Additional Guidance

The SDOHCC Consent profile allows the representation of SDOH consent. One specific use for this profile is to represent a consent to release information on a patient to a community-based organization. This is usually necessary when PII or PHI is moving from a HIPAA covered entity (e.g. provider) to a non-HIPAA environment. The patient must usually consent to this exchange of personal information. The section that follows provides additional guidance on some elements in the SDOHCC Consent profile.

Consent.identifier

Consent.identifier should be used to provide an identifier that is recognized by the issuing organization for the specific patient.

Consent.status

Consent.status requires a code from the "ConsentState" value set. In general, Consent.status should reference the value “active” when being exchange with a community-based organization.

Consent.scope

Consent.scope requires a code from the "ConsentScopeCodes" value set to which it is bound with binding strength: Extensible. In general, Consent.scope should reference the value “Privacy Consent”.

Consent.category

Consent.category requires a code from the "ConsentCategoryCodes" value set to which it is bound with binding strength: Extensible. In general, Consent.category should reference the value “information disclosure”.

Consent.patient

US Core does not offer a Consent Profile. For this reason, SDOHCC Consent does not restrict Consent.patient to US Core Patient Profile. However, if an implementer is creating US Core profiles (e.g., US Core Condition, US Core Procedure, etc.) that require US Core Patient for Subject, then US Core Patient should also be used in other profiles (e.g., Observation, ServiceRequest, Consent, etc.) which do not currently specify US Core Patient.

Request for comments

We have not chosen to additionally constrain the Consent resource and are seeking input on the appropriateness of constraining the following elements.

• Consent.dateTime
• Consent.performer
• Consent.organizaiton
• Consent.provision
• Consent.provision.actor
• Consent.provision.action

• Text Summary
• Differential Table
• Snapshot Table
• Snapshot Table (Must Support)
• All

This structure is derived from Consent

Name	Flags	Card.	Type	Description & Constraints
Consent		0..*	Consent	A healthcare consumer's choices to permit or deny recipients or roles to perform actions for specific purposes and periods of time
identifier	S	0..*	Identifier	Identifier for this record (external references) Binding: (unbound) (required)
status	S	1..1	code	draft | proposed | active | rejected | inactive | entered-in-error
scope	S	1..1	CodeableConcept	Which of the four areas this resource covers (extensible)
category	S	1..*	CodeableConcept	Classification of the consent statement - for indexing/retrieval
patient	S	1..1	Reference(Patient)	Who the consent applies to
Documentation for this format

