cdaefa:Consent Directive Observation Entry (Template)

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A consent directive observation is a specialization of the IHE PCC simple observation content module (1.3.6.1.4.1.19376.1.5.3.1.4.13) that uses a specific vocabulary.

Standards

• IHE PCC simple observation content module (1.3.6.1.4.1.19376.1.5.3.1.4.13)

Template

  <observation typeCode='OBS' moodCode='EVN'>
     <templateId root='1.3.6.1.4.1.19376.1.5.3.1.4.13'/>
     <templateId root='1.2.276.0.76.3.1.81.81.6.4.1'/>
     <id root=' ' extension=' '/>
     <code code='A|R|P|X' displayName='Active|Refused|Pending|Rescinded' 
              codeSystem='2.16.840.1.113883.12.498' 
              codeSystemName='HL7 Consent Status'/>
     <value xsi:type='CD' code=' ' displayName=' ' 
                          codeSystem='1.2.276.0.76.3.1.81.81.5.1' 
                          codeSystemName='eCR Consent Authorization Code'/>
     <text><reference value='#xxx'/></text>
     <statusCode code='completed'/>
     <effectiveTime>
        <low value='YYYYMMDD'/>
        <high value='YYYYMMDD'/>
     </effectiveTime>  
     <author>
        
        <assignedAuthor>
           <templateId root='1.2.276.0.76.3.1.81.81.6.2.2'/> 
           <id root= extension=>
           <addr></addr>
           <telecom value= use=>
           <assignedPerson><name></name></assignedPerson>
           <representedOrganization><name></name></representedOrganization>
        </assignedAuthor>
     </author>    
     <reference typeCode='REFR'>
        <templateId root='2.16.840.1.113883.10.20.1.36'/>
        <externalDocument classCode='DOC' moodCode='EVN'>
           <id root='...' extension='...'/>
           <code code="59284-0" codeSystem="2.16.840.1.113883.6.1" 
     		  codeSystemName="LOINC" displayName="Consent"/>
           <text><reference value='...'/></text>
        </externalDocument>
     </reference>
  </observation>

Consent directives <observation> shall be represented as shown above. They SHOULD NOT contain any <repeatNumber>, <interpretationCode>, <value>, <methodCode> or <targetSiteCode> elements.

<templateId root='1.3.6.1.4.1.19376.1.5.3.1.4.13'/>
<templateId root='1.2.276.0.76.3.1.81.81.6.4.1'/>

The <templateId> elements shown above MUST be present, and indicate that this is a Consent Directive entry.

<code code='A|R|P|X' displayName='Active|Refused|Pending|Rescinded' codeSystem='2.16.840.1.113883.12.498' codeSystemName='HL7 Consent Status'/>

This code records the status of the consent:

• Active (code=’A’): The patient has given consent to using an eCR to support his treatment. Authorized users can read and write data to an eCR according to their roles.
• Rescinded (code=’X’): The patient has revoked his consent for using an eCR. During the grace period authorized users MAY still read the eCR in order to create copies for their internal documentation. The minimum and maximum duration of the grace period MUST be defined by the privacy concept of the eCR provider.
• Pending (code=’P’): Consent has not been sought (e.g. because the patient was uncautious) or has been asked but not been confirmed until now. In this state users MAY write documents to the eCR but MUST NOT read the eCR. The maximum duration of a pending status MUST be defined by the privacy concept of the eCR provider.
• Refused (code=’R’): If a pending consent is rejected or not confirmed the state of the consent is set to ‘R’. The eCR MUST immediately be closed and all copies of medical documents within the eCR MUST be deleted.

<value xsi:type='CD' code=' ' displayName=' ' codeSystem='1.2.276.0.76.3.1.81.81.5.1' codeSystemName='eCR Consent Authorization Code'/>

This element records the permissions that have been gratend (or revoked) by the consent. It MUST be typed as “CD”.

Multiple <value> elements MAY be used to record multiple permissions. Each <value> element should use one of the codes listed in appendix B.1.

If this element is omitted, ‘USE’ is assumed to be the permission assigned (or revoked) with the registered consent document.

Other code systems than the “eCR Consent Authorization” code system MAY be used.

<text><reference value='#xxx'/></text>

SHOULD contain a reference to the narrative description of the given consent that is provided in the section’s <text> element. Alternatively the description of the consent MAY be directly given within this element.

<effectiveTime><low value='YYYYMMDD' /><high value='YYYYMMDD'/></effectiveTime>

The start and end date of the consent validity MUST be provided by an <effectiveTime> element. The eCR managing system MUST ensure that the consent validity time span is within the maximum validity time span of an eCR (as stated in the eCR privacy concept).

<author>

The person to whom the consent was given MUST be recorded in a single <author> element.

The time of the consent form creation shall be recorded in the element. At least YYYYMMDD MUST be provided.

<assignedAuthor>

The assigned author MUST be encoded using the Assigned Human Entity Content Module (1.2.276.0.76.3.1.81.81.6.2.2) as defined in section 2.2 of this document.

