Medical Health Care

First time experience in owning a car

2010-11-09T04:12:00.000-08:00

It will be so interesting when you are in the process of owning a car. The reason is you have to select one from various types, designs, models, purposes, engines, etc. From all those consideration, the purpose should come first besides your current budget. Make a short list about the activities that you will do with your car. Perhaps you need it to transport the kids to school, shop to the groceries, take you to mountain, and others. The person who will use the car should be on your mind since you cannot buy sedan if you have more than five family members.

In this case, visiting a car dealer is really recommended. Go for the ford dealer in your town and look at what are available there. Or, just go online and get complete information from your home. You will see various types of car and of course you will get one as what you need. However, you should not choose in a hurry and it is better for you to check the detail of each car. If you think you need some test drive, you can do it to make you get the best choice. There will be transparent pricing and you will be helped in financing the car you like. You do not have to be in the difficult situation because the process is design to ease the customers to get the car easily.

Mesothelioma Law Firm Serving

2010-01-04T22:30:00.000-08:00

Mesothelioma laws provide a serving extremity to mortal sufferers. There are very many mesothelioma law firms around and the main reason why they specialize in these particular cases is the huge appearance the cases can bring. They help in filing lawsuits and helping the victims. When filing for a claim it is important to go through a skilled mesothelioma attorney or a reputed ineligible firmly. These are interlacing and unsound raddled cases. An intimate attorney can get you a good compensation in a short duration. Thus mesothelioma law firm is relevant in the following way.

Foremost, the companies that state workers to work exposed to asbestos have a case to answer because they have a moral duty to inform workers. Also, workers who are close to asbestos have protective cloths and equipment to protect then from the substance. When they leave the work, most workers take a shower and change cloths to avoid contaminating their families. On the internet, you will find easily many mesothelioma law firms advertising themselves and you should not just take them at face value. You need to contact them and visit their offices to get a first hand feel of what they are all about.

Medical Informatics, Pharma, Health IT, and Golden Advice That Sits Sadly Unused

2009-11-16T12:45:00.000-08:00

In recent correspondences with colleagues I was reminded of a letter I wrote seven years ago that was published in Bio-IT World, a journal about biomedicine focusing mainly on pharma, bioinformatics and related fields.

As the sole formally-trained Medical Informatics specialist at Merck, I wrote:

Medical Informatics MIA [Missing in Action - ed.]
Bio-IT World
August 13, 2002

Dear Bio-IT World:

I enjoyed reading the article "Informatics Moves to the Head of the Class" (June Bio·IT World). Thank you for spotlighting the National Library of Medicine (NLM) training programs in medical informatics and bioinformatics, of which I am a graduate (Yale, 1994).

Bioinformatics appears to receive more media attention and offer more status, career opportunities, and compensation than the less-prestigious medical informatics.

This disparity, however, may impede the development of next-generation medicines. Bioinformatics discoveries may be more likely to result in new medicines, for example via pharmacogenomics, when they are coupled with large-scale, concurrent, ongoing clinical data collection. At the same time, applied medical informatics, as a distinct specialty, is essential to the success of extensive clinical data collection efforts, especially at the point of care.

Hospital and provider MIS personnel are best equipped for implementing business-oriented IT, not clinical IT. Implementing clinical IT in patient-care settings constitutes one of the core competencies of applied medical informaticists.

Informatics specialists with a bioinformatics focus — even those coming from the new joint programs — usually are not proficient in hospital business and management issues that impede adoption of clinical IT in patient care settings. Such organizational and territorial issues are in no small way responsible for the low utilization of clinical IT in patient care settings.

It will be important for medical informaticists focused in the clinical domain and bioinformaticists specializing in the molecular domain to collaborate with other specialists in order to best integrate clinical and genomic data.

Further information on these issues can be found in the book Organizational Aspects of Health Informatics: Managing Technological Change, by Nancy M. Lorenzi and Robert T. Riley (Springer-Verlag, 1995). Various publications from the medical informatics community, such as the American Medical Informatics Association (www.amia.org) and the International Medical Informatics Association (www.imia.org), are also useful.

Scot Silverstein, MD
Director, Published Information Resources & The Merck Index
Merck Research Laboratories

I was also responsible for the entry of the term "Medical Informatics" into the controlled vocabulary pool used for various purposes at Merck.

As far as I can tell, the Medical Informatics talent gap still exists in all major pharmas despite writings on the topic from colleagues as well as myself. With the present turmoil including declining pipelines, mergers and mass layoffs pending in many large pharmas, and even despite Medical Informatics on a fast path to being declared a full medical subspecialty, it is likely this gap will persist for years longer. This is a shame. The field offers insights that can help R&D substantially, and I speak from direct experience from my time in that domain.

I am reminded via all this of another industry that seems to hurt itself via ignoring the advice of Medical Informatics professionals, the health IT industry. Healthcare IT is actually the core competence of Medical Informatics professionals, but those people are under-represented in the higher ranks of the health IT industry as well. Many job postings seek such people, but for lower level roles (as I've posted here in the past), and/or conflate formal training with informal experience and with those who qualify for the title of Medical Informaticist like I qualify (being an amateur radio licensee, extra class) as a professional RF engineer.

The irony is this: the wisdom of the Medical Informatics field on health IT goes back not years, but decades. It is advice that could have made the vendors much higher margins, allowed them to produce better products, avoid the government regulation that is now nearly inevitable (in some EU countries, clinical IT has already been determined to be a medical device requiring regulation), and in many cases, enabled corporate longevity.

Yet the teachings and accumulated wisdom of the field were, and largely still are, ignored, making books such as the new "H.I.T. or Miss: Lessons Learned from Health Information Technology Implementations" necessary even in 2009.

Here is just a small sampling of that wisdom:

Dr. Donald A. B. Lindberg (now Director of the U.S. National Library of Medicine at NIH), 1969:
"Computer engineering experts per se have virtually no idea of the real problems of medical or even hospital practice, and furthermore have consistently underestimated the complexity of the problems…in no cases can [building appropriate clinical information systems] be done, simply because they have not been defined with the physician as the continuing major contributor and user of the information."

Dr. Octo Barnett's [Harvard] health IT Ten Commandments, 1970:
1. Thou shall know what you want to do
2. Thou shall construct modular systems - given chaotic nature of hospitals
3. Thou shall build a computer system that can evolve in a graceful fashion
4. Thou shall build a system that allows easy and rapid programming development and modification
5. Thou shall build a system that has consistently rapid response time and is easy for the non-computernik to use
6. Thou shall have duplicate hardware systems
7. Thou shall build and implement your system in a joint effort with real users in a real situation with real problems
8. Thou shall be concerned with realities of the cost and projected benefit of the computer system
9. Innovation in computer technology is not enough; there must be a commitment to the potentials of radical change in other aspects of healthcare delivery, particularly those having to do with organization and manpower utilization
10. Be optimistic about the future, supportive of good work that is being done, passionate in your commitment, but always guided by a fundamental skepticism.

[Dr. Barnett played a key role in the 2009 National Research Council report about current approaches to health IT being inadequate, Press Release at http://www8.nationalacademies.org/onpinews/newsitem.aspx?RecordID=12572, and full report "COMPUTATIONAL TECHNOLOGY FOR EFFECTIVE HEALTH CARE: IMMEDIATE STEPS AND STRATEGIC DIRECTIONS. - ed.]

Dr. Morris Collen's Five Rules, 1972
Most common causes of health IT failure:

Suboptimal mix of medical and computer specialists … resulting in communications difficulties and in the computer staff underestimating the vast medical needs

Gross underestimation of the large amounts of money needed

Suboptimal systems approach with serious incompatibilities between modules

Unacceptable terminals

Inadequate management organization and poor judgment

Dr. R. Friedman, Reasons for slow spread of EMR, 1977:

Poor engineering and unreliability

Physicians not provided with computer-based applications that exceeded their own capability!

Inability to prove a positive effect on patient care

Difficulty transferring one application from one institution to another

(All taken from Collen's "A history of Medical Informatics in the United States, 1950-1990".)

I might add that the PC did not even exist in 1977, unless you consider the Altair and Heathkit H8 "personal computers."

Four-decades-old wisdom like this, and much more, sits out there in the ether and in the Medical Informatics field's professionals like a pot of gold, but is apparently considered as valuable as lead by the HIT - and pharma - industries. I find this amazing - and a pity.

-- SS

Washington Post Article: Electronic medical records not seen as a cure-all

2009-11-15T10:07:00.000-08:00

Regarding the very well done Sunday Oct. 25, 2009 story in the Washington Post "Electronic medical records not seen as a cure-all" by staff writer Alexi Mostrous - signup may be required for access - I have several observations.

