Codesystem-consent-category.xml

Definition for Code System Consent Category Codes

<CodeSystem xmlns="http://hl7.org/fhir">
  <id value="consent-category"/>
  <meta>
    <lastUpdated value="2016-08-11T17:02:54.322+10:00"/>
    <profile value="http://hl7.org/fhir/StructureDefinition/codesystem-shareable-definition"/>
  </meta>
  <text>
    <status value="generated"/>
    <div xmlns="http://www.w3.org/1999/xhtml">
      <h2>Consent Category Codes</h2>
      <div>
        <p>This value set includes sample Consent Category codes.</p>

      </div>
      <p>
        <b>Copyright Statement:</b> This is an example set.
      </p>
      <p>This code system http://hl7.org/fhir/consentcategorycodes defines the following codes:</p>
      <table class="codes">
        <tr>
          <td>
            <b>Lvl</b>
          </td>
          <td>
            <b>Code</b>
          </td>
          <td>
            <b>Display</b>
          </td>
          <td>
            <b>Definition</b>
          </td>
        </tr>
        <tr>
          <td>1</td>
          <td>cat1
            <a name="consent-category-cat1"> </a>
          </td>
          <td>Advance Directive Consent examples</td>
          <td/>
        </tr>
        <tr>
          <td>2</td>
          <td>  advance-directive
            <a name="consent-category-advance-directive"> </a>
          </td>
          <td>Advance Directive</td>
          <td>Any instructions, written or given verbally by a patient to a health care provider in
             anticipation of potential need for medical treatment</td>
        </tr>
        <tr>
          <td>1</td>
          <td>cat2
            <a name="consent-category-cat2"> </a>
          </td>
          <td>Medical/Procedure Informed Consent</td>
          <td>RWJ funded toolkit has several international example consent forms, and excellent overview
             of issues around medical informed consent</td>
        </tr>
        <tr>
          <td>2</td>
          <td>  medical-consent
            <a name="consent-category-medical-consent"> </a>
          </td>
          <td>Medical Consent</td>
          <td>Informed consent is the process of communication between a patient and physician that
             results in the patient’s authorization or agreement to undergo a specific medical intervention
             [AMA 1998]. For both ethical and legal reasons, patients must be given enough information
             to be fully informed before deciding to undergo a major treatment, and this informed consent
             must be documented in writing.</td>
        </tr>
        <tr>
          <td>1</td>
          <td>cat3
            <a name="consent-category-cat3"> </a>
          </td>
          <td>Example of US jurisdictional [federal and state] privacy consent</td>
          <td/>
        </tr>
        <tr>
          <td>2</td>
          <td>  hipaa
            <a name="consent-category-hipaa"> </a>
          </td>
          <td>HIPAA Authorization</td>
          <td>HIPAA 45 CFR Section 164.508 Uses and disclosures for which an authorization is required.
             (a) Standard: Authorizations for uses and disclosures. (1) Authorization required: General
             rule. Except as otherwise permitted or required by this subchapter, a covered entity may
             not use or disclose protected health information without an authorization that is valid
             under this section. When a covered entity obtains or receives a valid authorization for
             its use or disclosure of protected health information, such use or disclosure must be
             consistent with such authorization. Usage Note: Authorizations governed under this regulation
             meet the definition of an opt in class of consent directive.</td>
        </tr>
        <tr>
          <td>2</td>
          <td>  SSA-827
            <a name="consent-category-SSA-827"> </a>
          </td>
          <td>SSA Authorization to Disclose</td>
          <td>SA Form SSA-827 (Authorization to Disclose Information to the Social Security Administration
             (SSA)). Form is available at https://www.socialsecurity.gov/forms/ssa-827-inst-sp.pdf</td>
        </tr>
        <tr>
          <td>1</td>
          <td>cat4
            <a name="consent-category-cat4"> </a>
          </td>
          <td>US “Mixed” state HIE consent types</td>
          <td>May include federal and state jurisdictional privacy laws</td>
        </tr>
        <tr>
          <td>2</td>
          <td>  DCH-3927
            <a name="consent-category-DCH-3927"> </a>
          </td>
          <td>Michigan behavior and mental health consent</td>
          <td>Michigan DCH-3927 Consent to Share Behavioral Health Information for Care Coordination
             Purposes, which combines 42 CFR Part 2 and Michigan Mental Health Code, Act 258 of 1974.
