Generated Narrative: StructureDefinition Bundle-drug-stability-pq Name Flags Card. Type Description & Constraints Bundle 0..* Bundle Contains a collection of resources #xD; identifier S 0..1 Identifier Persistent identifier for the bundle #xD; type S 1..1 code collection Required Pattern: collection #xD; timestamp S 0..1 instant When the bundle was assembled #xD; Slices for entry S 12..* BackboneElement Entry in the bundle - will have a resource or information Slice: Unordered, Open by type:resource #xD; entry:Product-Identification 0..1 BackboneElement Entry in the bundle - will have a resource or information #xD; resource 0..1 MedicinalProductDefinitionDrugProductPq Detailed definition of a medicinal product #xD; entry:Drug-Ingredient 0..* BackboneElement Entry in the bundle - will have a resource or information #xD; resource 0..1 IngredientDrugPq An ingredient of a manufactured item or pharmaceutical product #xD; entry:Component-Substance 1..* BackboneElement Entry in the bundle - will have a resource or information #xD; resource 0..1 SubstanceDefinitionComponentSubstanceDrugPq The detailed description of a substance, typically at a level beyond what is used for prescribing #xD; entry:Specimen-Definition 1..* BackboneElement Entry in the bundle - will have a resource or information #xD; resource 0..1 SpecimenDefinitionDrugPq Kind of specimen #xD; entry:Batch-Lot-Information 0..* BackboneElement Entry in the bundle - will have a resource or information #xD; resource 0..1 MedicationBatchInformationDrugPq Definition of a Medication #xD; entry:Actual-Batch-Substance 1..* BackboneElement Entry in the bundle - will have a resource or information #xD; resource 0..1 SubstanceDrugPq A homogeneous material with a definite composition #xD; entry:Actual-Batch-Specimen 1..* BackboneElement Entry in the bundle - will have a resource or information #xD; resource 0..1 SpecimenDrugPq Sample for analysis #xD; entry:Protocol 1..1 BackboneElement Entry in the bundle - will have a resource or information #xD; resource 0..1 PlanDefinitionDrugPq The definition of a plan for a series of actions, independent of any specific patient or context #xD; entry:Test-Set 1..* BackboneElement Entry in the bundle - will have a resource or information #xD; resource 0..1 ActivityDefinitionDrugTestPq The definition of a specific activity to be taken, independent of any particular patient or context #xD; entry:Test-Method 1..* BackboneElement Entry in the bundle - will have a resource or information #xD; resource 0..1 ObservationDefinitionTestMethodPq Definition of an observation #xD; entry:Report 1..* BackboneElement Entry in the bundle - will have a resource or information #xD; resource 0..1 DiagnosticReportAnalysisDrugPQ A Diagnostic report - a combination of request information, atomic results, images, interpretation, as well as formatted reports #xD; entry:Result-Observations 1..* BackboneElement Entry in the bundle - will have a resource or information #xD; resource 0..1 ObservationTestResultDrugPq Measurements and simple assertions #xD; entry:Organization 1..* BackboneElement Entry in the bundle - will have a resource or information #xD; resource 0..1 OrganizationDrugPq A grouping of people or organizations with a common purpose #xD; Documentation for this format
HL7 International / Biomedical Research and Regulation
Stability Study domain: This Bundle profile represents the structured data used in CTD section 3.2.P.8 Stability, subsection 3.2.P.8.3 Stability Data, and CTD section 3.2.S.7 Stability, subsection 3.2.S.7.3 Stability Data.
A container for a collection of resources.
total.empty() or (type = 'searchset') or (type = 'history')
(type = 'searchset') or entry.search.empty()
FullUrl must be unique in a bundle, or else entries with the same fullUrl must have different meta.versionId (except in history bundles)
(type = 'history') or entry.where(fullUrl.exists()).select(fullUrl&iif(resource.meta.versionId.exists(), resource.meta.versionId, '')).isDistinct()
A document must have an identifier with a system and a value
type = 'document' implies (identifier.system.exists() and identifier.value.exists())
type = 'document' implies (timestamp.hasValue())
A document must have a Composition as the first resource
type = 'document' implies entry.first().resource.is(Composition)
A message must have a MessageHeader as the first resource
type = 'message' implies entry.first().resource.is(MessageHeader)
A subscription-notification must have a SubscriptionStatus as the first resource
type = 'subscription-notification' implies entry.first().resource.is(SubscriptionStatus)
entry.request.method PATCH not allowed for history
type = 'history' implies entry.request.method != 'PATCH'
Bundle resources where type is not transaction, transaction-response, batch, or batch-response or when the request is a POST SHALL have Bundle.entry.fullUrl populated
type='transaction' or type='transaction-response' or type='batch' or type='batch-response' or entry.all(fullUrl.exists() or request.method='POST')
Issue.severity for all issues within the OperationOutcome must be either 'information' or 'warning'.
