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

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

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

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

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WASHPOST: Not code, but 'outdated, costly, buggy technology'...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

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

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

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

Fools all.

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

$634,320,919

-- SS

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

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

Oct. 10, 2013 addendum:

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

-- SS

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

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

---

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

SUMMARY AS INTRODUCED:

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

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

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

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

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

-- SS

The HIT Scam

Worth a read -

The HIT Scam By Greg Scandlen

Notable in the piece are these observations:

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

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

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

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

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

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

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

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

-- SS 

HITECH and Experimental Airplanes

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

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

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

The answer to the last question?

Yes.

-- SS

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

I have called numerous times for a moratorium on ambitious national health IT programs.  See 2008 and 2009 posts here and here for example.  My calls are due to the prevalence of bad health IT (BHIT) in 2012, hopelessly deficient if not deranged talent management practices (especially when compared to clinical medicine) in the health IT industry, and complete lack of regulation, validation and quality control of these potentially harmful medical devices. 

I also called the HITECH stimulus act in its present form social policy malpractice.  (See my Sept. 2012 post "At Risk in the Computerized Hospital: The HITECH Act as Social Policy Malpractice, and Passivity of Medical Professional".)

Congress is starting to catch on:

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

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

In the letter the following is noted:

Dear Secretary Sebelius:

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

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

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

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

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

The House letter also notes:

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

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

The house committee members also note:

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

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

Finally, the letter calls for HHS to:

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

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

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

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

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

-- SS

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

 

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

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

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

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

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

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

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

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

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

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

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

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

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

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

 

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

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

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

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

-- SS

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

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

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

More on my presentation later.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

-- SS

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

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

Deal could endanger health care law

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

Politico.com

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

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

My suggestion:

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

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

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

Note what just occurred in the UK:

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

-- SS

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

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

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

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

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

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

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

... Spending Reduction Act of 2011

DIVISION A—APPROPRIATIONS PROVISIONS

... TITLE XIII—HEALTH INFORMATION TECHNOLOGY

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

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

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

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

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

This recent revelation should also be considered:

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

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

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

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

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

Or perhaps coffins.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

I reiterate from my January 2011 post:

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

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

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

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

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

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

-- SS

HITECH and Funding Cuts: The Battle Begins

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

... 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.

The battle's already begun. At "Meaningful Use incentives jeopardized by GOP bill", Jan. 28, 2011 by at Dan Bowman at FierceHealthIT.com, views exactly as I expected have begun being proffered by the industry:

... All of that [possibility of HITECH funding termination] has HIMSS Vice President for government relations Dave Roberts just a little on edge, reports Healthcare IT News.

"We're trying to tell people that this process is going on. This is only one body [of Congress]. Don't let this be a concern," he said. But "if this is a new way of thinking, that could be concerning. So I think that while this particular bill may not pass, it's something that has to be watched closely."

Patti Dodgren, CEO of Hielix--which helps to facilitate electronic health information exchanges across the U.S., shares Roberts' view. [Any possible conflicts of interest towards full-speed-ahead-damn-the-torpedoes health IT diffusion in that role, I ask? - ed.]

"Just the suggestion of repealing HITECH stimulus funds for physicians...is short-sighted at best, and threatens the very progress that is already beginning to be realized within the industry to move our healthcare system into the 20^th [yes, 20th] Century," Dodgren told FierceHealthIT. "All this bill serves to do is strengthen the cynics of health IT.

[Translation: "short sighted" and "cynic" = those more interested in taking the time to do health IT "right" and in patient rights and patient well being, than in personal gain - ed.]

We work with thousands of physicians and state government healthcare officials who have worked tirelessly over the past months to achieve the benefits that healthcare IT promises [no, Ms. Dodgren, they haven't, actually; you and they have merely encouraged a rushed, cavalier and reckless rollout (of a technology even HIMSS' former Chairman of the Board, a physician, admitted is not ready), damaging - not helping - health IT's prospects. See below - ed.], and this bill is a disservice to them and to the healthcare industry."

It may be a "disservice" to those who stand to profit from the health IT industry, but it's a great service to the healthcare industry and to the patients it serves.

I didn't really need to look, as experience at HC Renewal has proven time and again about the healthcare pundits, but the credentials of someone making such claims about health IT are not impressive IMO.

From an online bio, Ms. Dodgren holds the illustrious "CPHIMS" certification that I wrote about at my April 2008 post "Is the HIMSS Certified Professional in Healthcare Information and Management Systems stamp substantive, or just alphabet soup?". After 8 years as Director Budgeting & Financial Systems at (now-defunct) Digital Equipment Corp. (DEC) and 4 years as Senior Business Analyst at Dun & Bradstreet, she has been a "change management professional" for twenty years who "co-founded a management consulting practice which specializes in the application of change management principles to health information technology." I note no medical (or medical informatics) training or experience.

My reply to these people is as follows, as posted in a FierceHealthIT comment:

By S Silverstein MD | Posted 7:09pm | January 30, 2011

Patti Dodgren and Dave Roberts seem to favor continuation of a risky and even harmful national medical experiment that does not even have the fundamental decency to seek patient informed consent.

See http://hcrenewal.blogspot.com/2011/01/maude-and-hit-risk-mother-mary-what-in.html for examples of some of the risks.

The former Board Chair of HIMSS, Barry Chaiken, MD, MPH, FHIMSS said it best in July 2010:

http://histalk2.com/2010/07/19/histalk-interviews-barry-chaiken/

... We’re still learning, in healthcare, about that user interface. We’re still learning about how to put the applications together in a clinical workflow that’s going to be valuable to the patients and to the people who are providing care. Let’s be patient. Let’s give them a chance to figure out the right way to do this. Let’s give the application providers an opportunity to make this better.

Let the industry learn the responsible way, not on patients' and physicians' blood, sweat and tears through way-too-early national initiatives that will only add to the $14 trillion national debt (http://www.usdebtclock.org/), and throw some of the money into industry pockets.

Franky, as a physician with no financial conflict-of-interest axes to grind, I am increasingly disgusted with the cavalier, money-grubbing attitudes of the health IT industry and its pundits. Their attitudes and behaviors represent a poster study of healthcare industry at its worst.

This latter fact is not lost on me as I speak with government representatives seeking to improve medical drug/device watchdog legislation, and to attorneys looking to protect patients from harm or gain recompense for those already injured as a result of faulty IT.

-- 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