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

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

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

Deal could endanger health care law

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

Politico.com

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

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

My suggestion:

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

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

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

Note what just occurred in the UK:

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

-- SS

US House of Representatives Proposes to Defund Largest Non-Consented Medical Experiment in U.S. History: HITECH

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

Spending Reduction Act of 2011

... TITLE III—RESCISSION OF UNOBLIGATED STIMULUS FUNDS AND REPEAL OF CERTAIN STIMULUS PROVISIONS

SEC. 301. RESCISSION OF UNOBLIGATED STIMULUS FUNDS.

Effective on the date of the enactment of this Act, there are rescinded all unobligated balances of the discretionary appropriations made available by division A of the American Recovery and Reinvestment Act of 2009 (Public Law 111–5).

SEC. 302. REPEAL OF CERTAIN STIMULUS PROVISIONS.

Effective on the date of the enactment of this Act, subtitles B and C of title II and titles III through VII of division B of the American Recovery and Reinvestment Act of 2009 (Public Law 111–5) are repealed, and the provisions of law amended or repealed by such provisions of division B are restored or revived as if such provisions of division B had not been enacted.

Division A of the ARRA Act of 2009 (link to PDF) includes this:

SECTION 1. SHORT TITLE.
This Act may be cited as the ‘‘American Recovery and Reinvestment Act of 2009’’.

SEC. 2. TABLE OF CONTENTS.

... The table of contents for this Act is as follows:

DIVISION A—APPROPRIATIONS PROVISIONS

... TITLE XIII—HEALTH INFORMATION TECHNOLOGY

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

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

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

It looks like HITECH is one of a number of spending extravaganzas now on the proposed chopping block.

I can't be too sorry about this for these reasons:

• This country cannot afford HITECH at this time. We are broke, with some calling the economic crisis of 2008 worse than the crisis of 1929, and the national deficit ballooning far out of control. The money would be far better spent at this time on care of those who cannot afford it.
  

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

• Mass social experiments involving major systemic changes to our healthcare delivery system, with exceptional claims being made about IT, need to be backed by exceptional evidence. That evidence is lacking. (March 2011 addendum: the evidence might actually be in the negative direction. See my post "An Updated Reading List on Health IT.")
  

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

While this House Bill is just the initial battle in the repeal of this and other mass expenditures, I would not weep for the HITECH act's passing. It would allow the restoration of health IT back to an unrushed and careful endeavor. It would also give time to work out the significant issues causing health IT difficulty (such as raised in 2009 by our National Research Council) before we embark on national diffusion.

In other words, its passing would reduce risk and help restore an essential level of sanity and due diligence to the healthcare IT sector, now afflicted by irrational exuberance bordering on delirium. We would avoid the largest non-consented medical experiment in US history, which as I have repeatedly written I feel would be disastrous with current levels of understanding of this technology and how to design, deploy and manage it. (My relative's 2010 HIT-related injuries only strengthened my convictions in this regard.)

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

The next few months should be an interesting time in the politics of healthcare IT.

A replacement HITECH act that's "HI" on research and caution, but not so "HIGH" on stealth, coercion and euphoria (i.e., as on mind altering substances) would be welcomed.

-- SS

Professors at Harvard and Nottingham Medical School (UK): Are we repeating the UK's clinical IT failures in the US?

In the opinion piece "Don't Repeat the UK's Electronic Health Records Failure" (Huffington Post, Dec. 5, 2010), Dr. Stephen B. Soumerai, Professor of Population Medicine at Harvard Medical School and Dr. Anthony Avery, Professor of Primary Care at the University of Nottingham Medical School, UK share familiar themes on health IT.

These themes will be especially familiar to HC Renewal readers and to my students and other readers of my Medical Informatics teaching website.

The professors wrote:

Fueled by the economic stimulus passed by Congress in 2008 [The ARRA a.k.a. "American Recovery and Reinvestment Act" and the HITECH legislation it contained - ed.], the federal government has embarked on a controversial $30 billion program to induce doctors throughout the country to adopt electronic health records (EHRs) by 2014. The purpose is to create an interconnected system of electronic health records to improve safety and reduce medical costs.

