Medizininformatik Initiative - ImplementationGuide - Modul PRO v2026

Information captured by the author/maintainer of the questionnaire for development purposes, not intended to be seen by users.

Allows capture of todos, rationale for design decisions, etc. It can also be used to capture comments about the completion of the form in general. Allows commentary to be captured during the process of answering a questionnaire (if not already supported by the form design) as well as after the form is completed. Comments are not part of the "data" of the form. If a form prompts for a comment, this should be captured in an answer, not in this element. Formal assessments of the QuestionnareResponse would use [[[Observation]]].

Indicates the terminology server(s) that are known to be capable of returning and potentially expanding the value set(s) associated with the whole questionnaire or a particular group or question within the questionnaire (depending on where the extension appears). If a full URL is not provided AND the requested query is a terminology operation (e.g. $lookup or $expand) the client SHOULD execute the operation against the preferredTerminologyServer rather than the local repository.

This includes those referenced by answerValueSet as well as the unitValueSet extension.

Indicates the types of resources that can record answers to a Questionnaire. Open Issue: Should this extension be moved to core?

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

If present, indicates that this questionnaire has expectations with respect to assembly. Specifically, indicates whether this form requires assembly (i.e. it can't be used directly without invoking the $assemble operation operation on it) and/or whether it is intended for use only as a 'child' in an assembly process. The assembly processs might mean filling in item metadata based on information looked up from item.definitions and/or retrieving sub-questionnaires pointed to by sub-questionnaire extensions.

SDC-conformant Questionnaires SHALL declare this extension if they require an assembly process prior to use. If not declared, then the Questionnaire is not necessarily safe for use as a child form and does not require assembly prior to use.

An absolute URI that is used to identify this questionnaire when it is referenced in a specification, model, design or an instance; also called its canonical identifier. This SHOULD be globally unique and SHOULD be a literal address at which at which an authoritative instance of this questionnaire is (or will be) published. This URL can be the target of a canonical reference. It SHALL remain the same when the questionnaire is stored on different servers.

… This is the id that will be used to link a QuestionnaireResponse to the Questionnaire the response is for.

The name of the referenced questionnaire can be conveyed using the http://hl7.org/fhir/StructureDefinition/display extension.

A formal identifier that is used to identify this questionnaire when it is represented in other formats, or referenced in a specification, model, design or an instance.

Allows externally provided and/or usable business identifiers to be easily associated with the module.

Typically, this is used for identifiers that can go in an HL7 V3 II (instance identifier) data type, and can then identify this questionnaire outside of FHIR, where it is not possible to use the logical URI.

A natural language name identifying the questionnaire. This name should be usable as an identifier for the module by machine processing applications such as code generation.

Support human navigation and code generation.

The name is not expected to be globally unique. The name should be a simple alphanumeric type name to ensure that it is machine-processing friendly.

A short, descriptive, user-friendly title for the questionnaire.

This name does not need to be machine-processing friendly and may contain punctuation, white-space, etc.

The status of this questionnaire. Enables tracking the life-cycle of the content.

Allows filtering of questionnaires that are appropriate for use versus not.

The lifecycle status of an artifact.

A Boolean value to indicate that this questionnaire is authored for testing purposes (or education/evaluation/marketing) and is not intended to be used for genuine usage.

Enables experimental content to be developed following the same lifecycle that would be used for a production-level questionnaire.

Allows filtering of questionnaires that are appropriate for use versus not.

The types of subjects that can be the subject of responses created for the questionnaire.

A Questionnaire SHOULD specify the subject. However, it is optional to support legacy questionnaires.

If none are specified, then the subject is unlimited.

One of the resource types defined as part of this version of FHIR.

The date (and optionally time) when the questionnaire was published. The date must change when the business version changes and it must change if the status code changes. In addition, it should change when the substantive content of the questionnaire changes.

Note that this is not the same as the resource last-modified-date, since the resource may be a secondary representation of the questionnaire. Additional specific dates may be added as extensions or be found by consulting Provenances associated with past versions of the resource.

The name of the organization or individual that published the questionnaire.

Helps establish the "authority/credibility" of the questionnaire. May also allow for contact.

