Implementierungsleitfaden ISiK-Modul Dokumentenaustausch

Akteure und Interaktionen

Akteure und Interaktionen

Akteure

Dokumentenserver

Das bestätigungsrelevante System nimmt die Rolle des Dokumentenservers ein. Ein Dokumentenserver nimmt Dokumente von Clients zur Speicherung/Archivierung/Verwaltung entgegen und erlaubt Clients die Suche nach und den Abruf von Dokumenten. Dieses ISiK-Modul legt fest, welche Suchkriterien mindestens implementiert werden müssen und welche Kriterien darüber hinaus optional bereitgestellt werden können. Dokumentenserver müssen mindestens die Interaktion "Dokumentenabfrage" implementieren. Die Umsetzung der Dokumentenbereitstellung ist optional. Um Clients die Herstellung von Patienten- und Encounterkontext zu ermöglichen, müssen weiterhin die im Basismodul Stufe 2 festgelegten Interaktionen auf den Datenobjekten "Patient" und "Kontakt/Fall (Encounter)" implementiert werden.

(Webbasierter/Mobiler) Client

Clients können Dokumente von einem Dokumentenserver abfragen, um sie z.B. einem Anwender anzuzeigen. Dabei können sie die für die Server verpflichtend festgelegten Suchkriterien beliebig kombinieren. Clients sind nicht verpflichtet, alle von den Servern geforderten Suchkriterien zu unterstützen. Weiterhin können Clients neu erstellte, geänderte oder erweiterte Dokumente an einen Dokumentenserver übermitteln. Dabei müssen sie jedoch mindestens die in diesem Modul verpflichtend festgelegten Metadaten zu den Dokumenten bereitstellen. Sowohl die Implementierung der Interaktion "Dokumentenabfrage" als auch "Dokumentenbereitstellung" sind für Clients optional.

Interaktionen

Dokumentenabfrage und -Zugriff (bestätigungsrelevant)

UseCase: Ein (webbasierter/mobiler) Client möchte Dokumente anhand definierter Kriterien abfragen. Zur Dokumenten(-Metadaten)abfrage nutzt diese Spezifikation die SEARCH-Interaktionen auf der DocumentReference-Ressource gemäß der FHIR-Spezifikation. Dabei müssen ausgewählte Suchparameter von Dokumentenservern verpflichtend unterstützt werden. Die Selektion erfolgt anhand der Relevanz der Parameter für die identifizierten UseCases. Der Zugriff auf die von den DocumentReferences verlinkten Dokumente (z.B. im PDF-Format) erfolgt per READ-Interaktion auf der Binary-Ressource gemäß FHIR-Spezifikation.

Dokumentenbereitstellung (bestätigungsrelevant)

UseCase: Ein (webbasierter/mobiler) Client möchte neu erstellte, geänderte oder erweiterte Dokumente an einen Dokumentenserver übermitteln. Der Server nimmt Dokument und Metadaten entgegen, persistiert diese und stellt die anschließend für die Dokumentabfrage und den -zugriff bereit.

Update von Dokumentenmetadaten (optional)

UseCase: Ein Client möchte die Metadaten eines Dokumentes ändern, ohne den Inhalt des Dokumentes selbst zu beeinflussen oder eine neue Version des Dokumentes hochladen zu müssen. Dies ist nur für eine stark eingeschränkte Menge von Elementen möglich. Der Server stellt dafür eine Operation zur Verfügung, deren Parameter den änderbaren Elementen entsprechen.

Erzeugen von Dokumentenmetadaten (optional)

UseCase: Ein Client möchte ein gem. ISiK Basismodul Stufe 2 erzeugtes, strukturiertes, FHIR-basiertes Dokument an einen Dokumentenserver übermitteln. Der Server stellt dazu eine Operation zur Verfügung, die aus den strukturierten Daten des Dokumentes die erforderlichen Metadaten extrahiert und dem Client eine entsprechend ausgefüllte DocumentReference-Ressource zurückgibt. Diese Operation kann von einem Dokumentenserver aber auch einem Drittsystem bereitgestellt werden.

Interaktion: Dokumentenbereitstellung

Herstellung von Patient- und Encounterkontext

Vor der Bereitstellung von Dokumenten muss ein Client einen Patienten- und Encounterkontext herstellen, damit das Dokument serverseitig anhand der Patient- und Encounter-Verlinkungen in der DocumentReference korrekt zugeordnet werden kann. Zur Herstellung des Kontextes sind folgende Verfahren möglich:

SMARTApp Launch: Wenn der Aufruf der App im Rahmen des SMART-Frameworks erfolgt, kennt der Client bereits beim Start den aktuellen Patienten- und ggf. den Encounterkontext. Dabei wählt ein Anwender im Primärsystem (Server) einen Patienten und Fall aus und startet in diesem Kontext die App. Referenzen auf Patient und Encounter werden im Zuge der Authorisierung vom Server an Client übermittelt. (Siehe Modul Sicherheit - Launch Context und Scopes).
Bekannte Fallnummer: Der Client kennt die (Abrechnungs-)Fallnummer (z.B. durch das Einscannen eines Barcodes, oder beim Mapping von V2 auf FHIR aus PV1.#19). Der Client sucht den Encounter anhand der Fallnummer ([base]/Encounter?account:identifier=<Fallnummer>). Da unter einer Abrechnungs-Fallnummer mehrere Encounter (Besuche) zusammengefasst werden können (z.B. vorstationär + stationär + nachstationär), sollte als zusätzliches Suchkriterium entweder ein Datum/Zeitraum oder eine Selektion auf Encounter.status verwendet werden. Wenn ein zutreffender Encounter gefunden wurde, kann der Patientenkontext aus der subject-Referenz des Encounters entnommen werden.
Arbeitsliste: Der Client ruft auf dem Server eine Arbeitsliste ab (z.B. Liste aller Encounter, die aktuell auf einer bestimmten Station/Ambulanz stattfinden, Liste aller ServiceRequests/Tasks, die durch den Client abgearbeitet werden müssen (aktuell noch nicht im Scope der ISiK-Spezifikationen!) und etabliert den Kontext, nachdem der Benutzer einen Eintrag der Liste ausgewählt hat.
Manuelle Auswahl. Nach dem Start des Clients verwendet der Benutzer eine Suchmaske, in der anhand von Patientennummer oder anderer demografischer Daten gesucht werden kann. Der Client verwendet die Patient-Interaktionen des ISiK-Basismoduls, um auf dem Server nach zutreffenden Patienten zu suchen. Der Anwender wählt den gesuchten Patienten aus der Liste der Suchtreffer aus. Im Anschluss listet der Client, mithílfe der Encounter-Interaktionen des ISiK-Basismoduls, die relevanten Besuche des ausgewählten Patienten auf. (Anm.: Welche Besuche als "relevant" erachtet werden, liegt im Ermessen des Clients. Es könnte z.B. anhand von Encounter.period, Encounter.class und/oder Encounter.status gefiltert werden). Der Anwender wählt den zutreffenden Encounter aus.

Hinweis	Gefahr fehlerhafter Zuordnung!
	Die manuelle Auswahl von Patienten- und Fallkontext durch einen Benutzer ist fehleranfällig. Clients müssen geeigente Vorkehrungen und Plausibilitätsprüfungen implementieren um Falschzuordnungen zu verhindern.

Dokumentenübermittlung

Die Übermittlung des Dokumentes vom Client an den Server erfolgt mithílfe der $submit-document Operation.

