DraftCDAR2.1.a

HL7 Clinical Document Architecture, Release 2.1

For Comment Only Ballot May 2017

Role	HL7 Member	Role	HL7 Member
Co-Chair / Primary Editor	Calvin Beebe Mayo Clinic cbeebe@mayo.edu	Co-chair / Co-Editor / Modeling Facilitator	Austin Kreisler Leidos, Inc. AUSTIN.J.KREISLER@leidos.com
Co-chair	Benjamin Flessner Epic Benjamin@epic.com	Co-chair	Brett Marquard River Rock Associates brett@riverrockassociates.com
Co-chair	Gay Dolin MSN RN Intelligent Medical Objects (IMO) gdolin@imo-online.com	Co-chair	Rick Geimer Lantana Consulting Group rick.geimer@lantanagroup.com
Co-Editor / Vocabulary Facilitator	Robert Hausam MD Hausam Consulting LLC<br. rrhausam@gmail.com	Co-Editor	Jeff Brown American Society of Clinical Oncology's CancerLinQ jeff.brown@CancerLinQ.org
Co-Editor / Publication Facilitator	Andy Stechishin CANA Software & Services andy.stechishin@gmail.com

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1 CDA Overview

1.1 What is the CDA

The HL7 Clinical Document Architecture (CDA) is a document markup standard that specifies the structure and semantics of "clinical documents" for the purpose of exchange. A clinical document is a documentation of clinical observations and services, with the following characteristics:

• Persistence – A clinical document continues to exist in an unaltered state, for a time period defined by local and regulatory requirements (NOTE: There is a distinct scope of persistence for a clinical document, independent of the persistence of any XML-encoded CDA document instance).
• Stewardship – A clinical document is maintained by an organization entrusted with its care.
• Potential for authentication - A clinical document is an assemblage of information that is intended to be legally authenticated.
• Context - A clinical document establishes the default context for its contents.
• Wholeness - Authentication of a clinical document applies to the whole and does not apply to portions of the document without the full context of the document.
• Human readability – A clinical document is human readable.

A CDA document is a defined and complete information object that can include text, images, sounds, and other multimedia content.

1.1.1 Key aspects of the CDA

Key aspects of the CDA include:

• CDA documents are encoded in Extensible Markup Language (XML). (NOTE: When alternate implementations are feasible, suitable conformance requirements will be issued so that in future the syntax may not be limited to XML.)
• CDA documents derive their machine processable meaning from the HL7 Reference Information Model (RIM) and use the HL7 Version 3 Data Types Release 1.0.
• The CDA specification is richly expressive and flexible. Document-level, section-level and entry-level templates can be used to constrain the generic CDA specification (see The "A" in "CDA" and Section 4 CDA Implementation Guides .

1.1.2 Scope of the CDA

The scope of the CDA is the standardization of clinical documents for exchange.

The data format of clinical documents outside of the exchange context (e.g., the data format used to store clinical documents) is not addressed in this specification.

CDA documents can be transmitted using a variety of techniques, E.g. HL7 2.x messages, V3.0 messages, FHIR messages, Direct and Exchange solutions, etc. While the detailed specification for such messages and solutions are outside of the scope of the CDA, this specification does impose requirements upon the packaging of CDA documents in all of these and other contexts (see CDA Document Exchange).

The CDA does not specify the creation or management of documents, only their exchange markup. While it may be possible to directly use the CDA Schema in a document authoring environment, such use is not the primary purpose of the CDA specification.

Document management is critically interdependent with the CDA specifications, but the specification of document management messages is outside the scope of the CDA. (For more on this, see Relationship of the CDA to HL7 Messaging Standards).

NOTE: Several committees are developing structured document specifications that overlap in part with the CDA specification. The Structured Documents Technical Committee, in collaboration with Publishing and these other committees, is developing a Structured Documents Infrastructure chapter to clarify these relationships which should be available in upcoming editions.

1.1.3 Goals and Design Principles

The goals of the CDA are:

• Give priority to delivery of patient care.
• Allow cost effective implementation across as wide a spectrum of systems as possible.
• Support exchange of human-readable documents between users, including those with different levels of technical sophistication.
• Promote longevity of all information encoded according to this architecture.
• Enable a wide range of post-exchange processing applications.
• Be compatible with a wide range of document creation applications.
• Promote exchange that is independent of the underlying transfer or storage mechanism.
• Prepare the design reasonably quickly.
• Enable policy-makers to control their own information requirements without extension to this specification.

A number of design principles follow from consideration of the above goals:

• This architecture must be compatible with XML and the HL7 RIM.
• This architecture must be compatible with representations of clinical information arising from other HL7 committees.
• Technical barriers to use of the architecture should be minimized.
• The architecture specifies the representation of instances required for exchange.
• The architecture should impose minimal constraints or requirements on document structure and content required for exchange.
• The architecture must be scalable to accommodate fine-grained markup such as highly structured text and coded data.
• Document specifications based on this architecture should accommodate such constraints and requirements as supplied by appropriate professional, commercial, and regulatory agencies.
• Document specifications for document creation and processing, if intended for exchange, should map to this exchange architecture.
• CDA documents must be human readable using widely-available and commonly-deployed XML-aware browsers and print drivers and a generic CDA style sheet written in a standard style sheet language.
• Use open standards.

1.2 General CDA Concepts

1.2.1 Major Components of a CDA Document

This section serves as a high-level introduction to the major components of a CDA document, all of which are described again and in greater detail later on. The intent here is to familiarize the reader with the high-level concepts to facilitate an understanding of the sections that follow.

Major components of a prototypic CDA document are shown in the following skeletal example. (Note that many required components are missing to simplify the example. See Samples for a detailed conformant example).

A CDA document is wrapped by the <ClinicalDocument> element, and contains a header (see Header) and a body (see Body). The header lies between the <ClinicalDocument> and the <structuredBody> elements, and identifies and classifies the document and provides information on authentication, the encounter, the patient, and the involved providers.

The body contains the clinical report, and can be either an unstructured blob, or can be comprised of structured markup. The example shows a structured body, which is wrapped by the <structuredBody> element, and which is divided up into recursively nestable document sections.

A CDA document section is wrapped by the <section> element. Each section can contain a single narrative block (see Section Narrative Block), and any number of CDA entries (see Entry Acts) and external references.

The CDA narrative block is wrapped by the <text> element within the <section> element, and must contain the human readable content to be rendered. See also Human Readability and Rendering CDA Documents and CDA Conformance for principles governing the representation of the narrative block, and conformance requirements on the part of originators when populating the block, and recipients when rendering it.

Within a document section, the narrative block represents content to be rendered, whereas CDA entries represent structured content provided for further computer processing (e.g. decision support applications). CDA entries typically encode content present in the narrative block of the same section. The example shows two <observation> CDA entries, and a <substanceAdministration> entry containing a nested <supply> entry, although several other CDA entries are defined.

CDA entries can nest and they can reference external objects. CDA external references always occur within the context of a CDA entry. External references refer to content that exists outside this CDA document - such as some other image, some other procedure, or some other observation (which is wrapped by the <externalObservation> element). Externally referenced material is not covered by the authentication of the document referencing it.

Example X

<ClinicalDocument>
  ... CDA Header ...
  <structuredBody>
    <section>
      <text>...</text>
      <observation>...</observation>
      <substanceAdministration>
        <supply>...</supply>
      </substanceAdministration>
      <observation>
        <externalObservation>...
        </externalObservation>
      </observation>
    </section>
    <section>
        <section>...</section>
    </section>
  </structuredBody>
</ClinicalDocument>

1.2.2 The "A" in "CDA"

The notion of CDA "levels" in CDA, Release One anticipated a hierarchical set of XML DTDs or XML Schemas to achieve the goals enumerated above (see Goals and Design Principles). This hierarchy formed an "architecture", hence the "A" in "CDA".

While the notion of levels in CDA, Release Two remains constant, the approach to representing the hierarchies has changed. The current specification consists of a single CDA XML Schema, and the architecture arises from the ability to apply one or more of a hierarchical set of HL7 Templates, which serve to constrain the richness and flexibility of CDA.

The RIM's InfrastructureRoot class contains an attribute, templateId, which is available for use in CDA. Where templateId(s) have been defined within a CDA document instance, the constraints contained within the template are assumed to be imposed. See Section 4 CDA Templating for more details.

There is no requirement that CDA must be constrained, however implementations that use structured data elements to drive automated processes will typically reference templates found in CDA Implementation Guide(s). The use of entry-level templates enables the semantic interoperability of any structured content found in documents exchanged.

There are many kinds of HL7 Templates that might be created. Among them, three are particularly relevant for clinical documents: (1) those that constrain the document content or document-level templates, (2) those that constrain content expected in sections or section-level templates and (3) those that constrain the entries within document sections or entry-level templates. Additional templates can be defined as needed to enable consistency in demographic data found within a document of names, addresses and telecom references or phone numbers.

Table X: Evolution of CDA "levels" from CDA, Release One to CDA, Release Two

CDA, Release One	CDA, Release Two
CDA Level One	The unconstrained CDA.
CDA Level Two	The CDA specification with section-level templates applied.
CDA Level Three	The CDA specification with entry-level (and optionally section-level) templates applied.

An illustration of one possible hierarchy of CDA plus HL7 Templates is shown here:

Example X

• CDA Schema
  • CDA Schema :: Progress Note section-level template applied.
    • CDA Schema :: Progress Note section-level and Vital Signs entry-level template applied.
      • CDA Schema :: Endocrinology Progress Note section-level and Vital Signs entry-level template applied.
      • CDA Schema :: Progress Note section-level and ICU Vital Signs entry-level template applied.
  • CDA Schema :: Cardiology Progress Note section-level template applied
  • CDA Schema :: Cardiology Progress Note section-level and Cardiac Exam entry-level template applied.
  • CDA Schema :: Endocrinology Progress Note section-level template applied.
  • CDA Schema :: Endocrinology Progress Note section-level and Vital Signs entry-level template applied.

1.2.3 Human Readability and Rendering CDA Documents

The CDA requirement for human readability guarantees that a receiver of a CDA document can algorithmically display the clinical content of the note on a standard Web browser. CDA, Release 2.1, with its blend of narrative and CDA entries, presents challenges to this requirement. Among the requirements affecting the design of CDA Release 2.1 are the following:

• There must be a deterministic way for a recipient of an arbitrary CDA document to render the attested content.
  • Authenticated documents, need to convey with fidelity the clinical content reviewed by the legal and other authenticator(s).
  • Documents which are not authenticated, (e.g. Continuity of Care Document, other generated documents) need to ensure that receivers are able to accurately interpret the clinical content contained in the document and its associated entries.
• Human readability shall not require a sender to transmit a special style sheet along with a CDA document. It must be possible to render all CDA documents with a single style sheet and general-market display tools.
• Human readability applies to the authenticated narrative content. There may be additional information conveyed in the document that is there primarily for machine processing that is not authenticated and need not be rendered.
• When structured content is derived from narrative, there must be a mechanism to describe the process (e.g. by author, by human coder, by natural language processing algorithm, by specific software) by which machine-processable portions were derived from a block of narrative.
• When narrative is derived from structured content, there must be a mechanism to identify the process by which narrative was generated from structured data.

These principles and requirements have led to the current approach, where the material to be rendered is placed into the Section.text field (see Section Narrative Block). The content model of this field is specially hand crafted to meet the above requirements, and corresponds closely to the content model of sections in CDA, Release One. Structured observations can reference narrative content in the Section.text field. Multimedia observations are encoded outside the Section.text field, and the <renderMultiMedia> tag within the Section.text field provides an outgoing pointer that indicates where the referenced multimedia should be rendered.

1.2.4 XML Markup of CDA Documents

XML markup of CDA documents is prescribed in this specification. CDA instances are valid against the CDA Schema and may be subject to additional validation (see CDA Conformance). There is no prohibition against multiple schema languages (e.g., W3C, DTD, RELAXNG), as long as conforming instances are compatible.

Design Principles of the CDA Schema include:

• General Requirements: The design of the CDA Schema follows the more general requirements for CDA (see Goals and Design Principles).
• CDA Schema and V3 Implementation Technology Specification (ITS) : The CDA Schema will follow the general V3 XML ITS.
• RIM Mapping: The CDA Schema describes the style of XML markup of CDA instances for the purpose of exchange. It cannot be understood outside the context of this defining specification. At the same time, the CDA Schema is useful on its own for implementation purposes even though it is not intended to replicate or take the place of the R-MIM and HD. The CDA Schema, then, is not, in and of itself, an adequate map between conforming instance and the HL7 RIM. Semantic interoperability of CDA instances requires use and knowledge of the CDA Schema, R-MIM and HD as well as the corresponding RIM.
• Document Analysis: The CDA Schema and conformant instances should adhere to the requirements of document analysis in derivation of the content model.

  NOTE: Document analysis is a process that might be thought of as the document equivalent of a use case. Document analysis looks at a single instance or class of documents and analyzes their structure and content, often representing this as a tree structure "elm" notation. Document analysis also looks at the business rules for the lifecycle of that document or document class. Traditionally, document analysis determines the content model and overall structure and style of XML.

  Document analysis is an iterative step in content model derivation -- the "bottom up" approach to complement the "top down" derivation from the RIM. This will ensure that schemas and instances are not only RIM-derived, but represent recognizable artifacts in a simple manner.

• Forward and Backward Compatibility: The CDA Schema should adhere to the requirements for forward and backward compatibility. (See Backwards and Forwards Compatibility)
• Naming: While XML markup, by definition, is for machine processing, it should be optimized for human review, debug, and design. The CDA Schema is not "self-documenting", but meaning should be clear from tag name and documentation (e.g., mapping to RIM). The human-language sense of a tag name should not be counterintuitive.
• Vocabulary: Vocabulary can be enumerated within the CDA Schema or in an external, referenced source. It is preferable to enumerate it when the vocabulary terms are both limited (not too large in number) and stable (not subject to change between ballot cycles). Where vocabulary is either too large or is subject to change, it is preferable to maintain it external to the CDA Schema and incorporate it by reference. In these cases, XML schema validation will not suffice for conformance.

1.2.5 Security, Confidentiality, and Data Integrity

Application systems sending and receiving CDA documents are responsible for meeting all legal requirements for document authentication, confidentiality, and retention. For communications over public media, cryptographic techniques for source/recipient authentication and secure transport of encapsulated documents may be required, and should be addressed with commercially available tools outside the scope of this standard.

The CDA does provide confidentiality status information to aid application systems in managing access to sensitive data. Confidentiality status may apply to the entire document or to specified segments of the document.

1.2.6 Relationship of the CDA to HL7 Messaging Standards

A CDA document is a defined and complete information object that can exist outside of a messaging context and/or can be a payload within an HL7 message (see CDA Document Exchange in HL7 Messages). Thus, the CDA complements HL7 messaging specifications.