(Not including the observation that Mr. Mostrous probably deserves an award for being the first major newspaper reporter to broach this topic in a serious and balanced manner.)

First, I believe healthcare IT can live up to all the predictions made about its benefits - but only if done well. There is massive complexity behind those two words "done well", and that is HIT's key stumbling block in 2009. I believe we are only in the adolescent stage of knowing how to "do health IT well."

Second, I should point out that the intended consequences of health IT include, among many other things, the following "hiding in plain sight" (i.e., not often verbalized) intended consequences:

The improvement of medicine ... in the context of protection of patient rights established over centuries of development of modern medicine.

The improvement of IT itself through cross disciplinary collaboration between IT and medicine, of the science of IT (computer science), the social aspects of computerization ("sociotechnical issues"), and improvement of the our understanding of the intersection of medicine and computers.

Instead, we largely have the opposite. Patients' rights are trampled, and hostility and territoriality has arisen between clinicians (including medical informaticists) and IT, groups that rarely if ever interacted in hospitals ten or twenty years ago.

Of concern, when scientific study sections evaluate NIH grant proposals calling for testing of new IT that involves patients, patient protections and informed consent processes are a paramount concern since such activities are considered research. Yet, in implementing large clinical IT system in a hospital with new features, there are no formal regulations, and I'm not sure there's even IRB involvement in most cases. Patients do not get the chance to give informed consent to the use of these IT devices mediating their care. Why the difference?

The unintended results of computerization efforts have also included suppression of research on sociotechnical issues and on informatics, which must include study of the downsides of HIT, and of the failures in addition to the study of the successes. That is scientific fact - there is no room for debate, no room for spin on the need for careful study of the downsides of any mission critical domain. One would think there to be a vibrant literature on these issues, Yet searches on massive biomedical databases such as PubMed on, say, "cerner electronic health record" (or other vendors as well) are disappointing to say the least. Further, my own website on HIT difficulties remains nearly unique (PPT) after ten years online. That is not bragging; it is a disturbing finding to me - symptomatic of an industry that somehow has managed to avoid serious scrutiny.

In a field with downsides, there are:

1) those who know about the problems but fail to speak,
2) those who see the problems but fail to act, and
3) those who see, know and speak/write/research the problems.

That said, now on to the Washington Post article:

... bipartisan enthusiasm has obscured questions about the effectiveness of health information technology products, critics say. Interviews with more than two dozen doctors, academics, patients and computer programmers suggest that computer systems can increase errors, add hours to doctors' workloads and compromise patient care.

I would include the bipartisan enthusiasm under the subject header of "irrational exuberance", which itself falls under the header of "lack of domain knowledge." That itself is a consequence of both failure to study the issues, and suppression of those issues by those with an interest in doing so.

health IT's effectiveness is unclear.

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

The Senate Finance Committee has amassed a thick file of testimony alleging serious computer flaws from doctors, patients and engineers unhappy with current systems.

Being the ranking member of that committee, Sen. Grassley has a fiduciary responsibility to protect Medicare and Medicaid patients (and one might argue, to protect all patients since those programs often serve as models for private insurers). In that regard, the investigation he has initiated is part of his responsibility as a ranking member of Congress. Politics aside (and there are those who will resort to ad hominem "political witch hunt" arguments), he would have been negligent if he had not initiated an inquiry.

Sen. Grassley has taken on the pharma industry and the government's Food and Drug Administration itself, such as in this recent article "FDA fails to follow up on unproven drugs" where he concluded from a GAO study he ordered that "FDA has fallen far short of where it should be for patient safety." He seems quite serious about medical safety.

If only others in Congress had done their job similarly regarding national finance, we might now not be in the worst economic crisis since '29 with many major industries failing.

David Blumenthal, the head of health technology at the Department of Health and Human Services, acknowledged that the systems had flaws. "But the critical question is whether, on balance, care is better than before," he said. "I think the answer is yes."

This sounds uncomfortably like how a pharmaceutical company might respond to doubts about drug effectiveness and safety. In reality it's really irrelevant what he "thinks." Where's the data? Is this a political statement, a personal belief, or a statement backed up by scientific fact that is not cast into doubt by other research results? Our own National Research Council, Joint Commission, and other international organizations have written about their doubts and concerns about HIT [as that IT is designed and implemented in 2009]. If there is rigorous, systematic research weighing pro's and con's to back this assertion, I wish it would be published.

For his statement is really saying "we don't really know how many systems have flaws, we know some do, and we don't really know the full extent of the impact of those flaws, but because there can be some benefits, let's spend $50+ billion before we know the extent of the problems and fix them." I point out research from Harvard forty years ago, when Harvard informatics pioneer Dr. Octo Barnett published the "Ten Commandments of HIT." Two of those commandments were:

... 8. Thou shall be concerned with realities of the cost and projected benefit of the computer system [i.e., ROI - ed.]

10. Be optimistic about the future, supportive of good work that is being done, passionate in your commitment, but always guided by a fundamental skepticism.

The full set is in this post. Somewhere in the past 40 years, the rigorous ROI evaluations (which also must include systematic evaluations of risk, as any businessperson knows) and the fundamental skepticism seem to have gotten lost.

Over the next two months, Blumenthal will finalize the definition of "meaningful use," the standard that hospitals and physicians will have to reach before qualifying for health IT stimulus funds.

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

"If you look at other high-risk industries, like drug regulation or aviation, there's a requirement to report problems," said David C. Classen, an associate professor of medicine at the University of Utah who recently completed a study on health IT installations.

This is obvious, the reasons for it are obvious, and the reasons why health IT needs a requirement for problems reporting (one aspect of post-marketing surveillance, the "Phase IV" study as it is known in pharma) is obvious. Yet in 2009, no such requirement exists (see my post "Our Policy Is To Always Have Unabashed Faith In The Computer" for more on why we need reporting requirements.) Why do these requirements simply not exist in HIT?

"It's been a complete nightmare," said Steve Chabala, an emergency room physician at St. Mary Mercy Hospital in Livonia, Mich., which switched to electronic records three years ago. "I can't see my patients because I'm at a screen entering data." Last year, his department found that physicians spent nearly five of every 10 hours on a computer, he said. "I sit down and log on to a computer 60 times every shift. Physician productivity and satisfaction have fallen off a cliff."

The industry in the past has called such physicians "luddites", "resistant to change", "stubborn" etc. However, argumentum ad hominem is a fallacious mode of argument that has no place in a scientific field such as biomedicine. There also seems to be quite a lot of such concerns expressed by a large number of physicians, nurses, etc., and dismissing their concerns with a wave of the hand is cavalier in the extreme - again, these are first principles, without room for argument or debate. Let's study the issues rigorously and scientifically before resorting to ad hominem.

Other doctors spoke of cluttered screens, unresponsive vendors and illogical displays. "It's a huge safety issue," said Christine Sinsky, an internist in Dubuque, Iowa, whose practice implemented electronic records six years ago.

See my eight part series on mission hostile clinical IT here for examples of what Dr. Sinsky is referring to.

She emphasized that electronic records have improved her practice. "We wouldn't want to go back," she said. "But EHRs are still in need of significant improvement."

Yes, not cancellation, but improvement. And, quite importantly, before tens of billions of dollars are spent. Hospitals and physician offices are not an IT development laboratory, since the users of these facilities (patients) have very special rights and the clinicians, very special obligations and responsibilities.

Legal experts say it is impossible to know how often health IT mishaps occur. Electronic medical records are not classified as medical devices, so hospitals are not required to report problems.

That after decades of HIT development, sales and implementation we cannot know with certainty how often mishaps occur is, quite simply, a scandal of major proportions. Quoting an old House of God law, #10: "if you don't take a temperature, you can't find a fever." Another applicable aphorism seen on another discussion board: "you can only be so negligent or craven before the only remaining rationale is that you intended the result."

"Doctors who report problems can lose their jobs," Hoffman said.

I've taken risks with my own career in criticizing health IT, as have my colleagues. Hoffman is not exaggerating.

"Hospitals don't have any incentive to do so [speak out about problems with HIT] and may be in breach of contract if they do."

Imagine the outcry if the same prevailed regarding drugs or medical devices. The cemeteries would be lined with people whose epitaph could read "we bury our mistakes."

While orange-shirted vendor employees "ran around with no idea how to work their own equipment," the internist said, doctors struggled to keep chronically ill patients alive. "I didn't go through all my training to have my ability to take care of patients destroyed by devices that are an impediment to medical care."

This gets to issues I first raised in my website on HIT difficulties: who are these IT personnel, and what are their qualifications, exactly, to be working in mission critical medical environments? How is their competence evaluated?

