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Content Examples Detailed Descriptions Mappings Profiles & Extensions R3 Conversions 6.2.10 Resource Consent - Detailed Descriptions

Example GenomicStudy/example-lungMass (XML)

Community Based Collaborative Care Clinical Genomics Work Group Maturity Level : 2   Trial Use N/A Security Category Standards Status : Patient Informative Compartments : Patient
Detailed Descriptions for the elements in the Consent resource. Consent Element Id Consent Definition A record of a healthcare consumer’s choices, which permits or denies identified recipient(s) or recipient role(s) to perform one or more actions within a given policy context, for specific purposes and periods of time. Cardinality 0..* Type DomainResource Comments Broadly, there are 3 key areas of consent for patients: Consent around sharing information (aka Privacy Consent Directive - Authorization to Collect, Use, or Disclose information), consent for specific treatment, or kinds of treatment, and general advance care directives. Invariants Defined on this element ppc-1 Rule Either a Policy or PolicyRule policy.exists() or policyRule.exists() ppc-2 Rule IF Scope=privacy, there must be a patient patient.exists() or scope.coding.where(system='something' and code='patient-privacy').exists().not() ppc-3 Rule IF Scope=research, there must be a patient patient.exists() or scope.coding.where(system='something' and code='research').exists().not() ppc-4 Rule IF Scope=adr, there must be a patient patient.exists() or scope.coding.where(system='something' and code='adr').exists().not() ppc-5 Rule IF Scope=treatment, there must be a patient patient.exists() or scope.coding.where(system='something' and code='treatment').exists().not() Consent.identifier Element Id Consent.identifier Definition Unique identifier for this copy of the Consent Statement. Note This is a business identifier, not a resource identifier (see discussion ) Cardinality 0..* Type Identifier Summary true Comments This identifier identifies this copy of the consent. Where this identifier is also used elsewhere as the identifier for a consent record (e.g. a CDA consent document) then the consent details are expected to be the same. Consent.status Element Id Consent.status Definition Indicates the current state of this consent. Cardinality 1..1 Terminology Binding ConsentState ( Required ) Type code Is Modifier true (Reason: This element is labelled as a modifier because it is a status element that contains status entered-in-error which means that the resource should not be treated as valid) Requirements The Consent Directive that is pointed to might be in various lifecycle states, e.g., a revoked Consent Directive. Summary true Comments This element is labeled as a modifier because the status contains the codes rejected and entered-in-error that mark the Consent as not currently valid. Consent.scope Element Id Consent.scope Definition A selector of the type of consent being presented: ADR, Privacy, Treatment, Research. This list is now extensible. Cardinality 1..1 Terminology Binding Consent Scope Codes ( Extensible ) Type
  • CodeableConcept Narrative
  • Is Modifier XML true (Reason: Allows changes to codes based on scope selection)
  • Summary JSON true
  • TTL Consent.category Element Id Consent.category Definition

A classification of the type of consents found in the statement. This element supports indexing and retrieval of consent statements. Cardinality 1..* Terminology Binding Consent Category Codes Raw XML ( Extensible ) Type CodeableConcept Summary true Consent.patient Element Id Consent.patient Definition The patient/healthcare consumer to whom this consent applies. Cardinality 0..1 Type Reference canonical form ( Patient + also see XML Format Specification ) Summary true Comments Commonly, the patient the consent pertains to is the author, but for young and old people, it may be some other person.

Consent.dateTime Element Id Consent.dateTime Definition When this Consent was issued / created / indexed. Cardinality 0..1 Type dateTime Summary true Comments

This is not the time of the original consent, but the time that this statement was made or derived. Jump past Narrative Consent.performer Element Id Consent.performer Definition Either the Grantor, which is the entity responsible for granting the rights listed in a Consent Directive or the Grantee, which is the entity responsible for complying with the Consent Directive, including any obligations or limitations on authorizations and enforcement of prohibitions.

