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HITSP Summary Documents Using HL7 Continuity of Care Document (CCD) Component is essentially a subset of the data in an EHR or PHR system that has been developed for interoperability purposes for specific business Use Cases. This subset contains the minimum critical or pertinent medical information of sections and data elements used in those business cases. The information in the subset of data to be exchanged and the EHR or PHR system must be consistent. Furthermore there should be no data elsewhere in the EHR or PHR system that would contradict the meaning of any data in the summary. The expectation is that consuming systems will be able to use the information received as appropriate information to input and/or update information in their instantiation of the healthcare record. This specification does not define the policies applicable to the import of this information.
An Interoperability Specification (IS) may constrain this Component to satisfy the requirements of an information exchange scenario. An Interoperability Specification describes the specific context of exchange and may declare additional constraints, e.g., by requiring the presence of information modules that are otherwise described in this Component as optional. Thus, to satisfy the Use Case of a consumer updating their registration information and medication history, the IS may impose requirements on the exchange to always contain the Person Information and Medications modules.
This Component should not be used outside the context of an Interoperability Specification as this may result in loss of interoperability.
However, the modules defined in this Component are intended for use and reuse whenever summary information such as a consumer's patient registration, medical history, immunizations, or other information modules defined in this Component are needed. Individual modules defined in this specification may be reused in other defined document types, such as operative notes, to convey similar information in other Use Cases. HITSP has assigned template identifiers to the reusable information modules to facilitate this reuse and provide a method for implementers to declare conformance to the templates within this Component.
Specific constraints related to each of the modules are defined in HITSP/C83 CDA Content Modules. Vocabulary constraints on Content Modules data are specified in HITSP/C80 Clinical Document and Message Terminology.
Table 2-1 Component Constraints
|
Constraint |
Constraint Section |
|
No applicable constraints |
Although no component dependencies exist, it is important to note the following dependencies that are specific to HITSP constructs:
Table 2-2 Component Dependencies
|
Standard/HITSP Component |
Depends On |
Dependency Type |
Purpose |
|
HITSP/C32 - Summary Documents Using HL7 Continuity of Care Document (CCD) |
HITSP/C83 - CDA Content Modules |
General |
Constraints on Content Module fields |
|
HITSP/C32 - Summary Documents Using HL7 Continuity of Care Document (CCD) |
HITSP/C/80 - Clinical Document and Message Terminology |
General |
Vocabulary constraints on Content Modules data defined in HITSPC/83 |
Note: We have added template identifiers to the document specifications that follow. These template identifiers are recommended to be used in exchanges, but are not required to restrictions on major change. It is possible that these identifiers could be required in future editions of this specification.
This section describes the specific Content Modules used by this Component. Implementers will need to refer to HITSP/C83 CDA Content Modules, to see the fields that HITSP is constraining differently from the standard.
Table 2-3 defines the Content Modules used by the HITSP Summary Documents Using HL7 Continuity of Care Document (CCD) Component.
NOTE: Content Modules in this document map to the CCD Entry elements. The CCD sections themselves are not repeatable.
Table 2-3 Content Modules
|
Constraint ID |
Content Module |
HITSP Optional Entry [1] |
HITSP Repeatable Entry [2] |
Specification Reference |
|
Advance Directive |
O |
N |
||
|
Allergy / Drug Sensitivity |
O |
N |
See HITSP/C83 Section 2.2.1.2 Allergies and Other Adverse Reactions Section |
|
|
Comment |
O |
Y |
||
|
Condition |
O |
N |
||
|
Encounter |
O |
N |
||
|
Healthcare Provider |
O |
Y |
||
|
Immunization |
O |
N |
||
|
Information Source |
R |
Y |
||
|
Insurance Provider |
O |
N |
||
|
Language Spoken |
R2 |
Y |
||
|
Medication Prescription and Non-Prescription |
O |
N |
||
|
Person Information |
R |
N |
||
|
Plan of Care |
O |
N |
||
|
Pregnancy |
O |
N |
||
|
Procedure |
O |
N |
||
|
Support |
R2 |
Y |
||
|
Vital Sign |
O |
N |
||
|
Results |
O |
N |
Conformance statements are used to provide explicit guidance, or rules, on the structure or content of a CDA document. These are identified as numbered statements, the format for the identifier is [docId]-[###] where docId is the mnemonic of the defining document, and the number is any numbering scheme. Note that conformance statement identifiers may not be stable over time; references in validation error reports or other specifications should also cite the specific version and date of publication of the Component where the conformance statement is located.