I think these are questions that need to be answered.

-- SS

Next Steps for our Community Quality Registry

2009-11-13T03:00:00.000-08:00

I've previously described the Beth Israel Deaconess Physician Organization's (BIDPO) decision to create a community registry for quality data warehousing in support of meaningful use.

As the project has progressed, we've made several decisions that I'd like to share.

What quality indicators will we store?

We've inventoried all the pay for performance reporting requirements of our local payers and crosswalked it with the 17 quality metrics required for meaningful use, as documented on the new HHS Blog.

In summary, the measures will include treatment process and outcomes data for:

Acute Bronchitis

Adverse drug events

Asthma

Cancer Screening

Cardiovascular Conditions

Depression

Diabetes

HIV

Hypertension

Immunizations

Lead Screening

Medical Home

Pediatrics

Pharyngitis

Reproductive Health

Substance Abuse

Surgery Patients

Tobacco

URI

Vital Signs

You'll find the details in this presentation.

Other decisions we've made include:

1. All our data content transfers from eClinicalWorks and our home built EHR will be done using the HITSP C32 implementation guide of CCD.

2. Transport will be done using the HITSP Service Collaboration 112, specifically using TLS with certificate exchange. We will use the NEHEN network (diagramed above) for routing from our EHR hosting site to the quality data center.

3. To protect confidentiality we will pseudonymise the data, separating identifiers from the data itself. BIDPO will be able to re-identify data for queries such as assembling quality measures from different data sources, but a breach of the registry itself will not release any patient identified information.

This project will enable us to implement and refine many of the standards recommended by HITSP and the HIT Standards Committee. I will continue to report experiences from our implementation efforts which I hope will be used to enhance the standards implementation guides.

The China Study

2009-11-12T03:00:00.000-08:00

As readers of my blog know I'm a vegan, a locovore, and grow my own vegetables organically. I avoid caffeine and exercise by climbing, cycling, hiking, kayaking, and skiing.

As a vegan, I cannot get B12 from vegetables, so I take a B supplement.

Living in the Northeast, wearing sunscreen while outdoors, and working indoors during the week, I do not produce all the Vitamin D my body needs. Of course, this is just an artifact of a modern office-bound existence. I take Vitamin D each day. Vitamin D toxicity can be problem, since it is a fat soluble vitamin retained in the body (along with Vitamin A,E and K), so more is not better. Take the amount recommended by your doctor.

There are many books about healthy living, but the one book that incorporates all the elements that I have found to work for me is The China Study by T. Colin Campbell. The book examines the relationship between food and health, incorporating data about cancer rates, heart disease, diabetes and their prevalence among different societies with different diets. The data is compelling - an all vegetable, high fiber diet markedly reduces and reverses the lifestyle diseases which afflict our affluent industrial society.

I highly recommend the book, as well as the work of Michael Pollan.

You'll discover that the food industry is not our friend - highly processed, high calorie foods, rich in high fructose corn syrup are killing us, but making profits for the agribusiness, the meat industry, and food packaging conglomerates. The food industry lobby is one of the strongest in Washington, making the status quo very challenging to change.

Healthcare reform starts at home - read The China Study and decide for your self.

Try an organic, locally grown, all vegetable diet with minimal Vitamin B12 and Vitamin D supplements and no caffeine. Your body will thank you for it. I realize that such a diet is not possible in some urban locations where food choices may be limited to convenience stores. I know that fresh vegetables may be more expensive per calorie and thus unaffordable.

My hope is that by putting more government resources into diet education and support for the right foods, we'll be able to eat our way back to health, a better economy, and higher quality lives.

The Magic of Middleware

2009-11-11T03:00:00.000-08:00

As I mentioned in my blog about Certification verses Meaningful Use, there will be 9 data exchanges required in 2011

ePrescribing

Sending reminders to patients

Checking insurance eligibility

Submitting claims

Providing patients with an electronic copy of their record

Providing patients electronic access to their records

Capability to exchange key clinical information (e.g., problem list, medication list, allergies, test results) among care providers and patient authorized entities

Capability to submit data to immunization registries

Capability to provide syndromic surveillance data to public health agencies

It's unlikely that clinician offices and hospitals will rip and replace existing systems. It will take several years for vendors to create upgraded software versions which support all these exchanges and for organizations to deploy them. That means that in the interim, it's likely that we'll need middleware at the border of organizations which translates legacy standards and proprietary vocabularies into the data exchange standards which will be required by the December interim final rule.

Over the past few months, I'm met with many middleware companies. Here are the ones to watch:

Emdeon - provides clearinghouse services and analytics. Although it typically has focused on X12 administrative transactions, its infrastructure could easily be leveraged to transport clinical content

Surescripts - provides the eRx transactions among payers, providers, and pharmacies. Although this infrastructure transports chiefly NCPDP content, it could easily be leveraged to transport other types of clinical content

Intersystems - provides an integration engine for communication within and between enterprises

Edifecs - provides data transport and data mining/business intelligence services on transported data

Orion Healthcare - provides software which maps various standards from one to another and provides transport

Health Language Inc. - provides vocabulary translation services

Intelligent Medical Objects - provides vocabulary translation services and tools which enable clinicians to translate free text into controlled vocabularies.

Visionshare - provides transport of data to Medicare (CMS) using the internet and not a proprietary network. You can imagine a company like Visionshare providing a secure front end from clinician offices to the Nationwide Health Information Network.

Covisint - originally provided supply chain integration for the auto industry, but is now expanding into healthcare transactions such as automated clinician credential verification for the AMA.

Although at some future point, EHR software vendors will include standard content/vocabulary interfaces and the NHIN (aka "the Healthcare Internet) will provide secure transport, these middleware companies will help us with the glide path from the present to the future. I'm confident there will be disruptive innovation in the middleware market, including the notion of using PHRs such as Microsoft Healthvault and Google Health as hubs to collect patient data and exchange it as the patient wishes.

It's hard to predict the future, but if HIPAA administrative simplification provides us with lessons learned about adoption and implementation, middleware vendors will be very important in the years ahead.

AstraZeneca Settles

2009-11-10T12:49:00.000-08:00

Here is the latest in the parade of legal settlements of cases of alleged wrong-doing by health care organizations. As reported by Duff Wilson in the New York Times,

The pharmaceutical company AstraZeneca said Thursday that it had reached a $520 million agreement to settle two federal investigations and two whistle-blower lawsuits over the sale and marketing of its blockbuster psychiatric drug Seroquel.

One of the investigations related to 'selected physicians who participated in clinical trials involving Seroquel,' AstraZeneca disclosed in a government filing. The other case related to off-label promotion of the drug.

Seroquel was the top-selling antipsychotic drug in America. It had $17 billion in sales in the United States since 2004, according to IMS Health, a research firm.

Tony Jewell, a company spokesman, declined to be more specific about the physicians or clinical trials under investigation. He said the company was in final negotiations to settle the whistle-blower suits and reach a corporate integrity agreement with the Justice Department.

The name of the whistle-blowers and other details of the suits remained sealed in federal court. Stephen A. Sheller, a lawyer in Philadelphia for the whistle-blowers, and Patricia Hartman, a spokeswoman for the United States attorney in Philadelphia, both declined to comment.

Here we go again. As the Times article noted,

AstraZeneca, based in Britain, joins a list of drug makers that have paid billions to settle inquiries initiated by complaints from former company insiders.

Earlier this year, Eli Lilly & Company paid $1.4 billion over its marketing of Zyprexa, another antipsychotic drug. And Pfizer announced it would pay $2.3 billion, including a record $1.195 billion criminal fine, mostly over its painkiller Bextra, which has been withdrawn from the market.

Does anyone really still believe that integrity agreements, and settlements assessed against huge corporations deter such profitable bad behavior? A half a billion dollar one-time settlement is just a small cost of doing business for a company that sold $17 billion worth of the offending drug in the last five years. As in the case of many other previously announced settlements, it appears that nobody who authorized, directed, or implemented the bad behavior that led to the settlement will suffer any sort of negative consequences.

We previously discussed allegations that AstraZeneca manipulated and suppressed clinical research, and organized deceptive marketing campaigns in support of Seroquel sales (here, and here). If we do not discourage such practices, they will continue to bias the clinical evidence making expensive drugs and devices seem more effective and less dangerous than they really are. Is it any wonder that we over-use and over-pay for these products? Anyone seriously interested in reforming health care to improve quality and access while moderating costs ought to pay attention to behavior that leads to such over-use and over-payment.

