New ONC Director Karen De Salvo seems no better than her predecessors - risk, harms and deaths due to health IT apparently OK for now, and all we need is a "Safety Center"

Karen De Salvo has assumed the role of Director of ONC, the office of the National Coordinator for Health IT at HHS (http://www.healthit.gov/newsroom/dr-karen-desalvo-md).

A pretty face, but here's evidence of the same old tired political hucksterism and spin concerning healthcare information technology. 

In response to perhaps the most candid exposé in the public media to date of the risks and defects of current commercial health IT, industry conflicts of interest, and injuries and deaths, that appeared on July 20, 2014 in the Boston Globe under the title "Hazards tied to medical records rush" (http://tinyurl.com/lm7x34h) by the Globe's Washington bureau chief Christopher Rowland, Ms. De Salvo authored a letter to the editor.

DeSalvo is new to the job, but not to the political message of unbridled health IT hyper-enthusiasm and pointless "Safety Centers", instead of formal regulation as in other mission critical industries using IT (including pharma, for one).

Her letter to the Boston Globe attempts to put lipstick on a pig regarding a technology largely reviled by physicians and nurses due to its poor user experience and defects (rampant due to the free-for-all of this healthcare sector's unprecedented regulatory accommodation, that is, no regulation) that cause patient endangerment.  See http://hcrenewal.blogspot.com/2010/01/honest-physician-survey-on-ehrs.html, http://hcrenewal.blogspot.com/2014/02/ehrs-real-story-sobering-assessment.html and http://hcrenewal.blogspot.com/2013/11/another-survey-on-ehrs-affinity-medical.html as just a few examples.

What politicians do:  they spin like neutron stars

Her letter, with my comments:

http://www.bostonglobe.com/opinion/editorials/2014/07/26/many-health-success-stories-note/MyyGM3uq2LU0GqGLLqYJ7M/story.html

Letters | CHALLENGES IN THE MOVE TO ELECTRONIC MEDICAL RECORDS

July 27, 2014

Many health-IT success stories to note

I was disappointed to read “Risks, some dire, tied to medical records rush” (Page A1, July 20), as it failed to mention any examples of patients and their health care providers benefiting from the use of health information technology, including electronic health records. 

As to "disappointment", nearly the entire healthcare and lay press is filled with "success stories" and other propaganda.  There is, in fact, no need for artificial and industry-favoring "balance" in the rare article about the downsides. The industry has its own very large mouthpiece.  (This is the response we at HC Renewal give to critique that we're not "balanced" in every post.  It would be as if every article on defective avionics and pilot training issues that cause hundreds to die (e.g, Air France Flight 447, http://en.wikipedia.org/wiki/Air_France_Flight_447) should be accompanied by articles on just how many non-fatal flights there are, too; or as if every article about criminals has to mention there are good people, too.)

Such success stories are playing out across the country daily, including in Boston, and their omission from the article incompletely portrays the important role of electronic health records in improving patient safety and outcomes.

Is this and example of a far-left "you have to break an egg to make an omelette" (even if the 'egg' is a human being) thinking?   This statement, attempting redirection from the downsides, in effect says: "It's OK to sacrifice 100 in experimentation to (potentially) 'save' 10,000 - or 1,000 to 'save' 100,000."

Problem is, this is not how Western medicine is supposed to work - by HHS's own policies on research ethics, and international agreements and treaties based on work that arose after WW2's medical abuses, no less, e.g., the Nuremberg laws.

In medicine, legal and ethical standards such as the NIH Guidelines for Conduct of Research Involving Human Subjects (http://grants.nih.gov/grants/policy/hs/regulations.htm), the World Medical Association Declaration Of Helsinki (http://www.wma.net/en/30publications/10policies/b3/) and others restrict introduction of new drugs and medical devices without informed consent, and without extensive preclinical and clinical testing and post-marketing surveillance, especially when risks of the technology are unknown.  

And health IT is decidedly experimental, considering we don't even know the true extent of harms, by multiple admissions (by FDA, IOM, ECRI etc., see http://hcrenewal.blogspot.com/2014/04/fda-on-health-it-risk-reckless-or.html).

Also see my post Mar. 12, 2012 post "Human Subjects Experimentation Directives Ignored in the Grand Health IT Experiment?" at http://hcrenewal.blogspot.com/2012/03/human-subjects-experimentation.html.  The highlights, emphases mine:

Directives for Human Experimentation
NUREMBERG CODE

1. The voluntary consent of the human subject is absolutely essential. This means that the person involved should have legal capacity to give consent; should be so situated as to be able to exercise free power of choice [that is, to opt-out - ed.], without the intervention of any element of force, fraud, deceit, duress, over-reaching, or other ulterior form of constraint or coercion; and should have sufficient knowledge and comprehension of the elements of the subject matter involved as to enable him to make an understanding and enlightened decision. This latter element requires that before the acceptance of an affirmative decision by the experimental subject there should be made known to him the nature, duration, and purpose of the experiment; the method and means by which it is to be conducted; all inconveniences and hazards reasonable to be expected; and the effects upon his health or person [information on HIT risk exists, such as on this blog - ed.] which may possibly come from his participation in the experiment. The duty and responsibility for ascertaining the quality of the consent rests upon each individual who initiates, directs or engages in the experiment. It is a personal duty and responsibility which may not be delegated to another with impunity.
2. The experiment should be so conducted as to avoid all unnecessary physical and mental suffering and injury.
3. No experiment should be conducted where there is an a priori reason to believe that death or disabling injury will occur; except, perhaps, in those experiments where the experimental physicians also serve as subjects.
4. During the course of the experiment the human subject should be at liberty to bring the experiment to an end [go back to paper - ed.] if he has reached the physical or mental state where continuation of the experiment seems to him to be impossible.
5. During the course of the experiment the scientist in charge must be prepared to terminate the experiment at any stage [go back to paper - ed.], if he has probable cause to believe, in the exercise of the good faith, superior skill and careful judgment required of him that a continuation of the experiment is likely to result in injury, disability, or death to the experimental subject.

