Id2.16.840.1.113883.10.20.29.1Effective Date2015‑08‑01
Statusdraft DraftVersion Label2.1
NameUSRealmHeaderforPatientGeneratedDocumentV2Display NameUS Realm Header for Patient Generated Document (V2)
Description
This template is designed to be used in conjunction with the US Realm Header (V2). It includes additional conformances which further constrain the US Realm Header (V2). The Patient Generated Document Header template is not a separate document type. The document body may contain any structured or unstructured content from C-CDA.
ContextPathname //
ClassificationCDA Document Level Template
Open/ClosedOpen (other than defined elements are allowed)
Used by / Uses
Used by 1 transaction and 0 templates, Uses 0 templates
Used by as NameVersion
2.16.840.1.113883.3.1937.99.3.4.34Transactionfinal US Realm Header for Patient Generated Document (V2)2015‑08‑01
RelationshipSpecialization: template 2.16.840.1.113883.10.12.1 CDA ClinicalDocument (2005‑09‑07)
ref
ad1bbr-

Version: template 2.16.840.1.113883.10.20.29.1 US Realm Header for Patient Generated Document (V2) (DYNAMIC)
ItemDTCardConfDescriptionLabel
cda:ClinicalDocument
CWhen asserting this templateId, all C-CDA 2.1 section and entry templates that had a previous version in C-CDA R1.1 SHALL include both the C-CDA 2.1 templateId and the C-CDA R1.1 templateId root without an extension. See C-CDA R2.1 Volume 1 - Design Considerations for additional detail (CONF:1198-32945).
USRedotsntV2
cda:templateId
II1 … 1MC-CDA R1.1 templateId root without an extensionCONFdots2936
@root
uid1 … 1F2.16.840.1.113883.10.20.29.1
cda:templateId
II1 … 1MSHALL contain exactly one [1..1] templateId (CONF:1198-28458) such that itCONFdots8458
@root
uid1 … 1F2.16.840.1.113883.10.20.29.1CONFdots8459
 SHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.29.1" (CONF:1198-28459).
@extension
st1 … 1F2015-08-01CONFdots2917
 SHALL contain exactly one [1..1] @extension="2015-08-01" (CONF:1198-32917).
cda:recordTarget
1 … 1MSHALL contain exactly one [1..1] recordTarget (CONF:1198-28460).

The recordTarget records the patient whose health information is described by the clinical document; each recordTarget must contain at least one patientRole element. If the document receiver is interested in setting up a translator for the encounter with the patient, the receiver of the document will have to infer the need for a translator, based upon the language skills identified for the patient, the patient’s language of preference and the predominant language used by the organization receiving the CDA. HL7 Vocabulary simply describes guardian as a relationship to a ward. This need not be a formal legal relationship. When a guardian relationship exists for the patient, it can be represented, regardless of who is present at the time the document is generated. This need not be a formal legal relationship. A child’s parent can be represented in the guardian role. In this case, the guardian/code element would encode the personal relationship of "mother" for the child’s mom or "father" for the child’s dad. An elderly person's child can be represented in the guardian role. In this case, the guardian/code element would encode the personal relationship of "daughter" or "son", or if a legal relationship existed, the relationship of "legal guardian" could be encoded.
CONFdots8460
cda:patientRole
1 … 1MThis recordTarget SHALL contain exactly one [1..1] patientRole (CONF:1198-28461).CONFdots8461
cda:id
II1 … *This patientRole SHALL contain at least one [1..*] id (CONF:1198-28462).CONFdots8462
cda:patient
1 … 1MThis patientRole SHALL contain exactly one [1..1] patient (CONF:1198-28465).CONFdots8465
cda:guardian
0 … *This patient MAY contain zero or more [0..*] guardian (CONF:1198-28469).CONFdots8469
cda:id
II0 … *RThe guardian, if present, SHOULD contain zero or more [0..*] id (CONF:1198-28470).CONFdots8470
cda:code
0 … 1RThe guardian, if present, SHOULD contain zero or one [0..1] code, which SHALL be selected from ValueSet Personal And Legal Relationship Role Type urn:oid:2.16.840.1.113883.11.20.12.1 DYNAMIC (CONF:1198-28473).CONFdots8473
 CONF
The value of @code shall be drawn from value set 2.16.840.1.113883.11.20.12.1 Personal And Legal Relationship Role Type (DYNAMIC)
cda:languageCommunication
0 … *RThis patient SHOULD contain zero or more [0..*] languageCommunication (CONF:1198-28474).CONFdots8474
cda:preferenceInd
0 … 1The languageCommunication, if present, MAY contain zero or one [0..1] preferenceInd (CONF:1198-28475).CONFdots8475
cda:providerOrganization
0 … 1This patientRole MAY contain zero or one [0..1] providerOrganization (CONF:1198-28476).