(However, there may be hope. Perhaps in the future there will be more effective deterrence. A recent indictment named not only the device company Stryker Biotech (a subsidiary of Stryker Corporation), but also its former CEO and three managers.)

The Genius of the AND

2009-11-10T03:00:00.000-08:00

Recently in Washington, an important political figure asked me why I had the reputation of resisting change.

Since I've spent my life catalyzing change and embracing the latest technology, I found this a very strange statement.

I have no idea how history will record my life and work, but I think the answer is - it depends who you ask.

Wes Rishel wrote a great blog today that reduces the debate about standards and interoperability into two points of view - “the healthcare informatics crowd" and "the Internet crowd".

I've spent the past 4 years facilitating standards harmonization in HITSP, bringing together 800 organizations to discuss the parsimonious number of standards needed to facilitate the data exchanges which will support meaningful use.

From the point of view of the healthcare informatics crowd, the harmonization of disparate approaches into CDA/CCD with XDS.b, XDR, XCA and XDM represents significant simplification and convergence of the major stakeholders in healthcare IT.

From the point of view of the Internet crowd, it represents a set of complex content and security constructs that puts the SDOs in the HTTP business.

The work I've done for the past 4 years aimed at unifying the industry on a web services approach, embracing web-centric standards such as SOAP, XML, and HTTPS. In 2006-2007, this was considered very forward looking. In 2009, RESTful data exchange of simple payloads with TLS and application level security is considered cutting edge.

Thus, my challenge as a leader is to bring together both the healthcare informatics crowd and the internet crowd, without having to take sides and choose either/or.

The answer to me is that we need to embrace both approaches - the right tool for the right job depending on what you want to achieve.

For provider to provider communication which requires the exchange of documents with non-repudiation as the medico-legal record for direct clinical care, the CDA/CCD has great metadata and the ability to support structured data as well as free text discharge summaries/operative notes/history&physicals.

For a summary record that represents a snapshot in time of problems, medications, and labs for transmission between EHRs and PHRs, the CCR and other formats such as Google's CCRg or PDF can do the job.

On the FACA blog today, Marc Overhage wrote about good enough standards for a particular purpose.

This blog posting is likely to generate debates from both the healthcare informatics crowd and the Internet crowd.

Certainly, I believe that a single standard with templates or subsets for a particular purpose would reduce costs and ease the vendor burden of having to support multiple standards, but the trick to accomplishing this is to ensure that the standard be simple enough to be easily implementable for "the little guy", the iPhone, and the use cases of EHR to PHR exchange where the goal is to provide basic summaries to patients. As I said in my blog last week, I'm convinced that the SDOs will continue to refine their content standards such as CDA and CCD to clean up the XML (get rid of moodCode) and provide templates to support a range of applications, both complex and simple (hide the OIDs so that most implementers do not need to deal with them).

Until then, we need a glide path that embraces the healthcare informatics crowd and the internet crowd, respecting the hard work and best thinking of both.

My proposal, as a private citizen and not in any of my committee roles is that we take the advice of Jim Collins in Built to Last in which he describes the "the tyranny of the OR verses the genius of the AND"

For provider to provider communication which requires the exchange of documents with non-repudiation as the medico-legal record for direct clinical care, we use the CDA/CCD.

For a summary record that represents a snapshot in time of problems, medications, and labs for transmission between EHRs and PHRs such as would be used by Microsoft, Google or Keas, the CCR or PDF is good enough.

We separate content and transport, recognizing that some organizations will use XDS.b and XDR for SOAP-based transport, while others will use RESTful approaches, enforcing privacy policy with security features at the application level.

As standards evolve we can revisit this with the aim of convergence as long as further parsimony does not impede innovation.

It is my hope, that by embracing the right tool for the right purpose, we can balance standardization, ease of implementation, and innovation.

The genius of the AND - I hope that both the healthcare informatics crowd and the Internet crowd can embrace this path forward.

An Alliance on Mental Illness or for Pharmaceutical Companies?

2009-11-09T12:21:00.000-08:00

A recent article by Gardner Harris in the New York Times focused on the financial links among health care corporations and not-for-profit disease (or patient) advocacy groups.

A majority of the donations made to the National Alliance on Mental Illness, one of the nation’s most influential disease advocacy groups, have come from drug makers in recent years, according to Congressional investigators.

The alliance, known as NAMI, has long been criticized for coordinating some of its lobbying efforts with drug makers and for pushing legislation that also benefits industry.

Last spring, Senator Charles E. Grassley, Republican of Iowa, sent letters to the alliance and about a dozen other influential disease and patient advocacy organizations asking about their ties to drug and device makers. The request was part of his investigation into the drug industry’s influence on the practice of medicine.

The mental health alliance, which is hugely influential in many state capitols, has refused for years to disclose specifics of its fund-raising, saying the details were private.

But according to investigators in Mr. Grassley’s office and documents obtained by The New York Times, drug makers from 2006 to 2008 contributed nearly $23 million to the alliance, about three-quarters of its donations.

Even the group’s executive director, Michael Fitzpatrick, said in an interview that the drug companies’ donations were excessive and that things would change.

However, he tried to downplay the influence of the pharmaceutical industry on the Alliance.

'I understand that NAMI gets painted as being in the pockets of pharmaceutical companies, and somehow that all we care about is pharmaceuticals,' Mr. Fitzpatrick said. 'It’s simply not true.'

Note the careful wording of this denial, though. He did not deny that most of what NAMI cares about is pharmaceuticals.

Moreover, the article suggested how cozy pharmaceutical companies and the Alliance's leadership have become.

The close ties between the alliance and drug makers were on stark display last week, when the organization held its annual gala at the Andrew W. Mellon Auditorium on Constitution Avenue in Washington. Tickets were $300 each. Before a dinner of roasted red bell pepper soup, beef tenderloin and tilapia, Dr. Stephen H. Feinstein, president of the alliance’s board, thanked Bristol-Myers Squibb, the pharmaceutical company.

'For the past five years, Bristol-Myers has sponsored this dinner at the highest level,' Dr. Feinstein said.

He then introduced Dr. Fred Grossman, chief of neuroscience research at Bristol-Myers, who told the audience that 'now, more than ever, our enduring relationship with NAMI must remain strong.'

Documents obtained by The New York Times show that drug makers have over the years given the mental health alliance — along with millions of dollars in donations — direct advice about how to advocate forcefully for issues that affect industry profits.

In a letter today to the NY Times, NAMI Executive Director Fitzpatrick tried again to correct "misimpressions."

First, the National Alliance on Mental Illness, or NAMI, has always disclosed corporate and foundation sources of revenue. Until this year, specific amounts remained private for competitive fund-raising reasons.

Second, your estimate that pharmaceutical companies account for three-quarters of “donations” has been misinterpreted as a share of NAMI’s total annual budget — which is actually about 50 percent.

Perusal of the 2008 NAMI Annual Report does include this impressive list of "Corporate Partners":

Abbott
Alexza Pharmaceuticals
Amazon
AstraZeneca
Blue Cross Blue Shield
Bristol-Myers Squibb
College of Psychiatric and Neurologic
Pharmacists
Corcept Therapeutics
Cyberonics
Delivery Agent, Inc.
Forest Laboratories
GEO Care
GoodSearch.com
The Health Central Network
Janssen Pharmaceutica
Eli Lilly and Company
Magellan Health Services
McNeil Pediatrics
Neuronetics
Novartis
Otsuka America Pharmaceuticals
Pfizer
PhRMA
RF Binder
Sanofi-Aventis
Shire
Solvay
Validus Pharmaceuticals
WellPoint
Wyeth
YTB Travel Network

The NAMI web-site now includes lists of specific corporate donations that individually exceeded $5000 since the beginning of 2009. So far this year, the biggest pharmaceutical corporate donors appear to be AstraZeneca ($350,000), Bristol-Myers-Squibb ($506,205), and Eli Lilly ($675,500).

Looking at the latest Form 990 filed on behalf of NAMI with the US Internal Revenue Service (available from GuideStar here) provides more interesting detail. (Keep in mind that the 2008 form covers July 1, 2007 to June 30, 2008.)   This form listed the organization's total revenue as $13,788,288, and expenses as $12,796,205. These expenses included $1,785,060 (13.9%) for management and $1,520,637 (11.9% ) for fund-raising. The form listed eight NAMI executives who made more than $100,00 a year, including Mr Fitzpatrick ($210,685 total compensation).

So, in summary, it appears that corporate donations, mainly from a few large pharmaceutical companies, supply a substantial portion, (maybe half, if I read the letter by Mr Fitzpatrick correctly) of the annual budget of NAMI. About one-quarter of that budget is spent on administration and fund-raising, including six-figure salaries for at least eight executives.  So who do you expect would more easily get access to the $200K+/year NAMI Executive Director, an executive of a pharmaceutical firm that supplies more than $500,000 a year, or a NAMI member who pays $35 dues?

