EHRs: A Remnant of Obamacare

The Electronic Health Record was mandated by the ACA. It was imagined and managed by a physician from Boston and its implementation can at best be called poor. We have been opposing its implementation for a decade and have been examining it for well over three decades. Simply stated the fatal flaw was that instead of being the patient's record, it was a health provider's record of a patient and as the patient went from site to site the systems could not communicate with each other.

Now Kaiser presents a sad tale of how this thing has started to cost lives. They note:

But 10 years after President Barack Obama signed a law to accelerate the digitization of medical records — with the federal government, so far, sinking $36 billion into the effort — America has little to show for its investment. KHN and Fortune spoke with more than 100 physicians, patients, IT experts and administrators, health policy leaders, attorneys, top government officials and representatives at more than a half-dozen EHR vendors, including the CEOs of two of the companies. The interviews reveal a tragic missed opportunity: Rather than an electronic ecosystem of information, the nation’s thousands of EHRs largely remain a sprawling, disconnected patchwork. Moreover, the effort has handcuffed health providers to technology they mostly can’t stand and has enriched and empowered the $13-billion-a-year industry that sells it. By one measure, certainly, the effort has achieved what it set out to do: Today, 96 percent of hospitals have adopted EHRs, up from just 9 percent in 2008. But on most other counts, the newly installed technology has fallen well short. Physicians complain about clumsy, unintuitive systems and the number of hours spent clicking, typing and trying to navigate them — which is more than the hours they spend with patients. Unlike, say, with the global network of ATMs, the proprietary EHR systems made by more than 700 vendors routinely don’t talk to one another, meaning that doctors still resort to transferring medical data via fax and CD-ROM. ­Patients, meanwhile, still struggle to access their own records — and, sometimes, just plain can’t. Instead of reducing costs, many say, EHRs, which were originally optimized for billing rather than for patient care, have instead made it easier to engage in “upcoding” or bill inflation (though some say the systems also make such fraud easier to catch).

In my opinion it is due to the gross incompetence of the Government and the influx of politically motivated individuals into this system. As noted, I can use my bank card in almost any country in the world. Get off a flight in Paris, go to a Kiosk, get Euros, stop at an ATM in Nova Scotia and get Canadian dollars. Fast, secure, interconnected. Not the EHR.

It had added a burden to every physician. There is now another employee sitting there typing into a computer hopefully getting it right. Or the physician is looking at the screen typing away as the patient wonders if they hear them.

I believe these systems can be a tremendous support to physicians. However as currently embodied, by law, they are a disaster. As noted, I cannot access images. If I did a CAT in location one and an MRI at location two then it is unlikely I could do a correlation. I would have to take everything to location 3!

Worse, a key to patient care is looking for trends and changes. I would watch blood sugar, HbA1c, weight, creatinine, etc. The systems for the most part still enter and display by visit, not by patient history. Generally if nothing changed you are fine, if it is changing, I would try to find out why and then see if that is normal. Not with any of these systems.

Finally, any Government mandate and designed system is subject to massive flaws. So now you want Universal Medicare! They can't get the trains to run on time. 

EHR Again

HHS has published a set of recommendations to reduce the burden of the EHR on the delivery of health care.

They note:

Based on this input, the draft strategy outlines three overarching goals designed to reduce clinician burden:

1. Reduce the effort and time required to record health information in EHRs for clinicians;
2. Reduce the effort and time required to meet regulatory reporting requirements for clinicians, hospitals, and healthcare organizations; and
3. Improve the functionality and intuitiveness (ease of use) of EHRs.

 As we have been noting for a decade this thrust of the ACA and its manager at the time was a massive useless burden on medicine and the patient. It was in my opinion thrust upon all of us by individuals who had apparently no idea what they were doing. 

This of course seems to be the general thrust of Governments.

The EHR Continues

In a New Yorker piece by Gawande he bemoans the EHR he is forced to use. We have been bemoaning this for the past decade. EHRs are not easy, they take away from patient interaction, often alienate the patient from the physician and cost more. Furthermore they really are no patient records but institutional and fail to be portable. Other than that I guess they are fine. They were mandated by the Obama Administration as part of the ACA. As anticipated being mandated by a physician with a strong political bent, they are classic "we know what's best" designs.

