A Dream of Reason

By BRIAN KLEPPER and DAVID KIBBE

The dream of reason did not take power into account...Modern medicine is one of those extraordinary works of reason...But medicine is also a world of power.

-Paul Starr, The Social Transformation of American Medicine, 1984

Today's unveiling of a Declaration of Health Data Rights is an important action, long overdue, that represents a collaborative effort by a group of health care professionals - activists, entrepreneurs, technologists and clinicians - all colleagues we hold in high esteem.

The Declaration's several points arise from a single, simple premise: that patients own their own data, and that that ownership cannot be pre-empted by a professional or an institution. And there lies its power, especially in the context of early 21st Century health care. It is a transformative ideal that currently is not the norm. But we join our colleagues in declaring that it should be.

It is fair to note that this effort - making sure that all of us have immediate access to personal health information in easy-to-use (i.e., electronic or "computable”) format - is NOT the most important thing we need to achieve in health care right now. We all know that the system is wildly out of balance, with costs so excessive that even the insured mainstream of Americans risk financial ruin with a major health event, and quality that varies from superb to atrocious. Restoring a semblance of stability and sustainability to America's health system will require many measures that may not include an individual's right to control his/her own health information.

But it is an appropriate, critically necessary seed, nonetheless. Information withheld from patients, purchasers and professionals, wittingly or unwittingly, is the deepest root of America's health care crisis. Too often it is an act of power, enabling - and we use this word in the clinical sense - actions without accountability, and trumping the checks and balances that laws and markets strive for in progressive societies. There are many other roots to our current dilemma, of course, but nothing is as pernicious or corrosive as the lack of information transparency. It has been the practice in American health care for decades, with ramifications so grave that, by itself, it has placed the nation’s future in peril.

And so the right place to begin is with a straightforward statement that health information belongs first and foremost to patients. We hope that this seed will take root, that doctors around the country will erect a small poster in their waiting rooms saying "We support the Declaration of Health Data Rights."

And we also hope this event will spur a new sensibility about who owns information, about accountability, so that pricing and quality information on doctors, hospitals, health plans, drugs, devices, diagnostic procedures and treatments become freely available to health care patients and purchasers, so that absolute power is trumped and so Americans can have health care that is trustworthy, excellent and affordable, no matter where it is received.

Brian Klepper PhD is a health care market analyst and advisor to the industry. David C. Kibbe MD MBA is a Family Physician and Senior Advisor to the American Academy of Family Physicians who consults on health care professional and consumer technologies.

Clinical Groupware: When Not-As-Good Is Actually Better

By DAVID C. KIBBE

In a February 13, 2009 blog post I introduced the idea of Clinical Groupware as a low cost, modular, and cloud computing alternative to traditional electronic health record technology for physicians and medical practices. Central to the concept of Clinical Groupware is IT support for care coordination and continuity, achieved through shared access to personal care plans and point-of-care decision supports. In this post I'd like to put a few more ideas on the table, specifically with respect to the market niche that Clinical Groupware may ultimately fill, including comments by several individuals whose opinions or work may be crucial to the success of Clinical Groupware over the next 1-3 years. (Anything farther out than that is simply dreaming.) Consider this an interim report on an emerging story with an indefinite timeline.

Interest in this topic has been, of course, heightened by the recently passed federal AARA/HITECH, provisions of which will provide incentive payments to physicians of as much as $44,000 over a five year period commencing in 2011, provided that the physicians can demonstrate the "meaningful use" of "certified EHR technology." It's always more exciting when there's real money in the mix. Will Clinical Groupware qualify as "certified EHR technology?" Many physicians and developers are hoping it will. Here's why.

I see Clinical Groupware as a disruptive, low cost but high capability technology, an alternative to the costly EHR technologies that are now implemented in about 15-20% of ambulatory care settings; the rest of the market has not become consumers of these products. When 80% of potential customers aren't buying, one thing you can say for certain is that non-consumption is an important characteristic of that particular market. And that's what we have here. Doctors have taken a long look in the vendors' shop window and overwhelmingly decided that the combination of cost and performance characteristics offered there don't warrant a "buy now" decision.

Notice, there is no Apple iPhone adoption problem among doctors. To the extent that there does exist an "EHR adoption problem" for physicians, we should look to the characteristics of the products on the market for the sources of the problem, and not simply blame the purchasers out-of-hand. In my own experience most physicians are not Luddites, nor are they frightened by or confused by information technology in general. They purchase and use technologies they see as valuable to them and their patients, and that offer the performance characteristics they want at the price point they deem reasonable. It's just plain silly to get angry at physicians for being prudent shoppers. No one blames auto consumers for not having liked the Edsall or the Pontiac Aztek.

