Curb Your Enthusiasm…

High Tech people are very enthusiastic people. We are optimistic, confident and creative and if I may be allowed to say so, really, really smart. We start out by saying “Hello World!” not “Hi, I’m Jack or Jane”. We hail the entire Universe and assume it knows who we are, or that it will soon find out, because the sky is not the limit and we are going to change the world, all at once. We don’t wear pocket protectors or duct tape on our spectacles. We wear defiantly baggy clothes; have tattoos and piercings in all the right places, ride motorcycles and listen to the latest music. Actually many of us are former or part-time musicians, or at least dabble in painting, spiritual philosophy and sometimes even a little writing. We don’t make telephones or missiles or coffee makers, but we make your phone smart, your missile guided and your brew master programmable. We solve problems and sometimes we get carried away.

Back during the heyday of the Certification Commission for Health Information Technology (CCHIT), a grumbling sound began to emerge from the medical community moaning and groaning about the Big Boy EMRs certified to meet CCHIT’s standards. Those who underwent the onerous CCHIT certification process which began in earnest in 2006 were said to be nothing more than “bloatware”, expensive, cumbersome and useless software developed by programmers who know nothing about the practice of medicine and forced on physicians by an emerging semi-governmental effort and greedy, unscrupulous EMR vendors. This of course gave birth to the most ridiculous slogan in EMR advertising: built by doctors for doctors. Every fledgling new entrant to the EMR market and every retrofitted DOS program with less functionality than Microsoft Office seemed to have been built by doctors, presumably by the one MD usually introduced at the beginning of the “About Us” inspirational story. Obviously there were some true stories too, and some MDs ended up specializing in C++. The CCHIT wars have ended and even the great CCHIT era crusader, Dr. Al Borges, seems to have gone silent somewhere around 2010, but the notion that EMRs, or EHRs now, are falling short of expectations because they were built by programmers has become a widely accepted “fact”.

Very few products successfully sold for mass consumption are ever built by end users, software included. A retrospective look at the EHR market would indicate that regulations and certifications and now also incentives and penalties were applied too soon in a normal market cycle. EMRs were never allowed to evolve, just like any other product, based on user preferences as manifested in buy/no buy decisions. Try to imagine what would have happened to the cell phone market if during the first years of its existence someone would have mandated, for quality and consistency reasons, that the antenna should always be on the left side and it should be between 1” and 2.4” in length and no less than 0.25” in diameter. And then the Department of Motor Vehicles in collaboration with the Department of Homeland Security and Motorola would have provided everybody with a hefty tax deduction for buying a certified cell phone. It wouldn’t have mattered much who actually built those cell phones. Since High Tech people are more enthusiastic than most, we are now not only fixing in amber the size and shape of our software product, but also endeavoring to prescribe how it should be changed and how it should be used. To use the early cell phone analogy, we are standardizing the button sizes, adding a 911 auto dial button and mandating users to push that button after an accident if they want Progressive to honor their claims.

ONC is short for the Office of the National Coordinator for Health Information Technology. It is the highest office in the land for High Tech people working in health care, and enthusiasm should probably be its middle name, rainbows, stars and all. ONC is not really writing EHR software, but from its high perch it is guiding programmers on what to build, in what order to build things and recently began dabbling in advising on how to build EHRs. Many veteran EMR programmers weary of the built-by-programmer vs. built-by-doctor fight are probably breathing a sigh of relief right about now, because customers, who don’t like what they see in the product, can now be redirected to log their complaints with the powers to be at ONC. Fortunately, for every veteran EMR programmer laying down his arms, there are dozens of brand new and experienced High Tech people enthusiastically answering the call to arms for solving the national crisis posed by our health care system.

Old EMR programmers assumed that they know nothing about medicine, and although believing that doctors are equally ill-equipped to architect software, programmers recognized that doctors are their customers and mighty tough customers at that. EMRs were a tool & die business, something one sells and another buys, if needed. The new and very enthusiastic High Tech people in health care, unburdened by any previous EMR scars and bruises, have a different mindset (or so they say), most likely brought about by ONC’s very successful public relations efforts. EHRs and Health IT in general are now a cause, something you advocate for, something you believe in, something you write about, something to be fostered, promoted, or adopted. Health IT is an ideology. Health IT is a political issue that should support governments. Health IT is a social issue that should reduce disparities. Health IT should change medicine as we know it. Well, not that we actually know medicine in the classic meaning of the term, but we just know better in general.

After all, we changed the world already. Just look at the Internet. We have no money to buy books, but we have Facebook. We have no food to speak of, but we have democracy in Egypt. We can’t afford tuition, but we have Khan. We have no jobs, but we have passionate blogs and tweets that reach billions in an instant. We make no saleable products, but we can market with laser accuracy. We have no money for doctors, but we have Google. We have no friends, but we have Siri to keep us company in big old empty houses. We have no worldly possessions, but we own the world of Zynga. We have no clue, but we have data. We can do the same for medicine. We can make it virtual, free, fun, engaging, personalized, simple, participatory, democratic, pain-free and expertise-free. We don’t know what DNA stands for, but sequencing the genome sounds like something we can write software for. We don’t care if observations are prospective or retrospective, as long as we have plenty of data points. We feel strongly that double blinding something is cruelly medieval, in an age of transparency and visibility. We have created a world where babies can manage hedge funds, lizards can sell insurance, everybody can run an agribusiness and every barefoot, malnourished child in Rwanda has a fair shot at the Nobel Prize. We can fix health care once and for all, and we know exactly how to do it.

“Hello Health Care!”

One Little Ewe Lamb

“There were two men in one city: the one rich, and the other poor….. “
(II Samuel 12:1-12)

Thus begins the story of King David’s punishment for robbing a simple man of his life and of his one beloved wife. I have had the incredible fortune of being taught the Bible in the City of David, probably a stone throw away from where he perpetrated a sin that haunts his people to this very day. I was taught the Bible not as a divine text, but as a political, historical and philosophical manuscript written by ancient sages, and David’s story was not about the perils of philandering. It was about the disastrous results of social injustice. The story is not a Socialist manifesto. The Bible in its entirety accepts the fact that there are rich men and poor men and David was not admonished for not redistributing his riches equally amongst the poor. The line of decency is crossed when the rich and powerful wantonly decide to take away the poor man’s “one little ewe lamb”, not to love and cherish as the poor man and his family did, but to carelessly slaughter and serve at some casual meal. The predicted future for such rich men and for their people is that “the sword shall never depart from thy house”. Of course, this is just a story, but over the thousands of years since Nathan the Prophet delivered his indictment, many nations and great kingdoms came to experience gruesome violence and ultimately collapsed due to excesses of the rich and powerful, and careless disregard for basic social justice.

Today, America is taking the first step towards joining the pantheon of cruel nations doomed by history to crash and burn. The Grand Old Party of Abraham Lincoln, who went to war with itself to rectify social injustice, is asking the American people to elect the Romney/Ryan pair to the highest offices in the land, based on their solemn promise to hunt down all remaining little ewe lambs of the poor and serve them up butchered and dressed as an afternoon snack for the rich men they represent, because the only way for poor people to survive and avert the wrath of the rich is to make the sacrifices necessary for feeding the rich men’s insatiable appetite for tender shish-kebab.

I am not an economist or a financial expert of any sort, and I have no appreciation for the fine differences between long term and short term capital gains, or the multitude of tangled terms used to obscure intended and unintended realities from common folks who have not experienced any type of gains in half a century. I am perfectly willing to accept the obvious fact that the US is spending more than it’s making and that we must make more and that, at least temporarily, we must tighten our collective belts. The Romney/Ryan notion of fiscal responsibility is placing the rich folks, each with his own private belt, at the soft center of the beltless masses of poor people, all surrounded by one national belt, which is to be tightened at the same time as the epicenter of wealthy individuals loosen their belts by a few notches. The incredibly well calculated idea is that the circumference of all of us can be reduced while the wealthy center is actually increasing its girth. Millions of faceless and nameless poor people will of course suffocate to death during this geometric wizardry if allowed to proceed, but the captains and titans in our midst will thrive, and promise to eventually share a bit of their good fortunes with the surviving cannon fodder in their immediate vicinity.

If you are one of the fewer and fewer citizens who are not poor, and if you think that when the Great Republican belt tightening exercise commences, you could wrestle yourself a cozy place close enough to the center to allow you to keep your belt where it is today, or if you’re lucky maybe even relax it a notch or two, while shielding your eyes and ears from your neighbors getting crushed at the periphery, remember that this great nation was created as “one nation under God, indivisible, with liberty and justice for all”, and God has spoken on this matter over five thousand years ago, and regardless of your beliefs, history is teaching us that nothing that was built on social injustice and “that which is evil” can stand for very long, and no matter how many fortunes were bestowed on a man or a nation in the past, once “the poor man’s lamb” is not safe from the selfish greed of the rich and powerful, sooner or later calamity always follows.

