Da Vinci Clinical Data Exchange (CDex)
2.1.0 - STU 2.1

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## Data Type Profile: CDex Signature Profile

Official URL: http://hl7.org/fhir/us/davinci-cdex/StructureDefinition/cdex-signature | Version: 2.1.0
Standards status: Trial-use | Maturity Level: 2 | Computable Name: CDexSignature
Other Identifiers: OID:2.16.840.1.113883.4.642.40.21.42.6
Copyright/Legal: Used by permission of HL7 International all rights reserved Creative Commons License

This Signature DataType profile enforces the various elements of signature documented in the CDex guide. It adds the following mandatory (min=1) constraints:

- A `Signature.type` fixed to ASTM Standard, E1762-95(2013) code = “1.2.840.10065.1.12.1.5” (Verification Signature)
- A `Signature.who` for the organization or practitioner who signed the Bundle which is either:
  1. a reference to US-Core Practitioner, US-Core PractitionerRole, or US-Core Organization or
  2. an NPI or Tax ID and name of the organization or practitioner
- A `Signature.data` representing the base64 encoded Signature (JWS, image, etc)

In addition, the following mandatory (min=1) element is inherited from the base standard:

- `Signature.when` - a system timestamp when the signature was created

Usage:

- Use this DataType Constraint: CDex SDC QuestionnaireResponse Profile and CDex Signature Bundle Profile

### 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

Name | Flags | Card. | Type | Description & Constraints
--- | --- | --- | --- | ---
Signature | C | 0..* | Signature | JWS Digital Signature ele-1: All FHIR elements must have a @value or children cdex-13: The signature element must have either reference to the signer or the signer's identifier and name.
Slices for type | S Σ | 1..* | Coding | Indication of the reason the entity signed the object(s) Slice: Unordered, Open by value:$this Binding: SignatureTypeCodes (preferred): An indication of the reason that an entity signed the object. ele-1: All FHIR elements must have a @value or children
type:verify | S Σ | 1..1 | Coding | Verification Signature Binding: SignatureTypeCodes (preferred): An indication of the reason that an entity signed the object. ele-1: All FHIR elements must have a @value or children Required Pattern: At least the following
system |  | 1..1 | uri | Identity of the terminology system Fixed Value: urn:iso-astm:E1762-95:2013
code |  | 1..1 | code | Symbol in syntax defined by the system Fixed Value: 1.2.840.10065.1.12.1.5
display |  | 1..1 | string | Representation defined by the system Fixed Value: Verification Signature
when | S Σ | 1..1 | instant | When the signature was created ele-1: All FHIR elements must have a @value or children
who | S Σ | 1..1 | Reference(US Core Practitioner Profile(3.1.1) | US Core Practitioner Profile(6.1.0) | US Core Practitioner Profile(7.0.0) | HRex Organization Profile(1.1.0)) | Organization or practitioner who signed the Bundle ele-1: All FHIR elements must have a @value or children
reference | S Σ C | 0..1 | string | Literal reference, Relative, internal or absolute URL ele-1: All FHIR elements must have a @value or children
identifier | S Σ C | 0..1 | Identifier | NPI or US Tax ID ele-1: All FHIR elements must have a @value or children
use | ?!Σ | 0..1 | code | usual | official | temp | secondary | old (If known) Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known . ele-1: All FHIR elements must have a @value or children
type | S Σ | 1..1 | CodeableConcept | Description of identifier Binding: CDex Identifier Types Value Set (required) ele-1: All FHIR elements must have a @value or children
value | S Σ | 1..1 | string | The value that is unique ele-1: All FHIR elements must have a @value or children Example General: 123456
display | S Σ C | 0..1 | string | Text alternative for the resource ele-1: All FHIR elements must have a @value or children
data | S | 1..1 | base64Binary | base64 encoded signature (JWS, image, etc) ele-1: All FHIR elements must have a @value or children
Documentation for this format

