BfArM Digitale Anwendungen
3.0.2-RC1 - draft

​BfArM Digitale Anwendungen - Local Development build (v3.0.2-RC1) built by the FHIR (HL7® FHIR® Standard) Build Tools. See the Directory of published versions

Changelog

Test System (3.0.2-RC1)

WIP

  • Added Use of package "hl7.fhir.uv.xver-r5.r4" for extended R5 extension support.
  • Added New profiles for the Directory of Medical Aid and Implant Interfaces (HIIS):
    • Attachment: Hiis
    • CodeSystem: HiisCatalogEntryType
    • CodeSystem: HiisDeviceDefinitionRelationType
    • CodeSystem: HiisEndpointConnectionType
    • CodeSystem: HiisManufacturerType
    • Coding: HiisCatalogEntryType
    • Coding: HiisCountry
    • Coding: HiisEbm
    • Coding: HiisEndpointConnectionType
    • Coding: HiisLanguage
    • Coding: HiisManufacturerType
    • Extension: HiisCatalogEntryHistory
    • Extension: HiisCatalogEntryReferencedItemLink
    • Extension: HiisCategorySubjects
    • Extension: HiisDeviceDataRecorderEndpointLink
    • Extension: HiisDeviceDefinitionMivSet
    • Extension: HiisQuestionnaireItemDescription
    • Extension: HiisQuestionnaireResponseAnswerRange
    • Extension: HiisQuestionnaireResponseItemInapplicable
    • NamingSystem: HiisId
    • NamingSystem: HiisQuestionnaireId
    • Operation: DeviceDefinitionEndpoints
    • Operation: DeviceDefinitionSupportedDevices
    • Operation: DeviceDefinitionSupportingInterfaces
    • Profile: HiisCatalogEntry
    • Profile: HiisCategory
    • Profile: HiisDeviceDataRecorderDefinition
    • Profile: HiisDeviceDataRecorderEndpoint
    • Profile: HiisManufacturer
    • Profile: HiisPersonalHealthDeviceDefinition
    • Profile: HiisQuestionnaire
    • Profile: HiisQuestionnaireResponse
    • SearchParameter: DeviceDefinitionDeviceName
    • SearchParameter: DeviceDefinitionDeviceSearch
    • SearchParameter: DeviceDefinitionManufacturerName
    • SearchParameter: DeviceDefinitionMivSet
    • ValueSet: HiisAttachmentContentType
    • ValueSet: HiisCatalogEntryStatus
    • ValueSet: HiisCatalogEntryType
    • ValueSet: HiisDeviceDefinitionRelationType
    • ValueSet: HiisEbm
    • ValueSet: HiisEndpointConnectionType
    • ValueSet: HiisManufacturerType
    • ValueSet: HiisQuestionnaireItemType
    • ValueSet: HiisQuestionnaireQuestionItemType
    • ValueSet: HiisQuestionnaireResponseStatus
    • ValueSet: HiisQuestionnaireStatus
  • Added New extension "HealthAppHiisTrustAttributes" for specifying trust attributes for communication with medical aid interfaces.
  • Added New extension "HealthAppMivSet" for specifying supported mandatory interoperable value sets (vibW).
  • Added Extension of extension "HealthAppPrescriptionUnitKontraindikation" with "ausschlusskriterien_relativ_diagnose" (Coding), "ausschlusskriterien_relativ_other" (string), "ausschlusskriterien_studienspezifisch" (string) and "kontraindikationen_other" (string).
  • Changed Renaming of "diagnose" to "kontraindikationen_diagnose" in extension "HealthAppPrescriptionUnitKontraindikation".

Version 3.0.1

27.12.2025

  • Added New extension "HealthAppPrescriptionUnitCodeValidUntil" for optional specification of the latest prescription date of the PZN.
  • Changed Update of reference to German base profile "de.basisprofil.r4" to version 1.5.4.
  • Changed Update of internally used HAPI-FHIR server and associated reallocation of internally used resource IDs.

Version 2.0.7

12.12.2024 – 31.03.2026

  • Added Extension of profile "HealthAppCatalogEntry" with use of new extension "HealthAppCatalogEntryHistory" for output of change history.
  • Added CodeSystem "HealthAppHistoryEntryType"
  • Added Coding "HealthAppHistoryEntryType"
  • Added ValueSet "HealthAppHistoryEntryType"
  • Changed In "HealthAppPrescriptionUnit", the field "valueCodeableConcept.text" in "useContext" "age" is used for an optional comment.

Version 2.0.6

25.03.2024

  • Added Extension of extension "HealthAppPrescriptionUnitVertragsaerztlicheLeistungen" with "explanation" (string).
  • Added CodeSystem "urn:ietf:bcp:13".
  • Changed Addition of used file types in ValueSet "HealthAppAttachment".

