Paula Anthony, chief information officer of East Texas Medical Center Regional Healthcare System, based in Tyler, said her hospital system includes several small, rural hospitals that struggled to buy healthcare IT systems on their own. Nevertheless, due to lack of interoperability, “When hospitals joined our system, we basically had to throw out everything they had,” Anthony said, adding that interfaces are “highly unusable in the community hospital arena.”
Without naming two of the specific IT system vendors involved or their products, Anthony described them as “major players in the hospital vendor market. These were top-tier vendors and top-tier products, but in the end of the day, we couldn't have moved the data. I mean we could have, if we spent another year at it and built this hairy interface.” But Anthony said that would have created an infrastructure so difficult to maintain and upgrade that it would have been too fragile and “too dangerous” to tolerate.
“I would not have taken the risk to my patients with that kind of fragility,” she said.
Brian Klepper, an Atlantic Beach, Fla.-based healthcare analyst and a member of the Health 2.0 Advisors, a consulting firm for companies wanting to enter the healthcare IT market, was far more pointed in his criticism of CCHIT.
Klepper said CCHIT was “dominated by a vendor mentality” that is focused on “very narrow conceptions of what healthcare IT should be” that are “cementing us in old technologies and setting us back a generation.”
“If we still do not have interoperability after all this effort, it says something about who is controlling the process,” Klepper said, adding such a lack of interoperability “is holding our entire healthcare system hostage.”
“CCHIT has dragged its feet on this,” Klepper said. “It is important to note, it is critical to note, that many organizations are simply ignoring CCHIT. While we are busy establishing guidelines and criteria, the market is going to do what it needs to be done. When the market ignores what you are doing, that means you are not current.”
Klepper called for either a sweeping change of CCHIT leadership or to have HHS authorize competing organizations to certify EHR systems.
Leavitt said he sympathized with the work group's assignment.
“You're being asked to do in four days of meetings what we've been trying to do in four years,” Leavitt said. CCHIT was awarded a $7.5 million HHS contract in 2005 to fund a testing and certification program for healthcare IT systems. “We were created, basically, as part of a strategic plan the first national coordinator created, David Brailer.”
Leavitt said CCHIT had attempted to incorporate into its testing and certification criteria every interoperability standard available, but said under the Bush administration's national IT plan, interoperability was to be the bailiwick of health information exchanges and “HIEs didn't go anywhere.”
Another problem with interoperability that CCHIT faced was a turf war between two standards development organizations that finally led to the development of a compromise, the Continuity of Care Document, or CCD, standard that was subsequently anointed by the federally supported Health Information Technology Standards Panel. That truce didn't come until 2007, however.
The CCD can be used for peer-to-peer communications of patient-care summaries between the EHR systems of office-based physicians and EHRs at other physician offices, at hospitals, as well as between the doctors and their patients' personal health-record systems.
Starting with the 2008 round of testing, every CCHIT-certified system has to import and export to the CCD format, Leavitt said. “We did our part and made sure that EHRs were able to import and export.” But, he said, “There are no standardized HIEs and almost none of them using the standardized format that the government of approved.”
Gordon Gillerman is the division chief of the standards division of the National Institute of Standards and Technology, which will advise ONC on recognizing “a program or programs” for certification of health IT systems under the American Recovery and Reinvestment Act of 2009, commonly known as the stimulus law. Gillerman testified Tuesday as to the NIST role in that decisionmaking process.
In addition, Gillerman said one of the decisions federal policy wonks will have to make is whether there needs to be an accreditation organization overseeing the organization or organizations chosen to certify IT systems under the stimulus law. They will have to find a “sweet” spot between overdesigning an oversight mechanism and underdesigning one.
“How bad can things be if the products don't meet the requirements?” he asked, rhetorically. “We should associate the amount of resources to the amount of risk.”
Gillerman said the CCHIT approach of raising certification standards for EHR systems over time is quite common in industry. It is an approach members of Congress adopted in the stimulus law when it also instructed HHS to ratchet up criteria for the achievement of the “meaningful use” standard providers must meet to qualify for federal EHR subsidy payments.
“It works in a lot of areas very, very well,” Gillerman said. “Regulatory agencies do it. Electrical safety standards have improved tremendously over the years.” But he cautioned, with healthcare IT, “I think one of the things that's difficult is where you have interoperability issues.” It isn't impossible, he said, but “great care has to be taken.”
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