As the product manager of Corepoint Integration Engine, it has been an interesting learning experience from the time the decision was made to pursue the EHR modular certification to the time certification was achieved. And, before beginning the certification trek, time was spent trying to uncover the real story of whether an integration engine even needed to be certified as an EHR Module.
After many hours of sorting through FAQs on the ONC web-site, reading countless blog and news articles, and sitting in on presentations at HIMSS11, we decided to proactively take the path of EHR Certification rather than wait for guidance on whether it was required. The most important factor for us was to continue to deliver confidence to our customers who were positioned to meet the Meaningful Use requirements and avoid putting their incentives at risk.
With the certification now achieved, what did the process look like?
Sorting through the NIST test requirements, there were a few modules that centered on the exchange of clinical data and thus seemed very applicable to interface engines. In addition to any selected modules, all certification candidates must pass the Privacy and Security tests at a minimum.
Once the appropriate tests were selected, it was time to walk through the NIST test procedures step-by-step. While the test procedures could be open for interpretation at times, the general concepts seemed to be appropriate for what one might expect for Stage 1 testing.
For the Privacy and Security tests, the basic requirements one would expect to be required were included. From a file security standpoint, encryption and integrity were tested for basic functionality. From a user security standpoint, access, authentication and other user controls were tested.
For the tests surrounding the exchange of data, the test requirements were, again, appropriate for Stage 1. The ability to display a CCR and CCD using a style sheet was required, as was the ability to deliver validated and conformant CCR or CCD documents to a remote location.
So, what do I expect from Stage 2? I would expect the testing requirements around the exchange of data to become more exhaustive and more aligned to ensure that any certified EHR would be able to actively participate in common HIE structures.
At a minimum, I would want to see testing that shows that an EHR can comply with the Direct Project standards of exchange of data documents by e-mail using secure XDM standards. In addition, I think it would be appropriate to test commonly used HIE communication standards such as the XDS IHE profile. Ensuring that vendors begin to offer these standards will push the industry further into the interoperability world.
If the ultimate goal is higher quality care at a reduced cost, then better information must be made available at the moment it is required. Stage 1 is a needed and valid step to ensure that EHRs can support CCRs or CCDs at a fundamental level, but much more will be needed in Stage 2 to push the industry towards better and more efficient exchange of data.
Additional reading: Thirteen Steps to Selecting the Right HL7 Interface Engine
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