Codesystem-consent-policy.xml

Definition for Code System Consent PolicyRule Codes

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  <id value="consent-policy"/> 
  <meta> 
    <lastUpdated value="2018-04-03T12:05:46.262+10:00"/> 
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      <h2> Consent PolicyRule Codes</h2> 
      <div> 
        <p> This value set includes sample Regulatory consent policy types from the US and other regions.</p> 

      </div> 
      <p> This code system http://hl7.org/fhir/consentpolicycodes defines the following codes:</p> 
      <table class="codes">
        <tr> 
          <td style="white-space:nowrap">
            <b> Code</b> 
          </td> 
          <td> 
            <b> Display</b> 
          </td> 
          <td> 
            <b> Definition</b> 
          </td> 
        </tr> 
        <tr> 
          <td style="white-space:nowrap">cric
            <a name="consent-policy-cric"> </a> 
          </td> 
          <td> Common Rule Informed Consent</td> 
          <td> 45 CFR part 46 §46.116 General requirements for informed consent; and §46.117 Documentation
             of informed consent. https://www.gpo.gov/fdsys/pkg/FR-2017-01-19/pdf/2017-01058.pdf</td> 
        </tr> 
        <tr> 
          <td style="white-space:nowrap">illinois-minor-procedure
            <a name="consent-policy-illinois-minor-procedure"> </a> 
          </td> 
          <td> Illinois Consent by Minors to Medical Procedures</td> 
          <td> The consent to the performance of a medical or surgical procedure by a physician licensed
             to practice medicine and surgery, a licensed advanced practice nurse, or a licensed physician
             assistant executed by a married person who is a minor, by a parent who is a minor, by
             a pregnant woman who is a minor, or by any person 18 years of age or older, is not voidable
             because of such minority, and, for such purpose, a married person who is a minor, a parent
             who is a minor, a pregnant woman who is a minor, or any person 18 years of age or older,
             is deemed to have the same legal capacity to act and has the same powers and obligations
             as has a person of legal age. Consent by Minors to Medical Procedures Act. (410 ILCS 210/0.01)
             (from Ch. 111, par. 4500) Sec. 0.01. Short title. This Act may be cited as the Consent
             by Minors to Medical Procedures Act. (Source: P.A. 86-1324.) http://www.ilga.gov/legislation/ilcs/il
            cs3.asp?ActID=1539&amp;ChapterID=35</td> 
        </tr> 
        <tr> 
          <td style="white-space:nowrap">hipaa-auth
            <a name="consent-policy-hipaa-auth"> </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 SJALL
             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 style="white-space:nowrap">hipaa-npp
            <a name="consent-policy-hipaa-npp"> </a> 
          </td> 
          <td> HIPAA Notice of Privacy Practices</td> 
          <td> § 164.520  Notice of privacy practices for protected health information. (1) Right to
             notice. Except as provided by paragraph (a)(2) or (3) of this section, an individual has
             a right to adequate notice of the uses and disclosures of protected health information
             that may be made by the covered entity, and of the individual's rights and the covered
             entity's legal duties with respect to protected health information. Usage Note: Restrictions
             governed under this regulation meet the definition of an implied with an opportunity to
             dissent class of consent directive.</td> 
        </tr> 
        <tr> 
          <td style="white-space:nowrap">hipaa-restrictions
            <a name="consent-policy-hipaa-restrictions"> </a> 
          </td> 
          <td> HIPAA Restrictions</td> 
          <td> HIPAA 45 CFR § 164.510 - Uses and disclosures requiring an opportunity for the individual
             to agree or to object. A covered entity may use or disclose protected health information,
             provided that the individual is informed in advance of the use or disclosure and has the
             opportunity to agree to or prohibit or restrict the use or disclosure, in accordance with
             the applicable requirements of this section. The covered entity may orally inform the
             individual of and obtain the individual's oral agreement or objection to a use or disclosure
             permitted by this section. Usage Note: Restrictions governed under this regulation meet
             the definition of an opt out with exception class of consent directive.</td> 
        </tr> 
        <tr> 
          <td style="white-space:nowrap">hipaa-research
            <a name="consent-policy-hipaa-research"> </a> 
          </td> 
          <td> HIPAA Research Authorization</td> 
          <td> HIPAA 45 CFR § 164.508 - Uses and disclosures for which an authorization is required.
