MII PR MTB Molekularer Biomarker - MII IG Kerndatensatz-Modul Molekulares Tumorboard v2026.0.0

Unique id for inter-element referencing

0..*

Additional content defined by implementations
Slice: Unordered, Open by value:url

versionId

0..1

Version specific identifier

lastUpdated

0..1

When the resource version last changed

source

0..1

canonical(StructureDefinition)

Identifies where the resource comes from

profile

SΣ

0..*

Profiles this resource claims to conform to

security

0..*

Security Labels applied to this resource
Binding: All Security Labels (extensible): Security Labels from the Healthcare Privacy and Security Classification System.

tag

0..*

Tags applied to this resource
Binding: CommonTags (example): Codes that represent various types of tags, commonly workflow-related; e.g. "Needs review by Dr. Jones".

implicitRules

?!Σ

0..1

A set of rules under which this content was created

language

0..1

Language of the resource content
Binding: CommonLanguages (preferred): A human language.

Additional Bindings

Purpose

AllLanguages

Max Binding

0..1

Narrative

Text summary of the resource, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements

contained

0..*

Resource

Contained, inline Resources

0..*

Additional content defined by implementations
Slice: Unordered, Open by value:url

0..*

Extensions that cannot be ignored
Slice: Unordered, Open by value:url

identifier

0..*

Identifier

Business Identifier for observation

basedOn

ΣC

0..*

Fulfills plan, proposal or order
Constraints: ref-1

partOf

ΣC

0..*

Part of referenced event
Constraints: ref-1

status

?!Σ

1..1

registered | preliminary | final | amended +
Binding: ObservationStatus (required): Codes providing the status of an observation.

Slices for category

2..*

Kategorie
Slice: Unordered, Open by value:coding
Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories.

category:labCategory

1..1

Classification of type of observation
Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories.

0..1

Unique id for inter-element referencing

0..*

Additional content defined by implementations
Slice: Unordered, Open by value:url

1..1

Code defined by a terminology system

Required Pattern: At least the following

0..1

Unique id for inter-element referencing

0..*

Additional content defined by implementations

1..1

Identity of the terminology system
Fixed Value: http://terminology.hl7.org/CodeSystem/observation-category

0..1

Version of the system - if relevant

1..1

Symbol in syntax defined by the system
Fixed Value: laboratory

0..1

Representation defined by the system

0..1

If this coding was chosen directly by the user

0..1

Plain text representation of the concept

category:mbCategory

1..1

Classification of type of observation
Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories.

0..1

Unique id for inter-element referencing

0..*

Additional content defined by implementations
Slice: Unordered, Open by value:url

1..1

Code defined by a terminology system

Required Pattern: At least the following

0..1

Unique id for inter-element referencing

0..*

Additional content defined by implementations

1..1

Identity of the terminology system
Fixed Value: http://hl7.org/fhir/uv/genomics-reporting/CodeSystem/tbd-codes-cs

0..1

Version of the system - if relevant

1..1

Symbol in syntax defined by the system
Fixed Value: biomarker-category

0..1

Representation defined by the system

0..1

If this coding was chosen directly by the user

0..1

Plain text representation of the concept

category:geCategory

0..1

Classification of type of observation
Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories.

0..1

Unique id for inter-element referencing

0..*

Additional content defined by implementations
Slice: Unordered, Open by value:url

1..1

Code defined by a terminology system

Required Pattern: At least the following

0..1

Unique id for inter-element referencing

0..*

Additional content defined by implementations

1..1

Identity of the terminology system
Fixed Value: http://terminology.hl7.org/CodeSystem/v2-0074

0..1

Version of the system - if relevant

1..1

Symbol in syntax defined by the system
Fixed Value: GE

0..1

Representation defined by the system

0..1

If this coding was chosen directly by the user

0..1

Plain text representation of the concept

SΣ

1..1

Reference(MII PR Onkologie Diagnose Primärtumor | MII PR MTB Diagnose Primärtumor)

Code
Binding: MII VS Molekulare Biomarker (extensible)

subject

SΣC

0..1

Reference(Patient | Group)

Patient
Constraints: ref-1

focus

SΣC

0..*

What the observation is about, when it is not about the subject of record
Constraints: ref-1

encounter

SΣC

0..1

Reference(Encounter)

Kontakt
Constraints: ref-1

effective[x]

SΣ

0..1

Zeitpunkt der Beobachtung

effectiveDateTime

effectivePeriod

effectiveTiming

effectiveInstant

issued

SΣ

0..1

Freigabedatum

performer

ΣC

0..*

Who is responsible for the observation
Constraints: ref-1

ΣC

0..1

Actual result

valueQuantity

valueCodeableConcept

valueString

valueBoolean

valueInteger

valueRange

valueRatio

valueSampledData

valueTime

valueDateTime

valuePeriod

0..1

Why the result is missing
Binding: DataAbsentReason (extensible): Codes specifying why the result (Observation.value[x]) is missing.

