Princess Health and Death of EHR "Meaningul Use" imminent. (Hopefully the death of the 'National Programme for Health IT in the HHS' is imminent, too.). Princessiccia

Princess Health and Death of EHR "Meaningul Use" imminent. (Hopefully the death of the 'National Programme for Health IT in the HHS' is imminent, too.). Princessiccia

AMA Andy Slavitt CMS James Madara meaningful use NPfIT ONC

Gusty 10:39 Add Comment

I've written a number of posts on the Orwellian-named "Meaningful Use" experiment with electronic health records systems, imposed upon United States physicians by the Department of Health and Human Services through its Office of the National Coordinator for Health Information Technology (ONC).

See these posts and others retrieved by query link http://hcrenewal.blogspot.com/search/label/meaningful%20use:

Meaningful Use Final Rule: Have the Administration and ONC Put the Cart Before the Horse on Health IT?

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

Science or Politics? The New England Journal and "The 'Meaningful Use' Regulation for Electronic Health Records"

"Meaningful Use" not so meaningul: Multiple medical specialty societies now go on record about hazards of EHR misdirection, mismanagement and sloppy hospital computing

EHRs and "Meaningful Use": Begging the Question in the New England Journal of Medicine

The Scientific Justification for Meaningul Use, Stage 2: The NWB Methodology

Meaningful Use and the Devil in the Details: A Reader's View

  
In these posts and others I expressed significant skepticism about the 'Meaningful Use' scheme.

But what did I know?  Our betters in government and academia knew far better how to seriously annoy physicians, make more burdensome (and hence more dangerous) the already onerous task of EHR use, and waste the tax money we hard-working Americans pay to an increasingly bloated bureaucracy that acts as if money grows on trees (the U.S. debt has doubled in recent years to almost $19 billion, see http://www.usdebtclock.org/).

From the horse's mouth (or perhaps the animal's other end) at https://www.healthit.gov/providers-professionals/meaningful-use-definition-objectives:

Meaningful Use Defined

Meaningful use is using certified electronic health record (EHR) technology to:

• Improve quality, safety, efficiency, and reduce health disparities
• Engage patients and family
• Improve care coordination, and population and public health
• Maintain privacy and security of patient health information

I note that none of this was backed by science at the time of its formulation.

The end result of the MU experiment is this:

CMS�s Slavitt: End of meaningful use imminent in 2016
Internal Medicine News
WHITNEY MCKNIGHT
January 12, 2016

http://www.internalmedicinenews.com/practice-economics/health-reform/single-article/cmss-slavitt-end-of-meaningful-use-imminent-in-2016/94653f2ba164a8131ca214d5325c0d74.html

Meaningful use is on its way out.

Andy Slavitt, acting administrator of the Centers for Medicare & Medicaid Services, told investors attending the annual J.P. Morgan Healthcare Conference that CMS is pulling back from the health care IT incentive program in the coming months.

�The meaningful use program as it has existed will now be effectively over and replaced with something better,� Mr. Slavitt said. Without providing full details, he said that March 25 would be an important date as concerns the rollout of the new health IT initiatives.

The waste of resources and time, and the alienation of physicians by this grand(-ly foolish) experiment is significant:

�We have to get the hearts and minds of physicians back. I think we�ve lost them,� Mr. Slavitt said.

No foolin'.  Ya think?

This was predictable by anyone with half a brain about healthcare information technology reality.  (It's a real loss that hyper-enthusiast health IT geniuses responsible can't be fired and banned from the domain of healthcare - for life.)

Perhaps the officials at HHS got their first clue about clinician unhappiness via a long January 2015 letter from about 40 medical societies, including the AMA, American College of Physicians, American College of Surgeons, and numerous others that they did not exactly love these systems and the MU experiment.  See my January 28, 2015 post "Meaningful Use not so meaningful: Multiple medical specialty societies now go on record about hazards of EHR misdirection, mismanagement and sloppy hospital computing" at http://hcrenewal.blogspot.com/2015/01/meaningful-use-not-so-meaningul.html and the letter itself at http://mb.cision.com/Public/373/9710840/9053557230dbb768.pdf.

He noted that, when the meaningful use incentive program began, few physicians and practices used electronic health records and concerns were that many would not willingly embrace information technology. Now that �virtually everywhere care is delivered has a computer,� it�s time to make health care technology serve beneficiaries and the physicians who serve them, Mr. Slavitt said.

The revealing nature of this candid statement is breathtaking.  He's admitting that 1) many physicians, rightfully reluctant to not "willingly embrace" IT, had the technology imposed upon them by government (due to its "concerns") via penalties for non-adopters and 2) with the systems in the physicians' faces at the cost of hundreds of billions of dollars that could have been better spent on healthcare itself (e.g., for those subject to 'disparities", i.e., the poor), now it's time to make the systems serve patients and physicians.

Brilliant.

