R6 Ballot (2nd Draft)
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FHIR Infrastructure  Work Group | Maturity Level: 3 | Standards Status: Trial Use |
FHIR resources can be used to build documents that represent a composition: a coherent set of information that is a statement of healthcare information, including clinical observations and services. A document is a set of resources with a fixed presentation that is authored and/or attested by humans, organizations and devices.
A FHIR document instance is a Bundle of type document that
starts with a Composition and contains specific frozen versions of other
resources. Changes to a document Bundle may risk invalidating the attestation present within the document.
Implementations SHOULD have policies around when documents can be 'updated' (new version of the same
instance) vs. when a distinct document needs to be created, as well as what types of change are permitted,
in order to retain attestation validity. These rules might vary based on the type of document (e.g. legal
documents, clinical documents, etc.).
Documents built in this fashion may be exchanged between systems and
persisted in document storage and management systems, including systems such as IHE XDS .
Applications that declare support for FHIR documents with CapabilityStatement.document are asserting conformance to the rules defined on this page.
FHIR documents may serve clinical purposes (focused on patient healthcare information) and non-clinical purposes (e.g. practice guidelines, patient handouts, etc.). HL7 has plans to develop profiles in the future giving additional guidance on appropriate representation of clinical documents in general, specific types of clinical documents (e.g. Consolidated CDA), and other non-clinical documents (Death Certificate, Medication Registration Information).
FHIR documents are not intended to capture unbounded data sets such as all data stored in an EHR. Rather,
consider the Bulk Data specification for use cases requiring access
to such data sets.
Note that FHIR defines both this document format (a document bundle containing a Composition resource and potentially other resources) and a DocumentReference resource. FHIR documents are used for documents that are authored and assembled in FHIR, while the DocumentReference resource is for general references to documents (which may include FHIR documents as well as PDFs, CDAs, etc.).
All documents have the same structure: a Bundle
of resources of type "document"
that has a Composition resource as the first resource
in the bundle, followed by a series of other resources, referenced from the Composition
resource, that provide the supporting details for the document. The bundle gathers all the content
of the document into a single XML or JSON document which may be signed and managed as required.
The resources may include both human readable and computer processable portions. In addition, the bundle
may include CSS stylesheets ,
Provenance statements and a signature.
The composition resource is the foundation of the clinical document, it:
Resources referenced by the Composition as listed below SHALL be included in the bundle when the document is assembled:
When these resources reference other resources, the referenced resources SHOULD also be included in the bundle. Omitting referenced resources could compromise the integrity and wholeness of the document, especially when considering that documents have legal retention periods that may be longer than the life of the FHIR server where the reference(s) point to.
In rare cases the referenced resources in Composition can also be contained resources within Composition provided that the resource(s) in question meets the restrictions for the use of contained resources (see Contained Resources for more information).
The document bundle SHALL include only:
There are two key identifiers in the document:
The document has several dates in it:
Document Bundles may be signed using digital signatures following the rules laid out in
the digital signatures page.
The signature SHOULD be provided by a listed attester of the document and the signature
SHOULD contain a KeyInfo
element that contains a KeyName element whose value is a URI that matches the fullUri for the matching attester resource.
Note that the document may be represented in either XML or JSON and interconverted between these or have its character encoding changed, all the while remaining the same document. Any additional documents derived from the same Composition SHALL have a different Bundle.identifier.
When the document is presented for human consumption, applications SHOULD present the collated narrative portions in order:
If the document is presented in a different order from that given above, it might not represent the original attested content. Implementation Guides may restrict document narrative and display behavior further.
The presentation of the document is called the 'attested content' of the document. The text of resources
outside Composition and the subject resource are not considered attested content (e.g. a Condition resource).
Specifically, the Composition.attester attests to the presented form of the document.
The Composition resource narrative should summarize the important parts of the document header that are required to establish clinical context for the document (other than the subject, which is displayed in its own right). To actually build the combined narrative, simply append all the narrative <div> fragments together.
The narrative of the subject resource (typically a Patient), referenced in 'Composition.subject' should clearly identify the subject and typically includes fields like name, identifier, etc.
The XML Tools reference implementation includes a XSLT transform that converts an XML document into browser-ready XHTML.
