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  1. FHIR Specification Feedback
  2. FHIR-11070

Change value set for Consent.category - 2016-09 core #89

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    • Resolution: Not Persuasive with Modification
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    • FHIR Core (FHIR)
    • DSTU2
    • Community-Based Care and Privacy
    • Consent
    • 6.4.4
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      Change value set to be:

      <ValueSet xmlns="http://hl7.org/fhir" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" xsi:schemaLocation="http://hl7.org/fhir ../../schema/valueset.xsd"> <text> <status value="generated"/> <div xmlns="http://www.w3.org/1999/xhtml"> This value set includes sample Consent Directive Type codes. </div> </text> <name value="Consent Directive Type Codes"/> <publisher value="CBCC"/> <copyright value="This is an example set, which includes several consent directive related LOINC codes; HL7 VALUE SET: ActConsentType(2.16.840.1.113883.1.11.19897)"/> <status value="draft"/> <telecom> <system value="url"/> <value value="http://hl7.org/fhir"/> </telecom> <description value="This value set includes sample Consent Directive Type codes, including several consent directive related LOINC codes; HL7 VALUE SET: ActConsentType(2.16.840.1.113883.1.11.19897); examples of US realm consent directive legal descriptions and references to online and/or downloadable forms such as the SSA-827 Authorization to Disclose Information to the Social Security Administration; and other anticipated consent directives related to participation in a clinical trial, medical procedures, reproductive procedures; health care directive (Living Will); advance directive, do not resuscitate (DNR); Physician Orders for Life-Sustaining Treatment (POLST)."/> <status value="draft"/> <concept> <code value="42 CFR Part 2 Consent/> <display value="42 CFR Part 2 Form of written consent"/> <definition value="Required elements in a written consent to a disclosure of information governed under 42 CFR Part 2. http://www.ecfr.gov/cgi-bin/text-idx?SID=69c4339acd2df9fab9dcbed15181917b&mc=true&node=pt42.1.2&rgn=div5"/> </concept> <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. [2005 Honor My Wishes]"/> </concept> <concept> <code value="common rule informed consent"/> <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="do not resuscitate"/> <display value="DNR"/> <definition value="A legal document, signed by both the patient and their provider, stating a desire not to have CPR initiated in case of a cardiac event. Note: This form was replaced in 2003 with the Physician Orders for Life-Sustaining Treatment [POLST]."/> </concept> <concept> <code value="EMRGONLY"/> <display value="emergency only"/> <definition value="Opt-in to disclosure of health information for emergency only consent directive. Comment: This general consent directive specifically limits disclosure of health information for purpose of emergency treatment. Additional parameters may further limit the disclosure to specific users, roles, duration, types of information, and impose uses obligations. [ActConsentDirective (2.16.840.1.113883.1.11.20425)]"/> </concept> <concept> <code value="Illinois Consent by Minors to Medical Procedures"/> <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/ilcs3.asp?ActID=1539&ChapterID=35" </concept> <concept> <code value="ICOL"/> <display value="information collection"/> <definition value="Consent to have healthcare information collected in an electronic health record. This entails that the information may be used in analysis, modified, updated. [VALUE SET: ActConsentType (2.16.840.1.113883.1.11.19897)]"/> </concept> <concept> <code value="IDSCL"/> <display value="information disclosure"/> <definition value="Consent to have collected healthcare information disclosed. [VALUE SET: ActConsentType (2.16.840.1.113883.1.11.19897)]"/> </concept> <concept> <code value="INFA"/> <display value="information access"/> <definition value="Consent to access healthcare information.[VALUE SET: ActConsentType (2.16.840.1.113883.1.11.19897)]"/> </concept> <concept> <code value="IRDSCL"/> <display value="information redisclosure"/> <definition value="Information re-disclosed without the patient's consent. [VALUE SET: ActConsentType (2.16.840.1.113883.1.11.19897)]"/> </concept> <concept> <code value="health care directive"/> <display value="health care directive"/> <definition value="Patient's document telling patient's health care provider what the patient wants or does not want if the patient is diagnosed as being terminally ill and in a persistent vegetative state or in a permanently unconscious condition.