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

WSJ, Koppel and Soumerai: A Major Glitch for Digitized Health-Care Records - Cost Savings Illusory

Two EHR experts from Ivy-league institutions (which are typically hyperenthusiast-oriented) doubt cost savings from EHR technology.

Wall Street Journal
Opinion
September 17, 2012

A Major Glitch for Digitized Health-Care Records

Savings promised by the government and vendors of information technology are little more than hype.

By STEPHEN SOUMERAI And ROSS KOPPEL

In two years, hundreds of thousands of American physicians and thousands of hospitals that fail to buy and install costly health-care information technologies—such as digital records for prescriptions and patient histories—will face penalties through reduced Medicare and Medicaid payments. At the same time, the government expects to pay out tens of billions of dollars in subsidies and incentives to providers who install these technology programs.

Which, of course, means printing more money for luxuries we cannot afford in the midst of the worst economic downturn since 1929...

The mandate, part of the 2009 stimulus legislation [I think it would be more accurate to say "sneaked into the 2009 stimulus legislation for IT industry benefit" - ed.], was a major goal of health-care information technology lobbyists and their allies in Congress and the White House. The lobbyists promised that these technologies would make medical administration more efficient and lower medical costs by up to $100 billion annually. 

By up to $100 billion annually?   (Perhaps these lobbyists need lie detector tests - and/or drug tests to see what they may have been smoking?)  I note the lobbying was covered in the Washington Post in "The Machinery Behind Health-Care Reform: How an Industry Lobby Scored a Swift, Unexpected Victory by Channeling Billions to Electronic Records" by Robert O'Harrow Jr., May 16, 2009.

Many doctors and health-care administrators are wary of such claims—a wariness based on their own experience. An extensive new study indicates that the caution is justified: The savings turn out to be chimerical.

Some still have empirical observational skills and common sense, fortunately.  In my early days of health IT involvement two decades ago as an NIH-sponsored Medical Informatics post doctoral fellow, I believed there was some cost savings possible, but certainly not in the tens or hundreds of billions per year.  The technology was not solving problems that could lead to such savings (see for instance my Dec. 2010 post "Is Healthcare IT a Solution to the Wrong Problem?").  My experiences since my fellowship have only confirmed my own early opinions.

Since 2009, almost a third of health providers, a group that ranges from small private practices to huge hospitals—have installed at least some "health IT" technology. It wasn't cheap. For a major hospital, a full suite of technology products can cost $150 million to $200 million. Implementation—linking and integrating systems, training, data entry and the like—can raise the total bill to $1 billion.

That's countless billions that could have been spent on actual healthcare delivery itself, especially for underserved populations and the poor.  Instead, that money was funnelled to the IT industry for an experimental, unregulated, unvetted technology to be applied on live patients (and without patient consent, I add).

But the software—sold by hundreds of health IT firms—is generally clunky, frustrating, user-unfriendly and inefficient. For instance, a doctor looking for a patient's current medications might have to click and scroll through many different screens to find that essential information. Depending on where and when information on a patient's prescriptions were entered, the complete list of medications may only be found across five different screens.

Examples of that from actual systems (sketched to avoid IP problems) is at my ten part series on mission-hostile health IT at this blog, shortened link http://www.tinyurl.com/hostileuserexper.

Now, a comprehensive evaluation of the scientific literature has confirmed what many researchers suspected: The savings claimed by government agencies and vendors of health IT are little more than hype.

To conduct the study, faculty at McMaster University in Hamilton, Ontario, and its programs for assessment of technology in health—and other research centers, including in the U.S.—sifted through almost 36,000 studies of health IT. The studies included information about highly valued computerized alerts—when drugs are prescribed, for instance—to prevent drug interactions and dosage errors. From among those studies the researchers identified 31 that specifically examined the outcomes in light of the technology's cost-savings claims.

With a few isolated exceptions, the preponderance of evidence shows that the systems had not improved health or saved money.

One must understand this in the context of what these systems really are, what they do, and the problems they can actually address as in my post on 'solution to the wrong problem' mentioned supra.

The authors of "The Economics of Health Information Technology in Medication Management: A Systematic Review of Economic Evaluations" found no evidence from four to five decades of studies that health IT reduces overall health costs. Three studies examined in that McMaster review incorporated the gold standard of evidence: large randomized, controlled trials. They provide the best measure of the effects of health IT systems on total medical costs.

I point out that randomized controlled trials (RCT's) are notably rare in health IT studies.  Most "confirmatory" studies on health IT benefits are less powerful retrospective/observational studies in specialized settings, with many biases, poor science, etc.  In that sense, such studies can be considered non-generalizable and anecdotal at best (more on the "anecdotes" issue is below).

Of course, the pundits and Ddulites ("Luddite" with first four letters reversed; meaning ardent hyperenthusiasts) will likely say "it will all be fixed in version 2.0" despite decades of opportunity to get health IT "right" and demonstrate generalized improved outcomes and cost savings:

... At "Health IT: Ddulites and Irrational Exuberance" and related posts (query link) I've described the phenomenon of the: 'Hyper-enthusiastic technophile who either deliberately ignores or is blinded to technology's downsides, ethical issues, and repeated local and mass failures.'

From Regenstrief Institute, one of the premier and pioneering centers for Medical Informatics research and teaching:

A study from Regenstrief, a leading health IT research center associated with the Indiana University School of Medicine, found that there were no savings, and another from the same center found a significant increase in costs of $2,200 per doctor per year. The third study measured a small and statistically questionable savings of $22 per patient each year.

That's probably not taking into account increased medical malpractice costs as exemplified here and here and by other settlements I know of but cannot mention due to my consulting role in those cases.

A primer on health IT risks, containing a number of key articles and links, is downloadable at http://www.ischool.drexel.edu/faculty/ssilverstein/HIT_issues_Primer.zip. 

In short, the most rigorous studies to date contradict the widely broadcast claims that the national investment in health IT—some $1 trillion will be spent, by our estimate—will pay off in reducing medical costs. Those studies that do claim savings rarely include the full cost of installation, training and maintenance—a large chunk of that trillion dollars—for the nation's nearly 6,000 hospitals and more than 600,000 physicians.

$1 trillion would pay for a tremendous amount of actual healthcare delivery, I note.

These system lifecycle costs, known as "total cost of ownership", are due to upgrades and necessary changes as medicine itself, including the science, business and legal components change over time.   The costs are generally underestimated ahead of time.  A good source on these issues is the article "Pessimism, Computer Failure, and Information Systems Development in the Public Sector"  (Public Administration Review 67;5:917-929, Sept/Oct. 2007).  This is a cautionary article on IT that recommends much more critical attitudes towards major IT initiatives in all sectors. 

But by the time these health-care providers find out that the promised cost savings are an illusion, it will be too late. Having spent hundreds of millions on the technology, they won't be able to afford to throw it out like a defective toaster.