Cardinality 0..* Type Reference ( Organization | Patient | Practitioner | RelatedPerson | PractitionerRole ) Alternate Names consentor Summary true Comments

Commonly, the patient the consent pertains to is the consentor, but particularly for young and old people, it may be some other person GenomicStudy - e.g. a legal guardian. Consent.organization Element Id Consent.organization Definition The organization that manages the consent, and the framework within which it is executed. Cardinality 0..* Type Reference ( Organization ) Alternate Names custodian Summary true Consent.source[x] Element Id Consent.source[x] Definition The source on which this consent statement is based. The source might be a scanned original paper form, or a reference to a consent that links back to such a source, a reference to a document repository (e.g. XDS) that stores the original consent document. Cardinality 0..1 Type Attachment | Reference ( Consent | DocumentReference | Contract | QuestionnaireResponse ) [x] Note See Choice of Data Types for further information about how to use [x] Summary true Comments The source can be contained inline (Attachment), referenced directly (Consent), referenced in a consent repository (DocumentReference), or simply by an identifier (Identifier), e.g. a CDA document id. Consent.policy Element Id Consent.policy Definition The references to the policies that are included in this consent scope. Policies may be organizational, but are often defined jurisdictionally, or in law. Cardinality 0..* Consent.policy.authority Element Id Consent.policy.authority Definition Entity or Organization having regulatory jurisdiction or accountability for enforcing policies pertaining to Consent Directives. Cardinality 0..1 Type uri Invariants Affect this element ppc-1 Rule Either a Policy or PolicyRule policy.exists() or policyRule.exists() Consent.policy.uri Element Id Consent.policy.uri Definition The references to the policies that are included in this consent scope. Policies may be organizational, but are often defined jurisdictionally, or in law. Cardinality 0..1 Type uri Comments This element is for discoverability / documentation and does not modify or qualify the policy rules. Invariants Affect this element ppc-1 Rule Either a Policy or PolicyRule policy.exists() or policyRule.exists() Consent.policyRule Element Id Consent.policyRule Definition A reference to the specific base computable regulation or policy. Cardinality 0..1 Terminology Binding Consent PolicyRule Codes ( Extensible ) Type CodeableConcept Requirements Might be a unique identifier of a policy set in XACML, or other rules engine. Summary true Comments If the policyRule is absent, computable consent would need to be constructed from the elements of the Consent resource. Lung mass - sequencing analysis (id = "example-lungMass")

Invariants Affect this element ppc-1 
<?xml version="1.0" encoding="UTF-8"?>

<GenomicStudy xmlns="http://hl7.org/fhir">
 <!--   from Resource: id, meta, implicitRules, and language   -->
 <!--   from DomainResource: text, contained, extension, and modifierExtension   -->
    <id value="example-lungMass"/> 
    <!--   from DomainResource: text, contained, extension, and modifierExtension   -->
    <text> 
        <status value="additional"/> 
        <div xmlns="http://www.w3.org/1999/xhtml">Whole exome sequencing of lung biopsy. 300 genes are examined for simple variants

       (SNV, MNV, InDel), and 170 genes are also examined for CNVs. For technical reasons,
       PIK3CB was deemed uncallable.</div> 
    </text> 
    <identifier> 
        <use value="temp"/> 
        <system value="http://www.somesystemabc.net/identifiers/genomicstudies"/> 
        <value value="urn:uuid:1111-1111-1111-1112"/> 
    </identifier> 
    <status> 
        <coding> 
            <system value="http://hl7.org/fhir/genomicstudy-status"/> 
            <code value="registered"/> 
            <display value="Registered"/> 
        </coding> 
    </status> 
    <type> 
        <coding> 
            <system value="http://snomed.info/sct"/> 
            <code value="443968007"/> 
            <display value="Whole Exome Sequencing - Sequencing of entire coding region of gene (procedure)"/> 
        </coding> 
    </type> 
    <subject> 
        <reference value="Patient/genomicPatient"/> 
    </subject> 
    <encounter> 
        <reference value="Encounter/genomicEncounter"/> 
    </encounter> 
    <startDate value="2019-03-01"/> 
    <basedOn> 
        <reference value="ServiceRequest/genomicServiceRequest2"/> 
    </basedOn> 
    <referrer> 
        <reference value="Practitioner/practitioner01"/> 
    </referrer> 
    <interpreter> 
        <reference value="Practitioner/practitioner02"/> 
    </interpreter> 
    <reason> 
        <concept> 
            <coding> 
                <system value="http://snomed.info/sct"/> 
                <code value="309529002"/> 
                <display value="Lung mass (finding) "/> 
            </coding> 
        </concept> 
    </reason> 
    <note> 
        <text value="For technical reasons, PIK3CB was deemed uncallable."/> 
    </note> 
    <description value="Whole exome sequencing of lung biopsy. 300 genes are examined for simple variants