At the clinical document level, template identifiers are employed to assert which template(s) the document conforms to. A document may assert conformance to more than one template. Template identifiers for context specific documents are declared in the Interoperability Specifications where the context is defined.
C32-[CT1-19] A CDA Document SHALL declare conformance to this specification by including a <templateID> element with the root attribute set to the value 2.16.840.1.113883.3.88.11.32.1.
Asserting conformance to this specification via the inclusion of the Summary Document templateID indicates that additional constraints from this specification are followed when applicable.
Required modules from this specification shall be present and follow the associated constraints
Modules that have been explicitly prohibited shall not be included
Optional modules, when present, will follow the associated constraints if that module also asserts conformance to this document, i.e., includes the associated templates
Additional CCD entry elements (the equivalent to modules in this specification) may be present. The consumer of the document may choose to accept or exclude the additional content, but shall not reject the document solely based upon the presence of the additional content
Additional guidelines and examples that support the underlying base or composite standards for the HITSP Summary Documents Using HL7 Continuity of Care Document (CCD) Component may be included in this section if appropriate in the future to help describe how this specification differs from the underlying standards.
Table 2-4 Regulatory Guidance
|
Standard |
Description |
|
No applicable regulatory guidance |
|
Table 2-5 Selected Standards
|
Standard |
Description |
|
Health Level Seven (HL7) Implementation Guide: CDA Release 2 Continuity of Care Document (CCD), April 01, 2007 |
The Continuity of Care Document implementation guide describes constraints on the HL7 Clinical Document Architecture, Release 2 (CDA) specification in accordance with requirements set forward in ASTM E2369-05 Standard Specification for Continuity of Care Record (CCR). The resulting specification, known as the Continuity of Care Document (CCD), is developed as a collaborative effort between ASTM and HL7. It is intended as an alternate implementation to the one specified in ASTM ADJE2369 for those institutions or organizations committed to implementation of the HL7 Clinical Document Architecture. For more information visit www.hl7.org |
|
Integrating the Healthcare Enterprise (IHE) Exchange of Personal Health Record Content (XPHR) |
The Exchange of Personal Health Record Content (XPHR) integration profile describes the content and format of summary information extracted from a PHR system used by a patient for import into healthcare provider information systems, and visa versa. The purpose of this profile is to support interoperability between PHR systems used by patients and the information systems used by healthcare providers. This profile does not address all the data exchange requirements of PHR systems. For more information visit www.ihe.org |
Table 2-6 Informative Reference Standards
|
Standard |
Description |
|
Health Level Seven (HL7) HL7 Version 3 Standard: Clinical Document Architecture (CDA), Release 2 |
The HL7 Clinical Document Architecture is an XML-based document markup standard that specifies the structure and semantics of clinical documents for the purpose of exchange. CDA is one instantiation of HL7's Version 3.0 Reference Information Model (RIM) into a specific message format. Of particular focus for HITSP Interoperability Specifications are message formats for Laboratory Results and Continuity of Care (CCD) documents. Release 2 of the HL7 Clinical Document Architecture (CDA) is an extension to the original CDA document markup standard that specifies the structure and semantics of clinical documents for the purpose of exchange. CDA R2 includes a prose document in HTML, XML schemas, data dictionary, and sample CDA documents. CDA R2 further builds upon other HL7 standards beyond just the Version 3.0 Reference Information Model (RIM) and incorporates Version 3.0 Data Structures, Vocabulary, and the XML Implementation Technology Specifications for Data Types and Structures. For more information visit www.hl7.org |
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