Clinical documents can be revised, and they can be appended to existing documents. Ideally, an updated document would declare itself as obsolete, and would contain an explicit pointer to a more recent version. This would lessen the chances of a healthcare provider basing treatment decisions on erroneous or incomplete data.

In practice, however, it is impossible to guarantee an explicit forward pointer from an outdated version to the newer version. Without a process that tracks the chain of custody of clinical documents and all of their copies, there can be no way to guarantee that a clinical document being viewed has not been subsequently revised.

To minimize the risk of viewing superseded information, there is a critical interdependence between clinical documents and document management systems. If CDA documents are viewed outside the context of a document management system, it cannot be known with certainty whether or not the viewed document has been revised. HL7 messages that carry CDA documents (such as the MDM messages in HL7 V2.x and the HL7 V3 Medical Records messages) convey critical contextual information that ensures accurate viewing of clinical data.

1.3 CDA Conformance

NOTE: See HL7 V3 Refinement and Localization for a complete discussion of V3 conformance.

A conformant CDA document is one that at a minimum validates against the CDA Schema, and that restricts its use of coded vocabulary to values allowable within the specified vocabulary domains. However a computer cannot validate every aspect of conformance. The focus of this section is to highlight these aspects of CDA that cannot be machine validated - particularly those aspects related to the CDA human readability requirements.

A document originator is an application role that creates a CDA document. CDA documents can be created via transformation from some other format, as a direct output of an authoring application, etc. The document originator often is responsible for communicating with a persistent storage location, often using HL7 V2 MDM or HL7 V3 Medical Records messages. The document originator is responsible for ensuring that generated CDA documents are fully conformant to this specification.

A document recipient is an application role that receives status updates and documents from a document originator or document management system. The document recipient is responsible for ensuring that received CDA documents are rendered in accordance to this specification.

Because CDA is an exchange standard and may not represent the original form of a document, there are no persistent storage requirements for CDA documents defined in this standard. However, as noted above (see Relationship of the CDA to HL7 Messaging Standards), document management is critically interdependent with the CDA specification. The custodian identified in the CDA header (see custodian) is the participant charged with maintaining the original document, which may be in some form other than CDA.

1.3.1 Recipient Responsibilities

• Assume default values where they are defined in this specification, and where the instance does not contain a value : Where CDA defines default values, the recipient must assume these values in the event that no value is contained in a CDA instance. (NOTE: These values have been identified as having Minimum Cardinality = 0 and code binding = "Fixed" or "Closed w/ Default".)
• Parse and interpret the complete CDA header : A recipient of a CDA document must be able to parse and interpret the complete CDA header. Because applications may choose to display demographic and other CDA header data drawn from a central master directory, the rendering of the CDA document header is at the discretion of the recipient. In addition, rendering of the CDA document header can be dependent on local business practice and context of use (e.g. electronic health record, de-identified scenario). Where a document originator wants to suggest a rendering, they can include one or more XML style sheets with an exchanged CDA document. Use of these style sheets is at the discretion of the recipient.
• Parse and interpret the CDA body sufficiently to be able to render it : A recipient of a CDA document must be able to parse and interpret the body of a CDA document sufficiently to be able to render it, using the following rendering rules:
  • If the CDA Body is non-XML, it will need to be rendered with a software tool that recognizes its particular MIME media type.
  • If the CDA Body is structured, the label of a section, as conveyed in the Section.title component, must be rendered. The absence of the Section.title component signifies an unlabeled section.
  • If the CDA Body is structured, the contents of the Section.text field must rendered per the rules defined in Section Narrative Block.
• A recipient of a CDA document is not required to parse and interpret the complete set of CDA entries contained within the CDA body. Within a local implementation, trading partners may ascribe additional recipient responsibilities to parse and interpret various entries.
• A recipient of a CDA document is not required to validate a CDA document against referenced templates. Within a local implementation, trading partners may ascribe additional recipient responsibilities for template validation.

1.3.2 Originator Responsibilities

• Properly construct CDA Narrative Blocks : An originator of a CDA document must ensure that the attested portion of the document body is structured such that a recipient, adhering to the recipient responsibilities above, will correctly render the document. This includes:
  • If the CDA Body is structured, the label of a section must be conveyed in the Section.title component. The absence of the Section.title component signifies an unlabeled section.
  • If the CDA Body is structured, the attested narrative contents of a section must be placed in the Section.text field, regardless of whether information is also conveyed in CDA entries. Attested multimedia referenced in the narrative must be added as ObservationMedia and/or RegionOfInterest CDA entries.
  • If the CDA Body is structured, the contents of the Section.text field must be created per the rules defined in Section Narrative Block.
• An originator of a CDA document is not required to fully encode all narrative into CDA entries within the CDA body. Within a local implementation, trading partners may ascribe additional originator responsibilities to create various entries.

1.4 CDA Extensibility

NOTE: See XML ITS - Informal Extensions for a complete discussion of V3 XML Extensibility rules.

Locally-defined markup may be used when local semantics have no corresponding representation in the CDA specification. CDA seeks to standardize the highest level of shared meaning while providing a clean and standard mechanism for tagging meaning that is not shared. In order to support local extensibility requirements, it is permitted to include additional XML elements and attributes that are not included in the CDA schema. These extensions should not change the meaning of any of the standard data items, and receivers must be able to safely ignore these elements. Document recipients must be able to faithfully render the CDA document while ignoring extensions.

Extensions may be included in the instance in a namespace other than the HL7v3 namespace, but must not be included within an element of type ED (e.g., <text> within <procedure>) since the contents of an ED datatype within the conformant document may be in a different namespace. Since all conformant content (outside of elements of type ED) is in the HL7 namespace, the sender can put any extension content into a foreign namespace (any namespace other than the HL7 namespace). Receiving systems must not report an error if such extensions are present.

When these extension mechanisms mark up content of general relevance, HL7 encourages users to get their requirements formalized in a subsequent version of the standard so as to maximize the use of shared semantics.

2 CDA Overview

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3 Introduction to CDA Technical Artifacts

A complete understanding of CDA requires an understanding of the normative artifacts used to define the specification. For CDA R2.1, "Section 5 - CDA Design" will be considered the definitive source for CDA conformance rules. With this revision, the contents of Section 5 have been created based on the the CDA R2.1 RMIM and the CDA specific conformance strategy that allows some attributes to be assumed by receivers, thus reducing document size. Readers are encouraged to reference the CDA RMIM (diagram) and the CDA Hierarchical Description (spreadsheet), as well as other sections of the CDA standard, to better understand CDA and best practices using CDA. Implementers need to understand that while a CDA instance must validate against the CDA Schema, it must also need to adhere to the conformance rules called out in Section 5. Be aware that not all rules can be defined for CDA are found in it's W3C schema; requirements for human readability, and appropriate representation of clinical content, are just some examples. As in CDA R2, the HL7 RIM remains the definitive source for class and attribute definitions.

The following sections summarize the artifacts used by CDA, and how they can be used by those seeking to implement or understand the CDA specification.

3.1 HL7 Reference Information Model

The definitive description of the HL7 Reference Information Model can be found here.

The HL7 RIM is the definitive reference source for class and attribute definitions. The CDA specification does not exhaustively replicate RIM definitions, but instead refers the reader to the RIM for complete definitions. While CDA may further constrain RIM definitions, at no time will CDA definitions conflict with those in the RIM.

CDA, Release Two is derived from HL7 RIM, Version 2.35.

Where a reader needs to see the complete definition of a RIM attribute or class, they should refer to the HL7 RIM.

3.2 HL7 V3 Data Types

HL7 defines both an abstract data type specification, which is the definitive reference, and an XML-specific data type representation.

Data types define the structural format of the data carried within a RIM attribute and influence the set of allowable values an attribute may assume. Some data types have very little intrinsic semantic content. However HL7 also defines more extensive data types such as the one for an entity's name. Every attribute in the RIM is associated with one and only one data type.

CDA, Release Two uses the HL7 V3 Data Types, Release One abstract and XML-specific specification.

A reader will often find that the XML-specific description of a data type is sufficient for implementation, but at times will want to refer to the abstract data type specification for a more comprehensive discussion.

3.3 HL7 Vocabulary Domains

The definitive description of HL7 V3 Vocabulary Domains can be found here.

Vocabulary domains represent value sets for coded CDA components. These domains can include HL7-defined concepts or can be drawn from HL7-recognized coding systems such as LOINC or SNOMED. The HL7 Vocabulary chapter is the definitive reference source for the definitions of HL7-defined concepts. In this specification, references to code bindings using "D:concept-domain" indicates that a concept domain has been specified and the documentation defined in the RIM Vocabulary chapter should be referenced for an understanding of the code system9s) to be used when creating a CDA document.

Valuesets referenced in CDA R2.1 can be found here. An alternative to Concept Domain binding, the Valueset binding allows for a subset of codes to be bound to a CDA coded attribute. In this specification references to using "V:value set" indicates that a value set has been specified. Note: A number of value set bindings have been specified using "<= code", where the "<=" binding indicates a given code and all subordinate coded concepts defined as "type of" that code, within the code system referenced, are allowed. In Section 5, those bindings are mapped to the equivalent valueset for the readers reference.

Lastly, single code bindings can also be found in CDA R2.1 specification. Where a single code binding is being specified, the specification will indicate "= code" syntax. In Section 5, single code bindings are defined as Fixed bindings, as only the code specified can be used in CDA document instances. A number of these code bindings have a minimum cardinality of zero, as indicated by the [0..1] cardinality reference. In the cases were the code is fixed and the minimum cardinality is zero, instances of CDA conformant documents are not required to include the attribute and code in the instance, as receivers are required to interpret the document instance as though the coded attribute had been sent.

Vocabulary domains have a coding strength that can be "Closed" or "Coded, No Extensions" (CNE), in which case the only allowable values for the CDA component are those in stated value set; or "Open" or "Coded, With Extensions" (CWE), in which case values outside the stated value set can be used if necessary. Every vocabulary domain has a unique HL7-assigned identifier, and every concept within a vocabulary domain has a unique code.

Where a coded CDA component is associated with a Closed or CNE value set, the allowable values are fixed by the standard, and are enumerated as shown in the following example:

Table X: Value set for relatedDocument.typeCode

v:x_ActRelationshipDocument [2.16.840.1.113883.1.11.11610] (CLOSED)
Code	Display Name		Code	Display Name
APND	is appendage		RPLC	replaces
XFRM]	transformation
Code System: ActRelationshipType (HL7) Code System OID: 2.16.840.1.113883.5.1002

A number of vocabulary domains and coding systems already in existence (e.g., LOINC, SNOMED) may be used to encode concepts in CDA documents (e.g., Section.code, Observation.code). These domains are referenced as external domains according to HL7 V3 processes. Where a coded CDA component is associated with an Open or CWE vocabulary domain, a preferred value set may be specified by the standard (such as for ClinicalDocument.code or for ClinicalDocument.confidentialityCode). Where the standard does not enumerate any values, the implementor is free to choose from any external source, such as LOINC or SNOMED or some other realm-specific vocabulary.

Where a reader needs to see the complete definition of an HL7-defined value, they should refer to the HL7 Vocabulary chapter.

3.4 HL7 CDA R-MIM

The definitive description of the HL7 V3 model refinement process, R-MIM development and interpretation can be found here.

The CDA R-MIM is described below (see CDA R-MIM).

HL7 specifications derived from the HL7 RIM use a process known as "cloning" to refine domain specific models from the base HL7 RIM. When a refined model makes use of a specialization of an HL7 RIM class, the new class in the refined model is known as a clone of the HL7 RIM class. These specializations may further constrain the base class, for example, by specifying more restrictive attribute cardinality or by further constraints on the allowed vocabulary values. Multiple clones of a particular HL7 RIM class may appear in a refined model, each representing a different specialization.

The CDA R-MIM is a graphical representation of the CDA specification. It is presented using diagramming conventions and notations that were developed by HL7 to represent the specific semantic constructs contained in the critical, "back-bone" classes of the RIM. Although it could be represented in UML notation, as the RIM is, the HL7 notation provides more details about the specific constraints and class clones being represented. The HL7 diagramming convention abbreviates some relationship conventions, enabling diagrams to be smaller and more concise and to convey more information visually.

The CDA R-MIM is a graphical aid to understanding the specification. Because the CDA Hierarchical Description, and subsequently the CDA Schema, are derived from the R-MIM, the R-MIM serves as a good basis for describing the standard. The narrative description of the specific clones used by CDA is organized to correspond with the R-MIM.

3.5 HL7 CDA Hierarchical Description

The definitive description of developing and interpreting HL7 Hierarchical Descriptions can be found here.

The CDA HD is described below (see CDA Hierarchical Description).

A Hierarchical Description is a tabular representation of the sequence of elements (i.e., classes, attributes and associations) represented in an R-MIM and that define the structure of the instance without reference to XML or any other implementation technology

The CDA HD is the definitive source for CDA conformance rules, and serves as the source from which the CDA Schema is derived. While a CDA instance must validate against the CDA Schema, it must also adhere to the conformance rules stated in the CDA Hierarchical Description. For CDA, Release 2.1, the CDA HD is uniquely identified by the string "POCD_HD000040UV". As described below (see Clinical Document), this value must be included in a CDA instance to serve as an unambiguous reference to the CDA, Release 2.1 specification.

3.6 HL7 CDA XML Implementation

The CDA Schema is derived through the use of the HL7 XML Implementation Technology Specification (ITS). The definitive description of HL7 XML ITS and the process used to go from Hierarchical Description to Schema can be found here.

The CDA Schema is described below (see CDA XML Implementation).

CDA, Release 2.1 is based on the HL7 V3 XML Implementable Technology Specification for V3 Structures, Release One.

Specific enhancements to the CDA Schema, above and beyond those defined in the HL7 V3 XML ITS, are described below in CDA XML Implementation.

Looking at the CDA R-MIM, a reader familiar with the RIM, the HL7 Development Framework and its rules for XML implementations, can identify the corresponding XML elements and attributes. Due to algorithmic generation of some of the element names, the correspondence may be unclear, and the reader should refer to the HL7 V3 XML ITS for more details.

3.7 Backwards and Forwards Compatibility

NOTE: A detailed list of all changes between CDA, Release 2.0 and CDA, Release 2.1 can be found in the appendix (see Changes from CDA Release 2.0).

CDA Release 2.1 represents a minor dot release enhancement to the CDA Release 2.0 standard. As such, the changes introduced into the CDA R2.1 schema should not generate errors when processing a legacy CDA R2.0 document instance. However, with the inclusion of new RIM attributes and RIM structural vocabulary (Class Codes, Mood Codes and Type Codes) CDA R2.1 will likely require changes to implementation guides previsouly based on CDA R2.0, when citing CDA R2.1 as their base. The enhancements provided are intended to reduce the usage of previous extensions and improve the semantic modeling capabilities found in CDA.