[2005 Honor My Wishes]"/> </concept> <concept> <code value="HIPAA Authorization"/> <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="HIPAA NPP"/> <display value="HIPAA Notice of Privacy Practices"/> <definition value="§ 164.520 â€" 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 Authorization"/> <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 may not be combined with any other document to create a compound authorization, except as follows: 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) 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 Restriction"/> <display value="HIPAA Self-Pay Restriction"/> <definition value="HIPAA 45 CFR § 164.522(a)â€"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_Behavioral_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_548864_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/professionals/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_contrast.pdf" /> </concept> <concept> <code value="NPP"/> <display value="notice of privacy practices"/> <definition value="Acknowledgement of custodian notice of privacy practices. Usage Notes: This type of consent directive acknowledges a custodian's notice of privacy practices including its permitted collection, access, use and disclosure of health information to users and for purposes of use specified. [ActConsentDirective (2.16.840.1.113883.1.11.20425)]"/> </concept> <concept> <code value="59284-0"/> <display value="Patient Consent "/> <definition value="Document of a patient consent for an unspecified healthcare service/procedure/activity. A patient consent form is a document that a patient signs to indicate that they give consent for (agree to allow) a particular action. Some common consent forms are for a procedure, surgery, organ donation, release of information. The actions for which a patient might be expected to give formal written consent can vary between providers, departments, facilities or regions and as with general legal documents, are numerous - thus the need for this generic term. http://s.details.loinc.org/LOINC/59284-0.html?sections=Simple"/> </concept> <concept> <code value="POLST"/> <display value="POLST"/> <definition value="The Physician Order for Life-Sustaining Treatment form records a person's health care wishes for end of life emergency treatment and translates them into an order by the physician. It must be reviewed and signed by both the patient and the physician, Advanced Registered Nurse Practitioner or Physician Assistant. [2005 Honor My Wishes] Comment: Opt-in Consent Directive with restrictions."/> </concept> <concept> <code value="57016-8 "/> <display value="Privacy policy acknowledgement Document"/> <definition value="A document showing patient acknowledgement/consent/dissent with respect to the privacy policies of an organization. This document is specific to an individual patient.http://s.details.loinc.org/LOINC/57016-8.html?sections=Simple Comment: May be an opt in, opt out, or implied Consent Directive with executed status."/> </concept> <concept> <code value="57017-6"/> <display value="Privacy policy Organization Document "/> <definition value="A document describing the privacy policy of an organization. This document is specific to an organization, not an individual patient. http://s.details.loinc.org/LOINC/57017-6.html?sections=Simple Comment: E.g., an opt in or implied Consent Directive with status = policy"/> </concept> <concept> <code value="64292-6 "/> <display value="Release of information consent "/> <definition value="A document containing record of patient consenting to release of information for a particular purpose. Examples of such documents include for patient release of information of medical condition and treatment, personal identifying information, or financial information http://s.details.loinc.org/LOINC/64292-6.html?sections=Simple"/> </concept> <concept> <code value="RESEARCH"/> <display value="research information access"/> <definition value="Consent to have healthcare information in an electronic health record accessed for research purposes. [VALUE SET: ActConsentType (2.16.840.1.113883.1.11.19897)]"/> </concept> <concept> <code value="RSDID"/> <display value="de-identified information access"/> <definition value="Consent to have de-identified healthcare information in an electronic health record that is accessed for research purposes, but without consent to re-identify the information under any circumstance. [VALUE SET: ActConsentType (2.16.840.1.113883.1.11.19897)"/> </concept> <concept> <code value="RSREID"/> <display value="re-identifiable information access"/> <definition value="Consent to have de-identified healthcare information in an electronic health record that is accessed for research purposes re-identified under specific circumstances outlined in the consent. [VALUE SET: ActConsentType (2.16.840.1.113883.1.11.19897)]"/> </concept> <concept> <code value="SSA-827"/> <display value="Form SSA-827"/> <definition value="SSA Form SSA-827 (Authorization to Disclose Information to the Social Security Administration (SSA))and its affiliated State disability determination services use Form SSA-827, Authorization to Disclose Information to the Social Security Administration (SSA) to obtain medical and other information needed to determine whether or not a claimant is disabled. Comment: Opt-in Consent Directive. Note: Form is available at https://www.socialsecurity.gov/forms/ssa-827-inst-sp.pdf "/> </concept> <concept> <code value="VA Form 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-identifiable 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 Form 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/medical/pdf/10-0485-fill.pdf"/> </concept> VA RESEARCH FORMS HERE <concept> <code value="VA Form 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 Form 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 Form 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 Form 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.northerncalifornia.va.gov/northerncalifornia/services/rnd/docs/vha-10-10116.pdf "/> </concept> <concept> <code value="VA Form 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.gov/compensation/consent_privateproviders.</concept> </define> </ValueSet>