As the author notes:

“They’re long, they’re deficient, they’re redundant,” she said. “Now I come to look at a patient, I pull up the problem list, and it means nothing. I have to go read through their past notes, especially if I’m doing urgent care,” where she’s usually meeting someone for the first time. And piecing together what’s important about the patient’s history is at times actually harder than when she had to leaf through a sheaf of paper records. Doctors’ handwritten notes were brief and to the point. With computers, however, the shortcut is to paste in whole blocks of information—an entire two-page imaging report, say—rather than selecting the relevant details. The next doctor must hunt through several pages to find what really matters. Multiply that by twenty-some patients a day, and you can see Sadoughi’s problem. The software “has created this massive monster of incomprehensibility,” she said, her voice rising. Before she even sets eyes upon a patient, she is already squeezed for time. And at each step along the way the complexity mounts.

In fact one spends more time trying to game the system and failing to diagnose the patient. The problem gets worse since all too often the software designers look upon the physicians as dolts. Dumb old folks they have to train like old dogs.

I suspect as we noted a decade ago that this will not change. Yes we have all this fancy technology but we practice medicine not programming. Worse yet the support and training staff do not understand their customer in many cases and worse yet they care less.

Same Word, New Meaning?

Having spent time studying Thomistic Philosophy, a painful intellectual experience if ever there was one, I was a bit surprised when I saw an article in NEJM entitled:

Classification, Ontology, and Precision Medicine

Now I know the meaning of classification and precision, but ontology was the study of "being". The Ontological Proof of the Existence of God and all that. But here the authors have abandoned this millennial old meaning to define it as:

Ontologies are systematic representations of knowledge that can be used to integrate and analyze large amounts of heterogeneous data, allowing precise classification of a patient. In this review, we describe ontologies and their use in computational reasoning to support precise classification of patients for diagnosis, care management, and translational research.

Got that? I have had to read this more than a dozen times, through my mild dyslexia and all, still do not get it. I think I get the point they are making that we now have vast amounts of data on patients and that data may dramatically change the way we do diagnosis. No surprise there.

So just what are these "systematic representations of knowledge" they are opining about? Well we have all this data, not that I would call it "knowledge". It seems that every time we have a discovery of some new gene interaction in say cancer, a few months later there is another. Add to that the networking of these genes, then add to that the in vivo interaction, and so forth. I suspect we may have just begun to understand some issue in cancer, some very few, but important issues.

The problem however is that data is not knowledge. Eliciting from data fundamental principles and then validating them and then creating "tools" to measure then is critical. Even then the tools we have to measure stuff may elicit a cloudy picture, take the PSA test as a simple example.

The authors further state:

Conventionally, most of us think about structure as the arrangement of data, either on an EHR screen or as a database schema behind the scenes. Semantics, in turn, refers to concepts and the relationships between them. Software systems require assertions about term equivalence. ... Semantics and structure are not orthogonal but deeply intertwined.

 Again I think I get the point. Syntax is how we put words together to form a sentence, semantics is how we obtain meaning from the sentence. At least that is what it was sixty years ago when I first grasped the idea. They conclude:

The second barrier is the cost and effort of getting data into and out of EHRs. Manual input of structured data by clinicians is not scalable and is not a good use of clinicians’ time. Emerging efforts on standard application interfaces with EHRs from devices and data sources could help, as could patient-collected and patient-entered information. Systematically harvesting signs, symptoms, severity, and other clinical details from dictated notes or even from audio capture of the patient encounter is becoming increasingly practical.

 I believe it is fair to say that the EHR was not to be used by anyone professionally but was developed as part of the OCare system to oversee physicians and hospitals. Fundamentally as we have argued for over a decade the implementation and execution if fatally flawed. It is not patient centered. It is a check mark that all providers must meet. "Meaningful Use" is the greatest misnomer in the world. It just added costs to the system without any fundamental benefit. Thus this conclusion is useful but limited.