The following updates have been made to the CDA document model, these include, but are not necessary limited to:

1. CDA R2 errata will be included
2. Extensions previously required and cited by CDA Implementation Guides
3. Attributes omitted from the classes derived from the RIM, where use cases exist for their inclusion
4. Additional values to value sets such as Mood codes, will be considered to ensure consistency with modeling from other committees
5. The inclusion of tables within tables in the narrative block will be considered as a minor presentation markup change.
6. Include current language about bindings if appropriate
7. Additional informative content will be considered for a number of topics:
   1. CDA Implementation Guides and Templating
   2. Vocabulary Binding Syntax in CDA
   3. Exchanging CDA documents

This section describes the types of changes that can be introduced to a new release of CDA and CDA principles of forward and backward compatibility. In general, changes can include the addition of new components; a renaming of components (including XML element and attribute names in the CDA Schema); a deprecation of components defined in a prior release; a change in cardinality of a component (to loosen); or a change in a vocabulary domain of a component {to add or change values, to change between Open (CWE) and Closed (CNE)}. The following set of guiding principles defines how CDA can continue to evolve, while protecting the investment implementers have made through their adoption of earlier releases.

• Documentation : A new release of CDA will enumerate all substantive changes from the previous release.
• Attested content : Attested, human readable content must be completely loss-less across CDA releases. Backwards and forwards compatibility on the attested content will be supported such that it will be possible for an automated transformation script to translate the human readable content in both directions.
• New components : A new release of CDA can introduce new components. To preserve roundtrip translation capability, a translation from the new release to a prior release must represent the new components as extensions (e.g. local markup or local namespace).
• Renaming : A new release of CDA can rename components (including XML element and attribute names). Where this occurs, a mapping table will list all changes. Renaming will adhere to the naming convention articulated above (see XML Markup of CDA Documents).
• Deprecated components : A new release of CDA can deprecate components defined in a prior release. Deprecated components will be removed from the subsequent release of the standard, and therefore their use is not recommended.
• Cardinality : A new release of CDA can change the cardinality of a component. Where an optional component becomes required, a translation between releases requires a dummy value or a null value.
• Changes to vocabulary domain : A new release of CDA can change the vocabulary domain of a component. Where this occurs, a mapping table will list changes.
• Change within Closed (CNE) : Where a value in a Closed (CNE) domain in a prior release is no longer present or has been renamed, a mapping table will indicate what the current value should be.
• Change within Open (CWE) : When a CWE domain is expanded, users should begin using the new codes in addition to any equivalent local codes they may already be using.
• Change from Open (CWE) to Closed (CNE) : To preserve roundtrip translation capability, a translation between releases must represent unrecognized components as extensions (e.g. local markup or local namespace). Ideally these situations will surface during a ballot cycle, allowing the Closed (CNE) domain to be sufficiently inclusive.

These guiding principles have lead to the current approach, defined in this Release 2.1 of the CDA standard. The goal is to ensure that the documents created using Release 2.0 can be processed by implementation adopting CDA R2.1 (with legacy extension references) with no loss of machine processable content or loss of attested, human-readable content.

4 CDA Document Exchange in HL7 Messages

NOTE: The exact method by which a CDA instance is packaged and exchanged is outside the scope of this standard. While the MIME packaging method described here is not normative, it does illustrate one mechanism that meets the document exchange requirements described below.

Any CDA exchange strategy must accommodate the following requirements:

• All components of a CDA document that are integral to its state of wholeness (such as attested multimedia) are able to be included in a single exchange package.
• Content needing to be rendered if exchanging across a firewall where the links won't be traversable, must be able to be included in a single exchange package.
• Additional files associated with a CDA document to provide the recipient with the sender's rendering suggestions (such as one or more style sheets) are able to be included in a single exchange package.
• There is no need to change any of the references (e.g., a reference to attested multimedia in a separate file) within the base CDA document when creating the exchange package.
• There is no need to change any of the references (e.g., a reference to attested multimedia in a separate file) within the base CDA document when extracting the contents of an exchange package.
• There is no need to change any values of attributes of type XML ID when creating the exchange package.
• There are no restrictions on the directory structure used by receivers. Receivers can place the components of the CDA document into directories of their choosing.
• Critical metadata about the CDA instance needed for document management (e.g. document state, document archival status) must be included in the exchange package. (For a complete discussion of clinical document metadata, document management, and HL7 V3 document states and state transitions, refer to the HL7 V3 Medical Records specification).

From the perspective of a V2.x, V3 message and FHIR, a CDA document can be thought of as a multimedia object that can be exchanged as a Multipurpose Internet Mail Extensions (MIME, RFC 2046) package, encoded as an encapsulated data type (ED).

The current MIME recommendation is to follow the approach described in the Internet standard RFC 2557 "MIME Encapsulation of Aggregate Documents, such as HTML (MHTML)", which is the approach for the MIME encapsulations of aggregate documents used by ebXML and DICOM.

In V2.x, CDA documents are to be exchanged in the OBX segment, in any message that can exchange documents (such as MDM). Within the OBX segment, the MIME package is placed in OBX.5 (Field 00573 Observation value), encoded as a V2.x encapsulated data type. The value of OBX.2 (Field 00570 Value Type) should be set to "ED". The value of OBX.3 should be the same as ClinicalDocument.code.

Many fields in the message will overlap in meaning with fields in the CDA document. The following table shows the correspondence between the HL7 V2 MDM message's TXA segment and components of CDA.

Table X: HL7 V2 TXA Segment :: CDA Mapping

TXA Field	CDA Component
TXA-2 Document type	ClinicalDocument.code
TXA-4 Activity date/time	ServiceEvent.effectiveTime
TXA-5 Primary activity provider code/name	ServiceEvent performer
TXA-6 Origination date/time	ClinicalDocument.effectiveTime
TXA-7 Transcription date/time	dataEnterer.time
TXA-9 Originator code/name	author
TXA-11 Transcriptionist code/name	dataEnterer
TXA-12 Unique document number	ClinicalDocument.id
TXA-13 Parent document number	ParentDocument.id
TXA-14 Placer order number	Order.id
TXA-18 Document confidentiality status	ClinicalDocument.confidentialityCode
TXA-22 Authentication person, time stamp	authenticator, legalAuthenticator
TXA-23 Distributed copies	informationRecipient

The following example shows a non-normative, valid use of RFC 2557 in a V2 message. Several other valid representations are possible.

Example X

MSH|...
EVN|...
PID|...
PV1|...
TXA|...
OBX|1|ED|11492-6^History and Physical^LN||
   ^multipart^related^A^
   MIME-Version: 1.0
   Content-Type: multipart/related; boundary="HL7-CDA-boundary";
   type="text/xml"; start="10.12.45567.43"
   Content-Transfer-Encoding: BASE64

   --HL7-CDA-boundary
   Content-Type: text/xml; charset="US-ASCII"
   Content-ID: <10.12.45567.43>

   ... Base 64 of base CDA document, which contains 
      ...
      <observationMedia classCode="OBS" moodCode="EVN">
         <id root="10.23.4567.345"/> 
         <value mediaType="image/jpeg">
            <reference value="left_hand_image.jpeg"/>
         </value>
      </observationMedia>
      ...

   --HL7-CDA-boundary
   Content-ID: <10.23.4567.345>
   Content-Location: canned_left_hand_image.jpeg
   Content-Type: image/JPEG

   ... Base64 image ...

   --HL7-CDA-boundary--

   ...

In V3, CDA documents can be exchanged in any message that can exchange documents (such as the HL7 V3 Medical Records messages). The Act.text RIM attribute contains the MIME package, encoded as an encapsulated data type.

As is the case with V2, many fields in the V3 message will overlap in meaning with fields in the CDA document. Since CDA and V3 Medical Records messages derive from a common model, the correspondence is clear, as shown in the following table.

Table X: HL7 V3 Medical Records :: CDA Mapping

HL7 V3 Medical Records Component	CDA Component	Comments
ClinicalDocument	ClinicalDocument	Medical Records includes attributes not present in CDA (text, statusCode, availabilityTime, reasonCode, completioncode, storageCode, copyTime); CDA includes attributes not present in Medical Records (title).
authenticator	authenticator
legalAuthenticator	legalAuthenticator
dataEnterer	dataEnterer
EncounterEvent / encounterPerformer	encompassingEncounter / encounterParticipant; serviceEvent / performer	The Medical Records encounterPerformer is split into two CDA participants.
responsibleParty	responsibleParty
custodian	custodian
participant	participant
informationRecipient	informationRecipient
recordTarget	recordTarget
author	author
subject	subject	The Medical Records subject is a directory of all subjects listed in the document.
relatedDocument / ParentDocument	relatedDocument / parentDocument
documentationOf / Event	documentationOf / serviceEvent
inFulfillmentOf / Order	inFulfillmentOf / order
componentOf / EncounterEvent	componentOf / encompassingEncounter

The following example shows a non-normative, valid use of RFC 2557 in a V3 message. Several other valid representations are possible.

Example X

<someMessage>
  <Act.Code code="11488-4" 
    codeSystem="2.16.840.1.113883.6.1" 
    displayName="Consultation note"/>
  <Act.text type="multipart/related">
MIME-Version: 1.0
Content-Type: multipart/related; boundary="HL7-CDA-boundary";
type="text/xml"; start="10.12.45567.43"
Content-Transfer-Encoding: BASE64

--HL7-CDA-boundary
Content-Type: text/xml; charset="US-ASCII"
Content-ID: <10.12.45567.43>

 ... Base 64 of base CDA document, which contains 
  ...
  <observationMedia classCode="OBS" moodcode="EVN">
    <id root="10.23.4567.345"/> 
    <value mediaType="image/jpeg">
      <reference value="left_hand_image.jpeg"/>
    </value>
  </observationMedia>
  ...

--HL7-CDA-boundary
Content-ID: <10.23.4567.345>
Content-Location: canned_left_hand_image.jpeg
Content-Type: image/JPEG

 ... Base64 image ...

--HL7-CDA-boundary--

      </Act.text>
    </someMessage>

In FHIR DSTU 2, CDA documents are to be exchanged using the FHIR http://www.hl7.org/FHIR/documentreference.htmlDocumentReference resource. A DocumentReference resource is used to describe a document that is made available to a healthcare system. A document is some sequence of bytes that is identifiable, establishes its own context (e.g., what subject, author, etc. can be displayed to the user), and has defined update management. The DocumentReference resource can be used with any document format that has a recognized mime type and that conforms to this definition.

A client can ask a server to generate a document reference from a document. The server reads the existing document and generates a matching DocumentReference resource, or returns one it has previously generated. Servers may be able to return or generate document references for the following types of documents, FHIR Documents, CDA Documents, or Other Documents.

For CDA documents, the uri returned is a reference to a Binary end-point that returns either a CDA document, or some kind of CDA Package that the server knows how to process (e.g., an IHE .zip, Multipart Mime package)

The operation is initiated by a named query, using _query=generate on the /DocumentReference end-point:

 GET [service-url]/DocumentReference/?_query=generate&uri=:url&...

The "uri" parameter is a relative or absolute reference to one of the document types described above. Other parameters may be supplied:

Name	Meaning
persist	Whether to store the document at the document end-point (/Document) or not, once it is generated. Value = true or false (default is for the server to decide).

5 CDA Design

NOTE: The definitive description of HL7 V3 model refinement, R-MIM development and interpretation can be found here.

The CDA R-MIM POCD_RM000040 can be found here: Link to wide graphic (opens in a new window)

A CDA document is comprised of a header and a body. The header identifies and classifies the document; provides information on authentication, the encounter, the patient, and the provider; and sets the context for the document as a whole. The body contains the clinical report, and is conceptually divided up into nested sections, each containing a narrative block to be rendered along with structured entries and external references.

5.1 Clinical Document

The ClinicalDocument class is the entry point into the CDA R-MIM, and corresponds to the <ClinicalDocument> XML element that is the root element of a CDA document instance. This section will outline the CDA Document's physical design, first in the header and then the body.

A CDA document is logically broken up into a CDA Header and a CDA Body. The CDA Header is comprised of ClinicalDocument attributes, participants, and act relationships. The CDA Body is the target of the ClinicalDocument component act relationship.

5.2 Header

The purpose of the CDA header is to enable clinical document exchange across and within institutions; facilitate clinical document management; and facilitate compilation of an individual patient's clinical documents into a lifetime electronic patient record.

5.2.1 ClinicalDocument

The CDA schema was produced by serialization of the CDA model. The starting point for his serialization was the ClinicalDocument class. The ClinicalDocument is the root element in a CDA document instance.

5.2.1.1 ClinicalDocument Attributes

This section describes attributes defined in the ClinicalDocument class.

The table below identifies the attributes of ClinicalDocument. For each item, the name is provided, along with the data type, cardinality*, code bindings, and binding strength. The links allow will access to the item's definition, data type definition, and when appropriate, the concept domain or value set used with the item.

Table X: ClinicalDocument Attributes

Attribute Name	Data Type	Cardinality	Code Binding	Binding Type
classCode	CS	[0..1]	DOCCLIN	Fixed
moodCode	CS	[0..1]	EVN	Fixed
typeId	II	[1..1]
templateId	II	[0..*]
id	II	[1..1]
code	CE	[1..1]	D:DocumentType	Open
title	TS	[0..1]
effectiveTime	TS	[0..1]
confidentialityCode	SET<CE>	[0..*]	V:x_BasicConfidentialityKind	Open
languageCode	CE	[0..1]	D:HumanLanguage	Closed
setId	II	[0..1]
versionNumber	ST.SIMPLE	[0..1]
copyTime (Deprecated)	TS	[0..1]

Note*: The cardinality represents to effective cardinality, taking into account 1.3.1 Recipient Responsibilities, relaxation of the requirement to exchange fixed and defaulted values.

ClinicalDocument.classCode

The ClinicalDocument.classCode in the CDA model is fixed to "DOCCLIN". As a result, in the CDA R2.1 Schema, the ClinicalDocument/@classCode has been fixed to "DOCCLIN".

As noted in section 1.3.1 Recipient Responsibilities, fixed and default values asserted in this standard are not required to be present in CDA document instances. However, CDA Implementation Guides can still require them via conformance statements.

Table X: Fixed ClinicalDocument.classCode

Code	Display Name
DOCCLIN	clinical document
Code System: ActClass (HL7) Code System OID: 2.16.840.1.113883.5.6

ClinicalDocument.moodCode

The ClinicalDocument.moodCode in the CDA model is fixed to "EVN" or event mood to indicate that this is documentation of a past service. In the CDA R2.1 Schema, the ClinicalDocument/@classCode has been fixed to "EVN".