Usually an organization but may be an individual. The publisher (or steward) of the questionnaire is the organization or individual primarily responsible for the maintenance and upkeep of the questionnaire. This is not necessarily the same individual or organization that developed and initially authored the content. The publisher is the primary point of contact for questions or issues with the questionnaire. This item SHOULD be populated unless the information is available from context.

Contact details to assist a user in finding and communicating with the publisher.

May be a web site, an email address, a telephone number, etc.

A free text natural language description of the questionnaire from a consumer's perspective.

This description can be used to capture details such as why the questionnaire was built, comments about misuse, instructions for clinical use and interpretation, literature references, examples from the paper world, etc. It is not a rendering of the questionnaire as conveyed in the 'text' field of the resource itself. This item SHOULD be populated unless the information is available from context (e.g. the language of the questionnaire is presumed to be the predominant language in the place the questionnaire was created).

The content was developed with a focus and intent of supporting the contexts that are listed. These contexts may be general categories (gender, age, ...) or may be references to specific programs (insurance plans, studies, ...) and may be used to assist with indexing and searching for appropriate questionnaire instances.

Assist in searching for appropriate content.

When multiple useContexts are specified, there is no expectation that all or any of the contexts apply.

A legal or geographic region in which the questionnaire is intended to be used.

It may be possible for the questionnaire to be used in jurisdictions other than those for which it was originally designed or intended.

Countries and regions within which this artifact is targeted for use.

Explanation of why this questionnaire is needed and why it has been designed as it has.

This element does not describe the usage of the questionnaire. Instead, it provides traceability of ''why'' the resource is either needed or ''why'' it is defined as it is. This may be used to point to source materials or specifications that drove the structure of this questionnaire.

The date on which the resource content was approved by the publisher. Approval happens once when the content is officially approved for usage.

The 'date' element may be more recent than the approval date because of minor changes or editorial corrections.

The date on which the resource content was last reviewed. Review happens periodically after approval but does not change the original approval date.

Gives a sense of how "current" the content is. Resources that have not been reviewed in a long time may have a risk of being less appropriate/relevant.

If specified, this date follows the original approval date.

The period during which the questionnaire content was or is planned to be in active use.

Allows establishing a transition before a resource comes into effect and also allows for a sunsetting process when new versions of the questionnaire are or are expected to be used instead.

The effective period for a questionnaire determines when the content is applicable for usage and is independent of publication and review dates. For example, a measure intended to be used for the year 2016 might be published in 2015.

The version of the code system which was used when choosing this code. Note that a well-maintained code system does not need the version reported, because the meaning of codes is consistent across versions. However this cannot consistently be assured, and when the meaning is not guaranteed to be consistent, the version SHOULD be exchanged.

Where the terminology does not clearly define what string should be used to identify code system versions, the recommendation is to use the date (expressed in FHIR date format) on which that version was officially published as the version date.

A representation of the meaning of the code in the system, following the rules of the system.

Need to be able to carry a human-readable meaning of the code for readers that do not know the system.

Note that FHIR strings SHALL NOT exceed 1MB in size

Indicates that this coding was chosen by a user directly - e.g. off a pick list of available items (codes or displays).

This has been identified as a clinical safety criterium - that this exact system/code pair was chosen explicitly, rather than inferred by the system based on some rules or language processing.

Amongst a set of alternatives, a directly chosen code is the most appropriate starting point for new translations. There is some ambiguity about what exactly 'directly chosen' implies, and trading partner agreement may be needed to clarify the use of this element and its consequences more completely.

The version of the code system which was used when choosing this code. Note that a well-maintained code system does not need the version reported, because the meaning of codes is consistent across versions. However this cannot consistently be assured, and when the meaning is not guaranteed to be consistent, the version SHOULD be exchanged.

Where the terminology does not clearly define what string should be used to identify code system versions, the recommendation is to use the date (expressed in FHIR date format) on which that version was officially published as the version date.

A representation of the meaning of the code in the system, following the rules of the system.

Need to be able to carry a human-readable meaning of the code for readers that do not know the system.

Note that FHIR strings SHALL NOT exceed 1MB in size

Indicates that this coding was chosen by a user directly - e.g. off a pick list of available items (codes or displays).