The 2012 Presidential election is not about different fiscal approaches to the national deficit. It’s not about efficiency of private markets as opposed to incompetence of public solutions. It’s not about health care or Obamacare. It’s not even about gay marriage or abortions. This upcoming election is unfortunately about politics as usual versus sheer evil. And it is your decision to make on November 6th. Please vote.

Dr. Gawande’s New Shiny Thing

Dr. Gawande has a new article in the New Yorker suggesting that hospital chains may very well be the solution to our health care problems. Dr. Gawande has a very engaging writing style and in addition to writing for the New Yorker, he writes books and delivers memorable speeches and he is also a surgeon at Brigham and Women’s hospital in Boston. In recent years, Dr. Gawande’s writings have become the cornerstone of health care policy and none more so than his 2009 New Yorker article explaining the inexplicable health care cost explosion and the variability of medical expenditures across the nation. As the New Yorker itself proudly noted, President Obama himself had a most fortuitous epiphany after reading the New Yorker article, and summarily decided that “This is what we’ve got to fix.”

In “The Cost Conundrum” Gawande explored the differences in expenditures for Medicare beneficiaries in two Texas towns whose names became synonymous with our health care issues, the expensive McAllen and the rather cheap El Paso, concluding that “across-the-board overuse of medicine” induced by “a culture of money” was the root cause for the “extreme” expenditures in McAllen. The article, accompanied by an illustration of a patient dressed like an ATM machine, quickly became the foundational axiom at the base of health care reform efforts, and Peter Orszag (the then OMB Director) immediately adopted this axiom and translated it into hard dollar amounts: “The result is an estimated $700 billion a year spent on health care that does nothing to improve patient health, but subjects you and me to tests and procedures that aren’t necessary and are potentially harmful – not to mention wasteful.”

One could identify here the beginnings of the currently undisputed rhetoric about a 30% waste in health care, the associated slogans of “more care is not better care”, “pay doctors for value not volume”, and the need to rein in greedy doctors who are knowingly harming patients to enrich themselves through the unfortunate fee-for service payment model. It didn’t matter much that respected researchers like Drs. Robert Berenson and Jack Hadley from the Urban Institute repeatedly disputed the findings of the Dartmouth Atlas on which the Gawande axiom was based. It didn’t even matter that Medicare itself came up with different numbers which show that McAllen is not really that expensive after all. Once the President decided that “this” is what we’ve got to fix, by golly “this” is what we are going to fix, whether it needs fixing or not.

Next Dr. Gawande turned his attention to learning from other industries and applying lessons learned to the troubled health care system. The first such industry was Agriculture, which has come a long way from “strangling the country” at the turn of the 20th century to today’s seemingly bottomless pit of cheap, genetically altered, antibiotics, pesticides, preservatives and other carcinogens laden foods, produced by sub-minimum wages illegal immigrants, and pushed by vertically integrated agribusinesses to every supermarket and every 7-11 across the land. Dr. Gawande is crediting this major development to Government intervention in the form of local extension services to diffuse experimental technology innovations to uneducated and initially resistant farmers, and to various assistive regulations. He sees a similar experimental approach being taken by the Affordable Care Act (ACA) and is hopeful that current health care initiatives will have the same beneficial effects as observed in agriculture.

Aviation with its almost perfect safety track record was the next industry to attract Dr. Gawande’s attention. The checklists used by pilots in commercial aviation seem to have some applicability to medicine. Although checklists were used by others with great success in health care, Dr. Gawande published an entire book on the subject and called it a Manifesto. Next came the race car industry, and in a commencement address at the Harvard Medical School, Dr. Gawande informed the class of 2011 that medicine needs them to be “pit crews” instead of traditional “cowboys”. I don’t know if Dr. Gawande watches too many John Wayne movies or too few car racing events, but old-time cowboys, although versatile and capable of performing many tasks, always worked in coordinated groups of various sizes and compositions, depending on the size of the outfit that employed them. By contrast in a pit crew, one member’s responsibility, which is strictly defined by regulations, starts and ends with the left rear lug nut even if the entire car is on fire. Despite the poor choice of words, the message is the same: standardized, repeatable protocols of care delivered by “medical systems” are superior.

In this month’s issue of the New Yorker, Dr. Gawande takes the systems approach to its logical conclusion. We need Big Medicine. We need chains of hospitals and clinics. Big chains, like the Cheesecake Factory. It seems that health care can also learn from the restaurant industry or retail in general, since CVS and Walmart are also fondly mentioned in the article. According to the story, Dr. Gawande and his children had a lovely dining experience at the local Cheesecake Factory establishment, ergo chain restaurants when managed well, can deliver a fantastic culinary experience for a rather affordable price. Of course, we all know that there are hundreds of other chain restaurants that cannot, and Dr. Gawande himself seemed very protective of his reservations at Per Se, but maybe the reason the Cheesecake Factory is so successful is the automation and team approach to food preparation. No Iron Chefs here. A well-oiled (no pun intended) machine of  managers and sub-managers and workers at various stations of cooking, cleaning and learning on the job, eerily similar to pit-crews, each responsible for a prescribed piece of work, manage to create in aggregate a consistently repeatable faux upscale dining experience for people who have no idea what Per Se is.

Exploring the excellence of chain establishments is not unique to Dr. Gawande, although he may have just turned it into official policy. Similar arguments were made recently by Dr. Peter Pronovost, comparing health care to the exclusive Capella hotel chain, an offshoot of the Ritz-Carlton glitzy chain, and reached similar conclusions. One could wonder how these learned essays would address what most people recognize as hospitality chains, such as Applebee’s, Chili’s, Holiday Inn or Motel 6. One could also observe that anybody with no particular credentials could open a restaurant or a Bed-and-Breakfast, or work at such “one-of-a-kind” place, just like there are no particular education and licensing requirements for working on a farm or for becoming a cowboy. A very interesting experiment would be to require that each mom-and-pop restaurant should have a Parisian Cordon Bleu graduate in order to open its doors, or that every Bed-and-Breakfast would need a Glion graduate on staff. I wonder if in that case, anecdotal evidence from hand-picked hospitality chains would still compare favorably to the one-off little establishments. I suspect not.

Dr. Gawande is proposing that medicine should become Big Medicine and doctors become broiler “chefs” with a computer monitor controlled by “headquarters” hanging above their “station”, or perhaps we don’t even need those super educated doctors and scullery maids can work their way up to “management”, just like his protagonist in the New Yorker story did, because he knew of no other place where he “could go in, know nothing, and learn top to bottom how to run a business”. They used to teach medicine that way before we had medical schools too.
So based on one dining experience at one chain restaurant, “liberals will have to accept the growth of Big Medicine, and conservatives will have to accept the growth of strong public oversight”. Just like we had to accept the growth of Big Farms, Big Banks, Big Automotive, Big Retail and Big Corporate everywhere, all with strong lobbying oversight and strong public subsidies and bailouts as necessary, and a slowly evolving definition of quality to mean cheap enough to keep the nouveau poor from jumping out of the experimental pot of boiling water.

Big Trash

Like most home buyers, I toured the house with my family, checking closet space and bathtubs and finally descended into the basement to see if it has any potential. It was a very large and dark basement mostly unfinished, but the scene in front of us was breathtaking. Thousands of glass jars and bottles of every conceivable shape and color, sparkling clean and neatly stacked in groups by size and shape, some in small pyramids, on a myriad of shelves, small tables and wooden crates. There were no labels on any of them and there were no tops. The ex-Marine Sergeant who built the house in the fifties and lived there ever since, must have spent a lot of time cleaning, processing, sorting and arranging glass containers for what seemed like an awful lot of years. Why did he do that? What did he see in those glass mazes he built in his basement? I never found out. We bought the house almost eight years ago, and had a “guy” come by and remove everything that was not nailed to the walls before the painters and floor refinishers showed up. Sgt. C.’s big collection of empty glass shells ended up as Big Trash, because although empty containers may hold certain fascination, particularly for those who lived through the Great Depression, there is absolutely nothing useful you can do with a basement full of glass.