Table X: Fixed ClinicalDocument.moodCode

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

The ClinicalDocument class inherits various attributes from the InfrastructureRoot class of the RIM, including ClinicalDocument.templateId and ClinicalDocument.typeId which are discussed here. All CDA classes inherit from infrastructureRoot, which is discussed in Section (link here).

ClinicalDocument.typeId

ClinicalDocument.typeId is a technology-neutral explicit reference to this CDA, Release Two specification, and must be valued as follows: ClinicalDocument.typeId.root = "2.16.840.1.113883.1.3" (which is the OID for HL7 Registered models); ClinicalDocument.typeId.extension = "POCD_HD000040" (which is the unique identifier for the CDA, Release Two Hierarchical Description).

ClinicalDocument.templateId

When a templateId is present in a CDA element, it signals the imposition of a set of template-defined constraints for that element. The templateId is one of the infrastructure attributes added to all CDA classes. It has only been displayed for ClinicalDocument, but is present in all CDA classes, where it can be used to identify constraints defined in an external Implementation Guide template.

ClinicalDocument.id

Represents the unique instance identifier of a clinical document.

ClinicalDocument.code

The code specifying the particular kind of document (e.g. History and Physical, Discharge Summary, Progress Note). The value set is drawn from LOINC, and has a CWE coding strength.

Within the LOINC database, beginning with version 2.09, May 2003, document type codes are those that have a value of "DOC" in the Scale component. This subset of LOINC is included in the appendix (see LOINC Document Codes).

NOTE: The hierarchical relationship among LOINC document codes is in evolution. Per the LOINC version 2.14 (December 2004) manual: As soon as possible, the component terms used in the creation of the names of document type codes will be mapped to either the UMLS Metathesaurus or SNOMED CT. This mapping will help to establish the meaning of the terms and will allow aggregation and classification of document type codes based on definitions, computable relationships, and subsumption hierarchies that exist in the reference terminology.

ClinicalDocument.title

Represents the title of the document. It's commonly the case that clinical documents do not have a title, and are collectively referred to by the display name of ClinicalDocument.code (e.g. a "consultation" or "progress note"). Where these display names are rendered to the clinician, or where the document has a unique title, the ClinicalDocument.title component should be used. In the example document in the appendix (see Sample Document), the value of ClinicalDocument.title = "Good Health Clinic Consultation Note".

ClinicalDocument.effectiveTime

Signifies the document creation time, when the document first came into being. Where the CDA document is a transform from an original document in some other format, the ClinicalDocument.effectiveTime is the time the original document is created. The time when the transform occurred is not currently represented in CDA.

ClinicalDocument.ConfidentialityCode

Confidentiality is a required contextual component of CDA, where the value expressed in the header holds true for the entire document, unless overridden by a nested value (as further described in CDA Context).

Table X: Value set for ClinicalDocument.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.

ClinicalDocument.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 a nested value (as further described in CDA Context).

ClinicalDocument.setId

Represents an identifier that is common across all document revisions.

ClinicalDocument.versionNumber

An integer value used to version successive replacement documents.

ClinicalDocument.copyTime (Deprecated)

Represents the time a document is released (i.e. copied or sent to a display device) from a document management system that maintains revision control over the document. Once valued, it cannot be changed. The intent is to give the viewer of the document some notion as to how long the document has been out of the safe context of its document management system.

Included for backwards compatibility with CDA, Release One. ClinicalDocument.copyTime has been deprecated because it is not part of the document at the time it is authenticated, but instead represents metadata about the document, applied at some variable time after authentication. Further use is discouraged.

5.2.2 Header Participants

This section describes classes related to the root ClinicalDocument class via a Participation.

5.2.2.1 authenticator

Represents a participant who has attested to the accuracy of the document, but who does not have privileges to legally authenticate the document. An example would be a resident physician who sees a patient and dictates a note, then later signs it. (See also legalAuthenticator)

A clinical document can have zero to many authenticators. Both authentication and legal authentication require that a document has been signed manually or electronically by the responsible individual.

Table X: Authenicator

Attribute Name	Data Type	Cardinality	Code Binding	Binding Type
typeCode	CS	[0..1]	AUTHEN	Fixed
time	TS	[1..1]
signatureCode	CV	[0..1]	S	Fixed
signatureText	ED	[0..1]

authenticator.typeCode

The ClinicalDocument.typeCode is fixed to "AUTHEN" to indicate that a participant has attested his participation through a signature.

Table X: Fixed authenticator.typeCode

Code	Display Name
AUTHEN	authenticator
Code System: ParticipationType (HL7) Code System OID: 2.16.840.1.113883.5.90

authenticator.time

Authenticator has a required authenticator.time indicating the time of authentication.

authenticator.signatureCode

Authenicator has a required authenticator.signatureCode, indicating that a signature has been obtained and is on file.

Table X: Fixed authenticator.signatureCode

Code	Display Name
S (Fixed)	signed
Code System: ParticipationSignature (HL7) Code System OID: 2.16.840.1.113883.5.89

Note: CDA Release One represented either an intended ("X") or actual ("S") authenticator. CDA Release 2 and 2.1 only represents an actual authenticator, so usage of "X" and "I" are deprecated.

authenticator.signatureText

A new attribute, SignatureText has been added to authenticator. The signature can be represented either inline or by reference according to the ED data type. Typical cases are:

1. Paper-based signatures: the ED data type may refer to a document or other resource that can be retrieved through an electronic interface to a hardcopy archive.
2. Electronic signature: this attribute can represent virtually any electronic signature scheme.
3. Digital signature: this attribute can represent digital signatures by reference to a signature data block that is constructed in accordance to a digital signature standard, such as XML-DSIG, PKCS#7, PGP, etc.

5.2.2.1.1 AssignedEntity

An authenticator is a person in the role of an assigned entity (AssignedEntity class). An assigned entity is a person assigned to the role by the scoping organization. The entity playing the role is a person (Person class). The entity scoping the role is an organization (Organization class). (See here for a description of "player" and "scoper" role associations.)

Table X: AssignedEntity

Attribute Name	Data Type	Cardinality	Code Binding	Binding Type
classCode	CS	[0..1]	ASSIGNED	Fixed
id	SET<II>	[1..*]
code	CE	[0..1]	D:RoleCode	Open
addr	SET<AD>	[0..*]
telecom	SET<TEL>	[0..*]

AssignedEntity.classCode

The classCode is fixed to "ASSIGNED", which is used in this context to indicate that a person in the employ of an organization was acting as their agent.

Table X: Fixed AssignedEntity.classCode

Code	Display Name
ASSIGNED	assigned entity
Code System: RoleClass (HL7) Code System OID: 2.16.840.1.113883.5.110

AssignedEntity.id

In this context, it is a unique identifier for the person in this Role.

AssignedEntity.code

Identifies the specific kind of Role to which an Role-instance belongs. The AssignedEntity.code is bound to D:RoleCode, which enables any code from the HL7 RoleCode vocabulary.

AssignedEntity.addr

A postal address for the Entity while in the Role.

AssignedEntity.telecom

A telecommunication address for the Entity while in the Role.

5.2.2.1.2 Person

Refer to Person as defined for Author participation.

5.2.2.1.3 Organization

Table X: Organization

Attribute Name	Data Type	Cardinality	Code Binding	Binding Type
classCode	CS	[0..1]	ORG	Fixed
determinerCode	CS	[0..1]	INSTANCE	Fixed
id	SET<II>	[0..*]
name	SET<ON>	[0..1]
telecom	SET<TEL>	[0..*]
addr	SET<AD>	[0..*]
standardIndustryClassCode	CE	[0..1]	D:OrganizationIndustryClass

Organization.classCode With the code fixed to "ORG", it indicates we are referencing an Organization.

Table X: Fixed Organization.classCode

Code	Display Name
ORG	organization
Code System: EntityClass (HL7) Code System OID: 2.16.840.1.113883.5.41

Organization.determinerCode

The determinerCode is fixed to "INSTANCE", which indicates that the scoping organization referenced, is a specific instance of an organization.

Table X: Fixed Organization.determinerCode

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

Organization.id

A unique identifier for the Organization.

Organization.name

A non-unique textual identifier or moniker for the organization.

Organization.telecom

A telecommunication address for the Organization.

Organization.addr

The postal or residential address of an organization.

Organization.standardIndustryClassCode

A code which identifies the industrial category of an organization. In the US Realm, it has been bound to the Code System: North American Industry Classification System [2.16.840.1.113883.6.85] (NAICS). The binding type is Open, so other code system and values sets may be used in the US and other realms. D:OrganizationIndustryClass

5.2.2.1.4 OrganizationPartOf

A scoping organization can be part of a larger organization. Where there is a need to include whole-part relationships, the OrganizationPartOf role can be used. OrganizationPartOf.statusCode indicates the state of the whole-part relationship (e.g. "active", "terminated").

Table X: OrganizationPartOf

Attribute Name	Data Type	Cardinality	Code Binding	Binding Type
classCode	CS	[0..1]	PART	Fixed
id	SET<II>	[1..*]
code	CE	[0..1]	D:RoleCode	Open
statusCode	CS	[0..1]	V:RoleStatus	Closed
effectiveTime	IVL<TS >	[0..1]

OrganizationPartOf.classCode

Table X: Fixed OrganizationPartOf.classCode

Code	Display Name
PART	part
Code System: RoleClass (HL7) Code System OID: 2.16.840.1.113883.5.110

OrganizationPartOf.id

A unique identifier for the player organization in this Role.

OrganizationPartOf.code

The specific kind of Role to which an Role-instance belongs.

OrganizationPartOf.statusCode

The state of this Role as defined in the state-transition model.

Table X: Value set for OrganizationPartOf.statusCode

V:RoleStatus [2.16.840.1.113883.5.1068] (CLOSED)
Code	Display Name		Code	Display Name
normal	normal		active	active
cancelled	cancelled		pending	pending
suspended	suspended		terminated	terminated
nullified	nullified
Code System: RoleStatus (HL7) Code System OID: 2.16.840.1.113883.5.1068

OrganizationPartOf.effectiveTime

The OrganizationPartOf.effectiveTime is an interval of time specifying the period during which the whole-part relationhship is in effect, if such time limit is applicable and known.

5.2.2.2 author

author

Represents the humans and/or machines that authored the document.

Table X: author

Attribute Name	Data Type	Cardinality	Code Binding	Binding Type
typeCode	CS	[0..1]	AUT	Fixed
functionCode	CE	[0..1]	D:ParticipationFunction	Open
contextControlCode	CS	[0..1]	OP	Fixed
time	TS	[1..1]

author.typeCode

The author.typeCode is fixed to "AUT", used to indicate the party that originates the document and is responsible for the information in the document.

Table X: Fixed author.typeCode

Code	Display Name
AUT	author
Code System: ParticipationType (HL7) Code System OID: 2.16.840.1.113883.5.90

author.functionCode

The author.functionCode is bound to the concept domain ParticipationFunction, which is used to specify the exact function an actor had in a service in all necessary detail. This domain may include local extensions (Open).

In some cases, the role or function of the author is inherent in the ClinicalDocument.code, such as where ClinicalDocument.code is "Medical Student Progress Note". The role of the author can also be recorded in the Author.functionCode or AssignedAuthor.code attribute. If either of these attributes is included, they should be equivalent to or further specialize the role inherent in the ClinicalDocument.code (such as where the ClinicalDocument.code is simply "Physician Progress Note" and the value of Author.functionCode is "rounding physician"), and shall not conflict with the role inherent in the ClinicalDocument.code, as such a conflict would constitute an ambiguous situation.

author.contextControlCode

The author.contextControlCode is fixed to "OP". It means that the author will replace the set of author participations that have propagated from ancestor Acts, and will itself be the only author to propagate to any child Acts that allow context to be propagated.

Table X: Fixed author.contextControlCode

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

author.time

The author.time is used to capture the time this specific author contributed content to the document.

5.2.2.2.1 AssignedAuthor

An author is a person in the role of an assigned author (AssignedAuthor class). The entity playing the role is a person (Person class) or a device (AuthoringDevice class). The entity scoping the role is an organization (Organization class), and is the organization from which the document originates.

Table X: AssignedAuthor

Attribute Name	Data Type	Cardinality	Code Binding	Binding Type
classCode	CS	[0..1]	ASSIGNED	Fixed
id	SET<II>	[1..*]
code	CE	[0..1]	D:RoleCode	Open
addr	SET<AD>	[0..*]
telecom	SET<TEL>	[0..*]

AssignedAuthor.classCode

The classCode is fixed to "ASSIGNED", which is used in this context to indicate that a person in the employ of an organization was acting as their agent.

Table X: Fixed AssignedAuthor.classCode

Code	Display Name
ASSIGNED	assigned entity
Code System: RoleClass (HL7) Code System OID: 2.16.840.1.113883.5.110

AssignedAuthor.id

In this context, it is a unique identifier for the person in this Role.

AssignedAuthor.code

Identifies the specific kind of Role to which an Role-instance belongs. The AssignedEntity.code is bound to D:RoleCode, which enables any code from the HL7 RoleCode vocabulary.

AssignedAuthor.addr

A postal address for the Entity while in the Role.

AssignedAuthor.telecom

A telecommunication address for the Entity while in the Role.

5.2.2.2.2 Person

A human being.

Table X: Person

Attribute Name	Data Type	Cardinality	Code Binding	Binding Type
classCode	CS	[0..1]	PSN	Fixed
determinerCode	CS	[0..1]	INSTANCE	Fixed
name	SET<PN>	[0..*]
desc	ED	[0..1]
birthTime	TS	[0..1]

Person.classCode

With the code fixed to "PSN", it indicates we are referencing a Person.

Table X: Fixed Person.classCode

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

Person.determinerCode

The determinerCode is fixed to "INSTANCE", which indicates that we are dealing with a specific person.

Table X: Fixed Person.determinerCode

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

Person.name

The person's name.

Note: The person name data type "PN" supports current, and historical names using validTime, and the specification of different use codes can indicate legal name, tribal name, stage name and others.

Person.desc

A textual or multimedia depiction of the person.

Person.birthTime

The date and time of a person's birth.

5.2.2.2.3 AuthoringDevice

Table X: AuthoringDevice

Attribute Name	Data Type	Cardinality	Code Binding	Binding Type
classCode	CS	[0..1]	DEV	Fixed
determinerCode	CS	[0..1]	INSTANCE	Fixed
code	CE	[0..1]	D:EntityCode
manufacturerModelName	SC	[0..1]	D:ManufacturerModelName
softwareName	SC	[0..1]	D:SoftwareName

AuthoringDevice.classCode

The AuthoringDevice.classCode if fixed to "DEV" indicating that a device was used to generate content in the document.

