R4 Ballot #2 (Mixed Normative/Trial use)
TerminologyThis page is part of the FHIR Specification (v3.5.0: R4 Ballot #2). The current version which supercedes this version is 5.0.0. For a full list of available versions, see the Directory of published versions 
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| FHIR Infrastructure Work Group | Maturity Level: 5 | Ballot Status: Normative |
Normative Candidate Note: This page is candidate normative content for R4 in the Infrastructure Package. Once normative, it will lose it's Maturity Level, and breaking changes will no longer be made.
Many elements in the FHIR resources have a coded value: some fixed string (a sequence of characters) assigned elsewhere that identifies some defined "concept". The sequence of characters and its meaning may be defined in one of several places:
code system, or HL7 v2 table), or SNOMED CT These methods of defining codes are collectively called "code systems". This list is far from complete; there are many ways to define code systems, and they vary widely in sophistication and size.
Throughout this specification, coded values are always treated as a pair
composed of "system" and "code", where the system is a URL that identifies the
code system that defines the codes. Note that system values are always
case sensitive. Different code systems make their own rules as to whether the codes
they define are case sensitive or not. Note that all the codes defined by FHIR
itself are case sensitive and SHALL be used in the provided case (usually, but
not always, lowercase).
The FHIR framework for using coded values is based on the fundamental framework defined in section 5 of the
HL7 v3 Core Principles document,
including the separation between code systems and value sets.
| When codes are carried in resources, one of several different data types is used: | |
| code | The instance represents the code only. The system is implicit - it is defined as part of the definition of the element, and not carried in the instance. |
| Coding | A data type that has a code and a system element that identifies where the definition of the code comes from |
| CodeableConcept | A type that represents a concept by plain text and/or one or more coding elements (See the datatype notes for a discussion of code translations and using text in CodeableConcept) |
| In addition, the following data types also carry coded values, or content that can be treated as a code and bound to a valueset: | |
| Quantity | The instance has system and code elements for carrying a code for the type of unit, and these can be bound to a value set |
| string | The instance carries a string. In some cases applications may wish to control the set of valid strings for a particular element, so the string value can be treated as a coded element (like code) |
| uri | Like string, URIs can be treated as a coded element |
Notes:
.The set of coded values that is allowed in an element is known as a "value set". Anywhere these data types are used, the specification "binds" a value set to the element, and for the types code, Coding, and CodeableConcept, always does.
The difference between a code system and a value set is an important distinction that is easily missed by implementers, since the difference is often overlooked in system design. For instance, it's not unusual to see an application table that is a mixed list of codes, containing some LOINC codes and also some additional in-house codes. Quite often, there is no explicit differentiation between them; only the fact that a code happens to look like a LOINC code betrays its origin.
For data exchange, on the other hand, explicitly tracking the source of the code is both important and necessary. In order to do this, each code system that defines codes is assigned a URL that identifies it, and all the codes it defines are actually a pair ("Code Pair": a name with a namespace). So in the case of this mixed list example from the previous paragraph, there are two code systems: LOINC (http://loinc.org) and a local one (let's say it has been given the URL: http://example.com/codesystems/additional-test-codes). The application table is a single value set (a set of Code Pairs) that includes codes from each of those two namespaces. The value set itself is given its own URL as an identifier (e.g. "http://example.com/fhir/ValueSet/test-codes"). This identifies the set of Code Pairs, but is never used as the namespace in a actual code pair, or in an instance. In FHIR, Code Pairs are always represented as "code" and "system", except for the simple data type code where the namespace (e.g. the system element/property) is fixed in the schema and not represented explicitly.
Note that for some code systems, there is a single correct mechanism by which to represent codes defined by the system as a single URL. These single URLs are used in the context of the RDF format to enable ontological reasoning. The URL is often a direct reference to a web source that can provide additional definitional material about the concept. Where the mechanism is known, and defined by the code system, it is described in this specification.
The URL in a system is always a reference to a code system,
not to a value set. The system ensures that codes can be unambiguously
traced back to their original definition, and that logical comparisons, matching and
inferences can be performed consistently by different systems. For this reason, choice
of the correct URI for the system attribute is critical.