0..*

High, low, normal, etc.
Binding: ObservationInterpretationCodes (extensible): Codes identifying interpretations of observations.

note

0..*

Annotation

Comments about the observation

bodySite

0..1

Observed body part
Binding: SNOMEDCTBodyStructures (example): Codes describing anatomical locations. May include laterality.

method

0..1

How it was done
Binding: ObservationMethods (example): Methods for simple observations.

specimen

0..1

Reference(Specimen)

Specimen used for this observation
Constraints: ref-1

device

0..1

Reference(Device | DeviceMetric)

(Measurement) Device
Constraints: ref-1

0..*

Provides guide for interpretation
Constraints: obs-3

0..1

Unique id for inter-element referencing

0..*

Additional content defined by implementations
Slice: Unordered, Open by value:url

?!Σ

0..*

Extensions that cannot be ignored even if unrecognized

low

0..1

Low Range, if relevant
Constraints: qty-3, sqty-1

high

0..1

High Range, if relevant
Constraints: qty-3, sqty-1

type

0..1

Reference range qualifier
Binding: ObservationReferenceRangeMeaningCodes (preferred): Code for the meaning of a reference range.

appliesTo

0..*

Reference range population
Binding: ObservationReferenceRangeAppliesToCodes (example): Codes identifying the population the reference range applies to.

age

0..1

Range

Applicable age range, if relevant
Constraints: rng-2

0..1

Reference(MII PR MolGen Variante)

Text based reference range in an observation

hasMember

ΣC

0..*

Reference(Observation | QuestionnaireResponse | MolecularSequence)

Related resource that belongs to the Observation group
Constraints: ref-1

Slices for derivedFrom

SΣC

0..*

Abgeleitet von
Slice: Unordered, Open by profile:resolve()
Constraints: ref-1

derivedFrom:variant

ΣC

0..*

Variant the biomarker is derived from
Constraints: ref-1

derivedFrom:genotype

ΣC

0..*

Reference(Genotype)

Genotype the biomarker is derived from
Constraints: ref-1

derivedFrom:haplotype

ΣC

0..*

Reference(Haplotype)

Haplotype the biomarker is derived from
Constraints: ref-1

Slices for component

SΣ

0..*

Komponenten
Slice: Unordered, Open by value:code

component:All Slices

Content/Rules for all slices

0..1

Unique id for inter-element referencing

0..*

Additional content defined by implementations
Slice: Unordered, Open by value:url

?!Σ

0..*

Extensions that cannot be ignored even if unrecognized

1..1

Type of component observation (code / type)
Binding: LOINCCodes (example): Codes identifying names of simple observations.

0..1

Actual component result

valueQuantity

valueCodeableConcept

valueString

valueBoolean

valueInteger

valueRange

valueRatio

valueSampledData

valueTime

valueDateTime

valuePeriod

0..1

Why the component result is missing
Binding: DataAbsentReason (extensible): Codes specifying why the result (Observation.value[x]) is missing.

0..*

High, low, normal, etc.
Binding: ObservationInterpretationCodes (extensible): Codes identifying interpretations of observations.

0..*

Provides guide for interpretation of component result

component:gene-studied

SΣ

0..*

Untersuchtes Gen

0..1

Unique id for inter-element referencing

0..*

Additional content defined by implementations
Slice: Unordered, Open by value:url

?!Σ

0..*

Extensions that cannot be ignored even if unrecognized

1..1

48018-6
Binding: LOINCCodes (example): Codes identifying names of simple observations.
Required Pattern: At least the following

0..1

Unique id for inter-element referencing

0..*

Additional content defined by implementations

1..*

Code defined by a terminology system
Fixed Value: (Complex)

0..1

Unique id for inter-element referencing

0..*

Additional content defined by implementations

1..1

Identity of the terminology system
Fixed Value: http://loinc.org

0..1

Version of the system - if relevant

1..1

Symbol in syntax defined by the system
Fixed Value: 48018-6

0..1

Representation defined by the system

0..1

If this coding was chosen directly by the user

0..1

Plain text representation of the concept

1..1

The HGNC gene symbol is to be used as display text and the HGNC gene ID used as the code. If no HGNC code issued for this gene yet, NCBI gene IDs SHALL be used.
Binding: HUGO Gene Nomenclature Committee Gene Names (HGNC) (extensible)

dataAbsentReason

0..1

Why the component result is missing
Binding: DataAbsentReason (extensible): Codes specifying why the result (Observation.value[x]) is missing.

0..*

High, low, normal, etc.
Binding: ObservationInterpretationCodes (extensible): Codes identifying interpretations of observations.