But this is all in retrospect. What's likely to happen in the future?

Of course no one can predict the future; all we have to go on is the past, and things don't always repeat themselves. But there is sound business theory based upon study and research over many decades, that can help us make educated guesses about future health IT product offerings, as well as about purchaser buying behavior. Clay Christensen, the noted Harvard Business School professor and author of several books on innovation, has described situations that favor the development of disruptive innovation in any industry. His ideas about change and innovation are worth a careful read:

The initial products and services in the original "plane of competition" are typically complicated and expensive, so that the only customers who can buy and use the products...are those with a lot of money and a lot of skill. In the computer industry, for example, mainframe computers made by companies like IBM comprised that original plane of competition from the 1950s through the 1970s... The same was true for much of the history of automobiles, telecommunications, printing, commercial and investment banking, beef processing, photography, steel making, and many, many other industries. The initial products and services were complicated and expensive.

Occasionally, however, a different type of innovation emerges in an industry -- a disruptive innovation. A disruptive innovation is not a breakthrough improvement. Instead of sustaining the traditional trajectory of improvement in the original plane of competition, the disruptor brings to the market a product or service that is actually not as good as those that the leading companies have been selling in their market. However, though they don't perform as well as the original products and services, disruptive innovations are simpler and more affordable. This allows them to take root in a simple, undemanding application, targeting customers who were previously non-consumers because they lacked the money or skill to buy and use the products sold in the original plane of competition. By competing on the basis of simplicity, affordability, and accessibility, these disruptions are able to establish a base of customers in an entirely different plane of competition...In contrast to traditional customers, these new users tend to be quite happy to have a product with limited capability or performance because it is infinitely better than their only alternative, which is nothing at all.

...When a disruptive technological enabler emerges, the leaders in the industry disparage and discourage it because with its orientation toward simplicity and accessibility, the disruption just isn't capable of solving the complicated problems that define the world in which the leading experts work. (The Innovator's Prescription, 2009, pgs. 5-6)

Is it accurate to compare the emerging Clinical Groupware with disruptive innovations in other industries, with the early PCs, the transistor radio, and Southwest Airlines, for example? Are we about to enter another "plane of competition" beyond the one that was established by EHR vendors like NextGen, GE Centricity, Epic, and Allscripts? And, perhaps most importantly, will the new EHR technology compete "on the basis of simplicity, affordability, and accessibility" with the older products in way's that establish "a new base of customers and disrupt the market?"

Well, one consistent sign of disruption is visible opposition and protectionism from companies who sell top tier products at the highest profit margins. And we are certainly seeing that! As reported in the Washington Post and elsewhere, the industry is attempting to raise barriers to new products characterized by simpler, more accessible, and less expensive EHR technology, mainly through regulatory control that would constrain the features and functions used to "certify" these products; through complex standards that make it more difficult for small companies to bring their products to market; and, most recently through state legislation that would ban non-certified products from being bought, sold, or used. (I understand that New Jersey state legislators with close ties to top tier vendors have introduced a bill that would make it illegal for anyone "to sell, offer for sale, give, furnish, or otherwise distribute to any person or entity in this State a health information technology product that has not been certified by CCHIT," and which would levy heavy fines on anyone who did. This would make it illegal, in effect, for Google Health or Microsoft HealthVault to operate in the state of New Jersey.)

But it is less the disparagement and discouragement to innovation, and more the enthusiasm and hopefulness attached to new health IT models, that indicates to me there may be a surge in popularity for Clinical Groupware during 2009 and 2010. A growing number of experienced engineers, technologists, patient advocates, and health professionals have indicated common support of the basic innovative ingredients in Clinical Groupware. These include: low cost, simplicity of use, interoperable modularity, software as a service, a focus on coordination, and engaged communications with patients and among providers. Here, for example, is Adam Bosworth of Keas, formerly Google VP in charge of Google Health, writing in a recent post on his blog:

...[M]ost small practices can’t really afford to use big iron EHR’s. Even if it is free, they can’t really afford to do it because it will still require training, more time per patient potentially, and so on. Lastly, most EHR’s don’t work with other EHR’s so that coordinated care across practices isn’t supported and most people who are elderly or who have serious illnesses have more than one physician treating them.

The way around this is to build systems that don’t just duplicate what physicians do today during their face to face meetings with their patients, but rather provide new capabilities that will help with continuous and coordinated care and can generate additive revenues for physicians and then evolve by adding those features that automate the current physician activities as demanded by the physicians.