The cost, however, was too high, Mr. Slavitt said. �As any physician will tell you, physician burden and frustration levels are real. Programs that are designed to improve often distract. Done poorly, measures are divorced from how physicians practice and add to the cynicism that the people who build these programs just don�t get it.�

The 'cynicism' (def: inclination to believe that people are motivated purely by self-interest; skepticism) that the builders of these programs don't "get it?"  It's not cynicism.  It's a rational conclusion arrived at via empirical observation.

I also recall in the not-so-distant past that physician complaints were dismissed as the complaints of "Luddites."  I've heard this at Informatics meetings, at medical meetings, at commercial health IT meetings (e.g., Microsoft's Health Users Group, and at HIMSS), at government meetings (e.g., GS1 healthcare), and others.

It's rewarding to finally have government officials admit those charges were, to be blunt about it, lies or delusions.

Soon, CMS will no longer reward health care providers for using technology, but will instead focus on patient outcomes through the merit-based incentive pay systems created by last year�s Medicare Access and CHIP Reauthorization Act (MACRA) legislation. 

Perhaps that's a move in the right direction; time will tell.  However, I'm sure physicians have GREAT confidence in how well that will work out, yet another government experimental project.

In addition to asking physicians to work with health care IT innovators to create systems that work best according to their practice�s respective needs, CMS is calling on the private sector to create apps and analytic tools that will keep data secure while fostering true and widespread interoperability.

This is in the realm of delusion.  Physicians "asked" to "work with" (for free?) the same "innovators" (i.e, health IT companies) whose "innovation" led to the massive disaffection for today's health IT, and the burdens that technology has placed on the medical profession, nurses and other clinicians as well?   Further, it's actually believed that the companies will listen, when they've failed to do so for several decades running?  My head spins.

Anyone seeking to block data transfer will find CMS is not their friend. Mr. Slavitt said. �We�re deadly serious about interoperability. Technology companies that look for ways to practice data blocking in opposition to new regulations will find that it will not be tolerated.�

And who, exactly, is going to enforce that edict on proprietary systems, which health IT companies view (correctly, from the business perspective) as giving them a competitive edge?  I'm sure the health IT companies, who now hold medicine captive, are shaking in their boots.

Dr. James L. Madara, CEO of the American Medical Association, echoed Mr. Slavitt�s comments on the current, negative impact of EHRs on physicians� practices. He noted that many physicians are spending at least 2 hours each workday using their EHR and may click up to 4,000 times per 8-hour shift.

I should open a clinic for health IT-caused carpal tunnel syndrome and repetitive motion injuries.  Oh wait!  There's no ICD-10 code for that to bill (see http://hcrenewal.blogspot.com/2016/01/repeated-crushing-by-alligators-and.html).

Dr. Madara outlined three AMA goals to help restore the physician-patient relationship. The first is to restructure the medical school curriculum, which he said essentially is the same as it has been for 100 years. New generations of physicians should be taught how to deliver collaborative care that includes telemedicine, more ambulatory care, and home care. Community-based partnerships, he said, would become key to treating chronic diseases like diabetes and would have to be factored into reimbursement models. The AMA also seeks to improve health outcomes and ensure thriving physician practices.

Central to the AMA�s plan for the future: Helping physicians restructure practice via technology. He announced that the AMA is a founding partner in the Silicon Valley (Calif.) based Health2047, a company focused on supporting health IT and other entrepreneurs in their efforts to provide physicians with digital tools that improve patient outcomes, among other innovations.

As to "helping physicians restructure practice via [information] technology", this seems an example of what I termed "Heath IT hyper-enthusiasm" writ large.  See My March 11, 2012 post "Doctors and EHRs: Reframing the 'Modernists v. Luddites' Canard to The Accurate 'Ardent Technophiles vs. Pragmatists' Reality" at http://hcrenewal.blogspot.com/2012/03/doctors-and-ehrs-reframing-modernists-v.html.

What is needed, as I have repeatedly written, is not to have physicians "restructure" practice to adopt to IT, rather to restructure IT (the systems themselves, the developmental methodologies, the backgrounds of the industry leadership, the industry itself) to match the needs of physicians and patients.

The AMA holds a minority of the nation's physicians as members; a 2011 article "American Medical Association membership woes continue" (CMAJ. 2011 Aug 9; 183(11): E713�E714, http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3153537/) indicated this:

In the early 1950s, about 75% of US physicians were AMA members. That percentage has steadily decreased over the years. In June, at the annual meeting of its policy-making body, the House of Delegates, the AMA announced that it lost another 12 000 members last year. That brings total membership below 216 000. Up to a third of those members don�t pay the full $420 annual dues, including medical students and residents. Not counting those members, somewhere in the neighbourhood of 15% of practising US doctors now belong to the AMA.

Hair-brained schemes to "restructure practice via technology" will likely drop those numbers further.

