemployment to direct care provision:

• A similar experiment in the much smaller and strongly government-managed healthcare system of the UK didn't exactly have stellar results (link, link). We also have been warned not to make the same multi-billion dollar errors (link).
  

• The cavalier attitudes by the administration-appointed ONC director Blumenthal towards evidence of health IT-caused adverse effects, including deaths, reported to him by the FDA (see this Feb. 23, 2010 Internal FDA Memorandum on Health IT Safety Issues, PDF).
  

Despite the fact that the Director of FDA's Center for Device and Radiological Health Jeffrey Shuren (a physician and lawyer) testified these reports were likely just the "tip of the iceberg", ONC director Blumenthal glibly stated, per the Aug. 2010 Huffington Post Investigative Fund article FDA, Obama Digital Medical Records Team at Odds over Safety Oversight, that FDA's reports of health IT related injuries and deaths were “anecdotal":

ONC director Blumenthal, the point man for the administration, has called the FDA’s injury findings “anecdotal and fragmentary.” He told the Investigative Fund that he believed nothing in the report indicated a need for regulation.

These exact cavalier attitudes about "anecdotes" just failed in the Supreme Court. (See my Mar. 27, 2011 post about the Zicam decision in "Those Who Dismiss Healthcare (and Healthcare IT) Adverse Events Reports as Mere "Anecdotes" Have Lost - Supreme Court-Style").

More reasons for diverting HITECH funds to patient care include government waste driven by irrational exuberance and idealism:

• The irrational exuberance and idealism about this technology purportedly saving money, a dreamer's dream explicitly refuted, for example, by notable figures at Wharton (link) and Stanford (link). (Also see "Pessimism, Computer Failure, and Information Systems Development in the Public Sector", Shaun Goldfinch, Public Administration Review 67;5:917-929, Sept/Oct. 2007).

• More on purported cost savings - Peter Orszag, former head of the Congressional Budget Office, said the use of electronic health records, without a major change in health care delivery, "would not significantly reduce overall health care costs" in the agency's 2007 report on long-term health care spending. He also said that according to data from the report, the return on investment for EHR's "is not going to be as substantial as people think." The CBO concluded that predictions of cost savings from EHR's relied on "overly optimistic" assumptions and said much is unknown about the potential impact of health information technology. [That is, it is an experimental technology - ed.] Mass savings from health IT is an assertion that is both unproven and highly unlikely in my view.

• Yet another irrationally exuberant dream about the use of the massive amounts of uncontrolled clinical data, entered by myriad observers in an infinite variety of situations into these systems, to be used for research. This is the antithesis of sound methods for data collection and management in medical research. It is a dreamer's concept of the "Randomized Controlled Clinical Trial Made Easy." (See my essay "The Syndrome of Inappropriate Overconfidence in Computing: An Invasion of Medicine by the Information Technology Industry." Also see "Have we suffered a complete breakdown in the scientific method with regard to EHR and clinical IT?".)

Finally, here's another reason to withdraw HITECH for now:

• As I'd written in a series of essays at this blog query link, we simply don't know how to make computerized medical information reasonably private and secure. (One might wonder whether the current administration, sponsors of the out-of-the-blue HITECH act, actually wants healthcare information to be private and secure.)
  

I reiterate from my January 2011 post:

I would not weep for the HITECH act's passing. It would allow the restoration of health IT back to an unrushed and careful experiment.

It would also give time to work out the significant issues causing health IT difficulty (such as raised in 2009 by our National Research Council) before we embark on national health IT diffusion.

In other words, its passing would reduce risk and help restore an essential level of sanity and due diligence to the healthcare IT sector, now afflicted by irrational exuberance bordering on delirium.

We would avoid the largest unconsented medical experiment in US history, which as I have repeatedly written I feel would be disastrous with current levels of understanding of this technology and how to design, deploy and manage it. (My relative's 2010 HIT-related injuries only strengthened my convictions in this regard.)

Disclosure: I have no financial conflicts of interest regarding HITECH or health IT to weep about. Others do, and it's not hard to predict their financial interests will push them to oppose HITECH repeal "by any means necessary."

A replacement HITECH act that's "HIGH" on research and caution, but not so high on stealth, coercion and idealistic euphoria would be welcomed.

-- SS