If present, this organization represents the provider organization where the person is claiming to be a patient.
CONFdots8476
cda:author
1 … *MSHALL contain at least one [1..*] author (CONF:1198-28477).

The author element represents the creator of the clinical document. The author may be a device, or a person. The person is the patient or the patient’s advocate.
CONFdots8477
cda:assignedAuthor
1 … 1MSuch authors SHALL contain exactly one [1..1] assignedAuthor (CONF:1198-28478).CONFdots8478
cda:id
II1 … *This assignedAuthor SHALL contain at least one [1..*] id (CONF:1198-28479).CONFdots8479
cda:code
0 … 1RThis assignedAuthor SHOULD contain zero or one [0..1] code (CONF:1198-28481).

When the author is a person who is not acting in the role of a clinician, this code encodes the personal or legal relationship between author and the patient.
CONFdots8481
cda:dataEnterer
0 … 1MAY contain zero or one [0..1] dataEnterer (CONF:1198-28678).

The dataEnterer element represents the person who transferred the content, written or dictated by someone else, into the clinical document. The guiding rule of thumb is that an author provides the content found within the header or body of the document, subject to their own interpretation, and the dataEnterer adds that information to the electronic system. In other words, a dataEnterer transfers information from one source to another (e.g., transcription from paper form to electronic system). If the dataEnterer is missing, this role is assumed to be played by the author.
CONFdots8678
cda:assignedEntity
1 … 1MThe dataEnterer, if present, SHALL contain exactly one [1..1] assignedEntity (CONF:1198-28679).CONFdots8679
cda:code
CE0 … 1This assignedEntity MAY contain zero or one [0..1] code, which SHOULD be selected from ValueSet Personal And Legal Relationship Role Type urn:oid:2.16.840.1.113883.11.20.12.1 DYNAMIC (CONF:1198-28680).CONFdots8680
 CONF
The value of @code shall be drawn from value set 2.16.840.1.113883.11.20.12.1 Personal And Legal Relationship Role Type (DYNAMIC)
cda:informant
0 … *MAY contain zero or more [0..*] informant (CONF:1198-28681) such that it

The informant element describes the source of the information in a medical document. Assigned health care providers may be a source of information when a document is created. (e.g., a nurse's aide who provides information about a recent significant health care event that occurred within an acute care facility.) In these cases, the assignedEntity element is used. When the informant is a personal relation, that informant is represented in the relatedEntity element, even if the personal relation is a medical professional. The code element of the relatedEntity describes the relationship between the informant and the patient. The relationship between the informant and the patient needs to be described to help the receiver of the clinical document understand the information in the document. Each informant can be either an assignedEntity (a clinician serving the patient) OR a relatedEntity (a person with a personal or legal relationship with the patient). The constraints here apply to relatedEntity.
CONFdots8681
cda:relatedEntity
1 … 1MSHALL contain exactly one [1..1] relatedEntity (CONF:1198-28682).CONFdots8682
cda:code
0 … 1This relatedEntity MAY contain zero or one [0..1] code (CONF:1198-28683).CONFdots8683
cda:custodian
1 … 1MSHALL contain exactly one [1..1] custodian (CONF:1198-28685).