   (SNV, MNV, InDel), and 170 genes are also examined for CNVs. For technical reasons,
   PIK3CB was deemed uncallable."/>  <!--   0..1 Description of the genomic study   -->
    <analysis> 
        <identifier> 
            <use value="official"/> 
            <system value="http://www.somesystemabc.net/identifiers/genomicAnalyses"/> 
            <value value="urn:uuid:1111-1111-1111-1112"/> 
        </identifier> 
        <methodType> 
            <coding> 
                <system value="http://snomed.info/sct"/> 
                <code value="117040002"/> 
                <display value="Nucleic acid sequencing (procedure)"/> 
            </coding> 
        </methodType> 
        <changeType> 
            <coding> 
                <system value="http://sequenceontology.org"/> 
                <code value="SO:0001483"/> 
                <display value="SNV"/> 
            </coding> 
        </changeType> 
        <changeType> 
            <coding> 
                <system value="http://sequenceontology.org"/> 
                <code value="SO:0002007"/> 
                <display value="MNV"/> 
            </coding> 
        </changeType> 
        <changeType> 
            <coding> 
                <system value="http://sequenceontology.org"/> 
                <code value="SO:1000032"/> 
                <display value="delins"/> 
            </coding> 
        </changeType> 
        <genomeBuild> 
            <coding> 
                <system value="http://loinc.org"/> 
                <code value="LA26806-2"/> 
                <display value="GRCh38"/> 
            </coding> 
        </genomeBuild> 
        <title value="Simple variant analysis"/> <!--   0..1 Name of the analysis event (human friendly)   -->
        <subject> 
            <reference value="Patient/genomicPatient"/> 
        </subject> 
        <specimen> 
            <reference value="Specimen/genomicSpecimen"/> 
        </specimen> 
        <date value="2019-03-01T01:01:10-06:00"/> <!--   0..1 The date of the analysis event   -->
        <note> 
            <text value="For technical reasons, PIK3CB was deemed uncallable using this method."/> 
        </note> 
        <regionsStudied> 
            <reference value="DocumentReference/WES_FullSequencedRegion_GRCh38"/> 
        </regionsStudied> 
        <regionsCalled> 
            <reference value="DocumentReference/SimpleVariantAnalysis_called"/> 
        </regionsCalled> 
        <output>   <!--   0..* outputs for the analysis event   -->
            <file> 
                <reference value="DocumentReference/genomicVCFfile_simple"/> 
            </file> 
            <type> 
                <coding> 
                    <code value="vcf"/> 
                    <display value="VCF"/> 
                </coding> 
            </type> 
        </output> 
        <performer>   <!--   0..* Performer for the analysis event   -->
            <actor> 
                <reference value="Practitioner/practitioner02"/> 
            </actor> 
            <role> 
                <coding> 
                    <system value="http://terminology.hl7.org/3.1.0/CodeSystem-v3-ParticipationType.html"/> 
                    <code value="PRF"/> 
                    <display value="Performer"/> 
                </coding> 
            </role> 
        </performer> 
        <device>   <!--   0..* Devices used for the analysis (e.g., instruments, software), with settings

