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Friday, August 24, 2012

(Resolved) ONC, Please tell me this is a Typo in MeaningfulUse Stage2

Update at 9:35 (after some sleep)
This is one of those situations where reading nearly 500 pages can be confusing, and where a minor wording change can be either ambiguous, or provide greater clarity.

(e) Patient engagement. (1) View, download, and transmit to 3rd party. (i) EHR technology must provide patients (and their authorized representatives) with an online means to view, download, and transmit to a 3rd party the data specified below. ... (B) (1) Electronically download -- an ambulatory summary ... in human readable format or formatted according to the standard.
The key is at the top of the section:  Provide patients with [the capability to] ... download ... in human readable format or formatted according to the standard.

It's the patient that has the choice, not the application.  Without the preface (see 4:35 update below), it would have been difficult to obtain that clarification. Phew.

It would have been clearer to say "AND", but their intent is clear.  Patient's aren't second class participants [and I know ONC didn't intend for them to be].  Back to updating the prior post.

-- Keith

I was reviewing the blue-lines on the changes from the proposed Meaningful Use Standards rule to the final rule tonight.  I found what I consider to be a major problem, which I hope is just a typo (and it could actually be).

Here's the markup:

It has to do with the insertion of the word OR into (e)(1)(i)(B).  Here's the differences:

Here's the text in the final rule with that insertion highlighted:

Download. (1) Electronically download an ambulatory summary or inpatient summary
(as applicable to the EHR technology setting for which certification is requested) in human
readable format OR formatted according to the standard adopted at § 170.205(a)(3) that
includes, at a minimum, the following data
I'm hoping this is JUST an editing mistake that can still be corrected.  As written, that text says that a patient portal can give a patient either their CCDA Document (using the standard), or it can be human readable format (e.g., plain text, PDF or some other format).

Following that, the transmission part of the reg says:

Transmit to third party. (1) Electronically transmit the ambulatory summary or inpatient
summary (as applicable to the EHR technology setting for which certification is requested)
created in paragraph (e)(1)(i)(B)(1) of this section in accordance with the standard specified in § 170.202(a).
What this means if this isn't a typo is that:

1.  Patients can be given second rate data, and
2.  When they go to transmit it to a third party, that third party will get second rate data as well, that won't be able to be incorporated into the record, because it won't follow the standards.

Remember, CDA is a human readable format, and the HL7 Blue Button Stylesheet will even allow it to be viewed as if it was text/plain, which enables (through a patient portal), patients to capture the text if they want.

I want the same data my doctor gets, in a way that can be used by my apps.

Please tell me this is a mistake.  Please?

4:35 am Update: I'm feeling only a little better after finding THIS on page 70 of the Prefatory material:
To be clear, we also require for certification that EHR technology be capable of enabling a patient or their authorized representative to be able to download a file formatted according to the Consolidated CDA.
That (and text preceding it) seems to confirm that it's a mistake, but the regulatory text is what counts, and it doesn't say that!


  1. What I like is ONC's expense-reducing strategy of publishing a poorly edited document for the stakeholder community to proofread for free. Better yet, it's apolitical.

  2. Keith, I appreciate that you advocate for the Patient, and you provide such a WEALTH of excellent information and research. Thank you.