What would such systems support? They would support having a way to chat with or exchange messages with a patient for a fee so that unnecessary office visits can be removed and the patient is more likely to reach out for help. Think eVisit-lite. They would support a simple way to monitor the health of a patient who either has a chronic disease or is on path to developing one, again for a fee, so that physicians are actually getting paid instead of punished for keeping their patients healthier since, ideally, healthier patients will generate fewer visits/procedures over time. In short these systems will support physicians managing an ongoing paid relationship with the patient rather than an episodic one measured only by in-office visits. What should be done about helping physicians who are afraid of losing time to retraining? These systems should be as easy to use as a Southwest airlines reservation page. These systems should have a cost so low that physicians don’t care. Most of these points aren’t typical of most of the big EHR’s currently being sold. Again, hence our fear that a de-facto monopoly of the incumbents will lose this opportunity to let 100 disruptive innovations flower. (May 29, 2009 http://adambosworth.net/)

Adam isn't the only one interested in letting "100 disruptions flower." Steve Downs and John Lumpkin at the prestigious Robert Wood Johnson FoundationNEJM editorial in late March, 2009. Downs and Lumpkin write -- their enthusiasm nearly jumping off the page -- in part: have recently blogged about the need to develop an "interoperable and substitutable web-platform" for EHR technology that is akin to the Apple iPhone apps model, an idea that is foundational to Clinical Groupware, and which was first described in detail by Ken Mandl and Isaac Kohane in a

Perhaps the key is to put more money behind companies that offer EHRs that allow 3rd party app development. Will seeding a fund convince other investors to get in? Are there startup ventures out there that could take advantage of the fund? A venture fund for app developers. Apple and Kleiner Perkins did this – they set up a $100 million fund to invest in companies that would develop applications for the iPhone. (June 4, 2009 http://www.thehealthcareblog.com/the_health_care_blog/2009/06/catalyzing-the-app-store-for-ehrs.html)

Meanwhile, over at ZDNet, noted business journalist Dana Blankenhorn is hopeful that David Blumenthal of ONC will come through as a supporter of innovation.

CCHIT changes its certification criteria every year, and every year it becomes more detailed. While the 2009-2010 standards have now been unveiled only 40 ambulatory EHRs have been approved under the 2008 standards, and only six are approved for emergency departments. By making all vendors jump through these hoops CCHIT imposes an enormous tax on all vendors and limits competition to those large enough to deal with it. What reformers ...seem to want is a more basic process, one that assures interoperability and encourages innovation. Placing that authority in the government instead of CCHIT does not guarantee this result, but it is certain CCHIT is not going down that road. What I expect to happen now is for the newly-appointed ONCHIT advisory committee to seek a compromise, and David Blumenthal will try to craft a solution that keeps all options open. (May 21, 2009 http://healthcare.zdnet.com/?p=2318)

Representatives from the medical specialty societies are also beginning to understand the value to their members of component-based EHR technology and software-as-a-service. For example, a senior team of researchers from the American Academy of Family Physicians, led by Paul Nutting at the University of Colorado Health Sciences Center, recently reported on initial lessons from 36 patient-centered medical homes. In their report in the May/June issue of Annals of Family Medicine, the authors highlighted as a common problem in medical home transformation the lack of a "plug-and-play" platform for EHR technology, and the slowness of response and high costs associated with some single-vendor EHR/EMR technology vendors. Among its findings and recommendations, the panel of authors stated:

...[I]t is possible and sometimes preferable to implement e-prescribing, local hospital system connections, evidence at the point of care, disease registries, and interactive patient Web portals without an EMR.

The AMA has just announced, in an appearance at the Microsoft Connected Health Conference, June 11, 2009, "..a new physician Web-based portal the AMA is developing ... will provide physicians access to practice-related products, services and resources in a single location. The AMA plans to launch its new portal nationally in early 2010." The platform will help physicians exchange health information with their patients through Microsoft's HealthVault application, and will include an ePrescribing module as well.