Table X: Fixed AuthoringDevice.classCode

Code	Display Name
DEV	role
Code System: EntityClass (HL7) Code System OID: 2.16.840.1.113883.5.41

AuthoringDevice.determinerCode

The determinerCode is fixed to "INSTANCE", which indicates we are referencing a specific device.

Table X: Fixed AuthoringDevice.determinerCode

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

AuthoringDevice.code

The AuthoringDevice.code is bound to the EntityCode domain.

AuthoringDevice.manufacturerModelName

Is used to convey a coded name for the device.

AuthoringDevice.softwareName

Is used to convey a coded name for the software used to author content.

5.2.2.2.4 MaintainedEntity

NOTE: In CDA, Release One, it was possible to specify those individuals responsible for the device. This functionality has been deprecated in CDA, Release Two. The MaintainedEntity class is present for backwards compatibility, and its use is discouraged, except where needed to support the transformation of CDA, Release One documents.

Table X: MaintainedEntity

Attribute Name	Data Type	Cardinality	Code Binding	Binding Type
classCode	CS	[0..1]	MNT	Fixed
effectiveTime	IVL<TS>	[0..1]

MaintainedEntity.classCode

With the classCode fixed to "MNT", it indicates that AuthoringDevice is maintained by person assuming responsibility for proper operation, quality, and safety.

Table X: Fixed MaintainedEntity.classCode

Code	Display Name
MNT	maintained entity
Code System: RoleClass (HL7) Code System OID: 2.16.840.1.113883.5.110

MaintainedEntity.effectiveTime

An interval of time specifying the period during which the Role is in effect.

5.2.2.3 custodian

custodian

Represents the organization that is in charge of maintaining the document. The custodian is the steward that is entrusted with the care of the document. Every CDA document has exactly one custodian.

The custodian participation satisfies the CDA definition of Stewardship (see What is the CDA). Because CDA is an exchange standard and may not represent the original form of the authenticated document, the custodian represents the steward of the original source document.

Table X: custodian

Attribute Name	Data Type	Cardinality	Code Binding	Binding Type
typeCode	CS	[0..1]	CST	Fixed

custodian.typeCode

The custodian.typeCode is fixed to "CST", which indicates in this instance an organization that is in charge of maintaining this document. Examples: Medical Records Dept in hospital, Health Information Management Dept., etc.

Table X:Fixed custodian.typeCode

Code	Display Name
CST	custodian
Code System: ParticipationType (HL7) Code System OID: 2.16.840.1.113883.5.90

A custodian is a scoping organization in the role of an assigned custodian (AssignedCustodian class). The steward organization (CustodianOrganization class) is an entity scoping the role of AssignedCustodian, and has a required CustodianOrganization.id.

5.2.2.3.1 AssignedCustodian

Table X: AssignedCustodian

Attribute Name	Data Type	Cardinality	Code Binding	Binding Type
classCode	CS	[0..1]	ASSIGNED	Fixed

AssignedCustodian.classCode

Table X: Fixed AssignedCustodian.classCode

Code	Display Name
ASSIGNED	assigned entity
Code System: RoleClass (HL7) Code System OID: 2.16.840.1.113883.5.110

5.2.2.3.2 CustodianOrganization

Table X: CustodianOrganization

Attribute Name	Data Type	Cardinality	Code Binding	Binding Type
classCode	CS	[0..1]	ORG	Fixed
determinerCode	CS	[0..1]	INSTANCE	Fixed
id	SET<II>	[1..*]
name	SET<ON>	[0..1]
telecom	SET<TEL>	[0..*]
addr	SET<AD>	[0..*]

CustodianOrganization.classCode With the code fixed to "ORG", it indicates we are referencing an Organization.

Table X: Fixed CustodianOrganization.classCode

Code	Display Name
ORG	organization
Code System: EntityClass (HL7) Code System OID: 2.16.840.1.113883.5.41

CustodianOrganization.determinerCode

The determinerCode is fixed to "INSTANCE", which indicates that the scoping organization referenced, is a specific instance of an organization.

Table X: Fixed CustodianOrganization.determinerCode

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

CustodianOrganization.id

A unique identifier for the Organization.

CustodianOrganization.name

A non-unique textual identifier or moniker for the organization.

CustodianOrganization.telecom

A telecommunication address for the Organization.

CustodianOrganization.addr

The postal or residential address of an organization.

5.2.2.4 dataEnterer (Transcriptionist)

dataEnterer

Represents the participant who has transformed a dictated note into text.

Table X: dataEnterer

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

dataEnterer.typeCode

The dataEnterer.typeCode is fixed to "ENT".

Table X: Fixed dataEnterer.typeCode

Code	Display Name
ENT	data entry person
Code System: ParticipationType (HL7) Code System OID: 2.16.840.1.113883.5.90

dataEnterer.contextControlCode

The dataEnterer.contextControlCode is fixed to "OP".

Table X: Fixed dataEnterer.contextControlCode

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

dataEnterer.time

The date and time the data was entered into the originating system.

5.2.2.4.1 AssignedEntity

Refer to AssignedEntity as defined for authenticator participation.

5.2.2.5 encounterParticipant

See EncompassingEncounter for a description of the encounterParticipant participant.

5.2.2.6 informant

informant

An informant (or source of information) is a person that provides relevant information, such as the parent of a comatose patient who describes the patient's behavior prior to the onset of coma.

Table X: informant

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

informant.typeCode The informant.typeCode is fixed to "INF", which indicates the source of reported information (e.g., a next of kin who answers questions about the patient's history).

Table X: Fixed informant.typeCode

Code	Display Name
INF	informant
Code System: ParticipationType (HL7) Code System OID: 2.16.840.1.113883.5.90

informant.contextControlCode

The informant.contextControlCode is fixed to "OP". It means that the informant will replace the set of informant participations that have propagated from ancestor Acts, and will itself be the only informant to propagate to any child Acts that allow context to be propagated.

Table X: Fixed informant.contextControlCode

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

An informant can be a person in one of two roles RelatedEntity or AssignedEntity.

5.2.2.6.1 RelatedEntity

The RelatedEntity role is used to represent an informant without a role.id (e.g. a parent or guy on the street). The informant in this case bears some formal or personal relationship to the patient. The role is unscoped, with the assumption that the patient is always the implied scoper. RelatedEntity.code can be used to specify the nature of the relationship.

Table X: RelatedEntity

Attribute Name	Data Type	Cardinality	Code Binding	Binding Type
classCode	CS	[0..1]	v:RoleClassMutualRelationship	Closed
code	CE	[0..1]	D:PersonalRelationshipRoleType	Open
addr	SET<AD>	[0..*]
telecom	SET<TEL>	[0..*]
effectiveTime	IVL<TS>	[0..1]

RelatedEntity.classCode

Table X: Value set for RelatedEntity.classCode

v:RoleClassMutualRelationship [2.16.840.1.113883.1.11.19316] (CLOSED)
Code	Display Name		Code	Display Name
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, GuarantorRole
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	coverage sponsor
STD	student		UNDWRT	underwriter
CAREGIVER	caregiver		PRS	personal relationship
Code System: RoleClass (HL7) Code System OID: 2.16.840.1.113883.5.110

RelatedEntity.code

The RelatedEntity.code is bound to the PersonalRelationshipRoleType concept domain.

RelatedEntity.addr

The RelatedEntity.addr is used to convey the postal address for the informant.

RelatedEntity.telecom

The RelatedEntity.telecom is used to convey the phone number for the informant.

RelatedEntity.effectiveTime

The RelatedEntity.effectiveTime is used to convey the time period that the role is/was in effect.

5.2.2.6.2 AssignedEntity

The AssignedEntity role is used for an identified informant, and is scoped by an Organization.

Refer to AssignedEntity as defined for authenticator participation.

5.2.2.7 informationRecipient

informationRecipient

Represents a recipient who should receive a copy of the document.

NOTE: The information recipient is an entity to whom a copy of a document is directed, at the time of document authorship. It is not the same as the cumulative set of persons to whom the document has subsequently been disclosed, over the life-time of the patient. Such a disclosure list would not be contained within the document, and it outside the scope of CDA.

Table X: informationRecipient

Attribute Name	Data Type	Cardinality	Code Binding	Binding Type
typeCode	CS	[1..1]	V:x_InformationRecipient	Closed

informationRecipient.typeCode

Two values are available for the informationRecipient.typeCode, the default value is primary information recipient an alternative value is tracker.

Table X: Value set for informationRecipient.typeCode

v:x_InformationRecipient [2.16.840.1.113883.1.11.19366] (CLOSED)
Code	Display Name		Code	Display Name
PRCP (Default)	primary information recipient		TRC	tracker
Code System: ParticipationType (HL7) Code System OID: 2.16.840.1.113883.5.90

5.2.2.7.1 IntendedRecipient

Identifies the person(s), organization or health chart to receive the document.

Table X: IntendedRecipient

Attribute Name	Data Type	Cardinality	Code Binding	Binding Type
classCode	CS	[1..1]	V:x_InformationRecipientRole	Closed
id	SET<II>	[1..*]
addr	SET<AD>	[0..*]
telecom	SET<TEL>	[0..*]

IntendedRecipient.classCode

Where a person is the intended recipient (IntendedRecipient class), the IntendedRecipient.classCode is valued with "ASSIGNED", and the playing entity is a person (Person class), optionally scoped by an organization (Organization class). Where the intended recipient is an organization, the IntendedRecipient.classCode is valued with "ASSIGNED", and the recipient is reflected by the presence of a scoping Organization, without a playing entity. Where a health chart is the intended recipient, the IntendedRecipient.classCode is valued with "HLTHCHRT" (health chart). In this case there is no playing entity, and an optional scoping organization (Organization class).

Table X: Value set for IntendedRecipient.classCode

V:x_InformationRecipientRole [2.16.840.1.113883.1.11.16772] (CLOSED)
Code	Display Name		Code	Display Name
ASSIGNED (Default)	assigned entity		HLTHCHRT	health chart
Code System: RoleClass (HL7) Code System OID: 2.16.840.1.113883.5.110

IntendedRecipient.id

Optional identifier of the intended recipient.

IntendedRecipient.addr

Optional postal address of the intended recipient.

IntendedRecipient.telecom

Optional phone number for the intended recipient.

5.2.2.7.2 Person

Refer to Person as defined for Author participation.

5.2.2.7.3 Organization

Refer to organization as defined for authenticator participation.

5.2.2.8 legalAuthenticator

Represents the participant(s) who has legally authenticated the document.

CDA R2.1, now supports [0.2] legal authenications. This enhancement was put into CDA to support the sharing of medical documents needing to take more than one legal authenication signature.

The CDA is a standard that specifies the structure of exchanged clinical documents. In the case where a local document is transformed into a CDA document for exchange, authentication occurs on the local document, and that fact is reflected in the exchanged CDA document. A CDA document can reflect the unauthenticated, authenticated, or legally authenticated state. The unauthenticated state exists when no authentication information has been recorded (i.e., it is the absence of being either authenticated or legally authenticated).

Both authentication and legal authentication require that a document has been signed manually or electronically by the responsible individual. A legalAuthenticator has a required legalAuthenticator.time indicating the time of authentication, and a required legalAuthenticator.signatureCode, indicating that a signature has been obtained and is on file.

Table X: legalAuthenticator[0..2]

Attribute Name	Data Type	Cardinality	Code Binding	Binding Type
typeCode	CS	[0..1]	LA	Fixed
contextControlCode	CS	[0..1]	OP	Fixed
time	TS	[1..1]
signatureCode	CV	[0..1]	S	Fixed
signatureText	ED	[0..1]

legalAuthenticator.typeCode

The ClinicalDocument.typeCode is fixed to "LA" to indicate that a participant has legally attested his participation through a signature.

Table X: Fixed legalAuthenticator.typeCode

Code	Display Name
AUTHEN	authenticator
Code System: ParticipationType (HL7) Code System OID: 2.16.840.1.113883.5.90

legalAuthenticator.contextControlCode

The legalAuthenticator.contextControlCode is fixed to "OP". It means that the legalAuthenticator will propagate to any child Acts that allow context to be propagated.

legalAuthenticator.time

legalAuthenticatorhas a required legalAuthenticator.time indicating the time of authentication.

legalAuthenticator.signatureCode

legalAuthenticatorhas a required legalAuthenticator.signatureCode, indicating that a signature has been obtained and is on file.

Table X: Fixed legalAuthenticator.signatureCode

Code	Display Name
S (Fixed)	signed
Code System: ParticipationSignature (HL7) Code System OID: 2.16.840.1.113883.5.89

Note: CDA Release One represented either an intended ("X") or actual ("S") legalAuthenticator. CDA Release 2 and 2.1 only represents an actual legalAuthenticator, so only S / Signed can be indicated for the signatureCode.

legalAuthenticator.signatureText

A new attribute, SignatureText has been added to legalAuthenticator. The signature can be represented either inline or by reference according to the ED data type. Typical cases are:

1. Paper-based signatures: the ED data type may refer to a document or other resource that can be retrieved through an electronic interface to a hardcopy archive.
2. Electronic signature: this attribute can represent virtually any electronic signature scheme.
3. Digital signature: this attribute can represent digital signatures by reference to a signature data block that is constructed in accordance to a digital signature standard, such as XML-DSIG, PKCS#7, PGP, etc.

Table X: Fixed legalAuthenticator.contextControlCode

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

A legalAuthenticator is a person in the role of an assigned entity (AssignedEntity class). An assigned entity is a person assigned to the role by the scoping organization. The entity playing the role is a person (Person class). The entity scoping the role is an organization (Organization class).

5.2.2.8.1 AssignedEntity

Refer to AssignedEntity as defined for authenticator participation.

5.2.2.8.2 Person

Refer to Person as defined for Author participation.

5.2.2.8.3 Organization

Refer to Organization as defined for authenticator participation.

5.2.2.8.4 OrganizationPartOf

Refer to OrganizationPartOf as defined for authenticator participation.

5.2.2.9 participant

participant

Table X: participant

Attribute Name	Data Type	Cardinality	Code Binding	Binding Type
typeCode	CS	[0..1]	ParticipationType	Fixed
functionCode	CE	[0..1]	D:ParticipationFunction	Open
contextControlCode	CS	[0..1]	OP	Fixed
time	TS	[1..1]

participant.typeCode

The participant.typeCode is can be any code defined in the ParticipationType domain. Which can be used to represent other participants not explicitly mentioned by other classes, that were somehow involved in the documented acts.

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

participant.functionCode

The participant.functionCode is bound to the concept domain ParticipationFunction, which is used to specify the exact function an actor had in a service in all necessary detail. This domain may include local extensions (Open).

participant.contextControlCode

The participant.contextControlCode is fixed to "OP". It means that the participantType code specified in participant.typeCode will replace the set of author participations that have propagated from ancestor Acts, and will itself be the only author to propagate to any child Acts that allow context to be propagated.

