Implementierungsleitfaden ISiK-Basismodul

ISiKBinary

Dieses Profil ermöglicht die Darstellung von FHIR-fremden Formaten (z.B. PDFs, Bilder, CDA) in ISiK Szenarien.

Motivation

Für FHIR-fremde Formate werden die Daten base64-codiert in der Binary-Ressource (in XML oder JSON) transportiert oder über die REST-API am Binary-Endpunkt in ihrem nativen Format bereitgestellt. Binary-Ressourcen werden von Attachment-Elementen in DocumentReference-Ressourcen verlinkt und damit in den Kontext anderer FHIR-Ressourcen (z.B. Patient und Encounter) gestellt.

Kompatibilität

Hinweise zu Inkompatibilitäten können über die Portalseite gemeldet werden.

Hinweis

Das ISIK-Binary-Profil ist nicht Bestandteil der Implementierung und des Bestätigungsverfahrens zum ISIK Basismodul. Das Profil ist Teil des ISIK Basismoduls, da es im Modul Dokumentenaustausch implementiert werden muss und ein hohes Potential für die Wiederverwednung in anderen Modulen naheliegt.

Metadaten

Canonical	https://gematik.de/fhir/isik/StructureDefinition/ISiKBinary
Status	active
Version	5.1.1
Basis	http://hl7.org/fhir/StructureDefinition/Binary

Inhalt

ISiKBinary (Binary)

Binary

There are no (further) constraints on this element

Element id

Binary

Short description

Pure binary content defined by a format other than FHIR

Definition

A resource that represents the data of a single raw artifact as digital content accessible in its native format. A Binary resource can contain any content, whether text, image, pdf, zip archive, etc.

Comments

Typically, Binary resources are used for handling content such as:

CDA Documents (i.e. with XDS)
PDF Documents
Images (the Media resource is preferred for handling images, but not possible when the content is already binary - e.g. XDS).

Data type

Binary

Mappings

rim: Entity. Role, or Act
rim: ED

S Σ

0..1

string

Element id

Binary.id

Short description

serverseitige, interne ID des Datensatzes

Definition

The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes.

Comments

bedingtes Pflichtfeld/bedingtes MS: Alle von einem Server bereitgestellten Ressourcen MÜSSEN über eine id verfügen. Von Clients erzeugte Ressourcen, die im Kontext einer CREATE-Interaktion übermittelt werden, MÜSSEN NICHT über eine idverfügen.

Data type

string

Meta

Conditions

The cardinality or value of this element may be affected by these constraints: ele-1

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

0..1

string

There are no (further) constraints on this element

Element id

Binary.meta.id

Short description

Unique id for inter-element referencing

Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

Data type

string

Mappings

rim: n/a

extension

0..*

Extension

There are no (further) constraints on this element

Element id

Binary.meta.extension

Short description

Additional content defined by implementations

Alternate names

extensions, user content

Definition

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 manageable, 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.

Comments

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.

Data type

Extension

Slicing

Unordered, Open, by url(Value)

Extensions are always sliced by (at least) url

Conditions

The cardinality or value of this element may be affected by these constraints: ele-1

Constraints

ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
ext-1: Must have either extensions or value[x], not both
extension.exists() != value.exists()

Mappings

rim: n/a
rim: N/A

versionId

0..1

Element id

Binary.meta.versionId

Short description

Eindeutiger Name der serverseitigen Version des Datensatzes

Definition

The version specific identifier, as it appears in the version portion of the URL. This value changes when the resource is created, updated, or deleted.

Comments

Alle von einem Server bereitgestellten Ressourcen SOLLEN über eine versionID verfügen. Von Clients erzeugte Ressourcen, die im Kontext einer CREATE-Interaktion übermittelt werden, MÜSSEN NICHT über eine versionIDverfügen.

