Implementation Guide for NeuroNation MED

Introduction

The NeuroNation MED application is a mobile application for computer-based cognitive training, which is based on playful exercises for various cognitive functions (Multi-Domain Cognitive Training). It is a medical device. For more information, please refer to: www.neuronation-med.com
This implementation guide defines the structure of the machine-readable export. The data can be exported by the user inside the app.

Data Export

The data is exported as a machine-readable XML file (FHIR, R4), following the specifications of DiGA Toolkit 1.0 (https://mio.kbv.de/display/DIGA1X0X0/DiGA+Toolkit+1.0.0). The file contains a Bundle. Inside the Bundle, all app data is listed using various resource types.

Resource Types Used Inside the Data Export

In the following, the Bundle and all resource types listed inside the Bundle are described:
Resource Type Description FHIR documentation
Patient Contains basic data of the user. Patient
Procedure Contains basic data concerning an exercise completed by the user. Exercises are given on a daily base to train cognitive functions. Procedure
Observation Contains additional performance data concerning an exercise completed by the user. Can also contain passively collected data related to a user completing regular evaluations in their training plan. Observation
Questionnaire Contains metadata of questionnaires, independent of the user. Questionnaires are given during regular evaluations of the training plan. Questionnaire
QuestionnaireResponse Contains actively collected data related to a user completing regular evaluations in their training plan. QuestionnaireResponse
DeviceDefinition Defines a part of the metadata concerning the medical device. DeviceDefinition
Device Defines a part of the metadata concerning the medical device. Device
Provenance Logs changes of the resources. Provenance
Composition Defines metadata for the Bundle. Composition
Bundle Contains all exported data. Bundle

Technical Details on Resource Types

In the following, technical details are given on each resource type listed above.

