CCHIT Has Company

It appears CCHIT, an offspring of the large HIT trade association HIMSS, won't get its wish for Health IT Certification hegemony. I think the outcome of a multidisciplinary HIT policy workgroup's deliberations on this issue reasonable:

Aug. 17, 2009

iHealthBeat.org

Policy Committee OKs Plan To Establish Multiple EHR Certifiers

On Friday, the [HHS] Health IT Policy Committee adopted recommendations that called for multiple entities to certify electronic health record systems, Health Data Management reports.

The committee's certification and adoption work group issued the recommendations (Goedert [1], Health Data Management , 8/14).

To receive official certification, EHR systems must meet a minimum set of criteria and achieve the "meaningful use" objectives of the federal economic stimulus package. Under the stimulus law, health care providers who demonstrate meaningful use of EHRs will receive Medicare and Medicaid incentive payments (O'Harrow, Washington Post , 8/15).

Recommendations

The work group recommended that:

* Certification criteria allow for open-source software;
* Certification processes should let health care organizations qualify for EHR subsidies under Stark Law exceptions that allow organizations to subsidize the cost of EHRs for physicians;
* Certification should last for four years;
* Multiple groups perform HHS certification under a single set of criteria;
* The National Institute for Standards and Technology should participate in accreditation and certification decisions;
* The Office of the National Coordinator for Health IT should define certification criteria;
* ONC should create an accreditation process for certification groups;
* Officials develop alternative certification processes for self-developed software; and
* Vendors are required to receive certification from only one group ( Health Data Management , 8/14).

The work group said it envisions the establishment of 10 to 12 different EHR certification groups, in addition to the Certification Commission for Health IT (Manos, Healthcare IT News , 8/14).

The recommendations now go to HHS for consideration ( Health Data Management, 8/14).

The workgroup said CCHIT is too closely aligned with the health IT industry, noted that the industry trade group HIMSS helped found CCHIT, and noted that CCHIT's members includes several people with ties to HIMSS and health IT companies. They were clearly uncomfortable with the potential conflicts of interest, especially if CCHIT gained sole responsibility for HIT "certification." [A term I put in quotes since it really is "features qualification" at this point, not certification such as a physician receives after passing Specialty Boards - ed.]

Having been on the receiving end of CCHIT bullying myself ("Open letter to Mark Leavitt, Chairman, Certification Commission for Healthcare Information Technology on Penalties For Use of Non-Certified HIT"), it's clear most Americans don't like bullies, especially bullying from powerful lobbying organizations such as HIMSS and its progeny. (It's also become clear they don't like 1000+ page healthcare reform plans shoved, unread, down their throats by political bullies.)

By the way, since the July 21, 2009 publication of my JAMA letter "Health Care Information Technology, Hospital Responsibilities, and Joint Commission Standards" and Koppel and Kreda's reply, pointing out the terrible situation that HIT "defects nondisclosure" and "hold harmless" clauses create for hospital executives, physicians and patients, I have heard from the Joint Commission, but not from HIMSS.

Perhaps HIMSS leadership believes I have nothing worthy to add to the discussion. (Perhaps another 'Open Letter' is called for.)

-- SS

Philips Medical: A Followup

In a Nov. 2008 post entitled "Who Leads in Intellectually Challenged Responses to Medical Informatics Backgrounds, The U.S. or Europe?", I chastised Philips Medical for their ossified and uninspired approach to biomedical informatics talent management (by nonmedical "experts", in fact), and that ossification's deleterious effect on innovation.

I forwarded the post to Philips management. Needless to say, I never received a response.

This appeared on Aug. 5, 2009 at layofftracker.blogspot.com:

Wednesday, August 5, 2009

Philips Healthcare announces layoffs

Got via a Tip.

Philips Healthcare announces layoffs. Memo below.