Perhaps they don't teach these things at Harvard?

Back to De Salvo's letter:

A fully electronic health system can help identify and prevent potential medical errors. The Office of the National Coordinator for Health IT has taken steps to address the safe use and implementation of electronic health records, including sponsoring the Institute of Medicine report referenced in the story.

And since that 2012 report, which acknowledges that bad health IT causes risks, errors and harms to a definite but unknown magnitude (see bottom section of my post at http://hcrenewal.blogspot.com/2012/03/doctors-and-ehrs-reframing-modernists-v.html), ONC has done next to nothing. People are exposed to risk, harms and deaths and that seems just fine to ONC, for if it were not, they would have acted aggressively - say, as if a type of jet plane, or nuclear power plant had been revealed to pose risks and dangers to the community.

As Mr. Rowland himself pointed out in the Boston Globe article:

... In 2011, the Institute of Medicine said the lack of a central repository for reporting error-prone software, patient injuries, and deaths, combined with nondiclosure and confidentiality clauses in vendor contracts, “pose unacceptable risks to safety.”

It strongly recommended that the Obama administration mandate that vendors report “deaths, serious injuries, and unsafe conditions” to a centralized, government-designated entity. Such reports should be made available to the public, it said, without information that would identify individual patients and providers.

Three years later, no such reporting system exists.

Instead, ONC takes the GM ignition switch approach (http://en.wikipedia.org/wiki/2014_General_Motors_recall):

... On February 7, 2014, GM recalled about 800,000 of its small cars due to faulty ignition switches, which could shut off the engine during driving and thereby prevent the airbags from inflating ... GM says it expects to charge $1.2 billion against its second quarter earnings as a result of its ongoing recalls, and the charge could get worse as lawsuits and investigations continue. 

The fault had been known to GM for at least a decade prior to the recall being declared.  Some have suggested that the company actually approved the switches in 2002 even though they knew they might not meet safety standards.

The company is facing multiple investigations into why it did not attempt to fix these faulty ignitions sooner, including a federal criminal probe, as well as a probe led by Anton Valukas, the latter of which produced a report which GM made public on June 5, 2014.

Instead of a serious approach to safety, ONC and De Salvo champion window dressing:

Most recently, the Office of the National Coordinator, the Food and Drug Administration, and the Federal Communications Commission issued a proposed plan that would include the creation of a health IT safety center, which would assist in the voluntary reporting of health IT-related medical errors. Many patient advocates, medical professionals, and other stakeholders have expressed support for this approach.

"Many?" - The consensus views, often dominated by industry insiders and others with conflicts of interest, is how ONC and De Salvo apparently think safeguarding the public is to be done.  Those who veer from this "consensus" with facts of risk and harms are to be ignored.

As to the hypocrisy and absurdity of a toothless "health IT safety center", see my April 9, 2014 post "FDA on health IT risk: reckless, or another GM-like political coverup?" at http://hcrenewal.blogspot.com/2014/04/fda-on-health-it-risk-reckless-or.html.

The hundreds of thousands of providers successfully and safely using electronic health records today show that health IT can, and does, improve health and health care.

Dr. Karen DeSalvo
National coordinator for health information technology
Department of Health and Human Services
Washington

Ms. De Salvo apparently never got this Mar. 14, 2014 CMS memo that was sent in response to a query by the American Association  of Physicians and Surgeons:

CMS: "we do not have any information that supports or refutes claims that a broader adoption of EHRs can save lives."  [But let's spend hundreds of billions of dollars anyway.]  Click to enlarge.

However, in politics, such issues do not seem to matter as compared to passing along the party line. 

In medicine, they do matter.  Very much so (see http://hcrenewal.blogspot.com/2011/06/my-mother-passed-away.html).

-- SS

When Money Talks, the Sick Will Walk, or Crawl - Three Illustrations of the Brave New World of Health Care

In the quaint days of yesteryear, there were those health professionals who thought of what they did as a calling.  The best care of the individual patient was supposed to come first, especially ahead of maximizing one's own income.  Now in the brave new world of neoliberalism, economism, unregulated, laissez faire capitalism - call it what you want - health care has become a business, an industry.  Protests that it still should be a calling are anechoic.

For example, who noticed when a very famous person wrote this in 2012?

Hospitals and other facilities 'must rethink their particular role in order to avoid having health become a simple 'commodity,' subordinate to the laws of the market, and, therefore, a good reserved to a few, rather than a universal good to be guaranteed and defended,'

For those who cannot tell who that was, see the end of this post.

Recently, some illustrations of how health care now puts money ahead of patients came to light.

Intellectual Property Rights Ahead of Sick Patients

The first example is from the KevinMD blog, written by medical and business student Samyutka Mullangi.

 My business ethics class recently discussed the case of Cipla Pharmaceuticals, an Indian generic drug manufacturer drawing the ire of big pharma by blithely ignoring international patents or employing workarounds to manufacture low-cost generics in direct violation of the patents. Cipla’s founder, Dr. Yusuf Hamied, stressed that Cipla’s goal wasn’t to steal from the bottom line of the likes of Merck and Eli Lilly, but rather to serve its mission of helping the world’s poor gain access to life-saving medications that they could otherwise not afford.