Patient

Profile on Simplifier

versionIdΣ1..1id
lastUpdatedΣ1..1instant
sourceΣ0..0uri
profileΣ1..1canonical(StructureDefinition)
securityΣ0..0CodingBinding
tagΣ0..0Coding
implicitRulesΣ ?!0..0uri
language0..0codeBinding
status1..1codeBinding
divI1..1xhtml
contained0..0Resource
useΣ ?!0..1codeBindingFixed Value
systemΣ1..1uriFixed Value
versionΣ0..1string
codeΣ1..1codeFixed Value
displayΣ1..1string
userSelectedΣ0..0boolean
textΣ0..1string
systemΣ1..1uri
valueS Σ1..1string
periodΣ I0..0Period
assignerΣ I0..0Reference(Organization)
useΣ ?!0..1codeBindingFixed Value
systemΣ1..1uriFixed Value
versionΣ0..1string
codeΣ1..1codeFixed Value
displayΣ1..1string
userSelectedΣ0..0boolean
textΣ0..1string
systemΣ1..1uriFixed Value
valueS Σ1..1string
periodΣ I0..0Period
assignerΣ I0..0Reference(Organization)
useΣ ?!0..1codeBindingFixed Value
systemΣ1..1uriFixed Value
versionΣ0..1string
codeΣ1..1codeFixed Value
displayΣ1..1string
userSelectedΣ0..0boolean
textΣ0..1string
systemΣ1..1uriFixed Value
valueS Σ I1..1string
periodΣ I0..0Period
assignerΣ I0..0Reference(Organization)
useΣ ?!0..1codeBindingFixed Value
systemΣ1..1uriFixed Value
versionΣ0..1string
codeΣ1..1codeFixed Value
displayΣ1..1string
userSelectedΣ0..0boolean
textΣ0..1string
systemΣ0..1uri
valueS Σ1..1string
periodΣ I0..0Period
referenceΣ I0..1string
typeΣ0..1uriBinding
identifierΣ0..1Identifier-Profil für die Abbildung eines Institutionskennzeichens (IKNR)
displayΣ1..1string
useΣ ?!0..1codeBinding
systemΣ1..1uriFixed Value
versionΣ0..1string
codeΣ1..1codeFixed Value
displayΣ1..1string
userSelectedΣ0..0boolean
textΣ0..1string
systemΣ0..1uri
valueS Σ1..1string
periodΣ I0..0Period
assignerΣ I0..0Reference(Organization)
useΣ ?!0..1codeBinding
systemΣ1..1uriFixed Value
versionΣ0..1string
codeΣ1..1codeFixed Value
displayΣ1..1string
userSelectedΣ0..0boolean
textΣ0..1string
systemΣ1..1uri
valueS Σ1..1string
periodΣ I0..0Period
assignerΣ I0..0Reference(Organization)
useΣ ?!0..1codeBinding
systemΣ1..1uriFixed Value
versionΣ1..1stringFixed Value
codeΣ1..1codeFixed Value
displayΣ1..1string
userSelectedΣ0..0boolean
textΣ0..0string
systemS Σ1..1uriFixed Value
valueS Σ1..1string
periodΣ I0..0Period
assignerΣ I0..0Reference(Organization)
useΣ ?!0..1codeBinding
systemΣ1..1uriFixed Value
versionΣ1..1string
codeΣ1..1codeFixed Value
displayΣ1..1string
userSelectedΣ0..0boolean
textΣ0..0string
systemS Σ1..1uriFixed Value
valueS Σ1..1string
periodΣ I0..0Period
assignerΣ I0..0Reference(Organization)
activeΣ ?!0..0boolean
useΣ ?!1..1codeBinding
textS Σ0..1string
url1..1System.StringFixed Value
valueStringS1..1string
url1..1System.StringFixed Value
valueStringS1..1string
url1..1System.StringFixed Value
valueStringS1..1string
givenS Σ0..1string
url1..1System.StringFixed Value
valueCodeS1..1codeBindingFixed Value
suffixΣ0..0string
periodΣ I0..0Period
useΣ ?!1..1codeBinding
textS Σ0..1string
url1..1System.StringFixed Value
valueStringS1..1string
url1..1System.StringFixed Value
valueStringS1..1string
url1..1System.StringFixed Value
valueStringS1..1string
givenΣ0..0string
suffixΣ0..0string
periodΣ I0..0Period
url1..1uriFixed Value
valueString0..1string
url1..1System.StringFixed Value
valueS Σ1..1string
useΣ ?!0..0codeBinding
rankΣ0..0positiveInt
periodΣ I0..0Period
other-amtlichI0..1Extension
birthDateS Σ0..1date
url1..1System.StringFixed Value
valueStringS0..1string
useΣ ?!0..0codeBinding
typeΣ1..1codeBinding
textΣ0..0string
url1..1System.StringFixed Value
valueStringS0..1string
url1..1System.StringFixed Value
valueStringS0..1string
url1..1System.StringFixed Value
valueStringS0..1string
PostfachI0..0Extension(string)
cityS Σ0..1string
districtΣ0..0string
stateΣ0..0stringBinding
postalCodeS Σ0..1string
countryS Σ0..1stringBinding
url1..1System.StringFixed Value
valueStringS1..1string
useΣ ?!0..0codeBinding
typeΣ1..1codeBinding
textΣ0..0string
StrasseI0..0Extension(string)
HausnummerI0..0Extension(string)
AdresszusatzI0..0Extension(string)
url1..1System.StringFixed Value
valueStringS0..1string
cityS Σ0..1string
districtΣ0..0string
stateΣ0..0stringBinding
postalCodeS Σ0..1string
countryS Σ0..1stringBinding
maritalStatus0..0CodeableConceptBinding
photoI0..0Attachment
systemΣ1..1uri
versionΣ0..0string
codeΣ1..1code
displayΣ1..1string
userSelectedΣ0..0boolean
textΣ0..0string
preferred0..0boolean
generalPractitionerI0..0Reference(Organization | Practitioner | PractitionerRole)
managingOrganizationΣ I0..0Reference(Organization)