We as a species are now collecting data. We’re not sure exactly why or how we’re going to use it, but we are convinced that we cannot, should not, discard any electronically recorded piece of information. You may clear your browsing history on your own computer, but somewhere, somehow, someone retains that information. You may delete all your text messages from your own phone, but they may still exist in some database somewhere in some cloud. You may delete your old emails, but somewhere there will still be a record for them. Your tweets, your Facebook messages, all other social media participation, every syllable you ever typed and every tag or image you touched, all these things are being neatly catalogued and stored in some data basement somewhere. And now we have apps that most of what they do, other than show you that cheesecake has more calories than turnips, is to collect even more bits and pieces of information and add them to that big basement in the sky.

Previous generations of human beings created as much data as we do. They shopped and traveled and engaged in conversations. They kept diaries and every single one ate, slept, walked, breathed in and out, had a heartbeat, loved and hated things, experienced profound happiness and despair, and when all was said and done, discarded the containers of life without a second thought. We are the generation of the Great Information age, and just like Sgt. C. we feel compelled to keep everything that was scarce and hard to come by only a few years ago. We talk about treasure troves and are so very certain that all those mountains of carefully scrubbed and meticulously arranged pieces of information will yield some miraculous result any day now. And if it’s not clear what miracle exactly, that’s because we need more data and we need to arrange it in other ways. I wonder if Sgt. C. was consciously shopping for foods packaged in glass containers, just so he can add another shiny piece of the puzzle to his collection.

I’d like to imagine that when Mrs. Sgt. C. whipped up a batch of her famous tomato sauce, she would stroll down to the basement and pick a nice jar to store the sauce in, or when Sgt. C. brought her flowers for her birthday, she would pick the nicest blue glass container to put the fresh daisies in. She probably never had to buy those ugly plastic Tupperware things either. There was some utility in Sgt. C.’s glass collection, but did it really warrant giving up an entire basement and countless hours of maintenance work? There is some utility in our big data collection too. When we need to sell tomato sauce or flowers to people, we can dig through our data basement and find just the right message and the right people to send that message to. Today’s Mad Men need not be as “creative” as Don Draper had to be in order to increase sales and profits for clients.

If Sgt. C. could have collected all the glass jars in the world and if he could have shared them with all people in this world, nobody would have needed to worry about storage for their secret recipe potato salad ever again. If we could listen to, collect and analyze every heartbeat in the world, we could instantly identify impeding disaster, and correct the problem. We could be saving lives judged worth saving. If we could know in real-time when people are sad, we could make them happy in real-time. If we could know in advance which people would become ill and exactly when, we could tell them and maybe treat them if it made economic sense. Eventually, we could ensure that all our babies are born healthy and with proper monitoring live long, productive and happy lives.

Mrs. Sgt. C. died at the turn of the new millennium, and Sgt. C. died a few short years after that. He never knew what eventually befell his glass containers collection. I am grateful for that. Perhaps if someone other than us would have bought his old house, those beautiful glass jars would still be there today and perhaps more would have been added. Perhaps a pattern would have emerged and something great would have happened. But it did not because I trashed his life’s work. We will most likely all die before our collection of digital shells of life will yield any benefits or alter the definition of humanity in any significant manner, and we will never know if our data basements will be preserved or relegated to the Big Trash pile. I am grateful for that too.

The Privacy of Your Digital Self

Everybody has a shadow. Although as a small child you may have tried, you cannot separate yourself from your shadow no matter what you do. Electronic medical records may be the first tiny step on the road to attaching yet another indivisible part to your persona, a “panoramic, high-definition, relatively comprehensive view of a patient that doctors can use to assess and manage disease”, and this, in the words of Dr. Eric Topol, is the “essence of digitizing a human being”. Dr. Abraham Verghese, named this digitized entity iPatient and expressed concern that the “iPatient threatens to become the real focus of our attention, while the real patient in the bed often feels neglected, a mere placeholder for the virtual record”. Whether you share Dr. Topol’s enthusiasm or Dr. Verghese’s worries, or experience a combination of both, your medical digital self, has been born. And nurtured by leaps and bounds in technology, it will soon grow to loom as large as your shadow at sunset.

Today’s electronic medical records contain a wealth of clinical and socio-economic data. By the time Dr. Topol’s creative destruction of medicine is well underway, electronic medical records will contain mountains of wearable sensors and monitoring devices data, along of course with your entire genome accurately sequenced and analyzed. You don’t have to be a tenured academic in search of grant funding to realize the endless possibilities created by electronic medical records data. Maybe we can find a cure for cancer, or at least figure out what causes it, and then find a cure. Since poverty is in many cases generational, maybe…. Or maybe not. Regardless of your research aspirations, the fact remains that this massive wealth of data is composed of millions (billions) of iPatients, or digitized human beings.

Unlike your childhood shadow, it seems that by erasing or masking some data elements, iPatients can be safely detached from Patients and aggregated in a fairly anonymous mass of iPatients. Assuming that this is true, and some are not so certain, two problems come to mind. First, iPatients pared down to complete anonymity make very poor subjects for serious clinical research. Second, by definition, complete genetic information cannot be anonymised. So what happens if we leave out serious clinical research and futuristic genetic profiles? Is there anything we can do with the simple, not so accurate and rarely complete, data provided by today’s anonymous iPatients? Well, we could do another study to see if we still have geographical variations in care and costs. We could fund the 127th study to figure out that poor people are sicker and sicker people have larger costs and poor and sick people have the highest costs, particularly amongst the elderly. We could get a bit more pragmatic and figure out where grocery stores should stock beer and where Napa Valley wine would sell better. Or we could satisfy our needs to reform our brethren and figure out where we can get the best bang for every buck spent on billboard space for antiabortion ads. Certainly, socially benevolent institutions may be able to find a myriad other uses for our aggregated iPatients, and medical records data adds a lot of “color” to the cut and dry claims data we are now using for similar purposes. But how do we go about aggregating our iPatients? Should all iPatients be available to whoever wants to use them, for whichever purpose?

Currently, iPatients are beginning to form in databases owned and maintained by Health Information Technology (HIT) vendors. The law of the land governing the travels and gatherings of iPatients is HIPAA and it says that each one of us has the right to view our iPatient (seriously?) and to some degree consent to any travel plans made by our physicians or hospitals for our iPatients. iPatients who have been altered in certain ways to facilitate some level of anonymity are beyond our control. That’s the law. The practice of the law is a bit more interesting. First, the language of the HIPAA consent is broad enough to allow health care providers to do anything they wish to do with our iPatient for the purpose of “health care operations”, which can include medical care, washing windows and turning a blind eye to iPatient trafficking. A HIPAA consent form is part of Patient registration in every health care provider settings, but is this really “informed consent”? Do Patients know for example that your contract with your HIT vendor allows that vendor to make copies of supposedly anonymised iPatients and “share” them with whomever they wish? Do you know that? Do Patients really understand the difference between a HIPAA covered entity and a commercial app provider who is not bound by any type of anonymity restrictions upon backend exportation of iPatients?

In the olden days, before iPatients were born, people assumed that the Hippocratic Oath was good enough assurance to allow them to bare their bodies and souls in a doctor’s office. Today, this trust-based act is being electronically recorded and persisted for posterity. In technology circles this is called Big Data. Unlike paper and pencil manufacturers, and unlike any other industry, the new purveyors of documentation tools for the medical profession are asserting a peculiar right to the information created and stored in their tools. The iPatients are not the Patient’s property and are not the doctor’s property, and are not “property” at all, therefore they belong to the “public”. And by “public” they are referring to anyone with backend access to medical records databases, or anyone who can afford to purchase such access. You, the Patient or the doctor, are not the public. Just try to see if you can freely access a recently liberated iPatient population in any way. The idea here is that talking about iPatients as property and asserting ownership of iPatients by Patients and physicians is somehow logically flawed in view of property laws. And the idea is that the same exclusive “public” is much better equipped to decide how your iPatients should be used to your benefit, and used they must be. You should “trust” that this is indeed so. Implicitly. There is no need to “verify” or for anybody to “bring data”. You don’t need to be asked if you would like to volunteer your iPatient for research and you don’t need to be asked if it’s OK for some corporation to use your iPatient to increase profit margins and you don’t need to be asked if your iPatient can be used against you in aggregate or on an individual basis. Where once you only needed to trust your doctor, now you need to trust the “system”. [Don’t confuse this with the ongoing government campaign to facilitate “trusted” exchange of information, which is only concerned with frontend access to data.]