This has been identified as a clinical safety criterium - that this exact system/code pair was chosen explicitly, rather than inferred by the system based on some rules or language processing.

Amongst a set of alternatives, a directly chosen code is the most appropriate starting point for new translations. There is some ambiguity about what exactly 'directly chosen' implies, and trading partner agreement may be needed to clarify the use of this element and its consequences more completely.

The version of the code system which was used when choosing this code. Note that a well-maintained code system does not need the version reported, because the meaning of codes is consistent across versions. However this cannot consistently be assured, and when the meaning is not guaranteed to be consistent, the version SHOULD be exchanged.

Where the terminology does not clearly define what string should be used to identify code system versions, the recommendation is to use the date (expressed in FHIR date format) on which that version was officially published as the version date.

A representation of the meaning of the code in the system, following the rules of the system.

Need to be able to carry a human-readable meaning of the code for readers that do not know the system.

Note that FHIR strings SHALL NOT exceed 1MB in size

Indicates that this coding was chosen by a user directly - e.g. off a pick list of available items (codes or displays).

This has been identified as a clinical safety criterium - that this exact system/code pair was chosen explicitly, rather than inferred by the system based on some rules or language processing.

Amongst a set of alternatives, a directly chosen code is the most appropriate starting point for new translations. There is some ambiguity about what exactly 'directly chosen' implies, and trading partner agreement may be needed to clarify the use of this element and its consequences more completely.

Information captured by the author/maintainer of the questionnaire for development purposes, not intended to be seen by users.

Allows capture of todos, rationale for design decisions, etc. It can also be used to capture comments about specific groups or questions within it. Allows commentary to be captured during the process of answering a questionnaire (if not already supported by the form design) as well as after the form is completed. Comments are not part of the "data" of the form. If a form prompts for a comment, this should be captured in an answer, not in this element. Formal assessments of the QuestionnareResponse would use [[[Observation]]].

Indicates the terminology server(s) that are known to be capable of returning and potentially expanding the value set(s) associated with the whole questionnaire or a particular group or question within the questionnaire (depending on where the extension appears). If a full URL is not provided AND the requested query is a terminology operation (e.g. $lookup or $expand) the client SHOULD execute the operation against the preferredTerminologyServer rather than the local repository.

This includes those referenced by answerValueSet as well as the unitValueSet extension.

An identifier that is unique within the Questionnaire allowing linkage to the equivalent item in a QuestionnaireResponse resource.

QuestionnaireResponse does not require omitted items to be included and may have some items that repeat, so linkage based on position alone is not sufficient.

This ''can'' be a meaningful identifier (e.g. a LOINC code) but is not intended to have any meaning. GUIDs or sequential numbers are appropriate here.

This element is a URI that refers to an ElementDefinition that provides information about this item, including information that might otherwise be included in the instance of the Questionnaire resource. A detailed description of the construction of the URI is shown in Comments, below. If this element is present then the following element values MAY be derived from the Element Definition if the corresponding elements of this Questionnaire resource instance have no value:

• code (ElementDefinition.code)
• type (ElementDefinition.type)
• required (ElementDefinition.min)
• repeats (ElementDefinition.max)
• maxLength (ElementDefinition.maxLength)
• answerValueSet (ElementDefinition.binding)
• options (ElementDefinition.binding).

A common pattern is to define a set of data elements and then build multiple questionnaires for different circumstances to gather the data. This element provides traceability to the common definition and allows the content for the question to come from the underlying definition.

The uri refers to an ElementDefinition in a StructureDefinition and always starts with the canonical URL for the target resource. When referring to a StructureDefinition, a fragment identifier is used to specify the element definition by its id Element.id. E.g. http://hl7.org/fhir/StructureDefinition/Observation#Observation.value[x]. In the absence of a fragment identifier, the first/root element definition in the target is the matching element definition.

A terminology code that corresponds to this group or question (e.g. a code from LOINC, which defines many questions and answers).

Allows linking of groups of questions to formal terminologies.

The value may come from the ElementDefinition referred to by .definition.

Codes for questionnaires, groups and individual questions.

A short label for a particular group, question or set of display text within the questionnaire used for reference by the individual completing the questionnaire.

