Einwilligungsmanagement

Source Document

In einigen Use Cases ist es erforderlich neben einer maschinen- und menschenlesbaren Einwilligungsvorlage auch eine Kopie der Originaleinwilligungsvorlage eines Forschungsprojektes inkl. alle Logos, Unterschriftenfelder, etc. mitzuführen und in einem beliebigen Format zur Verfügung stellen zu können.

Diese Referenz auf / Anlage eines Herkunftsdokuments kann mittels Extension Quelldokument des Questionnaires umgesetzt werden.

ConsentManagementSourceDocument (Extension)	I		Extension	There are no (further) constraints on this element Element id Extension Short description Optional Extensions Element Definition Optional Extension Element - found in all resources. Data type Extension 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
id		0..1	string	There are no (further) constraints on this element Element id Extension.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	I	0..*	Extension	There are no (further) constraints on this element Element id Extension.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 Sliced: Unordered, Open, by url(Value) Extensions are always sliced by (at least) url 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
url		1..1	uriFixed Value	Element id Extension.url Short description identifies the meaning of the extension Definition Source of the definition for the extension code - a logical name or a URL. Comments The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension. Data type uri Fixed value http://fhir.de/ConsentManagement/StructureDefinition/SourceDocument Mappings rim: N/A
value[x]		1..1		There are no (further) constraints on this element Element id Extension.value[x] Short description Value of extension Definition Value of extension - must be one of a constrained set of the data types (see Extensibility for a list). 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
valueAttachment			Attachment	Data type Attachment
id		0..1	string	There are no (further) constraints on this element Element id Extension.value[x].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	I	0..*	Extension	There are no (further) constraints on this element Element id Extension.value[x].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 Sliced: Unordered, Open, by url(Value) Extensions are always sliced by (at least) url 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
contentType	Σ	1..1	codeBinding	There are no (further) constraints on this element Element id Extension.value[x].contentType Short description Mime type of the content, with charset etc. Definition Identifies the type of the data in the attachment and allows a method to be chosen to interpret or render the data. Includes mime type parameters such as charset where appropriate. Requirements Processors of the data need to be able to know how to interpret the data. Comments Note that FHIR strings SHALL NOT exceed 1MB in size Data type code Binding The mime type of an attachment. Any valid mime type is allowed. Mime Types (required) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Examples General text/plain; charset=UTF-8, image/png Mappings rim: n/a v2: ED.2+ED.3/RP.2+RP.3. Note conversion may be needed if old style values are being used rim: ./mediaType, ./charset
language	Σ	0..1	codeBinding	There are no (further) constraints on this element Element id Extension.value[x].language Short description Human language of the content (BCP-47) Definition The human language of the content. The value can be any valid value according to BCP 47. Requirements Users need to be able to choose between the languages in a set of attachments. Comments Note that FHIR strings SHALL NOT exceed 1MB in size Data type code Binding A human language. CommonLanguages (preferred) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Examples General en-AU Mappings rim: n/a rim: ./language
data		1..1	base64Binary	There are no (further) constraints on this element Element id Extension.value[x].data Short description Data inline, base64ed Definition The actual data of the attachment - a sequence of bytes, base64 encoded. Requirements The data needs to able to be transmitted inline. Comments The base64-encoded data SHALL be expressed in the same character set as the base resource XML or JSON. Data type base64Binary Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: ED.5 rim: ./data
url	Σ	0..1	url	There are no (further) constraints on this element Element id Extension.value[x].url Short description Uri where the data can be found Definition A location where the data can be accessed. Requirements The data needs to be transmitted by reference. Comments If both data and url are provided, the url SHALL point to the same content as the data contains. Urls may be relative references or may reference transient locations such as a wrapping envelope using cid: though this has ramifications for using signatures. Relative URLs are interpreted relative to the service url, like a resource reference, rather than relative to the resource itself. If a URL is provided, it SHALL resolve to actual data. Data type url Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Examples General http://www.acme.com/logo-small.png Mappings rim: n/a v2: RP.1+RP.2 - if they refer to a URL (see v2.6) rim: ./reference/literal
size	Σ	0..1	unsignedInt	There are no (further) constraints on this element Element id Extension.value[x].size Short description Number of bytes of content (if url provided) Definition The number of bytes of data that make up this attachment (before base64 encoding, if that is done). Requirements Representing the size allows applications to determine whether they should fetch the content automatically in advance, or refuse to fetch it at all. Comments The number of bytes is redundant if the data is provided as a base64binary, but is useful if the data is provided as a url reference. 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 rim: N/A (needs data type R3 proposal)
hash	Σ	0..1	base64Binary	There are no (further) constraints on this element Element id Extension.value[x].hash Short description Hash of the data (sha-1, base64ed) Definition The calculated hash of the data using SHA-1. Represented using base64. Requirements Included so that applications can verify that the contents of a location have not changed due to technical failures (e.g., storage rot, transport glitch, incorrect version). Comments The hash is calculated on the data prior to base64 encoding, if the data is based64 encoded. The hash is not intended to support digital signatures. Where protection against malicious threats a digital signature should be considered, see Provenance.signature for mechanism to protect a resource with a digital signature. Data type base64Binary Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a rim: .integrityCheck[parent::ED/integrityCheckAlgorithm="SHA-1"]
title	Σ	0..1	string	There are no (further) constraints on this element Element id Extension.value[x].title Short description Label to display in place of the data Definition A label or set of text to display in place of the data. Requirements Applications need a label to display to a human user in place of the actual data if the data cannot be rendered or perceived by the viewer. 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())` Examples General Official Corporate Logo Mappings rim: n/a rim: ./title/data
creation	Σ	0..1	dateTime	There are no (further) constraints on this element Element id Extension.value[x].creation Short description Date attachment was first created Definition The date that the attachment was first created. Requirements This is often tracked as an integrity issue for use of the attachment. Data type dateTime 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 (needs data type R3 proposal)

Beispiel

<extension url="http://fhir.de/ConsentManagement/StructureDefinition/SourceDocument">
    <valueAttachment>
        <contentType value="application/pdf" />
        <data value="JVBERi0xLjcNJeLjz9MNCjU...." />
    </valueAttachment>
</extension>