And then there are the open source folks. Fred Trotter, an expert in online security and a leader in the free and open source, FOSS, movement in health IT has recently discussed in his blog how momentum is growing towards a disruptive set of innovations:

The ‘Clinical Groupware‘ people want to see the certification of a suite of technologies that may or may not add up to a traditional EHR. The EMR-lite people want to see faster and lighter tools. The PHR people and consumer advocates want EHR systems that empower the patient instead of the provider. The Health 2.0 people want to see completely different models of finance and care become possible. Of course, the FOSS people (like me) want FOSS EHRs to get equal footing. (June 2, 2009 http://www.fredtrotter.com/2009/06/02/can-cchit-move-beyond-problem-ehr-certification/ )

One of the nice things about blogging is that people respond with their thoughts and opinions, and sometimes with new information that adds value to an idea, making it a collective -- rather than a merely personal -- concept. This is what appears to be happening with Clinical Groupware. I've received hundreds of emails and telephone calls from people who have connected the dots around this concept in their own way; most simply want me to listen to and understand their approach or, in some cases, discuss their innovative products. But a few commenters have asked the necessary, hard questions about what will make Clinical Groupware a successful disruptive innovation in a marketplace -- medical practice health IT -- that has been notoriously difficult, even fickle, to sell into. These questions, in turn, have forced me to think more deeply and to reach out to experts and innovators whom I trust to test the ideas.

Next week, at the 6th Annual Healthcare Unbound Conference in Seattle, I'll be moderating a panel on Clinical Groupware with a number of representative companies, and discussing their business models with the audience. Should be very interesting, and I hope to report back to you as developments warrant.

David C. Kibbe MD MBA is a Family Physician and Senior Advisor to the American Academy of Family Physicians who consults on health care professional and consumer technologies.

The Health Industry's Achilles Heel

June 10, 2009

By BRIAN KLEPPER and DAVID C. KIBBE

"You never want a serious crisis to go to waste."

- Rahm Emanuel, White House Chief of Staff

Timing matters. The health industry has demonstrated steadfast resistance to reforms, but its recently diminished fortunes offer the Obama Administration an unprecedented opportunity to achieve meaningful change. The stakes are high, though. The Administration's health team must not miscalculate the industry's goals, or waver from goals that are in the nation's interest. The two are very different.

Aligning the forces of reform will be the first challenge. The White House and Congressional Democrats appear to be collaborating to develop a unified reform design. Even so, the effort is hardly pure. Lawmakers have been receptive to industry influence. The non-partisan Center for Responsive Politics reports that, in 2009, health care interests have already spent $128 million on Congressional lobbying contributions, more than any other sector. The tide now turned, most of that largess has gone to Democrats.

All reform discussions acknowledge the twin goals of universal (or expanded) coverage and controlling cost. But as the state initiatives in Massachusettsand California have shown, expanded coverage is easier. Coverage pays for care, so the industry is delighted to oblige. Cost reductions, though, are harder. The mechanisms that undergird health care's excesses are embedded in its operations, and waste is responsible for much of its profitability.

The Obama health team already has firsthand experience with the industry's maneuvering. First it saw the health IT vendors' association, HIMSS, hijack the well-intentioned $19 billion HITECH allocations for electronic health records by capturing control of the agency that specifies the certification criteria for product subsidies. Now those funds will probably favor outdated, non-interoperable, client-server technologies from a small number of legacy IT companies. Newer, more effective, less costly web-based tools from hundreds of innovative firms will likely have to base their success on market appeal, without the government's help.

And then there was the May 14 cost backpedaling by six major health industry associations. After apparently agreeing to voluntary cost reductions with President Obama, they reversed, insisting they had offered to only "ramp up savings" over an unspecified time frame. At least one health plan is already preparing an anti-reform campaign, similar to the Harry and Louise ads that helped turn public sentiment against the Clinton health reform effort.

These developments confirm the industry's focus on the status quo, backed by cash and lobbying strength. The question is whether it can again stave off reform, sealing another win at the American people's expense.

But the industry has an Achilles heel. Its fundamentals have eroded, potentially easing the way for operational restructuring. Consider the evidence that commercial health plan enrollment is in freefall, as mainstream purchasers - employers and individuals - are priced out of the coverage market.

• AIS and Kaiser Family Foundation data show that, after reaching 180 million enrollees in 2005, commercial health plan enrollment has plummeted by more than 20 million lives (11.3%).
• In recent discussions, health plan executives have acknowledged that the multiplier to estimate total covered lives from employee lives has fallen from 2.2 to 1.8. This 18 percent change mostly reflects kids whose parents' employers have stopped subsidizing dependent coverage. It could represent twelve million new uninsureds, previously unaccounted for, and another nine million new Medicaid lives.
• Last month the Wall Street Journal cited Wellpoint's loss of 500,000 lives since December 2008, and United's loss of 900,000 in the last year. Similar enrollment declines have been reported at health plans throughout the country, the result of a decade of premium growth at four times general inflation, exacerbated by a severely downturned economy.
• The Congressional Budget Office estimates that, in 2009, seven million Americans currently enrolled in commercial health plans will avail themselves of the COBRA subsidy that was part of the American Recovery and Reinvestment Act. Unless the economy rebounds or Congress extends the program, many of those enrollees will lose coverage as well.
  

