By Cindy Atoji

March 25, 2008 | The first version of Laika, a free and publicly available EHR testing tool, was released last Friday, say project leaders Rob McCready and Tom Neal. A collaborative effort between CCHIT and the Mitre Corp., Laika is an open source compliance testing platform intended to make it easier for electronic health record (EHR) vendors to test and verify their products in preparing for CCHIT (Certification Commission for Healthcare Information Technology) certification.

The project was named after Laika, the first animal -- a dog -- launched into space in space in 1957. Although Laika died not long after being in orbit, the achievement proved living creatures could survive the trip to orbit and helped pave the way for future manned flight. Organizers say the Laika name symbolizes their effort to prove the grand challenge of interoperable EHRs is attainable. Digital HealthCare and Productivity spoke with McCready, a lead software systems engineer at Mitre, and Neal, M.D., Mitre’s chief physician for health systems.  

DHP: Can you briefly describe what Laika is and why it’s important?

Neal: In the case of Laika, within the ONC (Office of the National Coordinator) and the federal health architecture, there’s a real need to standardize a process whereby we can certify EHRs. Some months ago, we partnered with CCHIT to help take a set of requirements and create an open source platform that could give CCHIT an opportunity to certify vendors who could then go out and say their EHRs had been through a standardized process. 

McCready:  This is to help accelerate the adoption of interoperable electronic health records in the United States. What Mitre is doing is providing a software testing tool for the certification commission. The model Tom [Neal] mentioned [encompasses] the testing tools, the criteria, the standards—everything you need to be interoperable. So it’s not only the standards but also now the code to meet the standard. [Laika] is a software testing framework that anyone can download—they can actually see how they grade according to the rules the U.S. is using to certify these health records offerings. The analogy is that it’s like Consumer Reports. They’re going to give you a grade on how well these EHR systems interoperate.

DHP: Is there anything else like this out there?

McCready: For the specific standards that we’ve been working with, we’ve been told by many people that this is the only one. There are other organizations that are developing open source testing tools, but none of the tools out there support the CCD (Continuity of Care Document), which essentially belongs to HL7 (Health Level Seven) and is constrained by HITSP (Healthcare Information Technology Standards Panel) according to the C32 spec. The standard that everyone is really focused on this year is the CCD/C32.

We’re the only one that we’re aware of right now that has any testing tool that fully supports generating, validating, and inspecting these documents. And we’re pushing this out there now so the EHR community can get ahead of the game. [Vendors] can actually start testing now in preparation for the 2008 process for CCHIT, which starts in July and runs for a year. The idea is to actually make the vendors become interoperable by giving them tools that are free to use to test [against] the standards that they have to support.

DHP: What is the current status and some milestones that have been achieved?

McCready: We released the open source project site in November of 2007 on www.projectlaika.org. We also published a design document in November that detailed what we were going to achieve for this month with our first release of Laika, [and] we presented Laika to the EHR vendor community at HIMSS. We’ve had a lot of visibility on the project, and we’ve had a lot of validation that this particular standard that we’re using--CCD/C32--is really important for the country as well as all these different vendors.

DHP: What was the reaction at HIMSS?

McCready: Positive. This is actually a service that we’re providing to the vendors. This is something that they need for the certification process—prior to July, they can actually test how well their [products] are going to grade; and [determine whether they’re] going to be certified, at least when it comes to this one specific document. The additional benefit is that this is something EHR vendors need when doing their own internal testing. It is essentially an infrastructure tool, a testing tool that private organizations would use when making a product.

Neal: It’s good to remind ourselves that Mitre is a disinterested party. This can add some value, because unfortunately there can be some tension between the vendors and CCHIT. So it’s nice to have a disinterested third party committed to understanding the domain and helping bring disparate energies together.

DHP: Give us a roadmap of what lies ahead. What other areas could the Laika framework expand to cover?

McCready: There are opportunities to investigate other standards. Additionally, there are a variety of ways to actually exchange these documents, so right now we can augment that with other standards for network interoperability. There has [also] been enormous interest in security and privacy. We’ve been asked, “After you demonstrate the data is interoperable, can you demonstrate that it’s secure? Can you test that the data is actually securely locked down with these EHR systems and that the right people have access to the data?” So these are things that we could do on the horizon.

We’re still working on the specific details but we are going to be making enhancements to Laika between now and least the September timeframe.

Ultimately our big milestone is July, when this will actually is used for certifying EHR systems in the U.S. We started a Beta test with five EHR vendors on March 19. The idea is to solicit feedback: We’ve released the tool [and asked], “What do you think?” [There will probably be] a few more iterations over the next few months to ensure its capabilities are locked tight and we’ve hardened the code. We feel very confident in July that CCHIT will be granting or refusing certification applications based on Laika.

DHP: How exactly will the automation of certification testing work?

McCready: The easiest way to describe the automation part of Laika is that it will automatically generate these documents according to the standard. It will also automatically validate and parse these documents. The technical terms we have are “Display and File” and “Generate and Format.” Those are the two different types of tests. But you can think of it as egress-ingress.

It will make sure when it generates or uses a file, that it’s appropriate according to the test case, and will make sure you can understand the data inside the file. The second part is the ingress into Laika, so you’d be providing a CCD/C32 file, you’d give it to Laika, and it would validate that according to the standard, it’s a valid document, and would actually look at the data inside of this document. It would automatically say, “The name is what it should be, the condition is what it should be; wait a second, the prescription code is wrong,” etc.

So it’s doing a lot of the mundane, repetitive legwork that you’d have to have a human being do. These documents have around a hundred fields, so this is a high-level clinical document associated with the patient. The idea is that we’re automating a mundane process and making it quicker and helping speed the certification process.

DHP: Laika is open source—what are the target platforms and how will it be released?

McCready: It’s an open source project. It’s an Apache 2.0 license, which provides an enormous amount of flexibility for the people who actually want to download and use it. Ultimately you’re free to download, use, modify, and even redistribute the code at your discretion. And that was done to make the EHR vendor community comfortable with using the software.

There was concern that some open source licenses are perceived as viral, meaning that once you install an open source package on your system that everything needs to be open source. That caused some concerns among business leaders, so we intentionally picked Apache 2.0. The software is available on projectlaika.org, and hosted by sourceforge.net.

As far as platforms, it’s a Web-based application and we’re testing it with IE7 (Internet Explorer 7), Firefox 2 or higher, and Safari. We’re trying to cover the Windows, Apple, and Linux platform. Additionally, you can even download and install the actual Laika server itself for testing, and that also supports Windows, Apple, and Linux platforms. We’re developing the code and testing it continually on all three of those. So we’re trying to be platform-agnostic as much as possible.

DHP: Are contributors needed to add breadth and depth to Laika testing environment?

McCready: We’re eager to expand the community. It’s open right now for anyone to propose contributions, and there are actually some features detailed on the project website that identify what we would like to do for the next six months. But right now the governance is a joint relationship between Mitre and CCHIT. Depending on business relationships or if someone can demonstrate outstanding contributions, we’re actually open to extending the governance of the project, but it has to be a joint agreement between the Mitre and CCHIT leadership.