Body

Editing tips and notes

1 CDA Overview

(content on separate page)

2 Introduction to CDA Technical Artifacts

(content on separate page)

3 CDA Document Exchange in HL7 Messages

(content on separate page)

4 CDA Templating

(content on separate page)

5 CDA R-MIM

(remaining content on separate page)

5.1 Header

(content on separate page)

5.2 Body

5.2.1 Body Choice

The CDA body choice can be either a document body in a format other than XML, or the CDA structured body. Every CDA document has exactly one body, associated with the ClinicalDocument class through the component relationship.

5.2.1.1 component

The component class relates the ClinicalDocument header to the body choice; NonXMLBody or StructuredBody.

component.typeCode

The component.typeCode is fixed to "COMP", which indicates that the body is a component part of the StructuredDocument.

Table X: Fixed component.typeCode

Code	Display Name
COMP	has component
Code System: ActRelationshipType (HL7) Code System OID: 2.16.840.1.113883.5.1002

component.contextConductionInd

The component.contextConductionInd indicator is fixed to "true". Ancestor elements () which propagate, will conduct through this component class to the associated child element.

5.2.1.2 NonXMLBody

The NonXMLBody class represents a document body that is in some format other than XML. The NonXMLBody can be used to represent scanned document(s) or legacy document(s) needing to be transferred using the CDA standard.

Table X: NonXMLBody Attributes

Attribute Name	Data Type	Cardinality	Code Binding	Binding Type
classCode	CS	[0..1]	DOCCLIN	Fixed
moodCode	CS	[0..1]	EVN	Fixed
text	ED	[1..1]
confidentialityCode	SET<CE>	[0..*]	V:x_BasicConfidentialityKind	Open
languageCode	CE	[0..1]	D:HumanLanguage	Closed

NonXMLBody.typeCode

The ClinicalDocument.classCode in the CDA model is fixed to "DOCCLIN".

Table X: Fixed NonXMLBody.classCode

Code	Display Name
DOCBODY	document body
Code System: ActClass (HL7) Code System OID: 2.16.840.1.113883.5.6

NonXMLBody.moodCode

The NonXMLBody.moodCode is fixed to "EVN" or event mood to indicate that this is documentation of a past service.

Table X: Fixed NonXMLBody.moodCode

Code	Display Name
EVN	event
Code System: ActMood (HL7) Code System OID: 2.16.840.1.113883.5.1001

NonXMLBody.text

NonXMLBody.text is used to reference data that is stored externally to the CDA document or to encode the data directly inline. Rendering a referenced non-XML body requires a software tool that recognizes the particular MIME media type for this type of body.

NonXMLBody.confidentialityCode

Confidentiality is a required contextual component of CDA, where the value expressed in the ClinicalDocument can be overridden for the NonXMLBody of the document.

Table X: Value set for NonXMLBody.confidentialityCode

X_BasicConfidentialityKind [2.16.840.1.113883.1.11.16926] (OPEN)
Code	Display Name		Code	Display Name
N	normal		R	restricted
V	very restricted
Code System: Confidentiality (HL7) Code System OID: 2.16.840.1.113883.5.25

* The codeSystem value is included here because confidentialityCode is of type CE, and therefore must carry both a code and a codeSystem.

NonXMLBody.languageCode

Specifies the human language of character data (whether they be in contents or attribute values). The values of the attribute are language identifiers as defined by the IETF (Internet Engineering Task Force) RFC 3066 for the Identification of Languages, ed. H. Alvestrand. 1995, which obsoletes RFC 1766. The HL7 code system for these values is "2.16.840.1.113883.6.121". Language is a contextual component of CDA, where the value expressed in the header holds true for the entire document, unless overridden by the NonXMLBody (as further described in CDA Context).

5.2.1.3 StructuredBody

The StructuredBody class represents a CDA document body that is comprised of one or more document sections.

Table X: StructuredBody Attributes

Attribute Name	Data Type	Cardinality	Code Binding	Binding Type
classCode	CS	[0..1]	DOCCLIN	Fixed
moodCode	CS	[0..1]	EVN	Fixed
confidentialityCode	SET<CE>	[0..*]	V:x_BasicConfidentialityKind	Open
languageCode	CE	[0..1]	D:HumanLanguage	Closed

StructuredBody.classCode

Table X: Fixed StructuredBody.classCode

Code	Display Name
DOCBODY	document body
Code System: ActClass (HL7) Code System OID: 2.16.840.1.113883.5.6

StructuredBody.moodCode

Table X: Fixed StructuredBody.moodCode

Code	Display Name
EVN	event
Code System: ActMood (HL7) Code System OID: 2.16.840.1.113883.5.1001

StructuredBody.confidentialityCode

Table X: Value set for StructuredBody.confidentialityCode

X_BasicConfidentialityKind [2.16.840.1.113883.1.11.16926] (OPEN)
Code	Display Name		Code	Display Name
N	normal		R	restricted
V	very restricted
Code System: Confidentiality (HL7) Code System OID: 2.16.840.1.113883.5.25

* The codeSystem value is included here because confidentialityCode is of type CE, and therefore must carry both a code and a codeSystem.

confidentialityCode.HumanLanguage

5.2.1.3.1 component

A component class is used to relate the body choice (NonXMLBody, StructuredBody) to it's component Section(s). See component for its attributes.

5.2.2 Section Attributes

Document sections can nest, can override context propagated from the header (see CDA Context, and can contain narrative and CDA entries.

Table X: Section Attributes

Attribute Name	Data Type	Cardinality	Code Binding	Binding Type
classCode	CS	[0..1]	DOCSECT	Fixed
moodCode	CS	[0..1]	EVN	Fixed
id	ii	[0..1]
code	CE	[1..1]	D:DocumentSectionType	Open
title	ST	[0..1]
text	ED.STRUCTURED_TEXT	[0..1]
confidentialityCode	SET<CE>	[0..*]	V:x_BasicConfidentialityKind	Open
languageCode	CE	[0..1]	D:HumanLanguage	Closed

An XML attribute "ID" of type XML ID, is added to Section within the CDA Schema. This attribute serves as the target of a reference (see reference). All values of attributes of type XML ID must be unique within the document (per the W3C XML specification).

Section.classCode

Table X: Fixed Section.classCode

Code	Display Name
DOCSECT	document section
Code System: ActClass (HL7) Code System OID: 2.16.840.1.113883.5.6

Section.moodCode

Table X: Fixed Section.moodCode

Code	Display Name
EVN	event
Code System: ActMood (HL7) Code System OID: 2.16.840.1.113883.5.1001

Section.id

The unique instance identifier of a particular document section.

Section.code

The code specifying the particular kind of section (e.g. Chief Complaint, Review of Systems, Assessment). The value set is drawn from LOINC, and has a CWE coding strength.

Section.title

Represents the label of a section. If valued, it is to be rendered as part of the narrative content of the clinical document body.

Section.text

Used to store narrative to be rendered. Also referred to as the CDA Narrative Block. See Section Narrative Block for details.

Section.confidentialityCode

A value for Section.confidentialityCode overrides the value propagated from StructuredBody. See CDA Context for more details.

Table X: Value set for Section.confidentialityCode

X_BasicConfidentialityKind [2.16.840.1.113883.1.11.16926] (OPEN)
Code	Display Name		Code	Display Name
N	normal		R	restricted
V	very restricted
Code System: Confidentiality (HL7) Code System OID: 2.16.840.1.113883.5.25

* The codeSystem value is included here because confidentialityCode is of type CE, and therefore must carry both a code and a codeSystem.

Section.languageCode

Specifies the human language of character data (whether they be in contents or attribute values). The values of the attribute are language identifiers as defined by the IETF (Internet Engineering Task Force) RFC 3066: Tags for the Identification of Languages, ed. H. Alvestrand. 1995 , which obsoletes RFC 1766. The HL7 code system for these values is "2.16.840.1.113883.6.121".

A value for Section.languageCode overrides the value propagated from StructuredBody. See CDA Context for more details.

5.2.3 Section Participants

5.2.3.1 author

The author participant (described above, see author), can be ascribed to a CDA section, where it overrides the value(s) propagated from the CDA header.

5.2.3.2 informant

The informant participant (described above, see informant), can be ascribed to a CDA section where it overrides the value(s) propagated from the CDA header.

5.2.3.3 subject

The subject participant represents the primary target of the entries recorded in the document. Most of the time the subject is the same as the recordTarget (see recordTarget), but need not be, for instance when the subject is a fetus observed in an obstetrical ultrasound.

The subject participant can be ascribed to a CDA section or a CDA entry. It propagates to nested components, unless overridden. The subject of a document is presumed to be the patient.

A subject is a person playing one of several possible roles (RelatedSubject class). The entity playing the role is a person (SubjectPerson class).

Table X: informant

Attribute Name	Data Type	Cardinality	Code Binding	Binding Type
typeCode	CS	[0..1]	INF	Fixed
contextControlCode	CS	[0..1]	OP	Fixed

subject.typeCode

Table X: Fixed subject.typeCode

Code	Display Name
SBJ	subject
Code System: ParticipationType (HL7) Code System OID: 2.16.840.1.113883.5.90

subject.contextControlCode

Table X: Fixed subject.contextControlCode

Code	Display Name
OP	overriding, propagating
Code System: ContextControl (HL7) Code System OID: 2.16.840.1.113883.5.1057

Table X: Value set for RelatedSubject.classCode

v:x_DocumentSubject [2.16.840.1.113883.1.11.19368] (CLOSED)
Code	Display Name		Code	Display Name
PAT (Default)	patient		PRS	personal relationship
Code System: RoleClass (HL7) Code System OID: 2.16.840.1.113883.5.110

Table X: Fixed SubjectPerson.classCode

Code	Display Name
PSN	person
Code System: EntityClass (HL7) Code System OID: 2.16.840.1.113883.5.41

Table X: Fixed SubjectPerson.determinerCode

Code	Display Name
INSTANCE	specific
Code System: EntityDeterminer (HL7) Code System OID: 2.16.840.1.113883.5.30

5.2.4 Section Relationships

5.2.4.1 component

The "component" Act Relationship is used to nest a Section within a Section. Context propagates to nested sections (see CDA Context).

Table X: Fixed component.typeCode

Code	Display Name
COMP	has component
Code System: ActRelationshipType (HL7) Code System OID: 2.16.840.1.113883.5.1002

5.2.4.2 entry

The relationship between a section and its entries is encoded in the intervening "entry" Act Relationship.

NOTE: See Referencing in and out of the narrative block for a discussion of referencing in and out of a section's narrative block.

The narrative of each Section, together with the multimedia content referenced in the narrative, comprises the complete authenticated content of the Section. This multimedia content consists of ObservationMedia and RegionOfInterest entries referenced by tags in the Section.text. This is the only case where the entries contain authenticated content that must be rendered with the narrative.

In terms of the relationship between a section and its entries, CDA defines a default general case, and a more specific case that can be used when applicable.

The entry relationship is defaulted to "COMP" (component), for the general case where the only assertion is that the related entries are contained within the source section and no other semantics are implied. In this case, the narrative is the original authenticated content. The CDA entries are created by various techniques (e.g., natural language processing, a human coder, a structured data entry tool that outputs both entries and a text report). The method of entry creation may be indicated by the entry participants (e.g., by identifying the algorithm or person that generated them). Relationships between various entries (such as two Observations or an Observation and an ObservationMedia) are encoded using the relationship types defined in entryRelationship.

