The implementers must be familiar with the context of the project, as it shall not be repeated in this document. The implementers must also be familiar with the content of the following documents:
CDA Release 2.0 Normative Web Edition, May, 2005
HL7 Implementation Guide: CDA Release 2 – Continuity of Care Document (CCD), HL7, April 1, 2007.
Integrating the Healthcare Enterprise, Patient Care Coordination Technical Framework, Volume 1 and Volume 2- Revision 10, IHE International, November 4, 2014.
Integrating the Healthcare Enterprise, Patient Care Coordination CDA Content Modules- Trial Implementation Supplement, December 3, 2014.
HL7 Implementation Guide for CDA Release 2: History and Physical (H&P) Notes, HL7, July 16, 2008.
It must also be noted that although the guidelines are based on the above documents, they contain specific developments particular to the project epSOS. This document can be used as a standalone to develop the syntax of the epSOS documents; however in order to achieve the full functionality of the epSOS Semantic Services, they are to be used within the context of the deliverable 3.9.1.
Prescribed and dispensed medications, including a specification of the Medication Summary section used in the Patient Summary document, have described in the previous chapter. The following sub-paragraphs specify how other sections that may be present in a Patient Summary are implemented.
According to requirements described in the Body Data Elements, the following sections - at least - shall be present in a Patient Summary document:
The eHDSI Medication Summary Section 1.3.6.1.4.1.12559.11.10.1.3.1.2.3
The eHDSI Allergies and Other Adverse Reactions Section 1.3.6.1.4.1.12559.11.10.1.3.1.2.12
The eHDSI List of Surgeries Section 1.3.6.1.4.1.12559.11.10.1.3.1.2.11
The eHDSI Active Problems Section 1.3.6.1.4.1.12559.11.10.1.3.1.2.9
The eHDSI Medical Devices Section 1.3.6.1.4.1.12559.11.10.1.3.1.2.4
Context
Pathname /
Classification
CDA Document Level Template
Open/Closed
Open (other than defined elements are allowed)
Used by / Uses
Used by 0 transactions and 0 templates, Uses 9 templates
While the XML Schema Language allows a schema location to be associated with an XML document by including a schemaLocation attribute associated with the http://www.w3.org/2001/XMLSchema-instance namespace, this is explicitly PROHIBITED by [ITS§1.4], and thus by the CDA standard.
Unique identifier of this instance of the clinical document.
Following attributes can be used to uniquely identify the instance:
@root: A unique identifier that guarantees the global uniqueness of the instance identifier. The root alone may be the entire instance identifier. Required if @nullFlavor is not present.
@extension: An optional character string as a unique identifier within the scope of the identifier root.
The @root attribute must be a UID. The allowable formats and values and procedures of this data type are strictly controlled by HL7. At this time, user-assigned identifiers may be certain character representations of ISO Object Identifiers (OID) and DCE Universally Unique Identifiers (UUID).
UUIDs SHALL be represented in the form XXXXXXXX-XXXX-XXXX-XXXX-XXXXXXXXXXXX, where each X is a character from the set [0-9a-zA-Z].
OIDs SHALL be represented in dotted decimal notation, where each decimal number is either 0, or starts with a nonzero digit. More formally, an OID SHALL be in the form [0-2](\.(0|[1-9][0-9]*))*.
By definition, a Patient Summary document describes the Patient Summary at the time of creation of the document, represented by the /ClinicalDocument/effectiveTime XML Element.
The time when this instance of the document has been authored may be instead recorded by the /ClinicalDocument/author/time element. (e.g. when a “spider” has collected information for generating this instance of the document; or a practitioner updated its local summary document).
Finally, the latest summary update, intended as the last date documented by this summary (e.g. the last update occurred to the PHR from which the PS data has been extracted) can be represented by the /ClinicalDocument/documentationOf/serviceEvent/effectiveTime/high XML Element (see section 2.1, CONF-2, CONF-3 and CONF-4 of the CCD specification).
This identifier is used to link together different versions of the same document: the CDA L3 document, the CDA PDF embedded document and the version in the national infrastructure.
The patient address element is required. If there is no information, the nullFlavor attribute shall have a value of 'NI' and no address parts shall be present, otherwise there shall be no nullFlavor attribute, and at least one of the address parts listed below shall be present.