Separating the label from the question text allows improved rendering. Also, instructions will often refer to specific prefixes, so there's a need for the questionnaire design to have control over what labels are used.

These are generally unique within a questionnaire, though this is not guaranteed. Some questionnaires may have multiple questions with the same label with logic to control which gets exposed. Typically, these won't be used for "display" items, though such use is not prohibited. Systems SHOULD NOT generate their own prefixes if prefixes are defined for any items within a Questionnaire.

The name of a section, the text of a question or text content for a display item.

When using this element to represent the name of a section, use group type item and also make sure to limit the text element to a short string suitable for display as a section heading. Group item instructions should be included as a display type item within the group.

The type of questionnaire item this is - whether text for display, a grouping of other items or a particular type of data to be captured (string, integer, coded choice, etc.).

Defines the format in which the user is to be prompted for the answer.

Time is handled using "string". File is handled using Attachment. (Content can be sent as a contained binary).

Distinguishes groups from questions and display text and indicates data type for questions.

The linkId for the question whose answer (or lack of answer) governs whether this item is enabled.

If multiple question occurrences are present for the same question (same linkId), then this refers to the nearest question occurrence reachable by tracing first the "ancestor" axis and then the "preceding" axis and then the "following" axis.

Specifies the criteria by which the question is enabled.

Note that FHIR strings SHALL NOT exceed 1MB in size

The criteria by which a question is enabled.

Controls how multiple enableWhen values are interpreted - whether all or any must be true.

This element must be specified if more than one enableWhen value is provided.

Controls how multiple enableWhen values are interpreted - whether all or any must be true.

An indication, if true, that the item must be present in a "completed" QuestionnaireResponse. If false, the item may be skipped when answering the questionnaire.

Questionnaire.item.required only has meaning for elements that are conditionally enabled with enableWhen if the condition evaluates to true. If an item that contains other items is marked as required, that does not automatically make the contained elements required (though required groups must contain at least one child element). The value may come from the ElementDefinition referred to by .definition.

Items are generally assumed not to be required unless explicitly specified. Systems SHOULD always populate this value

An indication, if true, that a QuestionnaireResponse for this item may include multiple answers associated with a single instance of this item (for question-type items) or multiple repetitions of the item (for group-type items)

Items may be used to create set of (related) questions that can be repeated to give multiple answers to such a set.

If a question is marked as repeats=true, then multiple answers can be provided for the question in the corresponding QuestionnaireResponse. When rendering the questionnaire, it is up to the rendering software whether to render the question text for each answer repetition (i.e. "repeat the question") or to simply allow entry/selection of multiple answers for the question (repeat the answers). Which is most appropriate visually may depend on the type of answer as well as whether there are nested items.

The resulting QuestionnaireResponse will be populated the same way regardless of rendering - one 'question' item with multiple answer values.

The value may come from the ElementDefinition referred to by .definition.

Items are generally assumed not to repeat unless explicitly specified. Systems SHOULD always populate this value

An indication, when true, that the value cannot be changed by a human respondent to the Questionnaire.

Allows certain information to be phrased (and rendered) as a question and an answer, while keeping users from changing it. May also be useful for preventing changes to pre-populated portions of a questionnaire, for calculated values, etc.

The value of readOnly elements can be established by asserting extensions for defaultValues, linkages that support pre-population and/or extensions that support calculation based on other answers.

The maximum number of characters that are permitted in the answer to be considered a "valid" QuestionnaireResponse.

For base64binary, reflects the number of characters representing the encoded data, not the number of bytes of the binary data. The value may come from the ElementDefinition referred to by .definition.

A reference to a value set containing a list of codes representing permitted answers for a "choice" or "open-choice" question.

LOINC defines many useful value sets for questionnaire responses. See LOINC Answer Lists. The value may come from the ElementDefinition referred to by .definition.

Indicates whether the answer value is selected when the list of possible answers is initially shown.

Use this instead of initial[v] if answerValueSet is present.

Only selected items explicitly marked to be selected

Text, questions and other groups to be nested beneath a question or group.

Reports can consist of complex nested groups.

There is no specified limit to the depth of nesting. However, Questionnaire authors are encouraged to consider the impact on the user and user interface of overly deep nesting.