Message from Steve Rusckowski

Dear Colleague,

In our Q2 and Semi-Annual 2009 Report released on July 13, Philips reported a year-on-year decline in Healthcare sales. While we are substantially lower in our profitability as compared to Q2 2008, material improvements were made in our profitability from Q1 2009 to now, due to our sustained efforts on cost-containment. However, we still fell short of our targets and there is risk for further deterioration in several of our markets.

To build a stronger organization for our future, we need to be a simpler, leaner, more flexible organization, while continuing to bring costs and capacity in line with current demand levels. Our long-term success will be measured by our ability to pro-actively and purposefully navigate through the lingering economic slowdown.

The Healthcare Executive Team, in collaboration with our extended management across the sector, will adapt our organization to the needs of the markets. Where we see opportunities we will seize them, where markets change we will take the necessary steps to enable profitable growth.

To safeguard and strengthen our business, our sector will expand, and where possible, accelerate our efforts to cut further operating costs, including an additional reduction in our workforce. After careful analysis and consideration, this action will impact nearly all of our businesses and functions within North America beginning this month.

The necessity of this workforce reduction is driven by increasing double-digit declines in equipment orders across all of our businesses in North America. The combination of tightening credit markets, persistent delays in capital equipment purchases, reimbursement pressures and the uncertainty of health care reform, are contributing to a weak overall U.S. health care market. [He forgot to mention innovation failure - ed.] Responding to these dynamics is crucial to secure our immediate business performance and preparation for our future.

In North America, the vast majority of employees affected by the workforce reduction will be notified next week. Some employees will be notified as early as this week, with others notified later, as business needs dictate. Impacted employees will be notified by management and/or representatives from Human Resources.

As always, Philips is fully committed to supporting all employees through this process and will treat everyone fairly, professionally and with respect. In accordance with local legislation and procedures, affected employees will be offered severance packages and other appropriate assistance and support. [Being treated with "respect" at a time of massive unemployment, of course, means being handed a few months' salary -- unless you are an executive -- and then being booted out the door - ed.].

I recognize the impact of these decisions is difficult and distracting on a personal and business level. [Getting laid off is indeed somewhat "personally distracting" - ed.] On behalf of the Executive Team, I want to thank you for pulling together and giving your best effort to stay focused during these challenging times.

It is important to recognize, we are battling a global recession, with impact extending across all sectors and geographies. While we are taking these measures within the North American region, we will continue to assess economic conditions and business challenges across our sector and will implement further cost measures whenever needed.

I will continue to keep our lines of communication open [to survivors - ed.], as we proceed ahead. As we do, let’s continue to focus on our customers, as we commit to supporting one another.

I remain confident in our business strategy and our collective passion to make a positive difference in health care.

Best regards,

Steve Rusckowski

CEO

Philips Healthcare

I suggest that to "build a stronger organization for our future" ("our" referring to those who actually retain their positions for now), Philips management start reforms at the top. One reform would be to re-evaluate just how "expert" their experts are.

Philips shareholders, take note.

-- SS

Lessons Unlearned: Health IT Failure, Act 2

The following appeared on the HISTalk site on 8/14/2009 from a writer with the screen name UCSFWatch:

From UCSFWatch: “Re: UCSF CIO’s e-mail. The GE Centricity Enterprise project is in full stop mode.” The attached and unverified e-mail from CIO Larry Lotenero says this: “The medical center’s Senior Management Group has engaged Kurt Salmon Associates (KSA) to assist us with a review of our IT clinical strategy. We are doing the review because we are dissatisfied with our progress to implement clinical applications to support the care of our patients. KSA will arrange interviews with many of you to capture your insights for the strategy planning. They will be on-site to begin their interviews on August 18. If KSA contacts you, I ask that you be as flexible as possible with your schedule to accommodate this process. We expect to receive a final report before November. For now, all activities associated with developing the GE clinical system should immediately be put on hold. Despite this action, we remain fully focused on our goal to complement our excellent clinical care providers with equally excellent clinical applications as soon as possible.”

If true (as it likely is), I find this remarkable.

I would have to refer to it as "UCSF Healthcare IT Failure, Act 2" for reasons just below.