#### Terminology Bindings

Path | Conformance | ValueSet / Code | URI
Signature.type | preferred | SignatureTypeCodes `http://hl7.org/fhir/ValueSet/signature-type` from the FHIR Standard
Signature.type:verify | preferred | Pattern: 1.2.840.10065.1.12.1.5("Verification Signature") `http://hl7.org/fhir/ValueSet/signature-type` from the FHIR Standard
Signature.who.identifier.use | required | IdentifierUse `http://hl7.org/fhir/ValueSet/identifier-use|4.0.1` from the FHIR Standard
Signature.who.identifier.type | required | CDexIdentifierTypes `http://hl7.org/fhir/us/davinci-cdex/ValueSet/cdex-identifier-types` from this IG

#### Constraints

Id | Grade | Path(s) | Details | Requirements
cdex-13 | error | Signature | The signature element must have either reference to the signer or the signer's identifier and name. : who.reference.exists() or (who.identifier.exists() and who.display.exists()) |

This structure is derived from Signature

Name | Flags | Card. | Type | Description & Constraints
--- | --- | --- | --- | ---
Signature | C | 0..* | Signature | JWS Digital Signature cdex-13: The signature element must have either reference to the signer or the signer's identifier and name.
Slices for type | S | 1..* | Coding | Indication of the reason the entity signed the object(s) Slice: Unordered, Open by value:$this
type:verify | S | 1..1 | Coding | Verification Signature Required Pattern: At least the following
system |  | 1..1 | uri | Identity of the terminology system Fixed Value: urn:iso-astm:E1762-95:2013
code |  | 1..1 | code | Symbol in syntax defined by the system Fixed Value: 1.2.840.10065.1.12.1.5
display |  | 1..1 | string | Representation defined by the system Fixed Value: Verification Signature
when | S | 1..1 | instant | When the signature was created
who | S | 1..1 | Reference(US Core Practitioner Profile(3.1.1) S | US Core Practitioner Profile(6.1.0) S | US Core Practitioner Profile(7.0.0) S | HRex Organization Profile(1.1.0) S | HRex PractitionerRole Profile(1.1.0)) | Organization or practitioner who signed the Bundle
reference | S C | 0..1 | string | Literal reference, Relative, internal or absolute URL
identifier | S C | 0..1 | Identifier | NPI or US Tax ID
type | S | 1..1 | CodeableConcept | Description of identifier Binding: CDex Identifier Types Value Set (required)
value | S | 1..1 | string | The value that is unique
display | S C | 0..1 | string | Text alternative for the resource
data | S | 1..1 | base64Binary | base64 encoded signature (JWS, image, etc)
Documentation for this format

#### Terminology Bindings (Differential)

Path | Conformance | ValueSet | URI
Signature.who.identifier.type | required | CDexIdentifierTypes `http://hl7.org/fhir/us/davinci-cdex/ValueSet/cdex-identifier-types` from this IG

#### Constraints

Id | Grade | Path(s) | Details | Requirements
cdex-13 | error | Signature | The signature element must have either reference to the signer or the signer's identifier and name. : who.reference.exists() or (who.identifier.exists() and who.display.exists()) |