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      Change value set to be: <ValueSet xmlns= "http://hl7.org/fhir" xmlns:xsi= "http://www.w3.org/2001/XMLSchema-instance" xsi:schemaLocation= "http://hl7.org/fhir ../../schema/valueset.xsd" > <text> <status value="generated"/> <div xmlns= "http://www.w3.org/1999/xhtml" > This value set includes sample Consent Directive Type codes. </div> </text> <name value="Consent Directive Type Codes"/> <publisher value="CBCC"/> <copyright value="This is an example set, which includes several consent directive related LOINC codes; HL7 VALUE SET: ActConsentType(2.16.840.1.113883.1.11.19897)"/> <status value="draft"/> <telecom> <system value="url"/> <value value= "http://hl7.org/fhir" /> </telecom> <description value="This value set includes sample Consent Directive Type codes, including several consent directive related LOINC codes; HL7 VALUE SET: ActConsentType(2.16.840.1.113883.1.11.19897); examples of US realm consent directive legal descriptions and references to online and/or downloadable forms such as the SSA-827 Authorization to Disclose Information to the Social Security Administration; and other anticipated consent directives related to participation in a clinical trial, medical procedures, reproductive procedures; health care directive (Living Will); advance directive, do not resuscitate (DNR); Physician Orders for Life-Sustaining Treatment (POLST)."/> <status value="draft"/> <concept> <code value="42 CFR Part 2 Consent/> <display value="42 CFR Part 2 Form of written consent"/> <definition value="Required elements in a written consent to a disclosure of information governed under 42 CFR Part 2. http://www.ecfr.gov/cgi-bin/text-idx?SID=69c4339acd2df9fab9dcbed15181917b&mc=true&node=pt42.1.2&rgn=div5 "/> </concept> <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. [2005 Honor My Wishes] "/> </concept> <concept> <code value="common rule informed consent"/> <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="do not resuscitate"/> <display value="DNR"/> <definition value="A legal document, signed by both the patient and their provider, stating a desire not to have CPR initiated in case of a cardiac event. Note: This form was replaced in 2003 with the Physician Orders for Life-Sustaining Treatment [POLST] ."/> </concept> <concept> <code value="EMRGONLY"/> <display value="emergency only"/> <definition value="Opt-in to disclosure of health information for emergency only consent directive. Comment: This general consent directive specifically limits disclosure of health information for purpose of emergency treatment. Additional parameters may further limit the disclosure to specific users, roles, duration, types of information, and impose uses obligations. [ActConsentDirective (2.16.840.1.113883.1.11.20425)] "/> </concept> <concept> <code value="Illinois Consent by Minors to Medical Procedures"/> <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/ilcs3.asp?ActID=1539&ChapterID=35 " </concept> <concept> <code value="ICOL"/> <display value="information collection"/> <definition value="Consent to have healthcare information collected in an electronic health record. This entails that the information may be used in analysis, modified, updated. [VALUE SET: ActConsentType (2.16.840.1.113883.1.11.19897)] "/> </concept> <concept> <code value="IDSCL"/> <display value="information disclosure"/> <definition value="Consent to have collected healthcare information disclosed. [VALUE SET: ActConsentType (2.16.840.1.113883.1.11.19897)] "/> </concept> <concept> <code value="INFA"/> <display value="information access"/> <definition value="Consent to access healthcare information. [VALUE SET: ActConsentType (2.16.840.1.113883.1.11.19897)] "/> </concept> <concept> <code value="IRDSCL"/> <display value="information redisclosure"/> <definition value="Information re-disclosed without the patient's consent. [VALUE SET: ActConsentType (2.16.840.1.113883.1.11.19897)] "/> </concept> <concept> <code value="health care directive"/> <display value="health care directive"/> <definition value="Patient's document telling patient's health care provider what the patient wants or does not want if the patient is diagnosed as being terminally ill and in a persistent vegetative state or in a permanently unconscious condition. [2005 Honor My Wishes] "/> </concept> <concept> <code value="HIPAA Authorization"/> <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="HIPAA NPP"/> <display value="HIPAA Notice of Privacy Practices"/> <definition value="§ 164.520 â€" 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 Authorization"/> <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 may not be combined with any other document to create a compound authorization, except as follows: 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) 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 Restriction"/> <display value="HIPAA Self-Pay Restriction"/> <definition value="HIPAA 45 CFR § 164.522(a)â€"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_Behavioral_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_548864_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/professionals/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_contrast.pdf " /> </concept> <concept> <code value="NPP"/> <display value="notice of privacy practices"/> <definition