Our Thoughts on the Draft Meaningful Use Certification Testing Criteria

June 17, 2010 at 3:37 pm 2 comments

The Health IT branch of the National Institute for Standards & Technology (NIST) has been hard at work publishing draft certification procedures for hospitals, doctors, and vendors looking to achieve each of the Meaningful Use requirements.  You can see what they’ve published so far here: http://healthcare.nist.gov/use_testing.

We recently found these wonderful documents, and after reading through the ones that pertain to Nimbus eRelease, we realized a couple of them require the use of explicit data formats where none are warranted.  Namely, they require health information that must be presented to patients in an electronic, human-readable format, be done so via a CCD or CCR.

We wrote up our thoughts and posted them to hit-tst-fdbk@nist.gov today.  For anyone interested, our comments are below.  We’ll let you know what they say.

To whom it may concern:

We have a question regarding the test procedures for the “Electronic copy of health information” criteria.  According to the Meaningful Use Interm Final Rule, the objective of these criteria is to “Provide patients with an electronic copy of their health information.”  While the IFR mentions the use of CDs, USB drives, and providing online access to the information, it neither mentions nor requires the use of a particular health record format when storing, transmitting, or displaying the information to patients.

Knowing that, we were surprised by what appears to be, an explicit requirement in the test procedures (§170.304 (f) & §170.306 (d)) to structure the underlying health information in the HL7 CCD or ASTM CCR formats.

Question: Assuming all of the required information (e.g. diagnostic test results, problem list, medication lists, allergies, discharge summary, and procedures) is shared with the patient electronically in a human readable format, does it matter what the underlying format of the data is?

Note: the testing procedure for “Electronic copy of discharge information” (§170.306 (e)) has the same electronic delivery and human readable requirements, but appropriately, in our opinion, does not explicitly require the use of a particular standard for the underlying data.

Why We’re Asking

We have a module that enables sharing health information with patients from any EHR, even if the EHR doesn’t know how to produce CCD or CCR-formatted data.  We’re able to do this by offering an online service that redirects printed output from EHRs to our secure portal, where is it turned into a PDF that is accessible by the patient.  With this service, providers can securely share health information with patients electronically online, and in the same human-readable format as if it was printed directly from the EHR.

Due to the “plug-and-play” nature of the service, and to ensure it works for all EHRs (even ones that will see little investment going forward), we cannot customize the service to build a CCD or CCR out of the data, en-route to creating a PDF.  Not only would it be prohibitively expensive, it would ultimately be of little value since the final objectives are only that the health information be complete, electronic, and human readable.  Clearly, all of these objectives can be met without requiring a specific format for the underlying data.

Please let us know if we’re misinterpreting the draft procedures or if there’s an opportunity to adjust them before they are finalized.

Thank you for your time, and for the great work you’re doing preparing providers and vendors for certification.

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2 Comments Add your own

  • 1. Sc ott Howard  |  July 15, 2010 at 7:35 am

    Have you received a response from NIST on requiring CCD/CCR format?

    • 2. justinwi  |  July 16, 2010 at 12:13 am

      Thanks for the question Scott. I have not received an official response, although the good people at NIST referred our question to the ONC where it is currently waiting.

      That said, it’s our interpretation that the final version of the Meaningful Use requirements make it very clear: a patient must have access to both a human readable copy of their health information, as well as a CCD or CCR.

      Here’s the pertinent section from ONC’s response to comments:

      “Yes, in order to meet this certification criterion, Certified EHR Technology must be able to generate an electronic copy that is in human readable format and as a CCD or CCR. If Certified EHR Technology is capable of generating one copy that could meet both of these requirements, we would consider that to be a compliant implementation of this capability.”

      Page 146 of http://www.ofr.gov/OFRUpload/OFRData/2010-17210_PI.pdf.

      Not precisely the answer we were looking for, but it’s an answer, and now we can proceed with.

      Feel free to shoot me a mail, or reply here, if you’d like chat about this further.


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