The custodian element represents the organization or person 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. Because CDA is an exchange standard and may not represent the original form of the authenticated document (e.g., CDA could include scanned copy of original), the custodian represents the steward of the original source document. The custodian may be the document originator, a health information exchange, or other responsible party. Also, the custodian may be the patient or an organization acting on behalf of the patient, such as a PHR organization.
CONFdots8685
cda:assignedCustodian
1 … 1MThis custodian SHALL contain exactly one [1..1] assignedCustodian (CONF:1198-28686).CONFdots8686
cda:representedCustodianOrganization
1 … 1MThis assignedCustodian SHALL contain exactly one [1..1] representedCustodianOrganization (CONF:1198-28687).

The representedCustodianOrganization may be the person when the document is not maintained by an organization.
CONFdots8687
cda:id
II1 … *This representedCustodianOrganization SHALL contain at least one [1..*] id (CONF:1198-28688).

The combined @root and @extension attributes record the custodian organization’s identity in a secure, trusted, and unique way.
CONFdots8688
cda:informationRecipient
0 … *MAY contain zero or more [0..*] informationRecipient (CONF:1198-28690).

The informationRecipient element records the intended recipient of the information at the time the document is created. For example, in cases where the intended recipient of the document is the patient's health chart, set the receivedOrganization to be the scoping organization for that chart.
CONFdots8690
cda:intendedRecipient
1 … 1MThe informationRecipient, if present, SHALL contain exactly one [1..1] intendedRecipient (CONF:1198-28691).CONFdots8691
cda:id
II0 … *RThis intendedRecipient SHOULD contain zero or more [0..*] id (CONF:1198-28692).

The combined @root and @extension attributes to record the information recipient’s identity in a secure, trusted, and unique way.
CONFdots8692
@root
uid0 … 1 The id, if present, SHOULD contain zero or one [0..1] @root (CONF:1198-28693).CONFdots8693
cda:legalAuthenticator
0 … 1MAY contain zero or one [0..1] legalAuthenticator (CONF:1198-28694).

In a patient authored document, the legalAuthenticator identifies the single person legally responsible for the document and must be present if the document has been legally authenticated. (Note that per the following section, there may also be one or more document authenticators.) Based on local practice, patient authored documents may be provided without legal authentication. This implies that a patient authored document that does not contain this element has not been legally authenticated. The act of legal authentication requires a certain privilege be granted to the legal authenticator depending upon local policy. All patient documents have the potential for legal authentication, given the appropriate legal authority. Local policies MAY choose to delegate the function of legal authentication to a device or system that generates the document. In these cases, the legal authenticator is the person accepting responsibility for the document, not the generating device or system. Note that the legal authenticator, if present, must be a person.
CONFdots8694
cda:assignedEntity
1 … 1MThe legalAuthenticator, if present, SHALL contain exactly one [1..1] assignedEntity (CONF:1198-28695).CONFdots8695
cda:id
II1 … *This assignedEntity SHALL contain at least one [1..*] id (CONF:1198-28696).

The combined @root and @extension attributes to record the information recipient’s identity in a secure, trusted, and unique way.
CONFdots8696
cda:code
CE0 … 1This assignedEntity MAY contain zero or one [0..1] code (CONF:1198-28697).CONFdots8697
cda:authenticator
0 … *MAY contain zero or more [0..*] authenticator (CONF:1198-28699).CONFdots8699
cda:assignedEntity
1 … 1MThe authenticator, if present, SHALL contain exactly one [1..1] assignedEntity (CONF:1198-28700).CONFdots8700
cda:id
II1 … *This assignedEntity SHALL contain at least one [1..*] id (CONF:1198-28701).

