On balance, it would appear that members of the open-source healthcare software community are satisfied with the proposed changes in the way electronic health records systems will be tested and certified by the federally supported Certification Commission for Healthcare Information Technology.
Earlier this month, CCHIT announced it was adding two new testing and certification regimes to meet what CCHIT Chairman Mark Leavitt called an anticipated stampede toward EHR adoption, triggered by an estimated $34 billion in Medicare and Medicaid subsidy payments under the American Recovery and Reinvestment Act of 2009. In both new schemes, CCHIT said it would test and certify that EHR systems effectively meet the meaningful use standards now under development by HHS instead of just CCHITs own long list of discrete EHR functions used exclusively in the three previous rounds of CCHIT testing up to this point.
The stimulus law requires providers to not only use certified EHR systems, but also to use them in a meaningful manner. The CMS, which will oversee the official rulemaking process for HHS in determining meaningful use, is expected to have an initial set of standards ready for publication early next year.
The changes to the certification process also seem to align with requests made of CCHIT by open-source advocates to make its testing and certification process more amenable to the peculiarities of open source development, according to four open-source mavens contacted for this story.
It was surprising to us, said Fred Trotter, a programmer, blogger and co-founder of the Liberty Medical Software Foundation, Houston, a recently formed not-for-profit organization seeking to promote what Trotter describes as free and open-source software (FOSS) in the U.S. healthcare IT market. Im happy and everybody in the community is happy, too.
And in a recent e-mail to community members, Trotter said, I am personally endorsing the new CCHIT certification programs for certification for ARRA funding.
That happy state of affairs reflects a sea change for Trotter, who as recently as March, in an e-mail to open-source community members, wrote: The largest single threat to the future of FOSS in healthcare in the U.S. is the certification process mandated by the stimulus act, adding that CCHIT has had an anti-open source stance for years.
Open-source advocates indicated their focus would be on the two new testing regimes directly linked to the meaningful-use criteria. Trotter and others said the new programs will afford the open-source community, as well as vendors of proprietary software and end users, more flexibility. They also expressed satisfaction that CCHIT had addressed open-source issues as quickly as it has.
One prominent wellspring of open-source clinical IT system software is the Veterans Affairs Department. Copies of the VAs Veterans Health Information Systems and Technology Architecture, or VistA software system, often called FOIA VistA because of its availability under the Freedom of Information Act, are available to the public without charge.
Technically, the VistA system is referred to as public domain software, although the bulk of the VistA code was developed by programmers operating within the VA in a fashion that was similar to the development model of open-source used to produce the popular Linux operating system and Apache Web server software, according to VistA cognoscenti.
A VistA cousin, the Resource and Patient Management System, or RPMS, developed by the Indian Health Service, also available under FOIA, is starting to find some traction outside the IHS with public health clinics.
Physician Edmund Billings is the chief medical officer and executive vice president of Medsphere Systems, Carlsbad, Calif., the developer of OpenVistA, a commercial version of the VistA clinical IT system used by the Veterans Affairs healthcare system. Medsphere also owns the intellectual property rights to the VueCentric graphical user interface of RPMS. Medsphere is in the process of seeking certification for its version of VistA and RPMS, he said.
Billings also said he sees the changes at CCHIT as positive developments, but was holding back on a full endorsement. Im pleasantly surprised, he said. I think the way CCHIT handled this was graceful and thoughtful and responsive to the industry. It hit me that they were listening. It opened the door. We are happy with the modular option. Still, he said, I think the devil will be in the details.
Although Medspheres VistA derivative is not yet CCHIT-certified, according to Billings, The go forward for Medsphere is to be a certified EHR technology as to the stimulus bill. Our clients are going to want to get paid for meaningful use and part of our service is to get them certified for meaningful use.
In addition, Billings said it makes sense, from the governments point of view, to have a certification system linked to what the government is paying for, i.e., meaningful use.
Mike Ginsburg is marketing manager for Document Storage Systems, Juno, Fla., developer of vxVistA, also a commercial VistA derivative. DSS received CCHIT certification for vxVistA in 2007. Ginsburg, too, said, Generally, we were happy that CCHIT was paying attention to the open-source community, but added that he, too, will withhold final judgment until the details of the program are made known.
Well see what the specifics are, he said. Whatever we have to do to allow our customers to be eligible for ARRA money, thats what well do.
Joseph Dal Molin is a Toronto-based IT consultant on the board of directors of WorldVistA, a not-for-profit organization that developed WorldVistA EHR VOE, an open-source variant of the VAs system that also received CCHIT certification in 2007.
Dal Molin is currently working in Amman, Jordan, as a consultant with Electronic Health Solutions, a not-for-profit corporation set up by the Jordanian health system, which is installing WorldVistA at a government-run hospital and outpatient clinic. Perot Systems was hired as the lead integrator on the pilot project.
Cost, not complexity, was the biggest problem the WorldVistA community had with CCHIT under its initial testing and certification model, Dal Molin said.
WorldVistAs EHR was CCHIT-certified in April 2007 to the then-current 2006 criteria, a certification thats good through April 2010. It cost the organization $38,000 for initial testing and around $4,800 per year to continue to use the CCHIT seal in WorldVistA advertising, Dal Molin said. That adds up to nearly $50,000 for the three-year life of the certification, a lot of money for a small, not-for-profit organization, Dal Molin said.
Having gone through the comprehensive model, I think its doable, Dal Molin said. For the open-source community, all they need to do is drop the costs, because you really are gambling. We felt we would be investing all of WorldVistas savings and not being assured of getting anything back.
On the one hand, that comprehensive model might seem stringent, but on the other hand, Dal Molin argued against dumbing down the proposed new meaningful-use certification criteria too much.
Were thankful that CCHIT is listening to making certification more accessible to others and so on, but ultimately, certification has to serve clinical improvement, not giving people and easy pass to going after ARRA money. That would be, ultimately, a mistake, he said.
While open-source software has captured only a tiny fraction of the healthcare IT market thus far, there is plenty of room for growth.
Meanwhile, Congress, HHS, and a handful of commercial vendors and consultants are raising the open-source profile. This week, HHS is hosting a two-day conference in Washington, D.C., on its CONNECT project, an open-source software interface the government developed to link federal healthcare IT systems to the proposed National Health Information Network.
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