In 1890 Samuel Warren and Louis D. Brandeis published an article in the Harvard Law Review titled “The Right to Privacy”

… “Thus, in very early times, the law gave a remedy only for physical interference with life and property, for trespasses vi et armis. Then the "right to life" served only to protect the subject from battery in its various forms; liberty meant freedom from actual restraint; and the right to property secured to the individual his lands and his cattle. Later, there came a recognition of man's spiritual nature, of his feelings and his intellect. Gradually the scope of these legal rights broadened; and now the right to life has come to mean the right to enjoy life--the right to be let alone, the right to liberty secures the exercise of extensive civil privileges; and the term "property" has grown to comprise every form of possession-- intangible, as well as tangible.
…..
Recent inventions and business methods call attention to the next step which must be taken for the protection of the person, and for securing to the individual what Judge Cooley calls the right "to be let alone."
…..
The principle which protects personal writings and all other personal productions, not against theft and physical appropriation, but against publication in any form, is in reality not the principle of private property, but that of an inviolate personality.” [emphasis added]

The iPatient is quickly becoming the repository for much of that “inviolate personality” and our “recent inventions and business methods” are practically screaming for attention to what must be done to secure an individual’s right “to be let alone”. A more recent Supreme Court opinion, written by Justice Stevens in 1977 in the case of Whalen v. Roe recognized that much, “A final word about issues we have not decided. We are not unaware of the threat to privacy implicit in the accumulation of vast amounts of personal information in computerized data banks or other massive government files”, but stopped short of addressing the larger issue. It’s up to our elected representatives to legislate appropriately, and that time has come.

For starters, people should be made aware of all so called secondary and tertiary uses of their medical records whether anonymised or not. And people should have a choice of what types of usage they are willing to contribute medical records to. Blanket statements like “operations” are just not good enough. Recognizing, as Justice Stevens did, that “[t]he right to collect and use such data for public purposes is typically accompanied by a concomitant statutory or regulatory duty to avoid unwarranted disclosures”, the word "typically" must be replaced by "always", and should include backend wholesale disclosures by those who have no ownership rights to our intangible possessions. And if we must strike a balance between the public good and the privacy of our inviolate personality, we must make sure that the public referred to here is all of us, and that the good is indeed good enough, and that the balance is not calculated by corporate, political and moneyed interests, but that the balance is struck, in our customary ways, by We the People……

Finding Utility in an EHR

If you are like most physicians in this country, you probably bought yourself an EHR, either recently or a while back. If you are like the docs quoted on the various EHR vendor websites, you took to it like fish to water and are thoroughly enjoying your new computerized system. If you are like most other physicians, you are slugging your way through, a bit slower than usual, with a bit less money in your wallet, either hopeful that things will get better or perhaps still hopeful that this is just a bad dream. If you are like most EHR users, you probably compromised on an EHR that seemed to be not as bad as the others, compromised with the documentation style seemingly imposed by your EHR and are now dragging a tablet from exam room to exam room, and that tablet gets awfully heavy after a few hours of seeing patients. Perhaps you found nifty little ways to “cheat” and leave the tablet in your office, or maybe you broke down and installed desktops in your exam rooms, or perhaps you tried to use the almighty iPad, and found that it takes a couple of hours to finish your charts after your last patient left the building. People keep telling you that things will get better, that you will get used to it and that practice makes perfect. You may not be convinced, but what other choices are there? You have to “get with the program”, get your Meaningful Use money and adapt to the new ways of doing business in health care. You are wrong.

If you played any type of contact sports in high school or college, you probably bought yourself a mouth guard at some point.  You can take it out of the package and pop it in your mouth, and you may have done that in a pinch, but it works and fits much better if you take it home, soften it in boiling water and mold it to perfectly fit your mouth.  An old business adage says that you have to spend money to make money. With EHRs you have to spend time to save time (and maybe make a little bit of money too). You have to spend time softening and molding that EHR to fit your future practice. The biggest mistake people make, is to attempt to push and shove an off-the-shelf EHR into their current practice. This is not much different and makes as much sense as using Microsoft Word on a tablet with a stylus to hand write on it. So how do you go about molding an EHR to fit a future environment that is both enabled and limited by the introduction of the same EHR? Is your EHR a chicken or an egg? And no, I don’t think I want to hear the answer to this one.

I’m certain you heard lots of experts talk about “workflow redesign”. In a small practice, there is very little to “redesign” and the work flows predictably from appointment making, to office visit, to claim submission and hopefully payment for services rendered. However, a properly utilized EHR can help create a smarter distribution of workloads.  

Figure 1: EHR enabled office visit (click picture to enlarge)

Figure 1 shows a typical office based encounter when an EHR is utilized to redistribute workload. The flow of the visit has not changed, but the workers are now different. Before we examine the new workloads, let’s keep in mind three things:

1. The EHR is sunk cost. You already paid for it and any additional tasks that can be offloaded to the EHR are net gains to you and your practice.
2. You are the only billable resource in the practice.  Any tasks that can safely be offloaded away from you can increase billings (or leisure time, or quality of service).
3. Patients are a completely free resource. Granted, not all your patients can contribute the same amount of work (i.e. engagement), but whatever is contributed is again a net gain to your practice.

In our simple example, the computer has picked up a variety of tasks previously performed by staff. These are mostly mundane and repetitive tasks suitable for machines. Patients picked up some tasks for which they are much better suited than any of your staff, with the added benefit of creating an informed and engaged patient. And yes, I know that this is not applicable to 85 years old ladies with a 4th grade literacy level, but surely you have some patients that can and wish to participate in their care this way. Since your staff has a bit less work to do now, they can take on some of the things you currently do. For this to happen, you must staff your practice adequately. If the person that rooms the patient cannot be entrusted with much more than politely sitting the patient in the exam room, this is not going to work very well. Otherwise, the entire “I didn’t go to medical school to be a data entry clerk” quandary should be largely resolved. You will always have to document your exam, and may need to add comments here and there, but basically, your nurse should have checked all the boxes and clicked all the buttons before you entered the room, giving you the freedom to truly listen to your patient without having to worry too much about the computer.

Skeptical? Of course you are. Unfortunately, there are no EHRs that come out of the box with all those efficiencies built in or with simple cookbook instructions on how to get there. So here are a few pointers to get you started.

1. Make your own visit templates. Either you tweak the ones included in a good EHR or start from scratch and create exactly what you like. In most cases this is immensely time consuming, but if you don’t spend time upfront to mold your visit templates to your liking, you will never derive maximum utility from the EHR. Remember the paper forms you used before the EHR? Somebody had to make those forms too. EHR templates are more flexible than paper forms and creating your own templates will take more time and expertise. You will have to try them out and adjust as you go. You don’t really need hundreds of templates. A dozen or so, well-chosen ones should make a good start. If your EHR allows you to configure flowsheets, make a bunch of those as well.
2. Create order sets and if your EHR allows, add those to pertinent templates. You can start with simple things and work your way up to more complex visits. You shouldn’t need too many here either. You don’t want to have so many templates and order sets that it becomes difficult to find the one you need. Fewer and more general ones work better.
3. Configure pick lists and favorites. Everywhere you can, create short lists of frequently used items. This is especially helpful for orders and diagnoses.
4. Deploy the patient portal that comes with your EHR and don’t be afraid to open it up for patients to do as much as possible online. Have your staff actively promote the portal to patients and give out instructions on how to use it. It will take time for patients to get used to online interaction with your practice, and it will take time for staff to get accustomed to it too, but savings can be significant depending on who your patients are, of course.
5. Make sure that every automated billing feature available from your vendor is turned on and working properly. It won’t hurt to contact the vendor and find out if there’s anything new in this area that you are not aware of, particularly if you had this EHR for a few years. Some of these things will cost you extra, but are well worth the expense.

Generally speaking, every time you find yourself doing something that is not direct patient care, you should pause and ask if this particular task could be delegated to staff, patients or computers, and if there is a way to use your EHR to that end. The answers are not going to be obvious and since most people use only a fraction of features available in an EHR, it may require some digging, exploring and even advanced training. But if you stick with the principles illustrated in Figure 2 below, you will discover that your EHR, although far from perfect, can and will provide you with measurable utility.

