"The fact that they are in communication with us is good," said Fred Trotter, a Houston-based programmer and open-source advocate. Trotter is one of two co-founders of the new Liberty Medical Software Foundation. Houston psychiatrist and fellow open-source maven Ignacio Valdez is the other co-founder. Dave Whitten, a programmer working with the Veterans Affairs Department, is a founding director. Whitten is the chief technical officer of WorldVistA, also a not-for-profit organization, formed to promote the use of an open-source version of the VA's VistA clinical information system in healthcare organizations outside the VA.
Trotter said the launch of the foundation last month has been about two years in the making.
"This is a brainchild of Dr. Valdez and I," Trotter said. "He has been working on VistA. But I'm not associated with a product or a code base. We wanted to do stuff for the community with the foundation and the not-for-profit. We want to be in a position by that time frame to take positions effectively as an organization. I'd like to have a position on meaningful use and a formal position on certification subject to our negotiations with CCHIT. That's one of the primary motivations for doing things as we are." Trotter said the organization also plans to hold conferences to showcase open-source software applications in healthcare.
The stimulus law requires providers to make "meaningful use" of "certified" EHR systems to be eligible for its $34 billion in IT subsidy payments, but the law does not designate CCHIT as the only HHS-recognized IT certification authority, a status CCHIT currently enjoys. Rather, the stimulus law charges the National Coordinator for Health Information Technology, in consultation with the director of the National Institute of Standards and Technology, to "keep or recognize a program or programs" for certification of health IT, leaving the door open for an alternative to CCHIT specializing in certifying open-source systems.
In an e-mail on the listserv of the Hardhats, a group of programmers involved with VistA, Trotter explained his beef with CCHIT.
"Everyone I have talked to in the FOSS (free and open-source software) community has indicated that the feature-bucket testing model that CCHIT currently puts forward does not work for us," Trotter wrote. "I would like to work with CCHIT, but not under the constraints of accepting aspects of the current model that are broken."
During the April discussions, CCHIT Chairman Mark Leavitt attempted to assure the open-source developers and advocates that CCHIT was willing to discuss adapting its testing and certification programs to the needs of the open-source model of development. But also at that meeting, Trotter suggested the open-source community might seek HHS approval for an alternative process to CCHIT to certify open-source healthcare systems.
The idea of a separate certification process for open source hasnt disappeared, Trotter said.
Under the stimulus law, HHS must recognize a first batch of certification criteria by Dec. 31, but to meet that deadline and to publish the criteria and put them up for public comment, the conventional wisdom has it that a first draft must be ready by late August. Work on them is already under way at HHS.
Also today, the Health IT Policy Committee, an HHS-run advisory body also created under the stimulus law, meets in Washington and is expected to release a draft description of "meaningful use" on which crafters of certification criteria and the organizations that will perform certification testing will take direct aim. Thus, Trotter said, time is of the essence, and so the open-source community may not be able to wait for the details of an accommodation with CCHIT to be ironed out before moving forward with its own request for certification authority.
"They've been very fair with us, and theyve been very straightforward, so I think it will go well," Trotter said of CCHIT personnel in advance of today's meeting. "There is a time issue; the fact that they are deciding the certification issue is right now."
WorldVistA obtained CCHIT certification for an open-source version of VistA in April 2007. That certification lasts for three years. Whitten says the effort was a drain on the organization's finances, and since then, CCHIT has come out with second and third versions of testing criteria, adding hundreds of new hurdles to meet. CCHIT announced recently it will hold up testing systems against its newest, fourth set of criteria, waiting for any additions or modifications to be required under the stimulus law. Whitten said WorldVistA has already begun working on readying its open-source system for recertification testing next year, an effort led by physician programmer and volunteer Nancy Anthracite.
"We are taking all the resources we can get to do it," Whitten said. "We pray that we can get it done. It certainly takes more the more certification criteria they add to it. It's huge and it's a hard problem. We could do with another 100 volunteers just from all the new criteria that are there. That's the part of growing. We have challenges, and we try to meet those challenges. We've made the commitment to doing it, but it's not like we're the Rockefeller Foundation."
Whitten said that Trotter is hoping for more flexibility in having an open-source alternative to CCHIT certification. Whitten also said the open-source community will have a hard time replicating the CCHIT organization, but if interoperability is the goal, CCHIT needs to learn from the open-source community as well.
"I think CCHIT; they're heart is in the right place. But they aren't having to do it themselves," Whitten said. "They just say, This is the poster on the wall; just do these things and you're OK. An open-source effort relies on having all the details specified, but CCHIT doesn't provide the details. All they have to do is to have the functions they can present to a jury.
"Ultimately, CCHIT is going to have to adapt to this whether, it is an open-source initiative or not," Whitten said. "If they don't have hard decisions that are made, they're still not going to get to interoperability. In some sense CCHIT folks are hoping the CCR (Continuity of Care Record) and CCD (Continuity of Care Document) guys are going to deal with everything. They're hoping the HL7 (Health Level 7) guys have put enough data points out there that interoperability will occur.
"CCHIT people are not trying to figure out what it takes to accomplish what they want to do," Whitten said. "If they did, they wouldn't be throwing out 500 requirements a year."