But the United Kingdom has spent the last 6 years working on the same idea, and it's proven to be a colossal failure -- so much so that the government is drastically cutting its program. What happened to their plan? Should we be paying attention before rushing ahead with our own?

My response to that question is clear, such as at my Nov. 2008 post "Should The U.S. Call A Moratorium On Ambitious National Electronic Health Records Plans?" and the followup Jan. 2009 post "I Ask Again: Should The U.S. Call A Moratorium On Ambitious National Electronic Health Records Plans?" where I wrote:

$50 billion a year is big money that might be better spent elsewhere - such as providing care for the poor and for disadvantaged children - until we know how to get HIT right.

I suggest it may be best not to go all-out for HIT under the current paradigm. It is my belief, in fact, based on the above issues [UK and US issues - ed.] plus a chronic influx of HIT difficulty and mismanagement stories I hear from colleagues, ex-colleagues, recruiters, etc., that healthcare organizations not contractually obligated should consider a postponement of plans to purchase clinical IT (i.e., systems for direct use by clinicians such as EHR's).

This postponement should last at least until the issues that lead to ineffective and counterproductive HIT can be better understood and corrections initiated in the industry.

The professors further write:

In 2005 the United Kingdom embarked on the largest investment ($18 billion) in health information technology in the world. Yet despite expectations that the system would increase efficiency and reduce medical errors, their efforts neither improved health nor saved money -- in fact in some cases, they may have led to patient harm.

Britain's government-run medical system is obviously different from our complex public-private insurance system. [I had written that a smaller, socialized healthcare system should be far easier to automate than our own in the US - ed.] However, its electronic health record project bears an uncanny resemblance to the program President Obama is starting.

They then delineated a number of problems:

Too large and ambitious: The UK project tried to accomplish too much, too fast, attempting to digitize health records for the whole population in a period of four years. This massive undertaking is years behind schedule and has delivered only a fraction of what it promised. Despite all the money poured into the system, the vast majority of hospitals in the UK still don't have integrated electronic health records.

Why? The reasons sound familiar:

... Because non-clinicians developed the system, the electronic forms they designed have little to do with how doctors treat patients -- making it unworkable for many physicians. As the Chair of the British House of Commons Public Accounts Committee recently stated, "This is the biggest IT [Information Technology] project in the world and it is turning into the biggest disaster."

The "biggest IT disaster in the world" is not an honor I wish to see repeated in the U.S.

On another familiar problem:

Too dependent on commercial, proprietary companies: Rather than create one system and beta-test it, the UK government depended on four companies to build the system, two of which quit or were fired for missing deadlines. So the health records were never developed in the south of England. The computer software was secret and proprietary. There was no accountability to the public, and the vendors did not provide enough technical support to clinicians having trouble using the records.

The resulting software errors and crashes caused missing or incorrect clinical information and sometimes threatened patient safety, for example by causing surgical delays and the cancellation of hundreds of operations.

The inquiring mind would want to know about actual patient injuries and deaths that likely resulted from such problems...

The professors observe:

If a country like Britain -- which already has a national health system and is a fraction of the size of the US -- had so many problems with electronic health records, imagine the problems America would face.

This sounds like my comments in a public comment letter of March 9, 2010 to HHS/ONC (Re: RIN 0991-AB59, "Proposed Establishment of Certification Programs for Health Information Technology") where I wrote, among many other things:

... We ignore the UK experience at our peril, an experience in a medical environment smaller and far more government-controlled than our own.

... I believe that a rushed National Program for HIT in the United States will suffer the same fate as the aforementioned National Programme for IT in the UK, and perhaps even a worse fate as the UK’s socialized medicine system is certainly a smaller, more homogeneous and more controllable testbed environment for experimenting with HIT.

The professors relate:

Even our partial adaption of electronic health records is causing problems. Over the last couple of years, doctors and hospitals have reported to the FDA dozens of medical injuries -- including six deaths and preventable heart attacks -- caused by problems related to computerized health records such as software errors and unreadable computer screens. Some errors resulted in drug doses that were 10 times higher than intended. FDA officials called this the "tip of the iceberg."