Hinweis: Der zum Zeitpunkt der Erstellung dieser Spezifikation vorliegende IHE MHD-Implementierungsleitfaden sieht für die Dokumentenbereitstellung ein Transaction-Bundle mit POST-Interaktionen vor. Aus Gründen, die in der diesbezüglichen Diskussion im internationalen FHIR-Chat nachzulesen sind, ist dieses Vorgehen jedoch zu hinterfragen und wird seitens IHE voraussichtlich in künftigen MHD-Versionen geändert. Siehe hierzu Kapitel Kompatibilität

Um den hier erarbeiteten Vorschlag einer Dokumentenübermittlung mittels Operations der internationalen FHIR-Community im Allgemeinen und IHE im Besonderen vorstellen zu können, in der Hoffnung und Erwartung, dass diese dem Vorgehen folgen, wird dieser Teil der ISiK-Spezifikation ausnahmsweise auf Englisch spezifiziert.

OperationDefinition `$submit-document`

Invocations

URL: [base]/$submit-document

Parameters (In)

Name	Cardinality	Type	Documentation
metadata	1..1	DocumentReference	DocumentReference containing document metadata
payload	1..1	Binary	Binary containing document payload

Return Values (Out)

Name	Cardinality	Type	Documentation
output-metadata	1..1	DocumentReference	DocumentReference as persisted by the server
information	0..*	OperationOutcome	Additional information and/or warnings about the operation the server whishes to convey to the client

Expected behaviour:

Servers SHALL store the submitted binary with the associated metadata and make it available through the FHIR API
If the submission contains a structured FHIR document-Bundle, Servers MAY chose to store additional representations of the document, e.g. native FHIR (XML and/or JSON) for FHIR aware Clients and/or an HTML-Document representing the document's narrative to allow easy read access for FHIR agnostic clients. The Binary representation mostly serves the purpose of archiving an immutable version of the document, rather than making it available to other consumers! If Servers can provide multiple representations of the same document, this SHOULD be reflected in multiple content-elements in the DocumentReference with the respective mime-type.
If a Client submits a DocumentReference which includes a relatesTo-Element, the Server SHALL process the submission in accordance with relatesTo.code as either a replacement, transformation, appendix or a signature of the document referenced in relatesTo.target. If applicable, Servers SHALL update the status of the related DocumentReference to superseded.
Servers SHALL return HTTP 412 (precondition failed) the relatesTo.target reference does not resolve on the server.
Servers SHALL ignore any information submitted by the Client in DocumentReference.content.attachment.url and assume the content to be the Binary submitted with the payloadparameter.
Servers SHALL adjust the content-element to reflect how and where the document has been stored by the server.

In-Parameters-Profil (ISiK)

Parameters			Parameters	There are no (further) constraints on this element Data Type Parameters
parameter	S	2..		There are no (further) constraints on this element Element Id Parameters.parameter Sliced: Unordered, Open, by name(Value)
metadata	S	1..1		There are no (further) constraints on this element Element Id Parameters.parameter:metadata Short description Dokumentenmetadaten in Form einer DocumentReference-Ressource Comments ...
name	S		Fixed Value	There are no (further) constraints on this element Element Id Parameters.parameter:metadata.name Short description Name des Parameters Comments =metadata Fixed Value metadata
resource	S	1..	Erforderliche Metadaten für Dokumentenaustausch in ISiK	There are no (further) constraints on this element Element Id Parameters.parameter:metadata.resource Short description Resource vom Typ `DocumentReference` Data Type Erforderliche Metadaten für Dokumentenaustausch in ISiK
content		..1		There are no (further) constraints on this element Element Id Parameters.parameter:metadata.resource.content
payload	S	1..1		There are no (further) constraints on this element Element Id Parameters.parameter:payload Short description das Dokument Definition Das Dokument (z.B. PDF, DOC, JPEG etc.) base64-codiert eingebettet in eine Binary-Ressource
name	S		Fixed Value	There are no (further) constraints on this element Element Id Parameters.parameter:payload.name Short description Name des Parameters Comments =payload Fixed Value payload
resource	S	1..	ISiKBinary	There are no (further) constraints on this element Element Id Parameters.parameter:payload.resource Short description Ressource vom Typ `Binary` Data Type ISiKBinary

Feldname	Kurzbeschreibung	Hinweise
Parameters.parameter
Parameters.parameter:metadata	Dokumentenmetadaten in Form einer DocumentReference-Ressource	...
Parameters.parameter:metadata.name	Name des Parameters	=metadata
Parameters.parameter:metadata.resource	Resource vom Typ `DocumentReference`
Parameters.parameter:payload	das Dokument
Parameters.parameter:payload.name	Name des Parameters	=payload
Parameters.parameter:payload.resource	Ressource vom Typ `Binary`

Out-Parameters-Profil (ISiK)

Parameters			Parameters	There are no (further) constraints on this element Data Type Parameters
parameter	S	1..		There are no (further) constraints on this element Element Id Parameters.parameter Sliced: Unordered, Open, by name(Value)
output-metadata	S	1..1		There are no (further) constraints on this element Element Id Parameters.parameter:output-metadata Short description Dokumentenmetadaten wie sie vom Server verstanden/persistiert wurden Comments ...
name	S		Fixed Value	There are no (further) constraints on this element Element Id Parameters.parameter:output-metadata.name Short description Name des Parameters Comments =output-metadata Fixed Value output-metadata
resource	S	1..	Erforderliche Metadaten für Dokumentenaustausch in ISiK	There are no (further) constraints on this element Element Id Parameters.parameter:output-metadata.resource Short description Ressource vom Type `DocumentReference` Data Type Erforderliche Metadaten für Dokumentenaustausch in ISiK
id	S	1..		There are no (further) constraints on this element Element Id Parameters.parameter:output-metadata.resource.id Short description Serverseitig zugewiesene Datensatz-ID Comments Der Server mus dem Datensatz eine eindeutige ID zuweisen und diese zurückgeben.
type				There are no (further) constraints on this element
coding		2..		There are no (further) constraints on this element Element Id Parameters.parameter:output-metadata.resource.type.coding
XDS		1..		There are no (further) constraints on this element Element Id Parameters.parameter:output-metadata.resource.type.coding:XDS Comments Der Server muss fehlende XDS-Type-Codes anhand des übermittelten KDL-Codes ergänzen.
category				There are no (further) constraints on this element
XDS				There are no (further) constraints on this element Element Id Parameters.parameter:output-metadata.resource.category.coding:XDS Comments Der Server muss fehlende XDS-Class-Codes anhand des übermittelten KDL-Codes ergänzen.
information		0..1		There are no (further) constraints on this element Element Id Parameters.parameter:information Short description Informationen/Hinweise zum Ergebnis der Operation Comments ...
name	S		Fixed Value	There are no (further) constraints on this element Element Id Parameters.parameter:information.name Short description Name des Parameters Comments =information Fixed Value information
resource	S	1..	OperationOutcome	There are no (further) constraints on this element Element Id Parameters.parameter:information.resource Short description Ressource vom Type `OperationOutcome` Data Type OperationOutcome

Feldname	Kurzbeschreibung	Hinweise
Parameters.parameter
Parameters.parameter:output-metadata	Dokumentenmetadaten wie sie vom Server verstanden/persistiert wurden	...
Parameters.parameter:output-metadata.name	Name des Parameters	=output-metadata
Parameters.parameter:output-metadata.resource	Ressource vom Type `DocumentReference`
Parameters.parameter:output-metadata.resource.id	Serverseitig zugewiesene Datensatz-ID	Der Server mus dem Datensatz eine eindeutige ID zuweisen und diese zurückgeben.
Parameters.parameter:information.name	Name des Parameters	=information
Parameters.parameter:information.resource	Ressource vom Type `OperationOutcome`

Beispiel:

Hinweis: Die Binary-Ressourcen sind der Lesbarkeit halber verkürzt dargestellt!