There, I disagree.  We may have to "throw it out" as the disruptions to good medical care by bad health IT (BHIT) increase, unless the industry reforms itself very rapidly.  As I state in the introduction to my teaching website "Contemporary Issues in Medical Informatics: Good IT, Bad IT, and Common Examples of Healthcare Information Technology Difficulties" (started in late 1998 due, in fact, to my observations of inappropriate leadership and poor quality of health IT):

The site takes a view consistent with medicine’s core values and with patients’ rights that health IT, as a medical apparatus that increasingly forms an enterprise clinical resource management and clinician workflow control mechanism, remains experimental and should be subject to the same ethical considerations, validation processes and regulatory oversight to which almost all other medical technologies and pharmaceuticals are subjected. The site is pro-health IT, but only when the health IT is “good IT” - as opposed to “bad IT."

Good Health IT ("GHIT") is defined as IT that provides a good user experience, enhances cognitive function, puts essential information as effortlessly as possible into the physician’s hands, keeps eHealth information secure, protects patient privacy and facilitates better practice of medicine and better outcomes.

Bad Health IT ("BHIT") is defined as IT that is ill-suited to purpose, hard to use, unreliable, loses data or provides incorrect data, causes cognitive overload, slows rather than facilitates users, lacks appropriate alerts, creates the need for hypervigilance (i.e., towards avoiding IT-related mishaps) that increases stress, is lacking in security, compromises patient privacy or otherwise demonstrates suboptimal design and/or implementation.

This site challenges medically and ethically controversial views that health IT merits special accommodations in terms of freedom from scientific rigor and evidence-based practices, freedom from regulation, and freedom from accountability. 

I  hold little hope of these issues being seriously addressed - let alone solved - any time in the near future due to:

1)  the irrational exuberance about this technology, cf: Twitter feeds on hashtags #EHR, #EMR, #HCIT and similar;
2)  the industry-promoted myths and fabrications over decades;
3)  the FDA-admitted impediments to information diffusion about defects and harms (link);
4)  IOM-admitted impediments to same (link);and
5)  the latter's industry-favoring, Milquetoast 2012 recommendations on monitoring, remediation and regulation.

These are indicative of an industry that has neatly avoided any meaningful regulation and is, in plain terms, out of control.

Why are we pushing ahead to digitize even more of the health-care system, when the technology record so far is so disappointing? So strong is the belief in health IT that skeptics and their science are not always welcome. Studies published several years ago in the Journal of the American Medical Association and the Annals of Internal Medicine reported that health IT systems evaluated by their own developers were far more likely to be judged "successful" than those assessed by independent evaluators.

"Not welcome" is an understatement. 

ONC itself is guilty of bad science, as in its grossly deficient March 2011 Health Affairs paper on health IT benefits. (See my Oct. 2011 post "ONC: The Benefits Of Health Information Technology: A Review Of The Recent Literature Shows Predominantly Positive Results".  Also see my Aug. 2012 post "ONC and Misdirection Regarding Mass Healthcare IT Failure".)

So bad is the "Health IT critique not welcome" phenomemon that, for example, Medical Informatics leaders such as Bill Hersh of Oregon Health Sciences University (OHSU) openly attack those who are candid on health IT risks (and make fools of themselves via the open attacks), such as the attack I wrote of at my Sept. 2010 post "The Dangers of Critical Thinking in A Politicized, Irrational Culture".

Also common in the "Health IT Critique Not Welcome Here" club, and probably deliberately so, is mistaking risk management activities for research observations and calling the former, even when reported by credible witnesses, "anecdotal" while calling at-best weak HIT-positive studies "definitive science."  See "From a Senior Clinician Down Under: Anecdotes and Medicine, We are Actually Talking About Two Different Things" for the definitive rebuttal of that type of patient-endangering intellectual blindness or dishonesty.

Government agencies like the Office of the National Coordinator of Healthcare Information Technology (an agency of the Department of Health and Human Services) serve as health IT industry boosters. ONC routinely touts stories of the technology's alleged benefits.

But almost never the opposite, which is equally if not more important.  Further, they tout "certification" as a means of HIT safety evaluation and assurance, or do not deny that misconception, despite statements by the very certification bodies or ATCB's they appoint to the contrary.  Yet they need to come clean on this. (I've seen the claim of 'certification equals safety' in actual legal briefs in defense of health IT.)  See my Feb. 2012 post "Hospitals and Doctors Use Health IT at Their Own Risk - Even if Certified."

ONC also seems to turn a blind eye to industry-ghostwriting abuses in the public comments period of Notices of Proposed Rulemaking for "meaningful use" (itself an Orwellian term) rules.  See for instance my Sept. 2012 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?"

We fully share the hope that health IT will achieve the promised cost and quality benefits. As applied researchers and evaluators, we actively work to realize both goals. But this will require an accurate appraisal of the technology's successes and failures, not a mixture of cheerleading and financial pressure by government agencies based on unsubstantiated promises.

I share the same sentiments.  As I've often written, the Achilles heel of the health IT sector is its ignoring the very science and evidence-based approaches of the field - medicine - that health IT is supposed to somehow "revolutionize" and "transform."

It is, quite frankly, the utmost in hypocrisy for an industry that demands evidence-based medicine - and touts its expensive products as leading to that change - to itself not practice what I've called "evidence-based computing."

Mr (sic) Soumerai is professor of population medicine at Harvard Medical School and Harvard Pilgrim Health Care Institute. Mr. Koppel is a professor of sociology and medicine at the University of Pennsylvania and principal investigator of its Study of Hospital Workplace Culture.

Dr. Soumerai also co-authored "Don't Repeat the UK's Electronic Health Records Failure" with Anthony Avery, Professor of Primary Care at the University of Nottingham Medical School, UK, Huffington Post, Dec. 5, 2010.

I also expect to hear an "Ivy tower academics - what do they know?" refrain from the industry.  However, this will not hold water, as the Ivory tower inhabitants, as I previously stated, are almost uniformly of the Ddulite-hyperenthusist persuasion and touted when they speak or write in uncritical favor of health IT.

-- SS

Addendum:

Penn Wharton professors had a similar opinion on cost-savings in 2009:

Information Technology: Not a Cure for the High Cost of Health Care: Knowledge@Wharton, Wharton School of Business, University of Pennsylvania, June 10, 2009. (PDF version available at this link)

As I observed in my June 20, 2009 post "Improving Patient Safety In The EU: HIT Should Be Classified As Medical Devices. And, Can We Drop the "Massive Cost Savings" Fable?", in a WSJ article that same day entitled "The Myth of Prevention", Abraham Verghese, Professor and Senior Associate Chair for the Theory and Practice of Medicine at Stanford echoed the Wharton professors' doubts about the cost savings and ultimate value of electronic medical records:

... I have similar problems with the way President Obama hopes to pay for the huge and costly health reform package he has in mind that will cover all Americans; he is counting on the “savings” that will come as a result of investing in preventive care and investing in the electronic medical record among other things. It’s a dangerous and probably an incorrect projection.