The correct value to use in the system for a given code system can be determined by working through the following list, in order:
- if a code system is listed here with status = active, it SHALL be used - if a code system is registered here, the OID SHOULD be used (using the syntax urn:oid:[oid])
If a code system is not resolved by this list, and there is no publisher to consult, implementers
must choose a URI to use. The priority should be to choose a unique value that won't
accidentally be used by another implementer for a different purpose - or a very similar purpose
with a different scope. See Registering Code Systems for further advice.
For publishers of code systems, the following considerations should be kept in mind when defining the correct URI to use:
Note: if the code system is made available packaged inside a ValueSet resource, the
correct URL for the system value is ValueSet.codeSystem.system, not ValueSet.uri.
When an element is bound to a value set, the binding has these properties:
| Name | A descriptive name used when presenting information about the binding |
| Strength | How the binding should be understood - see below |
| Reference | A URL that defines the value set. Usually, this is a direct reference to a ValueSet resource, but can be a more indirect reference, where the value set is inferred |
| Description | A text description of the use of the codes. If there is no reference, this must be populated. When there is a reference, this can be used to make additional notes about the use and implementation of the value set |
A binding is always represented using an ElementDefinition.binding.
There are a number of places in the specification where value sets are referenced in order to bind a coded value to a value set:
| ElementDefinition.binding.valueSet | Used to bind a defined element to a value set |
| ConceptMap.source[x] and .target[x] | Used to indicate the scope of the mapping in the Concept Map - from one value set to another |
| Questionnaire.group.question.options | Indicates that answers to a set of questions come from a value set |
| ValueSet.compose.import | The content of a value set includes the content in the imported value set too |
| OperationDefinition.parameter.binding | Used to bind a defined parameter to a value set |
| ValueSet Reference Extension | Indicates that a particular coded value was chosen from the specified value set |
When referencing value sets, the reference is usually made to the definition of a value set - that is, a value set that defines what codes are in the value set. A terminology server is required to convert this definition to the actual expansion that specifies what codes are in the value set in the context of operation.
There are two types of value set references in this list, direct and logical.
A direct value set reference has the type Reference, and refers directly to a ValueSet based on a URL, usually to a terminology server running a FHIR RESTful API. When accessing a value set based on this kind of reference, a system should access the URL directly (after converting a relative reference to an absolute reference according to the local context). If this process fails, the system is unable to resolve the value set and must handle the error appropriately.
Example:
GET fhir/Questionnaire/234
<Questionnaire>
...
<question>
<options>
<reference value="ValueSet/234234"/>
</options>
</question>
....
</Questionnaire>
This specifies that the values for a particular questionnaire come from the ValueSet with id 234234 on the same FHIR end-point. To resolve this, the system would GET fhir/ValueSet/234234
Typically, a direct reference like this is good for in-process references, in closed or carefully managed eco-systems. In a more general context, these references tend to be fragile over time because web URLs - including RESTful API URLS - are easily reassigned. For this reason, systems are encouraged to use logical value set references.
A logical value set reference has the type uri, where an absolute URI is provided that matches the one in ValueSet.url. The value set URL can - and is preferred to be - a web address that actually resolves directly to a fixed web address that serves as the authoritative source for that value set. Alternatively, the system can query its terminology server(s) to resolve a value set with that URL as its identity.
Example:
<StructureDefinition>
...
<element>
...
<binding>
...
<valueSet value="http://hl7.org/fhir/ValueSet/clinical-findings"/>
</binding>
...
</element>
....
</StructureDefinition>
This specifies that the element is bound to the value set with a ValueSet.url of
http://hl7.org/fhir/ValueSet/clinical-findings . One way to access this value set is
to try GET http://hl7.org/fhir/ValueSet/clinical-findings - which works, for this value set - http://hl7.org/fhir/ValueSet/clinical-findings
returns the authoritative value set for this URL.
Alternatively, the value set could be resolved using a local terminology server. If that's running a FHIR Terminology Server, then this would work like this:
GET fhir/ValueSet?url=http://hl7.org/fhir/ValueSet/clinical-findings
if the terminology server knows the value set, then it will return the value set. If the URL doesn't resolve to an authoritative value set, and the terminology server(s) don't know the value set, the system is unable to resolve the value set and must handle the error appropriately.