Request

POST [base]/$submit-document

{
    "resourceType": "Parameters",
    "id": "submit-document-in-params",
    "meta": {
        "profile":  [
            "https://gematik.de/fhir/isik/v2/Dokumentenaustausch/StructureDefinition/SubmitDocumentInput"
        ]
    },
    "parameter":  [
        {
            "name": "metadata",
            "resource": {
                "masterIdentifier": {
                    "system": "urn:ietf:rfc:3986",
                    "value": "urn:oid:1.2.840.113556.1.8000.2554.58783.21864.3474.19410.44358.58254.41281.46340"
                },
                "type": {
                    "coding":  [
                        {
                            "system": "http://dvmd.de/fhir/CodeSystem/kdl",
                            "code": "PT130102",
                            "display": "Molekularpathologiebefund"
                        },
                        {
                            "system": "http://ihe-d.de/CodeSystem/IHEXDStypeCode",
                            "code": "PATH",
                            "display": "Pathologiebefundberichte"
                        }
                    ]
                },
                "resourceType": "DocumentReference",
                "id": "dok-beispiel-client",
                "meta": {
                    "security":  [
                        {
                            "code": "HTEST",
                            "system": "http://terminology.hl7.org/CodeSystem/v3-ActReason"
                        }
                    ],
                    "profile":  [
                        "https://gematik.de/fhir/isik/v2/Dokumentenaustausch/StructureDefinition/ISiKDokumentenMetadaten"
                    ]
                },
                "status": "current",
                "category":  [
                    {
                        "coding":  [
                            {
                                "code": "BEF",
                                "system": "http://ihe-d.de/CodeSystems/IHEXDSclassCode",
                                "display": "Befundbericht"
                            }
                        ]
                    }
                ],
                "description": "Molekularpathologiebefund vom 31.12.21",
                "subject": {
                    "reference": "Patient/PatientinMusterfrau"
                },
                "securityLabel":  [
                    {
                        "coding":  [
                            {
                                "code": "N",
                                "system": "http://terminology.hl7.org/CodeSystem/v3-Confidentiality"
                            }
                        ]
                    }
                ],
                "content":  [
                    {
                        "attachment": {
                            "contentType": "application/pdf",
                            "language": "de",
                            "url": "Binary/12345",
                            "creation": "2020-12-31T23:50:50-05:00"
                        },
                        "format": {
                            "code": "urn:ihe:iti:xds:2017:mimeTypeSufficient",
                            "system": "http://ihe.net/fhir/ihe.formatcode.fhir/CodeSystem/formatcode",
                            "display": "mimeType Sufficient"
                        }
                    }
                ],
                "context": {
                    "facilityType": {
                        "coding":  [
                            {
                                "code": "KHS",
                                "system": "http://ihe-d.de/CodeSystems/PatientBezogenenGesundheitsversorgung",
                                "display": "Krankenhaus"
                            }
                        ]
                    },
                    "practiceSetting": {
                        "coding":  [
                            {
                                "code": "ALLG",
                                "system": "http://ihe-d.de/CodeSystems/AerztlicheFachrichtungen"
                            }
                        ]
                    },
                    "encounter":  [
                        {
                            "reference": "Encounter/BeispielBesuch"
                        }
                    ]
                }
            }
        },
        {
            "name": "payload",
            "resource": {
                "resourceType": "Binary",
                "id": "Binary-PDF-Example-short",
                "contentType": "application/pdf",
                "securityContext": {
                    "reference": "Patient/PatientinMusterfrau"
                },
                "data": "JVBERi0xLjUNJeLjz9MNCjEw"
            }
        }
    ]
}

Response

{
    "resourceType": "Parameters",
    "id": "submit-document-out-params",
    "meta": {
        "profile":  [
            "https://gematik.de/fhir/isik/v2/Dokumentenaustausch/StructureDefinition/SubmitDocumentOutput"
        ]
    },
    "parameter":  [
        {
            "name": "output-metadata",
            "resource": {
                "masterIdentifier": {
                    "system": "urn:ietf:rfc:3986",
                    "value": "urn:oid:1.2.840.113556.1.8000.2554.58783.21864.3474.19410.44358.58254.41281.46340"
                },
                "type": {
                    "coding":  [
                        {
                            "system": "http://dvmd.de/fhir/CodeSystem/kdl",
                            "code": "PT130102",
                            "display": "Molekularpathologiebefund"
                        },
                        {
                            "code": "PATH",
                            "system": "http://ihe-d.de/CodeSystem/IHEXDStypeCode",
                            "display": "Pathologiebefundberichte"
                        }
                    ]
                },
                "resourceType": "DocumentReference",
                "id": "123456789",
                "meta": {
                    "security":  [
                        {
                            "code": "HTEST",
                            "system": "http://terminology.hl7.org/CodeSystem/v3-ActReason"
                        }
                    ],
                    "profile":  [
                        "https://gematik.de/fhir/isik/v2/Dokumentenaustausch/StructureDefinition/ISiKDokumentenMetadaten"
                    ]
                },
                "status": "current",
                "category":  [
                    {
                        "coding":  [
                            {
                                "code": "BEF",
                                "system": "http://ihe-d.de/CodeSystems/IHEXDSclassCode",
                                "display": "Befundbericht"
                            }
                        ]
                    }
                ],
                "description": "Molekularpathologiebefund vom 31.12.21",
                "subject": {
                    "reference": "Patient/PatientinMusterfrau"
                },
                "securityLabel":  [
                    {
                        "coding":  [
                            {
                                "code": "N",
                                "system": "http://terminology.hl7.org/CodeSystem/v3-Confidentiality"
                            }
                        ]
                    }
                ],
                "content":  [
                    {
                        "attachment": {
                            "contentType": "application/pdf",
                            "language": "de",
                            "url": "http://mein-dokumentenserver/dokumente/1231232312.pdf",
                            "creation": "2020-12-31T23:50:50-05:00"
                        },
                        "format": {
                            "code": "urn:ihe:iti:xds:2017:mimeTypeSufficient",
                            "system": "http://ihe.net/fhir/ihe.formatcode.fhir/CodeSystem/formatcode",
                            "display": "mimeType Sufficient"
                        }
                    }
                ],
                "context": {
                    "facilityType": {
                        "coding":  [
                            {
                                "code": "KHS",
                                "system": "http://ihe-d.de/CodeSystems/PatientBezogenenGesundheitsversorgung",
                                "display": "Krankenhaus"
                            }
                        ]
                    },
                    "practiceSetting": {
                        "coding":  [
                            {
                                "code": "ALLG",
                                "system": "http://ihe-d.de/CodeSystems/AerztlicheFachrichtungen"
                            }
                        ]
                    },
                    "encounter":  [
                        {
                            "reference": "Encounter/BeispielBesuch"
                        }
                    ]
                }
            }
        },
        {
            "name": "information",
            "resource": {
                "resourceType": "OperationOutcome",
                "id": "oo-beispiel",
                "issue":  [
                    {
                        "severity": "information",
                        "code": "informational",
                        "diagnostics": "Well done!"
                    }
                ]
            }
        }
    ]
}

Dokumentenabfrage und -zugriff

Dokumentenabfrage

Dokumente können anhand ihrer Metadaten gesucht werden. Im Rahmen der ISiK-Spezifikation müssen mindestens die im Kapitel Interaktionen mit MUSS gekennzeichneten Suchparameter unterstützt werden. Einzelnen Systemen steht es frei, darüber hinaus weitere FHIR-konforme Suchparameter zu implementieren.