Name	Flags	Card.	Type	Description & Constraints
Consent	I	0..*	Consent	A healthcare consumer's choices to permit or deny recipients or roles to perform actions for specific purposes and periods of time
id	Σ	0..1	string	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) Max Binding: AllLanguages: A human language.
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
identifier	SΣ	0..*	Identifier	Identifier for this record (external references) Example General: {"system":"urn:ietf:rfc:3986","value":"Local eCMS identifier"}
status	?!SΣ	1..1	code	draft | proposed | active | rejected | inactive | entered-in-error Binding: ConsentState (required): Indicates the state of the consent.
scope	?!SΣ	1..1	CodeableConcept	Which of the four areas this resource covers (extensible) Binding: ConsentScopeCodes (extensible): The four anticipated uses for the Consent Resource.
category	SΣ	1..*	CodeableConcept	Classification of the consent statement - for indexing/retrieval Binding: ConsentCategoryCodes (extensible): A classification of the type of consents found in a consent statement.
patient	SΣ	1..1	Reference(Patient)	Who the consent applies to
dateTime	Σ	0..1	dateTime	When this Consent was created or indexed
performer	Σ	0..*	Reference(Organization | Patient | Practitioner | RelatedPerson | PractitionerRole)	Who is agreeing to the policy and rules
organization	Σ	0..*	Reference(Organization)	Custodian of the consent
source[x]	Σ	0..1		Source from which this consent is taken
sourceAttachment			Attachment
sourceReference			Reference(Consent | DocumentReference | Contract | QuestionnaireResponse)
policy		0..*	BackboneElement	Policies covered by this consent
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
authority	I	0..1	uri	Enforcement source for policy
uri	I	0..1	uri	Specific policy covered by this consent
policyRule	ΣI	0..1	CodeableConcept	Regulation that this consents to Binding: ConsentPolicyRuleCodes (extensible): Regulatory policy examples.
verification	Σ	0..*	BackboneElement	Consent Verified by patient or family
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
verified	Σ	1..1	boolean	Has been verified
verifiedWith		0..1	Reference(Patient | RelatedPerson)	Person who verified
verificationDate		0..1	dateTime	When consent verified
provision	Σ	0..1	BackboneElement	Constraints to the base Consent.policyRule
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
type	Σ	0..1	code	deny | permit Binding: ConsentProvisionType (required): How a rule statement is applied, such as adding additional consent or removing consent.
period	Σ	0..1	Period	Timeframe for this rule
actor		0..*	BackboneElement	Who|what controlled by this rule (or group, by role)
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
role		1..1	CodeableConcept	How the actor is involved Binding: SecurityRoleType (extensible): How an actor is involved in the consent considerations.
reference		1..1	Reference(Device | Group | CareTeam | Organization | Patient | Practitioner | RelatedPerson | PractitionerRole)	Resource for the actor (or group, by role)
action	Σ	0..*	CodeableConcept	Actions controlled by this rule Binding: ConsentActionCodes (example): Detailed codes for the consent action.
securityLabel	Σ	0..*	Coding	Security Labels that define affected resources Binding: All Security Labels (extensible): Security Labels from the Healthcare Privacy and Security Classification System.
purpose	Σ	0..*	Coding	Context of activities covered by this rule Binding: PurposeOfUse (extensible): What purposes of use are controlled by this exception. If more than one label is specified, operations must have all the specified labels.
class	Σ	0..*	Coding	e.g. Resource Type, Profile, CDA, etc. Binding: ConsentContentClass (extensible): The class (type) of information a consent rule covers.
code	Σ	0..*	CodeableConcept	e.g. LOINC or SNOMED CT code, etc. in the content Binding: ConsentContentCodes (example): If this code is found in an instance, then the exception applies.
dataPeriod	Σ	0..1	Period	Timeframe for data controlled by this rule
data	Σ	0..*	BackboneElement	Data controlled by this rule
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
meaning	Σ	1..1	code	instance | related | dependents | authoredby Binding: ConsentDataMeaning (required): How a resource reference is interpreted when testing consent restrictions.
reference	Σ	1..1	Reference(Resource)	The actual data reference
provision		0..*	See provision (Consent)	Nested Exception Rules
Documentation for this format

Name	Flags	Card.	Type	Description & Constraints
Consent	I	0..*	Consent	A healthcare consumer's choices to permit or deny recipients or roles to perform actions for specific purposes and periods of time
identifier	Σ	0..*	Identifier	Identifier for this record (external references)
status	?!Σ	1..1	code	draft | proposed | active | rejected | inactive | entered-in-error Binding: ConsentState (required): Indicates the state of the consent.
scope	?!Σ	1..1	CodeableConcept	Which of the four areas this resource covers (extensible) Binding: ConsentScopeCodes (extensible): The four anticipated uses for the Consent Resource.
category	Σ	1..*	CodeableConcept	Classification of the consent statement - for indexing/retrieval Binding: ConsentCategoryCodes (extensible): A classification of the type of consents found in a consent statement.
patient	Σ	1..1	Reference(Patient)	Who the consent applies to
Documentation for this format

This structure is derived from Consent

Summary

Mandatory: 1 element
Must-Support: 5 elements

Differential View

This structure is derived from Consent

Name	Flags	Card.	Type	Description & Constraints
Consent		0..*	Consent	A healthcare consumer's choices to permit or deny recipients or roles to perform actions for specific purposes and periods of time
identifier	S	0..*	Identifier	Identifier for this record (external references) Binding: (unbound) (required)
status	S	1..1	code	draft | proposed | active | rejected | inactive | entered-in-error
scope	S	1..1	CodeableConcept	Which of the four areas this resource covers (extensible)
category	S	1..*	CodeableConcept	Classification of the consent statement - for indexing/retrieval
patient	S	1..1	Reference(Patient)	Who the consent applies to
Documentation for this format