The value set URL is allowed to be a URI such as a UUID (e.g. urn:uuid:c0e0d027-1250-4278-8f44-33a49dc67916). These value sets can never be accessed directly, and must come from a terminology server. Note that this specification defines many value sets that have a logical URL that is not resolvable (examples for SNOMED CT, RxNorm, LOINC)
Using a logical reference which is a direct reference to the authoritative value set is the easiest and most reliable approach. However, this requires suitable hosting arrangements, and cannot always be guaranteed, so it is not required.
Version specific Logical References
A value set has a two part identifier: a url, and a version. Some value sets only ever have a single 'version'; a revision of the value set contents will cause a new url to be assigned. Others, however, maintain the same URL, and change the version. A terminology server may have multiple value sets for the same ValueSet.url with different versions.
To be precise about which version of a value set is being referred to in a value set reference, append the version to the canonical url with a '|' like this:
<valueSet value="http://hl7.org/fhir/ValueSet/clinical-findings|0.8"/>
This is a version specific reference to a value set. Searching for this on a terminology server would look like this:
GET fhir/ValueSet?url=http://hl7.org/fhir/ValueSet/clinical-findings&version=0.8
Note that if a value set reference does not have a version, and the server finds multiple versions for the value set, the system using the value set should pick the latest version of the value set and use that. Note that this applies to all conformance resources.
Note that as a matter of ongoing development, a few elements that have coded data types are not bound to any value set at all. Bindings are to be provided for these elements.
Almost all of the elements that have a coded data type are bound to a value set. The bindings are associated with various degrees of flexibility as to how closely the value set should be followed:
| required | To be conformant, the concept in this element SHALL be from the specified value set. |
| extensible | To be conformant, the concept in this element SHALL be from the specified value set if any of the codes within the value set can apply to the concept being communicated. If the value set does not cover the concept (based on human review), alternate codings (or, data type allowing, text) may be included instead. |
| preferred | Instances are encouraged to draw from the specified codes for interoperability purposes but are not required to do so to be considered conformant. |
| example | Instances are not expected or even encouraged to draw from the specified value set. The value set merely provides examples of the types of concepts intended to be included. |
The precise conformance criteria for 'required' and 'extensible' binding strengths vary by the data type to which they are applied, as described in the paragraphs below.
Irrespective of the binding strength, when a StructureDefinition is used to describe local usage, it can bind the element to a different value set in order to be much more precise about exactly which coded values can be used for these elements, and/or increase the strength of the binding. There are different rules for this, depending on the binding strength, as discussed below. Generally it is expected that jurisdictions, projects and vendors will work together to choose actual working value sets.
To be conformant, codes in this element SHALL be from the specified value set.
In the standard, this is generally used for elements where the value needs to be strictly controlled so that everyone can interpret it with confidence. Generally, this is used for elements with type code:
,
Language Codes , UCUM , etc.)The other place where this is used is when profiling resources, and there is agreement within a particular context of use that a particular set of codes are the only ones that can be used. In these cases, the data type SHALL contain one of the values in the value set.
The following rules apply when required bindings are used with the CodeableConcept data type:
text can be provided as well, and is always recommended, but is not an acceptable substitute for the required codeIf a required binding is applied to an element with maximum cardinality > 1, the binding applies to all the elements.
The following rules apply when required bindings are used with the code data type:
When an element is bound to a required value set, derived profiles may state rules on which codes can be used, but cannot select new or additional codes for these elements.
To be conformant, codes in this element SHALL be from the specified value set if any of the codes within the value set
can apply to the concept being communicated. If the value set does not cover the concept (based on human review), an alternate
system/code from outside the value set (i.e. from a different value set or chosen from a code system directly) may be
used instead.
Note that it is the value set binding that is extensible, not the value set itself.