Data type

Conditions

The cardinality or value of this element may be affected by these constraints: ele-1

Constraints

ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())

Mappings

rim: n/a

lastUpdated

0..1

instant

Element id

Binary.meta.lastUpdated

Short description

Zeitpunkt der letzten Änderung

Definition

When the resource last changed - e.g. when the version changed.

Comments

Alle von einem Server bereitgestellten Ressourcen SOLLEN über ein lastUpdate verfügen. Von Clients erzeugte Ressourcen, die im Kontext einer CREATE-Interaktion übermittelt werden, MÜSSEN NICHT über ein lastUpdateverfügen.

Data type

instant

Conditions

The cardinality or value of this element may be affected by these constraints: ele-1

Constraints

ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())

Mappings

rim: n/a

source

0..1

uri

There are no (further) constraints on this element

Element id

Binary.meta.source

Short description

Identifies where the resource comes from

Definition

A uri that identifies the source system of the resource. This provides a minimal amount of Provenance information that can be used to track or differentiate the source of information in the resource. The source may identify another FHIR server, document, message, database, etc.

Comments

In the provenance resource, this corresponds to Provenance.entity.what[x]. The exact use of the source (and the implied Provenance.entity.role) is left to implementer discretion. Only one nominated source is allowed; for additional provenance details, a full Provenance resource should be used.

This element can be used to indicate where the current master source of a resource that has a canonical URL if the resource is no longer hosted at the canonical URL.

Data type

uri

Conditions

The cardinality or value of this element may be affected by these constraints: ele-1

Constraints

ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())

Mappings

rim: n/a

profile

0..*

canonical(StructureDefinition)

There are no (further) constraints on this element

Element id

Binary.meta.profile

Short description

Profiles this resource claims to conform to

Definition

A list of profiles (references to StructureDefinition resources) that this resource claims to conform to. The URL is a reference to StructureDefinition.url.

Comments

It is up to the server and/or other infrastructure of policy to determine whether/how these claims are verified and/or updated over time. The list of profile URLs is a set.

Data type

canonical(StructureDefinition)

Conditions

The cardinality or value of this element may be affected by these constraints: ele-1

Constraints

ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())

Mappings

rim: n/a

security

0..*

CodingBinding

There are no (further) constraints on this element

Element id

Binary.meta.security

Short description

Security Labels applied to this resource

Definition

Security labels applied to this resource. These tags connect specific resources to the overall security policy and infrastructure.

Comments

The security labels can be updated without changing the stated version of the resource. The list of security labels is a set. Uniqueness is based the system/code, and version and display are ignored.

Data type

Coding

Binding

Security Labels from the Healthcare Privacy and Security Classification System.

All Security Labels (extensible)

Conditions

The cardinality or value of this element may be affected by these constraints: ele-1

Constraints

ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())

Mappings

rim: n/a
v2: CE/CNE/CWE subset one of the sets of component 1-3 or 4-6
rim: CV
orim: fhir:Coding rdfs:subClassOf dt:CDCoding

tag

0..*

Coding

There are no (further) constraints on this element

Element id

Binary.meta.tag

Short description

Tags applied to this resource

Definition

Tags applied to this resource. Tags are intended to be used to identify and relate resources to process and workflow, and applications are not required to consider the tags when interpreting the meaning of a resource.

Comments

The tags can be updated without changing the stated version of the resource. The list of tags is a set. Uniqueness is based the system/code, and version and display are ignored.

Data type

Coding

Binding

Codes that represent various types of tags, commonly workflow-related; e.g. "Needs review by Dr. Jones".

CommonTags (example)

Conditions

The cardinality or value of this element may be affected by these constraints: ele-1

Constraints

ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())

Mappings

rim: n/a
v2: CE/CNE/CWE subset one of the sets of component 1-3 or 4-6
rim: CV
orim: fhir:Coding rdfs:subClassOf dt:CDCoding

implicitRules

Σ ?!