The National Programme for IT in the NHS (NPfIT) died several years ago (http://hcrenewal.blogspot.com/2011/09/npfit-programme-going-pffft.html).

It is my hope the death of "meaningful use" heralds the death of the equally wasteful and ill-thought-out National Program for health IT in the HHS, a.k.a. HITECH, and a return to recognition of the truth: that health IT is experimental, that it (and its subjects) must be treated with that in mind, that its progress cannot be mandated, and that the technology, as any other IT, needs to be approached with great skepticism e.g. per this article:

Pessimism, Computer Failure, and Information Systems Development in the Public Sector.  (Public Administration Review 67;5:917-929, Sept/Oct. 2007, Shaun Goldfinch, University of Otago, New Zealand).  Cautionary article on IT that should be read by every healthcare executive documenting the widespread nature of IT difficulties and failure, the lack of attention to the issues responsible, and recommending much more critical attitudes towards IT.  linkto pdf

-- SS

Princess Health and Turn, Turn, Turn - Another Health Care Revolving Door Update. Princessiccia

Princess Health and Turn, Turn, Turn - Another Health Care Revolving Door Update. Princessiccia

CDC CMS corporatism Covidien DHHS Medtronic Merck ONC revolving doors UnitedHealth

Gusty 10:46 Add Comment

It has been a while since our last revolving door update, so it's time to take another spin.


Summary of the Revolving Door Phenomenon

Before we get to some cases, though, let me summarize an important article on the revolving door that came out since.  This was published by U4, the "anti-corruption resource center" NGO based in lovely Bergen, Norway.  The title was "The Revolving Door Indicator: Estimating the distortionary power of the revolving door."  Although it's main point was to summarize a new measure the importance of the revolving door in a particular economic sector, it started with a very useful summary of the revolving door phenomenon.  It included a useful definition

According to Transparency International UK, the term 'revolving door' refers to 'the movement of   individuals between positions of public office and jobs in the private sector, in either direction.'

To expand,

The revolving door involves two distinct types of movement.  The first is from the public to the private sector, as regulators (ministers, cabinet secretaries, legislators, high-level officials, advisers) leave the public sector to enter the private sector they have regulated. The second is from the private to the public sector, as high-level executives of regulated companies enter the executive branch, the legislature, or key regulatory agencies.

It also included some idea of prevalence

The revolving door is particularly common in countries where explicit bribes cannot be paid safely, and thus regulators look forward to future employment with the regulated firms

We will discuss what the U4 report said about the implications of the revolving door after a quick review of the cases we have run across since May, 2014, involving the US government.  They will be listed in order of their appearance in the news.

Former National Coordinator for Health Information Technology and Colleague at ONC to Aledade (Company Supporting Accountable Care Organizations)

In June, 2014, various versions of this story appeared.  The Modern Healthcare version stated,

Dr. Farzad Mostashari, former head of the Office of the National Coordinator for Health Information Technology, is starting a new firm, Aledade, to help independent primary-care physicians form accountable care organizations. The startup has $4.5 million in seed funding from venture capital firm Venrock.

Independent practices looking to form ACOs have to expend money 'to hire the people, to get the agreements, to get the licenses, to do the legal work, to hire the executive director, and a medical director, practice transformation, the analytics software, the data warehousing, the EHR interfaces,' he said. 'All of that takes money,' often $1 million to $2 million.

Note that the current concept of the "accountable care organization" [ACO] includes heavy dependence on the electronic health records (EHRs) and other health information technology that Dr Mostashari had been so vigorously promoting as head of the ONC, so this transition seems to fit the revolving door rubric.

It also turns out that one of Dr Mostashari's former ONC colleagues was already at Aledade  

Mostashari will be joined by Mat Kendall, a former leader with the regional extension center program at ONC, who will be executive vice president

Former US Senators to Lobby for Medtronic and Covidien

In August, 2014, per Bloomberg,

Former U.S. Senators Trent Lott and John Breaux are part of a lobbying effort by companies that want to preserve the option of reducing their corporate taxes by moving their legal addresses overseas.

Nine U.S. companies that have sought cross-border mergers for tax reasons, are considering doing so or are targets of such deals have been pressuring lawmakers since April on legislation to stop the practice, federal disclosure reports show.

They include Medtronic Inc., the Minneapolis-based company that is seeking to acquire Dublin-based Covidien Plc. Medtronic paid Breaux-Lott Leadership Group $200,000 in June to block legislation from moving forward. Breaux, a Democrat, was once a member of the Senate Finance Committee. Lott, a Republican, is a former Senate majority leader.

Note that as Senator, Breaux had an important role in health policy, particularly the passage of the Affordable Care Act (ACA).

Former Assistant Secretary of Health and Human Services to Drinker Biddle & Reath (Lobbying Firm)

In August, 2014, per the Washington Post,

District Policy Group, the lobbying unit of law firm Drinker Biddle & Reath, is experimenting with a new model of using outside consultants to capture new business in the health-care field.