0..*

component:biomarker-category

Provides guide for interpretation of component result

SΣ

0..*

Biomarker-Kategorie

0..1

Unique id for inter-element referencing

0..*

Additional content defined by implementations
Slice: Unordered, Open by value:url

?!Σ

0..*

Extensions that cannot be ignored even if unrecognized

1..1

Type of component observation (code / type)
Binding: LOINCCodes (example): Codes identifying names of simple observations.
Required Pattern: At least the following

0..1

Unique id for inter-element referencing

0..*

Additional content defined by implementations

1..*

Code defined by a terminology system
Fixed Value: (Complex)

0..1

Unique id for inter-element referencing

0..*

Additional content defined by implementations

1..1

Identity of the terminology system
Fixed Value: http://hl7.org/fhir/uv/genomics-reporting/CodeSystem/tbd-codes-cs

0..1

Version of the system - if relevant

1..1

Symbol in syntax defined by the system
Fixed Value: biomarker-category

0..1

Representation defined by the system

0..1

If this coding was chosen directly by the user

0..1

Plain text representation of the concept

1..1

cell receptor | antigen | protein | immune stain
Binding: Molecular Biomarker Categories (example)

dataAbsentReason

0..1

Why the component result is missing
Binding: DataAbsentReason (extensible): Codes specifying why the result (Observation.value[x]) is missing.

0..*

High, low, normal, etc.
Binding: ObservationInterpretationCodes (extensible): Codes identifying interpretations of observations.

0..*

Documentation for this format

Provides guide for interpretation of component result

Terminology Bindings

Path	Status	Usage	ValueSet	Version	Source
Observation.meta.security	Base	extensible	SecurityLabels	📍4.0.1	FHIR Std.
Observation.meta.tag	Base	example	Common Tags	📍4.0.1	FHIR Std.
Observation.language	Base	preferred	Common Languages	📦4.0.1	FHIR Std.
Observation.status	Base	required	ObservationStatus	📍4.0.1	FHIR Std.
Observation.category	Base	preferred	Observation Category Codes	📦4.0.1	FHIR Std.
Observation.category:labCategory	Base	preferred	Observation Category Codes	📦4.0.1	FHIR Std.
Observation.category:mbCategory	Base	preferred	Observation Category Codes	📦4.0.1	FHIR Std.
Observation.category:geCategory	Base	preferred	Observation Category Codes	📦4.0.1	FHIR Std.
Observation.code	Base	extensible	MII VS Molekulare Biomarker	📦2026.0.0	This IG
Observation.dataAbsentReason	Base	extensible	DataAbsentReason	📦4.0.1	FHIR Std.
Observation.interpretation	Base	extensible	Observation Interpretation Codes	📦4.0.1	FHIR Std.
Observation.bodySite	Base	example	SNOMED CT Body Structures	📦4.0.1	FHIR Std.
Observation.method	Base	example	Observation Methods	📦4.0.1	FHIR Std.
Observation.referenceRange.type	Base	preferred	Observation Reference Range Meaning Codes	📦4.0.1	FHIR Std.
Observation.referenceRange.appliesTo	Base	example	Observation Reference Range Applies To Codes	📦4.0.1	FHIR Std.
Observation.component.code	Base	example	LOINC Codes	📦4.0.1	FHIR Std.
Observation.component.dataAbsentReason	Base	extensible	DataAbsentReason	📦4.0.1	FHIR Std.
Observation.component.interpretation	Base	extensible	Observation Interpretation Codes	📦4.0.1	FHIR Std.
Observation.component:gene-studied.code	Base	example	LOINC Codes	📦4.0.1	FHIR Std.
Observation.component:gene-studied.value[x]	Base	extensible	HUGO Gene Nomenclature Committee Gene Names (HGNC)	📦3.0.0	Genomics Reporting Implementation Guide v3.0
Observation.component:gene-studied.dataAbsentReason	Base	extensible	DataAbsentReason	📦4.0.1	FHIR Std.
Observation.component:gene-studied.interpretation	Base	extensible	Observation Interpretation Codes	📦4.0.1	FHIR Std.
Observation.component:biomarker-category.code	Base	example	LOINC Codes	📦4.0.1	FHIR Std.
Observation.component:biomarker-category.value[x]	Base	example	Molecular Biomarker Categories	📦3.0.0	Genomics Reporting Implementation Guide v3.0
Observation.component:biomarker-category.dataAbsentReason	Base	extensible	DataAbsentReason	📦4.0.1	FHIR Std.
Observation.component:biomarker-category.interpretation	Base	extensible	Observation Interpretation Codes	📦4.0.1	FHIR Std.

