Turn, Turn, Turn - Another Health Care Revolving Door Update

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

10:46 AM

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

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

8:28 PM

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

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

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

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

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

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

What politicians do:  they spin like neutron stars

Her letter, with my comments:

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

Letters | CHALLENGES IN THE MOVE TO ELECTRONIC MEDICAL RECORDS

July 27, 2014

Many health-IT success stories to note

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

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

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

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

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

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

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

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

Directives for Human Experimentation
NUREMBERG CODE

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

Perhaps they don't teach these things at Harvard?

Back to De Salvo's letter:

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

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

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

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

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

Three years later, no such reporting system exists.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

-- SS

4:52 PM

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

8:32 AM

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

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

Wall Street Journal
Opinion
September 17, 2012

A Major Glitch for Digitized Health-Care Records

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

By STEPHEN SOUMERAI And ROSS KOPPEL

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

"Not welcome" is an understatement. 

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

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

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

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

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

ONC also seems to turn a blind eye to industry-ghostwriting abuses in the public comments period of Notices of Proposed Rulemaking for "meaningful use" (itself an Orwellian term) rules.  See for instance my Sept. 2012 posts "Health IT Vendor EPIC Caught Red-Handed: Ghostwriting And Using Customers as Stealth Lobbyists - Did ONC Ignore This?" and "Was EPIC successful in watering down the Meaningful Use Stage 2 Final Rule?"

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

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

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

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

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

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

-- SS

Addendum:

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

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

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

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

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

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

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

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

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

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

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

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

Scot Silverstein, M.D.
Faculty
Biomedical Informatics
Drexel University Institute for Healthcare Informatics
Philadelphia

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

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

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

-- SS

3:24 AM

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

-- SS

10:36 AM

Is the Meaningful Use Stage 2 Final Rule invalid?

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

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

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

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

Tens of billions of taxpayer dollars are at issue here.

-- SS

9:58 AM

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

Note: Also see the followup Sept. 5, 2012 post "Was EPIC successful in watering down the Meaningful Use Stage 2 Final Rule?" at http://hcrenewal.blogspot.com/2012/09/from-what-i-can-tell-epic-was.html.

-----------------------

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

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

From the primary source linked in the Histalk note:

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

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

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

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

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

Another example - University of Miami:

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

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

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

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

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

and

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

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

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

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

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

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

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

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

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

-- SS

Addendum:

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

Also see the followup Sept. 5, 2012 post "Was EPIC successful in watering down the Meaningful Use Stage 2 Final Rule?" at http://hcrenewal.blogspot.com/2012/09/from-what-i-can-tell-epic-was.html.

-- SS

Note:

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

6:22 AM