Table X: Fixed participant.contextControlCode

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

participant.typeCode.time

The participant.typeCode.time is the date and time the specific participation occurred.

5.2.2.9.1 AssociatedEntity

A participant is a person or organization in the role of a participating entity (AssociatedEntity class). The entity playing the role is a person (Person class). The entity scoping the role is an organization (Organization class).

Table X: AssociatedEntity

Attribute Name	Data Type	Cardinality	Code Binding	Binding Type
classCode	CS	[1..1]	V:RoleClassAssociative	Closed
id	SET<II>	[0..*]
code	CE	[0..1]	D:RoleCode	Open
addr	SET<AD>	[0..*]
telecom	SET<TEL>	[0..*]

AssociatedEntity.classCode

When the participating entity is an organization, this is reflected by the presence of a scoping Organization, without a playing entity. Otherwise, the participating entity is considered a person with or without a scoping Organization.

Table X: Value set for ParticipatingEntity.classCode

V:RoleClassAssociative [2.16.840.1.113883.1.11.19313] (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
Code System: RoleClass (HL7) Code System OID: 2.16.840.1.113883.5.110

AssociatedEntity.id

An identifier for the associate person (when present) or the organization.

AssociatedEntity.code

An optional role code taken from the RoleCode concept domain. This binding is open so other code systems can be used.

AssociatedEntity.addr

The postal address for the associate person (when present) or the organization.

AssociatedEntity.telecom

The phone number for the associated person (when present) or the organization.

5.2.2.9.2 Person

Refer to Person as defined for Author participation.

5.2.2.9.3 Organization

Refer to Organization as defined for authenticator participation.

5.2.2.10 performer

See ServiceEvent for a description of the performer participant.

5.2.2.11 recordTarget

recordTarget

The recordTarget represents the medical record that this document belongs to.

A clinical document typically has exactly one recordTarget participant. In the uncommon case where a clinical document (such as a group encounter note) is placed into more than one patient chart, more than one recordTarget participants can be stated.

The recordTarget(s) of a document are stated in the header and propagate to nested content, where they cannot be overridden (see See CDA Context).

Table X: recordTarget

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

recordTarget.typeCode

The recordTarget.typeCode is fixed to "RCT" and indicates that this is a record target participation.

Table X: Fixed recordTarget.typeCode

Code	Display Name
RCT	record target
Code System: ParticipationType (HL7) Code System OID: 2.16.840.1.113883.5.90

recordTarget.contextControlCode

The recordTarget.contextControlCode is fixed to "OP". It means that the recordTarget identified in the header will propagate to any child Acts that allow context to be propagated.

Table X: Fixed recordTarget.contextControlCode

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

A recordTarget is represented as a relationship between a person and an organization, where the person is in a patient role (PatientRole class). The entity playing the role is a patient (Patient class). The entity scoping the role is an organization (Organization class). A patient is uniquely identified via the PatientRole.id attribute.

5.2.2.11.1 PatientRole

Table X: PatientRole

Attribute Name	Data Type	Cardinality	Code Binding	Binding Type
classCode	CS	[0..1]	PAT	Fixed
id	SET<II>	[1..*]
addr	SET<AD>	[0..*]
telecom	SET<TEL>	[0..*]

PatientRole.classCode

The PatientRole.classCode is fixed to "PAT" to indicate a person (Patient) as a recipient of health care services from a healthcare provider.

Table X: Fixed PatientRole.classCode

Code	Display Name
PAT	patient
Code System: RoleClass (HL7) Code System OID: 2.16.840.1.113883.5.110

PatientRole.id

A unique identifier for the person in this patient role.

PatientRole.addr

The postal address for the Patient.

PatientRole.telecom

The phone number for the Patient.

5.2.2.11.2 Patient

Table X: Patient

Attribute Name	Data Type	Cardinality	Code Binding	Binding Type
classCode	CS	[0..1]	PSN	Fixed
determinerCode	CS	[0..1]	INSTANCE	Fixed
id (Deprecated)	SET<II>	[0..*]
name	SET<PN>	[0..*]
desc	ED	[0..1]
administrativeGenderCode	CE	[0..1]	D:administrativeGender	Open
birthTime	TS	[0..1]
deceasedInd	BL	[0..1]
deceasedTime	TS	[0..1]
multipleBirthInd	BL	[0..1]
multipleBirthOrderNumber	INT	[0..1]
maritalStatusCode	CE	[0..1]	D:MaritalStatus	Open
religiousAffiliationCode	CE	[0..1]	D:ReligousAffiliation	Open
raceCode	SET<CE>	[0..*]	D:Race	Open
ethnicGroupCode	SET<CE>	[0..*]	D:Ethnicity	Open

Patient.classCode

The Patient.classCode is fixed to "PSN", indicating that the entity is a person.

Table X: Fixed Patient.classCode

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

Patient.determinerCode

The determinerCode is fixed to "INSTANCE", which indicates a specific person is a patient.

Table X: Fixed Patient.determinerCode

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

Patient.id (Deprecated)

CDA Release 1.0 allowed for additional person identifiers, corresponding to the Patient.id attribute in CDA Release 2.1. This attribute is included for backwards compatibility and has been deprecated because having two different ways to identify a patient can result in inconsistent usage. Further use of Patient.id is discouraged.

Patient.name

The patient's name.

Note: The person name data type "PN" supports current, and historical names using validTime, and the specification of different use codes can indicate legal name, tribal name, stage name and others.

Patient.desc

A textual or multimedia depiction of the patient.

Patient.administrativeGenderCode

The gender (i.e., the behavioral, cultural, or psychological traits typically associated with one sex) of a living subject as defined for administrative purposes.

Patient.birthTime

The date and time of the patient's birth.

Patient.deceasedInd

An indication that the subject is dead.

Patient.deceasedTime

The date and time that the patient's death occurred.

Patient.multipleBirthInd

An indication as to whether the patient was part of a multiple birth.

Patient.multipleBirthOrderNumber

The order within a multiple birth in which this patient was born.

Patient.maritalStatusCode

The domestic partnership status of the patient.

Patient.religiousAffiliationCode

The primary religious preference of the patient.

Patient.raceCode

The race of the patient.

Note: More than one race code is now supported in CDA R2.1.

Patient.ethnicGroupCode

The ethnic group of the patient.

Note: More than one race code is now supported in CDA R2.1.

5.2.2.11.3 Organization

Refer to Organization as defined for authenticator participation.

5.2.2.11.4 LanguageCommunication

A patient's language communication skills can be expressed in the associated LanguageCommunication class.

Table X: LanguageCommunication

Attribute Name	Data Type	Cardinality	Code Binding	Binding Type
languageCode	CE	[0..1]	D:HumanLanguage	Open
modeCode	CE	[0..1]	D:LanguageAbilityMode	Open
proficiencyLevelCode	CE	[0..1]	D:LanguageAbilityProficiency	Open
preferenceInd	BL	[0..1]

LanguageCommunication.languageCode

A language for which the patient has some level of proficiency for communication.

LanguageCommunication.modeCode

The method of expression of the language, e.g. expressed spoken, expressed written, expressed signed, received spoken, received written, received signed

LanguageCommunication.proficiencyLevelCode

The level of proficiency the patient has in a particular language, e.g. excellent, good, fair, poor

LanguageCommunication.preferenceInd

An indicator specifying whether the language is preferred by the patient for the associated mode.

5.2.2.11.5 Birthplace

A Patient's birthplace is represented as a relationship between a patient and a place. The Birthplace class is played by a place (Place class), and scoped by the patient (Patient class).

Table X: Birthplace

Attribute Name	Data Type	Cardinality	Code Binding	Binding Type
classCode	CS	[0..1]	BIRTHPL	Fixed

Birthplace.classCode

The Birthplace.classCode it fixed to "BIRTHPL" indicating in this context, that the Place referenced is the birth place of the patient.

Table X: Fixed Birthplace.classCode

Code	Display Name
BIRTHPL	birthplace
Code System: RoleClass (HL7) Code System OID: 2.16.840.1.113883.5.110

5.2.2.11.6 Place

Table X: Place

Attribute Name	Data Type	Cardinality	Code Binding	Binding Type
classCode	CS	[0..1]	PLC	Fixed
determinerCode	CS	[0..1]	INSTANCE	Fixed
name	SET<ON>	[0..1]
addr	SET<AD>	[0..*]

Place.classCode

A physical place or site with its containing structure. May be natural or man-made. The geographic position of a place may or may not be constant.

Table X: Fixed Place.classCode

Code	Display Name
PLC	place
Code System: EntityClass (HL7) Code System OID: 2.16.840.1.113883.5.41

Place.determinerCode

The determinerCode is fixed to "INSTANCE", which indicates a specific place is being identified.

Table X: Fixed Place.determinerCode

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

Place.name

The name of place of birth (E.g. Queen Mary)

Place.addr

The postal address for the patient's birthplace.

5.2.2.11.7 Guardian

A patient's guardian is a person or organization in the role of guardian (Guardian class). The entity playing the role of guardian is a person (Person class) or organization (Organization class). The entity scoping the role is the patient (Patient class).

Where a guardian is not explicitly stated, the value should default to local business practice (e.g. the patient makes their own health care decisions unless incapacitated in which case healthcare decisions are made by the patient's spouse).

Table X: Guardian

Attribute Name	Data Type	Cardinality	Code Binding	Binding Type
classCode	CS	[1..1]	GUARD	Fixed
id	SET<II>	[0..*]
code	CE	[0..1]	D:RoleCode	Open
addr	SET<AD>	[0..*]
telecom	SET<TEL>	[0..*]

Guardian.classCode

The Guardian.classCode is fixed to "GUARD", indicating that the associated person or institution are legally empowered with responsibility for the care of a ward.

Table X: Fixed Guardian.classCode

Code	Display Name
GUARD	guardian
Code System: RoleClass (HL7) Code System OID: 2.16.840.1.113883.5.110

Guardian.code

An optional role code taken from the RoleCode concept domain. This binding is open so other code systems can be used.

Guardian.addr

The guardian's postal address.

Guardian.telecom

The guardian's phone number.

5.2.2.11.8 Person

Refer to Person as defined for Author participation.

5.2.2.11.9 Organization

Refer to organization as defined for authenticator participation.

5.2.2.12 responsibleParty

See EncompassingEncounter for a description of the responsibleParty participant.

5.2.2.13 Participant Scenarios

Several CDA Header participations can be played by the same person. In such cases, the person should be identified as the player for each appropriate participation. For instance, if a person is both the author and the authenticator of a document, the CDA Header should identify that person as both the author participant and the authenticator participant.

On other occasions, CDA Header participants are played by different people. The following table shows a number of scenarios and the values for various participants.

Table X: CDA participation scenarios

1. StaffPhysicianOne sees a patient as a consultant, dictates a note, and later signs it.

*Author — StaffPhysicianOne Encounter Participant — StaffPhysicianOne (typeCode="CONS") Legal Authenticator — StaffPhysicianOne

2. StaffPhysicianOne sees a patient and dictates a note. StaffPhysicianTwo later signs the note. *

*Author — StaffPhysicianOne Legal Authenticator — StaffPhysicianTwo

3. ResidentOne sees a patient with StaffPhysicianOne. ResidentOne dictates a note and later signs it. The note is co-signed by StaffPhysicianOne. *

*Author — ResidentOne Authenticator — ResidentOne Encounter Participant — StaffPhysicianOne (typeCode="ATND") Legal Authenticator — StaffPhysicianOne

4. ResidentOne sees a patient with StaffPhysicianOne. ResidentOne dictates a note and later signs it. The note is co-signed by StaffPhysicianTwo. *

Author — ResidentOne Authenticator — ResidentOne Encounter Participant — StaffPhysicianOne (typeCode="ATND") Legal Authenticator — StaffPhysicianTwo

5. ResidentOne sees a patient with StaffPhysicianOne. ResidentOne dictates a note, and goes off on vacation. The note is signed by ResidentTwo and by StaffPhysicianOne. *

Author — ResidentOne Authenticator — ResidentTwo Encounter Participant — StaffPhysicianOne (typeCode="ATND") Legal Authenticator — StaffPhysicianOne

6. ResidentOne sees a patient with StaffPhysicianOne. ResidentOne dictates a note, which is later signed by ResidentTwo and StaffPhysicianTwo. *

Author — ResidentOne Authenticator — ResidentTwo Encounter Participant — StaffPhysicianOne (typeCode="ATND") Legal Authenticator — StaffPhysicianTwo

7. StaffPhysicianOne receives an abnormal lab result, attempts to contact patient but can't, and writes and signs a progress note.

Author — StaffPhysicianOne Legal Authenticator — StaffPhysicianOne

8. ResidentSurgeonOne is operating on a patient with StaffSurgeonOne. StaffSurgeonOne dictates an operative report and later signs it.

Author — StaffSurgeonOne Authenticator — null (need not be included) Legal Authenticator — StaffSurgeonOne Performer — StaffSurgeonOne (typeCode="PPRF") Performer — ResidentSurgeonOne (typeCode="SPRF")

* Note that the ability of one clinician to co-sign or to sign on behalf of another clinician is subject to regulatory and local practice constraints.

5.2.3 Header Relationships

This section describes classes related to the root ClinicalDocument class via an ActRelationship.

5.2.3.1 ParentDocument

ParentDocument

The ParentDocument represents the source of a document revision, addenda, or transformation.

5.2.3.1.1 relatedDocument

The optional relatedDocument class is used to associate a ClinicalDocument to a ParentDocument.

Table X: relatedDocument Attributes

Attribute Name	Data Type	Cardinality	Code Binding	Binding Type
typeCode	CS	[1..1]	x_ActRelationshipDocument	Closed

relatedDocument.typeCode

Allowable values for the intervening relatedDocument.typeCode are shown in the following table.

Table X: Value set for relatedDocument.typeCode

v:x_ActRelationshipDocument [2.16.840.1.113883.1.11.11610] (CLOSED)
Code	Display Name		Code	Display Name
APND	is appendage		RPLC	replaces
XFRM]	transformation
Code System: ActRelationshipType (HL7) Code System OID: 2.16.840.1.113883.5.1002

A conformant CDA document can have a single relatedDocument with typeCode "APND"; a single relatedDocument with typeCode "RPLC"; a single relatedDocument with typeCode "XFRM"; a combination of two relatedDocuments with typeCodes "XFRM" and "RPLC"; or a combination of two relatedDocuments with typeCodes "XFRM" and "APND". No other combinations are allowed.

5.2.3.1.2 ParentDocument

The ParentDocument identifies and optionally provides a reference to the original document serving as the source for the current document revision, addendum or transformation.

