FHIR Osiris Implementation Guide
1.1.0 - trial-implementation

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## Resource Profile: Validation

Official URL: https://ig-osiris.cancer.fr/ig/osiris/StructureDefinition/data-validation | Version: 1.1.0
Draft as of 2025-04-03 | Computable Name: DataValidation

Validation information about data from a Variant / Expression / Fusion / CopyNumber profile.

Usage:

- Examples for this Resource Profile: VerificationResult/fhir-osiris-example-validation-1

### Formal Views of Profile Content

Description of Profiles, Differentials, Snapshots and how the different presentations work.

- Key Elements Table
- Differential Table
- Snapshot Table
- Statistics/References
- All

Nom | Drapeaux | Card. | Type | Description et contraintes
--- | --- | --- | --- | ---
VerificationResult |  | 0..* | VerificationResult | Describes validation requirements, source(s), status and dates for one or more elements dom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources dom-3: 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 dom-4: If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated dom-5: If a resource is contained in another resource, it SHALL NOT have a security label dom-6: A resource should have narrative for robust management
implicitRules | ?!Σ | 0..1 | uri | A set of rules under which this content was created ele-1: All FHIR elements must have a @value or children
modifierExtension | ?! | 0..* | Extension | Extensions that cannot be ignored ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both
target | S Σ | 1..1 | Reference(Single Nucleotide Polymorphism | Gene Fusion | Gene Expression | Variant Copy Number) | A resource that was validated ele-1: All FHIR elements must have a @value or children
status | S Σ | 1..1 | code | Validation status of the detected alteration (attested | validated | in-process | req-revalid | val-fail | reval-fail) Binding: status (required): The validation status of the target. ele-1: All FHIR elements must have a @value or children
validationType | S Σ | 1..1 | CodeableConcept | Type of validation of the detected alteration (Experimental | By biologist | In silico) Binding: Osiris Validation Type (extensible) ele-1: All FHIR elements must have a @value or children
validationProcess | S Σ | 0..1 | CodeableConcept | Validation method Binding: validation-process (example): The primary process by which the target is validated. ele-1: All FHIR elements must have a @value or children
Documentation for this format

#### Terminology Bindings

Path | Conformité | ValueSet | URI
VerificationResult.status | required | status `http://hl7.org/fhir/ValueSet/verificationresult-status|4.0.1` from the FHIR Standard
VerificationResult.validationType | extensible | OsirisValidationType `https://ig-osiris.cancer.fr/ig/osiris/ValueSet/OsirisValidationType` from this IG
VerificationResult.validationProcess | example | validation-process `http://hl7.org/fhir/ValueSet/verificationresult-validation-process` from the FHIR Standard

This structure is derived from VerificationResult

Nom | Drapeaux | Card. | Type | Description et contraintes
--- | --- | --- | --- | ---
VerificationResult |  | 0..* | VerificationResult | Describes validation requirements, source(s), status and dates for one or more elements
target | S | 1..1 | Reference(Single Nucleotide Polymorphism | Gene Fusion | Gene Expression | Variant Copy Number) | A resource that was validated
status | S | 1..1 | code | Validation status of the detected alteration (attested | validated | in-process | req-revalid | val-fail | reval-fail)
validationType | S | 1..1 | CodeableConcept | Type of validation of the detected alteration (Experimental | By biologist | In silico) Binding: Osiris Validation Type (extensible)
validationProcess | S | 0..1 | CodeableConcept | Validation method
Documentation for this format

#### Terminology Bindings (Differential)

Path | Conformité | ValueSet | URI
VerificationResult.validationType | extensible | OsirisValidationType `https://ig-osiris.cancer.fr/ig/osiris/ValueSet/OsirisValidationType` from this IG