             (a) Standard: Authorizations for uses and disclosures. (3) Compound authorizations. An
             authorization for use or disclosure of protected health information SHALL not be combined
             with any other document to create a compound authorization, except as follows: (i) An
             authorization for the use or disclosure of protected health information for a research
             study may be combined with any other type of written permission for the same or another
             research study. This exception includes combining an authorization for the use or disclosure
             of protected health information for a research study with another authorization for the
             same research study, with an authorization for the creation or maintenance of a research
             database or repository, or with a consent to participate in research. Where a covered
             health care provider has conditioned the provision of research-related treatment on the
             provision of one of the authorizations, as permitted under paragraph (b)(4)(i) of this
             section, any compound authorization created under this paragraph must clearly differentiate
             between the conditioned and unconditioned components and provide the individual with an
             opportunity to opt in to the research activities described in the unconditioned authorization.
             Usage Notes: See HHS http://www.hhs.gov/hipaa/for-professionals/special-topics/research/index.html
             and OCR http://www.hhs.gov/hipaa/for-professionals/special-topics/research/index.html</td> 
        </tr> 
        <tr> 
          <td style="white-space:nowrap">hipaa-self-pay
            <a name="consent-policy-hipaa-self-pay"> </a> 
          </td> 
          <td> HIPAA Self-Pay Restriction</td> 
          <td> HIPAA 45 CFR § 164.522(a) Right To Request a Restriction of Uses and Disclosures. (vi)
             A covered entity must agree to the request of an individual to restrict disclosure of
             protected health information about the individual to a health plan if: (A) The disclosure
             is for the purpose of carrying out payment or health care operations and is not otherwise
             required by law; and (B) The protected health information pertains solely to a health
             care item or service for which the individual, or person other than the health plan on
             behalf of the individual, has paid the covered entity in full. Usage Note: Restrictions
             governed under this regulation meet the definition of an opt out with exception class
             of consent directive. Opt out is limited to disclosures to a payer for payment and operations
             purpose of use. See HL7 HIPAA Self-Pay code in ActPrivacyLaw (2.16.840.1.113883.1.11.20426).</td> 
        </tr> 
        <tr> 
          <td style="white-space:nowrap">mdhhs-5515
            <a name="consent-policy-mdhhs-5515"> </a> 
          </td> 
          <td> Michigan MDHHS-5515 Consent to Share Behavioral Health Information for Care Coordination
             Purposes</td> 
          <td> On January 1, 2015, the Michigan Department of Health and Human Services (MDHHS) released
             a standard consent form for the sharing of health information specific to behavioral health
             and substance use treatment in accordance with Public Act 129 of 2014. In Michigan, while
             providers are not required to use this new standard form (MDHHS-5515), they are required
             to accept it. Note: Form is available at http://www.michigan.gov/documents/mdhhs/Consent_to_Share_Be
            havioral_Health_Information_for_Care_Coordination_Purposes_548835_7.docx For more information
             see http://www.michigan.gov/documents/mdhhs/Behavioral_Health_Consent_Form_Background_Information_54
            8864_7.pdf</td> 
        </tr> 
        <tr> 
          <td style="white-space:nowrap">nyssipp
            <a name="consent-policy-nyssipp"> </a> 
          </td> 
          <td> New York State Surgical and Invasive Procedure Protocol</td> 
          <td> The New York State Surgical and Invasive Procedure Protocol (NYSSIPP) applies to all operative
             and invasive procedures including endoscopy, general surgery or interventional radiology.