A section may also have no narrative content in the case where the entries represent information that is not part of the clinical content of the document. A report may embed information referencing evidence data, reagents, calibration or other information that may be used for later processing but is not part of the clinical content. Such entries are also linked to the Section with ActRelationships possessing typeCode="COMP".

The entry relationship "DRIV" (is derived from) can be used in the special case where the narrative is fully derived from CDA Entries. When a report consisting entirely of structured entries is transformed into CDA, the encoding application must ensure that the authenticated content (narrative plus multimedia) is a faithful and complete rendering of the clinical content of the structured source data. This ensures that the narrative plus multimedia represents, as in all CDA documents, the complete authenticated content of the Section. In this case, narrative plus multimedia does not contain any clinical content that is not present in the Entries. An example of this case is a DICOM Structured Reporting document of obstetrical measurements made by ultrasound, rendered into a tabular report by a program converting it to CDA narrative block. If the typeCode of the ActRelationship linking these Entries to the Section was "DRIV", it would indicate to a receiving application: 1) the source of the narrative block is the Entries; 2) the contents of the two are equivalent.

The entries sourced from a Section may have a mix of ActRelationship typeCodes. In such a case, the union of the targets with a "DRIV" relationship are those used to generate the narrative block, and are those that, taken in total, are equivalent to the narrative block. Additional entries with "COMP" relationships are contained within the same section, with no implied semantics.

Table X: Value set for entry.typeCode

V:x_ActRelationshipEntry [2.16.840.1.113883.1.11.19446] (CLOSED)
Code	Display Name		Code	Display Name
COMP (Default)	has component		DRIV	is derived from
Code System: ActRelationshipType (HL7) Code System OID: 2.16.840.1.113883.5.1002

5.2.5 Section Narrative Block

The Section.text field is used to store narrative to be rendered, as described above in CDA Conformance, and is therefore referred to as the CDA Narrative Block.

The CDA Narrative Block schema can be found here.

The content model of the CDA Narrative Block schema is specially hand crafted to meet the requirements outlined above (see Human Readability and Rendering CDA Documents). The schema is registered as a MIME type (text/x-hl7-text+xml), which is the fixed media type for Section.text. Components of the schema are described in the sections that follow.

5.2.5.1 <content>

The CDA <content> element is used to wrap a string of text so that it can be explicitly referenced, or so that it can suggest rendering characteristics. The <content> element can nest recursively, which enables wrapping a string of plain text down to as small a chunk as desired.

The <content> element contains an optional identifier, that can serve as the target of a reference. All values of attributes of type XML ID must be unique within the document (per the W3C XML specification). The originalText component of a RIM attribute present in any CDA entry can make explicit reference to the identifier, thereby indicating the original text associated with the attribute in the CDA entry.

Note: The <content> element is not the only element which can serve as the target of a reference. All narrative elements (including <text>) contain an ID element which can be referenced by the originalText component in a CDA entry. <content> is simply a tool which can be used to reference only a portion of a longer string contained in another narrative element.

Example X

<section>
   <code code="10153-2" 
    codeSystem="2.16.840.1.113883.6.1" 
    codeSystemName="LOINC"/>
   <title>Past Medical History</title>
   <text>
    There is a history of <content ID="a1">Asthma</content>
   </text>
   <entry>
      <observation classCode="OBS" moodCode="EVN">
         <code code="195967001" 
          codeSystem="2.16.840.1.113883.6.96" 
          codeSystemName="SNOMED CT" 
          displayName="Asthma">
            <originalText>
               <reference value="#a1"/>
            </originalText>
         </code>
         <statusCode code="completed"/>
      </observation>
   </entry>
</section>

There is no requirement that CDA entries must reference into the CDA Narrative Block. The referencing mechanism can be used where it is important to represent the original text component of a coded CDA entry.

The <content> element contains an optional "revised" attribute that can be valued with "insert" or "delete", which can be used to indicate narrative changes from the last version of a CDA document. The attribute is limited to a single generation, in that it only reflects the changes from the preceding version of a document. If applied, it needs to be used in conjunction with standard CDA revision tracking. Changes to a CDA document that has been released for patient care still require a formal versioning and revision, and the revised document can optionally carry the "revised" attribute to show the delta in the narrative. Receivers are required to interpret the "revised" attribute when rendering by visually distinguishing or suppressing deleted narrative.

5.2.5.2 <linkHtml>

The CDA <linkHtml> is a generic referencing mechanism, similar, but not identical, to the HTML anchor tag. It can be used to reference identifiers that are either internal or external to the document.

Multimedia that is integral to a document, and part of the attestable content of the document requires the use of the ObservationMedia CDA entry, which is referenced by the <renderMultiMedia> element (see <renderMultiMedia>). Multimedia that is simply referenced by the document and not an integral part of the document can use <linkHtml>.

The source of a link uses the linkHtml.href attribute. The target of an internal reference is an identifier of type XML ID, which can exist on other elements in the same or a different narrative block, or XML ID attributes that have been added to the <section>, <ObservationMedia>, or <renderMultiMedia> elements of the CDA Schema. The linkHtml.name attribute is deprecated, because attributes of type XML ID provide an alternative and more consistent target for referencing. Following the conventions of HTML, an internal link is prefaced with the pound sign, as shown in the following example.

Example X

<section ID="SECT001">
   <code code="10164-2" codeSystem="2.16.840.1.113883.6.1" 
    codeSystemName="LOINC"/>
   <title>History of Present Illness</title>
   <text>Mr. Smith is a 57 year old male presenting with 
    chest pain. He sustained a myocardial infarction 3 years 
    ago, ...
   </text>
</section>

 ...

<section ID="SECT003">
   <code code="10153-2" codeSystem="2.16.840.1.113883.6.1" 
    codeSystemName="LOINC"/>
   <title>Past Medical History</title>
   <text>History of coronary artery disease, as noted
    <linkHtml href="#SECT001">above</linkHtml>.</text>
</section>

CDA links do not convey shareable meaning. Shareable semantics are only achieved by the inclusion of CDA entries and their associated formalized relationships. There is no requirement that a receiver render an internal or external link, or the target of an external link.

5.2.5.3 <sub> and <sup>

The CDA <sub> and <sup> elements are used to indicate subscripts and superscripts, respectively.

Receivers are required to interpret these elements when rendering by visually distinguishing subscripted and superscripted characters.

5.2.5.4 <br>

The CDA <br/> element is used to indicate a hard line break. It differs from the CDA <paragraph> element in that the <br/> element has no content. Receivers are required to interpret this element when rendering so as to represent a line break.

5.2.5.5 <footnote> and <footnoteRef>

The CDA <footnote> element is used to indicate a footnote. The element contains the footnote, inline with the flow of text to which it is applied.

The <footnoteRef> element can reference an existing footnote in the same or different CDA Narrative Block of the same document. It can be used when the same footnote is being used multiple times. The value of the footnoteRef.IDREF must be an footnote.ID value in the same document.

Receivers are required to interpret these elements when rendering by visually distinguishing footnoted text. The exact rendition is at the discretion of the recipient, and might include a mark at the location of the footnote with a hyperlink to the footnoted text, a simple demarcation (such as "This is the text [this is the footnote] that is being footnoted"), etc.

5.2.5.6 <renderMultiMedia>

The CDA <renderMultiMedia> element references external multimedia that is integral to a document, and part of the attestable content of the document, and serves to show where the referenced multimedia is to be rendered.

The <renderMultiMedia> element has an optional <caption>, and contains a required referencedObject attribute (of type XML IDREFS), the values of which must equal the XML ID value(s) of ObservationMedia or RegionOfInterest CDA entries within the same document.

Example X

<section>
   <code code="8709-8" codeSystem="2.16.840.1.113883.6.1" 
    codeSystemName="LOINC"/>
   <title>Skin exam</title>
   <text>Erythematous rash, palmar surface, left index 
    finger.<renderMultiMedia referencedObject="MM1"/>
   </text>
   <entry>
      <observationMedia classCode="OBS" moodCode="EVN" ID="MM1">
         <id root="2.16.840.1.113883.19.2.1"/>
         <value xsi:type="ED" mediaType="image/jpeg">
            <reference value="left_hand_image.jpeg"/>
         </value>
      </observationMedia>
   </entry>
</section>

Multimedia that is simply referenced by the document and not an integral part of the document must use <linkHtml>.

The expected behavior is that the referenced multimedia should be rendered or referenced at the point of reference. Where a caption is present, it must also be rendered. <renderMultiMedia> can either reference a single ObservationMedia, or one or more RegionOfInterest. If <renderMultiMedia> references a single ObservationMedia, that ObservationMedia should be rendered or referenced at the point of reference. If <renderMultiMedia> references one or more RegionOfInterest, all RegionOfInterests should be rendered or referenced at the point of reference, atop the multimedia they are regions of. If <renderMultiMedia> references more than one RegionOfInterest, each RegionOfInterest must be a region on the same multimedia.

5.2.5.7 <paragraph>

A CDA <paragraph> is similar to the HTML paragraph, which allows blocks of narrative to be broken up into logically consistent structures. A CDA <paragraph> element contains an optional caption, which if present must come first before any other character data.

5.2.5.8 <list>

A CDA <list> is similar to the HTML list. A CDA <list> has an optional caption, and contains one or more <item> elements. A CDA <item> element contains an optional caption, which if present must come first before any other character data. The required listType attribute specifies whether the <list> is ordered or unordered (with unordered being the default). Unordered lists are typically rendered with bullets, whereas ordered lists are typically rendered with numbers, although this is not a requirement.

5.2.5.9 <table>

The CDA <table> is similar to the HTML table. The table markup is for presentation purposes only and, unlike a database table, does not possess meaningful field names. Remember to access the discrete data conveyed in a CDA document, process the RIM models contained within the <entry> element.

CDA modifies the strict XHTML table model by removing formatting tags and by setting the content model of cells to be similar to the contents of other elements in the CDA Narrative Block. A notable enhancement to the CDA R2.1 standard is the support of the <table> element within <td> & <th> elements. The support of tables within tables was not supported in CDA R2.0, but has been added for those implementation requiring complex table layouts.

The table.border, table.cellspacing, and table.cellpadding attributes are deprecated, because the styleCode attribute (see styleCode attribute) provides a more consistent way for senders to suggest rendering characteristics.

5.2.5.10 <caption>

The CDA <caption> is a label for a paragraph, list, list item, table, or table cell. It can also be used within the <renderMultiMedia> element to indicate a label for referenced ObservationMedia and RegionOfInterest entries. A <caption> contains plain text and may contain links and footnotes.

5.2.5.11 styleCode attribute

The styleCode attribute is used within the CDA Narrative Block to give the instance author the ability to suggest rendering characteristics of the nested character data. Receivers are not required to render documents using the style hints provided and can present stylized text in accordance with their local style conventions.

The value set is drawn from the HL7 styleType vocabulary domain, and has a CWE coding strength.

Table X: Value set for styleCode (CWE)

Code	Definition
Font style (Defines font rendering characteristics.)
Bold	Render with a bold font.
Underline	Render with an underlines font.
Italics	Render italicized.
Emphasis	Render with some type of emphasis.
Table rule style (Defines table cell rendering characteristics.
Lrule	Render cell with left-sided rule.
Rrule	Render cell with right-sided rule.
Toprule	Render cell with rule on top.
Botrule	Render cell with rule on bottom.
Ordered list style (Defines rendering characteristics for ordered lists.)
Arabic	List is ordered using Arabic numerals: 1, 2, 3.
LittleRoman	List is ordered using little Roman numerals: i, ii, iii.
BigRoman	List is ordered using big Roman numerals: I, II, III.
LittleAlpha	List is ordered using little alpha characters: a, b, c.
BigAlpha	List is ordered using big alpha characters: A, B, C.
Unordered list style (Defines rendering characteristics for unordered lists.)
Disc	List bullets are simple solid discs.
Circle	List bullets are hollow discs.
Square	List bullets are solid squares.