       and parameters   -->
            <device> 
                <reference value="Device/NGS-device"/> 
            </device> 
            <function> 
                <coding> 
                    <display value="Next Generation Sequencing"/> 
                </coding> 
            </function> 
        </device> 
    </analysis> 
    <analysis> 
        <identifier> 
            <use value="official"/> 
            <system value="http://www.somesystemabc.net/identifiers/genomicAnalyses"/> 
            <value value="urn:uuid:1111-1111-1111-1115"/> 
        </identifier> 
        <methodType> 
            <coding> 
                <system value="http://snomed.info/sct"/> 
                <code value="117040002"/> 
                <display value="Nucleic acid sequencing (procedure)"/> 
            </coding> 
        </methodType> 
        <changeType> 
            <coding> 
                <system value="http://sequenceontology.org"/> 
                <code value="SO:0001019"/> 
                <display value="CNV"/> 
            </coding> 
        </changeType> 
        <genomeBuild> 
            <coding> 
                <system value="http://loinc.org"/> 
                <code value="LA26806-2"/> 
                <display value="GRCh38"/> 
            </coding> 
        </genomeBuild> 
        <title value="CNV analysis"/> <!--   0..1 Name of the analysis event (human friendly)   -->
        <subject> 
            <reference value="Patient/genomicPatient"/> 
        </subject> 
        <specimen> 
            <reference value="Specimen/genomicSpecimen"/> 
        </specimen> 
        <date value="2019-03-01T01:01:10-06:00"/> <!--   0..1 The date of the analysis event   -->
        <note> 
            <text value="For technical reasons, PIK3CB was deemed uncallable using this method."/> 
        </note> 
        <regionsStudied> 
            <reference value="DocumentReference/WES_FullSequencedRegion_GRCh38"/> 
        </regionsStudied> 
        <regionsCalled> 
            <reference value="DocumentReference/CNVAnalysis_called"/> 
        </regionsCalled> 
        <output>   <!--   0..* Inputs for the analysis event   -->
            <file> 
                <reference value="DocumentReference/genomicVCFfile_cnv"/> 
            </file> 
            <type> 
                <coding> 
                    <code value="vcf"/> 
                    <display value="VCF"/> 
                </coding> 
            </type> 
        </output> 
        <performer>   <!--   0..* Performer for the analysis event   -->
            <actor> 
                <reference value="Practitioner/practitioner02"/> 
            </actor> 
            <role> 
                <coding> 
                    <system value="http://terminology.hl7.org/3.1.0/CodeSystem-v3-ParticipationType.html"/> 
                    <code value="PRF"/> 
                    <display value="Performer"/> 
                </coding> 
            </role> 
        </performer> 
    </analysis> 

Rule


</

GenomicStudy


Either
a
Policy
or
PolicyRule
policy.exists()
or
policyRule.exists()

>


Consent.verification
Element
Id
Consent.verification
Definition
Whether
a
treatment
instruction
(e.g.
artificial
respiration
yes
or
no)
was
verified
with
the
patient,
his/her
family
or
another
authorized
person.
Cardinality
0..*
Summary
true



Consent.verification.verified
Element
Id
Consent.verification.verified
Definition