             Form is available at http://www.michigan.gov/documents/mdch/DCH-3927_Consent_to_Share_Health_Informa
            tion_477005_7.docx</td>
        </tr>
        <tr>
          <td>2</td>
          <td>  squaxin
            <a name="consent-category-squaxin"> </a>
          </td>
          <td>Squaxin Indian behavioral health and HIPAA consent</td>
          <td>Squaxin Indian HIPAA and 42 CFR Part 2 Consent for Release and Exchange of Confidential
             Information, which permits consenter to select healthcare record type and types of treatment
             purposes.  This consent requires disclosers and recipients to comply with 42 C.F.R. Part
             2, and HIPAA 45 C.F.R. parts 160 and 164. It includes patient notice of the refrain policy
             not to disclose without consent, and revocation rights. https://www.ncsacw.samhsa.gov/files/SI_Conse
            ntForReleaseAndExchange.PDF</td>
        </tr>
        <tr>
          <td>1</td>
          <td>cat5
            <a name="consent-category-cat5"> </a>
          </td>
          <td>Example international health information exchange consent type</td>
          <td/>
        </tr>
        <tr>
          <td>2</td>
          <td>  nl-lsp
            <a name="consent-category-nl-lsp"> </a>
          </td>
          <td>NL LSP Permission</td>
          <td>LSP (National Exchange Point) requires that providers, hospitals and pharmacy obtain explicit
             permission [opt-in] from healthcare consumers to submit and retrieve all or only some
             of a subject of care’s health information collected by the LSP for purpose of treatment,
             which can be revoked.  Without permission, a provider cannot access LSP information even
             in an emergency. The LSP provides healthcare consumers with accountings of disclosures.
             https://www.vzvz.nl/uploaded/FILES/htmlcontent/Formulieren/TOESTEMMINGSFORMULIER.pdf,
             https://www.ikgeeftoestemming.nl/en, https://www.ikgeeftoestemming.nl/en/registration/find-healthcar
            e-provider</td>
        </tr>
        <tr>
          <td>2</td>
          <td>  at-elga
            <a name="consent-category-at-elga"> </a>
          </td>
          <td>AT ELGA Opt-in Consent</td>
          <td>Pursuant to Sec. 2 no. 9 Health Telematics Act 2012, ELGA Health Data ( “ELGA-Gesundheitsdaten”)
             = Medical documents. Austria opted for an opt-out approach. This means that a person is
             by default ‘ELGA participant’ unless he/she objects. ELGA participants have the following
             options: General opt out: No participation in ELGA, Partial opt-out: No participation
             in a particular ELGA application, e.g. eMedication and Case-specific opt-out: No participation
             in ELGA only regarding a particular case/treatment. There is the possibility to opt-in
             again. ELGA participants can also exclude the access of a particular ELGA healthcare provider
             to a particular piece of or all of their ELGA data. http://ec.europa.eu/health/ehealth/docs/laws_aus
            tria_en.pdf</td>
        </tr>
        <tr>
          <td>1</td>
          <td>cat6
            <a name="consent-category-cat6"> </a>
          </td>
          <td>Examples of US Research Consent Types</td>
          <td/>
        </tr>
        <tr>
          <td>2</td>
          <td>  nih-hipaa
            <a name="consent-category-nih-hipaa"> </a>
          </td>
          <td>HHS NIH HIPAA Research Authorization</td>
          <td>Guidance and template form https://privacyruleandresearch.nih.gov/pdf/authorization.pdf</td>
        </tr>
        <tr>
          <td>2</td>
          <td>  nci
            <a name="consent-category-nci"> </a>
          </td>
          <td>NCI Cancer Clinical Trial consent</td>
          <td>see http://ctep.cancer.gov/protocolDevelopment/docs/Informed_Consent_Template.docx</td>
        </tr>
        <tr>
          <td>2</td>
          <td>  nih-grdr
            <a name="consent-category-nih-grdr"> </a>
          </td>
          <td>NIH Global Rare Disease Patient Registry and Data Repository consent</td>
          <td>Global Rare Disease Patient Registry and Data Repository (GRDR) consent is an agreement
             of a healthcare consumer to permit collection, access, use and disclosure of de-identified
             rare disease information and collection of bio-specimens, medical information, family
             history and other related information from patients to permit the registry collection
             of health and genetic information, and specimens for pseudonymized disclosure for research
             purpose of use. https://rarediseases.info.nih.gov/files/informed_consent_template.pdf</td>
        </tr>
