Tuesday, May 5, 2009

"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.
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HITECH lists the following "meaningful uses" of EHR technology:
  1. The ability to do ePrescribing.
  2. Engagement in health information exchange to improve quality of care, e.g. care coordination.
  3. 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 Internet and World Wide Web are 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. If that occurs, it will not only be yet another serious compromise for American health care's future, but it will 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.

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. Their collected collaborative columns may be found here.
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