Figure 2: Principles of the quest for utility (click on picture to enlarge)

The Bionic Medicine of Programmable People

A couple of weeks ago I wrote a post about the clueless, but endearing, enthusiasm of technology people as applied to solving the health care problem. A few days ago Dr. Davis Liu published a post on The Health Care Blog describing the vision of Vinod Khosla, the famed venture capital maven, of replacing doctors with machines. It turns out that Mr. Khosla wrote a series of three articles at the beginning of the year in a technology publication describing how his pioneering vision will replace people in industries where either he or his wife are investing capital. Venture capitalists (VCs), although I’m sure they wouldn’t agree with this assessment, are a combination of professional gamblers and loan sharks. The secret to success is pure luck and ruthlessness, and when the combination works and the ball lands on the exact number on the spinning roulette, venture capitalists make lots of money. This is very different than running a business ala Warren Buffet or even Mitt Romney, let alone inventing a business like Apple or Microsoft. In return for risking funds, venture capital gets its juiciest pound of flesh when the funded business sells itself to the public, hopefully for more than it is really worth, and hopefully for a lot more than the venture capitalist risked. For that to happen, you have to create demand for whatever your fund is investing in at the moment. This is why you find VCs shedding tears at the mere thought of global warming, or telling us that the future is all about “I Robot”, or miraculous genetic “I am Legend” drugs , or “gamification” or whatever happens to make up their current investment portfolio. The problem with letting venture capital dictate humanity’s agenda is that the globe is getting warmer; people are getting poorer, sicker and dumber while a few VCs are getting richer.

So what is Mr. Khosla selling us now? It seems that his machines, outfitted with “bionic” software are set to replace the 80% of “middling” doctors and also 80% of equally “middling” teachers. Only physicians like Dr. House will remain standing (for a short time) so they can be “leveraged” to create even more “bionic” software, and may I suggest that Albus Dumbledore could be used to illustrate the surviving human teachers of the bionic era. If you are a little bit familiar with the startup world, then you probably know that a business based on services provided by people is not an appealing investment gamble, because it doesn’t scale well, i.e. revenues and EBIDTA cannot go simultaneously through the roof at the same incendiary rate, because people need to be paid for labor. The trick is to find a business model where no labor is required or to find laborers who don’t require payment. A couple of centuries ago we “imported” such laborers from Africa. Today we are “exporting” labor to where those laborers naturally reside. For tomorrow, we are proposing to make machines that work for free. And this in a nutshell is Mr. Khosla’s vision.

Let’s pause for a moment and address the technorati among us. This is not about medical technology for Dr. Leonard McCoy and Dr. Beverly Crusher or about the holographic doctor in Star Trek Voyager, all very awesome and super cool. This is not about stardate 43632.8 or a galaxy far far away. This is about a time frame of “five or ten years” for “bionic” software and “a decade or two” for an army of “Dr. Algorithm” practicing independently. It should be obvious even to the most ardent believers that, in such a short period of time, neither the science of medicine nor technology will be anywhere near the creation of the medical droid that administered to Padme in childbirth. However, these time frames are short enough to appear on corporate financial projections and startup pro-forma budgets. This is about real money and about some flimsy machinery deployed to play doctor to the poor (China and India are mentioned by Mr. Khosla, but the Mississippi Delta can’t be far behind), and if folks are harmed in the process, oh well…. (See below).

Now, how about this “bionic” software that Mr. Khosla envisions to be a temporary bridge between human cognitive endeavor and full machine control in “a decade or two”? Turns out that the term was introduced by a serial entrepreneur in the social media/marketing, hotter than molten lava, sector. Later adopted by the O'Reilly AlphaTech Ventures folks who invest in clicks and links and data as well, “bionic” software has something to do with “programmable people” and “it has the potential to unlock a massive amount of unrealized human potential”, presumably as programmed and networked by VC funded programmers. According to Dennis K. Berman, a WSJ journalist writing about technology and “corporate scandals”, also cited by Mr. Khosla, we should accept the “rise of the machines” just like we accept earthquakes and hurricanes because it is simply inevitable. And if we still have any doubts regarding the superior intelligence of Jeopardy winning machines, we are reminded that “systems are now of such scale that they can analyze the value of tens of thousands of mortgage-backed securities by picking apart the ongoing, dynamic creditworthiness of tens of millions of individual homeowners. Just such a system has already been built for Wall Street traders”. I am so totally convinced now, but if you need more real life examples, you should read about the $108 million in venture funds going to “bionic” software helping pharmaceutical companies track social media activity to identify doctors more likely to influence their peers, or the $84 million venture investment in “bionic” software to spy on customers and make them buy more fatty food stuff.

According to Mr. Khosla, soon we will advance beyond simplistic “bionic assistance” to “lazy” doctors, and we will no longer be “free to be stupid or political” and “reject” the “cost optimization” served by “Doctor Algorithm” in its medical practice and none of us will need those multitudes of “average” doctors stuck in the “18th century tradition of “first do no harm””. Since VCs are only interested in engineering, as opposed to social engineering, their off the cuff suggestions for the “middling” 80% in any profession or occupation, where wages are proposed to be eliminated from the expenses column, is usually something vapid like “empathy, advice and caring”. Of course “empathy, advice and caring” doesn’t pay anything like actual doctoring, and it is precisely those large wages that need to be eliminated. Highly educated professional workers are also much harder to transform into “programmable people”, like say, the young girls working in one of those infernal laptop assembly lines in China. So once the new troves of captive cheaper-than-machine labor pools have been secured, all that is left in the quest for zero COGS, within the short cash horizons of venture capital, is to eliminate those expensive and volatile knowledge workers from the balance sheet. And since Mr. Khosla’s educated estimate is that “medical diagnosis or 90% of it is an easier task than Jeopardy”, and since he urges us “not to extrapolate the past and what has or has not worked”, it should be easy as pie to imagine a future almost completely free of professional physicians, classroom teachers and non-programmable people in general.

Thus, in Mr. Khosla’s hospital of the future, medicine will be practiced by thinking machines, while floor scrubbing, sheets changing and bed-pan emptying will be left to humans. Eventually, the medical machines, or the few human lords remaining, will probably take on the last yard of efficiency and create menial machines for janitorial purposes, at which point the only human beings in a hospital will be the patients in the beds, and venture capital’s ROI will be inching towards infinity. Unfortunately for Mr. Khosla, or future generations thereof, the transactional volume will be trending to absolute zero, since the “middling” 80%, after advancing to the mindless 80%, are now mostly extinct or have reverted to gathering wild berries where vegetation still remains. I hope being the Supreme Ruler of nothing at all proves to be a very satisfying experience for Khosla Ventures.

EHRs Can’t Talk to Each Other?

When the hypothetical naked, unconscious and alone patient presents at your ER with no immediately evident reasons for his distress and presumably holding his driver license between his clenched teeth, would you find it helpful if you could see a nicely typed, or hand written, list of diagnoses and current medications for this hapless person?

When a family moves across the country and brings in their eight year old for her first visit with the new pediatrician, would it be helpful to see a slightly fuzzy image of her immunizations list from back home?

When an elderly patient you’ve been seeing for umpteen years is shipped to the hospital in the middle of the night, would it be helpful to find the admission record in your to-do list for today?

                                                           *****************

Perhaps these things would be nice to have, but EHRs can’t talk to each other, so before any of these miracles can occur we must make EHRs communicate. How do we make EHRs talk to each other? That’s simple: we look at how people talk to each other, and apply the same principles to EHRs. Thus, EHRs have to share the same language, use the same syntax, know when to speak and when to listen, and when not in physical proximity, use a variety of paraphernalia to carry voice over large stretches of land and sea. And since EHRs are really computers and this is after all the 21st century, we have the blueprint for a solution in our hands, because any computer in Papua New Guinea can talk to any computer in Boonville, Missouri. How? By using the magic of the Internet.

The Internet is a collection of electricity, plastic, metal, wires and thin air that can carry incredible amounts of yes/no (+/-, 0/1) payloads from any one point to another.  The magic of the Internet is the set of agreements between all users of this global town hall on how to transport and process the yes/no (standards) and how to combine all yes/no blips into meaningful content (software). It is really magical because I can’t think of any other subject on which humanity agreed to agree. When you think about it this way, how awful it must seem that EHRs cannot agree to agree with all humanity, join the town hall conversation and talk to each other on our Internet, particularly since all EHRs, without exception, are using the Internet to talk to all sorts of other entities, but for some peculiar reason, they refuse to directly address each other. How rude.

So our government, in its infinite wisdom, and for the benefit of the citizenry, has decided to crack down on these rude EHRs and force them into polite discourse on the Internet, and in deference to their historical aloofness, the government is building an Internet just for EHRs, so they feel special. The Health Internet will still use the plastic and metal of our Internet, but it will have brand new agreements on how to move those yes/no bits across the wires, and all sorts of contracts and definitions on how to combine them into a meaningful exchange. To that end, our government is busy defining standards and regulations and terminologies for EHRs to use when talking to each other, because what EHRs have to say is so important, so complex and so sensitive that they cannot possibly be expected to convey the true meaning of their information through the plebeian Internet we all use. Didn’t I just say that EHRs are already using the plain Internet to talk to other entities? Yes, and in all fairness, EHRs have never actually said that the plain Internet is not acceptable to them, but the government, being a kind and thoughtful government, figured that this may be the case, and it is always best to provide solutions where no problems exist, just to be on the safe side.