Constraints

Id	Grade	Path(s)	Description	Expression
dom-2	error	Observation	If the resource is contained in another resource, it SHALL NOT contain nested Resources	`contained.contained.empty()`
dom-3	error	Observation	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-4	error	Observation	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-5	error	Observation	If a resource is contained in another resource, it SHALL NOT have a security label	`contained.meta.security.empty()`
dom-6	best practice	Observation	A resource should have narrative for robust management	text.`div`.exists()
ele-1	error	ALL elements	All FHIR elements must have a @value or children	`hasValue() or (children().count() > id.count())`
ext-1	error	ALL extensions	Must have either extensions or value[x], not both	`extension.exists() != value.exists()`
obs-3	error	Observation.referenceRange	Must have at least a low or a high or text	`low.exists() or high.exists() or text.exists()`
obs-6	error	Observation	dataAbsentReason SHALL only be present if Observation.value[x] is not present	`dataAbsentReason.empty() or value.empty()`
obs-7	error	Observation	If Observation.code is the same as an Observation.component.code then the value element associated with the code SHALL NOT be present	`value.empty() or component.code.where(coding.intersect(%resource.code.coding).exists()).empty()`
qty-3	error	Observation.referenceRange.low, Observation.referenceRange.high	If a code for the unit is present, the system SHALL also be present	`code.empty() or system.exists()`
ref-1	error	Observation.basedOn, Observation.partOf, Observation.subject, Observation.focus, Observation.encounter, Observation.performer, Observation.specimen, Observation.device, Observation.hasMember, Observation.derivedFrom, Observation.derivedFrom:variant, Observation.derivedFrom:genotype, Observation.derivedFrom:haplotype	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'))`
rng-2	error	Observation.referenceRange.age	If present, low SHALL have a lower value than high	`low.empty() or high.empty() or (low <= high)`
sqty-1	error	Observation.referenceRange.low, Observation.referenceRange.high	The comparator is not used on a SimpleQuantity	`comparator.empty()`

This structure is derived from MII_PR_MolGen_MolekularerBiomarker

Summary

Must-Support: 3 elements

Structures

This structure refers to these other structures:

Key Elements View

Name	Flags	Card.	Type	Description & Constraints Filter: Bindings Constraints Obligations
Observation	C	0..*	MII_PR_MolGen_MolekularerBiomarker	Measurements and simple assertions Constraints: obs-7, obs-6
meta	SΣ	0..1	Meta	Metadata about the resource
profile	SΣ	0..*	canonical(StructureDefinition)	Profiles this resource claims to conform to
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created
modifierExtension	?!	0..*	Extension	Extensions that cannot be ignored Slice: Unordered, Open by value:url
status	?!Σ	1..1	code	registered \| preliminary \| final \| amended + Binding: ObservationStatus (required): Codes providing the status of an observation.
Slices for category	S	2..*	CodeableConcept	Kategorie Slice: Unordered, Open by value:coding Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories.
category:labCategory		1..1	CodeableConcept	Classification of type of observation Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories.
coding	Σ	1..1	Coding	Code defined by a terminology system Required Pattern: At least the following
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
system		1..1	uri	Identity of the terminology system Fixed Value: http://terminology.hl7.org/CodeSystem/observation-category
version		0..1	string	Version of the system - if relevant
code		1..1	code	Symbol in syntax defined by the system Fixed Value: laboratory
display		0..1	string	Representation defined by the system
userSelected		0..1	boolean	If this coding was chosen directly by the user
category:mbCategory		1..1	CodeableConcept	Classification of type of observation Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories.
coding	Σ	1..1	Coding	Code defined by a terminology system Required Pattern: At least the following
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/uv/genomics-reporting/CodeSystem/tbd-codes-cs
version		0..1	string	Version of the system - if relevant
code		1..1	code	Symbol in syntax defined by the system Fixed Value: biomarker-category
display		0..1	string	Representation defined by the system
userSelected		0..1	boolean	If this coding was chosen directly by the user
category:geCategory		0..1	CodeableConcept	Classification of type of observation Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories.
coding	Σ	1..1	Coding	Code defined by a terminology system Required Pattern: At least the following
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
system		1..1	uri	Identity of the terminology system Fixed Value: http://terminology.hl7.org/CodeSystem/v2-0074
version		0..1	string	Version of the system - if relevant
code		1..1	code	Symbol in syntax defined by the system Fixed Value: GE
display		0..1	string	Representation defined by the system
userSelected		0..1	boolean	If this coding was chosen directly by the user
code	SΣ	1..1	CodeableConcept	Code Binding: MII VS Molekulare Biomarker (extensible)
subject	SΣC	0..1	Reference(Patient \| Group)	Patient Constraints: ref-1
focus	SΣC	0..*	Reference(MII PR Onkologie Diagnose Primärtumor \| MII PR MTB Diagnose Primärtumor)	What the observation is about, when it is not about the subject of record Constraints: ref-1
encounter	SΣC	0..1	Reference(Encounter)	Kontakt Constraints: ref-1
effective[x]	SΣ	0..1		Zeitpunkt der Beobachtung
effectiveDateTime			dateTime
effectivePeriod			Period
effectiveTiming			Timing
effectiveInstant			instant
issued	SΣ	0..1	instant	Freigabedatum
value[x]	ΣC	0..1		Actual result
valueQuantity			Quantity
valueCodeableConcept			CodeableConcept
valueString			string
valueBoolean			boolean
valueInteger			integer
valueRange			Range
valueRatio			Ratio
valueSampledData			SampledData
valueTime			time
valueDateTime			dateTime
valuePeriod			Period
dataAbsentReason	C	0..1	CodeableConcept	Why the result is missing Binding: DataAbsentReason (extensible): Codes specifying why the result (Observation.value[x]) is missing.
Slices for derivedFrom	SΣC	0..*	Reference(DocumentReference \| ImagingStudy \| Media \| QuestionnaireResponse \| Observation \| MolecularSequence)	Abgeleitet von Slice: Unordered, Open by profile:resolve() Constraints: ref-1
derivedFrom:variant	ΣC	0..*	Reference(MII PR MolGen Variante)	Variant the biomarker is derived from Constraints: ref-1
derivedFrom:genotype	ΣC	0..*	Reference(Genotype)	Genotype the biomarker is derived from Constraints: ref-1
derivedFrom:haplotype	ΣC	0..*	Reference(Haplotype)	Haplotype the biomarker is derived from Constraints: ref-1
Slices for component	SΣ	0..*	BackboneElement	Komponenten Slice: Unordered, Open by value:code
component:All Slices				Content/Rules for all slices
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
code	Σ	1..1	CodeableConcept	Type of component observation (code / type) Binding: LOINCCodes (example): Codes identifying names of simple observations.
dataAbsentReason	C	0..1	CodeableConcept	Why the component result is missing Binding: DataAbsentReason (extensible): Codes specifying why the result (Observation.value[x]) is missing.
component:gene-studied	SΣ	0..*	BackboneElement	Untersuchtes Gen
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
code	Σ	1..1	CodeableConcept	48018-6 Binding: LOINCCodes (example): Codes identifying names of simple observations. Required Pattern: At least the following
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (Complex)
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
system		1..1	uri	Identity of the terminology system Fixed Value: http://loinc.org
version		0..1	string	Version of the system - if relevant
code		1..1	code	Symbol in syntax defined by the system Fixed Value: 48018-6
display		0..1	string	Representation defined by the system
userSelected		0..1	boolean	If this coding was chosen directly by the user
text		0..1	string	Plain text representation of the concept
value[x]	Σ	1..1	CodeableConcept	The HGNC gene symbol is to be used as display text and the HGNC gene ID used as the code. If no HGNC code issued for this gene yet, NCBI gene IDs SHALL be used. Binding: HUGO Gene Nomenclature Committee Gene Names (HGNC) (extensible)
dataAbsentReason	C	0..1	CodeableConcept	Why the component result is missing Binding: DataAbsentReason (extensible): Codes specifying why the result (Observation.value[x]) is missing.
component:biomarker-category	SΣ	0..*	BackboneElement	Biomarker-Kategorie
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
code	Σ	1..1	CodeableConcept	Type of component observation (code / type) Binding: LOINCCodes (example): Codes identifying names of simple observations. Required Pattern: At least the following
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (Complex)
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/uv/genomics-reporting/CodeSystem/tbd-codes-cs
version		0..1	string	Version of the system - if relevant
code		1..1	code	Symbol in syntax defined by the system Fixed Value: biomarker-category
display		0..1	string	Representation defined by the system
userSelected		0..1	boolean	If this coding was chosen directly by the user
text		0..1	string	Plain text representation of the concept
value[x]	Σ	1..1	CodeableConcept	cell receptor \| antigen \| protein \| immune stain Binding: Molecular Biomarker Categories (example)
dataAbsentReason	C	0..1	CodeableConcept	Why the component result is missing Binding: DataAbsentReason (extensible): Codes specifying why the result (Observation.value[x]) is missing.
Documentation for this format