I find it remarkable that this resource- and money-wasting scenario (with possible adverse patient care repercussions) can occur:

• In a state that's in a severe economic crisis,

• At an organization that failed severely in a HIT and administrative IT merger just ten years ago (in the failed, late 1990's attempted merger between UCSF and Stanford's medical centers, see the 2000 stories "UCSF/Stanford: Marriage was rough; divorce is expensive" here and "A thousand MIS personnel cannot merge two healthcare systems" here),

• With an EHR product, Centricity, that is the descendant of Logician that others have implemented successfully (including myself, speaking from experience),

• With GE, a major global high technology vendor, presiding over this new failure at a major academic medical center,
  

• With ample preventive material available in books, journals on the web about such failures (e.g., at the many pages and links here and here, as just a few examples).
  

This last point raises additional questions:

• Do IT managers at UCSF and GE actually read the HIT literature and the web, I wonder? Have they ever done a Google search on "healthcare IT difficulties" or "healthcare IT failure", or related concepts?
  

• Do they think the materials found via such searches frivolous, useless, or not credible?
  

Finally, it is quite remarkable that the best UCSF can do is hire yet another expensive management consulting firm to try to remediate this failure. What are UCSF IT personnel paid to do, exactly?

Perhaps AMIA, AHRQ, HHS and others in the administration need to focus less on new research on figuring why these situations occur, and devote resources to ensuring modern knowledge of HIT failure scenarios already extant is leveraged.

If not, we're likely (as I fear) to have a lot of UCSF Act 2's in the next few years, as organizations attempt to implement HIT by 2014 so as to not be penalized by HIT provisions in the ARRA act.

Perhaps (again, if the HISTalk note is true), we need to bring back the likes of "Neutron Jack" (Jack Welch, well known for laying off less than stellar divisions at GE), and perhaps the Governator needs to "terminate" the roles of the leadership of this project.

Gov. Schwarzenegger had a way with those
who fiddled around destructively with computers...

See other disappointing stories about events at UCSF on this blog at this link.

-- SS

A University Leader's Goal: "Taking New Biotechnology ... to Market?"

An article from the San Francisco Chronicle noted how the new Chancellor of the University of California - Davis (UC-Davis), Linda Katehi, is already contending with controversy. One brief section about her goals for the campus caught my eye. The article noted that Dr Katehi (who has a doctorate in engineering) holds 16 patents, then:

Now Katehi wants to transfer that entrepreneurship to the campus she'll lead.

'The campus is in a wonderful position to become a major force in improving and strengthening the economy of the state,' Katehi told The Chronicle, adding that she'll help UC Davis to become more aggressive in taking new biotechnology and agriculture products to market.

So it would seem that Dr Katehi's goals are making UC-Davis more entrepreneurial, strengthening the California economy, and marketing selling biotechnology products. All of that would make some sense if UC-Davis were a biotechnology company.

However, it is not. UC-Davis, of course, is a major academic campus of the University of California system, with multiple graduate and professional schools, including a medical school. Its mission is:

Through a distinctive tradition of core-discipline excellence, interdisciplinary collaborations and productive partnerships, UC Davis teaches students to think critically, objectively and creatively and to be lifelong learners, engaged leaders and productive citizens; pursues research to advance knowledge and to address state, national and global challenges; and serves the public through the generation, broad dissemination and application of knowledge.

The statement does mention "application" as well as dissemination of knowledge. It seems quite a stretch, though, for that one word to justify putting a priority on entrepreneurship, economic development, and marketing biotechnology products. In fact, Dr Katehi's goals seem to be far removed from, if not in conflict with the university's mission. This is just a recent example of how the leaders of academic institutions seem to be forgetting or radically deconstructing their academic missions, and in particular, how leaders of academic medicine seem to think that their job is to sell drugs and devices.