issues.exists() implies (issues.issue.severity = 'information' or issues.issue.severity = 'warning')
Use and meaning of issues for documents has not been validated because the content will not be rendered in the document.
type = 'document' implies issues.empty()
type = 'searchset' implies link.where(relation = 'self' and url.exists()).exists()
For collections of type document, message, searchset or collection, all entries must contain resources, and not have request or response elements
type in ('document' | 'message' | 'searchset' | 'collection') implies entry.all(resource.exists() and request.empty() and response.empty())
For collections of type history, all entries must contain request or response elements, and resources if the method is POST, PUT or PATCH
type = 'history' implies entry.all(request.exists() and response.exists() and ((request.method in ('POST' | 'PATCH' | 'PUT')) = resource.exists()))
For collections of type transaction or batch, all entries must contain request elements, and resources if the method is POST, PUT or PATCH
type in ('transaction' | 'batch') implies entry.all(request.method.exists() and ((request.method in ('POST' | 'PATCH' | 'PUT')) = resource.exists()))
For collections of type transaction-response or batch-response, all entries must contain response elements
type in ('transaction-response' | 'batch-response') implies entry.all(response.exists())
ClinicalDocument, if bundle.type = document
The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes.
Within the context of the FHIR RESTful interactions, the resource has an id except for cases like the create and conditional update. Otherwise, the use of the resouce id depends on the given use case.
The metadata about the resource. This is content that is maintained by the infrastructure. Changes to the content might not always be associated with version changes to the resource.
All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
A set of rules under which this content was created
A reference to a set of rules that were followed when the resource was constructed, and which must be understood when processing the content. Often, this is a reference to an implementation guide that defines the special rules along with other profiles etc.
Asserting this rule set restricts the content to be only understood by a limited set of trading partners. This inherently limits the usefulness of the data in the long term. However, the existing health eco-system is highly fractured, and not yet ready to define, collect, and exchange data in a generally computable sense. Wherever possible, implementers and/or specification writers should avoid using this element. Often, when used, the URL is a reference to an implementation guide that defines these special rules as part of its narrative along with other profiles, value sets, etc.
This element is labeled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies its meaning or interpretation
The base language in which the resource is written.
Language is provided to support indexing and accessibility (typically, services such as text to speech use the language tag). The html language tag in the narrative applies to the narrative. The language tag on the resource may be used to specify the language of other presentations generated from the data in the resource. Not all the content has to be in the base language. The Resource.language should not be assumed to apply to the narrative automatically. If a language is specified, it should it also be specified on the div element in the html (see rules in HTML5 for information about the relationship between xml:lang and the html lang attribute).
A persistent identifier for the bundle that won't change as a bundle is copied from server to server.
Persistent identity generally only matters for batches of type Document, Message, and Collection. It would not normally be populated for search and history results and servers ignore Bundle.identifier when processing batches and transactions. For Documents the .identifier SHALL be populated such that the .identifier is globally unique.
Indicates the purpose of this bundle - how it is intended to be used.
It's possible to use a bundle for other purposes (e.g. a document can be accepted as a transaction). This is primarily defined so that there can be specific rules for some of the bundle types.
Indicates the purpose of a bundle - how it is intended to be used.
The date/time that the bundle was assembled - i.e. when the resources were placed in the bundle.