Of course,

 Students hailing from careers in pharma vehemently stated their opposition to Cipla’s cause, invoking the necessity for pharmaceutical companies to amortize their costs through sales. Though the incremental costs per pill of actual manufacturing were negligible, the high initial investments in research trials and production required a modicum of intellectual property protection.

The argument was briefly halted when 

 a classmate from the Middle East, who had been holding back furious tears through most of the discussion, raised a trembling hand and broke his silence. He told us of how his father, when he contracted diabetes, would not have survived if not for the availability of exactly such generic drugs.

He said, 'This entire discussion disgusts me.'  

However, very soon another student piped up and started talking about incentivizing.  Mullangi noted that

 At the business school, we use words like incentives, value proposition and return on equity. The liberals in the room had to couch their arguments in these terms. It would have been indelicate to talk about human rights and moral obligations.

While the end of the post suggested that medical students may not understand the language of business students, while business students may not understand the language of medical students.  However, it is clearly discussion of what matters to patients, empathy, ethics, morals that is "indelicate," and incentives, value propositions, and returns on equity have won out.


Efficiency Ahead of Patients' Needs

Just published online in JAMA was a commentary by Dr Christine K Cassel, and Robert S Saunders of the National Quality Forum summarizing recent findings by the US President's Council of Advisors on Science and Technology on Health Care [Cassel CK, Saunders RS. Engineering a better health care system; a report from the President's Council of Advisors on Science and Technology.  JAMA 2014; doi:10.1001/jama.2014.8906.]  While it started with the usual paean to

an increased need to ensure care remains high quality, affordable, and centered around the needs of patients and families.

What it was really about was how

systems engineering ... includes a range of tools to improve efficiency and reliability

So, for example, while some people dislike the US fee-for-service payment system because it may encourage unneeded, useless, or even dangerous care, these authors noted just that it

rewards inefficiency and serves as a disincentive to more efficient care.

The whole point was about increasing efficiency.  But efficiency according to economists is "the use of resources so as to maximize the production of goods and services." (per Wikipedia.)  It is not about health care outcomes, benefits versus harms, or health care quality.  And there was not a word in the paper about patients' values or preferences, benefits or harms, or adverse effects of medical interventions.


The Highest Bidder, not the Sickest Patient, Gets the Earliest Appointment

The starkest example appeared in a Bloomberg article, aptly titled "Doctors for the 1 Percent."  The new start-up HelloMD is

a company that connects patients with the best doctors in San Francisco, Los Angeles and Las Vegas, as determined through a selection process. HelloMD offers faster appointments than regular patients can get, for a price: Its customers pay the doctors higher rates than insurance plans offer. And they pay those rates in cash.

So,

HelloMD is a portal to the top specialists in every field, letting you buy your way to the front of the line.

So in the brave new world of HelloMD, presumably a wealthy patient with a chronic or even trivial problem could bid his or her way to specialty care ahead of a more acutely and severely ill patient who lacks the extra money (and even if the latter patient has full conventional health insurance.)   Most codes of medical conduct suggest that the needs (meaning clinical needs) of individual patients come first, presumably ahead of the wants of wealthier patients.  Yet HelloMD allows the wants of the rich trump the needs of the less rich.  (For any rich people who think that may be good for them, remember there is always somebody richer.)  To an old school doctor, this seems completely unethical.  (And some lawyers might think that participating doctors risk violating any contracts they have with health insurance companies.) 

(Note: see another post about HelloMD on the Health Business Blog.O

Summary

So right now those who believe that health care should be a business, not a calling, are winning.  In an era of deregulation and rampant suspicion of anything government can do to level the playing field, those with more money will win, and patients, no matter how sick, will lose.

By the way, anyone thinking that they are rich enough to buy their way to good care in this brave new world, remember there will always be someone ahead of you who is richer. 

Good health care will not survive long in a time when it is indelicate to talk about human rights and moral obligations.  Obviously, true health care reform will take more than talk.


Answer to Quiz - Pope Benedict XVI, see this post.

The Parts of Professionalism We Are Not Supposed to Discuss

A recent article in a a relatively obscure medical ethics journal dared to approach some important aspects of medical ethics that medical ethicists fear to discuss, but did not address the reasons for this fear or what to do about it. (Glenn JE. The eroding principle of justice in teaching medical ethics.  HEC Forum 2012; 24: 293-305.  Link here.)

The Basic Ethics Case - A Prescription for the Patient's Spouse?

Glenn began with a case typically discussed in medical school ethics courses:

a scenario where a standardized patient asks the student at the end of the examination if his prescription can be written in his spouse’s name as the spouse has health insurance which includes prescription drug coverage while the patient does not.

This

poses the question as to whether it is ethical for physicians to deceive third party payers to secure coverage for their patients.

The Politically Correct Way to Teach the Case

Glenn stated that there is a politically correct way for faculty to teach this case:

 Though we are never expressly instructed to tow [sic] a party line, there is a 'correct' answer to this ethical quandary as far as the institution we work for is concerned. Students who express a willingness to practice deception of third party payers for the good of their patients are to be commended for having their heart in the right place. However, we discuss many reasons why this action would not be a good solution to the problem. One of the issues is that to do so would be committing fraud.

Now, of course, writing a prescription for a patient who does not actually need the drug in question, understanding that the patient will give the drug to someone else who does not have insurance coverage to pay for it, is dishonest.  However, the larger point that Glenn made is that it is not politically correct to allow discussion about why the patient made such a request in the first place, and that this ought to be troubling.