Local extensions to the styleType vocabulary domain must follow the following convention: [x][A-Za-z][A-Za-z0-9]* (first character is "x", second character is an upper or lower case A-Z, remaining characters are any combination of upper and lower case letters or numbers).

The styleCode attribute can contain multiple values, separated by white space. Where an element containing a styleCode attribute is nested within another element containing a styleCode attribute, the style effects are additive, as in the following example:

Example X

<section>
   <text><content styleCode="Bold">This is rendered bold, 
    <content styleCode="Italics">this is rendered bold and 
    italicized,</content> this is rendered bold. </content>
    <content styleCode="Bold Italics">This is also rendered 
    bold and italicized.</content>
   </text>
</section>

5.2.5.12 Referencing in and out of the narrative block

NOTE: See entry for a discussion of the relationships between a section and its contained entries.

To summarize the mechanisms for referencing in and out of the CDA Narrative Block:

CDA entries can point in to the <content> element of the CDA Narrative Block (see <content>).

The <linkHtml> element of the CDA Narrative Block can reference targets that are either internal or external to the document (see <linkHtml>).

The <footnoteRef> element of the CDA Narrative Block can reference a <footnote> element in the same or different CDA Narrative Block of the same document (see <footnote> and <footnoteRef>).

The <renderMultiMedia> element of the CDA Narrative Block can point out to CDA ObservationMedia and RegionOfInterest entries of the same document (see <renderMultiMedia>).

5.2.6 Entry Acts

CDA entries represent the structured computer-processable components within a document section. Each section can contain zero to many entries.

Clinical documents contain a wide breadth of content, requiring much of the RIM to enable a full and complete encoding. The current set of CDA entries have been developed in response to identified requirements and scenarios that are in CDA's scope. Rather than creating specific entries for each scenario, similar requirements are merged to create broader entries, which can then be constrained within a particular realm or implementation. This approach is consistent with the approach taken by CEN, DICOM, and OpenEHR.

The model for CDA entries is derived from the shared HL7 Clinical Statement model, which is a collaborative project between several committees striving to provide a consistent representation of clinical observations and acts across various V3 specifications.

5.2.6.1 Act

A derivative of the RIM Act class, to be used when the other classes present in the CDA Clinical Statement choice pattern are not appropriate.

Table X: Act Attributes

RIM Attribute(s)	Data Type	Cardinality	Code Binding	Binding Type
classCode	CS	[1..1]	V:x_ActClassDocumentEntryAct	Closed
moodCode	CS	[1..1]	V:x_DocumentActMood	Closed
id	SET <II>	[0..*]
code	CD	[1..1]	D:ActCode	Open
actonNegationInd	BL	[0..1]
negationInd (Deprecated)	BL	[0..1]
text	ED	[0..1]
statusCode	CS	[0..1]	V:ActStatus	Closed
effectiveTime	IVL<TS>	[0..1]
activityTime	GTS	[0..1]
availabilityTime	TS	[0..1]
priorityCode	CE	[0..1]	D:ActPriority	Open
confidentialityCode	SET<CE>	[0..*]	D:Confidentiality	Open
uncertaintyCode	CE	[0..1]	D:ActUncertainty	Open
reasonCode	SET<CE>	[0..*]	D:ActReason	Open
languageCode	CE	[0..1]	D:HumanLanguage	Closed

NOTE: Act Negation

Act.actionNegationInd, indicates that the Act statement is a negation of the Act in Event mood as described by the descriptive attributes. For Act, actionNegationInd indicates that the act itself did not occur. I.e. no act took place. Some properties such as Act.id, Act.moodCode, and the participations are not affected. These properties always have the same meaning: i.e., the author remains the author of the negative Act. An act statement with negationInd is still a statement about the specific fact described by the Act.

Act.negationInd, is deprecated in RIM 2.35, and CDA R2.1 retains it for backwards compatibility. CDA R2.1 compliant implementation guides should use actionNegationInd moving forward.

NOTE: Act Time References

Two new time references have been included in CDA Acts, in addition to effectiveTime, activityTime and availabilityTime are now available for CDA documents and CDA IGs.

Act.effectiveTime is used to indicate the clinically or operationally relevant time of a procedure, exclusive of administrative activity.

Act.activityTime is a time expression specifying when an act occurs, inclusive of administrative time E.g. times of component actions, such as preparation and clean-up. Depending on the mood code used, it represents the time the act occurred, is supposed to occur, is scheduled to occur, etc.

Act.availabilityTime is the point in time at which information about an act instance (regardless of mood) first became available to a system. The availabilityTime is metadata describing the recording of, not the act itself.

Table X: Value set for Act.classCode

x_ActClassDocumentEntryAct [2.16.840.1.113883.1.11.19599] (CLOSED)
Code	Display Name		Code	Display Name
ACT	Act		ACCM	accommodation
CONS	consent		CTTEVENT	clinical trial timepoint event
INC	incident		INFRM	inform
PCPR	care provision		REG	registration
SPCTRT	specimen treatment		TRNS	transportation
ACSN	accession		CONTREG	container registration
DISPACT	disciplinary action		EXPOS	exposure
AEXPOS	acquisition exposure		TEXPOS	transmission exposure
LIST	working list		MPROT	monitoring program
REV	review		STORE	storage
TRFR	transfer
Code System: ActClass (HL7) Code System OID: 2.16.840.1.113883.5.6

Table X: Value set for Act.moodCode

V:x_DocumentActMood [2.16.840.1.113883.1.11.19458] (CLOSED)
Code	Display Name		Code	Display Name
APT	appointment		ARQ	appointment request
EVN	event		DEF	definition
RQO	request		INT	intent
PRMS	promise		PRP	proposal
RSK	risk
Code System: ActMood (HL7) Code System OID: 2.16.840.1.113883.5.1001

5.2.6.2 Encounter

A derivative of the RIM PatientEncounter class, used to represent related encounters, such as follow-up visits or referenced past encounters.

NOTE: The EncompassingEncounter class in the CDA Header (see Header Relationships) represents the setting of the clinical encounter during which the documented act occurred. The Encounter class in the CDA Body is used to represent other related encounters.

Table X: Encounter Attributes

RIM Attribute(s)	Data Type	Cardinality	Code Binding	Binding Type
classCode	CS	[1..1]	ENC	Fixed
moodCode	CS	[1..1]	V:x_DocumentEncounterMood	Closed
id	SET <II>	[0..*]
code	CD	[1..1]	D:ActCode	Open
actonNegationInd	BL	[0..1]
negationInd (Deprecated)	BL	[0..1]
text	ED	[0..1]
statusCode	CS	[0..1]	V:ActStatus	Closed
effectiveTime	IVL<TS>	[0..1]
activityTime	GTS	[0..1]
availabilityTime	TS	[0..1]
priorityCode	CE	[0..1]	D:ActPriority	Open
confidentialityCode	SET<CE>	[0..*]	D:Confidentiality	Open
uncertaintyCode	CE	[0..1]	D:ActUncertainty	Open
reasonCode	SET<CE>	[0..*]	D:ActReason	Open
languageCode	CE	[0..1]	D:HumanLanguage	Closed
admissionReferralSourceCode	<CE>	[0..1]	D:EncounterReferralSource	Open
lengthOfStayQuantity	<PQ>.TIME	[0..1]
dischargeDispositionCode	<CE>	[0..1]	D:EncounterDischargeDisposition	Open
preAdmitTestInd	BL	[0..1]
specialCourtesiesCode	SET<CE>	[0..*]	D:EncounterSpecialCourtesy	Open
specialArrangementCode	SET<CE>	[0..*]	D:SpecialArrangement	Open

Table X: Fixed Encounter.classCode

Code	Display Name
ENC (Fixed)	encounter
Code System: ActClass (HL7) Code System OID: 2.16.840.1.113883.5.6

Table X: Value set for Encounter.moodCode

V:x_DocumentEncounterMood [2.16.840.1.113883.1.11.19459] (CLOSED)
Code	Display Name		Code	Display Name
APT	appointment		ARQ	appointment request
EVN	event		DEF	definition
RQO	request		INT	intent
PRMS	promise		PRP	proposal
Code System: ActMood (HL7) Code System OID: 2.16.840.1.113883.5.1001

5.2.6.3 Observation

A derivative of the Observation(§ RIM 5.36) class, it is intended to result in new information about a subject. The main difference between Observations and other Acts is that Observations have a value attribute. The code attribute of Observation and the value attribute of Observation must be considered in combination to determine the semantics of the observation.

Table X: Observation Attributes

RIM Attribute(s)	Data Type	Cardinality	Code Binding	Binding Type
classCode	CS	[1..1]	V:ActClassObservation	Closed
moodCode	CS	[1..1]	V:x_ActMoodDocumentObservation	Closed
id	SET <II>	[0..*]
code	CD	[1..1]	D:ObservationType	Open
actonNegationInd	BL	[0..1]
negationInd (Deprecated)	BL	[0..1]
derivationExpr	ST	[0..1]
title	ED	[0..1]
text	ED	[0..1]
statusCode	CS	[0..1]	V:ActStatus	Closed
effectiveTime	IVL<TS>	[0..1]
activityTime	GTS	[0..1]
availabilityTime	TS	[0..1]
priorityCode	CE	[0..1]	D:ActPriority	Open
confidentialityCode	SET<CE>	[0..*]	D:Confidentiality	Open
repeatNumber	IVL<INT>	[0..1]
uncertaintyCode	CE	[0..1]	D:ActUncertainty	Open
languageCode	CE	[0..1]	D:HumanLanguage	Closed
isCriterionInd	BL	[0..1]
value	SET<ANY>	[0..*]	D:ObservationValue	Open
valueNegationInd	BL	[0..1]
interpretationCode	SET<CE>	[0..*]	D:ObservationInterpretation	Open
methodCode	SET<CE>	[0..*]	D:ObservationMethod	Open
targetSiteCode	SET<CD>	[0..*]	D:ActSite	Open

NOTE: Observation Negation

Observation.actionNegationInd, indicates that the Act statement is a negation of the Act in Event mood as described by the descriptive attributes. For Observations, actionNegationInd indicates that the act itself did not occur. I.e. no observation took place. To indicate that an observation did occur but the finding was negative, use Observation.valueNegationInd.

Observation.valueNegationInd, indicates that when the observation event occurred, the finding communicated by the value attribute was NOT found. So, when we want to indicate the patient does not have asthma, we can negate a finding of asthma, using this indicator. Note: This attribute should only be used when the terminology used for Observation.value is not itself capable of expressing negated findings. (E.g. ICD9).

Observation.negationInd, is deprecated in RIM 2.35, and CDA R2.1 retains it for backwards compatibility. It was deprecated as the type of negation required knowledge of template documentation to determine the actual type of negation I.e. value or action negation. CDA R2.1 compliant implementation guides should use actionNegationInd or valueNegationInd moving forward.

NOTE: Time References

Two new time references have been included in CDA Observation, in addition to effectiveTime, activityTime and availabilityTime are now available for CDA documents and CDA IGs.