Here we have another example of a respected patient advocacy organization which gets a substantial portion of its revenue from (presumably the marketing departments of) a few large pharmaceutical companies. (See another example here.) Its well-paid executive director can at best bring himself to deny that the only purpose of the organization is to support pharmaceutical marketing and lobbying. It seems reasonable that for supplying half the budget, the pharmaceutical companies expect considerable help not only with marketing but also with advocacy of policies that favor their corporate goals.

As I have said before, I do not have a problem with pharmaceutical and other health care corporations marketing their products, and expressing their views on policy. I do have a problem with corporate marketing or policy advocacy is disguised as grass-roots, not-for-profit education and advocacy. If ostensibly not-for-profit disease (or patient) advocacy organizations like NAMI want to continue to accept corporate money, they should make it clear that they speak for their corporate donors as well as, and probably with priority over their members and patients with the diseases of interest.  Well-intentioned people who pay their dues, and/or make small contributions to NAMI to help the mentally ill might want to consider whether they are likely to have any influence compared to the individual pharmaceutical executives who oversee $500,000+ a year corporate donations.

ADDENDUM (2 November, 2009) - See also comments on the Furious Seasons blog.

Certification Verses Meaningful Use

2009-11-09T03:00:00.000-08:00

Recently, clinicians have asked me "why should I implement my organization's preferred EHR when I've found a less expensive vendor that promises meaningful use?"

This illustrates a basic misunderstanding of the difference between Certification and Meaningful Use.

The certification process will be codified in a December 2009 Notice of Proposed Rulekmaking (NPRM) and will define the process for certifying electronic health records including modular and open source approaches. (The Standards for data exchange will be codified in a December 2009 Interim Final Rule and become law immediately.) We know that ONC will specify certification criteria and that NIST will oversee certification conformance testing which will be performed by multiple organizations. However, we will not have the final certification criteria or the defined process until Spring after a period of comment on the NPRM.

Meaningful Use is about electronic documentation to enhance quality/efficiency and actual data exchange among payers, providers and patients. The definition of meaningful use will be codified in a December 2009 Notice of Proposed Rulemaking. We will not have the final meaningful use criteria until Spring after a period of comment on the NPRM.

Thus, it is too early for any software company to declare their product will meet all Certification criteria. In the interim, a vendor can claim product conformance with the latest CCHIT criteria, which is the best indicator of functionality we have at the moment.

Meaningful Use is not about products but about processes - how the software is used and how data flows in an ecosystem of stakeholders. Vendors should not be making claims about meaningful use.

Take a look at the data exchanges in the August 2009 recommendations for meaningful use:

ePrescribing

Sending reminders to patients

Checking insurance eligibility

Submitting claims

Providing patients with an electronic copy of their record

Providing patients electronic access to their records

Capability to exchange key clinical information (e.g., problem list, medication list, allergies, test results) among care providers and patient authorized entities

Capability to submit data to immunization registries

Capability to provide syndromic surveillance data to public health agencies

To achieve these 9 data exchanges, multiple sending and receiving parties need to participate.

In the case of Beth Israel Deaconess, achieving this level of interoperability by 2011 will require that we focus on a small number of software vendors. Over time, as standards and implementation guides become more specific and widely implemented, it will be easier to add additional vendors. However for now, we are focusing on getting the work done with our home built EHR and one purchased EHR (eClinicalWorks). Given scope, time, and resources, there is no way we can implement all 9 data exchanges among payers, providers and patients with another purchased EHR in time for Stimulus funding.

Thus, as you make decisions about what EHR to use, remember that certification describes the features of a product. Meaningful use describes actual data capture and exchange among multiple stakeholders in an entire healthcare ecosystem.

Products may be certified in a single clinician office, but meaningful use "takes a village". It cannot be promised by a vendor.

Saving Health Care--Saving America

2009-11-08T13:58:00.000-08:00

Saving Health Care--Saving AmericaBy BRIAN KLEPPER, DAVID C. KIBBE, ROBERT LASZEWSKI and ALAIN ENTHOVENSo far, Congress' response to the health care crisis has been alarmingly disappointing in three ways. First, by willingly accepting enormous sums from health care special interests, our representatives have obligated themselves to their benefactors' interests rather than to those of the American

Cool Technology of the Week

2009-11-06T03:00:00.000-08:00

On November 4, I met with my director of IS at Needham hospital and we discussed the effort involved in creating a lab ordering/resulting dictionary that links together clinician offices, Meditech sites, and commercial labs. Imagine a spreadsheet with 3 columns of lab codes that is 12000 lines long!

Clem McDonald, who oversees the Lister Hill National Center for Biomedical Communications at NLM and is the developer of Logical Observation Identifiers, Names, Codes (LOINC). Using data from several sources, including the Indiana HIE, United Healthcare and a few other sources, Clem and his team were able to identify a set of about 300 LOINC order codes that cover about 98 - 99% of the most common laboratory orders.

On November 2, several members of the HITSP Care Management and Health Records TC met at the National Library of Medicine to discuss the development of a value set for creating an common interoperable set of laboratory order codes. Present at this meeting was an unprecedented collaboration of people representing healthcare providers, laboratory vendors, HIT Vendors, HIE developers and payers.

You'll find the details in Keith Boone's blog.

When I described the notion of a single lab compendium for the country, eliminating the need for custom mappings at every institution and clinician's office, my Director of IS agreed - that's cool!

Let's hope we can get rapid adoption of a universal lab ordering compendium in labs, hospitals, and clinician offices. Time and money will be saved, quality and safety will improve.

Academic Freedom and ED EHR's Down Under: An Update

2009-11-05T17:24:00.000-08:00

At the post "Academic Freedom Curtailed?" I wrote:

The essay on Emergency Department electronic health record (EHR) problems in the Australian state of New South Wales (NSW) by medical informatics professor Dr. Jon Patrick, Health Information Technologies Research Laboratory (HITRL), University of Sydney, that I referenced in my posts "The Story of the Deployment of an ED Clinical Information System ‐ Systemic Failure or Bad Luck" and "NSW Nightmare and Overuse of Computers" appears to have been censored. This apparently occurred at the level of the the government.

Professor Patrick has updated his web page that formerly contained a link to his essay on problems with EHR's in that state's EDs.

He advises:

... This document has been temporarily withdrawn by the university following a complaint from NSWHealth. I think the University has acted appropriately by investigating the complaint and I do not yet consider it an act of censorship. I am working through the issues with the University and expect that the essay will be re-published.

I would like to thank all the people who have written to me to offer support and I would encourage you to write to me if you are interested in the matter so that i can demonstrate to the university the importance of this issue to both the Australian and international communities. I do not wish for people to write to anyone else but me. I have no wish to run a public campaign and I am not available for statements to the press about this particular matter. This matter has brought to light many interesting and illuminating things that i will be happy to share in the next version of the Critical Essay.

Jon Patrick 27th October 2009 0930 Eastern Australian Summer time

He then follows up with this:

Update on the withdrawal of "Essay No.6"

It is now two weeks since the original essay was withdrawn. In that time I have been able to establish confidently that NSWHealth phoned my Head of Department and asked him to remove the article without giving a specific complaint. He refused. Subsequently a person from another faculty took up the cause and succeeded in persuading an appropriate person to order withdrawal of the essay. To this time i have not received a specific complaint let alone a written complaint. The Univeristy's Office of General Counsel has studied the essay at my request through my Dean, and found that it is "consistent with the University's Public Comment Policy". I am awaiting further investigations by the University.

Subsequently I have received many messages of support from around the world, and importantly much more information to be included in the essay. I am preparing a much enhanced version.

5th November 2009 1150 Eastern Australian Summer time

I sincerely hope this matter will be resolved in favor of dissemination of the enhanced and updated piece. I think it contains information that is quite valuable to a worldwide audience of clinicians, IT vendors and patients.

I also note that those who aim to suppress a document such as this in the age of informational computing, one product of which is the Internet, should be confined to using only the Commodore PET due to their technological and sociological ineptitude:

State-of-the-art computing for the would-be Health IT article police

-- SS

AMA Supports the House Democratic Health Care Bill--Take Another Look

2009-11-05T12:14:00.000-08:00

The AMA came out in support of the House Democratic health care bill this afternoon—sort of. From their press release:“The American Medical Association (AMA) today announced support for concurrent passage of H.R. 3962 and H.R. 3961, U.S. House of Representatives health system reform bills."I would suggest the operative word is "concurrent."HR 3962 is the big House health care bill. HR 3961 is the

Is Someone at Jefferson Regional Medical Center Lying About EHR Safety?