        <tr>
          <td>2</td>
          <td>  va-10-10116
            <a name="consent-category-va-10-10116"> </a>
          </td>
          <td>VA Form 10-10116</td>
          <td>VA Form 10-10116 Revocation of Authorization for Use and Release of Individually Identifiable
             Health Information for Veterans Health Administration Research. Note: VA Form 10-10116
             is available @ http://www.northerncalifornia.va.gov/northerncalifornia/services/rnd/docs/vha-10-1011
            6.pdf</td>
        </tr>
        <tr>
          <td>2</td>
          <td>  nih-527
            <a name="consent-category-nih-527"> </a>
          </td>
          <td>NIH Authorization for the Release of Medical Information</td>
          <td>NIH Authorization for the Release of Medical Information is a patient’s consent for the
             National Institutes of Health Clinical Center to release medical information to care providers,
             which can be revoked. Note: Consent Form available @ http://cc.nih.gov/participate/_pdf/NIH-527.pdf</td>
        </tr>
        <tr>
          <td>2</td>
          <td>  ga4gh
            <a name="consent-category-ga4gh"> </a>
          </td>
          <td>Population origins and ancestry research consent</td>
          <td>Global Alliance for Genomic Health Data Sharing Consent Form is an example of the GA4GH
             Population origins and ancestry research consent form. Consenters agree to permitting
             a specified research project to collect ancestry and genetic information in controlled-access
             databases, and to allow other researchers to use deidentified information from those databases.
             http://www.commonaccord.org/index.php?action=doc&amp;file=Wx/org/genomicsandhealth/REWG/Demo/Roberta
            _Robinson_US</td>
        </tr>
      </table>
    </div>
  </text>
  <url value="http://hl7.org/fhir/consentcategorycodes"/>
  <identifier>
    <system value="urn:ietf:rfc:3986"/>
    <value value="urn:oid:2.16.840.1.113883.4.642.1.973"/>
  </identifier>
  <version value="1.6.0"/>
  <name value="Consent Category Codes"/>
  <status value="draft"/>
  <experimental value="true"/>
  <publisher value="CBCC"/>
  <contact>
    <telecom>
      <system value="other"/>
      <value value="http://hl7.org/fhir"/>
    </telecom>
  </contact>
  <description value="This value set includes sample Consent Category codes."/>
  <copyright value="This is an example set."/>
  <caseSensitive value="true"/>
  <valueSet value="http://hl7.org/fhir/ValueSet/consent-category"/>
  <hierarchyMeaning value="subsumes"/>
  <content value="complete"/>
  <property>
    <code value="notSelectable"/>
    <uri value="http://hl7.org/fhir/concept-properties#notSelectable"/>
    <description value="Indicates that the code is abstract - only intended to be used as a selector for other
            concepts"/>
    <type value="boolean"/>
  </property>
  <concept>
    <code value="cat1"/>
    <display value="Advance Directive Consent examples"/>
    <property>
      <code value="notSelectable"/>
      <valueBoolean value="true"/>
    </property>
    <concept>
      <code value="advance-directive"/>
      <display value="Advance Directive"/>
      <definition value="Any instructions, written or given verbally by a patient to a health care provider in
       anticipation of potential need for medical treatment"/>
    </concept>
  </concept>
  <concept>
    <code value="cat2"/>
    <display value="Medical/Procedure Informed Consent"/>
    <definition value="RWJ funded toolkit has several international example consent forms, and excellent overview
     of issues around medical informed consent"/>
    <property>
      <code value="notSelectable"/>
      <valueBoolean value="true"/>
    </property>
    <concept>
      <code value="medical-consent"/>
      <display value="Medical Consent"/>
      <definition value="Informed consent is the process of communication between a patient and physician that
       results in the patient’s authorization or agreement to undergo a specific medical intervention
       [AMA 1998]. For both ethical and legal reasons, patients must be given enough information
       to be fully informed before deciding to undergo a major treatment, and this informed consent
       must be documented in writing."/>
    </concept>
  </concept>
  <concept>
    <code value="cat3"/>
    <display value="Example of US jurisdictional [federal and state] privacy consent"/>
    <property>
      <code value="notSelectable"/>
      <valueBoolean value="true"/>
    </property>
    <concept>
      <code value="hipaa"/>
      <display value="HIPAA Authorization"/>
      <definition value="HIPAA 45 CFR Section 164.508 Uses and disclosures for which an authorization is required.