Observation.effectiveTime is used to indicate the clinically or operationally relevant time of an observation, exclusive of administrative activity. For example, in a Blood Gas Analysis (BGA), a result might not be available for several minutes after the specimen was taken. The effectiveTime is the time the specimen was taken, the availabilityTime would be the time the result was available for review. For clinical Observations, the effectiveTime represents the time at which the observation holds (is effective) for the patient. In V2 the effectiveTime was known as the biologically relevant time.

Observation.activityTime is a time expression specifying when an Observation occurs, inclusive of administrative time E.g. times of component actions, such as preparation and clean-up. Depending on the mood code used, it represents the time the observation occurred, is supposed to occur, is scheduled to occur, etc. When an observation of a prior symptom is made, the activityTime describes the time the observation is made, as opposed to effectiveTime which is the time the symptom is reported to have occurred. Thus the activityTime may be entirely different from the effectiveTime for the same observation instance.

Observation.availabilityTime is the point in time at which information about an observation instance (regardless of mood) first became available to a system. The availabilityTime is metadata describing the recording of, not the Observation itself. For CDA documents, the availabilityTime reported for its contents, would represent the time the observation first became available to a source system generating the CDA document.

Table X: Value set for Observation.classCode

V:ActClassObservation [2.16.840.1.113883.1.11.11529] (CLOSED)
Code	Display Name		Code	Display Name
OBS (Default)	Observation		ALRT	detected issue
BATTERY	battery		CLNTRL	clinical trial
CONC	concern		COND	Condition
CASE	public health case		OUTB	outbreak
DGIMG	diagnostic image		GEN	genomic observation
DETPOL	determinant peptide		EXP	expression level
LOC	locus		PHN	phenotype
POL	polypeptide		SEQ	bio sequence
SEQVAR	bio sequence variation		INVSTG	investigation
OBSSER	observation series		OBSCOR	correlated observation sequences
POS	position		POSACC	position accuracy
POSCOORD	position coordinate		SPCOBS	specimen observation
VERIF	Verification		ROIBND	bounded ROI
ROIOVL	overlay ROI		LLD (Deprecated)	left lateral decubitus
PRN (Deprecated)	prone		RLD (Deprecated)	right lateral decubitus
SFWL (Deprecated)	Semi-Fowler's		SIT (Deprecated)	sitting
STN (Deprecated)	standing		SUP (Deprecated)	supine
RTRD (Deprecated)	reverse trendelenburg		TRD (Deprecated)	trendelenburg
CNOD (Deprecated)	Condition Node
Code System: ActClass (HL7) Code System OID: 2.16.840.1.113883.5.6

Table X: Value set for Observation.moodCode

V:x_ActMoodDocumentObservation [2.16.840.1.113883.1.11.19644] (CLOSED)
Code	Display Name		Code	Display Name
APT	appointment		ARQ	appointment request
EVN	event		DEF	definition
GOL	goal		INT	intent
PRMS	promise		PRP	proposal
RSK	risk		RQO	request
Code System: ActMood (HL7) Code System OID: 2.16.840.1.113883.5.1001

Reference Range

An Observation can have zero to many referenceRange relationships, which relate an Observation to the ObservationRange class. Reference ranges are essentially descriptors of a class of result values assumed to be "normal", "abnormal", or "critical." Those can vary by sex, age, or any other criterion.

Table X: Fixed referenceRange.typeCode

Code	Display Name
REFV	has reference values
Code System: ActRelationshipType (HL7) Code System OID: 2.16.840.1.113883.5.1002

Observation Range

Table X: Value set for ObservationRange.classCode

V:ActClassObservation [2.16.840.1.113883.1.11.11529] (CLOSED)
Code	Display Name		Code	Display Name
OBS (Default)	Observation		ALRT	detected issue
BATTERY	battery		CLNTRL	clinical trial
CONC	concern		COND	Condition
CASE	public health case		OUTB	outbreak
DGIMG	diagnostic image		GEN	genomic observation
DETPOL	determinant peptide		EXP	expression level
LOC	locus		PHN	phenotype
POL	polypeptide		SEQ	bio sequence
SEQVAR	bio sequence variation		INVSTG	investigation
OBSSER	observation series		OBSCOR	correlated observation sequences
POS	position		POSACC	position accuracy
POSCOORD	position coordinate		SPCOBS	specimen observation
VERIF	Verification		ROIBND	bounded ROI
ROIOVL	overlay ROI		LLD (Deprecated)	left lateral decubitus
PRN (Deprecated)	prone		RLD (Deprecated)	right lateral decubitus
SFWL (Deprecated)	Semi-Fowler's		SIT (Deprecated)	sitting
STN (Deprecated)	standing		SUP (Deprecated)	supine
RTRD (Deprecated)	reverse trendelenburg		TRD (Deprecated)	trendelenburg
CNOD (Deprecated)	Condition Node
Code System: ActClass (HL7) Code System OID: 2.16.840.1.113883.5.6

Table X: Fixed ObservationRange.moodCode

Code	Display Name
EVN.CRT	event criterion
Code System: ActMood (HL7) Code System OID: 2.16.840.1.113883.5.1001

5.2.6.4 ObservationMedia

A derivative of the RIM Observation class that represents multimedia that is logically part of the current document. This class is only for multimedia that is logically part of the attested content of the document. Rendering a referenced ObservationMedia requires a software tool that recognizes the particular MIME media type. The distinction between ObservationMedia and ExternalObservation is that ObservationMedia entries are part of the attested content of the document whereas ExternalObservations are not. For instance, when a clinician draws a picture as part of a progress note, that picture is represented as a CDA ObservationMedia. If that clinician is also describing a finding seen on a chest-x-ray, the referenced chest-x-ray is represented as a CDA ExternalObservation.

Table X: ObservationMedia Attributes

RIM Attribute(s)	Data Type	Cardinality	Code Binding	Binding Type
classCode	CS	[1..1]	V:ActClassObservation	Closed
moodCode	CS	[1..1]	EVN	Fixed
id	SET <II>	[0..*]
languageCode	CE	[0..1]	D:HumanLanguage	Closed
value	ED	[1..1]

NOTE: XML ID Attribute added

An XML attribute "ID" of type XML ID, is added to ObservationMedia within the CDA Schema. This attribute serves as the target of a <renderMultiMedia> reference (see <renderMultiMedia>). All values of attributes of type XML ID must be unique within the document (per the W3C XML specification).

Table X: Value set for ObservationMedia.classCode

V:ActClassObservation [2.16.840.1.113883.1.11.11529] (CLOSED)
Code	Display Name		Code	Display Name
OBS (Default)	Observation		ALRT	detected issue
BATTERY	battery		CLNTRL	clinical trial
CONC	concern		COND	Condition
CASE	public health case		OUTB	outbreak
DGIMG	diagnostic image		GEN	genomic observation
DETPOL	determinant peptide		EXP	expression level
LOC	locus		PHN	phenotype
POL	polypeptide		SEQ	bio sequence
SEQVAR	bio sequence variation		INVSTG	investigation
OBSSER	observation series		OBSCOR	correlated observation sequences
POS	position		POSACC	position accuracy
POSCOORD	position coordinate		SPCOBS	specimen observation
VERIF	Verification		ROIBND	bounded ROI
ROIOVL	overlay ROI		LLD (Deprecated)	left lateral decubitus
PRN (Deprecated)	prone		RLD (Deprecated)	right lateral decubitus
SFWL (Deprecated)	Semi-Fowler's		SIT (Deprecated)	sitting
STN (Deprecated)	standing		SUP (Deprecated)	supine
RTRD (Deprecated)	reverse trendelenburg		TRD (Deprecated)	trendelenburg
CNOD (Deprecated)	Condition Node
Code System: ActClass (HL7) Code System OID: 2.16.840.1.113883.5.6

Table X: Fixed ObservationMedia.moodCode

Code	Display Name
EVN	event (occurrence)
Code System: ActMood (HL7) Code System OID: 2.16.840.1.113883.5.1001

5.2.6.5 Organizer

A derivative of the RIM Act class, which can be used to create arbitrary groupings of other CDA entries that share a common context. An Organizer can contain other Organizers and/or other CDA entries, by traversing the component relationship. An Organizer can refer to external acts by traversing the reference relationship. An Organizer cannot be the source of an entryRelationship relationship.

NOTE: CDA entries such as Observation can also contain other CDA entries by traversing the entryRelationship class. There is no requirement that the Organizer entry be used in order to group CDA entries.

Table X: Organizer Attributes

RIM Attribute(s)	Data Type	Cardinality	Code Binding	Binding Type
classCode	CS	[1..1]	V:x_ActClassDocumentEntryOrganizer	Closed
moodCode	CS	[1..1]	EVN	Fixed
id	SET <II>	[0..*]
code	CD	[1..1]	D:ActCode	Open
text	ED	[0..1]
statusCode	CS	[0..1]	V:ActStatus	Closed
effectiveTime	IVL<TS>	[0..1]
activityTime	GTS	[0..1]
availabilityTime	TS	[0..1]
priorityCode	CE	[0..1]	D:ActPriority	Open
confidentialityCode	SET<CE>	[0..*]	D:Confidentiality	Open

Table X: Value set for Organizer.classCode

V:x_ActClassDocumentEntryOrganizer [2.16.840.1.113883.1.11.19598] (CLOSED)
Code	Display Name		Code	Display Name
BATTERY	battery		CLUSTER	Cluster
Code System: ActClass (HL7) Code System OID: 2.16.840.1.113883.5.6

Table X: Fixed Organizer.moodCode

Code	Display Name
EVN	event (occurrence)
Code System: ActMood (HL7) Code System OID: 2.16.840.1.113883.5.1001

5.2.6.6 Procedure

A derivative of the RIM Procedure class, is represents an act whose immediate and primary outcome (post-condition) is the alteration of the physical condition of the subject.

Table X: Procedure Attributes

RIM Attribute(s)	Data Type	Cardinality	Code Binding	Binding Type
classCode	CS	[1..1]	V:ActClassProcedure	Closed
moodCode	CS	[1..1]	V:x_DocumentProcedureMood	Closed
id	SET <II>	[0..*]
code	CD	[1..1]	D:ActProcedureCode	Open
actonNegationInd	BL	[0..1]
negationInd (Deprecated)	BL	[0..1]
text	ED	[0..1]
statusCode	CS	[0..1]	V:ActStatus	Closed
effectiveTime	IVL<TS>	[0..1]
activityTime	GTS	[0..1]
availabilityTime	TS	[0..1]
priorityCode	CE	[0..1]	D:ActPriority	Open
confidentialityCode	SET<CE>	[0..*]	D:Confidentiality	Open
uncertaintyCode	CE	[0..1]	D:ActUncertainty	Open
languageCode	CE	[0..1]	D:HumanLanguage	Closed
isCriterionInd	BL	[0..1]
methodCode	CE	[0..*]	D:ProcedureMethod	Open
approachSiteCode	CE	[0..*]	D:ActSite	Open
targetSiteCode	CE	[0..*]	D:ActSite	Open

NOTE: Procedure Negation

Procedure.actionNegationInd, when set to "true", indicates that the Procedure statement is a negation of the Procedure in Event mood as described by the descriptive attributes. For Procedure, actionNegationInd indicates that the procedure itself did not occur. For instance, a negated "appendectomy performed" means that the author positively denies that there was ever an appendectomy performed, and that he takes the same responsibility for such statement and the same requirement to have evidence for such statement than if he had not used negation. Some properties such as Procedure.id, Procedure.moodCode, and the participations are not affected.