The group, which lobbies primarily on health-care policy, has taken the unusual step of forming an advisory board that includes external consultants. The outside advisers are not employees of the firm and instead receive a consultant�s fee, which means the firm does not have to pay their salary or benefits, but can still tout their services to clients.

The board was formed in July and is made up of four Drinker Biddle attorneys and two outside consultants, Tracy Sefl, a Democratic communications strategist, and Michael O�Grady, a health economics specialist and former Health and Human Services assistant secretary under President George W. Bush. Both Sefl and O�Grady have day jobs running their own consulting shops.

This seems to require no further comment.

Former Federal Trade Commissioner to Herbalife

In October, 2014, per the Hill,

Herbalife has hired a former federal regulator to run its compliance program as it deals with allegations of running a pyramid scheme.

Pamela Jones Harbour, who served at the Federal Trade Commission (FTC) from 2003 to 2010, has been named the company�s senior vice president of global member compliance and privacy, according to media reports.

The FTC opened a probe into Herbalife�s business practices earlier this year after lobbyists, interest groups and policymakers asked for a review.

Shortly after the FTC announced its investigation, the FBI began looking into how the direct-selling company recruits new distributors.

Herbalife is best known for its meal-replacement shakes and dietary supplement products. Harbour says she has been a Herbalife customer since 2004, according to Reuters, favoring the company�s Formula 1 shake mix.

Note that the FTC devotes considerable energy to health care issues, and Herbalife styles itself a "a global nutrition company" which makes "weight management" and "energy and fitness" products.

Director of US Centers for Disease Control and Prevention (CDC) to Merck as President of Merck Vaccines, then Executive Vice President for Strategic Communications, Global Public Policy and Population Health

In December, 2014, per a news release on BusinessWire,

Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced the appointment of Dr. Julie Gerberding, 59, as executive vice president for strategic communications, global public policy and population health, effective Dec. 15. In this newly created Executive Committee position, Gerberding, who most recently served as president of Merck Vaccines, will be responsible for Merck�s global public policy, corporate responsibility and communications functions, as well as the Merck Foundation and the Merck for Mothers program.

Note that

Prior to joining Merck, Gerberding served as director of the U.S. Centers for Disease Control and Prevention (CDC) from 2002-2009 and before that served as director of the Division of Healthcare Quality Promotion.

From UnitedHealth (Optum Subsidiary) Executive to Administrator of the Center for Medicare and Medicaid Services (CMS) of the Department of Health and Human Services

In January, 2015, per the Business Journals,

Marilyn Tavenner's replacement at the Center for Medicare and Medicaid Services is a former executive at one of the contractors for the initially botched HealthCare.gov insurance exchange.

Andy Slavitt, former group executive vice president of United Health Group's Optum unit, joined CMS last June to help fix HealthCare.gov. Now he'll be acting administrator of CMS.

An Optum subsidiary, Quality Software Services Inc., was one of the original contractors for HealthCare.gov. QSSI developed the exchange's data services hub and a registration tool that allows users to create secure accounts.

Apparently nothing succeeds like failure.


Discussion

I apologize for the somewhat desultory way I have been summarizing health care revolving door cases.  My excuse is that such cases are almost never publicized as such.  Most of the stories above were found when looking for something else.  Despite its potential importance, the revolving door phenomenon gets little consistent coverage in the news media, and the particular issue of the revolving door affecting health care is particularly anechoic.  (If one searches for "'health care revolving door," one finds discussion of patients who are frequently re-admitted to the hospital.)  There is one website devoted to the revolving door affecting the US government, (OpenSecrets.org has a database here.)   However, it is not searchable by sector, and seems not to be complete (that is, for example, it fails to contain most of the cases I listed above). 

None of the cases above got more than minimal media coverage, yet they all involved people who at one time held high government positions, including US Senators, director of the Centers for Disease Control and Prevention (CDC), a Federal Trade Commission (FTC) commissioner, the director of Center for Medicare and Medicaid Services (CMS) within the US Department of Health and Human Services (DHHS), an Assistant Secretary of DHHS, and the National Coordinator for Healthcare Information Technology. So the anechoic effect persists regarding this issue.

Yet the revolving door is a significant issue.  As discussed in the U4 article, 

The literature makes clear that the revolving door process is a source of valuable political connections for private firms. But it generates corruption risks and has strong distortionary effects on the economy, especially when this power is concentrated within a few firms.

Also, the principal way the revolving door can benefit a company is...