Version 2.0.1

10.08.2023

  • Added New extension "HealthAppQuestionnaireAnswerOptionDescription" for mapping "description" and "explanation" of "AnswerOption" in "HealthAppQuestionnaire".
  • Changed Adjustment of descriptions in CodeSystem "HealthAppPriceCode".
  • Fixed Correction of cardinalities in the conceptual data model.

Version 2.0.0

27.01.2023

  • Added Addition of NamingSystem "https://fhir.bfarm.de/Identifier/DipaId" as possible "identifier" in "HealthApp" for DiPA.
  • Added Addition of NamingSystem "https://fhir.bfarm.de/Identifier/DipaAeId" as possible "identifier" in "HealthAppPrescriptionUnit" for DiPA.
  • Added "HealthAppCatalogEntry" uses the property "additionalIdentifier" for linking to each other when a digital application is both DiGA and DiPA.
  • Added Extension of extension "HealthAppModuleMedicalDevice" with "isMedicalDevice" (boolean) and "nursingBenefit" (string).
  • Added Extension of code system "HealthAppPriceCode" with "additional-costs" and "maximum-amount" for DiPA.
  • Added New extension "HealthAppPrescriptionUnitErgaenzendeUnterstuetzungsleistungen" for DiPA.
  • Added In "HealthAppPrescriptionUnit", the "useContext" "focus" is used for dimensions of impairments in DiPA.
    • New CodeSystem "HealthAppSeverity"
    • New Coding "HealthAppFocus"
    • New Coding "HealthAppSeverity"
    • New Extension "HealthAppPrescriptionUnitUseContextValueSeverity"
    • New NamingSystem "HealthAppFocusId"
    • New ValueSet "HealthAppSeverity"
  • Changed From this version onwards, the profiling supports Digital Health Applications (DiGA) and Digital Nursing Applications (DiPA).
  • Changed In the URL of all profiles, the domain changes from "fhir.trustedhealthapps.org" to "fhir.bfarm.de".
  • Changed The base URL of the API changes from "https://diga-api.bfarm.de/fhir" to "https://diga.bfarm.de/api/fhir" or "https://dipa.bfarm.de/api/fhir".
  • Changed Update of reference to German base profile "de.basisprofil.r4" to version 1.4.0.
  • Changed The name of a digital application is mapped in "HealthApp" as "deviceName" of type "user-friendly-name" instead of previously as "udi-label-name".
  • Changed The name of a module is mapped in "HealthAppModule" as "deviceName" of type "model-name" instead of previously as "udi-label-name".
  • Changed The "useContext" in "HealthAppPrescriptionUnit" is now profiled using slices.
  • Removed The unused values "2b" and "3" in CodeSystem "HealthAppRiskClass" were removed.
  • Removed The unused property "userSelected" in extension "HealthAppModuleCategory" was removed.

Version 1.1.6

28.11.2022

  • Added New extension "HealthAppCatalogEntryTrialPeriod" on "HealthAppCatalogEntry" specifies the trial period.
  • Added New specification "propertyGroup.priceComponent.code" in "HealthAppPrescriptionUnit" for distinguishing between "manufacturer price" and "maximum amount".
  • Added Extension of extension "HealthAppModuleHardware" with "included" and "optional".

Version 1.1.5

16.04.2022

  • Minor corrections in description texts.
  • Adjustment of canonical claims.
  • Reference to German base profile in version 1.3.2.

Version 1.1.4

22.10.2021

Extension: HealthAppPrescriptionUnitAnwendungsdauer

Extension of description.

ValueSet: HealthAppAge

Removal of unused value 764868004.

Implementation Guide

  • Adjustment of information model to profiling.
  • Addition of Questionnaire and QuestionnaireResponse to endpoints.
  • Explanation of Must Support and cardinality added.

Version 1.1.3

21.07.2021

Profile: HealthAppModule

Correction of cardinality within languageCode.

Version 1.1.2

09.07.2021

All properties that related solely to Health-Apps and not to DiGA are no longer supported and have been removed from profiling. Descriptions have also been adjusted.

Profile: HealthAppEffect

No longer supported and has been removed.

Profile: HealthAppInsurance

No longer supported and has been removed.

Profile: HealthAppModule

The name and URL of extension HealthAppModuleMedicalDevice were corrected.