The combined @root and @extension attributes to record the authenticator’s identity in a secure, trusted, and unique way.
CONFdots8701
cda:code
CE0 … 1RThis assignedEntity SHOULD contain zero or one [0..1] code, which SHOULD be selected from ValueSet Personal And Legal Relationship Role Type urn:oid:2.16.840.1.113883.11.20.12.1 DYNAMIC (CONF:1198-28702).CONFdots8702
 CONF
The value of @code shall be drawn from value set 2.16.840.1.113883.11.20.12.1 Personal And Legal Relationship Role Type (DYNAMIC)
cda:participant
0 … *MAY contain zero or more [0..*] participant (CONF:1198-28703).

The participant element identifies other supporting participants, including parents, relatives, caregivers, insurance policyholders, guarantors, and other participants related in some way to the patient. A supporting person or organization is an individual or an organization with a relationship to the patient. A supporting person who is playing multiple roles would be recorded in multiple participants (e.g., emergency contact and next-of-kin)
CONFdots8703
@typeCode
cs1 … 1RThe participant, if present, SHALL contain exactly one [1..1] @typeCode (CONF:1198-28704).CONFdots8704
cda:associatedEntity
1 … 1MThe participant, if present, SHALL contain exactly one [1..1] associatedEntity (CONF:1198-28705).CONFdots8705
cda:code
0 … 1RThis associatedEntity SHOULD contain zero or one [0..1] code, which SHOULD be selected from ValueSet Personal And Legal Relationship Role Type urn:oid:2.16.840.1.113883.11.20.12.1 DYNAMIC (CONF:1198-28706).CONFdots8706
 CONF
The value of @code shall be drawn from value set 2.16.840.1.113883.11.20.12.1 Personal And Legal Relationship Role Type (DYNAMIC)
cda:inFulfillmentOf
0 … *MAY contain zero or more [0..*] inFulfillmentOf (CONF:1198-28707).CONFdots8707
cda:order
1 … 1MThe inFulfillmentOf, if present, SHALL contain exactly one [1..1] order (CONF:1198-28708).CONFdots8708
cda:id
II1 … *This order SHALL contain at least one [1..*] id (CONF:1198-28709).

A scheduled appointment or service event in a practice management system may be represented using this id element.
CONFdots8709
cda:documentationOf
0 … *MAY contain zero or more [0..*] documentationOf (CONF:1198-28710).CONFdots8710
cda:serviceEvent
1 … 1MThe documentationOf, if present, SHALL contain exactly one [1..1] serviceEvent (CONF:1198-28711).CONFdots8711
cda:code
CE0 … 1RThis serviceEvent SHOULD contain zero or one [0..1] code (CONF:1198-28712).

The code should be selected from a value set established by the document-level template for a specific type of Patient Generated Document.
CONFdots8712
cda:performer
0 … *RThis serviceEvent SHOULD contain zero or more [0..*] performer (CONF:1198-28713).CONFdots8713
cda:functionCode
CE0 … 1The performer, if present, MAY contain zero or one [0..1] functionCode (CONF:1198-28714).

The functionCode SHALL be selected from value set ParticipationType 2.16.840.1.113883.1.11.10901 When indicating the performer was the primary care physician the functionCode shall be =”PCP”
CONFdots8714
cda:assignedEntity
1 … 1MThe performer, if present, SHALL contain exactly one [1..1] assignedEntity (CONF:1198-28715).CONFdots8715
cda:id
II1 … *This assignedEntity SHALL contain at least one [1..*] id (CONF:1198-28716).

The combined @root and @extension attributes record the performer’s identity in a secure, trusted, and unique way.
CONFdots8716
cda:code
CE0 … 1This assignedEntity MAY contain zero or one [0..1] code, which SHOULD be selected from ValueSet Personal And Legal Relationship Role Type urn:oid:2.16.840.1.113883.11.20.12.1 DYNAMIC (CONF:1198-28718).

If the assignedEntity is an individual, the code SHOULD be selected from value set PersonalandLegalRelationshipRoleType value set
CONFdots8718
 CONF
The value of @code shall be drawn from value set 2.16.840.1.113883.11.20.12.1 Personal And Legal Relationship Role Type (DYNAMIC)