Procedure

Profile on Simplifier

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Observation

Profile on Simplifier

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Questionnaire

Profile on Simplifier

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QuestionnaireResponse

Profile on Simplifier

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DeviceDefinition

Profile on Simplifier

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Device

Profile on Simplifier

versionIdΣ1..1id
lastUpdatedΣ1..1instant
sourceΣ0..0uri
profileΣ1..1canonical(StructureDefinition)
securityΣ0..0CodingBinding
tagΣ0..0Coding
implicitRulesΣ ?!0..0uri
language0..0codeBinding
status1..1codeBindingFixed Value
divI1..1xhtml
contained0..0Resource
extensionI0..0Extension
useΣ ?!0..0codeBinding
codingΣ0..0Coding
textS Σ1..1string
systemΣ0..1uri
valueS Σ1..1string
periodΣ I0..0Period
assignerΣ I0..0Reference(Organization)
referenceS Σ I1..1string
typeΣ0..0uriBinding
identifierΣ0..0Identifier
displayΣ0..0string
statusΣ ?!0..0codeBinding
distinctIdentifier0..0string
manufacturer0..0string
manufactureDate0..0dateTime
expirationDate0..0dateTime
lotNumber0..0string
serialNumber0..0string
nameS1..1string
typeS1..1codeBinding
modelNumber0..0string
partNumber0..0string
systemΣ1..1uri
versionΣ0..1string
codeΣ1..1code
displayΣ0..1string
userSelectedΣ0..0boolean
textΣ0..0string
systemΣ1..1uri
versionΣ1..1string
codeΣ1..1code
displayΣ1..1string
userSelectedΣ0..0boolean
textS Σ0..1string
component0..0Identifier
valueS1..1string
patientI0..0Reference(Patient)
ownerI0..0Reference(Organization)
contactI0..0ContactPoint
locationI0..0Reference(Location)
url0..0uri
note0..0Annotation
safetyΣ0..0CodeableConcept
parentI0..0Reference(Device)