Consider how Dr David Korn, then Senior Vice President, Division of Biomedical and Health Sciences Research of the of the Association of American Medical Colleges (AAMC), wrote that medical schools and their parent universities must confront "societal demands that they become engines of economic development," so that they must "create a precarious equipoise between the world and values of commerce and those of traditional public service." Furthermore, the government and the public, " impatient for new medicinal products, disease preventions, and cures," "fail to understand or too easily forget that in our capitalistic economy the pathway by which research invention becomes beneficial application is often totally dependent on venture capital, the availability of which commonly demands the active participation of the academic inventors in the commercial venture; put simply, no participation, no money. It is this demand, more than any other cause, that has driven the dramatic increase in medical faculty entrepreneurship." [Korn D. Conflicts of interest in biomedical research. JAMA 2000; 284: 2234-7. Link here.] Thus, nine years ago, Dr Korn, and the AAMC seemed to have acquiesced to a radical restructuring of the academic medical mission to put entrepreneurship, and the development and marketing of commercial products ahead of teaching, research and patient care.

This fundamental change of the focus on academic medicine seems to have been accepted, if not embraced by other academic leaders, like Dr Katehi. It does seem to correlate with some notable changes in how academic medical leaders think and act: devaluing the education mission and demanding that faculty put a priority on bringing in money (see post here); , forming their own, often highly lucrative financial relationships with health care corporations (see post here); acquiescing to faculty becoming "key opinion leaders" and thus supporting marketing of drugs and devices (see post here and this link); allowing continuing medical education to serve marketing purposes (see link here); allowing drug and device company sponsors of clinical research to suppress and manipulate the research (see link here and here); etc, etc. Thus it seems to underlie many of the most dysfunctional aspects of our current health care system.

I find it hard to believe that the public really would want existing respected academic institutions to be turned into biotechnology companies, without any plans to replace their academic roles, and that it wanted faculty members to turn into product developers and salespeople. (Yes, there may be good reason for faculty who do basic science, but not clinical research to consult for health care corporations, in certain instances. But that is a relatively minor, and somewhat separate point.)

In my humble opinion, one goal of meaningful health care reform would be to refocus academic medicine on its academic mission, and let drug and device companies alone develop and market their products.

Ischemic Heart Attacks: Disease of Civilization

Or, more precisely, disease of industrial civilization.

The scientific literature contains examples of cultures that don't suffer from the chronic non-communicable diseases that are so common in modern societies. Much of what I've read indicates that heart attacks are practically unique to cultures that have adopted industrial foodways and a modern lifestyle, being infrequent or entirely absent in those that have not.

I recently came across an incredible paper from 1964 in the American Journal of Cardiology, titled "Geographic Pathology of Myocardial Infarction", by lead author Dr. Kyu Taik Lee (Am. J. Cardiol. 13:30. 1964). This was published during a period of intense research into the cardiovascular health of non-industrial cultures, including Dr. George V. Mann's famous study of the Masai.

The first thing Lee and his colleagues did was collect autopsy statistics from San Francisco and Los Angeles hospitals. They analyzed the data by race, including categories for Caucasian-Americans (white), Japanese-Americans, Chinese-Americans, and Filipino-Americans. All races had a similar incidence of autopsy-proven myocardial infarction (MI = heart attack), including both silent (healed) and fatal MI. For comparison, they included a table with autopsy data from hospitals in Tokyo, South Japan and North Japan. I'm including the data from Tokyo in the graph because it's also an urban environment, but the finding was the same in all three regions. Here's what they found, by age group: The Japanese had a very low rate of MI compared to both Caucasian-Americans and Japanese-Americans. The rate of MI in Caucasian-Americans and Japanese-Americans did not differ significantly. Thus, location but not race determined the susceptibility to MI.

Next, the investigators collected autopsy data from hospitals in New Orleans, again divided by race. This time they exained Caucasian-Americans and African-Americans. Both groups had a very high rate of MI, as expected, although the African-Americans had a lower rate than Caucasian-Americans. They also collected data from autopsies in Nigeria and Uganda for comparison. Here are the data for men: And for women: Again, location but not race largely determined the incidence of MI. MI was extremely rare in the African autopsies. Here's what they had to say:

There was only 1 case of healed myocardial infarction among over 4,000 adult autopsies in the Uganda series, and only 2 cases of healed myocardial infarction among over 500 adult autopsies in the Nigerian series. In the New Orleans Negro series the occurrence rate was far greater in every sex and age group than in either one of the Negro series in East and West Africa.