Note that Glenn did not explain how he inferred what the "correct" answer was, nor its actual source within the institution.

Over the first few years of having this conversation with young medical students, I have always come away feeling empty and flat. Framed as a session on the ethics of 'truth telling,' the conversation and the readings we provide to prepare for it works to obfuscate the much larger ethical issue impossible to tackle in an hour’s time. In essence, 'truth telling' is only a secondary ethical issue at play. The more important ethical issue is a question of social justice: what commitment do doctors have to poor patients and making sure that they get the health care services that they need?

Social Justice as Part of Professionalism, and its Avoidance

The article by Glenn then emphasized that some of the original conceptions of physicians' professionalism included social justice.  A definition promulgated by Herbert Swick in 2000 expressly included these relevant competencies.  Physicians ought to:
-  subordinate their own interests to the interests of others
-  respond to social needs and work toward the benefit of the communities in which they live and serve
-  adhere to the core humanistic values of honesty and integrity, compassion, altruism, empathy, respect for others, and trustworthiness.


Glenn noted that these three competencies, however, have been turned into a more narrow imperative, that

doctors should treat patients with an equally high quality irrespective of their race, ethnicity, gender, religion or cultural background according to what is best for them. In most codes of professionalism, however, class is not expressly implicated.

Note that Glenn did not question why the issues of race, ethnicity, gender, religion, or cultural background became important in this context.  He did further question why the issue of class did not.  While

 The professionalism code adopted by the American Board of Internal Medicine in 1999 was bolder and specifically states that doctors are to advocate for 'the best possible care [for their patients] regardless of the ability to pay'

Glenn asked

 But where in the medical school curriculum do we teach medical students to be strong patient advocates and take on third party payers and hospital administrators? We now discuss the importance of prescribing generic drugs and we warn against the influence of big pharma, but when do we teach students to rebel against the high cost of medical education that drives students toward boutique medicine and fields of specialty care that offer the most money and most comfortable lifestyles?

Furthermore, he noted,

 When it comes to justice in medical ethics instruction, the parameters of the discussion are usually constricted to focus on the conservation of health care resources and rationing care rather than providing more care to more patients.

So, now seemingly getting to the key question,

We have created an entire system where all the middlemen that stand between a patient and her health care are expecting to get rich. No oath or professionalism curriculum is structured to teach medical students how to ethically and morally navigate through that. How did the terms of the debate get so co-opted by the health care economists?

The Key Question also Avoided

However, after this build up, Glenn then had trouble grappling with that question.  He noted that the prices of various parts of US health care are rarely questioned, and wrote about some of the particular issues in pricing new technologies, including the costs of development of new drugs, the tax treatment of drug development, and whether the licenses drug companies obtain from universities to develop drugs are fairly priced.  He also touched on the rising cost of medical school tuition and students' consequent assumption of large levels of debt.  This was interesting, and provided some useful references, but never really directly addressed the key questions above: why was the discussion framed in terms only of current health economics, and more importantly,  why did he and other ethicists feel they could not openly discuss any larger issues?

Only at the very end of the article did this appear

the structure of our current medical system has created a network of health care providers, researchers, purveyors and administrators who have strong financial incentives to work against the best interests of patients. This situation makes it difficult to talk with students about the ethical principle of justice in any meaningful way that is not hypocritical, leaving it seldom emphasized relative to the other three core principles of medical ethics.

Glenn did not further explain these "financial incentives," detail further who had them, explain how they "work against the best interests of patients," and most importantly, explain how these incentives make "it difficult to talk with students about the ethical principal of justice in any meaningful way that is not hypocritical."  He concluded only

 How can we cultivate within our students an understanding of the threats to medical professionalism posed by the conflicts of interest inherent in the various financial and organizational arrangements in the practice of medicine?  We start by not shying away from the conversation.

Summary

So Professor Glenn argued that social justice has been considered part of health care ethics, and that ethicists should teach about it by questioning the current economic arrangements within the health care system.  He then suggested that ethicists have been somehow pressured not do raise such questions, and that this pressure has something to do with perverse incentives and conflicts of interest prevalent within health care.  However, he never actually addressed who pressured the ethicists, how the pressure was applied, and how that pressure was related to conflicts of interest.

Thus, it seems that authors in scholarly health care journals may now hint that there are certain things one must not discuss, that are taboo to discuss in health care, but cannot actually say what exactly is taboo, and why it became that way.  Thus, the article by Glenn seems related to what we sometimes coyly call the "anechoic effect,"  that the issues we discuss on Health Care Renewal often do not seem to be considered topics of polite conversation.  But in a strange recursive way, the article never could quite manage to discuss what it is it said others cannot discuss, which in a way just further validates the importance of the anechoic effect.

The Glenn article is reminiscent of another article we posted about.  That article, by Souba and colleagues,  found that there are many "elephants," that is,  unmentionable subjects, in academic medicine,  However, that article also never clearly defined what these unmentionable subjects actually are, other than subjects that displease those in power.  Thus this too reinforced just how taboo these topics are.  Even those willing to admit that taboo topics exist are still unable to name them.