Procedure.negationInd, is deprecated in RIM 2.35, and CDA R2.1 retains it for backwards compatibility. CDA R2.1 compliant implementation guides should use actionNegationInd moving forward.

NOTE: Procedure Time References

Two new time references have been included in CDA Procedures, in addition to effectiveTime, activityTime and availabilityTime are now available for CDA documents and CDA IGs.

Procedure.effectiveTime is used to indicate the clinically or operationally relevant time of a procedure, exclusive of administrative activity. For a surgical procedure (operation), the effectiveTime is the time relevant for the patient, i.e., between incision and last suture. For transportation acts, the effective time is the time the transported payload is en route.

Procedure.activityTime is a time expression specifying when a procedure occurs, inclusive of administrative time E.g. times of component actions, such as preparation and clean-up. Depending on the mood code used, it represents the time the procedure occurred, is supposed to occur, is scheduled to occur, etc. For Procedures the activityTime can provide a needed administrative function by providing a more inclusive time to be anticipated in scheduling.

Procedure.availabilityTime is the point in time at which information about a procedure instance (regardless of mood) first became available to a system. The availabilityTime is metadata describing the recording of, not the procedure itself.

Table X: Value set for Procedure.classCode

V:ActClassProcedure [2.16.840.1.113883.1.11.19665] (CLOSED)
Code	Display Name		Code	Display Name
PROC (Default)	procedure		SBEXT	Substance Extraction
SPECCOLLECT	Specimen Collection
Note: Although SBADM is technically allowed, is best used with the SubstanceAdministration Entry Class
SBADM	substance administration
Code System: ActClass (HL7) Code System OID: 2.16.840.1.113883.5.6

Table X: Value set for Procedure.moodCode

V:x_DocumentProcedureMood [2.16.840.1.113883.1.11.19460] (CLOSED)
Code	Display Name		Code	Display Name
APT	appointment		ARQ	appointment request
EVN	event		DEF	definition
RQO	request		INT	intent
PRMS	promise		PRP	proposal
Code System: ActMood (HL7) Code System OID: 2.16.840.1.113883.5.1001

5.2.6.7 RegionOfInterest

A derivative of the RIM Observation class that represents a region of interest on an image, using an overlay shape. RegionOfInterest is used to make reference to specific regions in images, e.g., to specify the site of a physical finding by "circling" a region in a schematic picture of a human body. The units of the coordinate values in RegionOfInterest.value are in pixels, expressed as a list of integers. The origin is in the upper left hand corner, with positive X values going to the right and positive Y values going down. The relationship between a RegionOfInterest and its referenced ObservationMedia or ExternalObservation is specified by traversing the entryRelationship or reference class, respectively, where typeCode equals "SUBJ". A RegionOfInterest must reference exactly one ObservationMedia or one ExternalObservation. If the RegionOfInterest is the target of a <renderMultimedia> reference, then it shall only reference an ObservationMedia and not an ExternalObservation.

Table X: RegionOfInterest Attributes

RIM Attribute(s)	Data Type	Cardinality	Code Binding	Binding Type
classCode	CS	[1..1]	ROIOVL	Fixed
moodCode	CS	[1..1]	EVN	Fixed
id	SET <II>	[0..*]
code	CE	[0..1]	V:ROIOverlayShape	Closed
value	LIST<INT>	[1..*]

NOTE: XML ID Attribute added

An XML attribute "ID" of type XML ID, is added to RegionOfInterest within the CDA Schema. This attribute serves as the target of a <renderMultiMedia> reference (see <renderMultiMedia>). All values of attributes of type XML ID must be unique within the document (per the W3C XML specification).

Table X: Fixed RegionOfInterest.classCode

Code	Display Name
ROIOVL	overlay ROI
Code System: ActClass (HL7) Code System OID: 2.16.840.1.113883.5.6

Table X: Fixed RegionOfInterest.moodCode

Code	Display Name
EVN (Fixed)	event (occurrence)
Code System: ActMood (HL7) Code System OID: 2.16.840.1.113883.5.1001

Table X: Value set for RegionOfInterest.code

V:ROIOverlayShape [2.16.840.1.113883.1.11.16117] (CLOSED)
Code	Display Name		Code	Display Name
CIRCLE	circle		ELLIPSE	ellipse
POINT	point		POLY	polyline
Code System: ActCode (HL7) Code System OID: 2.16.840.1.113883.5.4

EXAMPLE

The following example illustrates one sample use of RegionOfInterest. In this case, the clinician has identified a rash upon physical examination of the skin, and indicates this by creating a region of interest atop a hand image taken from an image library. The narrative block references the RegionOfInterest via the <renderMultiMedia> tag, and the referenced RegionOfInterest references the hand image.

Example X

<section>
   <code code="8709-8" codeSystem="2.16.840.1.113883.6.1" 
    codeSystemName="LOINC"/>
   <title>Skin Exam</title>
   <text>Erythematous rash, palmar surface, left index 
    finger.<renderMultiMedia referencedObject="MM2"/>
   </text>
   <entry>
      <observation classCode="OBS" moodCode="EVN">
         <code code="271807003" 
          codeSystem="2.16.840.1.113883.6.96" 
          codeSystemName="SNOMED CT" 
          displayName="Rash"/>
         <statusCode code="completed"/>
         <targetSiteCode code="48856004" 
          codeSystem="2.16.840.1.113883.6.96" 
          codeSystemName="SNOMED CT" 
          displayName="Skin of palmer surface of index finger">
            <qualifier>
               <name code="78615007" 
                codeSystem="2.16.840.1.113883.6.96" 
                displayName="with laterality"/>
               <value code="7771000" 
                codeSystem="2.16.840.1.113883.6.96" 
                displayName="left"/>
            </qualifier>
         </targetSiteCode>
         <entryRelationship typeCode="SPRT">
            <regionOfInterest classCode="ROIOVL" moodCode="EVN" ID="MM2">
               <id root="2.16.840.1.113883.19.3.1"/>
               <code code="ELLIPSE"/>
               <value value="3"/>
               <value value="1"/>
               <value value="3"/>
               <value value="7"/>
               <value value="2"/>
               <value value="4"/>
               <value value="4"/>
               <value value="4"/>
               <entryRelationship typeCode="SUBJ">
                  <observationMedia classCode="OBS" moodCode="EVN">
                     <id root="2.16.840.1.113883.19.2.1"/>
                     <value mediaType="image/jpeg">
                        <reference value="lefthand.jpeg"/>
                     </value>
                  </observationMedia>
               </entryRelationship>
            </regionOfInterest>
         </entryRelationship>
      </observation>
   </entry>
</section>

5.2.6.8 SubstanceAdministration

A derivative of the RIM SubstanceAdministration class, used for representing medication-related events such as medication history or planned medication administration orders.

Table X: SubstanceAdministration Attributes

RIM Attribute(s)	Data Type	Cardinality	Code Binding	Binding Type
classCode	CS	[1..1]	SBADM	Fixed
moodCode	CS	[1..1]	V:x_DocumentSubstanceMood	Closed
id	SET <II>	[0..*]
code	CD	[1..1]	D:ActSubstanceAdministrationCode	Open
actonNegationInd	BL	[0..1]
negationInd (Deprecated)	BL	[0..1]
text	ED	[0..1]
statusCode	CS	[0..1]	V:ActStatus	Closed
effectiveTime	GTS	[0..1]
activityTime	GTS	[0..1]
availabilityTime	TS	[0..1]
priorityCode	CE	[0..1]	D:ActPriority	Open
confidentialityCode	SET<CE>	[0..*]	D:Confidentiality	Open
repeatNumber	IVL<INT>	[0..1]
languageCode	CE	[0..1]	D:HumanLanguage	Closed
isCriterionInd	BL	[0..1]
approachSiteCode	CE	[0..1]	D:RouteOfAdministration	Open
routeSiteCode	SET<CD>	[0..*]	D:ActSite	Open
doseQuantity	IVL<PQ>	[0..*]
rateQuantity	IVL<PQ>	[0..*]
doseCheckQuantity	SET<RTO<PQ,PQ.TIME>>	[0..*]
maxDoseQuantity	SET<RTO<PQ,PQ.TIME>>	[0..*]
administrationUnitCode	CE	[0..1]	D:AdministrableDrugForm	Open

NOTE: Substance Administration Negation

SubstanceAdministration.actionNegationInd, when set to "true", indicates that the SubstanceAdministration statement is a negation of the SubstanceAdministration in Event mood as described by the descriptive attributes. Some properties such as SubstanceAdministration.id, SubstanceAdministration.moodCode, and the participations are not affected. These properties always have the same meaning: i.e., the author remains the author of the action negation SubstanceAdministration. A substance administration statement with negationInd is still a statement about the specific fact described by the SubstanceAdministration. For instance, a negated "aspirin administration" means that the author asserts that aspirin has not been administered, and that he takes the same responsibility for such statement and the same requirement to have evidence for such statement than if he had not used action negation.

SubstanceAdministration.negationInd, is deprecated in RIM 2.35, and CDA R2.1 retains it for backwards compatibility. CDA R2.1 compliant implementation guides should use actionNegationInd moving forward.

NOTE: Substance Administration Time References

Two new time references have been included in CDA SubstanceAdministration, in addition to effectiveTime, activityTime and availabilityTime are now available for CDA documents and CDA IGs.

SubstanceAdministration.effectiveTime is the clinically relevant time of an substance administration act, exclusive of administrative activity. It is used to indicate the time over which the substance is to be administered, including the frequency of administration (e.g., TID for 10 days).

SubstanceAdministration.activityTime is a time expression specifying when the substance administration activity occurs, inclusive of administrative time E.g. times of component actions, such as preparation and clean-up. The substance administration activityTime can provide a needed administrative function, by providing a more inclusive time to be anticipated in scheduling.

SubstanceAdministration.availabilityTime is the point in time at which information about a substance administration instance (regardless of mood) first became available to a system. The availabilityTime is metadata describing the recording of, not the substance administration itself.

Table X: Fixed SubstanceAdministration.classCode

Code	Display Name
SBADM	substance administration
Code System: ActClass (HL7) Code System OID: 2.16.840.1.113883.5.6

Table X: Fixed SubstanceAdministration.moodCode

V:x_DocumentSubstanceMood [2.16.840.1.113883.1.11.19461] (CLOSED)
Code	Display Name		Code	Display Name
EVN	event		DEF	definition
RQO	request		INT	intent
PRMS	promise		PRP	proposal
Code System: ActMood (HL7) Code System OID: 2.16.840.1.113883.5.1001

SubstanceAdministration.priorityCode categorizes the priority of a substance administration. SubstanceAdministration.doseQuantity indicates how much medication is given per dose. SubstanceAdministration.rateQuantity can be used to indicate the rate at which the dose is to be administered (e.g., the flow rate for intravenous infusions). SubstanceAdministration.maxDoseQuantity is used to capture the maximum dose of the medication that can be given over a stated time interval (e.g., maximum daily dose of morphine, maximum lifetime dose of doxorubicin). SubstanceAdministration.effectiveTime is used to describe the timing of administration. It is modeled using the GTS data type to accommodate various dosing scenarios, as illustrated in the following example.