value="Acknowledgement of custodian notice of privacy practices. Usage Notes: This type of consent directive acknowledges a custodian's notice of privacy practices including its permitted collection, access, use and disclosure of health information to users and for purposes of use specified. [ActConsentDirective (2.16.840.1.113883.1.11.20425)] "/> </concept> <concept> <code value="59284-0"/> <display value="Patient Consent "/> <definition value="Document of a patient consent for an unspecified healthcare service/procedure/activity. A patient consent form is a document that a patient signs to indicate that they give consent for (agree to allow) a particular action. Some common consent forms are for a procedure, surgery, organ donation, release of information. The actions for which a patient might be expected to give formal written consent can vary between providers, departments, facilities or regions and as with general legal documents, are numerous - thus the need for this generic term. http://s.details.loinc.org/LOINC/59284-0.html?sections=Simple "/> </concept> <concept> <code value="POLST"/> <display value="POLST"/> <definition value="The Physician Order for Life-Sustaining Treatment form records a person's health care wishes for end of life emergency treatment and translates them into an order by the physician. It must be reviewed and signed by both the patient and the physician, Advanced Registered Nurse Practitioner or Physician Assistant. [2005 Honor My Wishes] Comment: Opt-in Consent Directive with restrictions."/> </concept> <concept> <code value="57016-8 "/> <display value="Privacy policy acknowledgement Document"/> <definition value="A document showing patient acknowledgement/consent/dissent with respect to the privacy policies of an organization. This document is specific to an individual patient. http://s.details.loinc.org/LOINC/57016-8.html?sections=Simple Comment: May be an opt in, opt out, or implied Consent Directive with executed status."/> </concept> <concept> <code value="57017-6"/> <display value="Privacy policy Organization Document "/> <definition value="A document describing the privacy policy of an organization. This document is specific to an organization, not an individual patient. http://s.details.loinc.org/LOINC/57017-6.html?sections=Simple Comment: E.g., an opt in or implied Consent Directive with status = policy"/> </concept> <concept> <code value="64292-6 "/> <display value="Release of information consent "/> <definition value="A document containing record of patient consenting to release of information for a particular purpose. Examples of such documents include for patient release of information of medical condition and treatment, personal identifying information, or financial information http://s.details.loinc.org/LOINC/64292-6.html?sections=Simple "/> </concept> <concept> <code value="RESEARCH"/> <display value="research information access"/> <definition value="Consent to have healthcare information in an electronic health record accessed for research purposes. [VALUE SET: ActConsentType (2.16.840.1.113883.1.11.19897)] "/> </concept> <concept> <code value="RSDID"/> <display value="de-identified information access"/> <definition value="Consent to have de-identified healthcare information in an electronic health record that is accessed for research purposes, but without consent to re-identify the information under any circumstance. [VALUE SET: ActConsentType (2.16.840.1.113883.1.11.19897)"/> </concept> <concept> <code value="RSREID"/> <display value="re-identifiable information access"/> <definition value="Consent to have de-identified healthcare information in an electronic health record that is accessed for research purposes re-identified under specific circumstances outlined in the consent. [VALUE SET: ActConsentType (2.16.840.1.113883.1.11.19897)] "/> </concept> <concept> <code value="SSA-827"/> <display value="Form SSA-827"/> <definition value="SSA Form SSA-827 (Authorization to Disclose Information to the Social Security Administration (SSA))and its affiliated State disability determination services use Form SSA-827, Authorization to Disclose Information to the Social Security Administration (SSA) to obtain medical and other information needed to determine whether or not a claimant is disabled. Comment: Opt-in Consent Directive. Note: Form is available at https://www.socialsecurity.gov/forms/ssa-827-inst-sp.pdf "/> </concept> <concept> <code value="VA Form 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-identifiable 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 Form 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/medical/pdf/10-0485-fill.pdf "/> </concept> VA RESEARCH FORMS HERE <concept> <code value="VA Form 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 Form 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 Form 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 Form 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.northerncalifornia.va.gov/northerncalifornia/services/rnd/docs/vha-10-10116.pdf "/> </concept> <concept> <code value="VA Form 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.gov/compensation/consent_privateproviders .</concept> </define> </ValueSet>
    • Kathleen Connor/John Moehrke: 4-0-0
    • Correction
    • Compatible, substantive
    • DSTU2