The EHR, Legacy of Obamacare

Ten years ago we argued against the way the EHR was being developed. Some idealistic left wing academic took control and had designed the rules under which this system now works. What did we say then and what is true now"

1. Patient's Records should be the Patient's Records. Instead they are the provider's records and as such when you go from one provider to another the records are inaccessible. Google and Microsoft took a swing at it but looking back who trusts them?

2. Physicians are NOT Clerks: This means that we do not want the physician spending hours entering records and finding ways to make it easier but less effective. We now have EHR staff adding to costs which are one of the reasons for increasing Health Care expenses.

3. AI cannot replace a physician. Despite Watson and all that hype there must be a human to human interface. Try placing a call to customer service anywhere, you spend a half hour with some moronic speech recognition device and usually end up at the wrong place multiple times. Patients lie, the tell you they do not drink, much, do not smoke, at least before coming to your office, do not use drugs, except for those they got from their sister.

The list can go on. In today's NY Times an author notes:

The biggest price for “digital medicine” is being paid by physicians like the sad case seated before me, who is already considering jumping to venture capital or a start-up, not because that is where the heart is but because it’s a place to bail out to. By some estimates, more than 50 percent of physicians in the United States have at least one symptom of burnout, defined as a syndrome of emotional exhaustion, cynicism and decreased efficacy at work. It is on the increase, up by 9 percent from 2011 to 2014 in one national study. This is clearly not an individual problem but a systemic one, a 4,000-key-clicks-a-day problem. The E.H.R. is only part of the issue: Other factors include rapid patient turnover, decreased autonomy, merging hospital systems, an aging population, the increasing medical complexity of patients. Even if the E.H.R. is not the sole cause of what ails us, believe me, it has become the symbol of burnout.

Every patient is different, most are terrified that they are dying, on the spot or soon. Many have neglected the problem that has now morphed into something more serious. The Times also showed hod US life-expectancy had lagged behind other countries. A physician today can tell you why by just looking at their waiting room. A collection of obese humans refusing to change. But how does that get to an AI system of to an EHR.

As Osler said, paraphrasing, "If all else fails listen to the patient." In today's EHR world it should read: "If all else fails look at the patient."

Is Meaningful Use Meaningful?

The EHR/EHR is moving forward in its Government mandated manner but signs of revolt may still be simmering. In MedPageToday they report:

...Amherst, Mass, said that three of the physicians who left her practice in the last year did so because of frustration with the Meaningful Use requirements. She said the practice underwent an expensive audit associated with the program that lasted more than a year, which had the ironic effect of delaying other programs aimed at improving patients' health. If Stage 3 goes into effect, ... said, she will be obliged to stop accepting Medicare patients, leaving 1,500 elderly and disabled patients without a primary care doctor. "I couldn't take care of my patients and take care of myself," she said. Another physician mocked the requirement for a certain percentage of patients to use online patient portals to communicate with doctors. He said he has his secretary log in his patients, most of whom are geriatric, so that they can send "a note of clinical relevance... which says 'hi'."

There are levels of problems here. First is the ability of the physician to enter "meaningful" data. For the most part it is cut and paste. Second is the ability to look at trends. Medicine often is seeing if anything has changed; HbA1c, PSA, BP, weight, etc. Change and rates of change are critical. I see this in monitoring HbA1c and PSA levels, yes PSA levels. Sample blood glucose are useless, HbA1c is a 90 day average. It has value. Single PSA is meaningless, velocity is prognostic. Most EHR make one fumble for those metrics. Third, try and get them to interconnect! Even in an integrated hospital system. Take New York Presbyterian. Cornell does not communicate with Columbia, and patient portals are separate and patient appointments are catch as catch can.

They continue

...a pediatrician from Leominster, Mass., agreed that certain metrics were inappropriate for certain specialties. "I think of this every time I check the blood pressure on a screaming 3-year-old who has an ear infection." And a number of physicians, ..., commented on the futility of punishing providers for the failures of technology vendors. Stack said he has the knowledge and expertise to take a patient whose liver has ruptured through numerous protocols and into the operating room in just enough time to keep the patient from bleeding to death internally. " I shoudn't have to write the software code for the electronic health record at the same time."