At least the Glenn article did suggest, however vaguely, a relationship between conflicts of interest and the anechoic effect.  We have documented that individual and institutional conflicts of interest are rampant in health care, including, and probably particularly academic medicine.  For example, pharmaceutical companies (and also all sorts of other health care corporations) may pay medical school faculty members and administrators (as consultants, "key opinion leaders," speakers, advisers, even board members).  The leaders of academic medicine seem particularly prone to such conflicts. For example, a majority of US medical school department chairs have significant financial relationships with health care corporations (see post here).  We have shown how top medical school leaders may simultaneously serve on the boards of directors of health care corporations (see post here). Such health care corporations may now also support various aspects of medical academia (through research grants, "unrestricted" and other educational grants, other gifts to hospitals and universities, etc).  Financial conflicts of interest may help to directly enrich many faculty and academic leaders, and indirectly enrich them by enriching their organizations. People who are personally profiting from relationships with health care corporations are unlikely to question such relationships.  The leaders of organizations which depend on funding from such corporations are unlikely to question whether conflicts of interest might lead to corruption.  People whose colleagues, friends, family members, or supervisors are personally benefiting from conflicts of interest may hesitate to challenge such relationships.   Since these relationships permeate the economics of health care, is it any wonder that the entire topic has become taboo?  

So the first step in challenging this taboo is to acknowledge it exists, and to not "shy away" from discussing it, as Glenn suggested.  People are beginning to acknowledge there is an elephant in the room.  Now we have to describe the elephant, discuss the elephant, and eventually figure out how to get the elephant out of the room.     

Hat tip - to the Medical Professionalism Blog.

Good HIT, Bad HIT, HIMSS And Reckless Technology Advocacy: Will This Hurt President Obama?

HIMSS, the Health Information Systems Management Society, is the large vendor trade group representing healthcare IT sellers.

At the HIMSS blog entitled "Health IT is an essential element to transform the Nation’s healthcare system" (link), Carla M Smith, MA, CNM, FHIMSS writes this with regard to the House  letter to HHS Secretary Sebelius asking her to suspend payments for the EHR Incentive Payments authorized in the American Recovery & Reinvestment Act of 2009:

HIMSS opposes halting the Meaningful Use EHR Incentive Program. Health IT is an essential, foundational element of any meaningful transformation of the Nation’s healthcare delivery system. 

(Of course, not mentioned is "transformed" into what, exactly; this utopian ideation is a topic for another time.)

A chart is then presented as to "how US civilian hospitals have, since the first incentive payments were made in second quarter, 2011, matured in their use of health IT."  Then this statement is made:

Healthcare providers are adopting certified EHRs and using them for meaningful purposes; thus, achieving Congressional intent to improve the quality, safety, and cost-effectiveness of care in U.S.

Really?  (See my Feb. 2012 post "Hospitals and Doctors Use Health IT at Their Own Risk - Even if Certified.")

This non-evidence based, amoral advocacy by HIMSS for health IT may cost the President the November election.  HIMSS has beguiled the president into similar unquestioning advocacy for the technology in its present form, which his opponents are now (rightfully) seizing upon as in the House letter.

The reckless mistakes made by HIMSS and their advocates include these two:

1.   The unquestioned belief that this expensive technology would save billions of dollars in healthcare costs, instead of depleting precious healthcare resources better spent on, say, improvement of healthcare services for the poor.

2.  More importantly, the appallingly naïve belief that any health IT is good health IT, and that any health IT is only capable of good, not bad.

HIMSS has thus failed to recognize - or perhaps worse, recognized but recklessly ignored - the profound difference between good health IT (GHIT) and bad health IT (BHIT).

As I defined at my teaching site on Medical Informatics:

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.  

I am an advocate of the former, and an opponent of the latter.

Bad health IT is prevalent in 2012 due to lack of meaningful quality control, software validation, usability standards and testing, and regulation of any type - a situation HIMSS long favored.   (The failed National Programme for HIT [NPfIT] in the NHS learned this the hard way, as will Australians needing emergency care, I predict.)

Put bluntly, in the end BHIT maims and kills patients, squanders precious healthcare resources, and drains the treasury into IT industry pockets (see my Oct. 3, 2012 post "Honesty and Good Sense on Electronic Medical Records From Down Under" and this query link on health IT risks). 

Further, the failure to recognize that the technology's downsides need to be understood and remediated before national deployment occurs and under controlled conditions, not after (which uses patients as non-consenting experimental subjects for software debugging), speaks to gross corporate negligence on the part of HIMSS.  It's not as if they did not have advance warning of all of healthcare IT's deficiencies. 

BHIT also permits record alterations after the fact that may be to conceal medical error.  I am aware of numerous instances of such alterations, fortunately caught by critical-thinking, detail-minded attorneys.  However, like health IT harms, the incidences of known alteration attempts likely reflect the "tip of the iceberg."

HIMSS and its fellow travelers have thus led this administration down the Garden Path of health IT perdition.

I warned of this in a Feb. 18, 2009 Wall Street Journal letter to the editor:

Dear Wall Street Journal:

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. [That project, the NPfIT in the NHS, has now been abandoned - ed.]

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, MD

Mr. President, again, quite bluntly, the health IT industry took you for a ride, and the damage is done and is continuing due to lack of any meaningful health IT post market surveillance.   (As I wrote here, the untoward results have already been used against the current administration, with more perhaps to follow.)

In the U.S. we have the 1938 Federal Food, Drug, and Cosmetic Act (FD&C Act) in place:

The introduction of this act was influenced by the death of more than 100 patients due to a sulfanilamide medication where diethylene glycol was used to dissolve the drug and make a liquid form.  See Elixir Sulfanilamide disaster. It replaced the earlier Pure Food and Drug Act of 1906.

It should be honored, not ignored via special accommodation to the health IT industry and its trade group.

HITECH also needs to be put in dormancy until the problems with these unregulated medical devices get worked out in relatively small, controlled settings to minimize risk, with patient informed consent.  This is in accord with human rights documents dating at least to the Nuremberg Code, as in any new, experimental or partly-experimental medical device, pharmaceutical, or therapy.