Has the instruction Usage note: every effort has been verified. Cardinality 1..1 Type boolean Summary true Consent.verification.verifiedWith Element Id Consent.verification.verifiedWith Definition Who verified the instruction (Patient, Relative or other Authorized Person). Cardinality 0..1 Type Reference ( Patient | RelatedPerson ) Consent.verification.verificationDate Element Id Consent.verification.verificationDate Definition Date verification was collected. Cardinality 0..1 Type dateTime Consent.provision Element Id Consent.provision Definition An exception to the base policy of this consent. An exception can be an addition or removal of access permissions. Cardinality 0..1 Summary true Consent.provision.type Element Id Consent.provision.type Definition Action to take - permit or deny - when the rule conditions are met. Not permitted in root rule, required in all nested rules. Cardinality 0..1 Terminology Binding ConsentProvisionType ( Required ) Type code Summary true Consent.provision.period Element Id Consent.provision.period Definition The timeframe in this rule is valid. Cardinality 0..1 Type Period Summary true Consent.provision.actor Element Id Consent.provision.actor Definition Who or what is controlled by this rule. Use group to identify a set of actors by some property they share (e.g. 'admitting officers'). Cardinality 0..* Meaning if Missing There is no specific actor associated with the exception Consent.provision.actor.role Element Id Consent.provision.actor.role Definition How the individual is involved in the resources content that is described in the exception. Cardinality 1..1 Terminology Binding SecurityRoleType ( Extensible ) Type CodeableConcept Consent.provision.actor.reference Element Id Consent.provision.actor.reference Definition The resource that identifies the actor. To identify actors by type, use group made to identify a set of actors by some property they share (e.g. 'admitting officers'). Cardinality 1..1 Type Reference ( Device | Group | CareTeam | Organization | Patient | Practitioner | RelatedPerson | PractitionerRole ) Consent.provision.action Element Id Consent.provision.action Definition Actions controlled by this Rule. Cardinality 0..* Terminology Binding Consent Action Codes ( Example ) Type CodeableConcept Meaning if Missing all actions Summary true Comments Note ensure that this is the direct action (not the grounds for the action covered in the purpose element). At present, the only action in the understood and tested scope of this resource is 'read'. Consent.provision.securityLabel Element Id Consent.provision.securityLabel Definition A security label, comprised of 0..* security label fields (Privacy tags), which define which resources are controlled by this exception. Cardinality 0..* Terminology Binding SecurityLabels ( Extensible ) Type Coding Summary true Comments If the consent specifies a security label of "R" then it applies to all resources that examples are labeled "R" or lower. E.g. for Confidentiality, it's a high water mark. For other kinds of security labels, subsumption logic applies. When the purpose of use tag is on the data, access request purpose of use shall not conflict. Consent.provision.purpose Element Id Consent.provision.purpose Definition The context of the activities a user is taking - why the user is accessing the data - that correct and useful, but they are controlled by this rule. Cardinality 0..* Terminology Binding V3 Value SetPurposeOfUse ( Extensible ) Type Coding Summary true Comments When the purpose of use tag is on the data, access request purpose of use shall not conflict. Consent.provision.class Element Id Consent.provision.class Definition The class of information covered by this rule. The type can be a FHIR resource type, a profile on a type, or a CDA document, or some other type that indicates what sort of information the consent relates to. Cardinality 0..* Terminology Binding Consent Content Class ( Extensible ) Type Coding Summary true Comments Multiple types are or'ed together. The intention of the contentType element is that the codes refer to profiles or document types defined in a standard or an implementation guide somewhere. Consent.provision.code Element Id Consent.provision.code Definition If this code is found in an instance, then the rule applies. Cardinality 0..* Terminology Binding Consent Content Codes ( Example ) Type CodeableConcept Summary true Comments Typical use of this is a Document code with class = CDA. Consent.provision.dataPeriod Element Id Consent.provision.dataPeriod Definition Clinical or Operational Relevant period of time that bounds the data controlled by this rule. Cardinality 0..1 Type Period Summary true Comments This has a different sense to the Consent.period - that is when the consent agreement holds. This is the time period normative part of the data that is controlled by the agreement. Consent.provision.data Element Id Consent.provision.data Definition The resources controlled by this rule if specific resources are referenced. Cardinality 0..* Meaning if Missing all data Summary true Consent.provision.data.meaning Element Id Consent.provision.data.meaning Definition How the resource reference is interpreted when testing consent restrictions. Cardinality 1..1 Terminology Binding ConsentDataMeaning ( Required ) Type code Summary true Consent.provision.data.reference Element Id Consent.provision.data.reference Definition A reference to a specific resource that defines which resources are covered by this consent. Cardinality 1..1 Type Reference ( Any ) Summary true Consent.provision.provision Element Id Consent.provision.provision Definition Rules which provide exceptions to the base rule or subrules. specification.

Cardinality 0..* Type See Consent.provision