Example X

<section>
   <text>Take captopril 25mg PO every 12 hours, starting on 
    Jan 01, 2002, ending on Feb 01, 2002.
   </text>
   <entry>
      <substanceAdministration classCode="SBADM" moodCode="RQO">
         <effectiveTime xsi:type="IVL_TS">
            <low value="20020101"/>
            <high value="20020201"/>
         </effectiveTime>
         <effectiveTime xsi:type="PIVL_TS" operator="A">
            <period value="12" unit="h"/>
         </effectiveTime>
         <routeCode code="PO" 
          codeSystem="2.16.840.1.113883.5.112" 
          codeSystemName="RouteOfAdministration"/>
         <doseQuantity value="1"/>
         <consumable>
            <manufacturedProduct>
               <manufacturedLabeledDrug>
                  <code code="318821008" 
                   codeSystem="2.16.840.1.113883.6.96" 
                   codeSystemName="SNOMED CT" 
                   displayName="Captopril 25mg tablet"/>
               </manufacturedLabeledDrug>
            </manufacturedProduct>
         </consumable>
      </substanceAdministration>
   </entry>
</section>

The capture of medication-related information also involves the interrelationship of SubstanceAdministration with several other classes. The consumable participation is used to bring in the LabeledDrug or Material entity that describes the administered substance. The LabeledDrug class, which is an Entity class playing the Role of Manufactured Product, identifies the drug that is consumed in the substance administration. The medication is identified by means of the LabeledDrug.code or the LabeledDrug.name. The Material entity is used to identify non-drug administered substances such as vaccines and blood products.

Table X: Fixed consumable.typeCode

Code	Display Name
CSM	consumable
Code System: ParticipationType (HL7) Code System OID: 2.16.840.1.113883.5.90

Table X: Fixed ManufacturedProduct.classCode

Code	Display Name
MANU	manufactured
Code System: RoleClass (HL7) Code System OID: 2.16.840.1.113883.5.110

Table X: Fixed LabeledDrug.classCode

Code	Display Name
MMAT	A manufactured material.
Code System: EntityClass (HL7) Code System OID: 2.16.840.1.113883.5.41

Table X: Fixed LabeledDrug.determinerCode

Code	Display Name
KIND	described
Code System: EntityDeterminer (HL7) Code System OID: 2.16.840.1.113883.5.30

Table X: Fixed Material.classCode

Code	Display Name
MMAT	A manufactured material.
Code System: EntityClass (HL7) Code System OID: 2.16.840.1.113883.5.41

Table X: Fixed Material.determinerCode

Code	Display Name
KIND	described
Code System: EntityDeterminer (HL7) Code System OID: 2.16.840.1.113883.5.30

5.2.6.9 Supply

A derivative of the RIM Supply class, used for representing the provision of a material by one entity to another.

Table X: Supply Attributes

RIM Attribute(s)	Data Type	Cardinality	Code Binding	Binding Type
classCode	CS	[1..1]	SPLY	Fixed
moodCode	CS	[1..1]	V:x_DocumentSubstanceMood	Closed
id	SET <II>	[0..*]
code	CD	[1..1]	D:ActSupplyType	Open
actonNegationInd	BL	[0..1]
text	ED	[0..1]
statusCode	CS	[0..1]	V:ActStatus	Closed
effectiveTime	GTS	[0..1]
activityTime	GTS	[0..1]
availabilityTime	TS	[0..1]
priorityCode	CE	[0..1]	D:ActPriority	Open
confidentialityCode	SET<CE>	[0..*]	D:Confidentiality	Open
repeatNumber	IVL<INT>	[0..1]
independentInd	BL	[0..1]
languageCode	CE	[0..1]	D:HumanLanguage	Closed
isCriterionInd	BL	[0..1]
quantity	PQ	[0..1]
expectedUseTime	IVL<TS>	[0..1]

Table X: Fixed Supply.classCode

Code	Display Name
SPLY	supply
Code System: ActClass (HL7) Code System OID: 2.16.840.1.113883.5.6

Table X: Value set for Supply.moodCode

V:x_ClinicalStatementSubstanceMood [2.16.840.1.113883.1.11.19645] (CLOSED)
Code	Display Name		Code	Display Name
EVN	event		DEF	definition
RQO	request		INT	intent
PRMS	promise		PRP	proposal
Code System: ActMood (HL7) Code System OID: 2.16.840.1.113883.5.1001

The dispensed product is associated with the Supply act via a product participant, which connects to the same ManufacturedProduct role used for SubstanceAdministration.

Table X: Fixed product.typeCode

Code	Display Name
PRD	product
Code System: ParticipationType (HL7) Code System OID: 2.16.840.1.113883.5.90

The Supply class represents dispensing, whereas the SubstanceAdministration class represents administration. Prescriptions are complex activities that involve both an administration request to the patient (e.g. take digoxin 0.125mg by mouth once per day) and a supply request to the pharmacy (e.g. dispense 30 tablets, with 5 refills). This should be represented in CDA by a SubstanceAdministration entry that has a component Supply entry. The nested Supply entry can have Supply.independentInd set to "false" to signal that the Supply cannot stand alone, without it's containing SubstanceAdministration. The following example illustrates a prescription representation in CDA.

Example X

<section>
   <text>Digoxin 0.125mg, 1 PO qDay, #30, 5 refills.</text>
   <entry>
      <substanceAdministration classCode="SBADM" moodCode="RQO">
         <effectiveTime xsi:type="PIVL_TS">
            <period value="24" unit="h"/>
         </effectiveTime>
         <routeCode code="PO" 
          codeSystem="2.16.840.1.113883.5.112" 
          codeSystemName="RouteOfAdministration"/>
         <doseQuantity value="1"/>
         <consumable>
            <manufacturedProduct>
               <manufacturedLabeledDrug>
                  <code code="317896006" 
                   codeSystem="2.16.840.1.113883.6.96" 
                   codeSystemName="SNOMED CT" 
                   displayName="Digoxin 125micrograms tablet"/>
               </manufacturedLabeledDrug>
            </manufacturedProduct>
         </consumable>
         <entryRelationship typeCode="COMP">
            <supply classCode="SPLY" moodCode="RQO">
               <repeatNumber>
                  <low value="0"/>
                  <high value="5"/>
               </repeatNumber>
               <independentInd value="false"/>
               <quantity value="30"/>
            </supply>
         </entryRelationship>
      </substanceAdministration>
   </entry>
</section>

5.2.7 Entry Participants

CDA structures and entries can have various participants, some of which are also defined in the CDA header. As described in the discussion of CDA context (see CDA Context), participants propagated from the header can be overridden within the body.

5.2.7.1 author

The author participant (described above, see author), can be ascribed to a CDA section where it overrides the value(s) propagated from the CDA header, or can be ascribed to a CDA entry, where it overrides the value(s) propagated from a CDA section and propagates to nested entries.

5.2.7.2 consumable

The consumable participant is described above (see Entry Acts).

5.2.7.3 informant

The informant participant (described above, see informant), can be ascribed to a CDA section where it overrides the value(s) propagated from the CDA header, or can be ascribed to a CDA entry, where it overrides the value(s) propagated from a CDA section and propagates to nested entries.

5.2.7.4 participant

Can be used to represent any other participant that cannot be represented with one of the more specific participants. The participant can be ascribed to a CDA entry, and propagates to nested CDA entries, unless overridden.

Table X: Value set for participant.typeCode

v:ParticipationType [2.16.840.1.113883.1.11.10901] (CLOSED)
Code	Display Name		Code	Display Name
PART	Participation		ADM	admitter
ATND	attender		ADM	admitter
CALLBCK	callback contact		CON	consultant
DIS	discharger		ESC	escort
REF	referrer		TRANS	Transcriber
ENT	data entry person		WIT	witness
CST	custodian		DIR	direct target
BBY	baby		DEV	device
NRD	non-reuseable device		RDV	reusable device
EXPAGNT	ExposureAgent		EXPART	ExposureParticipation
EXPTRGT	ExposureTarget		EXSRC	ExposureSource
IND	indirect target		BEN	beneficiary
CAGNT	causative agent		COV	coverage target
GUAR	guarantor party		HLD	holder
DON	donor		RCV	receiver
IRCP	information recipient		NOT	ugent notification contact
PRCP	primary information recipient		REFB	Referred By
REFT	Referred to		TRC	tracker
LOC	location		DST	destination
ELOC	entry location		ORG	origin
RML	remote		VIA	via
RESP	responsible party		VRF	verifier
AUTHEN	authenticator
Use the following participations, only if the other participations provided in CDA will not work
RCT	record target		AUT	author (originator)
INF	informant		CSM	consumable
PRD	product		SBJ	subject
SPC	specimen		PRF	performer
DIST	distributor		PPRF	primary performer
SPRF	secondary performer		LA	legal authenticator
Code System: ParticipationType (HL7) Code System OID: 2.16.840.1.113883.5.90

Table X: Fixed participant.contextControlCode

Code	Display Name
OP	overriding, propagating
Code System: ContextControl (HL7) Code System OID: 2.16.840.1.113883.5.1057

A participant is an entity playing one of several possible roles (ParticipantRole class). The entity playing the role is a device (Device class) or other entity (PlayingEntity class). The scoper is any entity (Entity class).

Table X: Value set for ParticipantRole.classCode

V:RoleClassRoot [2.16.840.1.113883.1.11.13940] (CLOSED)
Code	Display Name		Code	Display Name
ROL (Default)	role		AFFL	affiliate
AGNT	agent		ASSIGNED	assigned entity
COMPAR	commissioning party		SGNOFF	signing authority or officer
CON	contact		ECON	emergency contact
NOK	next of kin		GUARD	guardian
CIT	citizen		COVPTY	covered party
CLAIM	claimant		NAMED	named insured
DEPEN	dependent		INDIV	individual
SUBSCR	subscriber		PROG	program eligible
CRINV	clinical research investigator		CRSPNSR	clinical research sponsor
EMP	employee		MIL	military person
GUAR	guarantor		INVSBJ	Investigation Subject
CASEBJ	Case Subject		RESBJ	research subject
LIC	licensed entity		NOT	notary public
PROV	healthcare provider		PAT	patient
PAYEE	payee		PAYOR	invoice payor
POLHOLD	policy holder		QUAL	qualified entity
SPNSR	underwriter		STD	student
UNDWRT	coverage sponsor		CAREGIVER	caregiver
PRS	personal relationship		ACCESS	access
ADMM	Administerable Material		BIRTHPL	birthplace
DEATHPLC	place of death		DST	distributed material
RET	retailed material		EXPR	exposed entity
HLD	held entity		HLTHCHRT	health chart
IDENT	identified entity		MANU	manufactured product
THER	therapeutic agent		MNT	maintained entity
OWN	owned entity		RGPR	regulated product
SDLOC	service delivery location		DSDLOC	dedicated service delivery location, health care facility
ISDLOC	incidental service delivery location		TERR	territory of authority
USED	used entity		WRTE	warranted product
EQUIV	equivalent entity		SAME	same
SUBY	subsumed by		GEN	has generalization
GRIC	has generic		INST	instance
SUBS	subsumer		CONT	content
EXPAGTCAR	exposure agent carrier		EXPVECTOR	exposure vector
FOMITE	fomite		INGR	ingredient
ACTI	active ingredient		ACTIB	active ingredient - basis of strength
ACTIM	active ingredient - moiety is basis of strength		ACTIR	active ingredient - reference substance is basis of strength
ADTV	additive		BASE	base
IACT	inactive ingredient		COLR	color additive, color
FLVR	flavor additive, flavor		PRSV	preservative
STBL	stabilizer		LOCE	located entity
STOR	stored entity		MBR	member
PART	part		ACTM	active moiety
SPEC	specimen		ALQT	aliquot
ISLT	isolate
Code System: RoleClass (HL7) Code System OID: 2.16.840.1.113883.5.110