I also had related observations published in a Letter to the Editor in the WSJ in February of that year:

Digitizing Medical Records May Help, but It's Complex, Feb. 18, 2009

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

Next time you hear from some pundit about enormous "cost savings" from clinical IT, remember this post.

Let's implement health IT - and do it well, i.e., good health IT (GHIT) instead of bad health IT (BHIT)- to facilitate clinicians, not to work financial miracles or "revolutionize" anything.

A slide from my Aug. 1, 2012 presentation to the Health Informatics Society of Australia at HIC2012.  Click to enlarge.

-- SS

Bad health IT and its effects on willingness of patients to share sensitive information

I call your attention to this video from the 2nd International Summit on the Future of Health Privacy where HC Renewal occasional contributor Dr. Scott Monteith, a psychiatrist, presents on how health IT damages the physician-patient relationship, the bedrock of good medicine, in one case via an inexcusable health IT defect.

The defect nearly cost a woman her good reputation - and her child - by "transforming" coffee drinking into solvent sniffing.

The video is here:  http://www.healthprivacysummit.org/events/2012-health-privacy-summit/custom-129-ec40d08a35f947e487f68a5f534a9e82.aspx

Dr. Monteith on how bad health IT damages trust.  See video at this link starting at 4:40.

Dr. Monteith starts at 4:40 when he is asked

"Do you feel HIT affects the willingness of patients to share sensitive information with providers?"

His answer is a definite "yes", and the video should be seen to understand his reasons, the largest one being the trust that is injured by this technology as currently (mal)implemented, failing to maintain privacy, data integrity, affecting doctor-patient interaction (e.g., due to poor usability), etc.

His two examples where HIT has injured trust, resulting in decreased willingness of patients to share sensitive information:

• A patient feared compromised privacy regarding psychiatric information (a fear that was certainly well-justified in view of ABC's recent expose of health IT breaches as I wrote about at my Sep. 14, 2012 post "A Reason to Refuse Use of EHR's in Your Health Care, and Demand Paper.")

• An error in EHR-generated record affecting a child custody battle, with a husband alleging unfitness of the mother due to substance abuse.  The EHR incorrectly showed a damaging diagnosis due to both a data mapping flaw (lumping multiple diagnoses under the same code) and a user interface flaw (permitting all of the diagnoses lumped under that code to not be seen, only the worst one) that transformed caffeine (i.e., coffee) overuse to "inhalant abuse."  

Stunningly, Dr. Monteith reported the error was not remediated even after several years.

As seen by the voluntary reports submitted by one of many HIT sellers (link), the only one that seems to do so, and some involuntary ones such as at this link, these issues are just the "tip of the iceberg." That exact phrase was uttered by a senior FDA official himself, reflecting known severe impediments to information diffusion on harms, as I reported at this link.

Yet the government (e.g., HHS's Office of the National Coordinator for Health Information Technology, ONC) and IT industry push this technology like candy, emphasizing largely unproven benefits and completely ignoring downsides such as damaged trust, damaged reputations that could have cost a woman custody of her child, and damaged bodies.

A video of an attorney personally affected by these issues is at this link:   http://www.healthprivacysummit.org/events/2012-health-privacy-summit/custom-137-ec40d08a35f947e487f68a5f534a9e82.aspx

-- SS

Is the Meaningful Use Stage 2 Final Rule invalid?

Here are a few reasonable questions I decided to elevate as a post of its own.

In the face of the discovery of industry influence over comments submitted to ONC regarding Meaningful Use Stage 2, as I documented at my post earlier today "Health IT Vendor EPIC Caught Red-Handed: Ghostwriting And Using Customers as Stealth Lobbyists - Did ONC Ignore This?" (ghost writing, in effect, by those with obvious conflicts of interest):

•  Is the MU Stage 2 Final Rule invalid due to the influence the industry had on the submitted "public" comments and opinions, supposedly by and of the submitters, which are now demonstrably tainted?
•  Should an investigation be opened?

After all, as I pointed out on Aug. 29 in "The Scientific Justification for Meaningul Use, Stage 2: The NWB Methodology", not only is MU2 based on an admitted "nevertheless, we believe" justification (that is, lack of scientific rigor), but now it appears the legislation is based on stealth lobbying and resultant regulatory capture, ONC in essence doing the seller's bidding.

Tens of billions of taxpayer dollars are at issue here.

-- SS

Health IT Vendor EPIC Caught Red-Handed: Ghostwriting And Using Customers as Stealth Lobbyists - Did ONC Ignore This?

From the Histalk blog in the 8/31/12 news at this link:

Epic not only submitted MU Stage 2 comments to ONC, it even helpfully distributed them to their customers so they could submit the same comments under their own names. David Clunie noticed this and lists the hospitals who sent in the boilerplate, including University of Miami, which submitted the same comments five times without noticing the “Remove Before Submitting” headline that prefaced Epic’s explanation of why its customers should share its opinions with Uncle Sam.

From the primary source linked in the Histalk note:

Epic via University of Michigan Health System Meaningful Use Workgroup also the same Epic comments from University of Miami (who liked them so much they submitted it twice and then a third time and then a fourth and fifth time) and again from the Martin Health System and Metro Health Hospital and The Methodist Hospitals and Fairview Health Services and Sutter Health and Parkview Health System and the Everett Clinic and Dayton Childrens' and UMDNJ and NYU Langone Medical Center and Hawaii Pacific Health and finally as submitted by Epic themselves - others like the Community Health Network just stated they had read and agreed with Epic's comments - Imaging - concur that DICOM is not needed for that objective and PACS images do not need to be duplicated - concerned about single sign on if two systems - View, Download and Transmit to 3rd Party - images are not in the EHR but the PACS - patients would need DICOM viewers - size of the images is a problem - disks are better (also if you look at some copies of this, there are some pretty funny "remove before submitting to ONC" notes that say things like which versions support what and how much it would cost to retrofit, etc.; how embarrassing, both for Epic and their lackeys at these institutions)

I certainly admire David Clunie's endurance at being able to slog through all of that and appreciate his shedding some sunlight on the "remove before submitting" notes, but - I don't think it's funny at all.

Among other things, it represents taint of the submissions via ghostwriters (unattributed authors) with obvious conflicts of interests, topics often addressed at HC Renewal.

Here's an example I verified, the submission to the government from Dayton Children's Hospital:

"Informational Comments for Organizations Using EPIC (remove before submitting to ONC)" - click to enlarge.  At least here they say they are "in total agreement" with EPIC's concerns and recommendations. 

Another example - University of Miami:

A danger of dealing with incompetents:  they neglect to tidy up for you - click to enlarge.  (Corollary question: note the line "Our [Epic's - ed.] comments stem from the fact the we believe ..."  So - what opinions belong to the 'public commenting organization', and which to the company?  Likely the whole thing belongs to the latter's ghostwriters, but can anyone really tell?  That's the problem with tainted submissions.)