Provenance

Profile on Simplifier

versionId1..
lastUpdated1..
source..0
profile1..1
security..0
tag..0
implicitRules..0
language..0
statusFixed Value
contained..0
referenceS1..
type..0
identifier..0
display..0
occurred[x]..0
recordedS
policy..0
location..0
reason..0
activity..0
system1..
version1..
code1..
display1..
userSelected..0
text..0
role..0
referenceS1..
type..0
identifier..0
display..0
onBehalfOf..0
roleS
whatSReference(https://fhir.kbv.de/StructureDefinition/KBV_PR_MIO_DIGA_AllergyIntolerance|1.1.0 | https://fhir.kbv.de/StructureDefinition/KBV_PR_MIO_DIGA_Appointment|1.1.0 | https://fhir.kbv.de/StructureDefinition/KBV_PR_MIO_DIGA_CarePlan|1.1.0 | https://fhir.kbv.de/StructureDefinition/KBV_PR_MIO_DIGA_Condition_Problem|1.1.0 | KBV_PR_MIO_DIGA_DeviceDefinition_DIGA | https://fhir.kbv.de/StructureDefinition/KBV_PR_MIO_DIGA_DeviceDefinition|1.1.0 | KBV_PR_MIO_DIGA_Device_DIGA | https://fhir.kbv.de/StructureDefinition/KBV_PR_MIO_DIGA_Device|1.1.0 | https://fhir.kbv.de/StructureDefinition/KBV_PR_MIO_DIGA_DocumentReference|1.1.0 | https://fhir.kbv.de/StructureDefinition/KBV_PR_MIO_DIGA_Encounter|1.1.0 | https://fhir.kbv.de/StructureDefinition/KBV_PR_MIO_DIGA_Goal|1.1.0 | https://fhir.kbv.de/StructureDefinition/KBV_PR_MIO_DIGA_MedicationAdministration_Medication_Intake|1.1.0 | https://fhir.kbv.de/StructureDefinition/KBV_PR_MIO_DIGA_Medication|1.1.0 | https://fhir.kbv.de/StructureDefinition/KBV_PR_MIO_DIGA_MedicationStatement_Medication_Information|1.1.0 | KBV_PR_MIO_DIGA_Observation_Assessment_Scale | https://fhir.kbv.de/StructureDefinition/KBV_PR_MIO_DIGA_Observation_Assessment_Score|1.1.0 | KBV_PR_MIO_DIGA_Observation_Blood_Pressure | KBV_PR_MIO_DIGA_Observation_Body_Height | KBV_PR_MIO_DIGA_Observation_Body_Temperature | KBV_PR_MIO_DIGA_Observation_Body_Weight | KBV_PR_MIO_DIGA_Observation_Diary_Entry | https://fhir.kbv.de/StructureDefinition/KBV_PR_MIO_DIGA_Observation_Environmental_Factor|1.1.0 | https://fhir.kbv.de/StructureDefinition/KBV_PR_MIO_DIGA_Observation_Functional_Assessment|1.1.0 | KBV_PR_MIO_DIGA_Observation_Glucose_Concentration | KBV_PR_MIO_DIGA_Observation_Head_Circumference | KBV_PR_MIO_DIGA_Observation_Heart_Rate | https://fhir.kbv.de/StructureDefinition/KBV_PR_MIO_DIGA_Observation_Life_Style_Factor|1.1.0 | KBV_PR_MIO_DIGA_Observation_Nutrition_Intake_Food_Composition_Types | KBV_PR_MIO_DIGA_Observation_Nutrition_Intake | KBV_PR_MIO_DIGA_Observation_Peripheral_Oxygen_Saturation | KBV_PR_MIO_DIGA_Observation_Respiratory_Rate | KBV_PR_MIO_DIGA_Observation_Free | KBV_PR_MIO_DIGA_Organization_Manufacturer | KBV_PR_MIO_DIGA_Organization | KBV_PR_MIO_DIGA_Patient | KBV_PR_MIO_DIGA_PractitionerRole | KBV_PR_MIO_DIGA_Practitioner | https://fhir.kbv.de/StructureDefinition/KBV_PR_MIO_DIGA_Procedure_Activity|1.1.0 | https://fhir.kbv.de/StructureDefinition/KBV_PR_MIO_DIGA_Questionnaire|1.1.0 | https://fhir.kbv.de/StructureDefinition/KBV_PR_MIO_DIGA_QuestionnaireResponse|1.1.0 | KBV_PR_MIO_DIGA_RelatedPerson)
system1..
version1..
code1..
display1..
userSelected..0
text..0
role..0
referenceS1..
type..0
identifier..0
display..0
onBehalfOf..0
signature..0