Premium pays for nearly all health care products and services - from office visits to stents - so decreasing enrollments have stressed the industry more than at any time in memory. Ancillary issues, like drops in investment income and anticipated payment reductions to Medicare Advantage health plans, are also reverberating throughout the industry, compounding its financial troubles.

But even in the face of hemorrhaging enrollments, the health plan sector has not visibly changed its medical management approaches. Instead, most organizations seem to be waiting, presumably for the new revenues associated with universal coverage. It seems likely that the health industry will campaign for Massachusetts-type reform that forces concessions from purchasers rather than in the ways health care is financed, delivered and supplied.

To be meaningful, though, reform must fix the three deep structural flaws that enable the excesses that have benefited the health industry and created the cost crisis. A specialty- rather than primary care-dominated system promotes more expensive downstream care at the expense of less costly upstream care. The lack of an interoperable information technology infrastructure has created barriers to quality/cost transparency, transactional streamlining, and science-driven decision support. And a fee-for-service reimbursement system has encouraged more care, independent of appropriateness, rather than the right care. Industry groups fight hard to preserve these approaches and the excesses they produce, and to block the most obvious remedies to overspending.

Health care could be far more affordable. Experts agree that at least one-third of all health care cost is inappropriate care or administrative waste. As a recent White House meeting showcased, many health care managers have attained consistent, significant savings through innovations ranging from primary care clinics, data analytics, and Web-based management tools to health literacy and incentive programs.

As health care financing pressures intensify, the Administration must leverage the industry's discomfort by making the achievement of expanded coverage contingent on key operational reforms: re-empowered primary care, a national technology framework for outcomes management and payment tied to results. These are pragmatic goals that, when implemented elsewhere, have been shown to improve quality and drive down cost. Carefully explained, they will make sense to most Americans.

Finally, being effective with this immensely important issue will demand that the Obama team reach out and recruit the active leadership and support of the nation's non-health care business leaders, the one group csollectively more powerful than the health care lobby.

If the Administration can get the backing of influential leaders outside health care, and if it is willing to hold out on expanded coverage until the industry accepts changes that can rightsize cost, then we'll have a chance to establish affordability and sustainability in American health care.

Brian Klepper is a health care analyst, consulting with the industry. David C. Kibbe is a Family Physician, Senior Advisor to the American Academy of Family Physicians and a technology consultant.

An Open Letter (4) to the New National Coordinator for Health IT: Part 2 - Bringing Patients Into Health IT Conversation About "Meaningful Use"

By DAVID C. KIBBE and BRIAN KLEPPER

The Obama health team at HHS and ONC are gradually establishing the rules that will determine how approximately $34 billion in ARRA/HITECH funds are spent on health IT over the next several years. But there is a "missing link" in these deliberations that, so far, has not been addressed by Congress or the Administration: how the patient's voice can be "meaningfully used" in health IT.

After all, we, the taxpayers, will pay for all this hardware, software, and associated training. There are many more consumers of health care than doctors or health care professionals. Shouldn't we have a say in what matters - in what is meaningful - to us?

It may have been an oversight, but patients and consumers have been left very much on HITECH's sidelines. The attention and the money is squarely aimed at the health care providers - doctors, clinics, and hospitals. The Act's intention is to create "interoperable" electronic health records that, in the future, will be more accessible to them: doctors, clinics, and hospitals.

This is a policy that is tied unnecessarily to an outdated vision. It is provider-centered, paternalistic and top-down. But it could be re-imagined to take advantage of the new ways millions of consumers, patients, and care giving families are using information and communications technologies to solve problems, form online communities, and share information and knowledge.

We're moving more fully as a society into the Age of the Internet and, as the economist Jane Sarasohn-Kahn's landmark study The Wisdom of Patients compellingly showed, patients are far ahead of the health care industry in using it to advantage. Consider:

• According to the latest Pew poll results "about half the public (49%) turned to the internet for information about the [swine flu] virus. Moreover, asked which news source had been most useful in this regard, 25% of respondents named the internet, putting it at the top of the list of information sources in terms of utility."
• An earlier Pew poll showed that between 75% and 80% of American Internet users have looked online for health information, an estimate consistent with similar polling from Harris Interactive's 2009 data. 78% of home broadband users look online for health information.
• Going online makes a difference in terms of decision-making, especially for e-patients with a chronic illness or a new diagnosis, according to Pew:
  
  
  "For example, 75% of e-patients with a chronic condition say their last health search affected a decision about how to treat an illness or condition, compared with 55% of other e-patients. Newly diagnosed e-patients and those who have experienced a health crisis in the past year are also particularly tuned in: 59% say the information they found online led them to ask a doctor new questions or get a second opinion, compared with 48% of those who had not had a recent diagnosis or health crisis. Some 57% of recently challenged or diagnosed e-patients say they felt eager to share their new health or medical knowledge with others, compared with 45% of other e-patients."