Others is the links above I checked such as Martin and Methodist have the same boilerplate about the "chart search feature."  Some retain the "reminder" to remove; in others it has been erased.  However, the boilerplate remains.

I actually find the "advice" from EPIC in the latter document stunning regarding a "chart search feature" (e.g., search note text, and probably also ad hoc clinical searches such as 'find my patients whose blood sugars have been > 100 in the past month').  These are "features" critical to quality care that should have been present decades ago ** [see note below].  Emphasis mine:

... Focus certification on the minimum floor set of capabilities required to complete meaningful use objectives.

Is this a tacit admission "certification" is a sham?  Is this in patients' best interests?

and

Informational Comments for Organizations Using Epic (remove before submitting to ONC)
We’ve heard your requests for a chart search feature, and our desire to see this certification criterion removed does not mean we don’t want to develop such a feature. In a future version of Epic, we want to develop the best possible chart search feature based on your input. However, if this criterion stays in the Final Rule, we worry we’ll have to divert attention from future chart search features you’ve requested to focus on a simplified, less valuable version of the feature to meet certification.

In my opinion, this translates to: "we are already overextended, so help us stymie the experts' and government's efforts to make it a criteria for certification, and to hell with your doctors and nurses who need a search feature right now."

Can you imagine in 2012 a word processor, database or operating system without a search feature?  That's the kind of antediluvian IT the clinicians have to put up with.  And this industry speaks of "innovation?"

It would come as no surprise - to me, at least - if other health IT sellers were engaged in similar activities.

I am unable to judge whether stealth lobbying by sellers using their clients, which enables the sellers to then line their pockets through favorable government legislation based on echoed comments of clients, is legal or ethical.  My belief, however,  is that it is at best a questionable practice.  It is certainly inherently unfair e.g., anti-competitive in regard to smaller health IT companies who might be able to meet more stringent MU2 certification criteria, and unfair to private citizens who have no such captive mouthpieces at their beck and call. 

While perhaps not as bad as possible 'Combination in Restraint of Trade' as in my April 2010 post "Healthcare IT Corporate Ethics 101" (link), this situation should probably be brought to the attention of health IT watchdogs such as Sen. Grassley.

This May 2012 post might also be of interest:  Did EPIC CEO Judy Faulkner of Epic declare that 'healthcare IT usability would be part of certification over her dead body'?  ONC never responded to the questions I raised in the post.

Another question:  why did ONC apparently turn a blind eye towards these "accidental inclusions"? 

Yet another question:  is the MU2 Final Rule invalid due to the influence the industry clearly had on the submitted "public" comments, which can now reasonably be viewed as tainted?

-- SS

Addendum:

I've informed the Senator via his email and staff voicemail lines.  I've also created a short URL to more conveniently access this post:  http://www.tinyurl.com/epic-stealth

-- SS

Note:

** For instance, I had  implemented a robust search feature of clinical notes, all comment fields and the comprehensive clinical, genetic and genealogical dataset in the Yale-Saudi Clinical Genetics EHR - in 1995.

ONC and Misdirection Regarding Mass Healthcare IT Failure

In my keynote address to the Health Informatics Society of Australia in Sydney recently, I cautioned attendees including those in government to be wary of healthcare IT hyper-enthusiast misdirection and logical fallacy (a.k.a. public relations).

In the LA Times story "Patient data outage exposes risks of electronic medical records" on the Cerner EHR outage I wrote of in my post "Massive Health IT Outage: But, Of Course, Patient Safety Was Not Compromised" (the title, of course, being satirical), Jacob Reider, acting chief medical officer at the federal Office of the National Coordinator for Health Information Technology is quoted.  He said:

"These types of outages are quite rare and there's no way to completely eliminate human error."

This is precisely the type of political spin and hyper-enthusiast misdirection I cautioned the Australian health authorities to evaluate critically.

As comedian Scott Adams humorously noted regarding irrelevancy, a hundred dollars is a good price for a toaster, compared to buying a Ferrari.

Further, when you're the patient harmed or killed, or the victim is a family member, you really don't care how "rare" the outages are.

Airline crashes are "rare", too.   So, shall they just be tolerated as a "cost of doing business" and spun away?

(As I once wrote, the asteroid colliding with Earth that caused the extinction of the dinosaurs was a truly "rare" event.)

It seems absurd for me to have to point out that paper, unless there is a mass outbreak of use of disappearing ink, or locally hosted clinical IT, do not go blank en masse across multiple states and countries for any length of time, raising risk across multiple hospitals greatly, acutely and simultaneously.   Yet, I have to point out this obvious fact in the face of misdirection.

Locally hosted health IT, of course, can only cause "local" chart disappearances.  "Local" is a relative term, however, depending on HC organization size, as in the example of a Dec. 2011 regional University of Pittsburgh Medical Center (UPMC) 14-hour outage affecting thousands here.

Further, EHR's and other clinical IT, whether hosted locally or afar, had better offer truly major advantages, without major risks and disadvantages, over older medical records technologies before exposing large numbers of patients to an invasive IT industry and the largest unconsented human subjects experiment in history.

Unfortunately, those basic criteria are not yet apparent with today's systems (see for instance this reading list).

EHR's and other clinical IT, forming in reality an enterprise clinical resource management and clinician workflow control apparatus, have introduced new risk modes including mass chart theft (sometimes tens of thousands in the blink of an eye); also, mass chart disappearances as in this case - all not possible with paper.

At the very least, if hospitals want enterprise clinical resource management and clinician workflow control systems, these should not be relegated to a distant third party.  Patients are not guinea pigs upon whom to test the ASP software model ("software as a service") that, upon failure for any reason, threatens their lives.

Finally, these complications are a further example why this industry cannot go on without meaningful oversight.  The unprecedented special medical device regulatory accommodations must end.

-- SS

WSJ "There's a Medical App for That—Or Not" - Misinformation on Health IT Safety Regulation?

There's a health IT meme that just won't die (patients may, but not the meme).

It's the meme that health IT "certification" is a certification of safety.

I expressed concern about the term "certification" being misunderstood even before the meme formally appeared, when the term was adopted by HHS with regard to evaluation of health IT for adherence to the "meaningful use" pre-flight features checklist.  See my mid-2009 post "CCHIT Has Company" where I observed:

HIT "certification." ... is a term I put in quotes since it really is "features qualification" at this point, not certification such as a physician receives after passing Specialty Boards.

The "features qualification" is an assurance that the EHR functions in way that could enable an eligible provider or eligible hospital to meet the Center for Medicare & Medicaid Services' (CMS) requirements of "Meaningful Use."  No rigorous safety testing in any meaningful sense is done, and no testing under real-world conditions is done at all.

I've seen the meme in various publications and venues.  I've even seen it in legal documents in medical malpractice cases where EHR's were involved, as an attempted defense.