             Other procedures that involve puncture or incision of the skin, or insertion of an instrument
             or foreign material into the body are within the scope of the protocol. This protocol
             also applies to those anesthesia procedures either prior to a surgical procedure or independent
             of a surgical procedure such as spinal facet blocks. Example: Certain 'minor' procedures
             such as venipuncture, peripheral IV placement, insertion of nasogastric tube and foley
             catheter insertion are not within the scope of the protocol. From http://www.health.ny.gov/professio
            nals/protocols_and_guidelines/surgical_and_invasive_procedure/nyssipp_faq.htm Note: HHC
             100B-1 Form is available at http://www.downstate.edu/emergency_medicine/documents/Consent_CT_with_co
            ntrast.pdf</td> 
        </tr> 
        <tr> 
          <td style="white-space:nowrap">va-10-0484
            <a name="consent-policy-va-10-0484"> </a> 
          </td> 
          <td> VA Form 10-0484</td> 
          <td> VA Form 10-0484 Revocation for Release of Individually-Identifiable Health Information
             enables a veteran to revoke authorization for the VA to release specified copies of individually-ide
            ntifiable health information with the non-VA health care provider organizations participating
             in the eHealth Exchange and partnering with VA. Comment: Opt-in Consent Directive with
             status = rescinded (aka 'revoked'). Note: Form is available at http://www.va.gov/vaforms/medical/pdf
            /vha-10-0484-fill.pdf</td> 
        </tr> 
        <tr> 
          <td style="white-space:nowrap">va-10-0485
            <a name="consent-policy-va-10-0485"> </a> 
          </td> 
          <td> VA Form 10-0485</td> 
          <td> VA Form 10-0485 Request for and Authorization to Release Protected Health Information
             to eHealth Exchange enables a veteran to request and authorize a VA health care facility
             to release protected health information (PHI) for treatment purposes only to the communities
             that are participating in the eHealth Exchange, VLER Directive, and other Health Information
             Exchanges with who VA has an agreement. This information may consist of the diagnosis
             of Sickle Cell Anemia, the treatment of or referral for Drug Abuse, treatment of or referral
             for Alcohol Abuse or the treatment of or testing for infection with Human Immunodeficiency
             Virus. This authorization covers the diagnoses that I may have upon signing of the authorization
             and the diagnoses that I may acquire in the future including those protected by 38 U.S.C.
             7332. Comment: Opt-in Consent Directive. Note: Form is available at http://www.va.gov/vaforms/medica
            l/pdf/10-0485-fill.pdf</td> 
        </tr> 
        <tr> 
          <td style="white-space:nowrap">va-10-5345
            <a name="consent-policy-va-10-5345"> </a> 
          </td> 
          <td> VA Form 10-5345</td> 
          <td> VA Form 10-5345 Request for and Authorization to Release Medical Records or Health Information
             enables a veteran to request and authorize the VA to release specified copies of protected
             health information (PHI), such as hospital summary or outpatient treatment notes, which
             may include information about conditions governed under Title 38 Section 7332 (drug abuse,
             alcoholism or alcohol abuse, testing for or infection with HIV, and sickle cell anemia).