Name | Flags | Card. | Type | Description & Constraints
--- | --- | --- | --- | ---
Signature | C | 0..* | Signature | JWS Digital Signature cdex-13: The signature element must have either reference to the signer or the signer's identifier and name.
id |  | 0..1 | string | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url
Slices for type | S Σ | 1..* | Coding | Indication of the reason the entity signed the object(s) Slice: Unordered, Open by value:$this Binding: SignatureTypeCodes (preferred): An indication of the reason that an entity signed the object.
type:verify | S Σ | 1..1 | Coding | Verification Signature Binding: SignatureTypeCodes (preferred): An indication of the reason that an entity signed the object. 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: urn:iso-astm:E1762-95:2013
version |  | 0..1 | string | Version of the system - if relevant
code |  | 1..1 | code | Symbol in syntax defined by the system Fixed Value: 1.2.840.10065.1.12.1.5
display |  | 1..1 | string | Representation defined by the system Fixed Value: Verification Signature
userSelected |  | 0..1 | boolean | If this coding was chosen directly by the user
when | S Σ | 1..1 | instant | When the signature was created
who | S Σ | 1..1 | Reference(US Core Practitioner Profile(3.1.1) S | US Core Practitioner Profile(6.1.0) S | US Core Practitioner Profile(7.0.0) S | HRex Organization Profile(1.1.0) S | HRex PractitionerRole Profile(1.1.0)) | Organization or practitioner who signed the Bundle
id |  | 0..1 | string | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url
reference | S Σ C | 0..1 | string | Literal reference, Relative, internal or absolute URL
type | Σ | 0..1 | uri | Type the reference refers to (e.g. "Patient") Binding: ResourceType (extensible): Aa resource (or, for logical models, the URI of the logical model).
identifier | S Σ C | 0..1 | Identifier | NPI or US Tax ID
id |  | 0..1 | string | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url
use | ?!Σ | 0..1 | code | usual | official | temp | secondary | old (If known) Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .
type | S Σ | 1..1 | CodeableConcept | Description of identifier Binding: CDex Identifier Types Value Set (required)
system | Σ | 0..1 | uri | The namespace for the identifier value Example General: http://www.acme.com/identifiers/patient
value | S Σ | 1..1 | string | The value that is unique Example General: 123456
period | Σ | 0..1 | Period | Time period when id is/was valid for use
assigner | Σ | 0..1 | Reference(Organization) | Organization that issued id (may be just text)
display | S Σ C | 0..1 | string | Text alternative for the resource
onBehalfOf | Σ | 0..1 | Reference(Practitioner | PractitionerRole | RelatedPerson | Patient | Device | Organization) | The party represented
targetFormat |  | 0..1 | code | The technical format of the signed resources Binding: Mime Types (required): The mime type of an attachment. Any valid mime type is allowed.
sigFormat |  | 0..1 | code | The technical format of the signature Binding: Mime Types (required): The mime type of an attachment. Any valid mime type is allowed.
data | S | 1..1 | base64Binary | base64 encoded signature (JWS, image, etc)
Documentation for this format

#### Terminology Bindings

Path | Conformance | ValueSet / Code | URI
Signature.type | preferred | SignatureTypeCodes `http://hl7.org/fhir/ValueSet/signature-type` from the FHIR Standard
Signature.type:verify | preferred | Pattern: 1.2.840.10065.1.12.1.5("Verification Signature") `http://hl7.org/fhir/ValueSet/signature-type` from the FHIR Standard
Signature.who.type | extensible | ResourceType `http://hl7.org/fhir/ValueSet/resource-types` from the FHIR Standard
Signature.who.identifier.use | required | IdentifierUse `http://hl7.org/fhir/ValueSet/identifier-use|4.0.1` from the FHIR Standard
Signature.who.identifier.type | required | CDexIdentifierTypes `http://hl7.org/fhir/us/davinci-cdex/ValueSet/cdex-identifier-types` from this IG
Signature.targetFormat | required | Mime Types (a valid code from `urn:ietf:bcp:13`) `http://hl7.org/fhir/ValueSet/mimetypes|4.0.1` from the FHIR Standard
Signature.sigFormat | required | Mime Types (a valid code from `urn:ietf:bcp:13`) `http://hl7.org/fhir/ValueSet/mimetypes|4.0.1` from the FHIR Standard

#### Constraints

Id | Grade | Path(s) | Details | Requirements
cdex-13 | error | Signature | The signature element must have either reference to the signer or the signer's identifier and name. : who.reference.exists() or (who.identifier.exists() and who.display.exists()) |

This structure is derived from Signature

Summary

Mandatory: 3 elements(2 nested mandatory elements)
Must-Support: 10 elements

Structures

This structure refers to these other structures:

- US Core Practitioner Profile (http://hl7.org/fhir/us/core/StructureDefinition/us-core-practitioner|3.1.1)
- US Core Practitioner Profile (http://hl7.org/fhir/us/core/StructureDefinition/us-core-practitioner|6.1.0)
- US Core Practitioner Profile (http://hl7.org/fhir/us/core/StructureDefinition/us-core-practitioner|7.0.0)
- HRex Organization Profile (http://hl7.org/fhir/us/davinci-hrex/StructureDefinition/hrex-organization)
- HRex PractitionerRole Profile (http://hl7.org/fhir/us/davinci-hrex/StructureDefinition/hrex-practitionerrole)

Slices

This structure defines the following Slices:

- The element 1 is sliced based on the value of Signature.type

Maturity: 2

Key Elements View

Name | Flags | Card. | Type | Description & Constraints
--- | --- | --- | --- | ---
Signature | C | 0..* | Signature | JWS Digital Signature ele-1: All FHIR elements must have a @value or children cdex-13: The signature element must have either reference to the signer or the signer's identifier and name.
Slices for type | S Σ | 1..* | Coding | Indication of the reason the entity signed the object(s) Slice: Unordered, Open by value:$this Binding: SignatureTypeCodes (preferred): An indication of the reason that an entity signed the object. ele-1: All FHIR elements must have a @value or children
type:verify | S Σ | 1..1 | Coding | Verification Signature Binding: SignatureTypeCodes (preferred): An indication of the reason that an entity signed the object. ele-1: All FHIR elements must have a @value or children Required Pattern: At least the following
system |  | 1..1 | uri | Identity of the terminology system Fixed Value: urn:iso-astm:E1762-95:2013
code |  | 1..1 | code | Symbol in syntax defined by the system Fixed Value: 1.2.840.10065.1.12.1.5
display |  | 1..1 | string | Representation defined by the system Fixed Value: Verification Signature
when | S Σ | 1..1 | instant | When the signature was created ele-1: All FHIR elements must have a @value or children
who | S Σ | 1..1 | Reference(US Core Practitioner Profile(3.1.1) | US Core Practitioner Profile(6.1.0) | US Core Practitioner Profile(7.0.0) | HRex Organization Profile(1.1.0)) | Organization or practitioner who signed the Bundle ele-1: All FHIR elements must have a @value or children
reference | S Σ C | 0..1 | string | Literal reference, Relative, internal or absolute URL ele-1: All FHIR elements must have a @value or children
identifier | S Σ C | 0..1 | Identifier | NPI or US Tax ID ele-1: All FHIR elements must have a @value or children
use | ?!Σ | 0..1 | code | usual | official | temp | secondary | old (If known) Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known . ele-1: All FHIR elements must have a @value or children
type | S Σ | 1..1 | CodeableConcept | Description of identifier Binding: CDex Identifier Types Value Set (required) ele-1: All FHIR elements must have a @value or children
value | S Σ | 1..1 | string | The value that is unique ele-1: All FHIR elements must have a @value or children Example General: 123456
display | S Σ C | 0..1 | string | Text alternative for the resource ele-1: All FHIR elements must have a @value or children
data | S | 1..1 | base64Binary | base64 encoded signature (JWS, image, etc) ele-1: All FHIR elements must have a @value or children
Documentation for this format

#### Terminology Bindings

Path | Conformance | ValueSet / Code | URI
Signature.type | preferred | SignatureTypeCodes `http://hl7.org/fhir/ValueSet/signature-type` from the FHIR Standard
Signature.type:verify | preferred | Pattern: 1.2.840.10065.1.12.1.5("Verification Signature") `http://hl7.org/fhir/ValueSet/signature-type` from the FHIR Standard
Signature.who.identifier.use | required | IdentifierUse `http://hl7.org/fhir/ValueSet/identifier-use|4.0.1` from the FHIR Standard
Signature.who.identifier.type | required | CDexIdentifierTypes `http://hl7.org/fhir/us/davinci-cdex/ValueSet/cdex-identifier-types` from this IG