2009-11-05T09:35:00.000-08:00

This curious story appeared about apparent clinician health IT safety concerns at Jefferson Regional Medical Center near Pittsburgh:

Switch to electronic records alarms Jefferson Regional physicians

By Walter F. Roche Jr.
PITTSBURGH TRIBUNE-REVIEW
Friday, October 30, 2009

Jefferson Regional Medical Center's attempts to convert to electronic medical records have some doctors concerned about patient safety.

In a memo issued this month, the hospital's Health Information Technology Committee announced the 373-bed facility in Jefferson Hills would revert to printed versions of patients' consultant reports "due to patient safety concerns from the majority of physicians."

Jefferson executives downplayed the memo and said they found no evidence that patient safety has been impacted, arguing a small group of physicians expressed concerns and not a majority, as the memo claimed.

"It was a very small number that were concerned. It wasn't the majority," said Dr. Richard F. Collins, Jefferson's vice president for medical affairs. "To this point, we haven't identified any issue of patient safety."

Now, one or the other must be true. Either a majority of physicians expressed concerns, or a small number did. Both cannot be true. Assuming the account in the Pittsburgh Tribune Review is accurate, someone is lying.

I should point out that the numbers ultimately do not matter - patient safety issues should never be determined via a headcount, and in fact hospital governance obligations under the Joint Commission and their own fiduciary responsibilities mandate the utmost conservatism and due diligence on safety concerns.

Perhaps the executives did find "no evidence" of safety issues. Regardless, I raise the following questions:

How was such a study performed, how were physicians and other clinicians involved in the study, and was it a rigorous study using validated methodologies, or cursory?

Who is most motivated to find an HIT system "safe", the HIT Committee and clinicians, or the administration?

I have served on HIT Committees; led them, in fact. Those committees "have the pulse" of clinician sentiment, even when they do not conduct formal surveys. In hospitals, the walls have ears, and the clinicians on HIT Committees understand what their colleagues are feeling - usually via direct and sometimes confrontational conversations.

HIT Committees charged with making HIT successful do not generally pull back from HIT projects without very good reason.

On the other hand, hospital executives who have signed off on investments of millions or tens of millions of dollars in IT investments do have a strong motive to ensure all goes well - either in reality or in the narrative they proffer.

This is especially true when conflicts of interest exist.

According to [VP for Medical Affairs] Collins and James Witenske, Jefferson's chief information officer, the transition [to EHR] began about a year ago and was completed in May. The hospital uses a system developed by Siemens, Collins said. He declined to disclose the cost.

I find this an interesting finding. After a short Google search, the following appeared:

Western Pennsylvania Hospital News
20 Years of Hospital Information Technology
by John Fries
(December 2005)

... James Witenske is chief information officer at Jefferson Regional Medical Center, having left Arthur Andersen four years ago to accept the position. Before working at the Big Eight firm, he served as chief information officer at UPMC Health System.
At Jefferson, IT takes place a bit differently that at other healthcare institutions. Where most hospitals have an IT department with staff, Witenske works almost exclusively with outside experts, one of whom is Ron Forys, a Siemens site executive who is based at Jefferson. It’s a complementary relationship – Witenske’s role is strategic and Forys’ is operational. Both are longtime technology professionals who have seen huge changes take place during the past two decades.

The hospital had/has its own vendor representative in a front line role, and apparently shied away from having its own IT staff. A person who comes from a consulting firm uses consultants whose loyalty is to the vendor, not the hospital, one of them as his operations guy.

This raises a number of questions:

Who paid/pays the Siemens Site Executive? The hospital, the vendor, or both?
Who did/does the Site Executive report to?
Did/does not the Site Executive have a conflict of interest with regard to physician opposition to the vendor's system?
What was/is the financial relationship between hospital executive leadership and the Site Executive? Between hospital executive leadership and the vendor?

These type of arrangements do raise my eyebrows, and the discrepancy between the HIT Committee's memo and the hospital executive's account, both of which cannot be true, could certainly be a symptom of conflicts of interest.

I have noted that a Congressional investigation of the health IT industry is now underway. This would not be a good time for hospital governance to downplay physician concerns about HIT, overruling their own HIT committee. For if a patient is injured or dies as a result of physician HIT concerns that were ignored, the executives could likely find themselves in a very unpleasant situation - and not just from malpractice attorneys.

Collins and other hospital officials who support the conversion say that once adopted and accepted, electronic records will increase patient safety and efficiency, and eliminate "piles of paper."

He apparently forgot the word "perfected." HIT in an experimental medical device. This VP for Medical Affairs makes no mention of the unintended consequences of poorly designed or implemented HIT. He either doesn't know about them (i.e., is dyscompetent regarding HIT) or is suffering the syndrome of inappropriate overconfidence in computers in the face of what seems like his own staff's concerns.

This is typical of the Wild West environment of Health IT.

-- SS

The House Bill Should Be Defeated on Saturday

2009-11-05T07:47:00.000-08:00

Here's the email I just sent my Congressman, freshman "Blue Dog" Frank Kratovil of Maryland:Please vote no this weekend on the House bill.This is not health care reform.This is at least a $1 trillion entitlement expansion paid for half with only modest provider cuts and $500 billion in taxes.Real cost containment would bend the curve and produce the savings needed to accomplish universal

The H1N1 and Seasonal Flu Vaccines

2009-11-05T03:00:00.000-08:00

On Monday, I received the 2009 Live Attenuated Intranasal (LAIV) H1N1 vaccine and the 2009 injectable seasonal flu vaccine.

As a healthy clinician under 50 who sees pediatric patients (mushroom and plant toxicology cases), I'm in the initial tier who qualify to receive the intranasal H1N1 live attenuated vaccine.

The experience of intranasal administration is interesting - inhaling an aerosolized liquid that slowly drips from your nasopharynx down your throat is not the most pleasant sensation. I suspect that pediatric patients will prefer the intranasal approach to an injection.

For 12 hours after receiving the vaccine, I experienced slight nasal congestion and mild fatigue. The complete fact sheet about risks and side effects is given to every patient.

During the same visit I received the 2009 Seasonal flu injection, an inactivated (killed virus) vaccine. Other than mild soreness at the injection site, I had no symptoms.

For me, the vaccines were a positive experience and will ensure that I am not a viral vector (call it personal anti-virus software) in the season ahead.

Since vaccine supplies are limited, it is important to understand the epidemiology of H1N1 (rates of reported cases per 100,000 population)

0 to 4 years — 22.9
5 to 24 years — 26.7
25 to 49 years — 6.97
50 to 64 years — 3.9
≥65 years — 1.3

You'll find a great UptoDate summary online.

Also, Harvard Health Publications has launched an iPhone App to provided the latest information about H1N1.

2009 a Pivotal Year in Healthcare IT

2009-11-04T07:07:00.000-08:00

2009 is proving to be a pivotal year in healthcare IT. Recent authoritative articles and reports on health IT problems largely validate the issues presented at this blog and others focusing on health IT issues, and at my academic website on HIT difficulties started over a decade ago, in 1998, freely available to the industry.

These articles and reports have ultimately led to a U.S. Senate investigation of the healthcare IT industry initiated in Oct. 2009 (link below).

2009 may be the year that healthcare IT vendors will finally begin to understand that not lending credence to decades of teachings from Medical Informatics professionals on healthcare IT design, implementation, lifecycle support, involvement of end users, and sales and marketing has been harmful to their businesses and to their investors. Instead, the commercial health IT companies took a simplistic management information systems-based approach to building medical devices in an incomparably complex environment they did not -- or did not care to – understand.

These devices are, in fact, virtual medical devices that happen to reside on a computer, not business computing systems that happen to be used by clinicians. These medical devices are soon to undergo regulation as such in the EU (pdf report from the Swedish Medical Products Agency here), Canada, the U.S. and other countries as well.

The teachings of Medical Informatics about such devices have been documented in the extensive literature of Medical Informatics. For example, the book “A History of Medical Informatics in the United States, 1950 to 1990” by informatics pioneer Morris F. Collen (published in 1995) explicitly demonstrates the progression of the field and the wisdom of the pioneers dating back to the 1950’s, as in the bons mots here.

The 2009 articles and reports below demonstrate numerous undesirable outcomes of the management information systems approach to development and implementation of virtual clinical devices:

The Joint Commission’s “Sentinel Event Alert on Healthcare IT” is here.

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

The UK Public Accounts Committee report on disastrous problems in their £12.7 billion national EMR program is here.