The rent-seeking channel: The revolving door is used to capture public resources, through legal and illegal means, rather than to increase production or efficiency.  Transparency International UK (2011) and the OECD (2009) point out that the revolving door may lead to various schemes involving conflicts of interest, both during and after a regulator�s term in public office. This in turn generates undue bureaucratic and political power for firms using such schemes

Furthermore,

The revolving door is also related to lawful behaviours (Brezis 2013), termed 'legal corruption' by Kaufmann and Vicente (2011). This phrase refers to 'efforts by companies and individuals to shape law or policies to their advantage, often done quasi-legally, via campaign finance, lobbying or exchange of favors to politicians, regulators and other government officials. [�] In its more extreme form, legal corruption can lead to control of entire states, through the phenomenon dubbed �state capture,� and result in enormous losses for societies'

So,

Firms connected through the revolving door may therefore derive undue advantages by legally and illegally influencing the formulation, adoption, and implementation of laws, regulations, and public policies. For example, when firms are connected to (former) members of Parliament [or the legislature], they may influence the enactment of laws and regulations in their favour. When firms are connected to (former) ministers [or in the US, cabinet secretaries] and their advisers, they may influence the upstream formulation and implementation of policies and regulations in their favour. When firms are connected to (former) high-level officials, they may influence the downstream implementation of regulations in their favour.

Finally,

Empirical studies suggest that the revolving door gives firms political and bureaucratic power that enables them to divert state resources by biasing public procurement processes (Goldman, Rocholl, and So 2013; Cingano and Pinotti 2013), obtaining preferential access to public finance (Faccio, Masulis, and McConnell 2006; Boubakri et al. 2012), and unduly benefiting from tax exemption, arrears, and subsidies (Faccio 2010; Slinko, Yakovlev, and Zhuravskaya 2005; Johnson and Mitton 2003).

Therefore, firms politically connected through the revolving door tend to shape laws and regulations in their favour and to divert state resources to their own benefit. They are unlikely to gain a productivity advantage, and indeed may reduce productivity in the private and the public sectors. The literature on state capture and political influence (Hellman and Kaufmann 2004; Hellman, Jones, and Kaufmann 2003; Slinko, Yakovlev, and Zhuravskaya 2005) supports the thesis that such distortions result from the high concentration of political and bureaucratic power among a few powerful firms.

That all suggests that the revolving door in health care ought to get attention beyond posts in Health Care Renewal, but so far there has been precious little of that.  The continuing egregiousness of the revolving door in health care shows how health care leadership can play mutually beneficial games, regardless of the their effects on patients' and the public's health.  Once again, true health care reform would cut the ties between government and corporate leaders that have lead to government of, for and by corporate executives rather than the people at large

Princess Health and ONC on healthcare IT and patient rights: These systems "have to be rolled out to know where the problems lie". Princessiccia

Princess Health and ONC on healthcare IT and patient rights: These systems "have to be rolled out to know where the problems lie". Princessiccia

Andrew Gettinger MD healthcare IT defects Healthcare IT experiment healthcare IT safety human experimentation ONC patient rights

Gusty 20:28 Add Comment

An anonymous commenter to my blog post about the USA Today article on bad health IT (http://hcrenewal.blogspot.com/2015/02/former-onc-director-david-blumenthal.html) noted this, that I myself missed:

Anonymous said...

Gettinger's comment is stunning, especially coming from a director of safety and quality for HHS' Office of the National Commissioner for Health Information Technology:

 "You don't just plunk down EHRs and everyone's happy. You use an incremental kind of approach (and) that takes time, that takes energy and that takes effort," he says, adding that they have to be rolled out to know where the problems lie.

February 1, 2015 at 9:17:00 PM EST

(Writing of ONC's Acting Director Andrew Gettinger MD, Office of Clinical Quality and Safety, http://www.healthit.gov/newsroom/andrew-gettinger-md.)

If quoted accurately, that's likely the end of the line for me regarding ONC and any concerns about patients' rights.  Patients are to be used as live subjects to debug software.

That is advocating human subjects experimentation without informed consent with a technology known to cause increased risk, harm and death, and there's nothing to debate there.  This statement would be perhaps appropriate for someone writing about animal experimentation. 

My own mother's dead, in fact, from that type of attitude.

Gettinger's statement will serve as the cover slide to my upcoming legal presentations to American Association for Justice state chapters and at the AAJ national meeting later this year, as well as to the Association of Health Care Journalists (AHCJ), to which I've been invited to speak.

-- SS

Princess Health and ONC: "The Benefits Of Health Information Technology: A Review Of The Recent Literature Shows Predominantly Positive Results" .Princessiccia

Princess Health and ONC: "The Benefits Of Health Information Technology: A Review Of The Recent Literature Shows Predominantly Positive Results" .Princessiccia

Healthcare IT ONC

Gusty 18:43 Add Comment

The Office of the National Coordinator for Health IT in the US (ONC) has just published an article in "Health Affairs" entitled "The Benefits Of Health Information Technology: A Review Of The Recent Literature Shows Predominantly Positive Results", Buntin, Burke, Hoaglin and Blumenthal, Health Affairs, 30, no.3 (2011):464-471, doi: 10.1377/hlthaff.2011.0178.

It is available at the hyperlink above, but may not be publicly accessible.

