The spectacle of government and healthcare leaders swarming around the sudden promise of electronic health records seemed to be a dramatic shift after years of indifference to the technology's potential. Pronouncements within a span of two weeks during late April and early May--from President Bush and HHS to healthcare leaders and federal lawmakers from both political parties--all added up to an unmistakable message for healthcare executives: Information technology, especially in the clinical setting, has been elevated to a top priority.
But it also highlighted the capital requirements and complex learning curve for electronic records networks that up to now have held the healthcare industry back. Nearly overshadowed by the spate of federal activity, a standards group emerged to present hospitals and other providers with a model for clinical IT planning just as the need for it became clear.
Bush late in April set a national goal of providing every American with an electronic health record within 10 years. He signed an executive order April 27 setting up a new HHS office to coordinate health information activities, standards development and partnerships between government and the private sector. Within 10 days, HHS Secretary Tommy Thompson had appointed the office's top official.
Only a few months earlier, at the annual conference of the Healthcare Information and Management Systems Society, leaders within the healthcare IT sector were concerned about the silence from federal officials and Congress regarding their roles in providing a boost for widespread clinical systems deployment (March 8, p. 18).
The appointment of David Brailer as HHS' point man for health information coordination was announced during a Washington brainstorming session put together with two weeks' notice to participants and only two days' notice to the press. The summit meeting gathered more than 100 healthcare and policy leaders "to see how we can press down on the accelerator and bring about the benefits of health IT even faster," Thompson said. "The benefits are enormous, but the task is also enormously complex. We need more than a business-as-usual approach."
Meanwhile, several healthcare groups chose that same week to issue reports or conduct presentations on how IT can improve healthcare quality while helping to contain costs. Growing numbers of Republicans and Democrats in Congress vowed to propose or support legislation to advance the issue.
For hospitals and physician groups trying to shape an appropriate response, a less flashy but no less important healthcare IT initiative came forward during the same span to provide the raw materials. A standards consensus-building group called Health Level 7 released an industry-endorsed outline to follow in planning for the complex task of designing an infrastructure for electronic records.
Experts who played a role in the initiative, which proposes a "functional model" of all that goes into an electronic record, say the just-released first draft will go a long way toward helping provider decisionmakers visualize what they should be agreeing on among themselves and asking of vendors before entering the market for clinically oriented IT.
Just having a clearly defined and common set of components to live by will help providers move faster and with more certainty to a decision on the elements of products they need to have in place to transform their patient-care operations, experts say. "The debate, the discussion, the deliberation about electronic health records can now go on with less confusion about the vocabulary," says Wes Rishel, past board chairman of Health Level 7.
"It allows for more intelligent buying," says Patricia Wise, director of HIMSS' electronic health record initiative.
Kick-starting IT investment
Lack of money to afford the expense still looms as the biggest barrier to deployment of clinical IT throughout the healthcare industry, but lack of consensus on the makeup of an electronic record also gets in the way by complicating the buying process and by creating wide variation in information systems from one provider organization to the next, observers say.
A year ago, Thompson charged the Institute of Medicine and Health Level 7 with the task of compiling a list of industry-standard functions as part of an HHS push for standardization of healthcare data that started in early 2003. The drive for functional standards brought with it high hopes that a defined electronic record could lead to a more informed private-sector IT marketplace as well as federal financial incentives based on a "pay for performance" formula--both key factors in kick-starting healthcare investment in costly and complex clinical IT.
As it turns out, speculation that HHS wanted to base a Medicare payment incentive on providers' deployment of a defined electronic record was off the mark, Wise says. "A year ago at this time, there were some comments made by federal officials that the electronic health record could stand as the basis for pay for performance," she says. "Those types of comments were taken literally. It was thought that if you had an electronic health record implemented, then reimbursement might immediately change."
But HHS spokesman Bill Pierce says the achievement of a draft standard represents "a continuing step" in the government's general objective "to move the entire U.S. health system more toward better use of the electronic health record for everyone."
The payoff for HHS--and the likely focus of its envisioned provider incentives--will center on the ability of well-defined electronic record systems to facilitate improvements in care to Medicare beneficiaries and better manage chronic diseases, Wise says.
Just having an electronic health record won't be enough. Conversely, not having such a capability will render providers incapable of qualifying for payment incentives based on demonstrated superior quality of care, she says. Only through well-designed IT systems will hospitals and physicians be able to manage target patient populations and then electronically capture and report the data necessary to qualify providers for performance-based payment, Wise says.
The government "wants to be able to pay for federally funded healthcare in a way that differentiates good-quality healthcare from other care," says Randy Thomas, vice president of implementation services at Healthlink, a Houston-based healthcare information technology consulting firm.
Development of both federal pay-for-performance formulas and private networks of electronic health records will have long time frames, but it's to the healthcare industry's advantage to get started now on the road to building the necessary networks, Wise says. "By the time you have an (electronic record) implemented, pay-for-performance will most likely also be going on."
