1.3.6.1.4.1.19376.1.5.3.1.1.7

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Consent to Share Information Specification 1.3.6.1.4.1.19376.1.5.3.1.1.7

Standards

CDAR2	Clinical Document Architecture, Release 2.0, 2005, HL7
XDS-SD	Scanned Documents

Conformance

CDA Release 2.0 documents that conform to the requirements of this content module shall indicate their conformance by the inclusion of the appropriate <templateId> elements in the header of the document. This is shown in the sample document below.

Sample Consent to Share Information Document

<ClinicalDocument xmlns='urn:hl7-org:v3'> <typeId extension="POCD_HD000040" root="2.16.840.1.113883.1.3"/> <templateId root='1.3.6.1.4.1.19376.1.5.3.1.1.7'/> <id root=' ' extension=' '/> <code code=' ' displayName=' ' codeSystem='2.16.840.1.113883.6.1' codeSystemName='LOINC'/> <title>Consent to Share Information</title> <effectiveTime value='20241017012005'/> <confidentialityCode code='N' displayName='Normal' codeSystem='2.16.840.1.113883.5.25' codeSystemName='Confidentiality' /> <languageCode code='en-US'/> : <component><structuredBody>     </structuredBody></component> </ClinicalDocument>

 

   <!-- Verify the document type code -->
   <assert test='cda:code[@code = "{{{LOINC}}}"]'>
     Error: The document type code of a Consent to Share Information must be {{{LOINC}}}
   </assert>
   <assert test='cda:code[@codeSystem = "2.16.840.1.113883.6.1"]'>
     Error: The document type code must come from the LOINC code 
     system (2.16.840.1.113883.6.1).
   </assert>

Conformance

A Consent document is an instance of the act of a patient signing a Patient Privacy Consent Policy and is a type of medical document, and incorporates the constraints defined for Medical Documents(1.3.6.1.4.1.19376.1.5.3.1.1.1) found above.

CDA Release 2.0 documents that conform to the requirements of this content shall indicate their conformance by the inclusion of the appropriate <templateId> element in the header of the document. This is shown below:

<ClinicalDocument xmlns='urn:hl7-org:v3'>
	<typeId extension="POCD_HD000040" root="2.16.840.1.113883.1.3"/>
	<templateId root="1.3.6.1.4.1.19376.1.5.3.1.1.7"/>
		:

A CDA Document may conform to more than one template, and can therefore have more that one <templateId> element. One of those <templateId> elements must appear exactly as shown above.

Constraints

A consent shall contain a text description of what the patient consented to, a list of codes indicating the policy(s) agreed to, a time range indicating the effective time of the consent, and shall contain a signature signifying the patient agreement to those policy(s) stated in the text description. Finally, consents should be attested to using an electronic digital signature, conforming to the ITI Digital Signature Profile.

The text description and signature may appear as a scanned image, when it does, it shall also conform to the constraints of the ITI Scanned Document profile.

A consent shall have one or more <serviceEvent> elements in the header identifying the policies authorized by the document (see Section 4.2.3.4 of CDAR2). Each <serviceEvent> element indicates informed consent to one and only one XDS Affinity Domain policy. More than one policy may be agreed to within a given consent document.

Consent documents should be attested to by either the patient and/or legal guardian, or a third party assigned by the XDS Affinity Domain or its member organizations. The attestation, if present, shall be performed using the ITI Digital Signature profile. The signer may be the patient, or a third party.