R1.5
@nullFlavor
cs
0 … 1
F
NI
hl7:streetAddressLine
0 … *
R
Patient's Number of Street/Patient's Number of Street
R1.5.1 / R1.5.2
hl7:city
0 … 1
R
Patient's City
R1.5.3
hl7:postalCode
0 … 1
R
Patient's Postal Code
R1.5.4
hl7:state
0 … 1
R
Patient's State or Province
R1.5.5
hl7:country
0 … 1
R
Patient's Country. When used addr.country it is always bound to the eHDSICountry value set
R1.5.6
Constraint
The content of this element SHALL be selected from ValueSet eHDSICountry urn:oid:1.3.6.1.4.1.12559.11.10.1.3.1.42.4
Patient’s telephone number / Patient e-mail address. The patient telephone or e-mail element is required. If there is no information, the nullFlavor attribute shall have a value of 'NI' and the "value" and "use" attributes shall be omitted, otherwise the nullFlavor attribute shall not be present, and the "value" and "use" attributes shall be present Optionalities and Cardinalities of the following two items shall be interpreted according to this rule: e.g. is not expected to have two nullFlavored telecom elements.
Patient's Date of Birth. The patient date of birth may be a partial date such as only the year.
R1.3
hl7:guardian
0 … *
R
The guardians of a patient shall be recorded in the <guardian> element beneath the /ClinicalDocument/recordTarget/patientRole/patient XML - <patient> element. Other patient contacts are described using the /ClinicalDocument/participant structure. The <associatedEntity> element defines the type of contact.
The relationship between the patient and the guardian or other contact should be recorded in the <code> element. The code attribute is required and comes from the HL7 PersonalRelationshipRoleType vocabulary (eHDSIPersonalRelationship value set).
The address of the guardian or other contact should be present, and shall be represented, as any other address would be in CDA.
The phone number of the guardian or other contact should be present, and shall be represented, as any other phone number would be in CDA.
The name of the guardian or other contact shall be present, and shall be represented, as any other name would be in CDA.
R1.7.A
@classCode
cs
1 … 1
F
GUARD
@nullFlavor
cs
0 … 1
Use nullFlavor if unknown or if no information is applicable
Example
<guardianclassCode="GUARD"> <templateIdroot="1.3.6.1.4.1.19376.1.5.3.1.2.4"/><codecode="AUNT"displayName="aunt"codeSystem="2.16.840.1.113883.5.111"/><addr> <streetAddressLine>2222 Home Street</streetAddressLine><city>London</city><state>London</state><postalCode>A1B 2C3</postalCode><country>UK</country></addr><telecomvalue="tel:+452070256161"/><telecomvalue="mailto:jsmith@myprovider.co.uk"/><guardianPerson> <name> <given>John</given><family>Español Smith</family></name></guardianPerson></guardian>
The guardian’s address element is required. If there is no information, the nullFlavor attribute shall have a value of 'NI' and no address parts shall be present, otherwise there shall be no nullFlavor attribute, and at least one of the address parts listed below shall be present
R1.7.A
@nullFlavor
cs
0 … 1
F
NI
hl7:streetAddressLine
0 … *
R
Guardian's Number of Street/Guardian's Number of Street
R1.7.3.2
hl7:city
0 … 1
R
Guardian's City
R1.7.3.3
hl7:postalCode
0 … 1
R
Guardian's Postal Code
R1.7.3.4
hl7:state
0 … 1
R
Guardian's State or Province
R1.7.3.5
hl7:country
0 … 1
R
Guardian's Country. When used addr.country it is always bound to the eHDSICountry value set
R1.7.3.6
Constraint
The content of this element SHALL be selected from ValueSet eHDSICountry urn:oid:1.3.6.1.4.1.12559.11.10.1.3.1.42.4
Guardian’s telephone number / Patient e-mail address. The guardian telephone or e-mail element is required. If there is no information, the nullFlavor attribute shall have a value of 'NI' and the "value" and "use" attributes shall be omitted, otherwise the nullFlavor attribute shall not be present, and the "value" and "use" attributes shall be present Optionalities and Cardinalities of the following two items shall be interpreted according to this rule: e.g. is not expected to have two nullFlavored telecom elements.
This element is derived from the IHE template LanguageCommunication (1.3.6.1.4.1.19376.1.5.3.1.2.1), however this template does not need the element preferenceInd because the language is already said to be the "preferred language".