Nom | Drapeaux | Card. | Type | Description et contraintes
--- | --- | --- | --- | ---
VerificationResult |  | 0..* | VerificationResult | Describes validation requirements, source(s), status and dates for one or more elements
id | Σ | 0..1 | id | Logical id of this artifact
meta | Σ | 0..1 | Meta | Metadata about the resource
implicitRules | ?!Σ | 0..1 | uri | A set of rules under which this content was created
language |  | 0..1 | code | Language of the resource content Binding: CommonLanguages (preferred): A human language.
Bindings Additionnels | But
AllLanguages | Binding Max
text |  | 0..1 | Narrative | Text summary of the resource, for human interpretation
contained |  | 0..* | Resource | Contained, inline Resources
extension |  | 0..* | Extension | Additional content defined by implementations
modifierExtension | ?! | 0..* | Extension | Extensions that cannot be ignored
target | S Σ | 1..1 | Reference(Single Nucleotide Polymorphism | Gene Fusion | Gene Expression | Variant Copy Number) | A resource that was validated
targetLocation | Σ | 0..* | string | The fhirpath location(s) within the resource that was validated
need | Σ | 0..1 | CodeableConcept | none | initial | periodic Binding: need (preferred): The frequency with which the target must be validated.
status | S Σ | 1..1 | code | Validation status of the detected alteration (attested | validated | in-process | req-revalid | val-fail | reval-fail) Binding: status (required): The validation status of the target.
statusDate | Σ | 0..1 | dateTime | When the validation status was updated
validationType | S Σ | 1..1 | CodeableConcept | Type of validation of the detected alteration (Experimental | By biologist | In silico) Binding: Osiris Validation Type (extensible)
validationProcess | S Σ | 0..1 | CodeableConcept | Validation method Binding: validation-process (example): The primary process by which the target is validated.
frequency |  | 0..1 | Timing | Frequency of revalidation
lastPerformed |  | 0..1 | dateTime | The date/time validation was last completed (including failed validations)
nextScheduled |  | 0..1 | date | The date when target is next validated, if appropriate
failureAction | Σ | 0..1 | CodeableConcept | fatal | warn | rec-only | none Binding: failure-action (preferred): The result if validation fails.
primarySource |  | 0..* | BackboneElement | Information about the primary source(s) involved in validation
id |  | 0..1 | string | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
who |  | 0..1 | Reference(Organization | Practitioner | PractitionerRole) | Reference to the primary source
type | Σ | 0..* | CodeableConcept | Type of primary source (License Board; Primary Education; Continuing Education; Postal Service; Relationship owner; Registration Authority; legal source; issuing source; authoritative source) Binding: primary-source-type (example): Type of the validation primary source.
communicationMethod | Σ | 0..* | CodeableConcept | Method for exchanging information with the primary source Binding: verificationresult-communication-method (example): Method for communicating with the data source (manual; API; Push).
validationStatus |  | 0..1 | CodeableConcept | successful | failed | unknown Binding: validation-status (preferred): Status of the validation of the target against the primary source.
validationDate |  | 0..1 | dateTime | When the target was validated against the primary source
canPushUpdates | Σ | 0..1 | CodeableConcept | yes | no | undetermined Binding: can-push-updates (preferred): Ability of the primary source to push updates/alerts.
pushTypeAvailable |  | 0..* | CodeableConcept | specific | any | source Binding: push-type-available (preferred): Type of alerts/updates the primary source can send.
attestation |  | 0..1 | BackboneElement | Information about the entity attesting to information
id |  | 0..1 | string | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
who | Σ | 0..1 | Reference(Practitioner | PractitionerRole | Organization) | The individual or organization attesting to information
onBehalfOf | Σ | 0..1 | Reference(Organization | Practitioner | PractitionerRole) | When the who is asserting on behalf of another (organization or individual)
communicationMethod | Σ | 0..1 | CodeableConcept | The method by which attested information was submitted/retrieved Binding: verificationresult-communication-method (example): Method for communicating with the data source (manual; API; Push).
date | Σ | 0..1 | date | The date the information was attested to
sourceIdentityCertificate |  | 0..1 | string | A digital identity certificate associated with the attestation source
proxyIdentityCertificate |  | 0..1 | string | A digital identity certificate associated with the proxy entity submitting attested information on behalf of the attestation source
proxySignature |  | 0..1 | Signature | Proxy signature
sourceSignature |  | 0..1 | Signature | Attester signature
validator |  | 0..* | BackboneElement | Information about the entity validating information
id |  | 0..1 | string | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
organization |  | 1..1 | Reference(Organization) | Reference to the organization validating information
identityCertificate |  | 0..1 | string | A digital identity certificate associated with the validator
attestationSignature |  | 0..1 | Signature | Validator signature
Documentation for this format