 It continues:

a professor at Harvard University and a researcher for the Children's Hospital Informatics Program at Boston Children's Hospital, said EHRs should be as adaptable as the apps on an iPhone. "If the makers of Angry Birds want to add a new bird they don't have to fly to Cupertino... to figure out how to do that."

 I could not have said it better myself!

The EHR and Washington

There is nothing better than a pediatrician who is an administrator, who wants to run for Governor and who in the process goes to Washington to specify how all physicians must in the future prepare their medical records. In fact in any real world one would find such a tale absurd, yet it is the truth. We now have the "meaningful use" standard, where did that come from, for the management of patient records. I thought this was stupid seven years ago, and yes even in 1992 when I first wrote of this, and still do.

Patient records are important, and part of the reason we never really got the problem solved is because it is really hard. Sometimes hard problems are hard for a reason.

At a recent AMA meeting as reported by Medpage the writer notes:


Almost immediately, physicians gave voice to the barriers to care they say are caused by electronic health records systems. Over the course of the 90-minute meeting they raised concerns over reduced productivity, the security of private patient medical records, interoperability, and government regulation. "We're removing the science from medicine," said one physician who described having to check "yes" and "no" boxes rather than being able to note subtle nuances his patients reported. "Thank God I learned to type in high school -- I never thought I'd use it," said another, explaining that she now has to make sure every employee she hires can type, regardless of the job for which they are hired.

It frankly is the arrogance of many who go to Washington who think that they know all there is to know...then again perhaps not.

The EHR and Its Performance

The NY Times bemoans the status of the EHR. As it states:

The ability to transfer electronic medical records from one doctor or hospital to another is essential to the smooth functioning of the health care system and to providing the best possible care to patients. Yet all too often these transfers are being blocked by developers of health information technology or greedy medical centers that refuse to send records to rival providers. This will not be an easy problem to fix, but some possible approaches were detailed in a report to Congress last week from the Office of the National Coordinator for Health Information Technology, a unit of the Department of Health and Human Services.

The problem, as we have noted over the past several years is several fold:

1. First, the Government directed the process. The same group who did the portal for ACA. In addition in my opinion the management team were politically selected not professionally selected.

2. The system should have been patient centered and not practice centered. Namely the system should have take advantage of a secure cloud based approach minimizing physician costs and overhead and allowing single points of collection and correlation. Unfortunately we have a plethora of systems which will be outdated and underused.

3. The system should be multimedia enabled. Now it is merely a text file system with some adjunct access for radiologists and perhaps pathologists. Other multimedia elements are piecemeal and unconnected.

4. The system should provide a customizable dashboard. If the patient is a Type 2 Diabetic one should see their BMI changes as well as HbA1c and others. If the patient has COPD the same.

The problem is NOT the vendors. The problem was in my opinion the very people who created this mess. We noted as such six years ago, but alas, it is this Administration.....And tens of billions of tax money has been spent and added costs to practices...not to mention physicians typing while not examining the patient!

The EHR: A Good Idea Gone Bad

The EHR was a good idea. Many physicians really need this once it works properly. In addition it was intended for sharing data between physicians for the purpose of lowering costs and increasing quality.

But, and this is a critical but, in my recent walks about the halls of local docs, I see the following. First, many have hired an additional staff person to type in the record. Why? Two reasons, first, they cannot figure it out, and second, the patients revolted when the doc spent all the time typing and clicking on the computer. I indicated as such early on. I had been working this issue for three decades, and still do not have a good idea what to do. Then there was that pediatrician from Boston who sat in DC and mandated an even poorer solution, in my opinion.

There is an interesting piece in Oncology Practice discussing this in an update. It states:

About 40% of physicians in the United States have adopted a basic electronic health record system, but few are able to use those systems to exchange clinical information with other offices or generate quality metrics, according to a survey of more than 1,800 physicians. 

