Who writes Clinical Notes?

This question was the fundamental question being addressed in a recent Structured Documents Workgroup meeting.  At the root of it is whether or not a patient authored note belongs, or doesn't belong in the CDA Consolidation Guide as it is further developed by HL7.  One of the reasons for concern is that at present, HL7 published documents are the fundamental unit of "standardization" (and in fact, this is true for just about every SDO).  While we need better ways of publishing this content, others, such as ANSI and ISO, and regulators which reference HL7 standards are still referring to these standards by the name of the publication.  If patient authored notes become part of the CDA Consolidation standard, it becomes much easier to cite (or in this case, re-cite) them in ongoing regulatory efforts.

One of the challenges of course, is that this also expands what CDA Consolidation is, and certainly expands the efforts for the next ballot cycle on the CDA Consolidation guide.  At issue here, I believe is a need to incorporate some work developed by one part of the community that is competing with the need of other members of that same community to meet a more restricted set of goals.  I'm quite sensitive to this tension, and I often fuss myself about the crazy schedules that SD sets for itself.

Structured Documents spent quite a bit of time discussing this last year.  In September, we established the following principles for inclusion in the CDA Consolidation product (or product family, it still isn't clear which this is).  This was the agreed upon outcome:


Scope of Consolidation: “CDA templates at entry, section and document level applied in primary clinical information records and for exchange supporting continuity of care.”

Criteria for Inclusion:

• New material will be included based on evaluation of these criteria:
• Nine original implementation guides are grandfathered
• New material meets the following tests:
• High reuse of Consolidation templates
• Covers primary data (documents originate for delivery of care, becomes part of patient record, in contrast to secondary use; templates, of course, can be reused)
• Used for provider/provider, provider/patient communication
• High use of semantically interoperable templates (“model of meaning”, in contrast to “model of use” templates)

Note, that nowhere in Structured Documents definition of "Clinical Information Records" do we make any distinction based on who the author of the document is.  I think many assumed that because we used the term "Clinical Information", the assumption was that it must be generated by a clinical practioner.  But we never said that, and many would argue that patients can be just as, or even more clinically informed that their providers about some content.

The patient [authored|generated] [note|document] (however you want to call it), meets the tests described in the criteria for inclusion above. 

1. The data in the document is intended for delivery of care, and can become part of the patient record.
2. It reuses the General Header constraints, and adds to them to identity documents that have been authored by a patient.  It allows for use of existing CCDA sections and entries in the document to support the patient generated content.
3. It is used for provider/patient communication.
4. The templates contained within it follow the model of meaning structure.

We (The HL7 Structured Documents Workgroup) agreed today to include this content in the next round of Consolidated CDA balloting.  This step puts patient generated content in health information exchanges on equal footing with clinician generated content.  And when you think about it, that silly little clipboard that goes into your record when you first start in a physician practice, is nothing more than the first of many pieces of patient generated content that appear in your medical record.  It's about time we acknowledged the contributions that patients already make to their records, and the need for more of this kind of communication between patients and providers in the standards for exchange.

     Keith