I wrote about the FDA's findings here, and conducted a "thought experiment" regarding what those numbers might extrapolate out to in my April 2010 post "If The Benefits Of Healthcare IT Can Be Guesstimated, So Can And Should The Dangers."

They continue:

... More than 50 medical organizations, including the AMA, have called on the Secretary of Health and Human Services to delay the program. In response, the administration delayed some of the required health IT functions, but kept the same 2014 deadline.

Indeed. They are courting disaster in my opinion, both clinically and financially, as I wrote in a Feb. 2009 Wall Street Journal letter to the editor entitled “Digitizing Medical Records May Help, but It's Complex”:

Dear WSJ,

You observe that the true political goal is socialized medicine facilitated by health care information technology. You note that the public is being deceived, as the rules behind this takeover were stealthily inserted in the stimulus bill.

I have a different view on who is deceiving whom. In fact, it is the government that has been deceived by the HIT industry and its pundits. Stated directly, the administration is deluded about the true difficulty of making large-scale health IT work. The beneficiaries will largely be the IT industry and IT management consultants.

For £12.7 billion the U.K., which already has socialized medicine, still does not have a working national HIT system, but instead has a major IT quagmire, some of it caused by U.S. HIT vendors.

HIT (with a few exceptions) is largely a disaster. I'm far more concerned about a mega-expensive IT misadventure than an IT-empowered takeover of medicine.

The stimulus bill, to its credit, recognizes the need for research on improving HIT. However this is a tool to facilitate clinical care, not a cybernetic miracle to revolutionize medicine. The government has bought the IT magic bullet exuberance hook, line and sinker.

I can only hope patients get something worthwhile for the $20 billion.

The professors then note:

How do we avoid the UK's failure? The administration or Congress should slow down the program and delete those parts of the legislation that fine doctors for not using this technology. There's no need to have this system in place by 2014. Instead, we should conduct rigorous studies of the cost-effectiveness of electronic health records systems before mandating their use. Rather than force doctors to choose from dozens of commercial software products developed in secret, we should take a hint from the non-commercial sector, such as the Veterans Administration, which uses "open-source" coding so people can work collaboratively to continuously improve the system.

Slowing down the program and performing rigorous studies of HIT before wide scale rollout are themes I raised, among other places, in my Dec. 2009 post "Tensions and Paradoxes in Electronic Patient Record Research: Critical Thinking on Health IT" where I wrote:

In conclusion, I believe this literature review supports the notion expressed in other studies and opinion pieces here and elsewhere that we really need to SLOW DOWN the current HIT stampede, largely promoted by the HIT industry lobby. We need to take the appropriate time to better understand how to "do HIT well" before plunging in as if we actually know what we're doing

as well as at my Oct. 2009 post "Washington Post Article: Electronic medical records not seen as a cure-all" where I wrote:

... The literature is indeed conflicting, and the need for rigorous scientific study has never been more essential considering the commitment of tens of billions of dollars towards health IT. The time for story telling, marketing based on opinion, name calling, leap-of-faith extrapolations of light year dimensions, and other forms of pseudoscience and non-science are over. The time for objective study is now.

The professors conclude:

The Obama administration wants government programs to be based on evidence of effectiveness. Simply following the lead of "IT believers" and salesmen without the requisite evidence will repeat the UK's failures. Now is the time to proceed carefully, consider existing research and the British experience, and chart a more rational course into the digital age of medicine.

I do not know if these two professors were familiar with my writings, but I am happy to see these themes (once treated as verboten and as grounds for marginalization by the HIT industry) increasingly going mainstream.

Patient well being - which includes you, dear readers - depends on that.

-- SS

Cart before the horse, again: IOM to study HIT patient safety for ONC; should HITECH be repealed?