Defining a monumental task
The scope of an electronic record far exceeds the notion of mere clinical record-keeping that the technology's name conjures up. Its functions and purposes extend to identifying and electronically capturing all tests, observations, treatment options and care plans for a given patient--collected from every encounter with a doctor or medical facility over a period of months or years.
It also acts as the vehicle of communication among all the clinicians, hospital managers and others involved in the care of a patient, both currently and eventually. Crucial to effective care are special functions set up to report and distribute test results immediately to the right caregivers and then deposit the data in a patient's computer file for subsequent use during an episode of treatment and follow-up care.
Outside the boundaries of clinical care, the same information collected in the course of patient treatment is valuable in many other ways: reporting communicable diseases and possible bioterror threats to public health agencies, for example, or gauging the effectiveness of clinical pathways and protocols in a hospital, a region or nationwide.
Underlying all functions for patient care and information-transfer support is a layer of IT infrastructure to ensure that data are accurately and securely conveyed and that information can be organized and shared from one provider to another and with appropriate outside agencies, while meeting federal requirements for privacy and security under the Health Insurance Portability and Accountability Act of 1996.
Those broad concepts of an electronic support structure for clinical operations evolved gradually over nearly a decade, mainly in a give-and-take between individual information technology vendors and their existing and prospective customers. The result has been scores of different product suites for hospitals--and hundreds for physician practices--each developed with an eye toward differentiation from competitors rather than a coordinated set of elements acknowledged as essential to most providers, Thomas says.
"Each vendor defines an electronic health record to their advantage, according to their strengths," she says.
That may or may not serve a healthcare organization's best interests, says Mac McClurkan, vice president and chief information officer of Bronson Healthcare Group, Kalamazoo, Mich., which is well on its way to completing an electronic record at 70 sites of care, including flagship Bronson Methodist Hospital.
McClurkan says providers too often "tend to buy whatever the vendor is selling, and later realize it did not meet their needs--but they never defined what the needs are."
In vendors' defense, however, they haven't always had enough direction from the healthcare community in creating what providers need, he adds. "It's tough for vendors to do that in isolation," McClurkan says. "There's a lot that by all rights is (providers') responsibility."
By defining those needs and assigning priorities to them, the new model for an electronic health record puts vendors on notice that the healthcare industry has taken back the initiative and will be looking for a certain subset of capabilities that can begin to solidly address an industrywide vision of efficiency, care quality, patient safety and improvement in health outcomes, says Donald Mon, vice president of practice leadership at the American Health Information Management Association.
"This is a voluntary standard for electronic health records that will advance the promise of the vision," Mon says. "What this does in one stroke is say, `OK, we are informing you of the vision. ... Now vendors, go and put that in your product.' "
Boiling it down, setting priorities
The work of Health Level 7 boils down the electronic record to a total of 130 functions in the areas of direct care, support for clinical operations and underlying information infrastructure. Those general areas are further divided into 13 categories of functions.
Each function also is assigned one of four priorities to guide current and future plans for phased development: essential now, essential in the future, optional, or not applicable for certain providers.
For healthcare organizations just getting started, the model is a road map of the most basic features that should underpin an electronic record, Mon says. Practical functions such as patient problem lists, medication administration, orders and results are "thoroughly threaded throughout the model," he says. Other functions, though often mentioned as components of clinical systems, were judged optional for now or essential further down the line: managing referrals from one provider to another, for example, or communicating by computer with patients and their families.
The model also recognizes significant differences in the needs and priorities of four distinct medical settings: acute-care facilities, ambulatory clinics, long-term-care facilities and community-based operations such as home care.
Only about 60 of the listed functions were designated as essential to acute-care facilities for the present; 30 were viewed as essential for IT systems serving ambulatory facilities.
Such a blueprint benefits vendors as much as their customers because it allows software firms to allocate time and money to a specific roster of IT features and functions instead of having to make educated guesses about whether there will be sufficient interest in a given feature under development, says Jon Zimmerman, vice president of the Soarian Health Connections unit of Siemens Health Services. "A good standard enables more meaningful innovation," he says.
Even for basic functions such as allergy and medication lists, the functional standards provide some direction to vendors where there had been no industry consensus until now, says Michael Myers, vice president and general manager of the Horizon Clinical Solutions division of McKesson Corp.
During the next two years, Health Level 7 will be monitoring the use of the "draft standard for trial use" and taking suggestions for changes before calling for a vote of its membership to make the model a fully accredited industry standard.
Thomas says the document won't likely be overhauled but rather will be subjected to "refinement at the margin." In the meantime, each healthcare IT vendor in the market will map its capabilities to the functions represented, allowing "a way to compare apples to apples" for prospective buyers as well as current customers that will be analyzing what they already have and what they still need to add, she says.
The push for ubiquitous electronic records by 2014 involves more than establishing current and future functions, Wise says. To meet the objectives, the industry also has a long list of technical tasks ahead of it to standardize sending, receiving, sharing and storing data among disparate computer systems from hundreds of software and IT services companies. Coordinating and promoting those efforts are among the duties assigned to the new HHS office.
Says Wise: "This is the overture of a symphony we're going to be hearing for the next 10 years."
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