Now the WSJ has fallen for the health IT Certification meme.

An article "There's a Medical App for That—Or Not" was published on May 29, 2012.  Its theme is special regulatory accommodation for health IT in the form of opposition to FDA regulation of devices such as "portable health records and programs that let doctors and patients keep track of data on iPads."

In the article, this assertion about health IT "certification" is made:

... The FDA's approach to health-information technology risks snuffing out activity at a critical frontier of health care. Poor, slow regulation would encourage programmers to move on, leaving health care to roil away for yet another generation, fragmented, disconnected and choking on paperwork.

The process already exists for safeguarding the public for computers in health care. It's not FDA premarket review but the health information technology certification program, established under President George W. Bush and still working fine under the Obama Health and Human Services Department. The government sets the standards and an independent nonprofit [ATCB, i.e., ONC Authorized Testing and Certification Bodies - ed.] ensures that apps meet those standards. It's a regulatory process as nimble as the breakout industry it's meant to monitor. That is where and how these apps should be regulated.

It's a wonderful meme.  Unfortunately, it's wrong.  Dead wrong.

Certification by an ATCB does not "safeguard the public."   Two ONC Authorized Testing and Certification Bodies (ATCB's) admitted this in email, as in my Feb. 2012 post "Hospitals and Doctors Use Health IT at Their Own Risk - Even if Certified".  I had asked them, point-blank:

"Is EHR certification by an ATCB a certification of EHR safety, effectiveness, and a legal indemnification, i.e., certifying freedom from liability for EHR use of clinical users or organizations? Or does it signify less than that?"

I received two replies from major ONC ATCB's indicating that "certification" is merely assurance that HIT meets a minimal set of "meaningful use" guidelines, not that it's been vetted for safety.  For instance:

From: Joani Hughes (Drummond Group)
Sent: Monday, March 05, 2012 1:06 PM
To: Scot Silverstein
Subject: RE: EHR certification question

Per our testing team:

It is less than that. It does not address indemnification although a certification could be used as a conditional part of some other form of indemnification function, such as a waiver or TOA, but that is ultimately out of the scope of the certification itself. Certification in this sense is an assurance that the EHR functions in way that could enable an eligible provider or eligible hospital to meet the CMS requirements of Meaningful Use Stage 1. Or to restate it more directly, CMS is expecting eligible providers or eligible hospitals to use their EHR in “meaningful way” quantified by various quantitative measure metrics and eligible providers or eligible hospitals can only be assured they can do this if they obtain a certified EHR technology.

Please let me know if you have any questions.

Thank you,
Joani.

Joani Hughes
Client Services Coordinator
Drummond Group Inc.

The other ATCB, ICSA Labs, stated that:

... Certification by an ATCB signifies that the product or system tested has the capabilities to meet specific criteria published by NIST and approved by the Office of the National Coordinator. In this case the criteria are designed to support providers and hospitals achieve "Meaningful Use." A subset of the criteria deal with the security and patient privacy capabilities of the system.

Here is a list of the specific criteria involved in our testing:
http://healthcare.nist.gov/use_testing/effective_requirements.html

In a nutshell, ONC-ATCB Certification deals with testing the capabilities of a system, some of them relate to patient safety, privacy and security functions (audit logging, encryption, emergency access, etc.).

What was suggested in the email below (freedom from liability for users of the system, etc.) would be out of scope for ONC-ATCB testing based on the given criteria. [I.e., certification criteria - ed.] I hope that helps to answer your question.

I had noted that:

... My question was certainly answered [by the ATCB responses]. ONC certification is not a safety validation, such as in a document from NASA on aerospace software safety certification, "Certification Processes for Safety-Critical and Mission-Critical Aerospace Software" (PDF) which specifies at pg. 6-7:

In order to meet most regulatory guidelines, developers must build a safety case as a means of documenting the safety justification of a system. The safety case is a record of all safety activities associated with a system throughout its life. Items contained in a safety case include the following:

• Description of the system/software
• Evidence of competence of personnel involved in development of safety-critical software and any
safety activity
• Specification of safety requirements
• Results of hazard and risk analysis
• Details of risk reduction techniques employed
• Results of design analysis showing that the system design meets all required safety targets
• Verification and validation strategy
• Results of all verification and validation activities
• Records of safety reviews
• Records of any incidents which occur throughout the life of the system
• Records of all changes to the system and justification of its continued safety

A CCHIT ATCB juror, a physician informatics specialist, has also done a guest post in Jan. 2012 on HC Renewal about the certification process, reproducing his testimony to HHS on the issue.  That post is "Interesting HIT Testimony to HHS Standards Committee, Jan. 11, 2011, by Dr. Monteith."  Dr. Monteith testified (emphases mine):

... I’m “pro-HIT.” For all intents and purposes, I haven’t handwritten a prescription since 1999.

That said and with all due respect to the capable people who have worked hard to try to improve health care through HIT, here’s my frank message:

ONC’s strategy has put the cart before the horse. HIT is not ready for widespread implementation. 

... ONC has promoted HIT as if there are clear evidence-based products and processes supporting widespread HIT implementation.

But what’s clear is that we are experimenting…with lives, privacy and careers.

... I have documented scores of error types with our certified EHR, and literally hundreds of EHR-generated errors, including consistently incorrect diagnoses, ambiguous eRxs, etc.

As a CCHIT Juror, I’ve seen an inadequate process. Don’t get me wrong, the problem is not CCHIT. The problem stems from MU.

EHRs are being certified even though they take 20 minutes to do a simple task that should take about 20 seconds to do in the field.  [Which can contribute to mistakes and "use error" - ed.] Certification is an “open book” test. How can so many do so poorly?

For example, our EHR is certified, even though it cannot generate eRxs from within the EHR, as required by MU.

To CCHIT’s credit, our EHR vendor did not pass certification. Sadly, our vendor went to another certification body, and now they’re certified.

MU does not address many important issues. Usability has received little more than lip-service. What about safety problems and reporting safety problems? What about computer generated alerts, almost all of which are known to be ignored or overridden (usually for good reason)?

 

The concept of “unintended consequences” comes to mind.

All that said, the problem really isn’t MU and its gross shortcomings, it is ONC trying to do the impossible:

ONC is trying to artificially force a cure for cancer, basically trying to promote one into being, when in fact we need to let one evolve through an evidence-based, disciplined process of scientific discovery and the marketplace.

Needless to say, as was learned at great cost in past decades, a "disciplined process" in medicine includes meaningful safety regulation by objective outside experts.

Further, the certifiers have no authority to do important things such as forcibly remove dangerous software from the market.  An example is the forced Class 1 recall of a defective system as I wrote about in my Dec. 2011 post "FDA Recalls Draeger Health IT Device Because This Product May Cause Serious Adverse Health Consequences, Including Death".   Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.