       (a) Standard: Authorizations for uses and disclosures. (1) Authorization required: General
       rule. Except as otherwise permitted or required by this subchapter, a covered entity may
       not use or disclose protected health information without an authorization that is valid
       under this section. When a covered entity obtains or receives a valid authorization for
       its use or disclosure of protected health information, such use or disclosure must be
       consistent with such authorization. Usage Note: Authorizations governed under this regulation
       meet the definition of an opt in class of consent directive."/>
    </concept>
    <concept>
      <code value="SSA-827"/>
      <display value="SSA Authorization to Disclose"/>
      <definition value="SA Form SSA-827 (Authorization to Disclose Information to the Social Security Administration
       (SSA)). Form is available at https://www.socialsecurity.gov/forms/ssa-827-inst-sp.pdf"/>
    </concept>
  </concept>
  <concept>
    <code value="cat4"/>
    <display value="US “Mixed” state HIE consent types"/>
    <definition value="May include federal and state jurisdictional privacy laws"/>
    <property>
      <code value="notSelectable"/>
      <valueBoolean value="true"/>
    </property>
    <concept>
      <code value="DCH-3927"/>
      <display value="Michigan behavior and mental health consent"/>
      <definition value="Michigan DCH-3927 Consent to Share Behavioral Health Information for Care Coordination
       Purposes, which combines 42 CFR Part 2 and Michigan Mental Health Code, Act 258 of 1974.
       Form is available at http://www.michigan.gov/documents/mdch/DCH-3927_Consent_to_Share_Health_Informa
      tion_477005_7.docx"/>
    </concept>
    <concept>
      <code value="squaxin"/>
      <display value="Squaxin Indian behavioral health and HIPAA consent"/>
      <definition value="Squaxin Indian HIPAA and 42 CFR Part 2 Consent for Release and Exchange of Confidential
       Information, which permits consenter to select healthcare record type and types of treatment
       purposes.  This consent requires disclosers and recipients to comply with 42 C.F.R. Part
       2, and HIPAA 45 C.F.R. parts 160 and 164. It includes patient notice of the refrain policy
       not to disclose without consent, and revocation rights. https://www.ncsacw.samhsa.gov/files/SI_Conse
      ntForReleaseAndExchange.PDF"/>
    </concept>
  </concept>
  <concept>
    <code value="cat5"/>
    <display value="Example international health information exchange consent type"/>
    <property>
      <code value="notSelectable"/>
      <valueBoolean value="true"/>
    </property>
    <concept>
      <code value="nl-lsp"/>
      <display value="NL LSP Permission"/>
      <definition value="LSP (National Exchange Point) requires that providers, hospitals and pharmacy obtain explicit
       permission [opt-in] from healthcare consumers to submit and retrieve all or only some
       of a subject of care’s health information collected by the LSP for purpose of treatment,
       which can be revoked.  Without permission, a provider cannot access LSP information even
       in an emergency. The LSP provides healthcare consumers with accountings of disclosures.