Terminology Bindings

Path	Status	Usage	ValueSet	Version	Source
Observation.status	Base	required	ObservationStatus	📍4.0.1	FHIR Std.
Observation.category	Base	preferred	Observation Category Codes	📦4.0.1	FHIR Std.
Observation.category:labCategory	Base	preferred	Observation Category Codes	📦4.0.1	FHIR Std.
Observation.category:mbCategory	Base	preferred	Observation Category Codes	📦4.0.1	FHIR Std.
Observation.category:geCategory	Base	preferred	Observation Category Codes	📦4.0.1	FHIR Std.
Observation.code	Base	extensible	MII VS Molekulare Biomarker	📦2026.0.0	This IG
Observation.dataAbsentReason	Base	extensible	DataAbsentReason	📦4.0.1	FHIR Std.
Observation.component.code	Base	example	LOINC Codes	📦4.0.1	FHIR Std.
Observation.component.dataAbsentReason	Base	extensible	DataAbsentReason	📦4.0.1	FHIR Std.
Observation.component:gene-studied.code	Base	example	LOINC Codes	📦4.0.1	FHIR Std.
Observation.component:gene-studied.value[x]	Base	extensible	HUGO Gene Nomenclature Committee Gene Names (HGNC)	📦3.0.0	Genomics Reporting Implementation Guide v3.0
Observation.component:gene-studied.dataAbsentReason	Base	extensible	DataAbsentReason	📦4.0.1	FHIR Std.
Observation.component:biomarker-category.code	Base	example	LOINC Codes	📦4.0.1	FHIR Std.
Observation.component:biomarker-category.value[x]	Base	example	Molecular Biomarker Categories	📦3.0.0	Genomics Reporting Implementation Guide v3.0
Observation.component:biomarker-category.dataAbsentReason	Base	extensible	DataAbsentReason	📦4.0.1	FHIR Std.

Constraints

Id	Grade	Path(s)	Description	Expression
dom-2	error	Observation	If the resource is contained in another resource, it SHALL NOT contain nested Resources	`contained.contained.empty()`
dom-3	error	Observation	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-4	error	Observation	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-5	error	Observation	If a resource is contained in another resource, it SHALL NOT have a security label	`contained.meta.security.empty()`
dom-6	best practice	Observation	A resource should have narrative for robust management	text.`div`.exists()
ele-1	error	ALL elements	All FHIR elements must have a @value or children	`hasValue() or (children().count() > id.count())`
ext-1	error	ALL extensions	Must have either extensions or value[x], not both	`extension.exists() != value.exists()`
obs-6	error	Observation	dataAbsentReason SHALL only be present if Observation.value[x] is not present	`dataAbsentReason.empty() or value.empty()`
obs-7	error	Observation	If Observation.code is the same as an Observation.component.code then the value element associated with the code SHALL NOT be present	`value.empty() or component.code.where(coding.intersect(%resource.code.coding).exists()).empty()`
ref-1	error	Observation.subject, Observation.focus, Observation.encounter, Observation.derivedFrom, Observation.derivedFrom:variant, Observation.derivedFrom:genotype, Observation.derivedFrom:haplotype	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'))`

Differential View

This structure is derived from MII_PR_MolGen_MolekularerBiomarker

Name	Flags	Card.	Type	Description & Constraints Filter: Bindings Constraints Obligations
Observation		0..*	MII_PR_MolGen_MolekularerBiomarker	Measurements and simple assertions
meta	S	0..1	Meta	Metadata about the resource
profile	S	0..*	canonical(StructureDefinition)	Profiles this resource claims to conform to
code		1..1	CodeableConcept	Code Binding: MII VS Molekulare Biomarker (extensible)
focus	S	0..*	Reference(MII PR Onkologie Diagnose Primärtumor \| MII PR MTB Diagnose Primärtumor)	What the observation is about, when it is not about the subject of record
Documentation for this format

Terminology Bindings (Differential)

Path	Status	Usage	ValueSet	Version	Source
Observation.code	Base	extensible	MII VS Molekulare Biomarker	📦2026.0.0	This IG

Snapshot View

Description & Constraints Filter: Filters

Observation

0..*

MII_PR_MolGen_MolekularerBiomarker

Measurements and simple assertions
Constraints: obs-7, obs-6

0..1

Logical id of this artifact

Meta

Metadata about the resource

0..1

Unique id for inter-element referencing

0..*

Additional content defined by implementations
Slice: Unordered, Open by value:url

versionId

0..1

Version specific identifier

lastUpdated

0..1

When the resource version last changed

source

0..1

canonical(StructureDefinition)

Identifies where the resource comes from

profile

SΣ

0..*

Profiles this resource claims to conform to

security

0..*

Security Labels applied to this resource
Binding: All Security Labels (extensible): Security Labels from the Healthcare Privacy and Security Classification System.

tag

0..*

Tags applied to this resource
Binding: CommonTags (example): Codes that represent various types of tags, commonly workflow-related; e.g. "Needs review by Dr. Jones".

implicitRules

?!Σ

0..1

A set of rules under which this content was created

language

0..1

Language of the resource content
Binding: CommonLanguages (preferred): A human language.