The authors all are, or were, ONC officials:

Melinda Beeuwkes Buntin (Melinda.buntin@hhs.gov) is director of the Office of Economic Analysis, Evaluation, and Modeling, Office of the National Coordinator for Health Information Technology (ONC), Department of Health and Human Services, in Washington, D.C. Matthew F. Burke is a policy analyst at the ONC. Michael C. Hoaglin is a former policy analyst at the ONC. David Blumenthal is the national coordinator for health information technology.

The abstract is as follows:

ABSTRACT
An unprecedented [indeed- ed.] federal effort is under way to boost [coerce? - ed.] the adoption of electronic health records and spur innovation in health care delivery.We reviewed the recent literature on health information technology to determine its effect on outcomes, including quality, efficiency, and provider satisfaction.We found that 92 percent of the recent articles on health information technology reached conclusions that were positive overall. We also found that the benefits of the technology are beginning to emerge in smaller practices and organizations, as well as in large organizations that were early adopters. However, dissatisfaction with electronic health records among some providers remains a problem and a barrier to achieving the potential of health information technology. [Some? That sounds like an understatement - ed.] These realities highlight the need for studies that document the challenging aspects of implementing health information technology more specifically and how these challenges might be addressed.

I have long stated, at least since 1999, that:

Healthcare information technology (HIT) holds great promise towards improving healthcare quality, safety and costs.

The new ONC review article is certainly pointing in this direction. Perhaps Health Affairs will release it to general circulation.

However, I also wrote:

As we enter the second decade of the 21st century, however, this potential has been largely unrealized. Significant factors impeding HIT achievement have been false assumptions concerning the challenges presented by this still-experimental technology, and underestimations of the expertise essential to achieve the potential benefits of HIT. This often results in clinician-unfriendly HIT design, and HIT leaders and stakeholders operating outside (often far outside) the boundaries of their professional competencies. Until these issues are acknowledged and corrected, HIT efforts will unnecessarily over-utilize precious healthcare resources, will be unlikely to achieve claimed benefits for many years to come, and may actually cause harm.

Whether the new ONC article demonstrates that these issues are starting to approach resolution, or is just another opinion paper not fully supported by facts, is not certain.

Two charts are presented that summarize the findings (click to enlarge):

(Click to enlarge.) Evaluations Of Outcome Measures Of Health Information Technology, By Type And Rating

(Click to enlarge.) Health Information Technology: Study Design And Scope Factors Associated With Positive Overall Conclusions

There are several caveats. The first has to do with possible selection bias that can be present in any review article.

On article selection for the review:

... we decided that to be included in this review, an article had to address a relevant aspect of health IT, as listed in the Appendix [7]; examine the use of health information technology in clinical practice; and measure qualitative or quantitative outcomes. Analyses that forecast the effects of a health IT component were included only if they were based on effects experienced during actual use. ... Using this framework, the review team removed 2,692 articles based on their titles. An additional 1,270 articles were determined to be outside the study�s scope after the team examined the article abstracts. For example, 269 abstracts focused solely on health IT adoption.

[What, exactly, does that mean? Were the problems with HIT adoption potentially significant towards causation of lack of benefit, and/or presence of harm, for instance? - ed]

By the third review stage, the review team had 231 articles. An additional forty-three were excluded after further review because they did not meet the criteria, and thirty-four review articles were dropped from the analyses because they did not present new work.

[What does that mean? Did they drop highly comprehensive articles showing uncertainty in the literature about HIT, such as Greenhalgh's "Tensions and Paradoxes in Electronic Patient Record Research: A Systematic Literature Review Using the Meta-narrative Method" from University College London? That article appeared in the Dec. 2009 Milbank Quarterly. I wrote about it at this link.]

This left 154 studies that met our inclusion criteria, 100 of which were conducted in the United States. This is comparable to the 182 studies found over a slightly longer time period that were evaluated by Goldzweig and colleagues.

I should also note that no mention is made of independent reviewers of the article corpus and elimination process. It appears the entire effort was conducted within ONC itself, where a bias towards finding positive results is likely present (and understandable).

Another caveat is the the Health Affairs/ONC article appears to bypass a body of literature, both peer-reviewed and non-peer reviewed, that sheds doubt on health IT in its present form from a number of angles such as I recently aggregated at "An updated reading list on HIT" and at "2009 a pivotal year in healthcare IT." Bypassing literature such as this is a possible major weakness.

Further, in the current political environment, it is not hard to imagine that articles highly critical of health IT, or revealing major mishaps and possibly exposing organizations to litigation, are scarce.

I addressed that in a paper "Remediating an Unintended Consequence of Healthcare IT: A Dearth of Data on Unintended Consequences of Healthcare IT." The paper itself was initially found needing revisions, largely in format, by a small group of blinded reviewers in the Medical Informatics community (with the exception of one faux-newshound who commented that "material like this could be read in any major newspaper", a rather perplexing comment considering the topic). Rather than revise, and not being on the tenure treadmill, I chose instead to publish at the Scribd link above.