             Comment: Opt-in Consent Directive. Note: Form is available at http://www.va.gov/vaforms/medical/pdf/
            vha-10-5345-fill.pdf</td> 
        </tr> 
        <tr> 
          <td style="white-space:nowrap">va-10-5345a
            <a name="consent-policy-va-10-5345a"> </a> 
          </td> 
          <td> VA Form 10-5345a</td> 
          <td> VA Form 10-5345a Individuals' Request for a Copy of Their Own Health Information enables
             a veteran to request and authorize the VA to release specified copies of protected health
             information (PHI), such as hospital summary or outpatient treatment notes. Note: Form
             is available at http://www.va.gov/vaforms/medical/pdf/vha-10-5345a-fill.pdf</td> 
        </tr> 
        <tr> 
          <td style="white-space:nowrap">va-10-5345a-MHV
            <a name="consent-policy-va-10-5345a-MHV"> </a> 
          </td> 
          <td> VA Form 10-5345a-MHV</td> 
          <td> VA Form 10-5345a-MHV Individual’s Request for a Copy of their own health information
             from MyHealtheVet enables a veteran to receive a copy of all available personal health
             information to be delivered through the veteran’s My HealtheVet account. Note: Form
             is available at http://www.va.gov/vaforms/medical/pdf/vha-10-5345a-MHV-fill.pdf</td> 
        </tr> 
        <tr> 
          <td style="white-space:nowrap">va-10-10116
            <a name="consent-policy-va-10-10116"> </a> 
          </td> 
          <td> VA Form 10-10-10116</td> 
          <td> VA Form 10-10116 Revocation of Authorization for Use and Release of Individually Identifiable
             Health Information for Veterans Health Administration Research. Comment: Opt-in with Restriction
             Consent Directive with status = 'completed'. Note: Form is available at http://www.northerncaliforni
            a.va.gov/northerncalifornia/services/rnd/docs/vha-10-10116.pdf </td> 
        </tr> 
        <tr> 
          <td style="white-space:nowrap">va-21-4142
            <a name="consent-policy-va-21-4142"> </a> 
          </td> 
          <td> VA Form 21-4142</td> 
          <td> VA Form 21-4142 (Authorization and Consent to Release Information to the Department of
             Veterans Affairs (VA) enables a veteran to authorize the US Veterans Administration [VA]
             to request veteran’s health information from non-VA providers. Aka VA Compensation Application
             Note: Form is available at http://www.vba.va.gov/pubs/forms/VBA-21-4142-ARE.pdf . For
             additional information regarding VA Form 21-4142, refer to the following website: www.benefits.va.go
            v/compensation/consent_privateproviders</td> 
        </tr> 
        <tr> 
          <td style="white-space:nowrap">ssa-827
            <a name="consent-policy-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 style="white-space:nowrap">dch-3927
            <a name="consent-policy-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 style="white-space:nowrap">squaxin
            <a name="consent-policy-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 style="white-space:nowrap">nl-lsp
            <a name="consent-policy-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 style="white-space:nowrap">at-elga
            <a name="consent-policy-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 style="white-space:nowrap">nih-hipaa
            <a name="consent-policy-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 style="white-space:nowrap">nci
            <a name="consent-policy-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 style="white-space:nowrap">nih-grdr
            <a name="consent-policy-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 style="white-space:nowrap">nih-527
            <a name="consent-policy-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 style="white-space:nowrap">ga4gh
            <a name="consent-policy-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> 
  <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-wg">
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  <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-ballot-status">
    <valueString value="Trial Use"/> 
  </extension> 
  <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fmm">
    <valueInteger value="1"/> 
  </extension> 
  <url value="http://hl7.org/fhir/consentpolicycodes"/> 
  <identifier> 
    <system value="urn:ietf:rfc:3986"/> 
    <value value="urn:oid:2.16.840.1.113883.4.642.1.1015"/> 
  </identifier> 
  <version value="3.3.0"/> 
  <name value="Consent PolicyRule Codes"/> 
  <status value="draft"/> 
  <experimental value="true"/> 
  <publisher value="FHIR Project (CBCC)"/> 
  <contact> 
    <telecom> 
      <system value="url"/> 
      <value value="http://hl7.org/fhir"/> 
    </telecom> 
  </contact> 
  <description value="This value set includes sample Regulatory consent policy types from the US and other regions."/> 