Additional Bindings

Purpose

AllLanguages

Max Binding

0..1

Narrative

Text summary of the resource, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements

contained

0..*

Resource

Contained, inline Resources

0..*

Additional content defined by implementations
Slice: Unordered, Open by value:url

0..*

Extensions that cannot be ignored
Slice: Unordered, Open by value:url

identifier

0..*

Identifier

Business Identifier for observation

basedOn

ΣC

0..*

Fulfills plan, proposal or order
Constraints: ref-1

partOf

ΣC

0..*

Part of referenced event
Constraints: ref-1

status

?!Σ

1..1

registered | preliminary | final | amended +
Binding: ObservationStatus (required): Codes providing the status of an observation.

Slices for category

2..*

Kategorie
Slice: Unordered, Open by value:coding
Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories.

category:labCategory

1..1

Classification of type of observation
Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories.

0..1

Unique id for inter-element referencing

0..*

Additional content defined by implementations
Slice: Unordered, Open by value:url

1..1

Code defined by a terminology system

Required Pattern: At least the following

0..1

Unique id for inter-element referencing

0..*

Additional content defined by implementations

1..1

Identity of the terminology system
Fixed Value: http://terminology.hl7.org/CodeSystem/observation-category

0..1

Version of the system - if relevant

1..1

Symbol in syntax defined by the system
Fixed Value: laboratory

0..1

Representation defined by the system

0..1

If this coding was chosen directly by the user

0..1

Plain text representation of the concept

category:mbCategory

1..1

Classification of type of observation
Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories.

0..1

Unique id for inter-element referencing

0..*

Additional content defined by implementations
Slice: Unordered, Open by value:url

1..1

Code defined by a terminology system

Required Pattern: At least the following

0..1

Unique id for inter-element referencing

0..*

Additional content defined by implementations

1..1

Identity of the terminology system
Fixed Value: http://hl7.org/fhir/uv/genomics-reporting/CodeSystem/tbd-codes-cs

0..1

Version of the system - if relevant

1..1

Symbol in syntax defined by the system
Fixed Value: biomarker-category

0..1

Representation defined by the system

0..1

If this coding was chosen directly by the user

0..1

Plain text representation of the concept

category:geCategory

0..1

Classification of type of observation
Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories.

0..1

Unique id for inter-element referencing

0..*

Additional content defined by implementations
Slice: Unordered, Open by value:url

1..1

Code defined by a terminology system

Required Pattern: At least the following

0..1

Unique id for inter-element referencing

0..*

Additional content defined by implementations

1..1

Identity of the terminology system
Fixed Value: http://terminology.hl7.org/CodeSystem/v2-0074

0..1

Version of the system - if relevant

1..1

Symbol in syntax defined by the system
Fixed Value: GE

0..1

Representation defined by the system

0..1

If this coding was chosen directly by the user

0..1

Plain text representation of the concept

SΣ

1..1

Reference(MII PR Onkologie Diagnose Primärtumor | MII PR MTB Diagnose Primärtumor)

Code
Binding: MII VS Molekulare Biomarker (extensible)

subject

SΣC

0..1

Reference(Patient | Group)

Patient
Constraints: ref-1

focus

SΣC

0..*

What the observation is about, when it is not about the subject of record
Constraints: ref-1

encounter

SΣC

0..1

Reference(Encounter)

Kontakt
Constraints: ref-1

effective[x]

SΣ

0..1

Zeitpunkt der Beobachtung

effectiveDateTime

effectivePeriod

effectiveTiming

effectiveInstant

issued

SΣ

0..1

Freigabedatum

performer

ΣC

0..*

Who is responsible for the observation
Constraints: ref-1

ΣC

0..1

Actual result

valueQuantity

valueCodeableConcept

valueString

valueBoolean

valueInteger

valueRange

valueRatio

valueSampledData

valueTime

valueDateTime

valuePeriod

0..1

Why the result is missing
Binding: DataAbsentReason (extensible): Codes specifying why the result (Observation.value[x]) is missing.

0..*

High, low, normal, etc.
Binding: ObservationInterpretationCodes (extensible): Codes identifying interpretations of observations.

note

0..*

Annotation

Comments about the observation

bodySite

0..1

Observed body part
Binding: SNOMEDCTBodyStructures (example): Codes describing anatomical locations. May include laterality.

method

0..1

How it was done
Binding: ObservationMethods (example): Methods for simple observations.

specimen

0..1

Reference(Specimen)

Specimen used for this observation
Constraints: ref-1

device

0..1

Reference(Device | DeviceMetric)

(Measurement) Device
Constraints: ref-1

0..*

Provides guide for interpretation
Constraints: obs-3

0..1

Unique id for inter-element referencing

0..*

Additional content defined by implementations
Slice: Unordered, Open by value:url

?!Σ

0..*

Extensions that cannot be ignored even if unrecognized

low

0..1

Low Range, if relevant
Constraints: qty-3, sqty-1

high

0..1

High Range, if relevant
Constraints: qty-3, sqty-1

type

0..1

Reference range qualifier
Binding: ObservationReferenceRangeMeaningCodes (preferred): Code for the meaning of a reference range.