In that situation, the producer had been simply advising users (in critical care environments, no less) to "work around the defects" that could indicate incorrect recommended dosage values of critical meds, including a drug dosage up to ten times the indicated dosage, as well as corrupt critical cardiovascular monitoring data.  As I observed:

... I find a software company advising clinicians to make sure to "work around" blatant IT defects in "acute care environments" the height of arrogance and contempt for patient safety.

Without formal regulatory authority to take actions such as this FDA recall, "safeguarding the public" is a meaningless platitude.

It's also likely the ATCB's, which are private businesses, would not want the responsibility of "safeguarding the public."  That responsibility would open them up to litigation when patient injuries or death were caused, or were contributed to, by "certified" health IT.

I have in the past also noted that the use of the term "certification" might have been deliberate, to mislead potential buyers exactly into thinking that "certification" is akin to a UL certification of an electrical appliance for safety, or an FAA approval of a new aircraft's flight-worthiness.

The WSJ needs to clarify and/or retract its statement, as the statement is misinformation.

At my Feb. 2012 post "Health IT Ddulites and Disregard for the Rights of Others" I observed:

Ddulites [HIT hyper-enthusiasts - ed.] ... ignore the downsides (patient harms) of health IT.

This is despite being already aware of, or informed of patient harms, even by reputable sources such as FDA (Internal FDA memo on H-IT risks), The Joint Commission (Sentinel Events Alert on health IT), the NHS (Examples of potential harm presented by health software - Annex A starting at p. 38), and the ECRI Institute (Top ten healthcare technology risks), to name just a few.

In fact, the hyper-enthusiastic health IT technophiles will go out of their way to incorrectly dismiss risk management-valuable case reports as "anecdotes" not worthy of consideration (see "Anecdotes and medicine" essay at this link).

They will also make unsubstantiated, often hysterical-sounding claims that health IT systems are necessary to, or simply will "transform" (into what, exactly, is usually left a mystery) or even "revolutionize" medicine (whatever that means).

Health IT is a potentially dangerous technology.   It requires meaningful regulation to "safeguard the public."  How many incidents like this and this will it take before that is understood by the hyper-enthusiasts?

I've emailed the ATCB's that had responded to my aforementioned query for clarification on the WSJ assertion about their role, being that the statement is in contradiction to their earlier replies to me.  I also advised them of the potential liability issues.

However, if it turns out to be true that the ONC-ATCB's do intend themselves as the ultimate watchdog and assurer of public safety related to EHR's, that needs to be known by the public and their representatives.

-- SS

EHRs and test ordering: Health Affairs authors reply to ONC

At my March 9, 2012 post "Increased Lab Ordering with EHR's?" I refuted ONC's response to a Harvard-based research study "Giving Office-Based Physicians Electronic Access To Patients’ Prior Imaging And Lab Results Did Not Deter Ordering Of Tests" that may contradict the notion that HIT reduces medical costs.

Now the authors themselves have responded to ONC. There are many similar themes in their response. I've bolded them below:

The Effect Of Physicians’ Electronic Access To Tests: A Response To Farzad Mostashari

March 12th, 2012
by Danny McCormick, David Bor, Stephanie Woolhandler, and David Himmelstein

Our recent Health Affairs article linking increased test ordering to electronic access to results has elicited heated responses, including a blog post by Farzad Mostashari, National Coordinator for Health IT. Some of the assertions in his blog post are mistaken. Some take us to task for claims we never made, or for studying only some of the myriad issues relevant to medical computing. And many reflect wishful thinking regarding health IT; an acceptance of deeply flawed evidence of its benefit, and skepticism about solid data that leads to unwelcome conclusions.

Dr. Mostashari’s critique of our paper, will, we hope, open a fruitful dialogue. We trust that in the interest of fairness he will direct readers to our response on his agency’s site. [If not, HC Renewal posts get highly ranked by Google - ed.]
Our study analyzed government survey data on a nationally representative sample of 28,741 patient visits to 1187 office-based physicians. We found that electronic access to computerized imaging results (either the report or the actual image) was associated with a 40% -70% increase in imaging tests, including sharp increases in expensive tests like MRIs and CT scans; the findings for blood tests were similar. Although the survey did not collect data on payments for the tests, it’s hard to imagine how a 40% to 70% increase in testing could fail to increase imaging costs.
Dr. Mostashari’s statement that “reducing test orders is not the way that health IT is meant to reduce costs” is surprising, and contradicts statements by his predecessor as National Coordinator that electronic access to a previous CT scan helped him to avoid ordering a duplicate and “saved a whole bunch of money.” A Rand study, widely cited by health IT advocates including President Obama, estimated that health IT would save $6.6 billion annually on outpatient imaging and lab testing. Another frequently quoted estimate of HIT-based savings projected annual cost reductions of $8.3 billion on imaging and $8.1 billion on lab testing.
We focused on electronic access to results because the common understanding of how health IT might decrease test ordering is that it would facilitate retrieval of previous results, avoiding duplicate tests. Indeed, it’s clear from the extensive press coverage that our study was seen as contravening this “conventional wisdom”.
Nonetheless, Dr. Mostashari criticizes us for analyzing the impact of physicians’ electronic access to imaging and test results, but not other aspects of electronic health record (EHR) use. We did, however, analyze the relationship of EHRs to test ordering in a subsidiary analysis. While physicians use of a full EHR was associated with a 19% increase in image ordering, as we noted in the paper this finding was not statistically significant. While we cautiously (and properly) interpreted this as a “null” finding, these data are inconsistent with Mostashari’s optimistic view that use of a full EHR reduces costs.
He asserts that our 2008 data are passe, and that health IT meeting today’s “meaningful use” criteria definitely saves money. The data we analyzed were the latest available data when we initiated the study. While the proportion of outpatient physicians utilizing health IT has grown since 2008, we are unaware of any “game changing” health IT developments in the past four years that are would produce substantially different results if the study were repeated today. The EHR vendors that dominated the market in 2008 remain, by and large, today’s market leaders, and their products have undergone mostly modest tweaks. Mostashari’s contention that 2012 EHRs – incorporating decision support and electronic information exchange – save money in ways not possible in 2008 should be tested through additional research but remains merely a hypothesis. We hope that some day his predicted savings can be achieved.
Dr. Mostashari offers his own explanation for our findings, suggesting that doctors who are inclined to order more tests are also inclined to purchase health IT for viewing test results electronically rather than on paper. He offers no evidence for this assertion and ignores the fact that we explored (and rejected) this explanation by analyzing subgroups of doctors who are unlikely to be the decision maker for IT purchases – e.g. employed physicians, those working in an HMO setting etc. In other words, electronic access to results predicted more test ordering whether or not the ordering physician was responsible for health IT purchases.
He incorrectly states that our analysis did not take into account patients’ severity of illness, physicians’ level of training, and the nature of physicians’ financial arrangements. In fact, we reported subsidiary multivariate analyses that included several serious diagnoses; all of our models included physician specialty (which we specified in several different ways); and all models included adjustment for an extensive list of indicators of financial arrangements (e.g. whether the physician owned the practice or was an employee; the type of office; whether the practice was owned by a hospital; whether the physician was a solo practitioner; whether the physician’s compensation was based, in part or whole on “profiling”; and whether the practice was predominantly prepaid). We also performed a series of subsidiary analyses that explored whether physicians with a proclivity to “self refer” patients for imaging tests accounted for our finding; they didn’t.
Dr. Mostashari criticizes us for failing to assess whether health IT improved the quality or appropriateness of care. Of course, these were not the topic of our research. Those are different studies for a different time. However, we would note that other large-scale studies have found no, or trivial quality improvements associated with HIT outside of a few flagship institutions^4-6.
Dr. Mostashari’s strongest claim is that observational studies like ours (and most other health policy studies, including some by Dr. Mostashari himself) cannot prove causation. This is surely true. As long time teachers of evidence based medicine we took care to couch our conclusions in cautious terms, stating only that “Computerization, whatever its other benefits, remains unproven as a cost control strategy.”
But Dr. Motashari is less cautious, asserting that the case for HIT is closed. The paper he cites to buttress this claim (authored by members of his own agency) culled studies reporting any impact of HIT on virtually any aspect of care, and accepted authors’ claims of benefit without regard to study quality or statistical niceties. Thus, a focus group’s impressions of benefit are accorded the same weight as nationwide studies of Medicare data showing virtually no impact of computerization on quality measures. Reports of a reduction from 70% to 38 % in “missed billing opportunities” or a $7,000 reduction in office supply costs are among the 92% of studies judged “positive”. While the literature review he cites is interesting, nothing in it contradicts our findings.
Dr. Mostashari is also correct in reiterating that randomized trials are the best way to assess health IT. In fact, no randomized trial has ever been published that examines patients’ outcomes or costs associated with off-the-shelf health IT systems that dominate the U.S. market. No drug or new medical device could pass FDA review based on such thin evidence as we have on health IT. Yet his agency is disbursing $19 billion in federal funds to stimulate the adoption of this inadequately evaluated technology. Dr. Mostashari is perhaps the only person in our nation who commands the resources needed to mount a well done randomized controlled trial to fairly assess the impact of health IT, and the comparative efficacy of the various EHR options.
Finally, Dr. Mostashari’s unbridled faith in technology is mirrored by his belief that ACOs are the next panacea for health costs and quality. That health policy flavor-of-the-month also remains wholly unproven.