Es gelten die allgemeinen Festlegungen zu Suchparametern gemäß ISiK Basisprofil Stufe 2

Die Ergebnisse einer Suchanfrage werden in Form eines Bundles zurückgegeben:

Bundle	I		Bundle	There are no (further) constraints on this element Element Id Bundle Short description Contains a collection of resources Definition A container for a collection of resources. Data Type Bundle Constraints bdl-7: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&resource.meta.versionId).isDistinct()` bdl-9:A document must have an identifier with a system and a value `type = 'document' implies (identifier.system.exists() and identifier.value.exists())` bdl-3:entry.request mandatory for batch/transaction/history, otherwise prohibited `entry.all(request.exists() = (%resource.type = 'batch' or %resource.type = 'transaction' or %resource.type = 'history'))` bdl-4:entry.response mandatory for batch-response/transaction-response/history, otherwise prohibited `entry.all(response.exists() = (%resource.type = 'batch-response' or %resource.type = 'transaction-response' or %resource.type = 'history'))` bdl-12:A message must have a MessageHeader as the first resource `type = 'message' implies entry.first().resource.is(MessageHeader)` bdl-1:total only when a search or history `total.empty() or (type = 'searchset') or (type = 'history')` bdl-2:entry.search only when a search `entry.search.empty() or (type = 'searchset')` bdl-11:A document must have a Composition as the first resource `type = 'document' implies entry.first().resource.is(Composition)` bdl-10:A document must have a date `type = 'document' implies (timestamp.hasValue())` Mappings rim:Entity. Role, or Act v2:N/A rim:N/A cda:ClinicalDocument, if bundle.type = document
identifier	Σ	0..1	Identifier	There are no (further) constraints on this element Element Id Bundle.identifier Short description Persistent identifier for the bundle Definition A persistent identifier for the bundle that won't change as a bundle is copied from server to server. Comments 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. Data Type Identifier Constraints ele-1:All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim:n/a v2:CX / EI (occasionally, more often EI maps to a resource id or a URL) rim:II - The Identifier class is a little looser than the v3 type II because it allows URIs as well as registered OIDs or GUIDs. Also maps to Role[classCode=IDENT] servd:Identifier w5:FiveWs.identifier cda:ClinicalDocument.id
type	Σ	1..1	codeBindingFixed Value	Element Id Bundle.type Short description document \| message \| transaction \| transaction-response \| batch \| batch-response \| history \| searchset \| collection Definition Indicates the purpose of this bundle - how it is intended to be used. Comments 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. Data Type code Binding Indicates the purpose of a bundle - how it is intended to be used. BundleType (required) Constraints ele-1:All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Fixed Value searchset Mappings rim:n/a w5:FiveWs.class
timestamp	Σ	0..1	instant	There are no (further) constraints on this element Element Id Bundle.timestamp Short description When the bundle was assembled Definition The date/time that the bundle was assembled - i.e. when the resources were placed in the bundle. Comments 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. Data Type instant Constraints ele-1:All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim:n/a w5:FiveWs.init cda:ClinicalDocument.effectiveTime
total	Σ I	1..1	unsignedInt	There are no (further) constraints on this element Element Id Bundle.total Short description If search, the total number of matches Definition If a set of search matches, this is the 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. Comments 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. Data Type unsignedInt Constraints ele-1:All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim:n/a
link	Σ	0..*	BackboneElement	There are no (further) constraints on this element Element Id Bundle.link Short description Links related to this Bundle Definition A series of links that provide context to this bundle. Comments Both Bundle.link and Bundle.entry.link are defined to support providing additional context when Bundles are used (e.g. HATEOAS). Bundle.entry.link corresponds to links found in the HTTP header if the resource in the entry was read directly. This specification defines some specific uses of Bundle.link for searching and paging, but no specific uses for Bundle.entry.link, and no defined function in a transaction - the meaning is implementation specific. Data Type BackboneElement Constraints ele-1:All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim:n/a
relation	Σ	1..1	string	There are no (further) constraints on this element Element Id Bundle.link.relation Short description See http://www.iana.org/assignments/link-relations/link-relations.xhtml#link-relations-1 Definition A name which details the functional use for this link - see http://www.iana.org/assignments/link-relations/link-relations.xhtml#link-relations-1. Comments Note that FHIR strings SHALL NOT exceed 1MB in size Data Type string Constraints ele-1:All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim:n/a
url	Σ	1..1	uri	There are no (further) constraints on this element Element Id Bundle.link.url Short description Reference details for the link Definition The reference details for the link. Comments see http://en.wikipedia.org/wiki/Uniform_resource_identifier Data Type uri Constraints ele-1:All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim:n/a
entry	Σ I	0..*	BackboneElement	Element Id Bundle.entry Short description Entry in the bundle - will have a resource or information Definition An entry in a bundle resource - will either contain a resource or information about a resource (transactions and history only). Data Type BackboneElement Sliced: Unordered, Open, by resource(Profile) Constraints ele-1:All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` bdl-8:fullUrl cannot be a version specific reference `fullUrl.contains('/_history/').not()` bdl-5:must be a resource unless there's a request or response `resource.exists() or request.exists() or response.exists()` Mappings rim:n/a
(All Slices)				There are no (further) constraints on this element
link	Σ	0..*	see (link)	There are no (further) constraints on this element Element Id Bundle.entry.link Short description Links related to this entry Definition A series of links that provide context to this entry.
fullUrl	Σ	1..1	uri	There are no (further) constraints on this element Element Id Bundle.entry.fullUrl Short description URI for resource (Absolute URL server address or URI for UUID/OID) Definition The Absolute URL for the resource. 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. The fullUrl element SHALL have a value except that: fullUrl can be empty on a POST (although it does not need to when specifying a temporary id for reference in the bundle) Results from operations might involve resources that are not identified. Comments fullUrl might not be unique in the context of a resource. Note that since FHIR resources do not need to be served through the FHIR API, 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, 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). Data Type uri Constraints ele-1:All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim:n/a
resource	Σ	0..1	Resource	There are no (further) constraints on this element Element Id Bundle.entry.resource Short description A resource in the bundle Definition The Resource for the entry. The purpose/meaning of the resource is determined by the Bundle.type. Data Type Resource Mappings rim:Entity. Role, or Act
search	Σ I	0..1	BackboneElement	There are no (further) constraints on this element Element Id Bundle.entry.search Short description Search related information Definition Information about the search process that lead to the creation of this entry. Data Type BackboneElement Constraints ele-1:All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim:n/a
mode	Σ	0..1	codeBinding	There are no (further) constraints on this element Element Id Bundle.entry.search.mode Short description match \| include \| outcome - why this is in the result set Definition 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. Comments 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. Data Type code Binding 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. SearchEntryMode (required) Constraints ele-1:All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim:n/a
score	Σ	0..1	decimal	There are no (further) constraints on this element Element Id Bundle.entry.search.score Short description Search ranking (between 0 and 1) Definition When searching, the server's search ranking score for the entry. Comments 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 for the EMPI search which relates to this element. Data Type decimal Constraints ele-1:All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim:n/a
request	Σ I	0..1	BackboneElement	There are no (further) constraints on this element Element Id Bundle.entry.request Short description Additional execution information (transaction/batch/history) Definition 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. Data Type BackboneElement Constraints ele-1:All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim:n/a
method	Σ	1..1	codeBinding	There are no (further) constraints on this element Element Id Bundle.entry.request.method Short description GET \| HEAD \| POST \| PUT \| DELETE \| PATCH Definition 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. Comments Note that FHIR strings SHALL NOT exceed 1MB in size Data Type code Binding HTTP verbs (in the HTTP command line). See [HTTP rfc](https://tools.ietf.org/html/rfc7231) for details. HTTPVerb (required) Constraints ele-1:All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim:n/a
url	Σ	1..1	uri	There are no (further) constraints on this element Element Id Bundle.entry.request.url Short description URL for HTTP equivalent of this entry Definition The URL for this entry, relative to the root (the address to which the request is posted). Comments 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]". Data Type uri Constraints ele-1:All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim:n/a
ifNoneMatch	Σ	0..1	string	There are no (further) constraints on this element Element Id Bundle.entry.request.ifNoneMatch Short description For managing cache currency Definition If the ETag values match, return a 304 Not Modified status. See the API documentation for "Conditional Read". Comments Note that FHIR strings SHALL NOT exceed 1MB in size Data Type string Constraints ele-1:All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim:n/a
ifModifiedSince	Σ	0..1	instant	There are no (further) constraints on this element Element Id Bundle.entry.request.ifModifiedSince Short description For managing cache currency Definition Only perform the operation if the last updated date matches. See the API documentation for "Conditional Read". Comments Note: This is intended for where precisely observed times are required, typically system logs etc., and not human-reported times - for them, see date and dateTime (which can be as precise as instant, but is not required to be) below. Time zone is always required Data Type instant Constraints ele-1:All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim:n/a
ifMatch	Σ	0..1	string	There are no (further) constraints on this element Element Id Bundle.entry.request.ifMatch Short description For managing update contention Definition Only perform the operation if the Etag value matches. For more information, see the API section "Managing Resource Contention". Comments Note that FHIR strings SHALL NOT exceed 1MB in size Data Type string Constraints ele-1:All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim:n/a
ifNoneExist	Σ	0..1	string	There are no (further) constraints on this element Element Id Bundle.entry.request.ifNoneExist Short description For conditional creates Definition Instruct the server not to perform the create if a specified resource already exists. For further information, see the API documentation for "Conditional Create". This is just the query portion of the URL - what follows the "?" (not including the "?"). Comments Note that FHIR strings SHALL NOT exceed 1MB in size Data Type string Constraints ele-1:All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim:n/a
response	Σ I	0..1	BackboneElement	There are no (further) constraints on this element Element Id Bundle.entry.response Short description Results of execution (transaction/batch/history) Definition 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. Data Type BackboneElement Constraints ele-1:All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim:n/a
status	Σ	1..1	string	There are no (further) constraints on this element Element Id Bundle.entry.response.status Short description Status response code (text optional) Definition 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. Comments Note that FHIR strings SHALL NOT exceed 1MB in size Data Type string Constraints ele-1:All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim:n/a