Version 1.1.1

07.07.2021

Changes to Profile: HealthAppPrescriptionUnit

  • Change to extension vertragsaerztlicheLeistungen:
    • New property required
  • Change to property useContext:
    • For gender, the ValueSet http://hl7.org/fhir/ValueSet/administrative-gender is now used

Version 1.1.0

05.07.2021

New Operation: DeviceDefinition/[id]/$everything

This new operation is used to return all information about a DiGA or DiGA module that is described in the resource or context for which this operation is called. The response is a Bundle of type searchset. At least the DeviceDefinition resource itself is returned together with all other resources on the server that relate to the DiGA or DiGA module.

New Profile: HealthAppEffect

This profile describes a positive care effect of a module of a Health-App or Digital Health Application (DiGA), for example as a specification of medical benefit or a patient-relevant structural and procedural improvement.

New Profile: HealthAppInsurance

This profile represents information about a health insurance.

New Profile: HealthAppQuestionnaire

This profile represents questionnaires that are answered by the manufacturer of the DiGA or the editorial team in the course of collecting quality data for a HealthApp or in the course of an application for inclusion in the DiGA directory.

New Profile: HealthAppQuestionnaireResponse

This profile represents the answers given by the manufacturer or editorial team for a specific questionnaire.

Changes to Profile: HealthApp

  • New extension handbook
  • New extension media
  • New extension summaries
  • Removal of extension zweckbestimmung
  • Removal of support for capability property
  • Refinement of short description and definition of supported elements
  • Change of NamingSystem URLs of identifiers

Changes to Profile: HealthAppModule

  • New extension handbook
  • New extension media
  • New extension medicalDevice
  • New extension summaries
  • Removal of extension prescriptionUnit
  • Changes to extension category:
    • identifier and type now use data type Coding instead of CodeableConcept
  • Changes to extension hardware:
    • New property optional
  • Support of property identifier
  • Support of property udiDeviceIdentifier
  • Support of property manufacturer
  • Support of property languageCode
  • Refinement of short description and definition of supported elements

Changes to Profile: HealthAppPrescriptionUnit

  • Removal of extension nichtErstattungsfaehigeKosten
  • Changes to extension indikation:
    • diagnose now uses data type Coding instead of CodeableConcept
  • Changes to extension kontraindikation:
    • diagnose now uses data type Coding instead of CodeableConcept
  • Changes to extension vertragsaerztlicheLeistungen:
    • New property ebm
  • Specification of used Codings in property useContext.value
  • Support of property effectivePeriod
  • Support of property instance:
    • Reference to DiGA module via extension deviceDefinition
  • New extensions nonRefundable and payor in property propertyGroup
  • New extension timing in property propertyGroup.priceComponent
  • Refinement of short description and definition of supported elements
  • Change of NamingSystem URL of identifier

Changes to Profile: HealthAppManufacturer

  • Support of property type
  • Support of property contact
  • Refinement of short description and definition of supported elements
  • Change of NamingSystem URL of identifier

Changes to Profile: HealthAppCatalogEntry

  • Refinement of short description and definition of supported elements
  • Change of NamingSystem URL of identifier

Changes to Data Type Profiling

Corresponding CodeSystem, NamingSystem and ValueSet resources are now available for all used Codings and Identifiers when these differ from the definitions in the base resources. Corresponding Coding profiles have also been defined.

Further Changes

The German base profile in version 1.0.0-rc4 is now used.

Note on Version 1.0

The predecessor version 1.0 is no longer being developed. The corresponding FHIR server will be shut down at the end of 2021.

Version 1.0.4

18.03.2021

  • Added The descriptions "Short description" and "Definition" were completed in the "Must support" fields of the FHIR profiles.
  • Added The information model was extended with a logical data model.

Version 1.0.3

22.01.2021

  • Fixed Correction of the HealthAppPrescriptionUnit example
  • Added CodeSystem HealthAppGender was added

Version 1.0.2

20.01.2021

  • Fixed Resolution of inconsistencies in HealthAppModule and HealthAppPrescriptionUnit
  • Changed The provided examples were updated

Version 1.0.1

12.01.2021

  • Fixed Errors in provided FHIR examples fixed
  • Added First version of API documentation added to implementation guide

Version 1.0.0

31.12.2020

Start of production operation of DiGA-API

Version 0.2.0

22.12.2020

First editorial additions to the implementation guide as well as adjustments to the associated profiled FHIR resources.

  • Added Integration of an information model draft and first use case drafts into the implementation guide
  • Changed Adjustments to the "Short description" and "Definition" fields of profiles

Version 0.1.0

18.12.2020

Initial publication of the implementation guide "Digital Health Applications" and associated profiled FHIR resources for describing the interface under development for providing data from the directory for Digital Health Applications

  • Added Working version of implementation guide "Digital Health Applications"
  • Added Working version of profiles for describing a DiGA core dataset, as provided via the interface according to § 21 para. 2 ff. DiGAV from 01.01.2021