Table X: Value set for Device.classCode

V:EntityClassDevice [2.16.840.1.113883.1.11.11623] (CLOSED)
Code	Display Name		Code	Display Name
DEV (Default)	role		CER	certificate representation
MODDV	imaging modality, ImagingModalityEntity
Code System: EntityClass (HL7) Code System OID: 2.16.840.1.113883.5.41

Table X: Fixed Device.determinerCode

Code	Display Name
INSTANCE	specific
Code System: EntityDeterminer (HL7) Code System OID: 2.16.840.1.113883.5.30

Table X: Value set for PlayingEntity.classCode

V:EntityClassRoot [2.16.840.1.113883.1.11.13922] (CLOSED)
Code	Display Name		Code	Display Name
ENT (Default)	entity		HCE	health chart entity
LIV	living subject		NLIV	non-person living subject
ANM	animal		MIC	microorganism
PLNT	plant		PSN	person
MAT	material		CHEM	chemical substance
FOOD	food		MMAT	manufactured material
CONT	container		HOLD	holder
DEV	device		CER	certificate representation
MODDV	imaging modality, ImagingModalityEntity		ORG	organization
PUB	public institution		STATE	state
NAT	Nation		PLC	place
CITY	city or town		COUNTRY	country
COUNTY	county or parish		PROVINCE	state or province
RGRP	group
Code System: EntityClass (HL7) Code System OID: 2.16.840.1.113883.5.41

Table X: Fixed PlayingEntity.determinerCode

Code	Display Name
INSTANCE	specific
Code System: EntityDeterminer (HL7) Code System OID: 2.16.840.1.113883.5.30

Table X: Value set for Entity.classCode

V:EntityClassRoot [2.16.840.1.113883.1.11.13922] (CLOSED)
Code	Display Name		Code	Display Name
ENT (Default)	entity		HCE	health chart entity
LIV	living subject		NLIV	non-person living subject
ANM	animal		MIC	microorganism
PLNT	plant		PSN	person
MAT	material		CHEM	chemical substance
FOOD	food		MMAT	manufactured material
CONT	container		HOLD	holder
DEV	device		CER	certificate representation
MODDV	imaging modality, ImagingModalityEntity		ORG	organization
PUB	public institution		STATE	state
NAT	Nation		PLC	place
CITY	city or town		COUNTRY	country
COUNTY	county or parish		PROVINCE	state or province
RGRP	group
Code System: EntityClass (HL7) Code System OID: 2.16.840.1.113883.5.41

Table X: Fixed Entity.determinerCode

Code	Display Name
INSTANCE	specific
Code System: EntityDeterminer (HL7) Code System OID: 2.16.840.1.113883.5.30

5.2.7.5 performer

The performer is a person who carries out or will carry out a particular act. The performer need not be the principal responsible participant, e.g. a surgery resident operating under supervision of attending surgeon is a performer.

Table X: Value set for performer.typeCode

v:ParticipationPhysicalPerformer [2.16.840.1.113883.1.11.10248] (CLOSED)
Code	Display Name		Code	Display Name
PRF (Default)	performer		DIST	distributor
PPRF	primary performer		SPRF	secondary performer
Code System: ParticipationType (HL7) Code System OID: 2.16.840.1.113883.5.90

5.2.7.6 product

The product participant is described above (see Entry Acts).

5.2.7.7 specimen

A specimen is a part of some entity, typically the subject, that is the target of focused laboratory, radiology or other observations. In many clinical observations, such as physical examination of a patient, the patient is the subject of the observation, and there is no specimen. The specimen participant is only used when observations are made against some substance or object that is taken or derived from the subject.

Table X: Fixed specimen.typeCode

Code	Display Name
SPC	specimen
Code System: ParticipationType (HL7) Code System OID: 2.16.840.1.113883.5.90

Table X: Fixed SpecimenRole.classCode

Code	Display Name
SPEC	specimen
Code System: RoleClass (HL7) Code System OID: 2.16.840.1.113883.5.110

5.2.7.8 subject

The subject participant (described above, see subject), can be ascribed to a CDA section, or it can be ascribed to a CDA entry, where it overrides the value(s) propagated from a CDA section and propagates to nested entries.

5.2.8 Entry Relationships

5.2.8.1 component

The component relationship has a source of Organizer (see Organizer, and a target that is another CDA entry, and is used to create groupings of CDA entries within an Organizer.

Table X: Fixed component.typeCode

Code	Display Name
COMP (FIXED)	has component
Code System: ActRelationshipType (HL7) Code System OID: 2.16.840.1.113883.5.1002

5.2.8.2 precondition

The precondition class, derived from the ActRelationship class, is used along with the Criterion class to express a condition that must hold true before some over activity occurs.

Table X: Fixed precondition.typeCode

Code	Display Name
PRCN	has pre-condition
Code System: ActRelationshipType (HL7) Code System OID: 2.16.840.1.113883.5.1002

Table X: Value set for Criterion.classCode

V:ActClassObservation [2.16.840.1.113883.1.11.11529] (CLOSED)
Code	Display Name		Code	Display Name
OBS (Default)	Observation		ALRT	detected issue
BATTERY	battery		CLNTRL	clinical trial
CONC	concern		COND	Condition
CASE	public health case		OUTB	outbreak
DGIMG	diagnostic image		GEN	genomic observation
DETPOL	determinant peptide		EXP	expression level
LOC	locus		PHN	phenotype
POL	polypeptide		SEQ	bio sequence
SEQVAR	bio sequence variation		INVSTG	investigation
OBSSER	observation series		OBSCOR	correlated observation sequences
POS	position		POSACC	position accuracy
POSCOORD	position coordinate		SPCOBS	specimen observation
VERIF	Verification		ROIBND	bounded ROI
ROIOVL	overlay ROI		LLD (Deprecated)	left lateral decubitus
PRN (Deprecated)	prone		RLD (Deprecated)	right lateral decubitus
SFWL (Deprecated)	Semi-Fowler's		SIT (Deprecated)	sitting
STN (Deprecated)	standing		SUP (Deprecated)	supine
RTRD (Deprecated)	reverse trendelenburg		TRD (Deprecated)	trendelenburg
CNOD (Deprecated)	Condition Node
Code System: ActClass (HL7) Code System OID: 2.16.840.1.113883.5.6

Table X: Fixed Criterion.moodCode

Code	Display Name
EVN.CRT	event criterion
Code System: ActMood (HL7) Code System OID: 2.16.840.1.113883.5.1001

5.2.8.3 referenceRange

The referenceRange relationship (described above, see Observation), has a source of Observation, and a target of ObservationRange.

5.2.8.4 entryRelationship

CDA has identified and modeled various link and reference scenarios. These scenarios enable CDA entries to be semantically linked to entries that exist within the same document (by traversing the entryRelationship class) or to objects external to it (by traversing the reference class).

In CDA R2.0, the following entryRelationships scenarios were provided as informative content:

Table X: Examples of typical entryRelationships

ActRelationship Type	Reasonable Source and Target entries	Comments
CAUS (is etiology for)	(Act | Observation | Procedure | SubstanceAdministration) CAUS (Observation)	Used to show that the source caused the target observation (for instance, source "diabetes mellitus" is the cause of target "kidney disease").
COMP (has component)	(Act | Observation | Procedure | SubstanceAdministration | Supply) COMP (Act | Observation | Procedure | SubstanceAdministration | Suppply)	Used to show that the target is a component of the source (for instance "hemoglobin measurement" is a component of a "complete blood count").
GEVL (evaluates (goal))	(Observation) GEVL (Observation)	Used to link an observation (intent or actual) to a goal to indicate that the observation evaluates the goal (for instance, a source observation of "walking distance" evaluates a target goal of "adequate walking distance").
MFST (is manifestation of)	(Observation) MFST (Observation)	Used to say that the source is a manifestation of the target (for instance, source "hives" is a manifestation of target "penicillin allergy").
REFR (refers to)	(Act | Observation | Procedure | SubstanceAdministration | Supply) REFR (Act | Observation | ObservationMedia | Procedure | RegionOfInterest | SubstanceAdministration | Supply)	Used to show a general relationship between the source and the target, when the more specific semantics of the relationship isn't known.
RSON (has reason)	(Act | Encounter | Observation | Procedure | SubstanceAdministration | Supply) RSON (Act | Encounter | Observation | Procedure | SubstanceAdministration | Supply)	Used to show the reason or rational for a service (for instance source "treadmill test" has reason "chest pain").
SAS (starts after start)	(Act | Encounter | Observation | Procedure | SubstanceAdministration | Supply) SAS (Act | Encounter | Observation | Procedure | SubstanceAdministration | Supply)	The source Act starts after the start of the target Act (for instance source "diaphoresis" starts after the start of target "chest pain").
SPRT (has support)	(Observation) SPRT (Observation | ObservationMedia | RegionOfInterest)	Used to show that the target provides supporting evidence for the source (for instance source "possible lung tumor" has support target "mass seen on chest-x-ray").
SUBJ (has subject)	(Observation | RegionOfInterest) SUBJ (Observation | ObservationMedia)	Used to relate a source region of interest to a target image, or to relate an observation to its subject observation (for instance, source "moderate severity" has subject target "chest pain").

NOTE: The preceding table provides examples of reasonable relationships between CDA entries, but does not represent a conformance constraint.

The ActRelationshipType "has subject" is similar to the ParticipationType "subject". Entries that primarily operate on physical subjects use the Participation, whereas entries that primarily operate on other entries use the ActRelationship.

XCRPT (is excerpt of) (Act | Observation) XCRPT (Act | Observation | Procedure | SubstanceAdministration | Supply) Used to show that the source is excerpted from the target (for instance source "hemoglobin value of 12" is an excerpt of target "complete blood count").

The distinction between an excerpt and an informant participant can be blurry — such as in the case of recording a patient's medication history where the clinician may obtain the information from an informant or may excerpt the information from another computer system. An informant (or source of information) is a person who provides relevant information. An informant class is in the header, and can be overridden in the body. An excerpt is a sub portion of some other act.

In CDA R2.1 any entry (excluding Organizer), may be related to another entry, using the entryRelationship class. In the entryRelationship class, the typeCode attribute is used to define the semantic relationship that exists between the source or parent entry and the destination or child entry. The valueset binding on typeCode was been significantly enhanced in CDA R2.1, and now any code present in the HL7 entryRelationship code system (RIM 2.35) may be used.