Using the good old Internet, a fairly experienced EHR vendor will connect you to a reference lab in about a week and shouldn’t charge you a single dime for the pleasure. A true Software-as-a-Service EHR, like athenahealth or Practice Fusion, could just “flip a switch” and have your EHR conversing freely with the lab. An even faster switch flipping event will connect you overnight to every pharmacy in the country and every health insurer too. If you have a nice EHR, (not expensive, just nice), a click of a button will send whatever you want to send to whomever you want to send it to. If you have a nice and service oriented EHR, like athenahealth, the stuff you receive from others will “magically” appear in your patient charts. This is called electronic faxing and it uses the Internet around the “antiquated” telephone endpoints. So does this mean that your EHR can talk to other EHRs after all?

Not quite. It is true that by using the F protocol (fax) your EHR can create an image of your documented thoughts and transmit it to another EHR to display this picture to another clinician, so you can “talk” to another doctor, but the EHR itself is left out in the cold because it cannot understand what you two are saying. The EHR is thus just a dumb messenger, shuffling pieces of paper from one master to another. And this is a huge problem for policy makers, although not so much for patient care (see opening questions above), because now your EHR cannot slice and dice, incorporate, analyze, aggregate or report on your conversations, so you can pretty much forget about clinical decision support for yourself and population management for everybody else. Of course, you are already collecting significant amounts of information that your EHR can understand (all those click boxes), so why not let your EHR into the conversation and let it exchange information with other EHRs in its own language of yes/no, +/-, 0/1? After all, that’s how it talks to labs and insurers, and nuances of human narrative seem to be disappearing into 140 characters, grammar free and syntax free, communications anyway.

Seeing that there are hundreds of different EHRs out there, deployed in thousands upon thousands of different configurations and locales, this seems a pretty daunting task, until we remember that there are thousands of pharmacies too and all sorts of pharmacy software packages floating around and your EHR can talk to all of them. The private market solution to this problem is to have everybody send everything to one central place specializing in sending things to everybody else, a giant Post Office on the Internet if you will, and we call it a clearinghouse. This could be built today. Right now. And Surescripts is making a feeble attempt to use the new Direct secure email protocol to do just that, but this is not catching on because the power of the clearinghouse is not in routing emails; we can do that on our own. The power of a clearinghouse lies in its ability to facilitate standardized, bi-directional, and real-time if necessary, Electronic Data Interchange (EDI), in other words make EHRs talk to each other, and all EHRs out there speak HL7 in many dialects. So what’s stopping EHRs from talking to each other in this facilitated manner?

Until recently, the only thing preventing EHRs from chatting over the Internet was corporate policy prohibiting this type of socialization outside corporate boundaries. It was a business decision made by those who own and use EHRs (not those who make them). This may be changing now (to a small degree), since the business of health care is changing, but we have recently run into another obstacle, which was intended to accomplish the exact opposite of what it is accomplishing. It was decided that clearinghouses are an outdated model of communications and that the current Internet is not good enough to accommodate the new and improved vision of how EHRs should communicate through networks of Health Information Exchange organizations. It costs physicians between nothing and a few pennies to use old clearinghouses services today, but it seems that connecting to the new Internet may be cost prohibitive for small practices and the proposed replacements to clearinghouses are struggling with something called sustainability. Existing clearinghouses are the products of many years of market consolidation and technology development and are very profitable now. Adding simple clinical transactions to their existing portfolios shouldn’t be too much of a stretch and the bigger the clearinghouse, the larger the economies of scale.

Obviously, the new Internet does not exist just yet and the new paradigm has never been validated to work on any significant scale, and so we wait for the countless committees our government has put together, with new ones seeming to crop up every day, to figure out their charters and mission statements, and define something that can be prototyped and later tested by volunteers somehow, and maybe turn out to be the new Internet - a more expensive, more complex and more fragmented version of what we have today, which may or may not survive market realities. In the meantime, if you are “just” a doctor taking care of patients, keep doing what you’re doing and if you can replace the print-fax-scan cycle with electronic faxing or secure email from your EHR, by all means do so. Of course, you could always pick up the phone and call someone. Information is information, and some of us can still talk, read and write. As long as you take good care of your patients and are able to find ways to communicate with other care facilities, very little else should be of concern. When all the trials and tribulations are exhausted and EHRs are finally allowed to talk to each other more efficiently, you will be the first to know.

Taxstereogram

On Thursday, June 28, 2012, the Supreme Court of the United States decided that requiring all individuals to purchase health insurance from a private corporation, or suffer a penalty, is an unconstitutional exercise of Congressional power, but if you stare at the Patient Protection and Affordable Care Act (PPACA) for long enough, at a certain angle, in a certain light, you can see a tax form, materializing above the viewable details of the act. Since Congress has plenty of latitude on taxing schemes, the health insurance tax, previously known as the individual mandate, was left standing as is.

This great innovation from Chief Justice Roberts was hailed as “A Marbury for our time”, referring to the landmark case of 1803 where Chief Justice Marshall asserted the right of the Court to invalidate acts of Congress if judicial review concluded that the acts are unconstitutional. The Roberts Court of 2012 is expanding the definition of judicial review from the review of actual acts of Congress to the review of what could have been acts of Congress, or a contextually appropriate mixture of the two. The trick here is to know when to plainly look at the legislation and when to concentrate and apply a wall-eyed or cross-eyed technique to discern the hidden meaning that could have been hidden by the content in plain view.

The Court began by looking at the PPACA as it appears to the untrained eye and declared that the Anti-Injunction Act (AIA) is not applicable to the penalty required from those who choose not to obey the individual mandate because said penalty is not a tax and the AIA is only applicable to taxes. This was followed by a blistering opinion explaining that the Commerce Clause of the Constitution cannot be expanded to give Congress the ability to force people to become active in a particular form of commerce by imposing penalties on inactivity, which is both unnecessary and improper. However, as the Chief Justice wrote, “[t]hat is not the end of the matter”. While continuing to look closely at the act, it seems that what looked like a penalty for not buying insurance to the untrained eye, is shaping up to be “imposing a tax on those who do not buy that product”. Ironically, a few pages prior to this momentous discovery, Chief Justice Roberts found it necessary to quote John Marshall in Gibbons: “[T]he enlightened patriots who framed our constitution, and the people who adopted it, must be understood to have employed words in their natural sense, and to have intended what they have said”. It seems that today’s enlightened patriots need not be understood in the same way, and there is no reason to assume that they actually intend what they say. Fair enough. At this point, it must have been too late to apply this realization to the AIA ruling, but not too late to let the individual mandate survive the constitutional challenge, because Congress can tax almost as it pleases. Almost.

If you think about it, applying a penalty to inactivity is just the Yin to the tax break Yang. So instead of giving those who purchase insurance a tax break, we can exact a penalty from those who do not purchase insurance. The latter has the advantage of increasing revenue without the added step of increasing the general tax burden first, and has the same effect. We are all familiar with tax breaks for various activities and the difference is only semantic. For example, instead of giving you a tax break for buying a fuel efficient car, the government could impose a penalty if you buy a regular car. Instead of a tax break for your mortgage, you pay a penalty if you choose not to buy a home. Instead of getting a tax break when you have a new baby, the government could penalize you if you don’t. Same thing, right? Yin-Yang.

This may be by far the most significant innovation introduced by this ruling. Congress now has a brand new, one-step, process to raise revenues without explicitly raising taxes. Better than cold fusion and almost as good as perpetuum mobile. Who needs to torture the old Commerce Clause when our visionary conservative Chief Justice set a powerful precedent for endless ways in which to penalize (i.e. tax) the people?

The 8th Pillar of the Patient Centered Medical Home

The Patient Centered Medical Home (PCMH) model of care is built on seven principles. Seven is a lucky number in some cultures, but if you ever tried to stand something up on seven legs, you probably know that eight is better and sturdier. The medical home is missing a pillar, and strangely enough the missing pillar is the very reason why the concept was originally proposed. The seven principles of the PCMH were jointly formulated by the primary care medical societies in 2002 to describe the characteristics of a PCMH practice, and consist of a personal physician, physician directed medical practice, whole person orientation, coordinated and/or integrated care, quality and safety, enhanced access and appropriate payment. So what are we missing?