In my July 2010 post "Meaningful Use Final Rule" I pointed out the cart-before-the-horse problem of creating "meaningful use" rules for health IT before usability issues were resolved:

From the HIMSS EHR Usability Task Force, June 2009:

Electronic medical record (EMR) adoption rates have been slower than expected in the United States, especially in comparison to other industry sectors and other developed countries. A key reason, aside from initial costs and lost productivity during EMR implementation, is lack of efficiency and usability of EMRs currently available. Achieving the healthcare reform goals of broad EMR adoption and “meaningful use” will require that efficiency and usability be effectively addressed at a fundamental level.

These "usability" problems require long term solutions. There are no quick fix, plug and play solutions. Years of research are needed, and years of system migrations as well for existing installations.

Yet we now have an HHS Final Rule on "meaningful use" regarding experimental, unregulated medical devices the industry itself admits have major usability problems, along with a growing body of literature on the risks entailed.

For crying out loud, talk about putting the cart before the horse...

Something's very wrong here...

Here we go again.

"Ready ... fire ... aim" seems the postmodern approach to healthcare IT:

Institute to study HIT patient safety for ONC
Mary Mosquera

Government Health IT, Thursday, September 30, 2010

The Institute of Medicine (IOM) announced it will conduct a year-long study for the Office of the National Coordinator for Health IT to identify best policies and practices for improving healthcare safety when using electronic health records.

The IOM, an arm of the National Academy of Sciences, will examine prevention of health IT-related errors, rapid reporting of patient safety concerns [To whom? The vendor, as now, so they can sit on the problems until it suits them to fix it? In the face of contractual gag clauses, I'm not sure where else such reports can go - ed.] and methods to promote safety-enhancing features of electronic health records (EHRs), said Dr. David Blumenthal, the national health IT coordinator.

The IOM will also make recommendations about the potential effects of government policies and private sector efforts to make the most of patient safety and avoid medical errors through health IT.

[In reading the hype right up to the ONC Director Blumenthal and the POTUS, one would get the impression that medical error-prevention was an inherent, deterministic characteristic of this 100% beneficent technology, so much so that simply putting it in will revolutionize medicine. Now, we all of a sudden need to study its safety? - ed].

... “This study will draw on IOM’s depth of knowledge in this area to help all of us ensure that HIT reaches the goals we are seeking for patient safety improvement,” Blumenthal said.

Earlier this year, the Health IT Policy Committee, a federal advisory group, conducted hearings about patient safety and EHRs. It recommended creating a national database to which healthcare providers can report patient data errors and unsafe conditions they encounter using EHRs.

[To reiterate, there is a major problem with this proposal: "providers" cannot do this with contractual gag clauses in effect. It also seems such databases belong at the state level, since the control of medicine traditionally resides in the states, but these days the Federal government seems to know no bounds - ed.]

The committee also urged the establishment of a patient safety organization to analyze the reports and share information from the database to make healthcare a learning system.

So, in the midst of a National Program for Health IT in the United States (NPfIT in the U.S.), with tens of billions of dollars earmarked for health IT already (money we don't really have, but it can be printed quickly, or borrowed from China) the IOM is going to study health IT safety, prevention of health IT-related errors, etc. ... only now?

Perhaps these studies should have been initiated, say, ten years ago, or at least before the beneficence of health IT and its capacity to revolutionize medicine was openly promoted by the past and current Administrations (the current one going so far as to institutionalize penalties for non adopters)?

A move like this suggests someone's blown the whistle on the purveyors of the NPfIT in the U.S. They are now attempting to cover their tracks regarding this glaring deficiency (unknown risk) in an already-initiated, extremely expensive national program based on equivocal studies and literature, an increasing amount of which is now refuting the grandiose claims made about health IT. The purveyors would seem to have a figurative gun at their heads causing them to ask the IOM for assistance at this rather late date in the scheme of things (could that gun be named Grassley?)

A tidbit of common sense regarding IT, all too lacking in today's national leadership:

• You should not need year-long IOM studies to study the safety of supposedly safe devices already slated for national rollout.