       https://www.vzvz.nl/uploaded/FILES/htmlcontent/Formulieren/TOESTEMMINGSFORMULIER.pdf,
       https://www.ikgeeftoestemming.nl/en, https://www.ikgeeftoestemming.nl/en/registration/find-healthcar
      e-provider"/>
    </concept>
    <concept>
      <code value="at-elga"/>
      <display value="AT ELGA Opt-in Consent"/>
      <definition value="Pursuant to Sec. 2 no. 9 Health Telematics Act 2012, ELGA Health Data ( “ELGA-Gesundheitsdaten”)
       = Medical documents. Austria opted for an opt-out approach. This means that a person is
       by default ‘ELGA participant’ unless he/she objects. ELGA participants have the following
       options: General opt out: No participation in ELGA, Partial opt-out: No participation
       in a particular ELGA application, e.g. eMedication and Case-specific opt-out: No participation
       in ELGA only regarding a particular case/treatment. There is the possibility to opt-in
       again. ELGA participants can also exclude the access of a particular ELGA healthcare provider
       to a particular piece of or all of their ELGA data. http://ec.europa.eu/health/ehealth/docs/laws_aus
      tria_en.pdf"/>
    </concept>
  </concept>
  <concept>
    <code value="cat6"/>
    <display value="Examples of US Research Consent Types"/>
    <property>
      <code value="notSelectable"/>
      <valueBoolean value="true"/>
    </property>
    <concept>
      <code value="nih-hipaa"/>
      <display value="HHS NIH HIPAA Research Authorization"/>
      <definition value="Guidance and template form https://privacyruleandresearch.nih.gov/pdf/authorization.pdf"/>
    </concept>
    <concept>
      <code value="nci"/>
      <display value="NCI Cancer Clinical Trial consent"/>
      <definition value="see http://ctep.cancer.gov/protocolDevelopment/docs/Informed_Consent_Template.docx"/>
    </concept>
    <concept>
      <code value="nih-grdr"/>
      <display value="NIH Global Rare Disease Patient Registry and Data Repository consent"/>
      <definition value="Global Rare Disease Patient Registry and Data Repository (GRDR) consent is an agreement
       of a healthcare consumer to permit collection, access, use and disclosure of de-identified
       rare disease information and collection of bio-specimens, medical information, family
       history and other related information from patients to permit the registry collection
       of health and genetic information, and specimens for pseudonymized disclosure for research
       purpose of use. https://rarediseases.info.nih.gov/files/informed_consent_template.pdf"/>
    </concept>
    <concept>
      <code value="va-10-10116"/>
      <display value="VA Form 10-10116"/>
      <definition value="VA Form 10-10116 Revocation of Authorization for Use and Release of Individually Identifiable
       Health Information for Veterans Health Administration Research. Note: VA Form 10-10116
       is available @ http://www.northerncalifornia.va.gov/northerncalifornia/services/rnd/docs/vha-10-1011
      6.pdf"/>
    </concept>
    <concept>
      <code value="nih-527"/>
      <display value="NIH Authorization for the Release of Medical Information"/>
      <definition value="NIH Authorization for the Release of Medical Information is a patient’s consent for the
       National Institutes of Health Clinical Center to release medical information to care providers,
       which can be revoked. Note: Consent Form available @ http://cc.nih.gov/participate/_pdf/NIH-527.pdf"/>
    </concept>
    <concept>
      <code value="ga4gh"/>
      <display value="Population origins and ancestry research consent"/>
      <definition value="Global Alliance for Genomic Health Data Sharing Consent Form is an example of the GA4GH
       Population origins and ancestry research consent form. Consenters agree to permitting
       a specified research project to collect ancestry and genetic information in controlled-access
       databases, and to allow other researchers to use deidentified information from those databases.
       http://www.commonaccord.org/index.php?action=doc&amp;file=Wx/org/genomicsandhealth/REWG/Demo/Roberta
      _Robinson_US"/>
    </concept>
  </concept>
</CodeSystem>