Back in 1967, the American Academy of Pediatrics (AAP) introduced the term “medical home” realizing that fragmented and incomplete medical records are an impediment to proper care for children with chronic conditions:

"For children with chronic diseases or disabling conditions, the lack of a complete record and a ‘medical home’ is a major deterrent to adequate health supervision. Wherever the child is cared for, the question should be asked, ‘Where is the child’s medical home?’ and any pertinent information should be transmitted to that place"

The pediatric medical home was a place where a longitudinal medical record would be compiled and aggregated from all care providers a sick child may encounter along the way, and the idea was that all those other providers of care would proactively inquire about a child’s medical home, and then promptly transmit their records to that central place, so that care can be adequately supervised by the child’s medical home. Not too bad for an idea that is almost half a century old, and little has changed since. Today’s medical records are increasingly electronic in format, but still scattered across various health care delivery locations. A primary care doctor may receive consult notes from specialists, but not always, and could in some cases download hospital notes from a physician portal or request that these be faxed over. The medical record available in a primary care practice whether PCMH designated or not, is never complete, which may not be a problem for generally healthy folks, but it certainly presents difficulties for people with chronic disease.

In the spirit of the first mention of the term “medical home”, an 8th principle should be added to the joint principles endorsed by the primary care associations, to establish the PCMH as the medical records aggregator. The 2002 joint principles of the PCMH have been operationalized by a variety of State and public organizations who certify primary care practices as PCMHs. Practices must meet an extensive set of requirements in several domains, and provide supporting documentation to that effect. For example, the current recognition program from NCQA, the leading PCMH certifying body, consists of 151 factors, some mandatory, some optional, and complicated methods for calculating the level of medical homeness a practice offers to its patients. As complex as the process may be, and as difficult as some measures are, the primary care practice has full control over all current PCMH defining factors (other than payment). This is not the case for our proposed 8th principle.  

To initiate the aggregation of medical records by the medical home, someone other than the primary care doctor, must ask the AAP question, “Where is the child’s medical home?”, and then proceed with information transmittal to that place. It is up to specialty clinics, hospitals, nursing homes and other facilities of care to initiate this aggregation. Obviously the PCMH must be able to receive, process and meaningfully aggregate the received information, and in return, make it available to all those other facilities as needed, and to patients at all times. Just like achieving current PCMH recognition does not require that you absolutely must have Electronic Health Records (EHR) software, meeting the 8th principle is entirely possible with nothing more than paper charts and a fax machine, although an EHR would make the process a lot easier for all involved.

So how would we go about adding a medical records home to the plain medical home? We could add half a dozen, or so, factors to be met to the existing NCQA standards and guidelines, while assuming that primary care practices have the necessary clout to force specialists and hospitals to push information back to the medical home on a consistent basis. Alternatively, we could just rely on the kindness of the “medical neighborhood” (a fairly new concept outlining how all providers should help PCMH practices) and hope for the best. Or, we could use the one giant lever at our disposal, which is being used for a variety of other purposes, and gradually add some measures to Meaningful Use.

Specialists have been complaining (and rightfully so) for almost two years that the Meaningful Use program was defined with primary care in mind. Here is an opportunity to add a specialty specific measure that will require all specialists to promptly transmit complete consult notes back to the referring primary care doctor. Hospitals should send ED summaries, admission notes, op-notes, discharge notes and instructions. And let’s make this achievable with large thresholds, by allowing fax, electronic fax, secure email (like Direct) or whatever the sender can use to send. We have plenty of time to insist on structured messages as the infrastructure for information exchange matures. The countermeasure for primary care docs would be the ability to incorporate the information into the electronic chart by scanning it in, receiving it electronically directly into the EHR and attaching it to the patient chart manually or automatically, or by any means necessary. Since most EHR products are capable of electronic faxing or secure email or both, the development effort for EHR vendors should be minimal. And I cannot imagine any doctor or hospital arguing that this measure imposes undue administrative burden, because this goes directly and unequivocally to better patient care.

This proposal wouldn’t be complete without addressing the small, but very energetic, minority of self-described patient advocates, who due to life changing events of their own, or because of other interests, are demanding that the mighty Meaningful Use lever be used to extract data from all medical facilities and transmit it in computable format to commercial medical records aggregators. The assumption being that “adequate health supervision” is most adequately performed by the patient and a myriad of completely free and exquisitely sophisticated tools to be defined later. There is no contradiction here, folks. If the patient prefers to have a separate medical records home, for one reason or another, by all means, let everybody transmit information to wherever the patient desires. If the patient doesn’t want anything transmitted, that’s fine too, and these “opt-out” choices would be counted as exclusions to the measure by primary care medical homes or specialists, or both. My guess would be that with all the managed and accountable care models proliferating out there, patients will be assigned to a medical home, and opt-out choices will be rare. Either way, and with the possible exception of Boston or Silicon Valley, most folks would welcome and be better served by medical records supervision delivered by real doctors and their clinical teams.

Speaking of doctors, I know that many of you consider the PCMH construct as nothing more than a burdensome layer of bureaucracy designed to bankrupt primary care. However, if you look at the seven original joint principles and the additional principle proposed here, it is impossible to argue that the essence of a “medical home” is inconsistent with good primary care, even though the processes around it may very well be. This is not much different than sitting for your medical boards, which may seem unduly bureaucratic, but do not invalidate the essence of being a physician. Furthermore, and adapting freely from Michelangelo, I would submit that the medical home is already there inside your practice and we only need to hew away the rough walls that obscure it from view, and from proper reimbursement.

Is Meaningful Use Too Successful?

Approximately a quarter million clinicians and hospitals have signed up for Meaningful Use incentives to date. Of those, almost a hundred thousand have received over $5 billion in incentives. In addition to the registered providers, there are significant numbers of practicing physicians who do not qualify for incentives, due to payor mix or practice characteristics, and who are also buying and using EHRs. Perhaps this is a bit slower than the most optimistic projections, but the entire program seems to be forging ahead rather well, and EHR adoption is steadily increasing.

The EHR incentive program is funded by taxpayer dollars to the tune of $30 billion, in the midst of a harsh recession, and is supposed to motivate our health care providers to purchase EHRs because according to the White House, the Secretary of Health and Human Services, the Centers for Medicare and Medicaid Services (CMS) and obviously the Office of the National Coordinator for Health Information Technology (ONC), EHRs are the cornerstone on which the nation will build strategies to control health care costs while improving population health and quality of care for individuals. Since health care has urgent problems that need to be resolved now, health care providers are receiving incentives to purchase software now, use it in prescribed ways now, and the bar is continuously raised until the ultimate goals are achieved. In addition to direct cash incentives to health care providers, both CMS and ONC are funding, through grant making, all sorts of other health care innovation activities, including new technologies, new care delivery models and novel payment arrangements.

One of the ONC initiatives is the Strategic Health IT Advanced Research Projects (SHARP) program aimed at development of new health information technologies. The SHARP grants, of $15 million each, were awarded over 2 years ago to several universities, with the ultimate goal to accelerate health IT adoption. The SHARP grant for “Health Care Application and Network Design” was awarded to Harvard University to “facilitate information exchange while ensuring the accuracy, privacy, and security of electronic health information”. The grantees chose to focus on developing an iPhone-like SMART platform for assembling EHRs. Not sure how this ties into network design or the accuracy, privacy and security of health information, and admittedly I have often expressed many reservations regarding the entire iPhone paradigm, both here and elsewhere, but this was 2 years ago.

This month’s issue of NEJM contains an article written by the Harvard SHARP grantees which is essentially a blistering attack on the EHR products currently on the market and those who manufacture and sell them. According to the authors, it is only a myth “that medicine requires complex, highly specialized information-technology (IT) systems”.  Since both authors are physicians, let’s assume that they are correct and medicine is as simple as they contend, in which case it is rather unclear to me why after two years and with $15 million in funding, they have not solved the problem in its entirety.

The answer is of course based on the vilification of very successful EHR vendors, since the authors “believe that EHR vendors propagate the myth that health IT is qualitatively different from industrial and consumer products in order to protect their prices and market share and block new entrants”. Although I don’t believe there is a dark EHR vendor conspiracy out there, and I don’t believe that health care has much in common with Twitter, Facebook and iTunes, I do agree that health care IT is similar to other “industrial” products, like say, banking, which maintains huge proprietary systems, based on Oracle and IBM software (very expensive) in private data centers (no Amazon clouds), and as funny as it may seem, one of the largest online brokerage firms is using the same MUMPS database as one of our largest EHR vendors, which by the way, is also used by the European project that is mapping the Milky Way galaxy. Just because something was first invented in the sixties (like the Internet), it doesn’t mean it has not changed since, and it doesn’t necessarily mean that it is now obsolete. Anyway, as it turns out, other industries cannot run multimillion dollar businesses with free iPhone apps either. Bummer.