  <caseSensitive value="true"/> 
  <valueSet value="http://hl7.org/fhir/ValueSet/consent-policy"/> 
  <hierarchyMeaning value="is-a"/> 
  <content value="complete"/> 
  <concept> 
    <code value="cric"/> 
    <display value="Common Rule Informed Consent"/> 
    <definition value="45 CFR part 46 §46.116 General requirements for informed consent; and §46.117 Documentation
     of informed consent. https://www.gpo.gov/fdsys/pkg/FR-2017-01-19/pdf/2017-01058.pdf"/> 
  </concept> 
  <concept> 
    <code value="illinois-minor-procedure"/> 
    <display value="Illinois Consent by Minors to Medical Procedures"/> 
    <definition value="The consent to the performance of a medical or surgical procedure by a physician licensed
     to practice medicine and surgery, a licensed advanced practice nurse, or a licensed physician
     assistant executed by a married person who is a minor, by a parent who is a minor, by
     a pregnant woman who is a minor, or by any person 18 years of age or older, is not voidable
     because of such minority, and, for such purpose, a married person who is a minor, a parent
     who is a minor, a pregnant woman who is a minor, or any person 18 years of age or older,
     is deemed to have the same legal capacity to act and has the same powers and obligations
     as has a person of legal age. Consent by Minors to Medical Procedures Act. (410 ILCS 210/0.01)
     (from Ch. 111, par. 4500) Sec. 0.01. Short title. This Act may be cited as the Consent
     by Minors to Medical Procedures Act. (Source: P.A. 86-1324.) http://www.ilga.gov/legislation/ilcs/il
    cs3.asp?ActID=1539&amp;ChapterID=35"/> 
  </concept> 
  <concept> 
    <code value="hipaa-auth"/> 
    <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 SJALL
     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="hipaa-npp"/> 
    <display value="HIPAA Notice of Privacy Practices"/> 
    <definition value="§ 164.520  Notice of privacy practices for protected health information. (1) Right to
     notice. Except as provided by paragraph (a)(2) or (3) of this section, an individual has
     a right to adequate notice of the uses and disclosures of protected health information
     that may be made by the covered entity, and of the individual's rights and the covered
     entity's legal duties with respect to protected health information. Usage Note: Restrictions
     governed under this regulation meet the definition of an implied with an opportunity to
     dissent class of consent directive."/> 
  </concept> 
  <concept> 
    <code value="hipaa-restrictions"/> 
    <display value="HIPAA Restrictions"/> 
    <definition value="HIPAA 45 CFR § 164.510 - Uses and disclosures requiring an opportunity for the individual
     to agree or to object. A covered entity may use or disclose protected health information,
     provided that the individual is informed in advance of the use or disclosure and has the
     opportunity to agree to or prohibit or restrict the use or disclosure, in accordance with
     the applicable requirements of this section. The covered entity may orally inform the
     individual of and obtain the individual's oral agreement or objection to a use or disclosure
     permitted by this section. Usage Note: Restrictions governed under this regulation meet
     the definition of an opt out with exception class of consent directive."/> 
  </concept> 
  <concept> 
    <code value="hipaa-research"/> 
    <display value="HIPAA Research Authorization"/> 
    <definition value="HIPAA 45 CFR § 164.508 - Uses and disclosures for which an authorization is required.
     (a) Standard: Authorizations for uses and disclosures. (3) Compound authorizations. An
     authorization for use or disclosure of protected health information SHALL not be combined
     with any other document to create a compound authorization, except as follows: (i) An
     authorization for the use or disclosure of protected health information for a research
     study may be combined with any other type of written permission for the same or another
     research study. This exception includes combining an authorization for the use or disclosure
     of protected health information for a research study with another authorization for the
     same research study, with an authorization for the creation or maintenance of a research
     database or repository, or with a consent to participate in research. Where a covered
     health care provider has conditioned the provision of research-related treatment on the
     provision of one of the authorizations, as permitted under paragraph (b)(4)(i) of this
     section, any compound authorization created under this paragraph must clearly differentiate
     between the conditioned and unconditioned components and provide the individual with an
     opportunity to opt in to the research activities described in the unconditioned authorization.