Example

   <entry>
	<templateId root='1.3.6.1.4.1.19376.1.5.3.1.4.13'/>
	<templateId root='1.2.276.0.76.3.1.81.81.6.4.1'/>

	<observation typeCode='OBS' moodCode='EVN'>
		<templateId root='1.3.6.1.4.1.19376.1.5.3.1.4.13'/>
		<templateId root='1.2.276.0.76.3.1.81.81.6.4.1'/>
    
		<id root='1.1.1.1' extension='consent-1'/>

<!-- the consent is active; documents may be registered and read -->
		<code code='P' displayName='Active' 
					codeSystem='2.16.840.1.113883.12.498' 
    					codeSystemName='HL7 Consent Status'/>

<!-- the consent allows for regular eCR use and allows eCR participants to autonomously
     Link visits to the eCR -->
		<value xsi:type='CD' code='SETUP' displayName='Setup and Use' 
				codeSystem='1.2.276.0.76.3.1.81.81.5.1' 
				codeSystemName='eCR Consent Authorization Code'/>
		<value xsi:type='CD' code='ENCLINK' displayName='Encounter Linkage' 
				codeSystem='1.2.276.0.76.3.1.81.81.5.1' 
				codeSystemName='eCR Consent Authorization Code'/>

		<text><reference value='#id-2'/></text>

		<statusCode code='completed'/>

<!-- the consent is valid for 2 years -->
		<effectiveTime>
				<low value='20110909'/>
				<high value='20130909'/>
		</effectiveTime>  

<!-- the consent was given to the identified physician on Sept. 9. 2011 -->
		<author>
			<time value="20110909"/>
			<assignedAuthor>
				<templateId root='1.2.276.0.76.3.1.81.81.6.2.2'/>
				<id extension='HPC-Physician-2' root='1.2.276.0.76.4.75'/>
				<code code='1.2.276.0.76.4.30' displayName='arzt-ghcs'/>
				...
			</assignedAuthor>
		</author>

<!-- reference to the consent, see following sections for examples -->
		<reference typeCode='REFR'>
			<templateId root='2.16.840.1.113883.10.20.1.36'/>
			...
    			<code code="59284-0" codeSystem="2.16.840.1.113883.6.1" 
      		      codeSystemName="LOINC" displayName="Consent"/>
			...
		</reference>
	</observation>
   </entry> 

Reference to a Consent that is stored as a Document

If the consent is available as a digital document within a Document Repository the reference points to the information object that represents the consent.

  <reference typeCode='REFR'>
     <templateId root='2.16.840.1.113883.10.20.1.36'/>
     <externalDocument classCode='DOC' moodCode='EVN'>
        <id root=' ' extension=' '/>
        <code code="59284-0" codeSystem="2.16.840.1.113883.6.1" 
  		  codeSystemName="LOINC" displayName="Consent"/>
        <text />
     </externalDocument>
  </reference>

For digitally signed consents and scanned consent documents that are stored in a document repository, the consent directive observation MUST contain a single reference to an external document. The <id> element MUST contain the appropriate root and extension attributes to identify the consent document. Within a Consent Update document a user may change the care team setup based on an existing consent (e.g. in cases where a consent with an eCR Authorization Code of ‘PARTMGMT’ is already registered). In this case the <externalDocument> MUST either explicitly refer to this consent (via <id>) or mark the identifier as existend but unknown (<id NullFlavor=”UNK”/>). If the identifier is nullified, the document processor SHOULD search for a matching consent and replace the nullified identfier with a reference to the respective consent.

  <reference typeCode='REFR'>
     <templateId root='2.16.840.1.113883.10.20.1.36'/>
     <externalDocument classCode='DOC' moodCode='EVN'>
        <id NullFlavor="UNK" />
        <code code="59284-0" codeSystem="2.16.840.1.113883.6.1" 
  		  codeSystemName="LOINC" displayName="Consent"/>
     </externalDocument>
  </reference>

Registration of a Paper Consent

For paper consents with wet signatures the <reference> element MUST contain an <externalDocument> element with an identifier that is nullified by a @NullFlavor value of ‘NA’.

  <reference typeCode='REFR' >
     <templateId root='2.16.840.1.113883.10.20.1.36'/>
     <externalDocument classCode='DOC' moodCode='EVN'>
        <id NullFlavor='NA' />
        <code code="59284-0" codeSystem="2.16.840.1.113883.6.1" 
                 codeSystemName="LOINC" displayName="Consent"/>
     </externalDocument>
  </reference>

Registration and Upload of a Digital Consent

Base64 encoded consent document can be included within the <text> element.

  <reference typeCode='REFR' >
     <templateId root='2.16.840.1.113883.10.20.1.36'/>
     <externalDocument classCode='DOC' moodCode='EVN'> 
        <id root=' ' extension=' '/>
        <
        <text representation=’B64’>Base64 encoded document</text>
     </externalDocument>
  </reference>

The <id> element MUST contain the local identifier of the document. The document processor MAY replace this identifier with a newly assigned id. In case that the document is not assigned a local identifier the <id> element MUST be marked with a NullFlavor of ‘UNK’. Consent document MUST always be given as uncompressed base64 encoded data.