0..1

uri

There are no (further) constraints on this element

Element id

Binary.implicitRules

Short description

A set of rules under which this content was created

Definition

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.

Comments

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 it's narrative along with other profiles, value sets, etc.

Data type

uri

Conditions

The cardinality or value of this element may be affected by these constraints: ele-1

Constraints

ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())

Mappings

rim: n/a

language

0..1

codeBinding

There are no (further) constraints on this element

Element id

Binary.language

Short description

Language of the resource content

Definition

The base language in which the resource is written.

Comments

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).

Data type

code

Binding

A human language.

CommonLanguages (preferred)

Binding extensions

maxValueSet	AllLanguages

Conditions

The cardinality or value of this element may be affected by these constraints: ele-1

Constraints

ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())

Mappings

rim: n/a

contentType

S Σ

1..1

codeBinding

Element id

Binary.contentType

Short description

MimeType der Binärdaten

Definition

MimeType of the binary content represented as a standard MimeType (BCP 13).

Comments

z.B. "application/pdf" oder "image/jpeg"
Begründung Pflichtfeld: Ohne Kenntnis des MimeTypes sind die Base65-codierten Daten in data nicht interpretierbar

Data type

code

Binding

The mime type of an attachment. Any valid mime type is allowed.

Mime Types (required)

Conditions

The cardinality or value of this element may be affected by these constraints: ele-1

Constraints

ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())

Mappings

rim: n/a
rim: ED.mediaType

securityContext

Σ C

0..1

Reference(Resource)

There are no (further) constraints on this element

Element id

Binary.securityContext

Short description

Identifies another resource to use as proxy when enforcing access control

Definition

This element identifies another resource that can be used as a proxy of the security sensitivity to use when deciding and enforcing access control rules for the Binary resource. Given that the Binary resource contains very few elements that can be used to determine the sensitivity of the data and relationships to individuals, the referenced resource stands in as a proxy equivalent for this purpose. This referenced resource may be related to the Binary (e.g. Media, DocumentReference), or may be some non-related Resource purely as a security proxy. E.g. to identify that the binary resource relates to a patient, and access should only be granted to applications that have access to the patient.

Comments

Very often, a server will also know of a resource that references the binary, and can automatically apply the appropriate access rules based on that reference. However, there are some circumstances where this is not appropriate, e.g. the binary is uploaded directly to the server without any linking resource, the binary is referred to from multiple different resources, and/or the binary is content such as an application logo that has less protection than any of the resources that reference it.

Data type

Reference(Resource)

Conditions

The cardinality or value of this element may be affected by these constraints: ele-1

Constraints

ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
ref-1: SHALL have a contained resource if a local reference is provided
reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids'))

Mappings

rim: n/a
rim: The target of a resource reference is a RIM entry point (Act, Role, or Entity)

data

1..1

base64Binary

Element id

Binary.data

Short description

Base64-codierte Binärdaten

Definition

The actual content, base64 encoded.

Comments

Begründung Pflichtfeld: Sind keine Binärdaten vorhanden, ist diese Ressource sinnlos.

Data type

base64Binary

Conditions

The cardinality or value of this element may be affected by these constraints: ele-1

Constraints

ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())