Composition

Profile on Simplifier

versionId1..
lastUpdated1..
source..0
profile1..1
security..0
tag..0
implicitRules..0
language..0
statusFixed Value
contained..0
referenceS1..
type..0
identifier..0
display..0
occurred[x]..0
recordedS
policy..0
location..0
reason..0
activity..0
system1..
version1..
code1..
display1..
userSelected..0
text..0
role..0
referenceS1..
type..0
identifier..0
display..0
onBehalfOf..0
roleS
whatSReference(https://fhir.kbv.de/StructureDefinition/KBV_PR_MIO_DIGA_AllergyIntolerance|1.1.0 | https://fhir.kbv.de/StructureDefinition/KBV_PR_MIO_DIGA_Appointment|1.1.0 | https://fhir.kbv.de/StructureDefinition/KBV_PR_MIO_DIGA_CarePlan|1.1.0 | https://fhir.kbv.de/StructureDefinition/KBV_PR_MIO_DIGA_Condition_Problem|1.1.0 | KBV_PR_MIO_DIGA_DeviceDefinition_DIGA | https://fhir.kbv.de/StructureDefinition/KBV_PR_MIO_DIGA_DeviceDefinition|1.1.0 | KBV_PR_MIO_DIGA_Device_DIGA | https://fhir.kbv.de/StructureDefinition/KBV_PR_MIO_DIGA_Device|1.1.0 | https://fhir.kbv.de/StructureDefinition/KBV_PR_MIO_DIGA_DocumentReference|1.1.0 | https://fhir.kbv.de/StructureDefinition/KBV_PR_MIO_DIGA_Encounter|1.1.0 | https://fhir.kbv.de/StructureDefinition/KBV_PR_MIO_DIGA_Goal|1.1.0 | https://fhir.kbv.de/StructureDefinition/KBV_PR_MIO_DIGA_MedicationAdministration_Medication_Intake|1.1.0 | https://fhir.kbv.de/StructureDefinition/KBV_PR_MIO_DIGA_Medication|1.1.0 | https://fhir.kbv.de/StructureDefinition/KBV_PR_MIO_DIGA_MedicationStatement_Medication_Information|1.1.0 | KBV_PR_MIO_DIGA_Observation_Assessment_Scale | https://fhir.kbv.de/StructureDefinition/KBV_PR_MIO_DIGA_Observation_Assessment_Score|1.1.0 | KBV_PR_MIO_DIGA_Observation_Blood_Pressure | KBV_PR_MIO_DIGA_Observation_Body_Height | KBV_PR_MIO_DIGA_Observation_Body_Temperature | KBV_PR_MIO_DIGA_Observation_Body_Weight | KBV_PR_MIO_DIGA_Observation_Diary_Entry | https://fhir.kbv.de/StructureDefinition/KBV_PR_MIO_DIGA_Observation_Environmental_Factor|1.1.0 | https://fhir.kbv.de/StructureDefinition/KBV_PR_MIO_DIGA_Observation_Functional_Assessment|1.1.0 | KBV_PR_MIO_DIGA_Observation_Glucose_Concentration | KBV_PR_MIO_DIGA_Observation_Head_Circumference | KBV_PR_MIO_DIGA_Observation_Heart_Rate | https://fhir.kbv.de/StructureDefinition/KBV_PR_MIO_DIGA_Observation_Life_Style_Factor|1.1.0 | KBV_PR_MIO_DIGA_Observation_Nutrition_Intake_Food_Composition_Types | KBV_PR_MIO_DIGA_Observation_Nutrition_Intake | KBV_PR_MIO_DIGA_Observation_Peripheral_Oxygen_Saturation | KBV_PR_MIO_DIGA_Observation_Respiratory_Rate | KBV_PR_MIO_DIGA_Observation_Free | KBV_PR_MIO_DIGA_Organization_Manufacturer | KBV_PR_MIO_DIGA_Organization | KBV_PR_MIO_DIGA_Patient | KBV_PR_MIO_DIGA_PractitionerRole | KBV_PR_MIO_DIGA_Practitioner | https://fhir.kbv.de/StructureDefinition/KBV_PR_MIO_DIGA_Procedure_Activity|1.1.0 | https://fhir.kbv.de/StructureDefinition/KBV_PR_MIO_DIGA_Questionnaire|1.1.0 | https://fhir.kbv.de/StructureDefinition/KBV_PR_MIO_DIGA_QuestionnaireResponse|1.1.0 | KBV_PR_MIO_DIGA_RelatedPerson)
system1..
version1..
code1..
display1..
userSelected..0
text..0
role..0
referenceS1..
type..0
identifier..0
display..0
onBehalfOf..0
signature..0

Bundle

Profile on Simplifier

versionIdΣ1..1id
lastUpdatedΣ1..1instant
sourceΣ0..0uri