    Description

      Existing Wording: Consent.category

      Definition

      A classification of the type of consents found in the statement. This element supports indexing and retrieval of consent statements.

      This value set is the designated 'entire code system' value set for Consent Category Codes

      Consent.category (Example)

      Code Display Definition

      cat1 Advance Directive Consent examples

      advance-directive Advance Directive Any instructions, written or given verbally by a patient to a health care provider in anticipation of potential need for medical treatment

      cat2 Medical/Procedure Informed Consent RWJ funded toolkit has several international example consent forms, and excellent overview of issues around medical informed consent

      medical-consent Medical Consent Informed consent is the process of communication between a patient and physician that results in the patients 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.

      cat3 Example of US jurisdictional [federal and state] privacy consent

      hipaa HIPAA Authorization 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.

      SSA-827 SSA Authorization to Disclose 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

      cat4 US Mixed state HIE consent types May include federal and state jurisdictional privacy laws

      DCH-3927 Michigan behavior and mental health consent 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_Information_477005_7.docx

      squaxin Squaxin Indian behavioral health and HIPAA consent 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_ConsentForReleaseAndExchange.PDF

      cat5 Example international health information exchange consent type

      nl-lsp NL LSP Permission 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 cares 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-healthcare-provider

      at-elga AT ELGA Opt-in Consent 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_austria_en.pdf

      cat6 Examples of US Research Consent Types

      nih-hipaa HHS NIH HIPAA Research Authorization Guidance and template form https://privacyruleandresearch.nih.gov/pdf/authorization.pdf

      nci NCI Cancer Clinical Trial consent see http://ctep.cancer.gov/protocolDevelopment/docs/Informed_Consent_Template.docx

      nih-grdr NIH Global Rare Disease Patient Registry and Data Repository consent 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

      va-10-10116 VA Form 10-10116 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-10-10116.pdf

      nih-527 NIH Authorization for the Release of Medical Information NIH Authorization for the Release of Medical Information is a patients 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

      ga4gh Population origins and ancestry research consent 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&file=Wx/org/genomicsandhealth/REWG/Demo/Roberta_Robinson_US

      Proposed Wording: Replace with this example value set @ http://gforge.hl7.org/gf/download/docmanfileversion/9293/14450/valueset-consentdirective-type%20STU3%20final.xml.

      Comment:

      The FHIR Consent Directive profile has been in ballot since DSTU1. During that period a landscape assessment of abstract and concrete consent directive types used in IHE BPPC, HL7 v2, v3, CDA and in real policy domains was captured as codes in a well documented value set. However, the Consent resource authors were under the impression that this was green fields, and that only a few example codes was warranted. Interestingly, they had no hesitation about creating a required Consent.status value set without research. The Consent.category codes selected are not representative, and do not leverage established HL7 abstract consent directive or consent type codes, or accurately represent real consent directive types, e.g., only one of multiple HIPAA Consent Directives was selected. The example abstract "cat#" codes are extremely poor - "cat 1" and "cat3" has no definition, "cat2" is a commentary on the RWJ source of medical consent examples. "cat4" and "cat5" are tautological.

      The total lack of precision in the http://hl7.org/fhir/consentcategorycodes value set should be compared with the proposed ConsentDirectiveType value set example value set @ http://gforge.hl7.org/gf/download/docmanfileversion/9293/14450/valueset-consentdirective-type%20STU3%20final.xml, which was under review by the CBCC WG before FMG decided to take over development of the consent for FHIR. There is no reason to settle on such a limited set of examples when there is many years of experience coding Consent Directive types in HL7.

      Summary:

      Change value set for Consent.category

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            k.connor Kathleen Connor
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