Speaking of mythology, the article goes on to regurgitate the most common myth, asserting without citation that “[c]ommercial EHRs evolved from practice-management (i.e., billing) systems, and in response to the patient-safety movement, vendors tacked on documentation modules and order entry for physicians”. Really? Did Cerner start out as a billing system? Did Epic? What about the many smaller ambulatory EHRs, like Amazing Charts, that don’t even have a practice management module? And how about the shiny new entrants who seem to not be as blocked out as the authors imply? How about Practice Fusion and athenahealth? No, they are not built on a bits and pieces apps model, but they are new and doing rather well, I believe. One with no billing at all and the other ironically, exactly evolved from a billing system, and both regarded as great innovations.

The frustration expressed in this article is pretty common fare from folks trying to enter the EHR market only to discover that the simplicity they envisioned from the outside is nothing more than a mirage. Health IT is a cruel temptress in that way, and many have succumbed to her lures of quick riches. However, this particular article was written by people who are funded by ONC as part of a national effort to get doctors and hospitals to buy and use EHRs, and this article is titled “Escaping the EHR Trap — The Future of Health IT”. Are the authors arguing that the EHRs that ONC wants people to purchase today are a trap? Should doctors and hospitals stop their Meaningful Use efforts and wait until Harvard, if “properly nurtured” (with more taxpayer dollars, I presume), comes up with their version of EHR? Does ONC support this position?

On the ONC website, the description of the Harvard SHARP grant opens with this sentence: “Today's HIT environment is largely populated by outdated one-size-fits-most systems”. This is the same website that was purpose built to encourage health care providers to buy EHRs. Is ONC knowingly paying hospitals and doctors billions of dollars to buy “outdated” systems? I don’t think so, but I do believe that ONC should come up with some sort of response to this article, and perhaps be more careful with the contents of their website and with their grant making processes.

The Other Side of the EHR Mirror

For almost three years now, since the advent of the HITECH Act, and prompted by the exorbitant prices of health care, an animated electronic medical records debate has been unfolding on a national stage. It seems that every possible or impossible solution to our health care woes is in some shape or form dependent on widespread use of computerized medical records. Computers have been utilized to change almost every industry, making products and services cheaper, more accessible and in some instances better, so the hope is that computers can do the same for health care services. There are three fundamental ways in which computerization of an industry is advantageous: process automation, improved information processing and better communications. Arguably, we can use all three in health care.

Process automation need not be construed as referring to the processing of people, although it often is. Health care has plenty of processes that can and should be automated. The most ubiquitous automation is in the form of electronic claim submission and the respective electronic remittance advice (ERA) from payers. The vast majority of physicians are using computers for this process, but even the most advanced practices still have billers in the back office eyeballing most outgoing claims and overseeing the electronic posting of payments. Not to mention the ever increasing burden of patient collections, or the sometimes automated process of checking eligibility for services, or the rarely automated process of verifying status of deductibles. Referrals and pre-authorizations are another labor intensive and time consuming set of processes that can and should be automated. Transitioning these largely administrative chores to the computer requires that rules and regulations are standardized in deference to physicians’ and patients’ judgment (nowhere on the horizon) and that computer software becomes much more reliable and “intelligent” than it currently is (slowly taking place). I’m sure you can think of other business processes than can, or may even already be automated with assistance from computers.

When it comes to automating clinical processes, current day computerized systems have precious little to offer, and perhaps that’s how it should be. Sure, many software products come with clinical decision support, order sets, template based protocols, algorithms and pathways, but none of these qualify as automation of processes, even in instances when a health system mandates adherence to protocols, because manual labor is always required and by definition, variability is certain to occur. However, bits and pieces of the larger clinical process can be and are automated, e.g. orders processing, calculations of numerical values and tracking of events. Other processes, such as transitions of care, could benefit from some automation as well (e.g. automatically sending admission/discharge information to a known primary care physician). When judiciously utilized, computer software can provide some measure of efficiency and quality assurance to the overall clinical process.

There is of course a certain overlap between those bits and pieces of clinical automation and the overarching information processing afforded by computerization. In most other industries held up as examples for what electronic health care should be, there is one basic entity that is being measured, calculated, analyzed, tabulated and displayed: dollars. Dollars across time, dollars across populations, dollars across products and services, dollars in and dollars out. The business of medicine, a.k.a. payers, is as good and as advanced in its electronic dollar information processing as any other industry, if not much better. Unfortunately, clinical information processing lacks a universal unit of measure for all things, and therefore requires much more sophisticated software, and larger efforts to collect the information to be processed. Meaningful Use and the various Quality Reporting programs are meant to facilitate and accelerate the collection of information, with the hope that sometime in the future the collected information will be of sufficient quality to enable meaningful information processing beyond what the insurance sector already does.

Industrial computer enabled communications can take two basic forms, ad-hoc and process driven, triggered by and directed to one of the following actors: customers, or personnel and machines, both of which can be internal or external to the business entity. Process driven communications, which are initiated by machines, are obviously part and parcel of process automation as discussed above. It is interesting to note that even in industries that are heavily computerized, communications to and from external entities, where a buyer/seller relationship does not exist, are either mostly manual and paper based, or very simplistic (e.g. ATM networks). And these are exactly the types of communications we are attempting to computerize in health care by means of health information exchange organizations and the Nationwide Health Information Network (NwHIN). We must realize that this is unprecedented in all those supposedly more computer savvy industries, particularly since the health information to be exchanged is very complex and to some extent “mission critical”.

Interactions of personnel with machines, i.e. use of Electronic Health Records (EHRs) by physicians and other clinical staff, has been the source of much angst and passionate debates on feasibility, merit, timing and approach, and having written thousands upon thousands of words on the subject, I will just say that when you compare health care enterprise software to other industries, ours is no worse, may very well be much better and most definitely includes many more choices than, say, banking software or supply chain software. The only difference is that the President of your bank is rarely in need of using the software, while the “president” of a medical practice must use the software all day, every day. This is where the problem is, and this where a solution is needed. Rearranging boxes and buttons on computer screens will not provide much relief.

Last, but not least, are the budding electronic communication channels between health care customers (patients) and health care industry machines. Here we take the fateful step to the other side of the EHR looking glass to see what patients see. Health care was never too terribly concerned with patients’ interactions with their medical records. Health care, although usually paid for when possible, was considered mostly an act of kindness, hence the “care” in health care. People did not “deliver” or “provide” care. Instead they “attended”, “administered”, “nursed” and generally cared for the sick, the wounded and the dying. The result was a rather unique relationship based on gratitude, fear, hope, trust, deference, commitment and all sorts of other human emotions. Examining the books was not in the realm of considerations and most patients lacked the basic abilities to do so. Over the years, health care, or rather medicine, has transformed into a profession and now it is morphing into a service business with providers and consumers. Like a bank. And everybody knows that you must keep an eye on the bookkeepers. As the preferred solution to our health care crisis is beginning to emerge, in the form of transferring more costs to consumers, so they can control expenditures by only purchasing what they can afford, it is becoming imperative to have smooth and comprehensive communications between patients and health care’s newfangled computers. Like a bank.

When EHRs started out, no special provisions were made for patients (or communications in general). Financial software started out much the same way, but since banking was always a consumer business, the advent of the Internet and now the mobile Internet, brought us very slick, very useful and very consumer friendly Portals. And health care was left behind. First very slowly, and more recently at an accelerated Meaningful Use pace, EHR vendors began providing Patient Portals, and providers began buying them and deploying them. The online services in Patient Portals range from pathetic to pretty darn good, but there is a long way to be traveled before we reach the functionality and usefulness available in the financial or retail sector. It will happen though, because just like nobody would open an account at a bank without online services, pretty soon nobody will be willing to purchase health services from a provider without a useful online presence. It will become a differentiating factor first and then it will become a given that you can get most of your health services online. Just like a bank.

The time when patient needs were overlooked by EHR vendors has long since passed, and I am expecting to see significant advances in consumer facing software in the next couple of years. Your customer should not need to go to Walmart for a telemedicine quickie, and shouldn’t need to “transfer” information to Microsoft for figuring out his health status, and shouldn’t have to download “free” apps to manage whatever ails them. You as a provider, and your now computerized health business, should be able to provide everything your customer needs (and more) on your own customer Portal, for the web, the iPhone and Android devices. And you will, because this is quickly becoming a cost of doing business. Just like a bank.