The ONC paper does acknowledge this:

A recent study found that for clinical trials, studies with positive results are roughly four times more likely to be published than those without positive findings. Because the articles were limited to health IT adopters, we anticipated that authors more often approached studies looking for benefits rather than adverse effects.

They do, however, then issue a value judgment:

It is important to note that although publication bias may lead to an underestimation of the trade-offs associated with health IT, the benefits found in the published articles are real.

I"m not sure a dear relative of mine would find that value judgment heartening. They suffered a crippling injury that would likely not have occurred if paper had been used in the ED rather than an EHR.

I note that if a pharmaceutical company were to issue such a value judgment about a drug as justification for national marketing, they'd likely be nailed to the cross...

The ONC paper also ignores accounts of "near misses" and actual patient injury from impeccable sources, such as in "Health informatics � Guidance on the management of clinical risk relating to the deployment and use of health software. UK National Health Service, DSCN18 (2009), formerly ISO/TR 29322:2008(E)":

Annex A

Examples of potential harm presented by health software

GP prescribing decision support
In 2004 the four most commonly used primary care systems were subjected to eighteen, potentially serious, realistic scenarios including an aspirin prescription for an eight year old, penicillin for a patient with penicillin allergy and a combined oral contraceptive for a patient with a history of deep vein thrombosis. Using dummy records, all eighteen scenarios failed to produce appropriate alerts by all of the systems, most of the time. The best score was a system that flagged up seven appropriate alerts. The health organization clearly has, in such a system deployment, a key responsibility to ensure that knowledge bases used within a design are correctly populated and aligned with clinical practice within their organization.

Inadvertent accidental prescribing of dangerous drugs (such as methotrexate)
This incident occurred when a user of a primary care system attempted to issue two repeat items. The items were highlighted and instead of the issue selected repeats button, the prescribe acute issues from the formulary button was pressed. This brought up the formulary dialogue which contained the high risk items. Either the issue button was then pressed or the particular items were double clicked. When the warning messages came up, they were all ignored and proceed and issue selected. The user chose the first item presented on the formulary list, which just so happened to be a methotrexate injection. In this particular case, it was determined that patient risk was minimal as the treatment was rarely used in primary care and would, in practice, be rejected by the pharmacist. To preclude any recurrence of the problem, access to the high risk formulary was removed from the formulary part of the acute drug issue dialogue. This example again demonstrates the need to align clinical practice and authority levels with the knowledge and rule bases within the system. Wherever possible, design and implementation of health software systems should be undertaken to improve control and accuracy, note introduce new exposures. Furthermore the hazard and risk assessment of this situation may well not apply in other settings, e.g. prescription issue by nursing staff on a ward versus a pharmacist in a retail store.

Incorrect patient details retrieved from radiology information system
This incident arose from the fact that medical reference numbers (MRNs) are usually prefixed by an alpha code. Some hospitals however do not use these prefixes and identical MRNs can be generated. This gave rise to the creation of shared MRNs and subsequent confusion of records in the central datastore when retrieval key is the Medical Record Number. Four specific instances were found where a patient number had been entered in the radiology information system and incorrect patient details had been retrieved. The manufacturer could have built in an appropriate format check during development. Alternatively, the problem could have been spotted by the health organization if a structured risk assessment had been undertaken.

Drug mapping error
Sodium valproate 200 mg slow release was incorrectly mapped to sodium valproate 200 mg in a formulary encoded into a health software system. These are anti-epilepsy drugs and thus the implications for patient safety could be significant. This particular incident is just one of many that have been reported in relation to drug mapping.

An initial investigation indicated that 35 prescriptions had been generated using the incorrect map. Corrective action included contacting the relevant primary care practices to check upon patient health and the supplier to correct the mapping process to ensure no further incorrect prescriptions were generated. As before, this was a design/coding error by the manufacturer but was compounded by the health organization not checking the mappings and failing either to build in appropriate prescribing controls, or map the controls to health organization individuals with the appropriate experience and authority.

Pre-natal screening
The ages of women who had undergone pre-natal screening were wrongly computed by a health software system. As a result 150 women were wrongly notified that they were at no risk. Of these, four gave birth to Down's syndrome babies and two others made belated decisions to have abortions.

Patient identification
A student died of meningitis because of a misspelling of her name and inadequacy in computer use. The student was admitted and a blood test proved negative for meningitis. The following day another blood test was taken and filed on a new computer entry but the letter ?p was missed in the spelling of the name. When a doctor looked up results they were presented with only the first negative tests result because of the misspelling. If the second result had been seen it would have triggered further investigations and probable diagnosis of meningitis. The investigating panel concluded that problems with the health software system had been greater than first thought and in this case there was a combination of a misspelled name and the doctor not being able to use the computer system property. The health software system could have been designed to use unique numbers either instead of the name or in addition to it.

