Non-Normative Content The Normative content for these specifications may be found on the HL7, IHE, and HITSP web sites.

Unstructured Document

[ClinicalDocument: templateId 2.16.840.1.113883.10.20.21.1.10]

An unstructured document is a document which is used when the patient record is captured in an unstructured format that is encapsulated within an image file or as unstructured text in an electronic file such as a word processing or Portable Document Format (PDF) document.
There is a need to raise the level of interoperability for these documents to provide full access to the longitudinal patient record across a continuum of care. Until this gap is addressed, image and multi-media files will continue to be a portion of the patient record that remains difficult to access and share with all participants in a patient's care. The Unstructured Document type addresses this gap by providing consistent guidance on the use of CDA for such documents.
An Unstructured Document (UD) document type can (1) include unstructured content, such as a graphic, directly in a text element with a mediaType attribute, or (2) reference a single document file, such as a word-processing document, using a text/reference element.
For guidance on how to handle multiple files, on the selection of media types for this IG, and on the identification of external files, see the subsections which follow the constraints below.
IHE's XDS-SD (Cross-Transaction Specifications and Content Specifications, Scanned Documents Module) profile addresses a similar, more restricted use case, specifically for scanned documents or documents electronically created from existing text sources, and limits content to PDF-A or text. This Unstructured Documents implementation guide is applicable not only for scanned documents in non-PDF formats, but also for clinical documents produced through word processing applications, etc.
For conformance with both specifications, please review the appendix on XDS-SD and US Realm Clinical Document Header Comparison and ensure that your documents at a minimum conform to all the SHALL constraints from either specification .

Unstructured Document Header Constraints

Unstructured Document Body Constraints

  1. SHALL contain exactly one [1..1] templateId ( CONF:7710, CONF:10054 ) such that it
    1. SHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.21.1.10"
  2. SHALL conform to General Header Constraints template (templateId: 2.16.840.1.113883.10.20.22.1.1) (CONF:9970)
  3. SHALL contain exactly one [1..1] recordTarget (CONF:7643)
    1. This recordTarget SHALL contain exactly one [1..1] patientRole
      1. This patientRole SHALL contain exactly one [1..1] id (CONF:7643)
  4. SHALL contain exactly one [1..1] author (CONF:7640)
    1. This author SHALL contain exactly one [1..1] assignedAuthor (CONF:7640)
      1. This assignedAuthor SHALL contain exactly one [1..1] addr (CONF:7641)
      2. This assignedAuthor SHALL contain exactly one [1..1] telecom (CONF:7642)
  5. SHALL contain exactly one [1..1] component
  6. SHALL contain exactly one [1..1] custodian (CONF:7645)
    1. This custodian SHALL contain exactly one [1..1] assignedCustodian (CONF:7645)
      1. This assignedCustodian SHALL contain exactly one [1..1] representedCustodianOrganization (CONF:7645)
        1. This representedCustodianOrganization SHALL contain exactly one [1..1] addr (CONF:7651)
        2. This representedCustodianOrganization SHALL contain exactly one [1..1] id (CONF:7648)
        3. This representedCustodianOrganization SHALL contain exactly one [1..1] name (CONF:7649)
        4. This representedCustodianOrganization SHALL contain exactly one [1..1] telecom (CONF:7650)

Unstructured Document Example

<?xml version="1.0" encoding="UTF-8"?>
<ClinicalDocument xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" xmlns="urn:hl7-org:v3" xsi:schemaLocation="urn:hl7-org:v3 CDA.xsd">
  <typeId root="2.16.840.1.113883.1.3"/>
  <id root="MDHT" extension="451462111"/>
  <code code="1602155850"/>
  <title>TEXT FOR TITLE</title>
  <effectiveTime/>
  <confidentialityCode code="1409619219"/>
  <setId root="MDHT" extension="2df40cd2-6e68-4a46-a530-b9688b28e2e4"/>
  <versionNumber value="1"/>
  <recordTarget>
    <patientRole>
      <id root="MDHT" extension="1872502613"/>
    </patientRole>
  </recordTarget>
  <author>
    <time/>
    <assignedAuthor>
      <id root="MDHT" extension="331795042"/>
      <addr/>
      <telecom/>
    </assignedAuthor>
  </author>
  <custodian>
    <assignedCustodian>
      <representedCustodianOrganization/>
    </assignedCustodian>
  </custodian>
  <component/>
</ClinicalDocument>