If there is at least one applicable concept in the extensibly bound value set with a meaning which includes but is more general than the meaning that is intended to be represented by the element in the resource instance, then the code that is used in the instance SHALL be taken from the value set and should be the closest available match for the intended element instance meaning (i.e. neither more general or more specific). Using a more specific code that more completely represents the intended meaning but is outside the value set is not allowed. However, the more specific code may also be included in the instance as an additional Coding if the data type is CodeableConcept, but it cannot be used instead of the code from the value set. This helps ensure that systems know which codes they should expect to receive and build logic for and it facilitates interoperability.
When a code for an applicable concept in the extensibly bound value set is used it should always be the closest available match for the intended element instance meaning, regardless of hierarchical (i.e. "is-a") relationships in the underlying code system(s) or a particular hierarchical "level" of the concept. However, as noted above, a code for a concept that is outside of the extensibly bound value set with a meaning which is "covered by" (i.e. is more specific than or has an "is-a" relationship to) a concept that is included in the value set cannot be used. In that case a code for a concept that is in the extensibly bound value set SHALL be used in the element instance and it should be the code for the concept that most closely matches the intended element instance meaning.
If the data type is CodeableConcept, then, as noted above, one of the Coding values SHALL be from the specified extensibly bound value set if a code in that value set applies, but if no applicable code exists in the value set alternate code(s) from outside the value set may be used instead. If no codes, including local codes, are available, then text alone (in CodeableConcept.text) may be used.
If the data type is Coding, then the code/system SHALL be from the specified value set if a code applies, but if no suitable code exists in the value set, an alternate code may be provided in its place.
If an extensible binding is applied to an element with maximum cardinality > 1, the binding applies to all the elements.
Identified gaps in value sets should be submitted to the organization administering the value set in order to improve interoperability in the future.
Extensible bindings are used when there is consensus at the specification or profiling level about the coded values that should be used, but it is impossible to create a bounded list of codes that are known to cover all use cases, including ones that are yet to arise.
When an element is extensibly bound to a value set, derived profiles may state rules on which codes can be used, but cannot select new or additional codes for these elements unless no codes with appropriate meanings are found in the base value set.
Note that if the valueset-reference extension is being used and the code in the element instance is from outside the extensibly bound value set, the extension must reference a different value set that the code was chosen from (or if no other value set reference is available the extension cannot be used in that instance).
Extensible binding examples
Instances are encouraged to draw from the specified codes for interoperability purposes but are not required to do so to be considered conformant.
If the data type is CodeableConcept, then one of the Coding values SHOULD be from the specified value set, but another code and/or text can be used in its place.
Preferred bindings are used when there is consensus at the specification level about the coded values that are the best to be used, but there is recognition that some implementation contexts are unable to use the recommended codes for a variety of reasons. Applications should consider adopting the preferred value set wherever possible, as these preferred value sets are the most likely to serve interoperability purposes in the future.
When an element is bound to a preferred value set, derived profiles may bind the element to any value set they choose.
Preferred binding examples
Instances are not expected or even encouraged to draw from the specified value set. The value set merely provides examples of the types of concepts intended to be included.
Example bindings are used when an element has a very broad meaning (such as List.code), or there is no consensus over the correct codes to be used. For these bindings:
Some other coded value MAY be used, or (for a CodeableConcept), a text alternative MAY be provided. Example value sets are provided to assist implementers to understand the correct use of an element. Value sets based on code systems such as SNOMED CT that have restrictive license terms will only be used as example bindings in the base FHIR specification, though implementation guides for particular jurisdictions may adopt value sets that require licenses. In addition, well-specified realm-specific ValueSets may also be used as example bindings in the base specification.
When an element is bound to an example value set, derived profiles may bind the element to any value set they choose.
In a few special cases, humans customarily use codes directly for elements that have type "string". A typical case is codes for states, and there are several places where a URI must come from a set of controlled values. An element of type string or uri can also be bound to a value set. When a string or URI is bound to a value set, the value property SHALL contain the code specified by the value set, and the system and display values are ignored.
FHIR has defined a Terminology Service specification which sets requirements for systems that support the use of codes, value sets and code systems.
®© HL7.org 2011+. FHIR Mixed Nomative/Trial Use Ballot #2 (v3.5.0-14907) generated on Sun, Aug 19, 2018 21:54+1000. QA Page
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