Finally, the sudden interest in health IT safety suggests the HITECH act on health IT with its timelines and penalties, 'smuggled' in under the auspices of the ARRA, is premature. HITECH's timelines should be delayed delayed until this technology and its safety is truly understood (or it should be repealed entirely and redone in a non-cavalier fashion).

-- SS

10/2/10 addendum:

I recall that we already have the 2009 National Research Council HIT study. It reported that HIT in its present form does not support physician cognitive needs and that our approaches to HIT are "insufficient" to achieve stated goals...

The U.S. National Research Council’s "Current Approaches to U.S. Health Care Information Technology are Insufficient" is here. A full report on an investigation of healthcare IT lack of progress is here (PDF).

From the NRC/NAS/IOM sites:

"The National Research Council (NRC) functions under the auspices of the National Academy of Sciences (NAS), the National Academy of Engineering (NAE), and the Institute of Medicine (IOM)." ... "The IOM is the health arm of the NAS."

The National Research Council report on HIT was basically buried. HITECH happened anyway.

ONC seems to now be going back to the same source(s), presumably for either a glowing report, or a report that it can safely ignore.

Finally:

That HIT effectiveness issues, safety issues, admittedly poor usability but "meaningful use" criteria crafted anyway, lack of clinician cognitive support requiring years of multidisciplinary research to correct, etc. - have had no inhibitory effect on grandiose, autocratic and highly expensive plans for national HIT also suggest political agendas far beyond "improving patient care."

-- SS

Meaningfully Experimental Protocols and Interfaces to Nowhere? Nagging Questions On Healthcare IT Remain

Despite a massive push in our (yet-unnamed) U.S. national program for health IT in the past year (which I shall christen as the NPfIT in the HHS), nagging questions about healthcare IT remain.

The first regards the Public Comment period on the "Meaningful Use" criteria for HIT, part of the Medicare and Medicaid Programs; Electronic Health Record Incentive Program Proposed Rule:

This proposed rule would implement the provisions of the American Recovery and Reinvestment Act of 2009 (ARRA) (Pub. L. 111-5) that provide incentive payments to eligible professionals (EPs) and eligible hospitals participating in Medicare and Medicaid programs that adopt and meaningfully use certified electronic health record (EHR) technology. The proposed rule would specify the initial criteria an EP and eligible hospital must meet in order to qualify for the incentive payment; calculation of the incentive payment amounts; payment adjustments under Medicare for covered professional services and inpatient hospital services provided by EPs and eligible hospitals failing to meaningfully use certified EHR technology; and other program participation requirements.

Perhaps submitting comments in the public forum of a blog will spread the message further than through the method above...

As I wrote in Oct. 2009 at "Washington Post Article: Electronic medical records not seen as a cure-all", there is a major problem with the term "meaningful use" itself:

This [term "meaningful use"] is an example of putting the cart before the horse, and is a semantically-based, self contained logical fallacy of sorts. If a health IT system is harmful, the term "meaningful use" is itself Orwellian. If we don't know if HIT is beneficial, or have doubts, then such as term presupposes that health IT is inherently beneficial. A better term would have been "good faith use" - use based on the faith or hope that health IT will have an overall positive effect. The term "meaningful use" jumps the gun and is more a political slogan than a "meaningful term."

I go further. Use of a term that a priori assumes some outcome reflects the antithesis of science. The term "meaningful use" in the domain of technology implies that those following the recipe for use of some technology, as well as their subjects, will experience meaningful outcomes. A parallel is in the logical fallacy of begging the question or circular argument, where the conclusion of an argument is among its premises.

'A priori knowledge' is knowledge known independently of experience, i.e., from reason alone; 'a posteriori knowledge' is knowledge proven through experience.

To say we as a society have a priori knowledge of the benefits of health IT would unarguably be an absurdity; to say we have uncontested a posteriori knowledge of same is, quite simply, a lie. Evidence of the portable, healthcare-improving qualities of health IT in its current form has been weak, and the literature challenging this often technologically-deterministic position is growing.