The Washington Post’s article on the influential HIT vendor lobby “The Machinery Behind Healthcare Reform” is here.

Hoffman and Podgurski’s paper from Case Western entitled “e-Health Hazards: Provider Liability and Electronic Health Record Systems” on EHR medical and legal risks is here.

My commentary on the May 2009 AMIA workshop report on healthcare IT failure with free PDF is available here.

My commentary on a sentinel Mar. 2009 JAMA article by University of Pennsylvania researchers Ross Koppel and David Kreda “Health Care Information Technology Vendors' Hold Harmless Clause: Implications for Patients and Clinicians” on unsafe contract terms demanded by healthcare IT, and the violations of Joint Commission safety standards and fiduciary responsibilities committed by hospital governance personnel who agree to such terms, is here.

A link to the Oct. 25, 2009 Washington Post article “Electronic medical records not seen as a cure-all” and my commentary are here.

Finally, and perhaps most importantly, the Oct. 16, 2009 letter to major healthcare IT vendors from Senator Charles E. Grassley (ranking member of the United States Senate Committee on Finance) initiating a Senate investigation of corporate practices is here (PDF).

I have used this medieval illustration in a prior post on these pages, but sadly in this case it is probably even more highly appropriate:

"Margaritas ante Porcos" - click to enlarge

Not to be gratuitously impolite, but hard truths are often an unpleasant medicine, especially when ignoring those truths results in adverse consequences to patients and their caregivers.

-- SS

Standards Lessons from the Web

2009-11-04T03:00:00.000-08:00

Following last week's HIT Standards Committee Implementation Workgroup Hearing , Microsoft's Sean Nolan and Gartner's Wes Rishel wrote thoughtful blogs.

They point out that the web has two basic standards - content (HTML) and transport (HTTP). Of course there are several other supporting standards such as DNS, TLS/SSL, URL syntax, CSS, etc. but to get started all you need is basic content and transport. You can learn everything you need to know to create a web page in under an hour.

At the hearings, I got that sense that much of the content we've (HITSP, HIT Standards Committee, the industry in general) proposed for healthcare such as NCPDP Script for eRx, HL7 2.x for lab, and X12 for administrative transactions is fine. There is some debate about the right level of simplification for a clinical summary standard, but I'm convinced that the SDOs will continue to refine clinical summaries in a way that ensures suitable content packages will be available for simple and complex use cases. There is additional vocabulary work to do, but that is already is in progress.

On the transport side, let's explore the options:

1. Do nothing and let the market develop a transport mechanism - after all that is what happened with HIPAA (it specified the content as X12 4010 and left implementation of transport up to the market)

I do not favor this option. In Massachusetts, NEHEN implemented secure appliances to solve the problem of data transport. We spent millions and took years to do this. HIPAA transactions are not as widely implemented as the industry would like, largely because transport standards were missing and implementation guidance for the content was not detailed enough. Of course, you could force everyone to sign up for the clearinghouse/intermediary of their choice but this creates heterogeneity, click fees, and unnecessary middlemen.

2. Specify all the standards and policies necessary for end to end secure transport.

Thus far, we've stayed architecturally neutral and provided a suite of standards for transport that ensure authentication, authorization, role-based access control, and auditing to support all policy variations. This approach has been a fine starting point, but it needs to be refined via policy so the number of standards can be constrained. For example, a policy which states that audit trails must be available showing who looked at what when is probably sufficient instead of requiring every organization to implement a standards-based audit trail. It's unclear what the business case is for a completely standardized, interoperable audit trail. Another example - If policy requires segmentation of the record into standard care, HIV care, mental health care, and substance abuse care, as well as requires that the application enables patients to record their preferences for release of these 4 segments, do we need access control standards or accept that the application adequately protects privacy?

If policies and certification ensure appropriate application behavior then point to point transport might be as simple as TLS with bilateral certificate exchange at the infrastructure level, substantially reducing the burden of implementation.

Of course, some may argue that an approach that uses simple web standards for securing transmission and leaves other privacy controls to the application cannot ensure "chain of trust" end to end security. It is true that each organization and stakeholder would have to decide if they trust the applications used by their trading partners. Our experience with NEHEN is that policy, data use and reciprocal support agreements (DURSA), and simple transport standards can facilitate rapid implementation of healthcare information exchange.

3. Deploy appliances that serve as secure gateways between organizations.

With policies and over the wire security standards, the market can develop appliances that securely transport packages of content. Some may be SOAP-based using CAQH Core or XDS/XDR and some may be REST-based. The folks at FHA Connect have done a great job creating an open source application that can serve as such an appliance.

One thing I've learned from negotiation (my Walks in the Woods) is that being dogmatic about one solution is rarely the right answer. Folks who know me often hear the word "parsimonious" - the smallest number of solutions needed to meet the needs of stakeholders. The answer is not 100 variations but a small number that provides business value - the right tool for the right job. From the work I've seen thus far, I think the transport solutions that will work for stakeholders include:

1. For those who want end to end standards controlled secure transport that guarantees integrity of documents - XDS, XDR, XDM and XCA fulfill the need. These standards are SOAP-based and enable use of WS* security controls, so they are useful for protecting privacy at the standards level.

2. For those who want standards-based security with simple implementation, an appliance such as FHA Connect, NEHEN, Intersystems' Ensemble, or Orion Health's Rhapsody is a very reasonable approach.

3. For those who want a secure channel for transporting data elements such as a problem lists, medication lists, and labs from EHR to PHR, a simple TLS and REST approach is good enough. Ideally, HITSP and the HIT Standards Committee workgroups will provide an implementation guide with standard URIs/querystrings so that we'll not have huge variation in REST APIs. Some have used the term "Healthcare Internet" to describe such an approach.

I look forward to the work of the next several months. I'm confident that HITSP, the HIT Standards Committee Workgroups, and the new HIT Policy Committee NHIN Workgroup will evaluate the options and make recommendations.

Human Need for Amino Acids

2009-11-03T20:18:00.000-08:00

Amino acids are simple organic compounds made of carbon, hydrogen, oxygen, nitrogen, and, in a few cases, sulfur. Amino acids join together to form protein molecules, the basic building blocks of all living things. Amino acids can vary widely. Only about 20 amino acids are common in humans and animals, with 2 additional ones present in a few animal species. There are over 100 lesser known amino acids found in other living organisms, particularly plants. The first few amino acids were discovered in the early 1800s. Although scientists determined that amino acids were unique compounds, they were unsure of their exact significance. Scientists did not understand their importance in the formation of proteins—chemical compounds responsible for the structure and function of all cells—until the first part of the twentieth century.

An important characteristic of amino acids is their ability to join together in chains. The chains may contain as few as 2 or as many as 3,000 amino acid units. Amino acids become proteins when 50 or more are bonded together in a chain. All the millions of different proteins in living things are formed by the bonding of only 20 amino acids. Like the 26 letters of the alphabet that join together to form different words, the 20 amino acids join together in different combinations and sequences to form a large variety of proteins. But whereas most words are formed by about 10 or fewer letters, proteins are formed by 50 to more than 3,000 amino acids. Because each amino acid can be used many times along the chain and because there are no restrictions on the length of the chain, the number of possible combinations for the formation of protein is truly enormous. The order of amino acids in the chain, however, is extremely important. Just as not all combinations of letters make sense, not all combinations of amino acids make functioning proteins. Some amino acid combinations can cause serious problems. Sickle-cell anemia is a serious, sometimes fatal disease caused by a single amino acid being replaced by a different one at the sixth position from the end of the protein chain in the hemoglobin molecule, the oxygen-carrying particle in red blood cells.

The 20 amino acids required by humans for making protein are necessary for the growth and repair of tissue, red blood cells, enzymes, and other materials in the body. Twelve of these amino acids, called non-essential amino acids, can be made within the body. The other eight, called the essential amino acids, cannot be made by the body and must be obtained from the diet. Proteins from animal sources—meat, eggs, milk, cheese—contain all the essential amino acids. Except for soybeans, vegetable proteins do not have all the essential amino acids. Combinations of different vegetables, however, form a complete source of essential amino acids.

Blood Supply and Diseases

2009-11-03T20:14:00.000-08:00

Blood supply refers to the blood resources in blood banks and hospitals that are available for use by the health care community. The blood supply consists of donated blood units (in pints) that are used in blood transfusions. A blood transfusion is a procedure whereby blood is administered through a needle into the vein of a person or animal. Such transfusions are usually performed in order to replace blood lost due to injury or surgery. Blood banks are institutions that store blood to be distributed to local hospitals and medical centers. There are a number of blood banks in every country of the world. Together they contain most of the nation's supply of donated blood. Many blood banks are run by the Red Cross, an organization that also conducts frequent blood drives throughout the world. In fact, the American Red Cross gathers half the blood used in the United States. The blood supply must be replenished constantly to meet the needs of hospitals and trauma units as well as to replace blood components that have a short shelf life.