location	Σ	0..1	uri	There are no (further) constraints on this element Element Id Bundle.entry.response.location Short description The location (if the operation returns a location) Definition The location header created by processing this operation, populated if the operation returns a location. Comments see http://en.wikipedia.org/wiki/Uniform_resource_identifier Data Type uri Constraints ele-1:All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim:n/a
etag	Σ	0..1	string	There are no (further) constraints on this element Element Id Bundle.entry.response.etag Short description The Etag for the resource (if relevant) Definition The Etag for the resource, if the operation for the entry produced a versioned resource (see Resource Metadata and Versioning and Managing Resource Contention). Comments Etags match the Resource.meta.versionId. The ETag has to match the version id in the header if a resource is included. Data Type string Constraints ele-1:All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim:n/a
lastModified	Σ	0..1	instant	There are no (further) constraints on this element Element Id Bundle.entry.response.lastModified Short description Server's date time modified Definition The date/time that the resource was modified on the server. Comments This has to match the same time in the meta header (meta.lastUpdated) if a resource is included. Data Type instant Constraints ele-1:All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim:n/a
outcome	Σ	0..1	Resource	There are no (further) constraints on this element Element Id Bundle.entry.response.outcome Short description OperationOutcome with hints and warnings (for batch/transaction) Definition An OperationOutcome containing hints and warnings produced as part of processing this entry in a batch or transaction. Comments 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. Data Type Resource Mappings rim:Entity. Role, or Act
DocumentReference	Σ I	0..*	BackboneElement	Element Id Bundle.entry:DocumentReference Short description DocumentReference Definition An entry in a bundle resource - will either contain a resource or information about a resource (transactions and history only). Data Type BackboneElement Constraints ele-1:All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` bdl-8:fullUrl cannot be a version specific reference `fullUrl.contains('/_history/').not()` bdl-5:must be a resource unless there's a request or response `resource.exists() or request.exists() or response.exists()` Mappings rim:n/a
link	Σ	0..*	see (link)	There are no (further) constraints on this element Element Id Bundle.entry:DocumentReference.link Short description Links related to this entry Definition A series of links that provide context to this entry.
fullUrl	Σ	0..1	uri	There are no (further) constraints on this element Element Id Bundle.entry:DocumentReference.fullUrl Short description URI for resource (Absolute URL server address or URI for UUID/OID) Definition The Absolute URL for the resource. 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. The fullUrl element SHALL have a value except that: fullUrl can be empty on a POST (although it does not need to when specifying a temporary id for reference in the bundle) Results from operations might involve resources that are not identified. Comments fullUrl might not be unique in the context of a resource. Note that since FHIR resources do not need to be served through the FHIR API, 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, 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). Data Type uri Constraints ele-1:All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim:n/a
resource	Σ I	1..1	Erforderliche Metadaten für Dokumentenaustausch in ISiK	Element Id Bundle.entry:DocumentReference.resource Short description A reference to a document Definition A reference to a document of any kind for any purpose. Provides metadata about the document so that the document can be discovered and managed. The scope of a document is any seralized object with a mime-type, so includes formal patient centric documents (CDA), cliical notes, scanned paper, and non-patient specific documents like policy text. Comments Usually, this is used for documents other than those defined by FHIR. Data Type Erforderliche Metadaten für Dokumentenaustausch in ISiK Constraints dom-2:If the resource is contained in another resource, it SHALL NOT contain nested Resources `contained.contained.empty()` dom-4:If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated `contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()` dom-3:If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource `contained.where((('#'+id in (%resource.descendants().reference \| %resource.descendants().as(canonical) \| %resource.descendants().as(uri) \| %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty()` dom-6:A resource should have narrative for robust management text.`div`.exists() dom-5:If a resource is contained in another resource, it SHALL NOT have a security label `contained.meta.security.empty()` Mappings rim:Entity. Role, or Act workflow:Event fhircomposition:when describing a Composition rim:Document[classCode="DOC" and moodCode="EVN"] cda:when describing a CDA
search	Σ I	0..1	BackboneElement	There are no (further) constraints on this element Element Id Bundle.entry:DocumentReference.search Short description Search related information Definition Information about the search process that lead to the creation of this entry. Data Type BackboneElement Constraints ele-1:All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim:n/a
mode	Σ	0..1	codeBinding	There are no (further) constraints on this element Element Id Bundle.entry:DocumentReference.search.mode Short description match \| include \| outcome - why this is in the result set Definition 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. Comments 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. Data Type code Binding 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. SearchEntryMode (required) Constraints ele-1:All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim:n/a
score	Σ	0..1	decimal	There are no (further) constraints on this element Element Id Bundle.entry:DocumentReference.search.score Short description Search ranking (between 0 and 1) Definition When searching, the server's search ranking score for the entry. Comments 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 for the EMPI search which relates to this element. Data Type decimal Constraints ele-1:All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim:n/a
request	Σ I	0..1	BackboneElement	There are no (further) constraints on this element Element Id Bundle.entry:DocumentReference.request Short description Additional execution information (transaction/batch/history) Definition 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. Data Type BackboneElement Constraints ele-1:All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim:n/a
method	Σ	1..1	codeBinding	There are no (further) constraints on this element Element Id Bundle.entry:DocumentReference.request.method Short description GET \| HEAD \| POST \| PUT \| DELETE \| PATCH Definition 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. Comments Note that FHIR strings SHALL NOT exceed 1MB in size Data Type code Binding HTTP verbs (in the HTTP command line). See [HTTP rfc](https://tools.ietf.org/html/rfc7231) for details. HTTPVerb (required) Constraints ele-1:All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim:n/a
url	Σ	1..1	uri	There are no (further) constraints on this element Element Id Bundle.entry:DocumentReference.request.url Short description URL for HTTP equivalent of this entry Definition The URL for this entry, relative to the root (the address to which the request is posted). Comments 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]". Data Type uri Constraints ele-1:All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim:n/a
ifNoneMatch	Σ	0..1	string	There are no (further) constraints on this element Element Id Bundle.entry:DocumentReference.request.ifNoneMatch Short description For managing cache currency Definition If the ETag values match, return a 304 Not Modified status. See the API documentation for "Conditional Read". Comments Note that FHIR strings SHALL NOT exceed 1MB in size Data Type string Constraints ele-1:All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim:n/a
ifModifiedSince	Σ	0..1	instant	There are no (further) constraints on this element Element Id Bundle.entry:DocumentReference.request.ifModifiedSince Short description For managing cache currency Definition Only perform the operation if the last updated date matches. See the API documentation for "Conditional Read". Comments Note: This is intended for where precisely observed times are required, typically system logs etc., and not human-reported times - for them, see date and dateTime (which can be as precise as instant, but is not required to be) below. Time zone is always required Data Type instant Constraints ele-1:All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim:n/a
ifMatch	Σ	0..1	string	There are no (further) constraints on this element Element Id Bundle.entry:DocumentReference.request.ifMatch Short description For managing update contention Definition Only perform the operation if the Etag value matches. For more information, see the API section "Managing Resource Contention". Comments Note that FHIR strings SHALL NOT exceed 1MB in size Data Type string Constraints ele-1:All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim:n/a
ifNoneExist	Σ	0..1	string	There are no (further) constraints on this element Element Id Bundle.entry:DocumentReference.request.ifNoneExist Short description For conditional creates Definition Instruct the server not to perform the create if a specified resource already exists. For further information, see the API documentation for "Conditional Create". This is just the query portion of the URL - what follows the "?" (not including the "?"). Comments Note that FHIR strings SHALL NOT exceed 1MB in size Data Type string Constraints ele-1:All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim:n/a
response	Σ I	0..1	BackboneElement	There are no (further) constraints on this element Element Id Bundle.entry:DocumentReference.response Short description Results of execution (transaction/batch/history) Definition 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. Data Type BackboneElement Constraints ele-1:All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim:n/a
status	Σ	1..1	string	There are no (further) constraints on this element Element Id Bundle.entry:DocumentReference.response.status Short description Status response code (text optional) Definition 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. Comments Note that FHIR strings SHALL NOT exceed 1MB in size Data Type string Constraints ele-1:All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim:n/a
location	Σ	0..1	uri	There are no (further) constraints on this element Element Id Bundle.entry:DocumentReference.response.location Short description The location (if the operation returns a location) Definition The location header created by processing this operation, populated if the operation returns a location. Comments see http://en.wikipedia.org/wiki/Uniform_resource_identifier Data Type uri Constraints ele-1:All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim:n/a
etag	Σ	0..1	string	There are no (further) constraints on this element Element Id Bundle.entry:DocumentReference.response.etag Short description The Etag for the resource (if relevant) Definition The Etag for the resource, if the operation for the entry produced a versioned resource (see Resource Metadata and Versioning and Managing Resource Contention). Comments Etags match the Resource.meta.versionId. The ETag has to match the version id in the header if a resource is included. Data Type string Constraints ele-1:All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim:n/a
lastModified	Σ	0..1	instant	There are no (further) constraints on this element Element Id Bundle.entry:DocumentReference.response.lastModified Short description Server's date time modified Definition The date/time that the resource was modified on the server. Comments This has to match the same time in the meta header (meta.lastUpdated) if a resource is included. Data Type instant Constraints ele-1:All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim:n/a
outcome	Σ	0..1	Resource	There are no (further) constraints on this element Element Id Bundle.entry:DocumentReference.response.outcome Short description OperationOutcome with hints and warnings (for batch/transaction) Definition An OperationOutcome containing hints and warnings produced as part of processing this entry in a batch or transaction. Comments 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. Data Type Resource Mappings rim:Entity. Role, or Act
signature	Σ	0..1	Signature	There are no (further) constraints on this element Element Id Bundle.signature Short description Digital Signature Definition Digital Signature - base64 encoded. XML-DSig or a JWT. Requirements 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. Comments 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. Data Type Signature Constraints ele-1:All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim:n/a rim:N/A