#### Terminology Bindings

Path | Conformité | ValueSet | URI
VerificationResult.language | preferred | CommonLanguages `http://hl7.org/fhir/ValueSet/languages` from the FHIR Standard
Bindings Additionnels | But
AllLanguages | Binding Max
VerificationResult.need | preferred | need `http://hl7.org/fhir/ValueSet/verificationresult-need` from the FHIR Standard
VerificationResult.status | required | status `http://hl7.org/fhir/ValueSet/verificationresult-status|4.0.1` from the FHIR Standard
VerificationResult.validationType | extensible | OsirisValidationType `https://ig-osiris.cancer.fr/ig/osiris/ValueSet/OsirisValidationType` from this IG
VerificationResult.validationProcess | example | validation-process `http://hl7.org/fhir/ValueSet/verificationresult-validation-process` from the FHIR Standard
VerificationResult.failureAction | preferred | failure-action `http://hl7.org/fhir/ValueSet/verificationresult-failure-action` from the FHIR Standard
VerificationResult.primarySource.type | example | primary-source-type `http://hl7.org/fhir/ValueSet/verificationresult-primary-source-type` from the FHIR Standard
VerificationResult.primarySource.communicationMethod | example | verificationresult-communication-method `http://hl7.org/fhir/ValueSet/verificationresult-communication-method` from the FHIR Standard
VerificationResult.primarySource.validationStatus | preferred | validation-status `http://hl7.org/fhir/ValueSet/verificationresult-validation-status` from the FHIR Standard
VerificationResult.primarySource.canPushUpdates | preferred | can-push-updates `http://hl7.org/fhir/ValueSet/verificationresult-can-push-updates` from the FHIR Standard
VerificationResult.primarySource.pushTypeAvailable | preferred | push-type-available `http://hl7.org/fhir/ValueSet/verificationresult-push-type-available` from the FHIR Standard
VerificationResult.attestation.communicationMethod | example | verificationresult-communication-method `http://hl7.org/fhir/ValueSet/verificationresult-communication-method` from the FHIR Standard

This structure is derived from VerificationResult

Résumé

Mandatory: 2 elements
Must-Support: 4 elements

Structures

This structure refers to these other structures:

- Single Nucleotide Polymorphism (https://ig-osiris.cancer.fr/ig/osiris/StructureDefinition/snp)
- Gene Fusion (https://ig-osiris.cancer.fr/ig/osiris/StructureDefinition/fusion)
- Gene Expression (https://ig-osiris.cancer.fr/ig/osiris/StructureDefinition/expression)
- Variant Copy Number (https://ig-osiris.cancer.fr/ig/osiris/StructureDefinition/copy-number)

Key Elements View

Nom | Drapeaux | Card. | Type | Description et contraintes
--- | --- | --- | --- | ---
VerificationResult |  | 0..* | VerificationResult | Describes validation requirements, source(s), status and dates for one or more elements dom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources dom-3: 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 dom-4: If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated dom-5: If a resource is contained in another resource, it SHALL NOT have a security label dom-6: A resource should have narrative for robust management
implicitRules | ?!Σ | 0..1 | uri | A set of rules under which this content was created ele-1: All FHIR elements must have a @value or children
modifierExtension | ?! | 0..* | Extension | Extensions that cannot be ignored ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both
target | S Σ | 1..1 | Reference(Single Nucleotide Polymorphism | Gene Fusion | Gene Expression | Variant Copy Number) | A resource that was validated ele-1: All FHIR elements must have a @value or children
status | S Σ | 1..1 | code | Validation status of the detected alteration (attested | validated | in-process | req-revalid | val-fail | reval-fail) Binding: status (required): The validation status of the target. ele-1: All FHIR elements must have a @value or children
validationType | S Σ | 1..1 | CodeableConcept | Type of validation of the detected alteration (Experimental | By biologist | In silico) Binding: Osiris Validation Type (extensible) ele-1: All FHIR elements must have a @value or children
validationProcess | S Σ | 0..1 | CodeableConcept | Validation method Binding: validation-process (example): The primary process by which the target is validated. ele-1: All FHIR elements must have a @value or children
Documentation for this format

#### Terminology Bindings

Path | Conformité | ValueSet | URI
VerificationResult.status | required | status `http://hl7.org/fhir/ValueSet/verificationresult-status|4.0.1` from the FHIR Standard
VerificationResult.validationType | extensible | OsirisValidationType `https://ig-osiris.cancer.fr/ig/osiris/ValueSet/OsirisValidationType` from this IG
VerificationResult.validationProcess | example | validation-process `http://hl7.org/fhir/ValueSet/verificationresult-validation-process` from the FHIR Standard