-- SS
 

HIMSS Senior Vice President on Medical Ethics: Ignore Health IT Downsides for the Greater Good

The Health Information Management Systems Society (HIMSS) is the large health IT vendor trade group in the U.S.  At a Sept. 21, 2012 HIMSS blog post, John Casillas, Senior Vice President of HIMSS Financial-Centered Systems and HIMSS Medical Banking Project dismisses concerns about health IT with the refrain:

... To argue that the existence of something good for healthcare in many other ways, such as having the right information at the point of care when it’s needed, is actually bad because outliers use it to misrepresent claims activity is deeply flawed.

Through the best use of health IT and management systems, we have the opportunity to improve the quality of care, reduce medical errors and increase patient safety. Don’t let the arguments of some cast a cloud over the critical importance and achievement of digitizing patient health records.

Surely, no one can argue paper records are the path forward. Name one other industry where this is the case. I can’t.

Let’s not let the errors of a few become the enemy of good.

The ethics of these statements from a non-clinician are particularly perverse.

The statement "Don’t let the arguments of some cast a cloud over the critical importance and achievement of digitizing patient health records" is particularly troubling.

When those "some" include organizations such as FDA (see FDA Internal 2010 memo on HIT risks, link) and IOM's Committee on Patient Safety and Health Information Technology (see 2012 report on health IT safety, link) both stating that harms are definite but magnitude unknown due to systematic impediments to collecting the data, and the ECRI Institute having had health IT in its "top ten healthcare technology risks" for several years running, link, the dismissal of "clouds" is unethical on its face.

These reports indicate that nobody knows if today's EHRs improve or worsen outcomes over good paper record systems or not.  The evidence is certainly conflicting (see here).

It also means that the current hyper-enthusiasm to roll out this software nationwide in its present state could very likely be at the expense of the unfortunate patients who find themselves as roadkill on the way to the unregulated health IT utopia.

That's not medicine, that's perverse human subjects experimentation without safeguards or consent.

As a HC Renewal reader noted:

Astounding hubris, although it does seem to be effective.  Such is PC hubris.  Who could ever call for reducing the budget of the NIH that is intended to improve health.  Has health improved?  No.

So why does a group with spotty successes if not outright failure never get cut?  It’s not the results, it’s the mission that deserves the funding.  So it’s not the reality of HIT, it’s the promise, the mission, that gets the support.  Never mind the outcome, it’s bound to improve with the continued support of the mission.

Is this HIMSS VP aware of these reports?  Does he even care?

Does he believe patients harmed or killed as a result of bad health IT (and I know of a number of cases personally through my advocacy work, including, horribly, infants and the elderly) are gladly sacrificing themselves for the greater good of IT progress?

It's difficult to draw any other conclusion from health IT excuses such as proffered, other than he and HIMSS simply don't care about unintended consequences of health IT.

Regarding "Surely, no one can argue paper records are the path forward" - well, yes, I can.  (Not the path 'forward', but the path for now, at least, until health IT is debugged and its adoption and effects better understood).  And I did so argue, at my recent posts "Good Health IT v. Bad Health IT: Paper is Better Than The Latter" and "A Good Reason to Refuse Use of Today's EHR's in Your Health Care, and Demand Paper".  I wrote:

I opine that the elephant in the living room of health IT discussions is that bad health IT is infrequently, if ever, made a major issue in healthcare policy discussions.

I also opine that bad health IT is far worse, in terms of diluting and decreasing the quality and privacy of healthcare, than a very good or even average paper-based record-keeping and ordering system.  

This is a simple concept, but I believe it needs to be stated explicitly. 

A "path forward" that does not take into account these issues is the path forward of the hyper-enthusiastic technophile who either deliberately ignores or is blinded to technology's downsides, ethical issues, and repeated local and mass failures.

If today's health IT is not ready for national rollout, e.g., causes harms of unknown magnitude (e.g., see this query link), results in massive breaches of security as the "Good Reason" post above, and mayhem such as at this link, then:

The best - and most ethical - option is to slow down HIT implementation and allow paper-based organizations and clinicians to continue to resort to paper until these issues are resolved.  Resolution needs to occur in lab or experimental clinical settings without putting patients at risk - and with their informed consent.

Anything else is akin to the medical experimentation abuses of the past that led to current research subjects protections such as the "Ethical Guidelines & Regulations" used by NIH.

-- SS

Know-Nothing, or Industry Shill? You Be The Judge.

I have not been writing much the past few weeks due to other concerns, and will probably not write much this summer.

However, I have been commenting on various posts on other blogs.  One resultant thread stands out as yet another example of a likely industry shill or sockpuppet defending the state of health IT, oddly at a blog on pharma (same blog as was the topic of tmy post "More 'You're Too Negative, And You Don't Provide The Solution To The Problems You Critique', This Time re: Pharma").

Industry-sponsored sockpuppetry is a form of stealth marketing or lobbying, through discreditation of detractors, although in a perverse form.

The following exchanges meet the sockpuppetry criteria once pointed out by business professional and HC Renewal reader Steve Lucas in 2010 in a post about an industry sockpuppet caught red-handed through IP forensics here:

... In reading this thread of comments I have to believe [anonymous commenter moniker] "IT Guy" is a salesperson. My only question is: Were you assigned this blog or did you choose it? We had this problem a number of years ago where a salesperson was assigned a number of blogs with the intent of using up valuable time in trying to discredit the postings.

In my very first sales class we learned to focus on irrelevant points, constantly shift the discussion, and generally try to distract criticism. I would say that HCR is creating heat for IT Guy’s employer and the industry in general.