appliesTo

0..*

Reference range population
Binding: ObservationReferenceRangeAppliesToCodes (example): Codes identifying the population the reference range applies to.

age

0..1

Range

Applicable age range, if relevant
Constraints: rng-2

0..1

Reference(MII PR MolGen Variante)

Text based reference range in an observation

hasMember

ΣC

0..*

Reference(Observation | QuestionnaireResponse | MolecularSequence)

Related resource that belongs to the Observation group
Constraints: ref-1

Slices for derivedFrom

SΣC

0..*

Abgeleitet von
Slice: Unordered, Open by profile:resolve()
Constraints: ref-1

derivedFrom:variant

ΣC

0..*

Variant the biomarker is derived from
Constraints: ref-1

derivedFrom:genotype

ΣC

0..*

Reference(Genotype)

Genotype the biomarker is derived from
Constraints: ref-1

derivedFrom:haplotype

ΣC

0..*

Reference(Haplotype)

Haplotype the biomarker is derived from
Constraints: ref-1

Slices for component

SΣ

0..*

Komponenten
Slice: Unordered, Open by value:code

component:All Slices

Content/Rules for all slices

0..1

Unique id for inter-element referencing

0..*

Additional content defined by implementations
Slice: Unordered, Open by value:url

?!Σ

0..*

Extensions that cannot be ignored even if unrecognized

1..1

Type of component observation (code / type)
Binding: LOINCCodes (example): Codes identifying names of simple observations.

0..1

Actual component result

valueQuantity

valueCodeableConcept

valueString

valueBoolean

valueInteger

valueRange

valueRatio

valueSampledData

valueTime

valueDateTime

valuePeriod

0..1

Why the component result is missing
Binding: DataAbsentReason (extensible): Codes specifying why the result (Observation.value[x]) is missing.

0..*

High, low, normal, etc.
Binding: ObservationInterpretationCodes (extensible): Codes identifying interpretations of observations.

0..*

Provides guide for interpretation of component result

component:gene-studied

SΣ

0..*

Untersuchtes Gen

0..1

Unique id for inter-element referencing

0..*

Additional content defined by implementations
Slice: Unordered, Open by value:url

?!Σ

0..*

Extensions that cannot be ignored even if unrecognized

1..1

48018-6
Binding: LOINCCodes (example): Codes identifying names of simple observations.
Required Pattern: At least the following

0..1

Unique id for inter-element referencing

0..*

Additional content defined by implementations

1..*

Code defined by a terminology system
Fixed Value: (Complex)

0..1

Unique id for inter-element referencing

0..*

Additional content defined by implementations

1..1

Identity of the terminology system
Fixed Value: http://loinc.org

0..1

Version of the system - if relevant

1..1

Symbol in syntax defined by the system
Fixed Value: 48018-6

0..1

Representation defined by the system

0..1

If this coding was chosen directly by the user

0..1

Plain text representation of the concept

1..1

0..1

Why the component result is missing
Binding: DataAbsentReason (extensible): Codes specifying why the result (Observation.value[x]) is missing.

0..*

High, low, normal, etc.
Binding: ObservationInterpretationCodes (extensible): Codes identifying interpretations of observations.

0..*

component:biomarker-category

Provides guide for interpretation of component result

SΣ

0..*

Biomarker-Kategorie

0..1

Unique id for inter-element referencing

0..*

Additional content defined by implementations
Slice: Unordered, Open by value:url

?!Σ

0..*

Extensions that cannot be ignored even if unrecognized

1..1

Type of component observation (code / type)
Binding: LOINCCodes (example): Codes identifying names of simple observations.
Required Pattern: At least the following

0..1

Unique id for inter-element referencing

0..*

Additional content defined by implementations

1..*

Code defined by a terminology system
Fixed Value: (Complex)

0..1

Unique id for inter-element referencing

0..*

Additional content defined by implementations

1..1

Identity of the terminology system
Fixed Value: http://hl7.org/fhir/uv/genomics-reporting/CodeSystem/tbd-codes-cs

0..1

Version of the system - if relevant

1..1

Symbol in syntax defined by the system
Fixed Value: biomarker-category

0..1

Representation defined by the system

0..1

If this coding was chosen directly by the user

0..1

Plain text representation of the concept

1..1

cell receptor | antigen | protein | immune stain
Binding: Molecular Biomarker Categories (example)

dataAbsentReason

0..1

Why the component result is missing
Binding: DataAbsentReason (extensible): Codes specifying why the result (Observation.value[x]) is missing.

0..*

High, low, normal, etc.
Binding: ObservationInterpretationCodes (extensible): Codes identifying interpretations of observations.

0..*