They also missed consideration of serious IT defects reports as in the FDA's Maude database that I wrote about at my Jan. 2011 post "MAUDE and HIT Risks."

Another confounding factor is the issue of possible unreliability of the medical literature itself as expressed in a recent post on the IBM Watson supercomputer exuberance:

Consider the issue of the medical literature suffering from numerous conflict of interest and dishonesty-related phenomema making it increasingly untrustworthy, as pointed out by Roy Poses in a Dec. 2010 post "The Lancet Emphasizes the Threats to the Academic Medical Mission", at my Aug. 2009 post "Has Ghostwriting Infected The "Experts" With Tainted Knowledge, Creating Vectors for Further Spread and Mutation of the Scientific Knowledge Base?" and elsewhere on this blog.

They do state what I have been writing about for over a decade now:

... In fact, the stronger finding may be that the �human element� is critical to health IT implementation. The association between the assessment of provider satisfaction and negative findings is a strong one. This highlights the importance of strong leadership and staff �buy-in� [which will only occur if the systems are not miserable examples of poor engineering, not due to P.R. or the irrational exuberance of others - ed.] if systems are to successfully manage and see benefit from health information technology. The negative findings also highlight the need for studies that document the challenging aspects of implementing health IT more specifically and how these challenges might be addressed.

Dear ONC: see this site, and the many posts since 2004 on this blog.

I was surprised to see this:

... Taking a cue from the literature on continuous quality improvement, every negative finding can be a treasure if it yields information on how to improve implementation strategies and design better health information technologies.

As in my post at this link, does this mean that 'anecdotal' accounts of HIT problems will no longer be summarily dismissed? I wonder.

I have also written in the past that in order to truly understand a domain, one must look at both evidence of the upside, and evidence of the downside. My concern is that the latter was not well addressed in this paper. A beneficial technology with a significant downside, especially in medicine, is not ready for national rollout (cf. Vioxx).

In summary, the new ONC paper may present a glimmer of hope that health IT is starting to produce real results. On the other hand, its possible deficiencies and biases might also make it more a political statement than anything else. It will certainly be used as such from the high government perch of HHS regardless. This has already started:

... President Obama and Congress envisioned that the HITECH Act would provide benefits in the form of lower costs, better quality of care, and improved patient outcomes. This review of the recent literature on the effects of health information technology is reassuring: It indicates that the expansion of health IT in the health care system is worthwhile.

[Note the use of "is worthwhile" as opposed to "may be worthwhile", a continuation of the "it's proven, nothing else to say" style I noted at my July 2010 post "Science or Politics? The New England Journal and "The 'Meaningful Use' Regulation for Electronic Health Records." Such statements of absolute certainty are of concern; they remind me of the global warming debate - ed.]

...Thus, with HITECH, providers have an unparalleled opportunity to accelerate their adoption of health information technology and realize benefits for their practices, institutions, patients, and the broader system. [Ditto - ed.]

Does the article truly show a breakthrough, or is it a flawed review by a governmental agency that will be used for political purposes? I simply do not know which.

I am certain, however, that there will be active debate and dissection of this paper and its source articles in the months to come by those with more time, resources, and expertise than I have at my disposal.

-- SS

March 10, 2011 addendum:

Trisha Greenhalgh at Barts and The London School of Medicine and Dentistry and the author of the aforementioned comprehensive review article "Tensions and Paradoxes in Electronic Patient Record Research: A Systematic Literature Review Using the Meta-narrative Method" (link to my essay), had this observation about the following passage in the ONC paper:

�Our findings must be qualified by two important limitations: the question of publication bias, and the fact that we implicitly gave equal weight to all studies regardless of study design or sample size.�

Prof. Greenhalgh relates: "Given these very fundamental acknowledged biases, I�m very surprised anyone published this paper in its present form.�

-- SS

March 14, 2011 addendum:

Dr. Roy Poses had this to say:

Dr Silverstein commented on a new review of research of health care information technology whose results were mainly optimistic. The authors were from the US government agency that promotes health care IT, so its optimism is not surprising. However, its credibility was unclear, since it did not appear to be systematic. [In general, one at least assesses and takes into account the methodologic quality of studies used in a systematic review, and does not "give equal weight to all studies regardless of study design or sample size" - ed.]

Furthermore, the authors had no methodologic standards whatsoever for article inclusion. [They did, sort of, as in my paragraphs "On article selection for the review:", but one might term the standards "loose" - ed.] The review included qualitative studies that were probably not meant to be evaluative, and observational studies subject to severe methodologic bias.

The publication of this review demonstrated how the conventional wisdom is continually reinforced based on the strength of the influence of its proponents, rather than the strength of the supporting evidence. Adaptation of new drugs and devices should be based on evidence that their benefits outweigh their harms, rather than the enthusiasm and financial interests of their proponents.

-- SS