Snapshot View

Name	Flags	Card.	Type	Description & Constraints
Consent	I	0..*	Consent	A healthcare consumer's choices to permit or deny recipients or roles to perform actions for specific purposes and periods of time
id	Σ	0..1	string	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) Max Binding: AllLanguages: A human language.
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
identifier	SΣ	0..*	Identifier	Identifier for this record (external references) Example General: {"system":"urn:ietf:rfc:3986","value":"Local eCMS identifier"}
status	?!SΣ	1..1	code	draft | proposed | active | rejected | inactive | entered-in-error Binding: ConsentState (required): Indicates the state of the consent.
scope	?!SΣ	1..1	CodeableConcept	Which of the four areas this resource covers (extensible) Binding: ConsentScopeCodes (extensible): The four anticipated uses for the Consent Resource.
category	SΣ	1..*	CodeableConcept	Classification of the consent statement - for indexing/retrieval Binding: ConsentCategoryCodes (extensible): A classification of the type of consents found in a consent statement.
patient	SΣ	1..1	Reference(Patient)	Who the consent applies to
dateTime	Σ	0..1	dateTime	When this Consent was created or indexed
performer	Σ	0..*	Reference(Organization | Patient | Practitioner | RelatedPerson | PractitionerRole)	Who is agreeing to the policy and rules
organization	Σ	0..*	Reference(Organization)	Custodian of the consent
source[x]	Σ	0..1		Source from which this consent is taken
sourceAttachment			Attachment
sourceReference			Reference(Consent | DocumentReference | Contract | QuestionnaireResponse)
policy		0..*	BackboneElement	Policies covered by this consent
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
authority	I	0..1	uri	Enforcement source for policy
uri	I	0..1	uri	Specific policy covered by this consent
policyRule	ΣI	0..1	CodeableConcept	Regulation that this consents to Binding: ConsentPolicyRuleCodes (extensible): Regulatory policy examples.
verification	Σ	0..*	BackboneElement	Consent Verified by patient or family
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
verified	Σ	1..1	boolean	Has been verified
verifiedWith		0..1	Reference(Patient | RelatedPerson)	Person who verified
verificationDate		0..1	dateTime	When consent verified
provision	Σ	0..1	BackboneElement	Constraints to the base Consent.policyRule
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
type	Σ	0..1	code	deny | permit Binding: ConsentProvisionType (required): How a rule statement is applied, such as adding additional consent or removing consent.
period	Σ	0..1	Period	Timeframe for this rule
actor		0..*	BackboneElement	Who|what controlled by this rule (or group, by role)
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
role		1..1	CodeableConcept	How the actor is involved Binding: SecurityRoleType (extensible): How an actor is involved in the consent considerations.
reference		1..1	Reference(Device | Group | CareTeam | Organization | Patient | Practitioner | RelatedPerson | PractitionerRole)	Resource for the actor (or group, by role)
action	Σ	0..*	CodeableConcept	Actions controlled by this rule Binding: ConsentActionCodes (example): Detailed codes for the consent action.
securityLabel	Σ	0..*	Coding	Security Labels that define affected resources Binding: All Security Labels (extensible): Security Labels from the Healthcare Privacy and Security Classification System.
purpose	Σ	0..*	Coding	Context of activities covered by this rule Binding: PurposeOfUse (extensible): What purposes of use are controlled by this exception. If more than one label is specified, operations must have all the specified labels.
class	Σ	0..*	Coding	e.g. Resource Type, Profile, CDA, etc. Binding: ConsentContentClass (extensible): The class (type) of information a consent rule covers.
code	Σ	0..*	CodeableConcept	e.g. LOINC or SNOMED CT code, etc. in the content Binding: ConsentContentCodes (example): If this code is found in an instance, then the exception applies.
dataPeriod	Σ	0..1	Period	Timeframe for data controlled by this rule
data	Σ	0..*	BackboneElement	Data controlled by this rule
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
meaning	Σ	1..1	code	instance | related | dependents | authoredby Binding: ConsentDataMeaning (required): How a resource reference is interpreted when testing consent restrictions.
reference	Σ	1..1	Reference(Resource)	The actual data reference
provision		0..*	See provision (Consent)	Nested Exception Rules
Documentation for this format