The author/time element represents the start time of the author’s participation in the creation of the clinical document. The author/time element SHALL be present.
Identification of the Healthcare Practitioner that is the author of this document or identification of an authoring device which generated this document.
Telephone or e-mail <telecom> element is required.
If there is no information, the nullFlavor attribute shall have a value of 'NI' and the "value" and "use" attributes shall be omitted, otherwise the nullFlavor attribute shall not be present, and the "value" and "use" attributes shall be present.
Attribute @value SHALL contain a URI if element telecom is used. The URI scheme SHALL be one of URLScheme.
If there is no information, the nullFlavor attribute shall have a value of 'NI' and the "value" and "use" attributes shall be omitted, otherwise the nullFlavor attribute shall not be present, and the "value" and "use" attributes shall be present.
Optionalities and Cardinalities of the following two items shall be interpreted according to this rule: e.g. is not expected to have two nullFlavored telecom elements.
The person taking responsibility for the medical content of the document. In Spain this is the regional authority in healthcare. This regional authority healthcare organization will send this to the NCP. The definition of the legal authenticator may vary accoriding to the rules set up in the framework agreement particular to each state. It may be a person or a regional authority, or an NCP.
If there is no information, the nullFlavor attribute shall have a value of 'NI' and the "value" and "use" attributes shall be omitted, otherwise the nullFlavor attribute shall not be present, and the "value" and "use" attributes shall be present.
Optionalities and Cardinalities of the following two items shall be interpreted according to this rule: e.g. is not expected to have two nullFlavored telecom elements.
from 2.16.840.1.113883.3.1937.777.11.10.101eHDSI Contact/Preferred HP/Legal Organization (DYNAMIC) The IHE PCC template Patient Contacts shall be used for describing the patient contacts or the preferred HP.
hl7:participant
0 … *
R
Contact person / Preferred Health Professional to contact about patient.
eHDStion
where [hl7:templateId/@root='1.3.6.1.4.1.19376.1.5.3.1.2.4']
@typeCode
cs
1 … 1
F
IND
R1.8.5
Participant typeCode
hl7:templateId
1 … 1
M
IHE Patient Contacts (IHE PCC)
eHDStion
@root
uid
1 … 1
F
1.3.6.1.4.1.19376.1.5.3.1.2.4
hl7:functionCode
0 … 1
C
eHDStion
Constraint
The element is mandatory when this participant is the preferred HP
The element identifies the type of contact. The classCode attribute shall be present, and contains a value from the eHDSIRoleClass value set when used for the patient contacts; ‘PRS’ when used for “Preferred HP / Legal Organization”.
The relationship between the patient and the guardian or other contact should be recorded in the element. The code attribute is required and comes from the HL7 PersonalRelationshipRoleType vocabulary with codeSystem (2.16.840.1.113883.5.111). The codeSystem attribute is required. The relationship between the patient and his preferred HP comes from the the full RoleCode (2.16.840.1.113883.5.111) codeSystem
Patient Contact's / Preferred HP's/Legal Organization telephone or e-mail element is required. If there is no information, the nullFlavor attribute shall have a value of 'NI' and the "value" and "use" attributes shall be omitted, otherwise the nullFlavor attribute shall not be present, and the "value" and "use" attributes shall be present
represents the healthcare providers involved in the current or pertinent historical care of the patient. Preferably, the patient’s key healthcare providers would be listed, particularly their primary physician and any active consulting physicians, therapists, and counselors
eHDSPCPR
@typeCode
cs
1 … 1
R
CONF
The value of @typeCode shall be drawn from value set 2.16.840.1.113883.1.11.19601x_ServiceEventPerformer (DYNAMIC)
If there is no information, the nullFlavor attribute shall have a value of 'NI' and the "value" and "use" attributes shall be omitted, otherwise the nullFlavor attribute shall not be present, and the "value" and "use" attributes shall be present.
Optionalities and Cardinalities of the following two items shall be interpreted according to this rule: e.g. is not expected to have two nullFlavored telecom elements.
This element is used in this template to embed the PDF representation of the original document produced in the Country of Affiliation (Country A). The reference element shall never be used for this template.
eHDSalPS
@mediaType
cs
1 … 1
F
application/pdf
@representation
cs
1 … 1
F
B64
Constraint
The encoding rules of the pdf, including the allowed pdf formats, SHALL be the same defined by the IHE XDS-SD profile