Table X: ParentDocument Attributes

Attribute Name	Data Type	Cardinality	Code Binding	Binding Type
classCode	CS	[0..1]	DOCCLIN	Fixed
moodCode	CS	[0..1]	EVN	Fixed
typeId	II	[1..1]
id	II	[1..*]
code	CE	[1..1]	D:DocumentType	Open
text	ED	[0..1]
setId	II	[0..1]
versionNumber	ST.SIMPLE	[0..1]

ParentDocument.classCode

The ParentDocument.classCode is fixed to "DOCCLIN".

Table X: Fixed ParentDocument.classCode

Code	Display Name
DOCCLIN	clinical document
Code System: ActClass (HL7) Code System OID: 2.16.840.1.113883.5.6

ParentDocument.moodCode

The ParentDocument.moodCode is fixed to "EVN".

Table X: Fixed ParentDocument.moodCode

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

ParentDocument.id

The ParentDocument.id is a required identifier, which uniquely identifies the parent document.

ParentDocument.code

The code specifying the particular kind of document (e.g. History and Physical, Discharge Summary, Progress Note). The value set is drawn from LOINC, and has a CWE coding strength.

ParentDocument.text

ParentDocument.text is modeled as an ED data type - allowing for the expression of the MIME type of the parent document. It is not to be used to embed the related document, and thus ParentDocument.text.BIN is precluded from use.

ParentDocument.setId

Optional setID for the parent document.

ParentDocument.versionNumber

Optional versionNumber of the parent document.

Additional Information on Document Identification, Revisions, and Addenda

A clinical document can be replaced by a new document and/or appended with an addendum.

A replacement document is a new version of the parent document. The parent document is considered superseded, but a system may retain it for historical or auditing purposes. The parent document being replaced is referenced via act relationship relatedDocument, where relatedDocument.typeCode is set to equal "RPLC" (for "replaces"). An example is a report found to contain an error that is subsequently replaced by the corrected report.

An addendum is a separate document that references the parent document, and may extend or alter the observations in the prior document. The parent document remains a current component of the patient record, and the addendum and its parent are both read by report recipients. The parent report (represented by the ParentDocument class) being appended is referenced via act relationship relatedDocument, where relatedDocument.typeCode is set to equal "APND" (for "appends").

Every CDA document must have a unique ClinicalDocument.id, and thus the replacement or addendum documents each have ClinicalDocument.id that is different from that of the parent document.

CDA documents may also contain a ClinicalDocument.setId and a ClinicalDocument.versionNumber, which together support a document identification and versioning scheme used in some document management systems. In this scheme, all documents in a chain of replacements have the same ClinicalDocument.setId and are distinguished by an incrementing ClinicalDocument.versionNumber. The initial version of a document gets, in addition to a new unique value for ClinicalDocument.id, a new value for ClinicalDocument.setId, and has the value of ClinicalDocument.versionNumber set to equal "1". A replacement document gets a new globally unique ClinicalDocument.id value, and uses the same value for ClinicalDocument.setId as the parent report being replaced, and increments the value of ClinicalDocument.versionNumber by 1. (Note that version number must be incremented by one when a report is replaced, but can also be incremented more often to meet local requirements.)

These relationships are illustrated in the following exhibit "Document Identification, Revisions, and Addenda Scenarios". Typical scenarios are a simple relacement (e.g. ClinicalDocument.id "1.2.345.6789.266" replacing ClinicalDocument.id "1.2.345.6789.123") and a simple append (e.g. ClinicalDocument.id "1.2.345.6789.456" appends ClinicalDocument.id "1.2.345.6789.123"). More complex scenarios that might be anticipated include: [1] replacement of an addendum (e.g. ClinicalDocument.id "1.2.345.6789.224" replaces ClinicalDocument.id "1.2.345.6789.456", which itself is an addendum to ClinicalDocument.id "1.2.345.6789.123") - expected behavior would be to render the replacement as the addendum (e.g. render ClinicalDocument.id "1.2.345.6789.224" as the addendum to ClinicalDocument.id "1.2.345.6789.123"); [2] addendum to a replaced document (e.g. ClinicalDocument.id "1.2.345.6789.456" appends ClinicalDocument.id "1.2.345.6789.123", which has been replaced by ClinicalDocument.id "1.2.345.6789.266") - expected behavior would be to render the addendum along with the replacement (e.g. render ClinicalDocument.id "1.2.345.6789.456" as an addendum to ClinicalDocument.id "1.2.345.6789.266").

Document transformations

A CDA document can be a transformation from some other format, meaning that it has undergone a machine translation from some other format (such as DICOM SR). In this case, relatedDocument.typeCode should be set to "XFRM".

A proper transformation must ensure that the human readable clinical content of the report is not impacted. Local business rules determine whether or not a transformed report replaces the source, but typically this would not be the case. If it is, an additional relationship of type "RPLC" is to be used. The "XFRM" relationship can also be used when translating a document in a local format into CDA for the purpose of exchange. In this case, the target of the "XFRM" relationship is the local document identifier.

Technical note: The inversionInd was not available in CDA R2.0, and CDA R2.0 assumed that the source document (ClinicalDocument) was a transformation of the target document (ParentDocument). The actual definition of "XFRM: Used when the target Act is a transformation of the source Act..." requires the use of inversionInd to establish the ClinicalDocument as the target and the ParentDocument as the source for the transformation. As a result, in CDA R2.1 when "XFRM" is assigned to the relatedDocument.typeCode the associated inversionInd is assumed to be fixed to true, but does not need to be present in the instance. In all other cases, "APND", "RPLC" the associated inversionInd is not present and assumed to be false. This enables wire format compatibility between CDA R2.0 and CDA R2.1, and ensures proper interpretation of the "XFRM" ActRelationshipType code.

Link to wide graphic (opens in a new window)

5.2.3.2 ServiceEvent

ServiceEvent

The ServiceEvent is used to represent the main activity being documented. It may used to represent a specific procedure, such as a colonoscopy, an appendectomy, or other clinical activity. When the ClinicalDocument represents a summary of care, the ServiceEvent.code can be set to "PCPR" to indicate the service is care provisioning.

5.2.3.2.1 documentationOf

The optional documentationOf class is used to associate a ClinicalDocument to a ServiceEvent.

Table X: documentationOf Attributes

Attribute Name	Data Type	Cardinality	Code Binding	Binding Type
typeCode	CS	[0..1]	DOC	Fixed

documentationOf.typeCode

The documentationOf.typeCode is fixed to "DOC" which indicates that the ClinicalDocument provides documentation is about ServiceEvent.

Table X: Fixed documentationOf.typeCode

Code	Display Name
DOC	documents
Code System: ActRelationshipType (HL7) Code System OID: 2.16.840.1.113883.5.1002

5.2.3.2.2 ServiceEvent

In some cases, the ServiceEvent is inherent in the ClinicalDocument.code, such as where ClinicalDocument.code is "History and Physical Report" and the procedure being documented is a "History and Physical". A ServiceEvent can further specialize the act inherent in the ClinicalDocument.code, such as where the ClinicalDocument.code is simply "Procedure Report" and the procedure was a "colonoscopy". If ServiceEvent is included, it must be equivalent to or further specialize the value inherent in the ClinicalDocument.code, and shall not conflict with the value inherent in the ClinicalDocument.code, as such a conflict would constitute an ambiguous situation.

Table X: ServiceEvent Attributes

Attribute Name	Data Type	Cardinality	Code Binding	Binding Type
classCode	CS	[0..1]	V:ActClassRoot	Fixed
moodCode	CS	[0..1]	EVN	Fixed
id	II	[0..*]
code	CD	[0..1]	D:ActCode	Open
statusCode	CS	[0..1]	V:ActStatus	Closed
effectiveTime	IVL<TS>	[0..1]

ServiceEvent.classCode

The ServiceEvent.classCode identifies the RIM Act class code of the service event instance.

Table X: Value set for ServiceEvent.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

ServiceEvent.moodCode

The ServiceEvent.moodCode is fixed to "EVN", which indicates documentation of a past service.

Table X: Fixed ServiceEvent.moodCode

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

ServiceEvent.id

The optional unique identifier for the ServiceEvent.

ServiceEvent.code

The particular kind of service event that the this instance represents within its class code. The ServiceEvent.code is bound to the D:ActCode concept domain.

ServiceEvent.statusCode

The ServiceEvent.statusCode can take on any of the values defined in the D:ActStatus domain.

ServiceEvent.effectiveTime

ServiceEvent.effectiveTime can be used to indicate the time the actual event (as opposed to the encounter surrounding the event) took place.

5.2.3.2.3 performer

The performer participant represents clinicians who actually and principally carry out the ServiceEvent.

Table X: performer

Attribute Name	Data Type	Cardinality	Code Binding	Binding Type
typeCode	CS	[1..1]	x_ServiceEventPerformer	Closed
functionCode	CE	[0..1]	D:ParticipationFunction	Open
time	TS	[1..1]

performer.typeCode

Allows for the optional identification of performers, primary performers and secondary performers.

Table X: Value set for performer.typeCode

v:x_ServiceEventPerformer [2.16.840.1.113883.1.11.19601] (CLOSED)
Code	Display Name		Code	Display Name
PRF	performer		PPRF	primary performer
SPRF	secondary performer
Code System: ParticipationType (HL7) Code System OID: 2.16.840.1.113883.5.90

performer.functionCode

Performer.functionCode can be used to specify addition detail about the function of the performer (e.g. scrub nurse, third assistant). The functionCode is bound to the D:ParticipationFunction concept domain.

performer.time

Performer.time can be used to specify the time during which the performer is involved in the activity.

5.2.3.2.4 AssignedEntity

A performer is an entity in the role of assigned entity (AssignedEntity class).

5.2.3.2.5 Person

An assigned entity is a person assigned to the role by the scoping organization. The entity playing the role is a person (Person] class).

5.2.3.2.6 Organization

The entity scoping the role is an organization (Organization class).

5.2.3.3 Order

Order

This class represents those orders that are fulfilled by this document. For instance, a provider orders an X-Ray. The X-Ray is performed. A radiologist reads the X-Ray and generates a report. The X-Ray order identifier is transmitted in the Order class, the performed X-Ray procedure is transmitted in the ServiceEvent class, and the ClinicalDocument.code would be valued with "Diagnostic Imaging Report".

5.2.3.3.1 inFullfillmentOf

The optional inFullfillmentOf class is used to associate a ClinicalDocument to an Order.

Table X: Fixed InFulfillmentOf.typeCode

Code	Display Name
FLFS	fulfills
Code System: ActRelationshipType (HL7) Code System OID: 2.16.840.1.113883.5.1002

5.2.3.3.2 Order

A reference to the fulfilled order.

Table X: Order Attributes

Attribute Name	Data Type	Cardinality	Code Binding	Binding Type
classCode	CS	[0..1]	V:ActClassRoot	Closed
moodCode	CS	[0..1]	RQO	Fixed
id	II	[1..*]
code	CD	[0..1]	D:ActCode	Open
priorityCode	CS	[0..1]	V:ActPriority	Open

Order.classCode

The Order.classCode identifies the RIM Act class code of the order instance.

Table X: Value set for Order.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

Order.moodCode

The Order.moodCode is fixed to "RQO", which indicates we are referencing the actual order instance.

Table X: Fixed Order.moodCode

Code	Display Name
RQO	request
Code System: ActMood (HL7) Code System OID: 2.16.840.1.113883.5.1001

Order.id

The Order.id is a unique identifier for the order that was fulfilled.

Order.code

The particular kind of order that the this instance represents within its class code. The optional Order.code is bound to the D:ActCode concept domain.

Order.priorityCode

The optional Order.priorityCode, identifies the priority requested when the order was placed. It is bound to the D:ActPriority concept domain.

5.2.3.4 Consent

Consent

Provides references to consents on file.

5.2.3.4.1 authorization

The optional authorization class is used to associate a ClinicalDocument to a Consent.

Table X: authorization Attributes

Attribute Name	Data Type	Cardinality	Code Binding	Binding Type
typeCode	CS	[0..1]	AUTH	Fixed

authorization.typeCode

Table X: Fixed authorization.typeCode

Code	Display Name
AUTH	authorized by
Code System: ActRelationshipType (HL7) Code System OID: 2.16.840.1.113883.5.1002

5.2.3.4.2 Consent

This class references the consents associated with this document.

Table X: Consent Attributes

Attribute Name	Data Type	Cardinality	Code Binding	Binding Type
classCode	CS	[0..1]	CONS	Fixed
moodCode	CS	[0..1]	EVN	Fixed
id	II	[0..*]
code	CD	[0..1]	D:ActCode	Open
statusCode	CS	[1..1]	completed	Fixed

Consent.classCode

The Consent.classCode is fixed to "CONS" to represent a consent. The Consent class represents informed consents and all similar medico-legal transactions between the patient (or his legal guardian) and the provider.

Table X: Fixed Consent.classCode

Code	Display Name
CONS	consent
Code System: ActClass (HL7) Code System OID: 2.16.840.1.113883.5.6

Consent.moodCode

The Consent.moodCode is fixed to "EVN" (event) which indicates the consent has already been captured and is assumed to be on file.

Table X:Fixed Consent.moodCode

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

Consent.id

Optional identifier for the consent.

Consent.code

The Consent.code is bound to the D:ActCode concept domain. It is used to optionally identify the type of consent (e.g. a consent to perform the related ServiceEvent, a consent for the information contained in the document to be released to a third party).

Consent.statusCode

Consents referenced in the CDA Header have been finalized (Consent.statusCode must equal "completed") and should be on file.

Table X: Fixed Consent.statusCode

Code	Display Name
completed	completed
Code System: ActStatus (HL7) Code System OID: 2.16.840.1.113883.5.14

5.2.3.5 EncompassingEncounter

EncompassingEncounter

This optional class represents the setting of the clinical encounter during which the documented act(s) or ServiceEvent occurred. Documents are not necessarily generated during an encounter, such as when a clinician, in response to an abnormal lab result, attempts to contact the patient but can't, and writes a Progress Note.

5.2.3.5.1 componentOf

The optional componentOf class is used to associate the ClinicalDocument to an EncompassingEncounter.

Table X: componentOf Attributes

Attribute Name	Data Type	Cardinality	Code Binding	Binding Type
typeCode	CS	[0..1]	COMP	Fixed

componentOf.typeCode

The componentOf.typeCode is fixed to "COMP", which indicates that the ClinicalDocument was created within the context of an encounter (encompassingEncounter).

Table X: Fixed componentOf.typeCode

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

5.2.3.5.2 EncompassingEncounter

The EncompassingEncounter represents an interaction between a patient and care provider(s) for the purpose of providing healthcare-related service(s).