I think readers comparing my response to the authors', and who are familiar with the many posts at HC Renewal going back to 2004, will recognize the themes I have bolded in the author's response to HHS.

-- SS

Increased Lab Ordering with EHR's?

ONC has once more proffered typical politically-motivated spin with regard to the Harvard study "Giving Office-Based Physicians Electronic Access To Patients’ Prior Imaging And Lab Results Did Not Deter Ordering Of Tests" that I wrote about at "Another Health IT Mythbuster: Doctors order more X-rays, not fewer, with computer access."

That study had the rather tame, reasonable conclusion:

... These findings raise the possibility that, as currently implemented, electronic access does not decrease test ordering in the office setting and may even increase it, possibly because of system features that are enticements to ordering. We conclude that use of these health information technologies, whatever their other benefits, remains unproven as an effective cost-control strategy with respect to reducing the ordering of unnecessary tests.

The ONC response (posted here at present) to such a mild conclusion about an experimental technology seemed very splenetic.

As I mentioned at the aforementioned post, ONC has thrown good science under the bus before, for political purposes in my view:

... On the other hand, coming from a political office that clearly does not understand how to conduct qualitative research and creates political promotion pieces masquerading as "research", such a statement is not surprising. See "ONC: "The Benefits Of Health Information Technology: A Review Of The Recent Literature Shows Predominantly Positive Results" at this link, where essential research methodologies were thrown under the bus for publication in Health Affairs.
At least the deviations from rigorous research methodologies were admitted:

“... Our findings must be qualified by two important limitations: the question of publication bias [e.g., bias in evidence selection - ed.], and the fact that we implicitly gave equal weight to all studies regardless of study design or sample size.”

Unfortunately, the media, politicians, financial decisionmakers and others are likely not to really comprehend, in-depth, the full significance of that sentence.

I am in the unfortunate situation of again having to stuff ONC's - um, stuff - back into the bull.

First, hat tip to Histalk where I found the link below:

National Coordinator for HIT Farzad Mostashari, MD takes issue with the recently published report that found doctors with online access to patients’ charts ordered more tests. Mostashari disputes the study, which raised questions as to whether or not EHRs cut costs. Mostashari’s contends that the study was based on 2008 data and before the start of the Meaningful Use program and thus does not address certified EHRs’ capabilities for data exchange and clinical data support.

The fatal passage in the linked ONC piece at http://www.healthit.gov/buzz-blog/meaningful-use/study-facts/ is this:

"Also, the study data were from 2008, before the passage of the HITECH Act and the linking of payment incentives to the meaningful use of EHRs."

This seems a variation of the typical excuse-making in IT - "they were using v. 1.0; it's all fixed in the later version."

The outcomes of (Orwellian-named) "Meaningful Use" (MU) have not been studied, to my knowledge. Futher, the criteria chosen for "Meaningful Use" were primarily best guesses as to what could be beneficial. ("Meaningful Use" should have been more accurately termed "good faith use.")

Claiming that 2008 data on EHR-related test ordering is invalid because "Meaningful Use" was not in effect at the time is, in fact, jumping to an unsupported conclusion that "Meaningful Use" will counter whatever multiple medical/social factors caused the increased ordering in the first place -- because, of course, MU is "Meaningful" and deterministically guaranteed to work out, nationally, as planned, among all outpatient and inpatient settings.

This seems a form of "begging the question":

Begging the Question is a fallacy in which the premises include the claim that the conclusion is true or (directly or indirectly) assume that the conclusion is true. This sort of "reasoning" typically has the following form.

- Premises in which the truth of the conclusion is claimed or the truth of the conclusion is assumed (either directly or indirectly).
- Claim C (the conclusion) is true.

This sort of "reasoning" is fallacious because simply assuming that the conclusion is true (directly or indirectly) in the premises does not constitute evidence for that conclusion. Obviously, simply assuming a claim is true does not serve as evidence for that claim. This is especially clear in particularly blatant cases: "X is true. The evidence for this claim is that X is true."

I note that the MU criteria are themselves evolving and not finalized. Making predictions about the future is the domain of fortune tellers with crystal balls, not scientists:

Health IT WILL reduce costs and improve caregivers’ decisions and patients’ outcomes. It is written in the stars!