Mappings

rim: n/a
rim: ED.data

<id value="ISiKBinary" />
<url value="https://gematik.de/fhir/isik/StructureDefinition/ISiKBinary" />
<version value="5.1.1" />
<name value="ISiKBinary" />
<title value="ISiKBinary" />
<status value="active" />
<experimental value="false" />
<date value="2025-12-17" />
<publisher value="gematik GmbH" />
<description value="Dieses Profil ermöglicht die Darstellung von FHIR-fremden Formaten (z.B. PDFs, Bilder, CDA) in ISiK Szenarien. \n\n### Motivation\nFür FHIR-fremde Formate werden die Daten base64-codiert in der Binary-Ressource (in XML oder JSON) transportiert oder \nüber die REST-API am Binary-Endpunkt in ihrem nativen Format bereitgestellt. \nBinary-Ressourcen werden von Attachment-Elementen in DocumentReference-Ressourcen verlinkt und damit in den Kontext anderer FHIR-Ressourcen (z.B. Patient und Encounter) gestellt. \n\n### Kompatibilität\n\nHinweise zu Inkompatibilitäten können über die [Portalseite](https://service.gematik.de/servicedesk/customer/portal/16) gemeldet werden.\n\n### Hinweis\n\nDas ISIK-Binary-Profil ist *nicht* Bestandteil der Implementierung und des Bestätigungsverfahrens zum ISIK Basismodul.\nDas Profil ist Teil des ISIK Basismoduls, da es im [Modul Dokumentenaustausch](https://simplifier.net/guide/isik-dokumentenaustausch-stufe-5/Einfuehrung/Artefakte/Datenobjekte_ISiKBinary) implementiert werden muss und ein hohes Potential für die Wiederverwednung in anderen Modulen naheliegt.  " />
<fhirVersion value="4.0.1" />
<kind value="resource" />
<abstract value="false" />
<type value="Binary" />
<baseDefinition value="http://hl7.org/fhir/StructureDefinition/Binary" />
<derivation value="constraint" />
<differential>
<element id="Binary.id">
<path value="Binary.id" />
<short value="serverseitige, interne ID des Datensatzes" />
<comment value="**bedingtes Pflichtfeld/bedingtes MS:** Alle von einem Server bereitgestellten Ressourcen MÜSSEN über eine `id` verfügen.\n  Von Clients erzeugte Ressourcen, die im Kontext einer CREATE-Interaktion übermittelt werden, MÜSSEN NICHT über eine `id`verfügen. " />
<mustSupport value="true" />
</element>
<element id="Binary.meta.versionId">
<path value="Binary.meta.versionId" />
<short value="Eindeutiger Name der serverseitigen Version des Datensatzes" />
<comment value="Alle von einem Server bereitgestellten Ressourcen SOLLEN über eine `versionID` verfügen.\n  Von Clients erzeugte Ressourcen, die im Kontext einer CREATE-Interaktion übermittelt werden, MÜSSEN NICHT über eine `versionID`verfügen. " />
</element>
<element id="Binary.meta.lastUpdated">
<path value="Binary.meta.lastUpdated" />
<short value="Zeitpunkt der letzten Änderung" />
<comment value="Alle von einem Server bereitgestellten Ressourcen SOLLEN über ein `lastUpdate` verfügen.\n  Von Clients erzeugte Ressourcen, die im Kontext einer CREATE-Interaktion übermittelt werden, MÜSSEN NICHT über ein `lastUpdate`verfügen. " />
</element>
<element id="Binary.contentType">
<path value="Binary.contentType" />
<short value="MimeType der Binärdaten" />
<comment value="z.B. &quot;application/pdf&quot; oder &quot;image/jpeg&quot;  \n    **Begründung Pflichtfeld:** Ohne Kenntnis des MimeTypes sind die Base65-codierten Daten in `data` nicht interpretierbar" />
<mustSupport value="true" />
</element>
<element id="Binary.data">
<path value="Binary.data" />
<short value="Base64-codierte Binärdaten" />
<comment value="**Begründung Pflichtfeld:** Sind keine Binärdaten vorhanden, ist diese Ressource sinnlos." />
<min value="1" />
<mustSupport value="true" />
</element>
</differential>