Over 4,500 autopsies and not a single fatal MI. If this isn't worth studying, what is? These data should be part of first-year training in medicine and health programs.

To satisfy the skeptics, Lee and colleagues imported hundreds of hearts from consecutive autopsies in Albany (USA), Africa, Korea and Japan. They had an American pathologist analyze them side-by side to eliminate any diagnostic bias. Here's what they found:

In the African Negro series no infarct was found in any age group [out of 244 hearts, 39 over 60 years old]. In the Korean series there were only 2 cases of myocardial infarction [out of 106 hearts] and they were both women... In the Japanese series there were 8 cases of myocardial infarction in 259 hearts. All were men...

In the American sample, nearly 40% of the hearts of men and women over 60 showed signs of MI. The findings of the American pathologist confirmed the international autopsy data, showing that diagnostic bias did not contribute to the results significantly. They also took measurements of the thickness of the coronary artery wall, an index of atherosclerosis. They found that the Americans had the most atherosclerosis, but all cultures had some degree of it and there was overlap in the amount of atherosclerosis between samples. This led the investigators to state:

Myocardial infarction and coronary thrombosis are almost nonexistent in Uganda and Nigeria, and the amount of coronary arteriosclerosis is significantly less in Africans than in whites. However, in the two groups there was some overlapping in the degree of arteriosclerosis. No Africans had infarcts, but some had the same or a greater degree of coronary arteriosclerosis as a few whites who had myocardial infarctions. One explanation for this may be that some difference in clotting or clot-lysis mechanisms is present in the two groups. In a previous study, we showed that the incidence of thromboembolic phenomena in the pulmonary circulation [blood clots in the lungs] was low in East Africans as compared with Americans.

Now, the authors' conclusions:

These data strongly suggest that among the Orientals the environmental factor is playing a major role in the etiology of myocardial infarction and coronary thrombosis. If the genetic factor is an important one, those Orientals who moved to this country many years ago or who were born in this country should still maintain their low occurrence rate of myocardial infarction at least to some extent, and one would not expect to see similar occurrence rates of myocardial infarction in Orientals and whites as old as 50 to 59 years... As with the Orientals, this suggests that for Negroes in the United States environmental factors are more important than genetic factors in the etiology of myocardial infarction.

Africans in Africa and Japanese in Japan = low incidence of MI. Africans, Japanese and Caucasians in the US = high and similar incidence of MI. Genes only influence a person's susceptibility to MI when they live in an environment that promotes MI. Otherwise, genes are basically irrelevant.

What do the traditional diets and lifestyles of Japan and Africa have in common? Not much. Even within Nigeria, the diet varies from heavily starch-based (root vegetables, soaked/fermented non-gluten grains, beans, plantains) to mostly reliant on high-fat dairy and meat. In fact, I believe it's the wrong question to ask. A better question is "what do we eat/do in the US that traditional Japanese, Koreans, Chinese, Polynesians, Melanesians and Africans don't"? For starters, none of them rely on industrial vegetable oils, sugar and wheat to nearly the same extent as modern America. Their food is generally prepared at home using wholesome ingredients and traditional methods.

They probably get more exercise than Americans, even if it's only walking in Tokyo or domestic tasks for women in parts of Africa. Traditional Africans surely get more sunlight and thus more vitamin D. I can't imagine life is less stressful in Tokyo than in San Francisco or Los Angeles.

I really like this study, and I think these graphs should be disseminated as much as possible. I've prepared high-resolution versions in JPEG, Powerpoint and PDF formats. E-mail me (click on my profile for the link) if you would like a copy. Let me know which format(s) you want.