Suchergebnisse können zahlreich sein. Server MÜSSEN daher FHIR-konformes Paging unterstützen. Server KÖNNEN im SearchSet-Bundle auch Ressourcen vom Typ OperationOutcome mit Informationen über die Suchergebnisse zurückgeben. Diese müssen in Bundle.entry.search.mode mit dem Wert outcome gekennzeichnet sein. Die Issues im OperationOutcome dürfen nur dem Schweregrad information oder warning entsprechen. Issues vom Schweregrad error oder fatal sind unzulässig.

Beispiele:

Suche anhand von Patientenkontext (PID) und Dokumentendatum: [base]/DocumentReference?patient.identifier=1234&creation=gt2021-10-06
Suche nach vorläufigen Endoskopiebefunden (anhand KDL-Dokumenttyp und docStatus): [base]/DocumentReference?type=http://dvmd.de/fhir/CodeSystem/kdl|DG02010&doc-status=preliminary
Suche von Dokumenten anhand der Nummer des Abrechnungsfalles: [base]/DocumentReference?encounter.account:identifier=56789

Dokumentenzugriff

Das den Metadaten zugeordnete Dokument kann jeweils unter DocumentReference.content.attachment.url vom Server abgerufen werden. Es gelten die Festlegungen gem. IHE ITI-68: Retrieve Document

Der einzige MIME-Type, den alle Dokumentenserver verpflichtend zurückgeben können MÜSSEN ist der MIME Type, der dem DocumentReference.content.attachment.contentType entspricht.

Dokumentenserver SOLLEN das Dokument präferiert über einen Binary-Endpunkt bereitstellen. Dieser verfügt über folgende Besonderheit:

Wenn der Zugriff mit dem Accept-Header application/fhir+xml oder application/fhir+json erfolgt, müssen die Daten als Binary-Ressource im angeforderten Format zurückgegeben werden.
Wenn der Zugriff mit einem anderen Accept-Header als application/fhir+xml oder application/fhir+json erfolgt, so soll das Dokument im angeforderten Format zurückgegeben werden, z.B. MUSS bei Zugriffen mit Accept-Header application/pdf das Dokument unmittelbar als PDF zurückgegeben werden, sofern dies dem Content-Type der Binary-Ressource entspricht.

Interaktion: Update von Metadaten

Herstellung von Dokumentenkontext

Der Client muss zunächst die URL der DocumentReference ermitteln, auf die das Update angewendet werden soll. Hierzu kann die Interaktion Dokumentenabfrage verwendet werden.

Metadatenupdate

Das Update der Metadaten erfolgt mittels der $update-metadata Operation. Hinweis: Der zum Zeitpunkt der Erstellung dieser Spezifikation vorliegende IHE-MHD-Implementierungsleitfaden sieht kein Metadatenupdate vor. Hier müsste stets ein neues Dokument ($submit-document mit Referenz auf das zu ersetzende Dokument in DocumentReference.relatesTo) übermittelt werden.

Für den ISiK-Usecase als maßgeblich relevant und unkritisch in Bezug auf die Versionierung hat sich jedoch das Element docStatuserwiesen, welches im IHE-Kontext keine Berücksichtigung findet. Im einrichtungsinternen Dokumentenaustausch kommt es häufig vor, dass sich der Status eines Dokumentes ändert (z.b. vorläufig -> final), ohne dass dies Auswirkungen auf den Inhalt hat. Die Anlage eines neuen Dokumentes wäre in diesem Kontext nicht effizient.