• The public appears ready to embrace shared online electronic medical record-keeping. A just-released joint NPR/Kaiser Family Foundation/Harvard School of Public report is summarized in the graph below, indicating not simply privacy concerns, but the strong conviction that this risk would be accompanied by the benefits of improved personal care and overall quality improvement.

• The public also seems ready, as are some physicans, to use online methods to establish patient-physician relationships and provide care services. As David Kibbe recently reported on THCB, online care and consumers' familiarity with and use of tele-health is steadily expanding. American Well and TelaDoc, Google Health, Microsoft HealthVault and a rapidly growing number of companies are part of an evolving ecosystem that speaks directly to the interest of patients and health consumers to engage in many kinds of online health experiences.

• The e-patient public is showing signs of engaging and even confronting established Medicine on the issue of access to their health data. A Google search on "e-patient Dave" yields almost 9,000 hits, the majority of these related to Dave deBronkart's revelation, covered extensively by the Boston Globe, the New York Times, and hundreds of blogs, that his hospital medical records were incomprehensible and often inaccurate. Dave, a kidney cancer survivor, had taken up the offer by Beth Israel Deaconess Medical Center's CIO, John Halamka, MD, of automated data transfer between the hospital's IT system and Dave's Google Health account. The good idea was to help Dave create a personal health summary at Google Health that could be refreshed by information from his doctors at BIDMC, and always be available to him as needed. Dave found, thought, that the hospital's IT system merely passed on billing diagnoses and codes, many of which were neither accurate nor up-to-date. The upshot: an apology from Halamka and BIDMC, a meeting with Google Health's team, and a change in policy at BIDMC. From now on, only physician-generated and reviewed diagnoses and problems will transfer to Google Health from BIDMC. This story of a modern day David representing e-patients versus a Goliath from the health care industry continues to reverberate in the industry and to have consequences for the future of personal health records.

So why not include health consumers and patients in the meaningful uses of health IT? Here's a short list of ideas about how to do this, provided in part by Don Kemper, the founder and CEO of HealthWise. We agree with his suggestions that "meaningful use" ought to include the routine practice of electronic communications with patients and care givers, starting with these five areas.

• 1. Prevention and screening reminders. As appropriate, these should be shared along with a personal health plan and full access to one's records.
  2. Patient decision aids for major surgery and procedures. This might include messaging pre-and post-surgery to help avoid waits and delays.
  3. Patient instructions for acute and chronic conditions. What to do at home; what signs of problems or improvements to look for; when to call if symptoms develop or improvements don’t occur as expected.
  4. Guided self-management messaging for chronic conditions. Instructions in self monitoring, lifestyle, medications management, action plans, etc.
  5. Visit preparation for scheduled visits. This could include questions to ask the doctor or provider and biometric instructions, e.g. the need to fast before a test.

Let's ask the question another way: If the HITECH monies are spent on CCHIT certified EHRs that can't do any of these patient-centered tasks, or EHRs that don't come equipped with the features and functions to extend health IT capability to the patients and consumers, do we really think that the money will have been spent wisely?

But that's the pathway we seem headed down, led by the vendors. As Dire Straits once said, "money for nothing....those guys ain't dumb."

David C. Kibbe MD MBA is a Family Physician and Senior Advisor to the American Academy of Family Physicians who consults on health care professional and consumer technologies. Brian Klepper PhD is a health care market analyst and a Founding Principal of Health 2.0 Advisors, Inc.

An Open Letter to the New National Coordinator for Health IT: Part 3 -- Certification As The Elephant in Health IT's Living Room

by DAVID C. KIBBE and BRIAN KLEPPER

In the first and second parts of this series we talked about how and why there is no universal definition for the term "EHR." Instead there is a legitimate, growing debate about the features and functions that "EHR technologies" should offer physicians seeking to qualify for HITECH incentive payments. We explored the layers of network technology, suggesting that federal regulators should "separate the data from the applications."