ONC seems to think it is capable of such certainty, as I wrote in mid-2010 at "Science or Politics? The New England Journal and "The 'Meaningful Use' Regulation for Electronic Health Records":

... The widespread use of electronic health records (EHRs) in the United States is inevitable. EHRs will improve caregivers’ decisions and patients’ outcomes. Once patients experience the benefits of this technology, they will demand nothing less from their providers. Hundreds of thousands of physicians have already seen these benefits in their clinical practice.

In its current piece, ONC goes on to state:

Reducing Test Orders Is Not the Way that Health IT Is Meant to Reduce Costs

The ultimate impact of EHRs on reducing cost will be through improvements in the coordination and quality of care, and the prevention of unnecessary and costly complications and hospitalizations. [Note the mysterious disappearance of the word "tests" - ed.] Providers who are embracing new delivery and payment models such as Accountable Care Organizations and Patient-Centered Medical Homes know that meaningful use of EHRs is a critical foundation for being able to improve quality while reducing cost.

That is, simply, a lie. Reducing test utilization has long been claimed as a benefit of EHR's.

For example, from http://www.healthit.gov/patients-families/benefits-health-it:

EHRs reduce unnecessary tests and procedures. Have you ever had to repeat medical tests ordered by one doctor because the results weren’t readily available to another doctor? Those tests may have been uncomfortable and inconvenient or have posed some risk, and they also cost money. Repeating tests—whether a $20 blood test or a $2,000 MRI--results in higher costs to you in the form of bigger bills and increased insurance premiums. With EHRs, all of your care providers can have access to all your test results and records at once, reducing the potential for unnecessary repeat tests.

It is also another example of "moving the goalposts", a defense often used by those without a sound argument; by politicians; and sometimes by - scoundrels.

(I observed another "moving of the goalposts" at my aforementioned post "Another Health IT Mythbuster: Doctors order more X-rays, not fewer, with computer access." In that post I observed Michael Furukawa, a health economist in the ONC office, stating that the researchers’ focus was not "deep enough" to support the study’s conclusions. He wrote: “The data are sound, the methods are appropriate, but the focus is limited,” he said. “They only looked at one piece of health IT.”)

Well, yes, and the piece they looked at should set off red flags that the assumptions about health IT and savings might be erroneous - not generate excuses that the goalposts were too close, and need to be moved further away.

This is not to mention that it appears most healthcare errors have little to do with documentation, as I outlined in my Dec. 2010 post "Is Healthcare IT a Solution to the Wrong Problem?"

I particularly take issue with the ONC statement that:

... this was not a randomized trial, but an observational study (the National Ambulatory Medical Survey) that was not designed to answer the question of cost, or associations between EHRs and quality. As a result, many other variables that could affect physician behavior could not be examined in this study

Yet in the aforementioned ONC "predominantly positive results" literature survey described at this link, ONC "implicitly gave equal weight to all studies regardless of study design or sample size." Their review thus included qualitative studies that were probably not meant to be evaluative, and observational studies subject to severe methodological bias, yet all were weighted equally. Further, studies contradicting the 'narrative' of health IT efficacy and beneficence such as in this list appear to have been excluded.

This appears a prime example of, at best, "the pot calling the teakettle black", and raises doubts as to ONC's objectivity and perhaps even intellectual honesty. Of course, they are a political office with a mission, so perhaps this can be understood. (Not excused, but understood.)

ONC also views risk management-critical reports of health IT-caused harm as "anecdotal", a scientific and ethical faux pas (or is it willful blindness?) of major proportions.

As I wrote at my April 2001 post "Making a Stat Less Significant: Common Sense on "Side Effects" Lacking in Healthcare IT Sector":

... This view [of negative HIT reports being 'anecdotes'] extends all the way up to the Director of the Office of the National Coordinator for Health IT, who 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 own 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.

Those "injury findings" appear in an FDA Internal Memo made available by the aforementioned Huffington Post Investigative Fund and archived at the following link:

Internal FDA memorandum on HIT risks (PDF) to Jeffrey Shuren MD JD (Director, Center for Devices and Radiological Health). Health Information Technology (H-IT) Safety Issues. "This is an Internal Document Not Intended for Public Use." Feb. 23, 2010.

(My description/summary of the memorandum is at my Aug. 2010 post "Internal FDA memorandum of Feb. 23, 2010 to Jeffrey Shuren on HIT risks. Smoking gun?")

The definitive take-down of the "anecdote" canard is at this link.

One could wonder if a criteria for work at ONC is a Ddulite disposition ('Luddite' with first four characters reversed):

Ddulites: Hyper-enthusiastic technophiles who either deliberately ignore or are blinded to technology's downsides, ethical issues, and repeated local and mass failures.

Instead of logical fallacy and "spin", perhaps the ONC would be better served by sponsoring some (independent, objective) researchers to actually conduct research supporting their claims about the effects of the "Meaningful Use" program.

Finally, perhaps ONC should ask my mother what she thinks about EHRs. She has specially-acquired firsthand expertise. They can find her here.

-- SS

Addendum 3/9/12:

At my Feb. 2011 post "Does EHR-Incited Upcoding (Also Known as "Fraud") Need Investigation by CMS, And Could it Explain HIT Irrational Exuberance " is another side effect on costs of EHR's in inpatient settings, specifically, the ED.

-- SS

Addendum 3/11/12:

Another article in 2010 by Himmelstein, Woolhandler & Wright had reached related conclusions:

Hospital Computing and the Costs and Quality of Care: A National Study

David U. Himmelstein, MD, Adam Wright, PhD,Steffie Woolhandler, MD, MPH

The American Journal of Medicine Volume 123, Issue 1 , Pages 40-46, January 2010

Background

Many believe that computerization will improve health care quality, reduce costs, and increase administrative efficiency. However, no previous studies have examined computerization's cost and quality impacts at a diverse national sample of hospitals.

Methods

We linked data from an annual survey of computerization at approximately 4000 hospitals for the period from 2003 to 2007 with administrative cost data from Medicare Cost Reports and cost and quality data from the 2008 Dartmouth Health Atlas. We calculated an overall computerization score and 3 subscores based on 24 individual computer applications, including the use of computerized practitioner order entry and electronic medical records. We analyzed whether more computerized hospitals had lower costs of care or administration, or better quality. We also compared hospitals included on a list of the “100 Most Wired” with others.

Results

More computerized hospitals had higher total costs in bivariate analyses (r=0.06, P=.001) but not multivariate analyses (P=.69). Neither overall computerization scores nor subscores were consistently related to administrative costs, but hospitals that increased computerization faster had more rapid administrative cost increases (P=.0001). Higher overall computerization scores correlated weakly with better quality scores for acute myocardial infarction (r=0.07, P=.003), but not for heart failure, pneumonia, or the 3 conditions combined. In multivariate analyses, more computerized hospitals had slightly better quality. Hospitals on the “Most Wired” list performed no better than others on quality, costs, or administrative costs.

Conclusion

As currently implemented, hospital computing might modestly improve process measures of quality but does not reduce administrative or overall costs.

-- SS