For many bundles, the timestamp is equal to .meta.lastUpdated, because they are not stored (e.g. search results). When a bundle is placed in a persistent store, .meta.lastUpdated will be usually be changed by the server. When the bundle is a message, a middleware agent altering the message (even if not stored) SHOULD update .meta.lastUpdated. .timestamp is used to track the original time of the Bundle, and SHOULD be populated. Usage: * document : the date the document was created. Note: the composition may predate the document, or be associated with multiple documents. The date of the composition - the authoring time - may be earlier than the document assembly time * message : the date that the content of the message was assembled. This date is not changed by middleware engines unless they add additional data that changes the meaning of the time of the message * history : the date that the history was assembled. This time would be used as the _since time to ask for subsequent updates * searchset : the time that the search set was assembled. Note that different pages MAY have different timestamps but need not. Having different timestamps does not imply that subsequent pages will represent or include changes made since the initial query * transaction | transaction-response | batch | batch-response | collection : no particular assigned meaning The timestamp value should be greater than the lastUpdated and other timestamps in the resources in the bundle, and it should be equal or earlier than the .meta.lastUpdated on the Bundle itself.
If a set of search matches, this is the (potentially estimated) total number of entries of type 'match' across all pages in the search. It does not include search.mode = 'include' or 'outcome' entries and it does not provide a count of the number of entries in the Bundle.
Only used if the bundle is a search result set. The total does not include resources such as OperationOutcome and included resources, only the total number of matching resources.
A series of links that provide context to this bundle.
Both Bundle.link and Bundle.entry.link are defined to support providing additional context when Bundles are used (e.g. [HATEOAS](http://en.wikipedia.org/wiki/HATEOAS)). Bundle.entry.link corresponds to links found in the HTTP header if the resource in the entry was [read](http://hl7.org/fhir/R5/http.html#read) directly. This specification defines some specific uses of Bundle.link for [searching](http://hl7.org/fhir/R5/search.html#conformance) and [paging](http://hl7.org/fhir/R5/http.html#paging), but no specific uses for Bundle.entry.link, and no defined function in a transaction - the meaning is implementation specific. The behavior of navigation link types (next/prev/first/last) are well defined for searchset and history Bundles but are not currently defined for other types. Implementers who choose to use such link relationships for other bundle types will need to negotiate behavior with their interoperability partners.
Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
Additional content defined by implementations
May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.
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.
Must have either extensions or value[x], not both
Extensions that cannot be ignored even if unrecognized
May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).
Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension).
Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
See http://www.iana.org/assignments/link-relations/link-relations.xhtml#link-relations-1
A name which details the functional use for this link - see [http://www.iana.org/assignments/link-relations/link-relations.xhtml#link-relations-1](http://www.iana.org/assignments/link-relations/link-relations.xhtml#link-relations-1).
Entry in the bundle - will have a resource or information
An entry in a bundle resource - will either contain a resource or information about a resource (transactions and history only).
For bundles of type 'document' and 'message', the first resource is special (must be Composition or MessageHeader respectively). For all bundles, the meaning of the order of entries depends on the bundle type
must be a resource unless there's a request or response
resource.exists() or request.exists() or response.exists()
fullUrl cannot be a version specific reference
fullUrl.exists() implies fullUrl.contains('/_history/').not()
A series of links that provide context to this entry.
URI for resource (e.g. the absolute URL server address, URI for UUID/OID, etc.)
The Absolute URL for the resource. Except for transactions and batches, each entry in a Bundle must have a fullUrl. The fullUrl SHALL NOT disagree with the id in the resource - i.e. if the fullUrl is not a urn:uuid, the URL shall be version-independent URL consistent with the Resource.id. The fullUrl is a version independent reference to the resource. Even when not required, fullUrl MAY be set to a urn:uuid to allow referencing entries in a transaction. The fullUrl can be an arbitrary URI and is not limited to urn:uuid, urn:oid, http, and https. The fullUrl element SHALL have a value except when: * invoking a create * invoking or responding to an operation where the body is not a single identified resource * invoking or returning the results of a search or history operation.
fullUrl might not be [unique in the context of a resource](http://hl7.org/fhir/R5/bundle.html#bundle-unique). Note that since [FHIR resources do not need to be served through the FHIR API](http://hl7.org/fhir/R5/references.html), the fullURL might be a URN or an absolute URL that does not end with the logical id of the resource (Resource.id). However, but if the fullUrl does look like a RESTful server URL (e.g. meets the [regex](http://hl7.org/fhir/R5/references.html#regex), then the 'id' portion of the fullUrl SHALL end with the Resource.id. Note that the fullUrl is not the same as the canonical URL - it's an absolute url for an endpoint serving the resource (these will happen to have the same value on the canonical server for the resource with the canonical URL).