Table X: Value set for entryRelationship.typeCode

V:ActRelationshipType [2.16.840.1.113883.1.11.10317] (CLOSED)
Code	Display Name		Code	Display Name
CIND	has contra-indication		PRCN	has pre-condition
RSON	has reason		BLOCK	Blocks
CURE	curative indication		CURE.ADJ	adjunct curative indication
DIAG	diagnosis		MITGT	mitigates
RCVY	Recovery		MTGT.ADJ	adjunct mitigation
SYMP	symptomatic relief		TRIG	has trigger
COMP	has component		ARR	arrival
CTRLV	has control variable		DEP	departure
OUTC	has outcome		OBJC	has continuing objective
OBJF	has final objective		GOAL	has goal
RISK	has risk		PERT	has pertinent information
SAE	starts after end of		SAS	starts after start of
CHRG	has charge		COST	has cost
CREDIT	has credit		DEBIT	has debit
AUTH	authorized by		CAUS	is etiology for
COVBY	covered by		DRIV	is derived from
ELNK	episodeLink		EVID	provides evidence for
EXACBY	exacerbated by		EXPL	has explanation
ITEMSLOC	items located		LIMIT	limited by
MFST	is manifestation of		NAME	assigns name
PREV	has previous instance		REFR	refers to
REFV	has reference values		RELVBY	relieved by
SPRT	has support		SPRTBND	has bounded support
SUBJ	has subject		SUMM	summarized by
SEQL	is sequel		APND	is appendage
COMPLY	Update		DOC	documents
FLFS	fulfills		OCCR	occurrence
OREF	references order		SCH	schedules request
GEN	has generalization		GEVL	evaluates (goal)
INST	instantiates (master)		MOD	modifies
MTCH	matches (trigger)		OPTN	has option
RCHAL	re-challenge		REV	reverses
RPLC	replaces		SUCC	succeeds
UPDT	updates (condition)		XCRPT	Excerpts
VRXCRPT	Excerpt verbatim		XFRM	transformation
Code System: ActRelationshipType (HL7) Code System OID: 2.16.840.1.113883.5.1002

Note: Implementation Guide ("IG") authors will need to exercise caution and ensure they fully understand the semantics of the relationship defined by the term they have selected. In addition, IG authors will need to understand the impact of both inversionInd and negationInd flags, as these attributes can materially impact those semantics when machine processing.

The entryRelationship.inversionInd can be set to "true" to indicate that the relationship should be interpreted as if the roles of the source and target entries were reversed. As in the example provided in CDA R2.0, "treadmill test" RSON (has reason) "chest pain". Inverted, this would have "chest pain" as the source and "treadmill test" as the target: "chest pain" RSON (inverted) "treadmill test". Inversion can be useful when the current context is describing the target of an act relationship that needs to be related back to the source.

The entryRelationship.negationInd can be set to "true" to indicate that the meaning of the link is negated. Examples where this might be useful:

• If the relationship without negation specifies that Act A has Act B as a component, then the negation indicator specifies that Act A does not have Act B as a component.
• If B is a reason for A, then negation means that B is not a reason for A.
• If B is a pre-condition for A, then negation means that B is not a precondition for A.

The entryRelationship.contextConductionInd differs from the otherwise common use of this attribute (see CDA Context) in that in all other cases where this attribute is used, the value is fixed at "true", whereas here the value is defaulted to "true", and can be changed to "false" when referencing an entry in the same document. Setting the context conduction to false when referencing an entry in the same document keeps clear the fact that the referenced object retains its original context.

5.2.8.5 reference

CDA entries can reference external objects such as external images and prior reports. These external objects are not part of the authenticated document content. They contain sufficient attributes to enable an explicit reference rather than duplicating the entire referenced object. The CDA entry that wraps the external reference can be used to encode the specific portions of the external reference that are addressed in the narrative block.

Each object allows for an identifier and a code, and contains the RIM Act.text attribute, which can be used to store the URL and MIME type of the object. External objects always have a fixed moodCode of "EVN".

The reference class contains the attribute reference.seperatableInd, which indicates whether or not the source is intended to be interpreted independently of the target. The indicator cannot prevent an individual or application from separating the source and target, but indicates the author's desire and willingness to attest to the content of the source if separated from the target. Typically, where seperatableInd is "false", the exchanged package should include the target of the reference so that the recipient can render it.

A description of allowable reference.typeCode values are shown in the following table.

Table X: Value set for reference.typeCode

V:ActRelationshipType [2.16.840.1.113883.1.11.10317] (CLOSED)
Code	Display Name		Code	Display Name
ELNK	episodeLink		REFR	refers to
SPRT	has support		RPLC	replaces
XCRPT	Excerpts
Code System: ActRelationshipType (HL7) Code System OID: 2.16.840.1.113883.5.1002

As in the table above (CDA entryRelationship Types), the following table is a guideline for reasonable relationships between CDA entries and external objects, and is not a conformance constraint.

Table X: CDA reference Types

ActRelationship Type	Reasonable Source and Target classes	Comments
ELNK (episode link)	(Observation) ELNK (ExternalObservation)	Used to show that the source and the target are part of the same episode (for instance, a diagnosis of "pneumonia" can be linked to an external problem list entry of "pneumonia" to show that the current diagnosis is part of the ongoing episode of pneumonia).
REFR (refers to)	(Act | Observation | Procedure | SubstanceAdministration | Supply) REFR (ExternalAct | ExternalDocument | ExternalObservation | ExternalProcedure)	Used to show a general relationship between the source and the target, when the more specific semantics of the relationship isn't known.
RPLC (replace)	(Act | Encounter | Observation | ObservationMedia | Organizer | Procedure | SubstanceAdministration | Supply) RPLC (ExternalAct | ExternalDocument | ExternalObservation | ExternalProcedure)	Used to indicate that the source entry is a replacement for the target external act.
SPRT (has support)	(Observation) SPRT (ExternalDocument | ExternalObservation)	Used to show that the target provides supporting evidence for the source.
SUBJ (has subject)	(Observation | RegionOfInterest) SUBJ (ExternalObservation)	Used to relate a source region of interest to a target image, or to relate an observation to its subject observation.
XCRPT (is excerpt of)	(Act | Observation) XCRPT (ExternalAct | ExternalDocument | ExternalObservation | ExternalProcedure)	Used to show that the source is excerpted from the target (for instance "the hemoglobin is 10.7" is an excerpt of an externally referenced "complete blood count").

Target classes of the reference relationship include ExternalAct, ExternalDocument, ExternalObservation, and External Procedure.

ExternalAct is a derivative of the RIM Act class, to be used when the other more specific classes are not appropriate.

Table X: Value set for ExternalAct.classCode

V:ActClassRoot [2.16.840.1.113883.1.11.13856] (CLOSED)
Code	Display Name		Code	Display Name
ACT (Default)	act		COMPOSITION	composition, Attestable unit
DOC	document		DOCCLIN	clinical document
CDALVLONE	CDA Level One clinical document		CONTAINER	record container
CATEGORY	category		DOCBODY	document body
CATEGORY	document section, Section		TOPIC	topic
EXTRACT	extract		EHR	electronic health record
FOLDER	folder		GROUPER	grouper
CLUSTER	Cluster		ACCM	accommodation
ACCT	account		ACSN	accession
ADJUD	financial adjudication, financial adjudication results		CACT	control act
ACTN	action		INFO	information
STC	state transition control		CNTRCT	contract
FCNTRCT	financial contract		COV	coverage
CONS	consent		CONTREG	container registration
CTTEVENT	clinical trial timepoint event		DISPACT	disciplinary action
EXPOS	exposure		AEXPOS	acquisition exposure
TEXPOS	transmission exposure		INC	incident
INFRM	inform		INVE	invoice element
LIST	working list		MPROT	monitoring program
OBS	Observation		ALRT	detected issue
BATTERY	battery		CLNTRL	clinical trial
CONC	concern		COND	Condition
CASE	public health case		OUTB	outbreak
DGIMG	diagnostic image		GEN	genomic observation
DETPOL	determinant peptide		EXP	expression level
LOC	locus		PHN	phenotype
POL	polypeptide		SEQ	bio sequence
SEQVAR	bio sequence variation		INVSTG	investigation
OBSSER	observation series		OBSCOR	correlated observation sequences
POS	position		POSACC	position accuracy
POSCOORD	position coordinate		SPCOBS	specimen observation
VERIF	Verification		ROIBND	bounded ROI
ROIOVL	overlay ROI		PCPR	care provision
ENC	encounter		POLICY	policy
JURISPOL	jurisdictional policy		ORGPOL	organizational policy
SCOPOL	scope of practice policy		STDPOL	standard of practice policy
PROC	procedure		SBEXT	Substance Extraction
SPECCOLLECT	Specimen Collection		SBADM	substance administration
REG	registration		REV	review
SPCTRT	specimen treatment		SPLY	supply
DIET	diet		STORE	storage
SUBST	Substitution		TRFR	transfer
TRNS	transportation		XACT	financial transaction
CNOD (Deprecated)	Condition Node		LLD (Deprecated)	left lateral decubitus
PRN (Deprecated)	prone		RLD (Deprecated)	right lateral decubitus
SFWL (Deprecated)	Semi-Fowler's		SIT (Deprecated)	sitting
STN (Deprecated)	standing		SUP (Deprecated)	supine
RTRD (Deprecated)	reverse trendelenburg		TRD (Deprecated)	trendelenburg
Code System: ActClass (HL7) Code System OID: 2.16.840.1.113883.5.6

Table X: Fixed ExternalAct.moodCode

Code	Display Name
EVN	event
Code System: ActMood (HL7) Code System OID: 2.16.840.1.113883.5.1001

ExternalDocument is a derivative of the RIM Document class, used for representing external documents. ExternalDocument.text is modeled as an ED data type - allowing for the expression of the MIME type of the external document.

Table X: Value set for ExternalDocument.classCode

V:ActClassDocument [2.16.840.1.113883.1.11.18938] (CLOSED)
Code	Display Name		Code	Display Name
DOC (Default)	document		DOCCLIN	clinical document
CDALVLONE	CDA Level One clinical document
Code System: ActClass (HL7) Code System OID: 2.16.840.1.113883.5.6

Table X: Fixed ExternalDocument.moodCode

Code	Display Name
EVN	event
Code System: ActMood (HL7) Code System OID: 2.16.840.1.113883.5.1001

ExternalObservation is a derivative of the RIM Observation class, used for representing external coded and other observations.

Table X: Value set for ExternalObservation.classCode

V:ActClassObservation [2.16.840.1.113883.1.11.11529] (CLOSED)
Code	Display Name		Code	Display Name
OBS (Default)	Observation		ALRT	detected issue
BATTERY	battery		CLNTRL	clinical trial
CONC	concern		COND	Condition
CASE	public health case		OUTB	outbreak
DGIMG	diagnostic image		GEN	genomic observation
DETPOL	determinant peptide		EXP	expression level
LOC	locus		PHN	phenotype
POL	polypeptide		SEQ	bio sequence
SEQVAR	bio sequence variation		INVSTG	investigation
OBSSER	observation series		OBSCOR	correlated observation sequences
POS	position		POSACC	position accuracy
POSCOORD	position coordinate		SPCOBS	specimen observation
VERIF	Verification		ROIBND	bounded ROI
ROIOVL	overlay ROI		LLD (Deprecated)	left lateral decubitus
PRN (Deprecated)	prone		RLD (Deprecated)	right lateral decubitus
SFWL (Deprecated)	Semi-Fowler's		SIT (Deprecated)	sitting
STN (Deprecated)	standing		SUP (Deprecated)	supine
RTRD (Deprecated)	reverse trendelenburg		TRD (Deprecated)	trendelenburg
CNOD (Deprecated)	Condition Node
Code System: ActClass (HL7) Code System OID: 2.16.840.1.113883.5.6

Table X: Fixed ExternalObservation.moodCode

Code	Display Name
EVN	event
Code System: ActMood (HL7) Code System OID: 2.16.840.1.113883.5.1001

ExternalProcedure is a derivative of the RIM Procedure class, used for representing external procedures.

Table X: Fixed ExternalProcedure.classCode

Code	Display Name
PROC	procedure
Code System: ActClass (HL7) Code System OID: 2.16.840.1.113883.5.6

Table X: Fixed ExternalProcedure.moodCode

Code	Display Name
EVN	event
Code System: ActMood (HL7) Code System OID: 2.16.840.1.113883.5.1001

6 CDA Hierarchical Description

(content on separate page)

7 CDA XML Implementation

(content on separate page)

8 Appendix

(content on separate page)