In scientific research, an experiment (Latin: ex- periri, "to try out") is a method of investigating causal relationships among variables, or to test a hypothesis. An experiment is a cornerstone of the empirical approach to acquiring data about the world and is used in both natural sciences and social sciences.

The truth is that healthcare IT remains an experiment, using virtual medical IT devices that are entirely unregulated. The "meaningful use" criteria, basically arrived at by opinions and committee consensus, must be viewed in that framework. (I note that some NPfIT experiments in other lands have not been very successful).

When the criteria are viewed in, say, the framework of a NIH grant proposal for testing some new technology, the correct term is not "meaningful use", it is "experimental protocol" or "research protocol." The government is paying for physicians to follow an experimental protocol, reimbursing them for part of the expense and labor, in the hope that the experiment will have beneficial effects and no major adverse side effects on the practice and financing of medicine.

If one accepts the premise that HIT -- and our collective understanding of how to design and implement it -- is fully proven and ready for societal rollout (which is the operative assumption of our government - witness the duress of penalties), then one is not following the methodologies of science. If, on the other hand, one accepts that it *is* an experimental technology, then one should also accept that the current rollout plans are nonscientific in the extreme. This is simply not how ethical biomedical research is conducted, e.g, without the consent of the subjects (patients) -- indeed, with actual coercion of the healthcare professionals -- and without regulation of the experimental technologies.

I therefore ask the following nagging but important question: why is the term "meaningful use" even in the lexicon of the U.S. NPfIT in the HHS? Why should physicians buy into this program?

Why should they not instead refuse to participate in an experiment that could waste their time or cause adverse consequences for which they are liable? Why should those who do participate not calculate the person-hours required to perform the experimental tasks as specified by the experimental protocol, and charge for their time and labor accordingly?

(See some related points at the vendor post "Readers Respond: The Exorbitant Cost of Meaningful Use" at the EMR Straight Talk site. Note: I have no relationships with, or connections to, this vendor.)

Further, what is missing in the experiment of unregulated IT medical devices is robust risk assessment, adverse events reporting, and perhaps most importantly, patient informed consent. It is also unclear if the "hold harmless" and "defects nondisclosure" clauses traditional in IT contracting, and that likely violate healthcare leadership fiduciary responsibilities and joint commission safety standards, will be forbidden in this grand experiment.

A second nagging question arises regarding a somewhat perplexing announcement: a HIT vendor's product that provides data interchange (i.e., an interface apparatus) between EMRs and other medical devices has received FDA pre-marketing clearance, making it available for sale.

On an Interface to Nowhere:

Thousands of medical devices are used in hospitals, physician offices and homes to help clinicians provide better care to patients. Medical devices are used to monitor patient vital signs, infuse medication and even help patients breathe. These devices capture important information about patient health, but oftentimes that information resides in disparate systems outside of the patient's electronic health record (EHR). To solve this problem, [vendor] created the CareAware device connectivity architecture to connect medical devices to the EHR, enabling bi-directional data sharing between medical devices and the patient record. The[vendor] CareAware iBus, a solution that connects medical devices to the EHR to support the entire care process, recently received 510(k) pre-market clearance from the U.S. Food and Drug Administration and is now available in the United States and all U.S. territories.

Here is the question:

How is it possible that an intermediary apparatus to interface medical devices to an EHR can be subject to FDA approval, but the EHRs themselves that this intermediary apparatus interfaces the devices to can be entirely unregulated? EHRs are not subject to FDA approval or any other regulatory agency's evaluation and approval whatsover.

Further, why is the FDA marginalized to the point where the only component of HIT they evaluate and approve are interfaces?

This is a somewhat jarring violation of common sense and first principles of systems thinking: that systems should be evaluated in their entirety, as unexpected adverse consequences are often the result of system-related failures exacerbated by the "weak links" in the system. This probably also violates the principles of resilience engineering, a term I first learned after presenting on IT difficulties to the IEEE Medical Technology Policy Committee a few years ago.

With regard to these nagging questions, I'm just asking. Let the reader decide if these are reasonable questions regarding their medical care.

I doubt I will receive official answers to my lèse majesté.

-- SS