Daher spezifiziert ISiK eine geeignete Operation, die das gezielte Ändern des Dokumentenstatus ermöglicht.

OperationDefinition `$update-metadata`

Invocations

URL: [base]/DocumentReference/[id]/$update-metadata

Parameters (In)

Name	Cardinality	Type	Binding	Documentation
docStatus	1..1	code	CompositionStatus (required)	new value for element `docStatus`

Expected behaviour:

Servers SHALL update the DocumentReference.docStatus with the submitted values
Servers SHALL ensure that DocumentReference.text reflects this change

Beispiel

[base]/DocumentReference/example/$update-metadata?docStatus=final

Hinweis	Work in Progress!
	Die hier vorliegende Definition der Operation dient als Vorschlag, der auf Basis von Implementierungserfahrungen weiterentwickelt werden soll. Kritik, Feedback und Verbesserungsvorschläge, insbesondere UseCases für das Update weiterer Metadaten-Elemente bitte im ISiK-Community-Chat diskutieren!

Erzeugen von Dokumentenmetadaten

Abgrenzung zu ISiK Stufe 2 (Basis) bei der Kommunikation strukturierter Dokumente (FHIR-Document-Bundle)

Interaktion ISiK Modul Basis Stufe 2: Bericht aus Subsystem

UseCase: Client übermittelt diverse strukturierte Informationen in Form eines Dokumentes an einen Empfänger. Der Empfänger (oder ggf. dessen Benutzer) kann selbst entscheiden, welche Informationen übernommen und ggf. weiterverarbeitet werden können/sollen. Als Minimum muss die Narrative (die HTML-Repräsentation des gesamten Dokumentes) übernommen werden.
HTTP-verb: POST auf [base]
Content: Bundle vom Typ document
erforderliches Verhalten: der Empfänger verarbeitet den Inhalt des Dokumentes (HTML + Ressourcen soweit möglich), das Original muss nicht zwingend persistiert werden. Es besteht kein zwingendes Erfordernis, dass das Dokument oder seine Inhalte über die API wieder bereitgestellt werden können.

Interaktion ISiK Modul Dokumentenaustausch Stufe 2: Dokumentenbereitstellung

UseCase: Client übermittelt ein strukturiertes Dokument zur inhaltsagnositschen, dauerhaften, ggf. rechtssicheren Archivierung
HTTP-verb: POST auf [base]/$submit-document
Content: Parameters (DocumentReference + Binary mit Base64-codiertem Bundle vom Typ document)
erforderliches Verhalten: das Dokument sowie seine Metadaten werden persistiert und über die API mittels der Interaktionen "Dokumentenabfrage" und "Dokumentenzugriff" bereitgestellt.

Typische Szenarien mit Koexistenz beider Interaktionen:

Der Empfänger eines Subsystem-Berichtes gem. Modul "Basis" möchte vor der Verarbeitung des Dokumenteninhalts das Original zur Archivierung an einen Dokumentenserver gem. Modul "Dokumentenaustausch" übermitteln und die Herkunft der extrahierten Daten aus dem Dokument nachvollziehbar machen.

Empfohlenes Vorgehen:

Erzeugen einer DocumentReference-Ressource (siehe dazu $generate-metadata)
Übermittlung der DocumentReference sowie des Base64-codierten Bundles gemäß Interaktion ISiK Modul Dokumentenaustausch Stufe 2
Extraktion und der verarbeitbaren Ressourcen aus dem Bundle
Verlinkung zwischen den extrahierten Ressourcen und dem Original-Dokument mittels einer Provenance-Ressource.

Der Sender eines Subsystem-Berichtes gem. Modul "Basis" möchte parallel zur Übermittlung an z.B. ein KIS zur Weiterverarbeitung der Informationen das Dokument ebenfalls im Original archivieren lassen.

Empfohlenes Vorgehen:

Erzeugen einer DocumentReference-Ressource (siehe dazu $generate-metadata)
Übermittlung der DocumentReference sowie des Base64-codierten Bundles gemäß Interaktion ISiK Modul Dokumentenaustausch Stufe 2
Übermittlung des Dokumentes zur Verarbeitung gemäß Interaktion ISiK Modul Basis Stufe 2: Bericht aus Subsystem

Der Empfänger eines Dokumentes gem. Modul "Dokumentenaustausch" möchte neben der Archivierung des Dokumentes auch dessen Inhalte weiterverarbeiten.

Empfohlenes Vorgehen:

Entgegennahme und Persistierung des Original-Dokumentes gemäß Interaktion ISiK Modul Dokumentenaustausch Stufe 2
Extraktion des Bundles aus der Binary-Ressource
Extraktion der verarbeitbaren Ressourcen aus dem Bundle
Verlinkung zwischen den extrahierten Ressourcen und dem Original-Dokument mittels einer Provenance-Ressource.

Operation $generate-metadata

Die Operation $generate-metadata wurde spezifiziert in Anlehnung an die Operation $generate im current build der FHIR-Kernspezifikation, die jedoch noch nicht in implementierbarem Zustand ist. Die hier getroffenen Änderungen werden parallel als Feedback zur Verbesserung der Kernspezifikation als ChangeRequest eingereicht. Um die Diskussion mit der internationalen Community zu erleichtern, erfolgt die Spezifikation der Operation in Englisch.

Hinweis	Work in Progress!
	Die hier vorliegende Definition der Operation dient als Vorschlag, der auf Basis von Implementierungserfahrungen weiterentwickelt werden soll. Kritik, Feedback und Verbesserungsvorschläge bitte im ISiK-Community-Chat diskutieren!

Invocations

URL: [base]/DocumentReference/$generate-metadata

Parameters (In)

Name	Cardinality	Type	Documentation
fhir-document	0..1	Bundle	FHIR document Bundle
non-fhir-document	0..1	Binary	non FHIR structured document or other document metadata source
non-fhir-document-type	0..1	code	type of submitted non fhir document
target-endpoint	0..1	uri	fhir endpoint on which matches for Patient (and other items) are searched

Return Values (Out)

Name	Cardinality	Type	Documentation
output-metadata	1..1	DocumentReference	DocumentReference created based on the submitted input
information	0..*	OperationOutcome	Additional information and/or warnings about the operation the server whishes to convey to the client

Expected behaviour:

Servers SHALL create DocumentReference Resources from the Bundle provided through the 'fhir.document' parameter by mapping the metadata fields from the Composition in the document Bundle according to the Composition-DocumentReference.Mapping
Servers SHALL attempt to match the target of Composition.subject to an existing Resource on it's own endpoint and populate DocumentReference.subject.reference accordingly.
If no matching target id found, the Server SHALL reply with HTTP 412 (precondition failed) and return an OperationOutcome
Servers MAY attempt to resolve additional references, such as Composition.author, Composition.encounter etc.
Servers MAY allow clients to redirect any attempts to find matches to another endpoint. This is especially helpful, when the $generate-metadata operation is provided by a third party other than the document's intended destination server.
Servers MAY offer additional mapping services for non-fhir-documents although these may need more advanced mapping/business logic, terminology mapping services and more complex patient matching. If they offer additional non-fhir mapping capabilities, Servers SHOULD expose a derived OperationDefinition in their CapabilityStatment, which clearly defines the acceptable non-fhir-document-types.
Clients SHOULD populate non-fhir-document-type with a code acceptable to the server, when submitting non-fhir-documents

In-Parameters Definition (ISiK)