     Usage Notes: See HHS http://www.hhs.gov/hipaa/for-professionals/special-topics/research/index.html
     and OCR http://www.hhs.gov/hipaa/for-professionals/special-topics/research/index.html"/> 
  </concept> 
  <concept> 
    <code value="hipaa-self-pay"/> 
    <display value="HIPAA Self-Pay Restriction"/> 
    <definition value="HIPAA 45 CFR § 164.522(a) Right To Request a Restriction of Uses and Disclosures. (vi)
     A covered entity must agree to the request of an individual to restrict disclosure of
     protected health information about the individual to a health plan if: (A) The disclosure
     is for the purpose of carrying out payment or health care operations and is not otherwise
     required by law; and (B) The protected health information pertains solely to a health
     care item or service for which the individual, or person other than the health plan on
     behalf of the individual, has paid the covered entity in full. Usage Note: Restrictions
     governed under this regulation meet the definition of an opt out with exception class
     of consent directive. Opt out is limited to disclosures to a payer for payment and operations
     purpose of use. See HL7 HIPAA Self-Pay code in ActPrivacyLaw (2.16.840.1.113883.1.11.20426)."/> 
  </concept> 
  <concept> 
    <code value="mdhhs-5515"/> 
    <display value="Michigan MDHHS-5515 Consent to Share Behavioral Health Information for Care Coordination
     Purposes"/> 
    <definition value="On January 1, 2015, the Michigan Department of Health and Human Services (MDHHS) released
     a standard consent form for the sharing of health information specific to behavioral health
     and substance use treatment in accordance with Public Act 129 of 2014. In Michigan, while
     providers are not required to use this new standard form (MDHHS-5515), they are required
     to accept it. Note: Form is available at http://www.michigan.gov/documents/mdhhs/Consent_to_Share_Be
    havioral_Health_Information_for_Care_Coordination_Purposes_548835_7.docx For more information
     see http://www.michigan.gov/documents/mdhhs/Behavioral_Health_Consent_Form_Background_Information_54
    8864_7.pdf"/> 
  </concept> 
  <concept> 
    <code value="nyssipp"/> 
    <display value="New York State Surgical and Invasive Procedure Protocol"/> 
    <definition value="The New York State Surgical and Invasive Procedure Protocol (NYSSIPP) applies to all operative
     and invasive procedures including endoscopy, general surgery or interventional radiology.
     Other procedures that involve puncture or incision of the skin, or insertion of an instrument
     or foreign material into the body are within the scope of the protocol. This protocol
     also applies to those anesthesia procedures either prior to a surgical procedure or independent
     of a surgical procedure such as spinal facet blocks. Example: Certain 'minor' procedures
     such as venipuncture, peripheral IV placement, insertion of nasogastric tube and foley
     catheter insertion are not within the scope of the protocol. From http://www.health.ny.gov/professio
    nals/protocols_and_guidelines/surgical_and_invasive_procedure/nyssipp_faq.htm Note: HHC
     100B-1 Form is available at http://www.downstate.edu/emergency_medicine/documents/Consent_CT_with_co
    ntrast.pdf"/> 
  </concept> 
  <concept> 
    <code value="va-10-0484"/> 
    <display value="VA Form 10-0484"/> 
    <definition value="VA Form 10-0484 Revocation for Release of Individually-Identifiable Health Information
     enables a veteran to revoke authorization for the VA to release specified copies of individually-ide
    ntifiable health information with the non-VA health care provider organizations participating
     in the eHealth Exchange and partnering with VA. Comment: Opt-in Consent Directive with
     status = rescinded (aka 'revoked'). Note: Form is available at http://www.va.gov/vaforms/medical/pdf
    /vha-10-0484-fill.pdf"/> 
  </concept> 
  <concept> 
    <code value="va-10-0485"/> 
    <display value="VA Form 10-0485"/> 
    <definition value="VA Form 10-0485 Request for and Authorization to Release Protected Health Information
     to eHealth Exchange enables a veteran to request and authorize a VA health care facility
     to release protected health information (PHI) for treatment purposes only to the communities
     that are participating in the eHealth Exchange, VLER Directive, and other Health Information
     Exchanges with who VA has an agreement. This information may consist of the diagnosis
     of Sickle Cell Anemia, the treatment of or referral for Drug Abuse, treatment of or referral
     for Alcohol Abuse or the treatment of or testing for infection with Human Immunodeficiency
     Virus. This authorization covers the diagnoses that I may have upon signing of the authorization
     and the diagnoses that I may acquire in the future including those protected by 38 U.S.C.
