A Clinical Document is a part of the medical record of a patient. A Clinical Document is a documentation of clinical observations and services and has the following characteristics:
Persistence - A clinical document continues to exist in an unaltered state, for a time period defined by local and regulatory requirements.
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.
Note: This definition is from ANSI/HL7 CDA R1.0-2000, and HL7 v3 CDA R2-2005.
Clinical Documents may provide significant context for the performance of imaging and related procedures, e.g., patient clinical history, pre-imaging-procedure lab test results, or patient advance medical directives.
Clinical Documents may be associated with Service Episodes, Service Requests, Requested Procedures, or other entities subsidiary to the Patient in the Real-World Model. Such associations are not explicitly modeled for the purposes of the Modality-IS or General Purpose Worklist contexts.
Clinical Documents are one sub-class of the class of healthcare Structured Documents; Structured Documents, in general, are not necessarily related to a patient. Structured Documents may be used for imaging procedure operational instructions, e.g., in product labeling, Procedure Plans, or patient care plans.
Notes: 1. The format and semantics of Structured Documents, including Clinical Documents, are defined outside the scope of the DICOM Standard (e.g., by HL7). DICOM provides the means to reference Structured Documents within the Modality-IS and General Purpose Worklist contexts.
2. The general class of Structured Documents is not modeled in the Real-World Model; only specific sub-classes, e.g., Clinical Documents, are modeled.