In addition to the basic style rules about Narratives, which must be followed, a document can reference or contain one or more stylesheets that contain additional styles that apply to the collated narrative. This is done by asserting stylesheet links on the Bundle:
<Bundle xmlns="http://hl7.org/fhir">
<!-- metadata and type -->
<link>
<relation value="stylesheet"/>
<url value="[uri]"/>
</link>
</Bundle>
The url can be an absolute reference to a CSS stylesheet or
a relative reference to a Binary resource that carries a
CSS stylesheet. Stylesheet references can only refer to
a CSS stylesheet - other forms of stylesheet are not acceptable.
Relative (internal) references SHOULD be used for stylesheets, because the viewer may be unable to resolve external content at the time of viewing, due to technical problems or local policy decisions.
Any stylesheet referenced or used SHALL NOT alter the presentation in such a way that it changes the clinical meaning of the content.
Unless otherwise agreed in local trading partner agreements, applications displaying the collated narrative SHOULD use the stylesheets specified by the document (see security note). Parties entering into a trading agreement to do otherwise should consider the implications this action will have on their long-term scope for document exchange very carefully. If the parties agree to use stylesheets that are not contained in the document, then it may be that they will never be able to share their documents safely in a more general context, such as a regional or national EHR or a global personal health record.
Document profiles are used to describe documents for a particular purpose. Document profiles may make rules about:
Applications should consider publishing Capability Statements that identify document types they support. Documents can identify a profile that they conform to by placing a profile identifier in the Bundle.meta.profile
element - see Profile Tags for a discussion of the utility
of this.
The authors/constructors and processors of Clinical Documents, whether human or software, have obligations that they must satisfy.
A document constructor is an application that creates a document. An author is a human, organization or device that uses the constructor to create a document. Between them, the constructor and the author may create new content resources and/or assemble already existing content resources while performing their tasks. They also have the following responsibilities:
A document processor is an application and/or human user that receives documents and extracts data from them or makes decisions because of them. The documents may be received directly from a document constructor, accessed via a document management system or forwarded by a third party. The document processor is responsible for ensuring that received documents are processed and/or rendered in accordance to this specification. A document processor has the obligation to assure that the following rules are followed:
In addition to these obligations, document receivers SHOULD carefully track the source of documents for new documents that supersede existing documents, particularly when the documents represent compositions that have been retracted. When documents have been replaced, they SHOULD either withdraw data extracted from superseded documents or warn users when they view the document or data taken from it.
There are several different RESTful end-points used when working with documents. The use of the various end-points can best be described by considering the consequences of posting to them:
| End-Point | Type of Content | Description |
| [baseurl]/Bundle | Document Bundle | This works like a normal end-point for managing a type of resource, but it works with whole document bundles - i.e. a read operation returns a bundle, an update gets a bundle and a search returns a bundle of bundles. Note that if documents are POSTed using a create interaction the Bundle.id will change, but the Bundle.identifier will not. See Serving Bundles using the RESTful API for further comment |
| [baseurl]/Composition | Composition Resource | The normal end-point for managing composition resources. This can be used while building a document or after breaking a document up into its constituent resources or when using compositions separately from documents |
| [baseurl]/Binary | Document Bundle | Just store the entire document as a sequence of bytes and return exactly that sequence when requested. There is no way to find content in the /Binary end-point, so usually this would be associated with a Document Reference so that applications can find and process the document, though this is not required |
| [baseurl] (e.g. a transaction) | Document Bundle | Ignore the fact that the bundle is a document and process all of the resources that it contains as individual resources. Clients SHOULD not expect that a server that receives a document submitted using this method will be able to reassemble the document exactly. (Even if the server can reassemble the document (see below), the result cannot be expected to be in the same order, etc. Thus a document signature will very likely be invalid.). See Accepting other Bundle types for further details |
Note: While these end-points are defined for use with document-related resources and document bundles, it is not necessary to use them. Documents may be transferred between systems using any method desired. In addition, servers and/or specifications may define additional operations for handling documents beyond the options described above.
A client can ask a server to generate a fully bundled document from a composition resource. For details, see Generate Document Operation.
FHIR ®© HL7.org 2011+. FHIR R6 hl7.fhir.core#6.0.0-ballot2 generated on Mon, Aug 12, 2024 16:59+0800.
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