I find it sad that a company would allow an employee to attack anyone in an open forum. IT Guy needs to check with his superiors to find out if they approve of this use of his time, and I hope he is not using a company computer, unless once again this attack is company sanctioned.

In the hopes that continued exposure of this nonsense can educate and thus help immunize against its effects, I present this:

At "In the Pipeline", a blog on medicinal chemistry (the science of drug making) and other pharma topics, a rebuttal to a claim that over 500,000 people (not 50K) might have died due to VIOXX was posted entitled "500,000 Excess Deaths From Vioxx? Where?"

That 500K possibility appeared on a UK site 'THE WEEK With the FirstPost' at "When half a million Americans died and nobody noticed."  The author of the FirstPost piece started out by raising the point made by publisher Ron Unz that life in China might be more valued than that in the U.S., where major pharma problems and scandals generally meet what this blog calls "the anechoic effect."  (In China, Unz noted, perpetrators of scandalous drug practices actually get arrested and suffer career repercussions.)

FirstPost notes:

ARE American lives cheaper than those of the Chinese? It's a question raised by Ron Unz, publisher of The American Conservative, who has produced a compelling comparison between the way the Chinese dealt with one of their drug scandals – melamine in baby formula - and how the US handled the Vioxx aspirin-substitute disaster ... (Unz) "The inescapable conclusion is that in today's world and in the opinion of our own media, American lives are quite cheap, unlike those in China." 

Not to argue to merits of the order of magnitude-expanded VIOXX claim, which I disagree with, but having concern for the general state of ethics in biomedicine in the U.S., I posted the following comment at the comment thread of the rebuttal post at "In the Pipeline" at this link:

6. MIMD on May 30, 2012 11:38 AM writes...

While I agree the VIOXX numbers here are likely erroneous, the point of the cheapening of the value of American life is depressingly accurate.

For instance, look how readily companies lay people off, ruining them, and perhaps forcing them out of the workforce forever.

Also, currently being pushed by HHS is a medical device for rapid national implementation known to cause injury and death. The government is partially financing it to the tune of tens of billions of dollars, probably with Chinese money no less.  [Either that, or with freshly-printed money adding to the trillions of $ in our deficit - ed.]

There are financial penalties for medical refuseniks (non-adopters).

However, FDA, the Institute of Medicine and others readily admit in publication thay have no idea of the magnitude of the harm because of lack of data collection, impediments to information diffusion and even legal censorship of the harms data. In effect, we don't even know if the benefits exceed the harms, and FDA and IOM admit it. FDA in fact refers to the known injuries and deaths from this device as "likely the tip of the iceberg."

Perhaps to some it's no longer a big deal if people are injured and/or die in data gathering for this medical enterprise.

E.g., see "FDA Internal Memo on H-IT Risks", and the Inst. of Medicine report in the same issues here.

It's all for the greater social good, they might say.

 

The following anonymous reply ensued:

10. Watson on May 30, 2012 1:47 PM writes...

@6 You keep using that word - "device" - I do not think it means what you think it means

 

I replied:

11. MIMD on May 30, 2012 3:48 PM writes...

 #10

'medical device' is the term chosen by FDA and SMPA (EU).
But that's a distraction from the points I raise in the linked post about the experiment.

To which this confused misdirection came forth from the ether:

12. Watson on May 30, 2012 4:46 PM writes...

The linked article is discussing the poor state of "medical device records" because of a lack of uniform specifications with respect to Health Information Technology, i.e. how these technologies code data and the challenges of making the data obtained uniform across a wide variety of implementations and vendors. [Erroneous, incomplete misdirection - ed.]

It seems that the concern, far from being that Health Information Technology is "killing" people, is that the Medical Device Records may contain duplicate reports for adverse health events because of health care providers encoding the data more than once for each event.  [What in the world? - ed.] This problem with replication exists because there are different health record systems where this data needs to be input, and perhaps the same patient uses different physicians who have different systems, but all of which are required to report adverse events. [I have little idea what this even means - ed.]

In other words, "Health Information Technology" is not some monolithic "device", and your conflation of "HIT" which is more properly an abstract term with the "devices" which are used to generate some forms of patient data is in my view the real distraction. [The "real" distraction from the ethical issues of the HIT experiment is terminology about medical devices?  Misdirection again from the ethical issue, and of a perverse nature - ed.]

Yes, some of the "devices" (a blood pressure monitor for example) may have underlying issues, which the FDA regulations for "medical device records" are designed to identify. The FDA, as a governmental entity has no constitutional power to mandate certain devices or implementations are to be used.  [Now we're in la-la land of misinformation and distraction- ed.] The power that the FDA does have is to inspect that the manufacturer of a device keeps appropriate medical device records (e.g. a lot of syringes, or a batch of formulated drug) and addresses any complaints about the device to the satisfaction of the FDA.

My replies:

17. MIMD on May 31, 2012 8:51 PM writes...

#12

It seems that the concern, far from being that Health Information Technology is "killing" people, is that the Medical Device Records may contain duplicate reports for adverse health events because of health care providers encoding the data more than once for each event

Yes, fix just that little problem and then the problems with clinical IT are solved! (Actually,I'm not even sure what you're referring to, but the evidence is that fixing it as you suggest is the cure.)  [Sarcasm - ed.]

The FDA, as a governmental entity has no constitutional power to mandate certain devices or implementations are to be used.

You are also right about FDA. They were completely toothless even in this situation.  [Sarcasm again - ed.]