We also argued that there is much to learn from development platforms, recently and in the distant past, that have used standards to open the aperture of innovation. The best of these standards have reflected the experience of what works rather than specifying how to make it work. Defining the standards for data, devices, and network technologies too restrictively could choke off innovation, rendering HITECH's offerings whose expense and complexity are a barrier to, rather than an incentive for, adoption by physicians. Incoming National Coordinator for HIT David Blumenthal, MD seems to have been considering just this concern when he recently wrote:

"... [M]any certified EHRs are neither user-friendly nor designed to meet HITECH’s ambitious goal of improving quality and efficiency in the health care system. Tightening the certification process is a critical early challenge for ONCHIT."

We're not sure what "tightening the certification process" means. But if the new Administration hopes to entice physicians to embrace health IT, we'll need a different process entirely than the one developed through the Bush Administration's sole-source contract with the Commission on Certification for Health IT (CCHIT), an organization originally founded and staffed by HIMSS (The Health Information Management Systems Society) and dominated by large, legacy-based technology firms.

Concern about whether current certification process is fair and configured to promote the common interest is hardly isolated or out of the mainstream. Last week the Markle Foundation issued a report - both of us served on the panel that developed it, but there were also many representatives from prominent industry groups - with this comment:

"A broader view of IT would seed innovation rather than lock in adoption of technology based on what is available today. Health information services and technologies need to innovate and evolve rapidly, as other sectors have transformed themselves by embracing and building upon the internet...To support meaningful use, HHS should endorse a simple specification for a minimal set of open technical standards for secure transport as well as a core set of data types. By creating an obvious and achievable starting place, HHS will enable many options for clinicians and consumers to retrieve and use information to accomplish the meaningful use objectives."

And in a slightly blunter and more acerbic assessment in a Healthcare Informatics interview, Intermountain Healthcare's CIO Mark Probst, newly appointed to the HIT Policy Committee formed by HITECH to advise the National Coordinator, said,

"I mean it’s sure nice for Epic or Cerner or Eclipsys to tell their clientele that if they want to add new functions, you’ve got to go through them. So my guess is standards are somewhat threatening to them. Do we want 15 different gauges of railroad going around the United States or half the country driving on the left and half on the right? I mean you’ve got to have some standards if you want to get some of the benefits out of the systems."

*****

HITECH lists the following "meaningful uses" of EHR technology:

• The ability to do ePrescribing.
• Engagement in health information exchange to improve quality of care, e.g. care coordination.
• Reporting of quality and performance metrics, in a manner to be specified by the Secretary of HHS.

The common link between these three seemingly different uses of EHR technology is health data connectivity of health data to improve service quality.

E-Prescribing is essentially designed to promote care coordination between patients, doctors, and pharmacists. It uses EHR technology that is dedicated to exchange of data between physicians ordering medications, pharmacists who are filling these prescription orders, and patients who request refills and are dispensed medications for treatment of their conditions and diseases. All of these processes are easier, safer, more convenient, and less costly to perform using EHR technology than by paper or fax, and therefore we agree that this is a "meaningful use" of such technology.

Health information exchange between and among providers, especially when these providers are independent entities or exist in separate geographical locations, helps create continuity of patients' experience by providing continuity of information flow and access where once there were only isolated silos of health data. There is widespread belief that health data sharing could improve care, safety, and decrease waste and duplication.

And quality reports are, in essence, statistical analyses of patient experience, sorted across many different variables: e.g., condition, acuity, physician, location. Providers submit the raw data for analysis and feedback, another kind of care coordination and communication activity, although the results are removed in many cases from direct patient care. Here too, we see that this feedback holds significant potential for improving care and eliminating unnecessary costs.

As National Coordinator David Blumenthal has pointed out, the current CCHIT certified products were not designed for these purposes. And that begs several questions:

• Should already certified products be de-certified unless they can demonstrate their ability to meet the new HITECH criteria of meaningful use?
• What would health IT that was designed to carry out these tasks look like?
• How might it be distributed and sold?
• Should pricing criteria be included in the certification process?
• How might it be able to accommodate new features and functions as these become desirable?
• What tools do the nation's best performing groups provide to their staffs to empower them to provide high-quality and efficient care?

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A new certification process could be streamlined in ways that encourage rather than stifle innovation. Certifying entities should be neutral, dispelling the perception of many in the industry that CCHIT's ties to HIMSS are conflicted. (Note that we are not arguing for disbanding or dismissing CCHIT. We are simply suggesting that it should not have a monopoly over the specification of certification criteria. Like other organizations, CCHIT could choose to apply to become one of the certifying entities under the new process.)