Parameters	I		Parameters	There are no (further) constraints on this element Element Id Parameters Data Type Parameters Constraints gen-in-1:Es muss entweder der Parameter `fhir-document` oder der parameter `non-fhir-document` übermittelt werden! `parameter.where(name = 'fhir-document').exists() xor parameter.where(name='non-fhir-document').exists()` gen-in-2:Wenn der Parameter `non-fhir-document` übermittelt wird, muss auch `non-fhir-document-type` übermittelt werden. `non-fhir-document-type` darf nicht in Verbindung mit `fhir-document` übermittelt werden. `parameter.where(name = 'non-fhir-document').exists().not() xor parameter.where(name = 'non-fhir-document-type').exists()`
parameter	S	2..		There are no (further) constraints on this element Element Id Parameters.parameter Sliced: Unordered, Open, by name(Value)
fhir-document	S	0..1		There are no (further) constraints on this element Element Id Parameters.parameter:fhir-document
name	S			There are no (further) constraints on this element Element Id Parameters.parameter:fhir-document.name Short description Name des Parameters Pattern fhir-document
resource	S	1..	ISiKBerichtBundle	There are no (further) constraints on this element Element Id Parameters.parameter:fhir-document.resource Data Type ISiKBerichtBundle
non-fhir-document		0..1		There are no (further) constraints on this element Element Id Parameters.parameter:non-fhir-document
name	S			There are no (further) constraints on this element Element Id Parameters.parameter:non-fhir-document.name Short description Name des Parameters Pattern non-fhir-document
resource	S	1..	ISiKBinary	There are no (further) constraints on this element Element Id Parameters.parameter:non-fhir-document.resource Data Type ISiKBinary
non-fhir-document-type		0..1		There are no (further) constraints on this element Element Id Parameters.parameter:non-fhir-document-type Short description genauer Typ der Dokumenttyp der Binärdaten
name	S			There are no (further) constraints on this element Element Id Parameters.parameter:non-fhir-document-type.name Short description Name des Parameters Pattern non-fhir-document-type
value[x]	S	1..		There are no (further) constraints on this element Element Id Parameters.parameter:non-fhir-document-type.value[x]
valueCode			code	There are no (further) constraints on this element Data Type code
target-endpoint		0..1		There are no (further) constraints on this element Element Id Parameters.parameter:target-endpoint Short description Server-Endpunkt auf dem passende Patient-/Encounter-Referenzen gesucht werden sollen. Wenn der Parameter nicht gesetzt wird, verwendet der Server, der die Operation ausführt, per default den eigenen Endpunkt
name	S			There are no (further) constraints on this element Element Id Parameters.parameter:target-endpoint.name Short description Name des Parameters Pattern target-endpoint
value[x]	S	1..		There are no (further) constraints on this element Element Id Parameters.parameter:target-endpoint.value[x]
valueUri			uri	There are no (further) constraints on this element Data Type uri

Out-Parameters Definition (ISiK)

Parameters			Parameters	There are no (further) constraints on this element Data Type Parameters
parameter	S	1..1		There are no (further) constraints on this element Element Id Parameters.parameter Sliced: Unordered, Open, by name(Value)
output-metadata	S	1..1		There are no (further) constraints on this element Element Id Parameters.parameter:output-metadata Short description Dokumentenmetadaten wie sie vom Server erzeugt/gemapped wurden Comments ...
name	S		Fixed Value	There are no (further) constraints on this element Element Id Parameters.parameter:output-metadata.name Short description Name des Parameters Fixed Value output-metadata
resource			Erforderliche Metadaten für Dokumentenaustausch in ISiK	There are no (further) constraints on this element Element Id Parameters.parameter:output-metadata.resource Data Type Erforderliche Metadaten für Dokumentenaustausch in ISiK
id	S	1..		There are no (further) constraints on this element Element Id Parameters.parameter:output-metadata.resource.id
information		0..1		There are no (further) constraints on this element Element Id Parameters.parameter:information Short description Informationen/Hinweise zum Ergebnis der Operation Comments ...
name	S		Fixed Value	There are no (further) constraints on this element Element Id Parameters.parameter:information.name Short description Name des Parameters Fixed Value information
resource			OperationOutcome	There are no (further) constraints on this element Element Id Parameters.parameter:information.resource Data Type OperationOutcome

ISiK-Spezifisches Mapping Composition -> DocumentReference

Path	map	comment
DocumentReference.masterIdentifier	Bundle.identifier
DocumentReference.identifier	Composition.identifier
DocumentReference.status	=current
DocumentReference.docStatus	Composition.status
DocumentReference.type.coding:KDL	Composition.type.coding[KDL]
DocumentReference.type.coding:XDS	Composition.type.coding[XDS]	Kann mittels Lookup in den KDL->XDS ConceptMaps anhand des KDL-Type-Codes ermittelt werden
DocumentReference.category.coding:XDS	Composition.category.coding[XDS]	Kann mittels Lookup in den KDL->XDS ConceptMaps anhand des KDL-Type-Codes ermittelt werden
DocumentReference.subject	Lookup Composition.subject.resolve().identifier[PID]	Ermittlung des korrekten Patienten auf dem Server anhand des Identifiers (PID) und/oder weiterer Kriterien erforderlich
DocumentReference.author	Composition.author
DocumentReference.relatesTo.code	Composition.relatesTo.code
DocumentReference.relatesTo.target	Lookup Composition.relatesTo.targetReference.resolve().identifier	Ermittlung der zu ersetzenden DocumentReference anhand des identifiers der referenzierten Composition erforderlich
DocumentReference.description	Composition.title
DocumentReference.content.attachment.contentType	`application/html` für den extrahierten Narrative, `application/fhir+xml` oder `application/fhir+json` für das Bundle
DocumentReference.content.attachment.language	=de sofern keine abweichende Angabe in Composition.language
DocumentReference.content.attachment.url	vom Server festgelegter Speicherort des Bundles/Narratives
DocumentReference.content.attachment.creation	Composition.date
DocumentReference.content.format	=urn:ihe:iti:xds:2017:mimeTypeSufficient
DocumentReference.context.encounter	Lookup Composition.encounter.resolve().identifier	Ermittlung des korrekten Encounters auf dem Server anhand des Identifiers(Fallnummer) und/oder weiterer Kriterien erforderlich
DocumentReference.context.facilityType	=KHS, sofern nichts anderes bekannt

Akteure und Interaktionen

Akteure

Dokumentenserver

(Webbasierter/Mobiler) Client

Interaktionen

Dokumentenabfrage und -Zugriff (bestätigungsrelevant)

Dokumentenbereitstellung (bestätigungsrelevant)

Update von Dokumentenmetadaten (optional)

Erzeugen von Dokumentenmetadaten (optional)

Interaktion: Dokumentenbereitstellung

Herstellung von Patient- und Encounterkontext

Dokumentenübermittlung

OperationDefinition $submit-document

Invocations

Parameters (In)

Return Values (Out)

In-Parameters-Profil (ISiK)

Out-Parameters-Profil (ISiK)

Beispiel:

Request

Response

Dokumentenabfrage und -zugriff

Dokumentenabfrage

Dokumentenzugriff

Interaktion: Update von Metadaten

Herstellung von Dokumentenkontext

Metadatenupdate

OperationDefinition $update-metadata

Invocations

Parameters (In)

Beispiel

Erzeugen von Dokumentenmetadaten

Abgrenzung zu ISiK Stufe 2 (Basis) bei der Kommunikation strukturierter Dokumente (FHIR-Document-Bundle)

Interaktion ISiK Modul Basis Stufe 2: Bericht aus Subsystem

Interaktion ISiK Modul Dokumentenaustausch Stufe 2: Dokumentenbereitstellung

Typische Szenarien mit Koexistenz beider Interaktionen:

Operation $generate-metadata

Invocations

Parameters (In)

Return Values (Out)

In-Parameters Definition (ISiK)

Out-Parameters Definition (ISiK)

ISiK-Spezifisches Mapping Composition -> DocumentReference

OperationDefinition `$submit-document`

OperationDefinition `$update-metadata`