Differential View

This structure is derived from VerificationResult

Nom | Drapeaux | Card. | Type | Description et contraintes
--- | --- | --- | --- | ---
VerificationResult |  | 0..* | VerificationResult | Describes validation requirements, source(s), status and dates for one or more elements
target | S | 1..1 | Reference(Single Nucleotide Polymorphism | Gene Fusion | Gene Expression | Variant Copy Number) | A resource that was validated
status | S | 1..1 | code | Validation status of the detected alteration (attested | validated | in-process | req-revalid | val-fail | reval-fail)
validationType | S | 1..1 | CodeableConcept | Type of validation of the detected alteration (Experimental | By biologist | In silico) Binding: Osiris Validation Type (extensible)
validationProcess | S | 0..1 | CodeableConcept | Validation method
Documentation for this format

#### Terminology Bindings (Differential)

Path | Conformité | ValueSet | URI
VerificationResult.validationType | extensible | OsirisValidationType `https://ig-osiris.cancer.fr/ig/osiris/ValueSet/OsirisValidationType` from this IG

Snapshot View

Nom | Drapeaux | Card. | Type | Description et contraintes
--- | --- | --- | --- | ---
VerificationResult |  | 0..* | VerificationResult | Describes validation requirements, source(s), status and dates for one or more elements
id | Σ | 0..1 | id | Logical id of this artifact
meta | Σ | 0..1 | Meta | Metadata about the resource
implicitRules | ?!Σ | 0..1 | uri | A set of rules under which this content was created
language |  | 0..1 | code | Language of the resource content Binding: CommonLanguages (preferred): A human language.
Bindings Additionnels | But
AllLanguages | Binding Max
text |  | 0..1 | Narrative | Text summary of the resource, for human interpretation
contained |  | 0..* | Resource | Contained, inline Resources
extension |  | 0..* | Extension | Additional content defined by implementations
modifierExtension | ?! | 0..* | Extension | Extensions that cannot be ignored
target | S Σ | 1..1 | Reference(Single Nucleotide Polymorphism | Gene Fusion | Gene Expression | Variant Copy Number) | A resource that was validated
targetLocation | Σ | 0..* | string | The fhirpath location(s) within the resource that was validated
need | Σ | 0..1 | CodeableConcept | none | initial | periodic Binding: need (preferred): The frequency with which the target must be validated.
status | S Σ | 1..1 | code | Validation status of the detected alteration (attested | validated | in-process | req-revalid | val-fail | reval-fail) Binding: status (required): The validation status of the target.
statusDate | Σ | 0..1 | dateTime | When the validation status was updated
validationType | S Σ | 1..1 | CodeableConcept | Type of validation of the detected alteration (Experimental | By biologist | In silico) Binding: Osiris Validation Type (extensible)
validationProcess | S Σ | 0..1 | CodeableConcept | Validation method Binding: validation-process (example): The primary process by which the target is validated.
frequency |  | 0..1 | Timing | Frequency of revalidation
lastPerformed |  | 0..1 | dateTime | The date/time validation was last completed (including failed validations)
nextScheduled |  | 0..1 | date | The date when target is next validated, if appropriate
failureAction | Σ | 0..1 | CodeableConcept | fatal | warn | rec-only | none Binding: failure-action (preferred): The result if validation fails.
primarySource |  | 0..* | BackboneElement | Information about the primary source(s) involved in validation
id |  | 0..1 | string | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
who |  | 0..1 | Reference(Organization | Practitioner | PractitionerRole) | Reference to the primary source
type | Σ | 0..* | CodeableConcept | Type of primary source (License Board; Primary Education; Continuing Education; Postal Service; Relationship owner; Registration Authority; legal source; issuing source; authoritative source) Binding: primary-source-type (example): Type of the validation primary source.
communicationMethod | Σ | 0..* | CodeableConcept | Method for exchanging information with the primary source Binding: verificationresult-communication-method (example): Method for communicating with the data source (manual; API; Push).
validationStatus |  | 0..1 | CodeableConcept | successful | failed | unknown Binding: validation-status (preferred): Status of the validation of the target against the primary source.
validationDate |  | 0..1 | dateTime | When the target was validated against the primary source
canPushUpdates | Σ | 0..1 | CodeableConcept | yes | no | undetermined Binding: can-push-updates (preferred): Ability of the primary source to push updates/alerts.
pushTypeAvailable |  | 0..* | CodeableConcept | specific | any | source Binding: push-type-available (preferred): Type of alerts/updates the primary source can send.
attestation |  | 0..1 | BackboneElement | Information about the entity attesting to information
id |  | 0..1 | string | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
who | Σ | 0..1 | Reference(Practitioner | PractitionerRole | Organization) | The individual or organization attesting to information
onBehalfOf | Σ | 0..1 | Reference(Organization | Practitioner | PractitionerRole) | When the who is asserting on behalf of another (organization or individual)
communicationMethod | Σ | 0..1 | CodeableConcept | The method by which attested information was submitted/retrieved Binding: verificationresult-communication-method (example): Method for communicating with the data source (manual; API; Push).
date | Σ | 0..1 | date | The date the information was attested to
sourceIdentityCertificate |  | 0..1 | string | A digital identity certificate associated with the attestation source
proxyIdentityCertificate |  | 0..1 | string | A digital identity certificate associated with the proxy entity submitting attested information on behalf of the attestation source
proxySignature |  | 0..1 | Signature | Proxy signature
sourceSignature |  | 0..1 | Signature | Attester signature
validator |  | 0..* | BackboneElement | Information about the entity validating information
id |  | 0..1 | string | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
organization |  | 1..1 | Reference(Organization) | Reference to the organization validating information
identityCertificate |  | 0..1 | string | A digital identity certificate associated with the validator
attestationSignature |  | 0..1 | Signature | Validator signature
Documentation for this format