The Resource for the entry. The purpose/meaning of the resource is determined by the Bundle.type. This is allowed to be a Parameters resource if and only if it is referenced by something else within the Bundle that provides context/meaning.
Information about the search process that lead to the creation of this entry.
match | include - why this is in the result set
Why this entry is in the result set - whether it's included as a match or because of an _include requirement, or to convey information or warning information about the search process.
There is only one mode. In some corner cases, a resource may be included because it is both a match and an include. In these circumstances, 'match' takes precedence.
Why an entry is in the result set - whether it's included as a match or because of an _include requirement, or to convey information or warning information about the search process.
When searching, the server's search ranking score for the entry.
Servers are not required to return a ranking score. 1 is most relevant, and 0 is least relevant. Often, search results are sorted by score, but the client may specify a different sort order. See [Patient Match](http://hl7.org/fhir/R5/patient-operation-match.html) for the EMPI search which relates to this element.
Additional execution information (transaction/batch/history)
Additional information about how this entry should be processed as part of a transaction or batch. For history, it shows how the entry was processed to create the version contained in the entry.
GET | HEAD | POST | PUT | DELETE | PATCH
In a transaction or batch, this is the HTTP action to be executed for this entry. In a history bundle, this indicates the HTTP action that occurred.
HTTP verbs (in the HTTP command line). See [HTTP rfc](https://tools.ietf.org/html/rfc7231) for details.
The URL for this entry, relative to the root (the address to which the request is posted).
E.g. for a Patient Create, the method would be "POST" and the URL would be "Patient". For a Patient Update, the method would be PUT and the URL would be "Patient/[id]".
If the ETag values match, return a 304 Not Modified status. See the API documentation for ["Conditional Read"](http://hl7.org/fhir/R5/http.html#cread).
Only perform the operation if the last updated date matches. See the API documentation for ["Conditional Read"](http://hl7.org/fhir/R5/http.html#cread).
Only perform the operation if the Etag value matches. For more information, see the API section ["Managing Resource Contention"](http://hl7.org/fhir/R5/http.html#concurrency).
Instruct the server not to perform the create if a specified resource already exists. For further information, see the API documentation for ["Conditional Create"](http://hl7.org/fhir/R5/http.html#ccreate). This is just the query portion of the URL - what follows the "?" (not including the "?").
Results of execution (transaction/batch/history)
Indicates the results of processing the corresponding 'request' entry in the batch or transaction being responded to or what the results of an operation where when returning history.
The status code returned by processing this entry. The status SHALL start with a 3 digit HTTP code (e.g. 404) and may contain the standard HTTP description associated with the status code.
The location (if the operation returns a location)
The location header created by processing this operation, populated if the operation returns a location.
The Etag for the resource, if the operation for the entry produced a versioned resource (see [Resource Metadata and Versioning](http://hl7.org/fhir/R5/http.html#versioning) and [Managing Resource Contention](http://hl7.org/fhir/R5/http.html#concurrency)).
Etags match the Resource.meta.versionId. The ETag has to match the version id in the header if a resource is included.
The date/time that the resource was modified on the server.
This has to match the same time in the meta header (meta.lastUpdated) if a resource is included.
OperationOutcome with hints and warnings (for batch/transaction)
An OperationOutcome containing hints and warnings produced as part of processing this entry in a batch or transaction.
For a POST/PUT operation, this is the equivalent outcome that would be returned for prefer = operationoutcome - except that the resource is always returned whether or not the outcome is returned. This outcome is not used for error responses in batch/transaction, only for hints and warnings. In a batch operation, the error will be in Bundle.entry.response, and for transaction, there will be a single OperationOutcome instead of a bundle in the case of an error.
Detailed definition of a medicinal product
A medicinal product, being a substance or combination of substances that is intended to treat, prevent or diagnose a disease, or to restore, correct or modify physiological functions by exerting a pharmacological, immunological or metabolic action. This resource is intended to define and detail such products and their properties, for uses other than direct patient care (e.g. regulatory use, or drug catalogs).