18. MIMD on May 31, 2012 9:10 PM writes...

#12

In other words, "Health Information Technology" is not some monolithic "device", and your conflation of "HIT" which is more properly an abstract term with the "devices" which are used to generate some forms of patient data is in my view the real distraction.

Those who conducted the Tuskegee experiments probably felt the same way.

It's all about definitions, not ethics, and not data - which FDA as well as IOM or the National Academies, our highest scientific body, among others, admits, as in the linked posts in #6, is quantitatively and structurally lacking on risks and harms.

I don't really mean to laugh at you, not knowing how little you really know about the Medical Informatics domain, but you bring to mind this Scott Adams adage on logical fallacy:

FAILURE TO RECOGNIZE WHAT’S IMPORTANT
Example: My house is on fire! Quick, call the post office and tell them to hold my mail!

And with that, I move on, letting others enjoy the risible comments from surely to follow! :-)

I could not have been more correct.

In typical industry shill/sockpuppet fashion comes this, with clear evidence of a not-so-clever liar which I've bolded:

19. Watson on June 1, 2012 12:35 AM writes...
@18

I read the articles you originally linked to, and my comments were based upon trying to interpret your meaning from those selections. I worked in the industry and had to deal with GMP, and had to make sure to follow all of the guidelines with respect to medical device manufacturing and electronic records. I understand the terminology very well. Luckily, I never had to deal with "health IT", but I did have to pore over enough pages of Federal Register legalese to know that what is sufficient is not necessarily what is best.  [Right.  See below - ed.]

Is that risible enough for you?

The link that you provided in @17 was a much more concrete example, and if you had referenced it in your original post, would have cleared up much of the confusion that I (and I assume @9) faced in understanding what it was you were trying to convey. It would have been useful if you had explained which device or devices you were talking about. If you had more than conjecture to back up the Chinese money trail, and if you had provided an example of a company that has been damaged by being a refusenik, those would have supported your argument as well. [Continuing haphazardly with the irrelevant as a distraction in an attempt to shift the focus from the ethical issue of nationally implementing HIT in a relative risk-information vacuum, having weakly conceded the main argument's been lost - ed.]

Straw man and ad hominem fallacies are pretty transparent around here, and I wish you the best with both. [Another attempt at diversion - ed.]

I assure you that I recognize what's important, that I have ethics, and that I care about people having reliable healthcare. [This seems a form of post-argument-lost attempt to seize the moral high ground - ed.]

I then point out the nature of what is likely a bold-faced lie.  Someone who's read the Federal Register in depth would likely know FDA's authority is not a "Constitutional power", as bolded below: 20. MIMD on June 1, 2012 6:44 AM writes... @19 The FDA taxonomy of HIT safety issues in the leaked Feb. 2010 "for internal use only" document "H-IT Safety Issues" available at the link in my post #6 is quite clear: - errors of commission - errors of omission or transmission - errors in data analysis - incompatibility between multi-vendor software applications or systems This is further broken down in Appendices B and C, with actual examples. Both this FDA internal report and the public IOM report of 2011 (as well as Joint Commission Sentinel Events Alert on health IT of a few years ago, and others) make it abundantly clear there is a dearth of data on the harms, due to multiple cultural, structural and legal impediments to information diffusion. Yes, it's in the linked IOM report at #6 entitled "Health IT and Patient Safety: Building Safer Systems for Better Care". See for instance the summary pg. S-2 where IOM states about limited[ed] transparency on H-IT risk that "these barriers to generating evidence pose unacceptable risks to safety." Argue with them, not me. Back to my original point: national rollout of this medical device (whatever you call it is irrelevant to my point, but see Jeff Shuren's statement to that effect here) under admitted conditions of informational scarcity regarding risks and harms represents a cheapening of the value of patient's lives. Cybernetics Over All. As to your other misdirection, spare me the lecture. It's not ad hominem to call statements like "The FDA, as a governmental entity has no constitutional power to mandate certain devices or implementations are to be used" for what they are - laughable (and I am being generous). FDA's authority is statutory, not written in the Constitution. Same with their parent, HHS. To get quite specific, on human subjects experimentation, which the H-IT national experiment is, the statutory authority for HHS research subject protections regulations derives from 5 U.S.C. 301; 42 U.S.C. 300v-1(b); and 42 U.S.C. 28. [The USC or United States Code is the codification by subject matter of the general and permanent laws of the United States.  HHS revised and expanded its regulations for the protection of human subjects in the late 1970s and early 1980s. The HHS regulations on human research subjects protections themselves are codified at 45 CFR (Code of Federal Regulations, aka Federal Register) part 46, subparts A through D. See http://www.hhs.gov/ohrp/humansubjects/guidance/. - ed.] A real scientist would have known things like this before posting, or have made it their business to know. Tell me: are you in sales? Not to point fingers, but with your dubious evasion of the ethical issue that was the sole purpose of my post, and your other postings using misdirection and logical fallacy to distract, you fit that mindset. You certainly don't sound like a scientist. Any med chemist worth their salt (pun intendend) would have absorbed the linked reports and ethical issues accurately, the first time. I then pointed out I've moved this 'discussion' to the HC Renewal Blog, as it is not relevant per se to pharma, the major concern of In the Pipeline. Industry shill/sockpuppet (as in the perverse example at this link) or just a dull, ill-informed but opinionated person who happens to read blogs for medicinal chemists, where layoffs have been rampant in recent years, takes issue with my attacks on those practices, and defends health IT like a shill? You be the judge. Whether a shill or know-nothing contributed the cited comments, it is my hope this post contributes to an understanding of pro-industry sockpuppetry. -- SS