Most importantly, the criteria for achieving certification should be closely linked to the "meaningful uses" specified by Congress in HITECH as ways physicians and hospitals can demonstrate improved performance associated with the tools, as justification for HITECH subsidies.

This could be easily achieved. ONC could interpret EHR technology as any software with the basic capability to create, protect (privacy and integrity), store, interpret, and exchange (i.e., import and export) a designated health data set, using existing, tested, and appropriate standards for this purpose. The designated health data set would be initiated with a small number of data elements that are already widely digitized and coded, such as problems and diagnoses, medication list and history, vital signs, and laboratory test results. Over time, and as exchange of this summary health data becomes routine, additional data elements could be added, as could new capabilities (e.g., decision support) for using the data.

Begin with a technological crawl, then walk, and eventually run. Build a platform capable of future extension beyond current transactions and technical specifications. Leave a lot of room for innovation.

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We believe that the market is moving inexorably to answer these questions, but that consideration of them by Dr. Blumenthal and ONC is a rare opportunity to accelerate the market response. By doing so, serious "new thinking" would likely be introduced into health IT. One of the consequences might be an entirely new process of qualification or certification of EHR technology from that currently proposed by HIMSS and CCHIT.

That "new thinking" would reflect the changes that have occurred in computing over the past few years since CCHIT defined EHR technology based on a client-server model that was dated even in 2004. For example, we have seen a major trend towards Internet-based applications, the so-called "cloud computing" revolution. In essence, this is the idea that one can access software applications as a service available over the Internet, instead of having to put the software programs on one's computer. Web-based software applications mean that customers need less specialized hardware and software to get more functionality at lower cost. Cloud computing allows us to make airline and hotel reservations over the Internet; to run word processing and spreadsheet applications, email, and contact database applications from a thin laptop computer or a cell phone; and to be free of dependence on particular devices or brands of hardware in order to participate in data exchange and communications.

A model of computing is emerging called Software as a Service, SaaS, in which the technology provides a platform into which multiple service applications can be "plugged" or "added" -- and often from competing companies that are also not the same as the company that owns the platform. Google Apps and the iPhone are the two primary examples of platforms that allow independent developers to create applications that can run on the platform, and in some cases interact with other applications. These applications may even be substitutable and be replaced by the user who is basing his/her choice of which app to use on the basis of pricing and value. Users of a Google home page can populate it with widgets (e.g. apps for weather, calendaring, email) from Yahoo.

Finally, the World Wide Web is increasingly being used as social media. From blogs, to Wikipedia, to Facebook and Twitter, online tools for communication and social interaction are transforming the way business is conducted and how society gets its information. Group efforts that used to require the filters of relatively rigid institutional structures, due primarily to the complexity of managing groups, are now as easy to organize as hitting the "Reply All" button on an email. We would guess that the number of physician exchanges taking place within Sermo and Ozmosis, two of the leading physician-based social networking sites, exceed by an order of magnitude the communications that take place through medical specialty societies taken all together. These new communications tools are creating unprecedented opportunities for people to express themselves, and medicine/health care is a primary cultural area being affected. People are regularly immersing themselves in virtual communities, like Patients Like Me or Diabetes Connect, organized around particular diseases; cyberspace is used to provide medical advice and visits with clinicians (see American Well or TelaDoc); and more and more patients/consumer are expecting their doctors to have an online presence through web portals and secure communications channels.

By contrast, the CCHIT-certified EHRs are overwhelmingly practice- and physician-centric software applications that pre-date the Internet. They were not designed with participatory medicine or consumer-generated health care in mind.

Shedding the bloated feature set now required for certification in favor of a "thin certification" based on data exchange and management would immediately stimulate the health IT economy. It would also focus Congress' understanding of "meaningful uses" that it hopes will encourage health IT among physicians and hospitals. Opening the aperture for innovation might easily create new jobs for new EHR technology products and services in e-Prescribing, care coordination, health data exchanges, and quality/cost performance reporting.

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HITECH is hugely important because it is the Obama Administration's first major step toward health care reform. The stimulus funds for health IT aspire to lay in a modern national health IT foundation that can facilitate the better care at lower cost our nation so desperately needs.

If the process moves forward as it is currently configured, a not-for-profit agency that is dominated by industry interests and that promotes technology that is largely outdated will have succeeded through its policy influence in securing much of that funding while holding newer, less costly, better technologies at bay. It would bel not only yet another serious compromise for American health care's future, but would signal that other important elements of meaningful health care change - universal coverage, a re-empowerment of primary care, greater quality/cost transparency, paying for results instead of procedures - will be equally elusive.