Entity, Role, or Act,ManufacturedProduct[classCode='MANU'].manufacturedProduct[classCode='MMAT']
Medicinal Product and Investigational Medicinal Product
An ingredient of a manufactured item or pharmaceutical product
The detailed description of a substance, typically at a level beyond what is used for prescribing
Substance (and derived classes: Chemical, Polymer, Protein, Nucleic_Acid, Structurally_Diverse)
A kind of specimen with associated set of requirements.
This resource is primarily used for the identification and definition of a medication, including ingredients, for the purposes of prescribing, dispensing, and administering a medication as well as for making statements about medication use.
Entity, Role, or Act,ManufacturedProduct[classCode=ADMM]
NewRx/MedicationPrescribed -or- RxFill/MedicationDispensed -or- RxHistoryResponse/MedicationDispensed -or- RxHistoryResponse/MedicationPrescribed
A homogeneous material with a definite composition
fhir:Substance rdfs:subClassOf rim:Entity, [ a owl:Restriction; owl:onProperty rim:Act.classCode; owl:allValuesFrom cs:EntityClass\#MAT ].
Entity, Role, or Act,Role[classCode=SPEC]
The definition of a plan for a series of actions, independent of any specific patient or context
This resource allows for the definition of various types of plans as a sharable, consumable, and executable artifact. The resource is general enough to support the description of a broad range of clinical and non-clinical artifacts such as clinical decision support rules, order sets, protocols, and drug quality specifications.
The definition of a specific activity to be taken, independent of any particular patient or context
This resource allows for the definition of some activity to be performed, independent of a particular patient, practitioner, or other performance context.
Set of definitional characteristics for a kind of observation or measurement produced or consumed by an orderable health care service.
An instance of this resource informs the consumer of a health-related service (such as a lab diagnostic test or panel) about how the observations used or produced by this service will look like.
Observation[classCode=OBS, moodCode=DEF]
A Diagnostic report - a combination of request information, atomic results, images, interpretation, as well as formatted reports
The findings and interpretation of diagnostic tests performed on patients, groups of patients, products, substances, devices, and locations, and/or specimens derived from these. The report includes clinical context such as requesting provider information, and some mix of atomic results, images, textual and coded interpretations, and formatted representation of diagnostic reports. The report also includes non-clinical context such as batch analysis and stability reporting of products and substances.
This is intended to capture a single report and is not suitable for use in displaying summary information that covers multiple reports. For example, this resource has not been designed for laboratory cumulative reporting formats nor detailed structured reports for sequencing.
Entity, Role, or Act,Observation[classCode=OBS, moodCode=EVN]
Measurements and simple assertions made about a patient, device or other subject.
Used for simple observations such as device measurements, laboratory atomic results, vital signs, height, weight, smoking status, comments, etc. Other resources are used to provide context for observations such as laboratory reports, etc.
A grouping of people or organizations with a common purpose
A formally or informally recognized grouping of people or organizations formed for the purpose of achieving some form of collective action. Includes companies, institutions, corporations, departments, community groups, healthcare practice groups, payer/insurer, etc.
Entity, Role, or Act,Organization(classCode=ORG, determinerCode=INST)
Digital Signature - base64 encoded. XML-DSig or a JWS.
The signature could be created by the "author" of the bundle or by the originating device. Requirements around inclusion of a signature, verification of signatures and treatment of signed/non-signed bundles is implementation-environment specific.
A Signature holds an electronic representation of a signature and its supporting context in a FHIR accessible form. The signature may either be a cryptographic type (XML DigSig or a JWS), which is able to provide non-repudiation proof, or it may be a graphical image that represents a signature or a signature process. This element allows capturing signatures on documents, messages, transactions or even search responses, to support content-authentication, non-repudiation or other business cases. This is primarily relevant where the bundle may travel through multiple hops or via other mechanisms where HTTPS non-repudiation is insufficient.
Captures issues and warnings that relate to the construction of the Bundle and the content within it.
Usage notes: These issues and warnings must apply to the Bundle as a whole, not to individual entries.Messages relating to the processing of individual entries (e.g. in a batch or transaction) SHALL be reported in the entry.response.outcome for that entry. If there are errors that arise in the creation of the Bundle, then that should be handled by an OperationOutcome being returned instead of the Bundle.