Table X: EncompassingEncounter Attributes

Attribute Name	Data Type	Cardinality	Code Binding	Binding Type
classCode	CS	[0..1]	ENC	Fixed
moodCode	CS	[0..1]	EVN	Fixed
id	II	[0..*]
code	CD	[0..1]	V:ActEncounterCode	Open
effectiveTime	IVL<TS>	[0..1]
admissionReferralSourceCode	CE	[0..1]	D:EncounterReferralSourceCode	Open
dischargeDispositionCode	CE	[0..1]	D:EncounterDischargeDisposition	Open

EncompassingEncounter.classCode

The EncompassingEncounter.classCode is fixed to "ENC" to represent a encounter. The encounter class is used to represent an interaction between a patient and healthcare participant(s) for the purpose of providing patient service(s) or assessing the health status of a patient.

Table X: Fixed EncompassingEncounter.classCode

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

EncompassingEncounter.moodCode

The EncompassingEncounter.moodCode is fixed to "EVN" (event) which indicates that the encounter is on-going or completed.

Table X: Fixed EncompassingEncounter.moodCode

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

EncompassingEncounter.id

The optional EncompassingEncounter.id can be used to uniquely identify the encounter.

EncompassingEncounter.code

The optional EncompassingEncounter.code is bound to the ActEncounterCode value set.

Table X: Value set for EncompassingEncounter.code

V:ActEncounterCode [2.16.840.1.113883.1.11.13955] (OPEN)
Code	Display Name		Code	Display Name
AMB	ambulatory		EMER	emergency
FLD	field		HH	home health
IMP	inpatient encounter		ACUTE	inpatient acute
NONAC	virtual		SS	short stay
VR	inpatient non-acute
Code System: ActCode (HL7) Code System OID: 2.16.840.1.113883.5.4

EncompassingEncounter.effectiveTime

For Encounters, the effectiveTime is the "administrative" time, i.e., the encounter start and end date as established by business rules. For inpatient encounters, the effectiveTime/low value is the admission date and time and the effectiveTime/high value is the discharge date and time. Note: If the encounter is still active at the time of document creation, the effectiveTime/high element can be omitted to indicate the encounter is on-going.

EncompassingEncounter.admissionReferralSourceCode

The optional EncompassingEncounter.admissionReferralSourceCode can be use to depict the type of place or organization responsible for the patient's care immediately prior to a patient encounter.

EncompassingEncounter.dischargeDispositionCode

The optional EncompassingEncounter.dischargeDispositionCode can be used to depict the disposition of the patient at the time of hospital discharge (e.g., discharged to home, expired, against medical advice, etc.).

5.2.3.5.3 location

The location participant (location class) relates a healthcare facility (HealthCareFacility class) to the encounter to indicate where the encounter took place.

Table X: location

Attribute Name	Data Type	Cardinality	Code Binding	Binding Type
typeCode	CS	[1..1]	LOC	Fixed

location.typeCode

Table X: Fixed participant.typeCode

Code	Display Name
LOC	location
Code System: ParticipationType (HL7) Code System OID: 2.16.840.1.113883.5.90

5.2.3.5.4 HealthCareFacility

The HealthCareFacility class supports the identification of the service delivery location. The location may be the setting (place) with an optional organizational reference, or a reference to the healthcare organization.

Table X: HealthCareFacility

Attribute Name	Data Type	Cardinality	Code Binding	Binding Type
classCode	CS	[0..1]	SDLOC	Fixed
id	SET<II>	[0..*]
code	CE	[0..1]	V:ServiceDeliveryLocation	Open

HealthCareFacility.classCode

The HealthCareFacility.classCode is bound to the ServiceDeliveryLocation valueset and defaulted to the "SDLOC" to indicate the service delivery location.

Table X: Value set for HealthCareFacility.classCode

v:RoleClassServiceDeliveryLocation [2.16.840.1.113883.1.11.16927] (CLOSED)
Code	Display Name		Code	Display Name
SDLOC (Default)	service delivery location		DSDLOC	dedicated service delivery location, health care facility
ISDLOC	incidental service delivery location
Code System: RoleClass (HL7) Code System OID: 2.16.840.1.113883.5.110

HealthCareFacility.id

An optional HealthCareFacility.id can be sent to uniquely identify the health care facility.

HealthCareFacility.code

The setting of an encounter (e.g. cardiology clinic, primary care clinic, rehabilitation hospital, skilled nursing facility) can be expressed in HealthCareFacility.code. A valueset ServiceDeliveryLocationRoleType is provided for the this field.

Note: In some cases, the setting of the encounter is inherent in the ClinicalDocument.code, such as where ClinicalDocument.code is "Diabetes Clinic Progress Note". The setting of an encounter can also be transmitted in the HealthCareFacility.code attribute. If HealthCareFacility.code is sent, it should be equivalent to or further specialize the value inherent in the ClinicalDocument.code (such as where the ClinicalDocument.code is simply "Clinic Progress Note" and the value of HealthCareFacility.code is "cardiology clinic"), and shall not conflict with the value inherent in the ClinicalDocument.code, as such a conflict would constitute an ambiguous situation.

5.2.3.5.5 Place

The entity playing the role of HealthCareFacility is a place (Place class).

The setting (place) and physical location are not the same. There is a many-to-many relationship between setting and the physical location where care is delivered. Thus, a particular room can provide the setting for cardiology clinic one day, and for primary care clinic another day; and cardiology clinic today might be held in one physical location, but in another physical location tomorrow.

5.2.3.5.6 Organization

The entity scoping the HealthCareFacility role is an organization (Organization class). When the location is an organization, this is indicated by the presence of a scoping Organization, without a playing Place.

5.2.3.5.7 responsibleParty

The responsibleParty participant represents the participant having primary legal responsibility for the encounter. This differs from the legalAuthenticator participant in that the legalAuthenticator may or may not be the responsible party, and is serving a medical records function by signing off on the document, moving it into a completed state.

responsibleParty.typeCode

The responsibleParty.typeCode is fixed to "RESP" to indicate the responsible party i.e. The person or organization that has primary responsibility for the encounter. The responsible party is not necessarily present in an action, but is accountable for the action through the power to delegate, and the duty to review actions with the performing actor after the fact. This responsibility may be ethical, legal, contractual, fiscal, or fiduciary in nature.

Table X: Fixed responsibleParty.typeCode

Code	Display Name
RESP	responsible party
Code System: ParticipationType (HL7) Code System OID: 2.16.840.1.113883.5.90

A responsibleParty is a person or organization in the role of an assigned entity (AssignedEntity class). An assigned entity is a person assigned to the role by the scoping organization. The entity playing the role is a person (Person class). The entity scoping the role is an organization (Organization class).

When the responsible party is an organization, the value for AssignedEntity.classCode is "ASSIGNED", and the responsible party is reflected by the presence of a scoping Organization, without a playing entity.

5.2.3.5.8 AssignedEntity

A performer is an entity in the role of assigned entity (AssignedEntity class).

5.2.3.5.9 Person

An assigned entity is a person assigned to the role by the scoping organization. The entity playing the role is a Person class.

5.2.3.5.10 Organization

The entity scoping the role is an organization (Organization class).

5.2.3.5.11 encounterParticipant

The encounterParticipant participant represents clinicians directly associated with the encounter (e.g. by initiating, terminating, or overseeing it).

Table X: performer

Attribute Name	Data Type	Cardinality	Code Binding	Binding Type
typeCode	CS	[1..1]	V:x_EncounterParticipant	Closed
time	TS	[0..1]

encounterParticipant.typeCode

The encounterParticipant typeCode is bound to the x_EncounterParticipant value set. It supports for the following participation: admitter, attender, consultant, discharger, and referrer.

Table X: Value set for encounterParticipant.typeCode

V:x_EncounterParticipant [2.16.840.1.113883.1.11.19600] (CLOSED)
Code	Display Name		Code	Display Name
ADM	admitter		ATND	attender
CON	consultant		DIS	discharger
REF
Code System: ParticipationType (HL7) Code System OID: 2.16.840.1.113883.5.90

encounterParticipant.time

An encounterParticipant is an entity in the role of assigned entity (AssignedEntity class). An assigned entity is a person assigned to the role by the scoping organization. The entity playing the role is a person (Person class). The entity scoping the role is an organization (Organization class).

5.2.3.5.12 AssignedEntity

A performer is an entity in the role of assigned entity (AssignedEntity class).

5.2.3.5.13 Person

An assigned entity is a person assigned to the role by the scoping organization. The entity playing the role is a Person class.

5.2.3.5.14 Organization

The entity scoping the role is an organization (Organization class).

5.3 Body

(content on separate page)

5.4 CDA Context

CDA context is set in the CDA header and applies to the entire document. Context can be overridden at the level of the body, section, and/or CDA entry.

5.4.1 Overview of CDA Context

A document, in a sense, is a contextual wrapper for its contents. Assertions in the document header are typically applicable to statements made in the body of the document, unless overridden. For instance, the patient identified in the header is assumed to be the subject of observations described in the body of the document, unless a different subject is explicitly stated, or the author identified in the header is assumed to be the author of the entire document, unless a different author is explicitly identified on a section. The objective of the CDA context rules are to make these practices explicit with relationship to the RIM, such that a computer will understand the context of a portion of a document the same way that a human interprets it.

At the same time, there is no guarantee that machine processing will identify a mistaken application of contextual rules. If a physician records an "outside diagnosis" in narrative but does not nullify the "informant" context, machine processing will not identify the switch in attribution. This is a special case illustrating the limits of automated validation of electronic records and would apply regardless of the context inheritance mechanism. In other words, from some errors of encoding, there is no recovery other than human review.

CDA's approach to context, and the propagation of that context to nested document components, follows these design principles:

• CDA uses the RIM context mechanism (contextControlCode for Participations; contextConductionInd for ActRelationships), and assigns fixed values to these attributes to accomplish the design objectives below, thus constraining the RIM context model. CDA extends the context propagation property to designated attributes of the CDA Header, which also propagate through any ActRelationship for which contextConductionInd="true".
• The CDA Header sets context for the entire document. A propagating value specified in the document header holds true throughout the document, unless explicitly overridden. This principal applies to both Participations and to designated attributes of the CDA Header. Contextual header components (i.e., those that have propagating values) include:
  • Author
  • Confidentiality
  • Data enterer
  • Human language
  • Informant
  • Legal authenticator
  • Participant
  • Record target
• Context components that can be overridden at the level of the document body include:
  • Confidentiality
  • Human language
• Context components that can be overridden at the level of a document section include:
  • Author
  • Confidentiality
  • Human language
  • Informant
  • Subject
• Context components that can be overridden at the level of a CDA entry include:
  • Author
  • Human language
  • Informant
  • Participant
  • Subject
• Context propagates from outer tags to nested tags. Context that is specified on an outer tag holds true for all nested tags, unless overridden on a nested tag. Context specified on a tag within the CDA body always overrides context propagated from an outer tag. For instance, the specification of authorship at a document section level overrides all authorship propagated from outer tags.
• Context is sometimes known precisely, and is sometimes unknown, such as in the case where a document is comprised of a large unparsed narrative block that potentially includes statements that contradict outer context. Because CDA context always propagates unless overridden, the representation of unknown context is achieved by overriding with a null value.

5.4.2 Technical Aspects of CDA Context

The RIM defines the "context" of an act as those participants of the act that can be propagated to nested acts. In the RIM, whether or not contextual participants do propagate to nested acts depends on whether or not the intervening act relationship between parent and child act allows for conduction of context. The explicit representation of context, and whether or not the context on an act can propagate to nested acts, is expressed via the RIM attributes Participation.contextControlCode and ActRelationship.contextConductionInd. CDA constrains the general RIM context mechanism such that context always overrides and propagates, as shown in the following table.

Table X: CDA constraints on RIM context attributes

RIM attribute	Cardinality	Conformance	Fixed Value
Participation.contextControlCode	1..1	Mandatory (NULL values not permitted)	"OP" (overriding, propagating)
ActRelationship.contextConductionInd	1..1	Mandatory (NULL values not permitted)	"true"*

*The one exception to this is entryRelationship.contextConductionInd, which is defaulted to "true", but can be changed to "false". See entryRelationship for details.

Where the context of a nested component is unknown, the propagated context must be overridden with a null-valued component, as shown in the following table.

Table X: Blocking context propagation with null values

Context	Null value representation
Author	AssignedAuthor.id = NULL; No playing entity; No scoping entity.
Confidentiality	confidentialityCode = NULL.
Human language	languageCode = NULL.
Informant	AssignedEntity.id = NULL; No playing entity; No scoping entity.
Participant	ParticipantRole.id = NULL; No playing entity; No scoping entity.

The following exhibit illustrates the CDA context model. ClinicalDocument has an author participant, a confidentialityCode, and a languageCode, all of which will propagate to nested acts. The component act relationship going from ClinicalDocument to bodyChoice has contextConductionInd fixed as "true", thus allowing for the propagation of context. The bodyChoice classes, NonXMLBody and StructuredBody, contain a confidentialityCode and languageCode which can be used to override the value specified in the header. The component act relationship going from StructuredBody to Section has contextConductionInd fixed at "true", thus the context on StructuredBody will propagate through to Section. Section can override confidentialityCode, languageCode, and author. A null value for the Section's author participant indicates that the author for that particular section is unknown.

Link to wide graphic (opens in a new window)

Because context is always overriding and propagating, one can compute the context of a given node by looking for the most proximate assertion. The following example is a sample XPath expression that can be used to identify the <author> context of a section or entry:

Example X

(ancestor-or-self::*/author)[position()=last()]

5.4.3 InfrastructureRoot & CDA Classes

All of CDA classes inherits 1 attribute and 3 element from InfrastructureRoot. Infrastructure Root provides a set of infrastructure attributes that may be used in instances of HL7-specified, RIM-based classes. When valued in an instance, these attributes indicate whether the information structure is being constrained by specifically defined templates, realms or common element types.

• An optional nullFlavor attribute has been added to each CDA class. When the class is null, this code can be used to indicate the flavor of null that is intended.

The following 3 optional elements have been added at the beginning of each CDA class:

• realmCode, is vocabulary domain qualifier that allows the vocabulary domain of coded attributes to be specialized according to the geographical, organizational, or political environment where the HL7 standard is being used. It is defined as a SET<CS>data type.
• typeId, is a unique identifier for an HL7 static structure that imposes constraints on an artifact. In CDA it must be defined at the root element, to indicate a CDA R2.1 document,with ClinicalDocument.typeId.root = "2.16.840.1.113883.1.3" (which is the OID for HL7 Registered models); ClinicalDocument.typeId.extension = "POCD_HD000040" (which is the unique identifier for the CDA, Release Two Hierarchical Description). As CMETs are not used in CDA, this element will not be used in other classes. It is defined as a II data type.
• templateId, is an optional unique identifier, which indicates to a receiver that a set of constraints have been defined for a given class and it's attributes. See section 4 on templates in CDA.