The Harris Interactive survey found that 45% of primary care physicians and 41% of specialists met the criteria for having a "basic" EHR system, defined as a system that allows physicians to maintain problem and medication lists, view laboratory and radiology results, record clinical notes, and order prescriptions electronically. 

A much smaller portion of physicians – 10% of those surveyed – met the study’s criteria for achieving "meaningful use" of their electronic systems. More primary care physicians (11%) were able to perform all 11 meaningful use elements identified by researchers, compared to 8% of specialists who were surveyed. 

The greatest problem is transferring data in a meaningful manner.  Consider the case of a colonoscopy. At one center, an academic center, the system is almost totally computerized. The report is detailed and complete with key photos of melanosis and polyps if present. All actions taken by the physician are noted including any and all drugs and physical findings. This then gets linked to the path report. Not at a suburban clinic at best one has as a record is that the exam was performed and it was unremarkable. To add to the problem the report must be mailed to the attending! One does not even know what anesthetic was used! Were there diverticula or hemorrhoids.

Billions were spent by the current administration, or wasted if facts be known, and care decreased, costs increased, and data is jut useless.

EHR and Their Collapse

The Electronic Health Record has been an oft praised tool and was incented by the Stimulus bubble of 2009. It was to have changed the practice of Medicine and saved billions. We have had serious concerns from several perspectives. First it detracts from "listening" to the patient, second it does not allow even minimal temporal record analysis, and third it was mandated by the Government.

Now comes a report by RAND, who had initially promoted the concept, which in amednews states:

Researchers at the RAND Corp. say their 2005 prediction that health information technology could save the U.S. more than $81 billion annually has not come to pass. But the organization isn’t placing the blame on itself for its inaccurate prognostication.

Instead, in a report in the January Health Affairs, researchers from the policy think tank placed the blame on “shortcomings in the design and implementation of health IT systems” 

 Instead of saving $81 billion I would argue it costing that on top of everything. It was not the shortcomings of the design, it was the demands of HHS and the meaningful use standard process. Physicians have added new staff, the avoid contact with patients, the systems cannot communicate, and the systems failed to allow simple correlations over time, such as weight and HbA1c.

The article continues:

They blamed vendors for creating systems that are difficult to use and can’t connect with other electronic health records, echoing physician complaints about them. However, the researchers also said doctors and hospitals have not invested the “considerable” time and effort necessary to learn how to use the systems, and adapt their work flow to ensure that technology is smoothing processes, not hindering them.

In reality the blame should be placed upon the current Administration and its process of Government mandated rules.

EHR Progress?

The EHR systems are still provider centric. Frankly this is one of the biggest mistakes ever. They require providers to transfer data, often in an unusable manner. Now we are seeing the 3rd generation coming.

As HealthCare states:


For Stage 3, the Health IT Policy Committee's Meaningful Use Workgroup wants physicians and hospitals to increase their use of clinical decision support; computerized physician order entry (CPOE); structured, machine-readable data; and medication reconciliation (the process of comparing a patient's medication orders to all the meds he or she has actually been taking). The plan also ramps up requirements for patient engagement. 

In a plan recently unveiled in Washington, D.C., the workgroup made its preliminary recommendations for Stage 3. 

New for Stage 3 would be requiring providers to enable at least 10% of their patients to submit their medical history electronically, to accept readings from home medical devices, and to update and correct information in EHRs. Providers also would need to supply electronic care plans to other providers and care sites when patients are referred or moved, and the referring site would be required to send a small percentage of results back, 

One need just look at what is proposed and the workload is increasing exponentially. Patient Care plans are like Grammar School Class Teacher Plans, they will become some off the shelf piece of pdf and that is NOT the way medicine is practiced. This appears to be a techy's dream of how complex to make something. What will this do to the practice of medicine. Already many physicians have hired another person to enter and keep the EHR, and many physicians may never look at or even know how to examine an EHR.

In addition the need to integrate with billing and authorization is totally lacking. The data is not patient centric and it fails to adequately deal with displaying data for chronic disease management. This is a total nightmare and will just explode the costs of health care with no positive benefit.