#### Constraints

Id | Grade | Path(s) | Details | Requirements
cdex-13 | error | Signature | The signature element must have either reference to the signer or the signer's identifier and name. : who.reference.exists() or (who.identifier.exists() and who.display.exists()) |

Differential View

This structure is derived from Signature

Name | Flags | Card. | Type | Description & Constraints
--- | --- | --- | --- | ---
Signature | C | 0..* | Signature | JWS Digital Signature cdex-13: The signature element must have either reference to the signer or the signer's identifier and name.
Slices for type | S | 1..* | Coding | Indication of the reason the entity signed the object(s) Slice: Unordered, Open by value:$this
type:verify | S | 1..1 | Coding | Verification Signature Required Pattern: At least the following
system |  | 1..1 | uri | Identity of the terminology system Fixed Value: urn:iso-astm:E1762-95:2013
code |  | 1..1 | code | Symbol in syntax defined by the system Fixed Value: 1.2.840.10065.1.12.1.5
display |  | 1..1 | string | Representation defined by the system Fixed Value: Verification Signature
when | S | 1..1 | instant | When the signature was created
who | S | 1..1 | Reference(US Core Practitioner Profile(3.1.1) S | US Core Practitioner Profile(6.1.0) S | US Core Practitioner Profile(7.0.0) S | HRex Organization Profile(1.1.0) S | HRex PractitionerRole Profile(1.1.0)) | Organization or practitioner who signed the Bundle
reference | S C | 0..1 | string | Literal reference, Relative, internal or absolute URL
identifier | S C | 0..1 | Identifier | NPI or US Tax ID
type | S | 1..1 | CodeableConcept | Description of identifier Binding: CDex Identifier Types Value Set (required)
value | S | 1..1 | string | The value that is unique
display | S C | 0..1 | string | Text alternative for the resource
data | S | 1..1 | base64Binary | base64 encoded signature (JWS, image, etc)
Documentation for this format

#### Terminology Bindings (Differential)

Path | Conformance | ValueSet | URI
Signature.who.identifier.type | required | CDexIdentifierTypes `http://hl7.org/fhir/us/davinci-cdex/ValueSet/cdex-identifier-types` from this IG

#### Constraints

Id | Grade | Path(s) | Details | Requirements
cdex-13 | error | Signature | The signature element must have either reference to the signer or the signer's identifier and name. : who.reference.exists() or (who.identifier.exists() and who.display.exists()) |

Snapshot View

Name | Flags | Card. | Type | Description & Constraints
--- | --- | --- | --- | ---
Signature | C | 0..* | Signature | JWS Digital Signature cdex-13: The signature element must have either reference to the signer or the signer's identifier and name.
id |  | 0..1 | string | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url
Slices for type | S Σ | 1..* | Coding | Indication of the reason the entity signed the object(s) Slice: Unordered, Open by value:$this Binding: SignatureTypeCodes (preferred): An indication of the reason that an entity signed the object.
type:verify | S Σ | 1..1 | Coding | Verification Signature Binding: SignatureTypeCodes (preferred): An indication of the reason that an entity signed the object. 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: urn:iso-astm:E1762-95:2013
version |  | 0..1 | string | Version of the system - if relevant
code |  | 1..1 | code | Symbol in syntax defined by the system Fixed Value: 1.2.840.10065.1.12.1.5
display |  | 1..1 | string | Representation defined by the system Fixed Value: Verification Signature
userSelected |  | 0..1 | boolean | If this coding was chosen directly by the user
when | S Σ | 1..1 | instant | When the signature was created
who | S Σ | 1..1 | Reference(US Core Practitioner Profile(3.1.1) S | US Core Practitioner Profile(6.1.0) S | US Core Practitioner Profile(7.0.0) S | HRex Organization Profile(1.1.0) S | HRex PractitionerRole Profile(1.1.0)) | Organization or practitioner who signed the Bundle
id |  | 0..1 | string | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url
reference | S Σ C | 0..1 | string | Literal reference, Relative, internal or absolute URL
type | Σ | 0..1 | uri | Type the reference refers to (e.g. "Patient") Binding: ResourceType (extensible): Aa resource (or, for logical models, the URI of the logical model).
identifier | S Σ C | 0..1 | Identifier | NPI or US Tax ID
id |  | 0..1 | string | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url
use | ?!Σ | 0..1 | code | usual | official | temp | secondary | old (If known) Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .
type | S Σ | 1..1 | CodeableConcept | Description of identifier Binding: CDex Identifier Types Value Set (required)
system | Σ | 0..1 | uri | The namespace for the identifier value Example General: http://www.acme.com/identifiers/patient
value | S Σ | 1..1 | string | The value that is unique Example General: 123456
period | Σ | 0..1 | Period | Time period when id is/was valid for use
assigner | Σ | 0..1 | Reference(Organization) | Organization that issued id (may be just text)
display | S Σ C | 0..1 | string | Text alternative for the resource
onBehalfOf | Σ | 0..1 | Reference(Practitioner | PractitionerRole | RelatedPerson | Patient | Device | Organization) | The party represented
targetFormat |  | 0..1 | code | The technical format of the signed resources Binding: Mime Types (required): The mime type of an attachment. Any valid mime type is allowed.
sigFormat |  | 0..1 | code | The technical format of the signature Binding: Mime Types (required): The mime type of an attachment. Any valid mime type is allowed.
data | S | 1..1 | base64Binary | base64 encoded signature (JWS, image, etc)
Documentation for this format