</StructureDefinition>

{

"resourceType": "StructureDefinition",
"id": "ISiKBinary",
"url": "https://gematik.de/fhir/isik/StructureDefinition/ISiKBinary",
"version": "5.1.1",
"name": "ISiKBinary",
"title": "ISiKBinary",
"status": "active",
"experimental": false,
"date": "2025-12-17",
"publisher": "gematik GmbH",
"description": "Dieses Profil ermöglicht die Darstellung von FHIR-fremden Formaten (z.B. PDFs, Bilder, CDA) in ISiK Szenarien. \n\n### Motivation\nFür FHIR-fremde Formate werden die Daten base64-codiert in der Binary-Ressource (in XML oder JSON) transportiert oder \nüber die REST-API am Binary-Endpunkt in ihrem nativen Format bereitgestellt. \nBinary-Ressourcen werden von Attachment-Elementen in DocumentReference-Ressourcen verlinkt und damit in den Kontext anderer FHIR-Ressourcen (z.B. Patient und Encounter) gestellt. \n\n### Kompatibilität\n\nHinweise zu Inkompatibilitäten können über die [Portalseite](https://service.gematik.de/servicedesk/customer/portal/16) gemeldet werden.\n\n### Hinweis\n\nDas ISIK-Binary-Profil ist *nicht* Bestandteil der Implementierung und des Bestätigungsverfahrens zum ISIK Basismodul.\nDas Profil ist Teil des ISIK Basismoduls, da es im [Modul Dokumentenaustausch](https://simplifier.net/guide/isik-dokumentenaustausch-stufe-5/Einfuehrung/Artefakte/Datenobjekte_ISiKBinary) implementiert werden muss und ein hohes Potential für die Wiederverwednung in anderen Modulen naheliegt.",
"fhirVersion": "4.0.1",
"kind": "resource",
"abstract": false,
"type": "Binary",
"baseDefinition": "http://hl7.org/fhir/StructureDefinition/Binary",
"derivation": "constraint",
"differential": {
"element": [
{
"id": "Binary.id",
"path": "Binary.id",
"short": "serverseitige, interne ID des Datensatzes",
"comment": "**bedingtes Pflichtfeld/bedingtes MS:** Alle von einem Server bereitgestellten Ressourcen MÜSSEN über eine `id` verfügen.\n  Von Clients erzeugte Ressourcen, die im Kontext einer CREATE-Interaktion übermittelt werden, MÜSSEN NICHT über eine `id`verfügen.",
"mustSupport": true
},
{
"id": "Binary.meta.versionId",
"path": "Binary.meta.versionId",
"short": "Eindeutiger Name der serverseitigen Version des Datensatzes",
"comment": "Alle von einem Server bereitgestellten Ressourcen SOLLEN über eine `versionID` verfügen.\n  Von Clients erzeugte Ressourcen, die im Kontext einer CREATE-Interaktion übermittelt werden, MÜSSEN NICHT über eine `versionID`verfügen."
},
{
"id": "Binary.meta.lastUpdated",
"path": "Binary.meta.lastUpdated",
"short": "Zeitpunkt der letzten Änderung",
"comment": "Alle von einem Server bereitgestellten Ressourcen SOLLEN über ein `lastUpdate` verfügen.\n  Von Clients erzeugte Ressourcen, die im Kontext einer CREATE-Interaktion übermittelt werden, MÜSSEN NICHT über ein `lastUpdate`verfügen."
},
{
"id": "Binary.contentType",
"path": "Binary.contentType",
"short": "MimeType der Binärdaten",
"comment": "z.B. &quot;application/pdf&quot; oder &quot;image/jpeg&quot;  \n    **Begründung Pflichtfeld:** Ohne Kenntnis des MimeTypes sind die Base65-codierten Daten in `data` nicht interpretierbar",
"mustSupport": true
},
{
"id": "Binary.data",
"path": "Binary.data",
"short": "Base64-codierte Binärdaten",
"comment": "**Begründung Pflichtfeld:** Sind keine Binärdaten vorhanden, ist diese Ressource sinnlos.",
"min": 1,
"mustSupport": true
}
]
}

}

ISiKBinary

ISiKBinary

Motivation

Kompatibilität

Hinweis

Metadaten

Inhalt

Constraints/Invarianten