The EHR Conundrum

I have written extensively on the EHR, electronic health record conundrum, over the past few years but the best description is given in a picture by a patient in this weeks JAMA.

The author states:

No one was more surprised than the physician himself. The drawing was unmistakable. It showed the artist—a 7-year-old girl—on the examining table. Her older sister was seated nearby in a chair, as was her mother, cradling her baby sister. The doctor sat staring at the computer, his back to the patient—and everyone else. All were smiling. The picture was carefully drawn with beautiful colors and details, and you couldn't miss the message. When he saw the drawing, the physician wrote a caption for it: “The economic stimulus bill has directed $20 billion to health care information technology, largely funding electronic medical record incentives. I wonder how much this technology will really cost?”

It is really worth a view of the picture. I have seen this in various modes:


1. A good friend and superb clinician well over 40 can now be seen asking questions while typing on his screen.


2. A dermatologist friend hired an additional staff person to create her records.


3. A group of residents spend their time looking at screens rather than going to patients.


4. A gerontologist scans his patients from the nurses station, never really looking in to even see if they are alive at a nursing home.


Osler would spin over in his grave. The culture of medicine is being lost. Once we actually looked at the urine and could even identify a disorder by its smell. That is unheard of today. One even uses an electronic stethoscope to record heart beats and use AI technology to seek out beat abnormalities.


That, I fear, is the risk with the EHR.

Electronic Medical Records: People are Now Thinking

tablets as to what an EMR, or EHR, is, others are now really starting to think about it. There is an interesting short piece by Kibbe and Klepper presenting some useful thoughts in terms of principles. Some I agree with others I have some issues, yet as we all know there is no general consensus and the Government mandates will not make it so. Just look at TSA, the Intel Community, and the like. No matter who runs the Government they never seem to get it right.

Yet I thought it would be useful to add some thoughts. For those of you wondering what I bring to the table I am now volunteering my time at the Brigham and Women's Radiology Department to try to sort through issues on the imaging side. At the other extreme I see on a day to day basis how clumsy the current system is. For I have digitized all family records and then print them out and hand carry between physicians. You see they do not use email, partly a HIPPA issue, partly an issue of added costs, partly a cultural issue.

So regarding EMR the following are my major principles:

1. Make it Patient Centric: The data should be in the hands of the patient, virtually as well as physically (electronically that is). To do this there must be a single registry. Well we have many of them as examples today, like Facebook and the like. Hundreds of millions are there already, even old folks.

2. Add Costs and Alternatives, or Feedback and Feedforward Work: Over the past twenty years we have observed in the literature and in the field two things. First if physicians are given costs information regarding alternative medications they generally choose the less expensive, subject to maintaining patient health. Second, if they are provided with alternative procedures, based on some agreed to set of standards, yes comparative clinical effectiveness, albeit "locally" sourced, say through their professional or local academic groups, they tend to reduce procedures. These are feedback systems reinforcing what works and feedforward systems making peer group "suggestions" or providing options. A simple example is do I get a CRP and an ESR, for a suspected thyroiditis and if not then which one?

3. Do Something: One of the problems of defining and then implementing the "right" system is that the result takes too long, it is filled with problems, it costs too much, and it is out of date when and if it is ever completed. Anyone who has ever been in the real world knows that. So the best approach is to just start with what is there now, say the Google or Microsoft systems, and then build upoon that. Yes the Kaiser system is great, expensive, and under a central control. It most likely will work no where else. But by just doing something and then reiterating one can in a Darwinian sense get somewhere. Namely bad ideas will not make it to fruition and stop the good.

4. Keep it Simple: This is the challenge. The success of the Internet was the success of TCP/IP over the IBM SNA world. One should keep the inner parts of the system as simple as possible and let the edges add the complexity, for they have it already.