#### Terminology Bindings

Path | Conformance | ValueSet / Code | URI
Signature.type | preferred | SignatureTypeCodes `http://hl7.org/fhir/ValueSet/signature-type` from the FHIR Standard
Signature.type:verify | preferred | Pattern: 1.2.840.10065.1.12.1.5("Verification Signature") `http://hl7.org/fhir/ValueSet/signature-type` from the FHIR Standard
Signature.who.type | extensible | ResourceType `http://hl7.org/fhir/ValueSet/resource-types` from the FHIR Standard
Signature.who.identifier.use | required | IdentifierUse `http://hl7.org/fhir/ValueSet/identifier-use|4.0.1` from the FHIR Standard
Signature.who.identifier.type | required | CDexIdentifierTypes `http://hl7.org/fhir/us/davinci-cdex/ValueSet/cdex-identifier-types` from this IG
Signature.targetFormat | required | Mime Types (a valid code from `urn:ietf:bcp:13`) `http://hl7.org/fhir/ValueSet/mimetypes|4.0.1` from the FHIR Standard
Signature.sigFormat | required | Mime Types (a valid code from `urn:ietf:bcp:13`) `http://hl7.org/fhir/ValueSet/mimetypes|4.0.1` from the FHIR Standard

#### Constraints

Id | Grade | Path(s) | Details | Requirements
cdex-13 | error | Signature | The signature element must have either reference to the signer or the signer's identifier and name. : who.reference.exists() or (who.identifier.exists() and who.display.exists()) |

This structure is derived from Signature

Summary

Mandatory: 3 elements(2 nested mandatory elements)
Must-Support: 10 elements

Structures

This structure refers to these other structures:

- US Core Practitioner Profile (http://hl7.org/fhir/us/core/StructureDefinition/us-core-practitioner|3.1.1)
- US Core Practitioner Profile (http://hl7.org/fhir/us/core/StructureDefinition/us-core-practitioner|6.1.0)
- US Core Practitioner Profile (http://hl7.org/fhir/us/core/StructureDefinition/us-core-practitioner|7.0.0)
- HRex Organization Profile (http://hl7.org/fhir/us/davinci-hrex/StructureDefinition/hrex-organization)
- HRex PractitionerRole Profile (http://hl7.org/fhir/us/davinci-hrex/StructureDefinition/hrex-practitionerrole)

Slices

This structure defines the following Slices:

- The element 1 is sliced based on the value of Signature.type

Maturity: 2

Other representations of profile: CSV, Excel, Schematron