Donation of blood by volunteers is critical in maintaining the supply of blood in blood banks. Beginning in the late 1990s, blood donations in the United States began to increase by 2 to 3 percent per year. But at the same time, the demand for blood increased by 6 to 8 percent. In 2000, about 13 million units of blood were used in the United States. Blood is collected from a donor by inserting a needle attached to a thin plastic tube into a vein of the arm. Blood flows through the tube and into a sterile plastic bag. The body of an average adult human contains approximately 6 quarts (5.6 micro liters) of blood, and the removal of one pint usually has little effect (although some people—especially those with low body weights—may experience temporary dizziness, nausea, or headache). Healthy donors can make blood donations about every eight weeks without causing harm to their bodies.

The collected blood of the donor is tested for hepatitis (a disease of the liver), syphilis (an STD, or sexually transmitted disease), human immunodeficiency virus (HIV; the virus believed to cause AIDS), and related viruses. It is also classified according to blood type and the presence of Rh, or Rhesus, factor. (Blood types are A, B, AB, and O. Rhesus factor is a substance, called an antigen, in the blood of most people.) It is extremely important that blood be marked correctly. Patients receiving donated blood that is incompatible with their own may suffer serious reactions to it. After being collected and classified, whole donated blood is refrigerated.

Most donated blood is separated into its components—plasma, red blood cells, white blood cells, and platelets—before being stored. This allows the blood of a single donor to be used for several patients who have different needs. Blood is separated by means of centrifugation, a process in which the blood is rapidly spun so that the heavier blood cells and platelets separate out from the lighter plasma. Plasma, the liquid part of blood, can be dried into a powder or frozen. Fresh frozen plasma and freeze-dried preparations containing clotting factors are used to treat patients with hemophilia. Hemophilia is an inherited disorder in which certain clotting factors are missing in the blood, resulting in excessive bleeding. Concentrated red blood cells are used to transfuse patients with anemia, a condition in which the blood contains an insufficient number of red blood cells. White blood cells and platelets are used for transfusions in patients who have a deficiency of these components in their blood.

When AIDS (acquired immunodeficiency syndrome) began to appear in hemophiliacs and surgical patients in the early 1980s, it was determined that these patients had contracted the disease through donated blood. In 1985, a test was developed to detect HIV—the virus believed to cause AIDS—in blood. Donors are now carefully screened to eliminate any who may be at risk for carrying the AIDS virus. Although the risk of contracting HIV from blood transfusions is remote, some patients who are scheduled to undergo surgery may choose to donate their own blood beforehand, in case a transfusion is necessary. It is important to know that a blood donor cannot contract AIDS or any other disease by donating blood. The equipment used to collect donated blood is used only once and then discarded. The restrictions on who can donate blood have been expanding steadily to reduce the risk of introducing infections into blood supplies. Almost all countries run a number of diagnostic tests to screen for viruses and other contaminants before shipping blood. Once-rare procedures, like stripping out white blood cells from donated blood to reduce the side effects from transfusions, is now commonplace.

Chlorine Filter Shower Head - Reducing The Risk Of Some Serious Diseases

2009-11-03T20:10:00.000-08:00

Chlorine filter shower head - sounds like a contradictory in terms doesn't it. After all, we have all been told that chlorination is vital to kill microbiological matter - without it, bacteria would run wild in drinking water causing serious gastrointestinal illnesses or even death.

However, as important as chlorination is, many do not realize how damaging it can be to their health.

Chlorine Health Effects - Asthma

Did you know that asthma, is one of the most common reason for Absence from school? Did you know that the U.S. swimming team has a disproportionately higher level of asthma suffers when compared to other teams within the overall U.S Olympic team.

What is the connection - you got it - chlorine. Chlorine worsens the condition of current asthma sufferers and increases the risk of getting asthma.

Whether you drink it via a glass of water or inhale it when you have a hot shower, chlorinated water can affect you.

More Health Effects - Cancer

When chlorinated water interacts with organic matter like hair, skin, urine etc - it forms disinfectant by products which scientists claim can cause cancer.

Don't think you are off the hook if you drink bottled water. You take showers don't you? Chlorine can seep through the skin or can be inhaled when it turns to steam in a hot shower.

Some scientist claim inhaling chlorine is more dangerous than drinking it via a glass of water. As a matter of fact, the EPA found that there are elevated amounts of chloroform in almost every American household due to the use of chlorinated water.

Therefore, it is vital to do what you can to lower the level of chlorine in your home.

Chlorine Filter Shower Head

This is one of the devices that can remove virtually 100% of chlorine from your shower water. It is easy to install and inexpensive.

Apart from the health effects, bathing in chlorine-free water leaves the skin and hair more radiant than bathing in regular tap water. This is because chlorine tends to dry out hair and skin.

What You Need To Do Now

Look for reputable suppliers of chlorine shower head filters. Reputable suppliers tends to sell certified filter units.

Certified devices have been tested and are guaranteed to remove contaminants of a certain class. Fort example, some certified filters can remove chlorine and sediment only others can remove a wider variety of contaminants

Foods To Eat When Pregnant: Do You Know Your Pregnancy Nutrients?

2009-11-03T19:46:00.000-08:00

We have all heard the cliché "you are what you eat", and like most clichés there is an element of truth in it. If you eat healthy nutritious foods then you will be healthy and full of energy. Eat unhealthy foods and the opposite applies. It's pretty simple really. This also applies to the pregnant mother when she is considering the health of her unborn child and the best foods to eat when pregnant. When she decides to eat healthy wholesome foods that are packed full of all the essential vitamins, minerals, proteins, carbohydrates and fats, she is already giving her unborn baby the fantastic start in life that it requires. It's important for expectant mother's to realise the implications of not following a proper pregnancy nutrition plan: low birth weight, birth defects, miscarriage and mortality.

So what are proteins? Proteins are known as the building blocks of life in that they are essential for cell wall development and cell repair. Basically you need proteins for the development of all the vital organs like the heart, lungs and kidneys, as well as muscle and tissue growth. Proteins cannot be stored in the body, so it's important to consume adequate amounts every day for the baby. Recommended daily intake is approximately 60 grams. Good sources of protein include lean meats such as chicken, turkey and fish, as well as pork, beef and lamb. There's also a wide variety of dairy products that you can choose from, including pasteurised cottage cheese, yogurt and hard cheeses. Of course, you should avoid uncooked eggs, soft cheeses made from unpasteurized milk like brie and feta, and blue veined cheeses which may harbour dangerous bacteria.

Calcium is essential for foetal development of bones and teeth, helps nerves and muscle formation and helps prevent blood clots. You will need about 1000mg/day while pregnant. It's very important to ensure that you are getting adequate levels during pregnancy, not just for the baby's health but also for the mother's health, as a lack of calcium during pregnancy can lead to osteoporosis for the mother later in life. Recommended foods to eat when pregnant that contain calcium include pasteurised dairy products like milk, yogurts and hard cheeses, dark green leafy vegetables and calcium-fortified foods like cereals and breads. If for some reason you have trouble getting the calcium that you require in your diet, your doctor can prescribe a pre-natal supplement.

Healthy fats are another important dietary element during pregnancy. Nut oils, olive oil, or avocados are good choices. Avoid trans-fats and aim for three servings of healthy fat each day. Trans-fats inhibit the conversion of fatty acids needed for foetal brain development and decrease the fat content of breast milk. It's not good for you and not good for your baby. If the food label includes the words "partially hydrogenated" in it, it means it has trans-fats in it and is to be avoided.

There are a variety of essential vitamins required by the developing foetus. Both vitamin A and D helps with foetal bone and teeth development, and can be sourced from milk, carrots, eggs and green vegetables. Vitamin E helps in the formation of red blood cells and can be found in vegetable oil, wheat germ and nuts, while vitamin C assists in building a healthy immune system and can be found in citrus fruits, green beans, potatoes and tomatoes.

Getting to know the right foods to eat when pregnant is the responsibility of every expectant mother. For the health of your unborn child, do it today.

The Neutered Public Option—Where’s the Rage?

2009-11-03T08:16:00.000-08:00

The public option contained in the House Democratic health care bill is hardly more than a neutered version of the “robust” public option one House Democrat after another said was a minimum requirement to keep their vote on health care reform. After threatening for months to fall on their swords if they didn’t get the “robust Medicare-like” version, there was nothing but enthusiastic support for