5. Let it be Organic: This means we do not need a single God like dictator who in their own mind has the solution to everything. No matter how smart we think we are we always miss something. Back to my old MIT days of teaching, to test an idea I made a dicta in class and watched the little sharks tear it apart. The result was a good idea, not necessarily what I pontificated at the beginning. One must be open to criticism. Unfortunately physicians are frequently not prone to that.

Well just some thoughts.

Electronic Medical Records: HHS Releases a Proposal

HHS released its proposal for EMR this past week. Dr Blumenthal the leader of the effort summarized the work, somewhat, in NEJM and he states:

"On December 30, the government took several critical steps toward a nationwide, interoperable, private, and secure electronic health information system. The Department of Health and Human Services (DHHS) released two proposed regulations affecting HIT . The first, a notice of proposed rule-making (NPRM), describes how hospitals, physicians, and other health care professionals can qualify for billions of dollars of extra Medicare and Medicaid payments through the meaningful use of electronic health records (EHRs). The second, an interim final regulation, describes the standards and certification criteria that those EHRs must meet for their users to collect the payments. "

We comment here on the second.

First the definition is as follows:

"4. Definition of Qualified Electronic Health Record (EHR)

Qualified EHR is defined at section 3000(13) of the PHSA as “an electronic record of health-related information on an individual that:

(A) includes patient demographic and clinical health information, such as medical history and problem lists; and

(B) has the capacity:

(i) to provide clinical decision support;

(ii) to support physician order entry;

(iii) to capture and query information relevant to health care quality; and

(iv) to exchange electronic health information with, and integrate such information from other sources.” We have adopted the statutory definition of Qualified EHR without modification."

The second part of the definition is rant with issues. As we have argued for the past year, and in fact for over two decades now, the complexity of an EMR is significant. Also as we have argued having the Federal Government define it is totally bassakwards. After all these are the same people who run TSA, the Treasury Department and the like. Not overly comforting. Let me take a closer look. What does "provide clinical decision support" really mean. Let us look at an example.

A 60 year old man comes in with lower back pain. Should we do an MRI, perhaps a herniated disc, yet many men have these with no symptoms. He may have prostate cancer mets, he may have multiple myeloma. Should not the physician using his or her standard differential diagnosis, based upon knowledge of the patient, make a judgment? Or are we using the EMR as the camel's nose in the tent regarding the Comparative Clinical Effectiveness scam which is rationing is Government clothes.

Let us go to the health care quality element. Again, what is quality, and are we then developing a system to monitor the health care provider and assessing his or her quality. If so then we may have increased the level of defensive medicine.

Finally exchanging information with whom and for what purpose. This is a massive task if we take this literally and also manage to stay within the bounds of HIPPA.

Let me continue from the HHS document:

"5. Definition of EHR Module

We have defined the term EHR Module to mean any service, component, or combination thereof that can meet the requirements of at least one certification criterion adopted by the Secretary.

Examples of EHR Modules include, but are not limited to, the following:

• an interface or other software program that provides the capability to exchange electronic health information;

• an open source software program that enables individuals online access to certain health information maintained by EHR technology;

• a clinical decision support rules engine;

• a software program used to submit public health information to public health authorities; and

• a quality measure reporting service or software program.

While the use of EHR Modules may enable an eligible professional or eligible hospital to create a combination of products and services that, taken together, meets the definition of Certified EHR Technology, this approach carries with it a responsibility on the part of the eligible professional or eligible hospital to perform additional diligence to ensure that the certified EHR Modules selected are capable of working together to support the may provide the additional capabilities necessary to meet the definition of Certified EHR Technology, but may not integrate well with each other or with the other EHR technology they were added to. As a result, eligible professionals and eligible hospitals that elect to adopt and implement certified EHR Modules should take care to ensure that the certified EHR Modules they select are interoperable and can properly perform in their expected operational environment."

Thus HHS is not only "choosing winners" but it has made itself the "winner". Unlike the Internet IETF approach of having the users and user groups holistically evolve the standards, HHS has taken the approach of having some group of GS 12s decide what is best. They will become the Certification agent for all EMRs.