     7332. Comment: Opt-in Consent Directive. Note: Form is available at http://www.va.gov/vaforms/medica
    l/pdf/10-0485-fill.pdf"/> 
  </concept> 
  <concept> 
    <code value="va-10-5345"/> 
    <display value="VA Form 10-5345"/> 
    <definition value="VA Form 10-5345 Request for and Authorization to Release Medical Records or Health Information
     enables a veteran to request and authorize the VA to release specified copies of protected
     health information (PHI), such as hospital summary or outpatient treatment notes, which
     may include information about conditions governed under Title 38 Section 7332 (drug abuse,
     alcoholism or alcohol abuse, testing for or infection with HIV, and sickle cell anemia).
     Comment: Opt-in Consent Directive. Note: Form is available at http://www.va.gov/vaforms/medical/pdf/
    vha-10-5345-fill.pdf"/> 
  </concept> 
  <concept> 
    <code value="va-10-5345a"/> 
    <display value="VA Form 10-5345a"/> 
    <definition value="VA Form 10-5345a Individuals' Request for a Copy of Their Own Health Information enables
     a veteran to request and authorize the VA to release specified copies of protected health
     information (PHI), such as hospital summary or outpatient treatment notes. Note: Form
     is available at http://www.va.gov/vaforms/medical/pdf/vha-10-5345a-fill.pdf"/> 
  </concept> 
  <concept> 
    <code value="va-10-5345a-MHV"/> 
    <display value="VA Form 10-5345a-MHV"/> 
    <definition value="VA Form 10-5345a-MHV Individual’s Request for a Copy of their own health information
     from MyHealtheVet enables a veteran to receive a copy of all available personal health
     information to be delivered through the veteran’s My HealtheVet account. Note: Form
     is available at http://www.va.gov/vaforms/medical/pdf/vha-10-5345a-MHV-fill.pdf"/> 
  </concept> 
  <concept> 
    <code value="va-10-10116"/> 
    <display value="VA Form 10-10-10116"/> 
    <definition value="VA Form 10-10116 Revocation of Authorization for Use and Release of Individually Identifiable
     Health Information for Veterans Health Administration Research. Comment: Opt-in with Restriction
     Consent Directive with status = 'completed'. Note: Form is available at http://www.northerncaliforni
    a.va.gov/northerncalifornia/services/rnd/docs/vha-10-10116.pdf "/> 
  </concept> 
  <concept> 
    <code value="va-21-4142"/> 
    <display value="VA Form 21-4142"/> 
    <definition value="VA Form 21-4142 (Authorization and Consent to Release Information to the Department of
     Veterans Affairs (VA) enables a veteran to authorize the US Veterans Administration [VA]
     to request veteran’s health information from non-VA providers. Aka VA Compensation Application
     Note: Form is available at http://www.vba.va.gov/pubs/forms/VBA-21-4142-ARE.pdf . For
     additional information regarding VA Form 21-4142, refer to the following website: www.benefits.va.go
    v/compensation/consent_privateproviders"/> 
  </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> 
    <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> 
    <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> 
    <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="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> 
</CodeSystem>