#### Terminology Bindings

Path | Conformité | ValueSet | URI
VerificationResult.language | preferred | CommonLanguages `http://hl7.org/fhir/ValueSet/languages` from the FHIR Standard
Bindings Additionnels | But
AllLanguages | Binding Max
VerificationResult.need | preferred | need `http://hl7.org/fhir/ValueSet/verificationresult-need` from the FHIR Standard
VerificationResult.status | required | status `http://hl7.org/fhir/ValueSet/verificationresult-status|4.0.1` from the FHIR Standard
VerificationResult.validationType | extensible | OsirisValidationType `https://ig-osiris.cancer.fr/ig/osiris/ValueSet/OsirisValidationType` from this IG
VerificationResult.validationProcess | example | validation-process `http://hl7.org/fhir/ValueSet/verificationresult-validation-process` from the FHIR Standard
VerificationResult.failureAction | preferred | failure-action `http://hl7.org/fhir/ValueSet/verificationresult-failure-action` from the FHIR Standard
VerificationResult.primarySource.type | example | primary-source-type `http://hl7.org/fhir/ValueSet/verificationresult-primary-source-type` from the FHIR Standard
VerificationResult.primarySource.communicationMethod | example | verificationresult-communication-method `http://hl7.org/fhir/ValueSet/verificationresult-communication-method` from the FHIR Standard
VerificationResult.primarySource.validationStatus | preferred | validation-status `http://hl7.org/fhir/ValueSet/verificationresult-validation-status` from the FHIR Standard
VerificationResult.primarySource.canPushUpdates | preferred | can-push-updates `http://hl7.org/fhir/ValueSet/verificationresult-can-push-updates` from the FHIR Standard
VerificationResult.primarySource.pushTypeAvailable | preferred | push-type-available `http://hl7.org/fhir/ValueSet/verificationresult-push-type-available` from the FHIR Standard
VerificationResult.attestation.communicationMethod | example | verificationresult-communication-method `http://hl7.org/fhir/ValueSet/verificationresult-communication-method` from the FHIR Standard

This structure is derived from VerificationResult

Résumé

Mandatory: 2 elements
Must-Support: 4 elements

Structures

This structure refers to these other structures:

- Single Nucleotide Polymorphism (https://ig-osiris.cancer.fr/ig/osiris/StructureDefinition/snp)
- Gene Fusion (https://ig-osiris.cancer.fr/ig/osiris/StructureDefinition/fusion)
- Gene Expression (https://ig-osiris.cancer.fr/ig/osiris/StructureDefinition/expression)
- Variant Copy Number (https://ig-osiris.cancer.fr/ig/osiris/StructureDefinition/copy-number)

Other representations of profile: CSV, Excel, Schematron