Specifically a Certified EHR is defined as:

"Certified EHR Technology is defined at section 3000(1) of the PHSA as “a qualified electronic health record that is certified pursuant to section 3001(c)(5) as meeting standards adopted under section 3004 that are applicable to the type of record involved.”

In this interim final rule, we have slightly revised the definition of Certified EHR Technology to make it more consistent with the initial standards, implementation specifications, and certification criteria that are being adopted. Certification criteria focus on the capabilities of Complete EHRs or EHR Modules and consequently, Certified EHR Technology should be defined in accordance with that approach.

We believe defining Certified EHR Technology in that manner will provide greater clarity and
meaning for this interim final rule.

We have defined Certified EHR Technology to mean:

A Complete EHR or a combination of EHR Modules, each of which:

1) meets the requirements included in the definition of a Qualified EHR; and

2) has been tested and certified in accordance with the certification program established by the National Coordinator as having met all applicable certification criteria adopted by the Secretary.

To clarify the meaning of “applicable certification criteria” in this definition’s second part, we note that Congress indicated their expectation that different types of HIT would be certified. Congress elaborated on this expectation with a parenthetical in the statutory definition, which references two examples, “an ambulatory electronic health record for office-based physicians” and “an inpatient hospital electronic health record for hospitals.”

For a variety of reasons, including that certain proposed meaningful use Stage 1 objectives only apply to an eligible professional or eligible hospital and that these two types of health care providers require different capabilities from Certified EHR Technology, we have adopted specific certification criteria that are only “applicable” to Complete EHRs or EHR Modules designed for use in an ambulatory setting (e.g., by eligible professionals) or an inpatient setting (e.g., by eligible hospitals).

We indicate in Table 1, and in the regulation text below, which certification criteria apply solely to Complete EHRs..."

Yes, this means that HHS will create standards and certify against their standards and if you do not comply then there will be penalties. Frankly what Government standard has ever made sense. Just look at HIPPA, despite the fact that when it was promulgated the Internet was blossoming, they demanded faxes.

The regulation outline is shown below. It is useful to see the extent of this regulation and then to read the specifics. It is this which will control and we believe will destroy any creativity in EMRs.

SUBCHAPTER D – HEALTH INFORMATION TECHNOLOGY

PART 170 – HEALTH INFORMATION TECHNOLOGY STANDARDS, IMPLEMENTATION SPECIFICATIONS, AND CERTIFICATION CRITERIA AND CERTIFICATION PROGRAMS FOR HEALTH INFORMATION TECHNOLOGY

Subpart A – General Provisions

Sec.

170.100 Statutory basis and purpose.

170.101 Applicability.

170.102 Definitions.

Subpart B – Standards and Implementation Specifications for Health Information Technology

Sec.

170.200 Applicability.

170.202 Transport standards for exchanging electronic health information.

170.205 Content exchange and vocabulary standards for exchanging electronic health information.

170.210 Standards for health information technology to protect electronic health information created, maintained, and exchanged.

170.299 Incorporation by reference.

Subpart C – Certification Criteria for Health Information Technology

Sec.

170.300 Applicability.

170.302 General certification criteria for Complete EHRs or EHR Modules.

170.304 Specific certification criteria for Complete EHRs or EHR Modules designed for an ambulatory setting.

170.306 Specific certification criteria for Complete EHRs or EHR Modules designed for an inpatient setting.

This is worth the read.

Now the real issue is that the Government never does anything itself. It in almost all cases contracts the work out to some beltway bandit. In particular to the lowest bidder. If you liked the mess at Newark Airport this weekend imagine that the team at HHS will do with EMRs and their Certification. A Government designed, Government Certified, Government paid for, and Government controlled system, with penalties for non compliance will truly be a disaster. There is no known example of this ever working. Industry does a better job. I come back to the IETF and the development of the Internet.

EMR are truly required if we ever hope to gain control over health care but placing the Government smack dab in the middle with cause just the opposite. Having spent many years in that environment I know from first hand experience what happens. One must be truly ignorant of all reality to assume that such a major system can be designed and controlled by the Government without a TSA type of outcome. The lowest priced bidder solution.