STU 3 Ballot

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4.3.1.973 Value Set http://hl7.org/fhir/ValueSet/consent-category

This is a value set defined by the FHIR project.

Summary

Defining URL:http://hl7.org/fhir/ValueSet/consent-category
Name:Consent Category Codes
Definition:This value set includes sample Consent Category codes.
Committee:Community Based Collaborative Care Work Group
OID:2.16.840.1.113883.4.642.2.973 (for OID based terminology systems)
Copyright:This is an example set.
Source ResourceXML / JSON

This value set is used in the following places:

4.3.1.973.1 Content Logical Definition


This value set includes codes from the following code systems:

 

4.3.1.973.2 Expansion

This expansion generated 11 Aug 2016


This value set contains 20 concepts

All codes from system http://hl7.org/fhir/consentcategorycodes

CodeDisplayDefinition
cat1Advance Directive Consent examples
  advance-directiveAdvance DirectiveAny instructions, written or given verbally by a patient to a health care provider in anticipation of potential need for medical treatment
cat2Medical/Procedure Informed ConsentRWJ funded toolkit has several international example consent forms, and excellent overview of issues around medical informed consent
  medical-consentMedical ConsentInformed consent is the process of communication between a patient and physician that results in the patient’s authorization or agreement to undergo a specific medical intervention [AMA 1998]. For both ethical and legal reasons, patients must be given enough information to be fully informed before deciding to undergo a major treatment, and this informed consent must be documented in writing.
cat3Example of US jurisdictional [federal and state] privacy consent
  hipaaHIPAA AuthorizationHIPAA 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-827SSA Authorization to DiscloseSA 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
cat4US “Mixed” state HIE consent typesMay include federal and state jurisdictional privacy laws
  DCH-3927Michigan behavior and mental health consentMichigan 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
  squaxinSquaxin Indian behavioral health and HIPAA consentSquaxin 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
cat5Example international health information exchange consent type
  nl-lspNL LSP PermissionLSP (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-healthcare-provider
  at-elgaAT ELGA Opt-in ConsentPursuant 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
cat6Examples of US Research Consent Types
  nih-hipaaHHS NIH HIPAA Research AuthorizationGuidance and template form https://privacyruleandresearch.nih.gov/pdf/authorization.pdf
  nciNCI Cancer Clinical Trial consentsee http://ctep.cancer.gov/protocolDevelopment/docs/Informed_Consent_Template.docx
  nih-grdrNIH Global Rare Disease Patient Registry and Data Repository consentGlobal 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-10-10116VA Form 10-10116VA 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-527NIH Authorization for the Release of Medical InformationNIH 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
  ga4ghPopulation origins and ancestry research consentGlobal 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

 

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Explanation of the columns that may appear on this page:

LevelA few code lists that FHIR defines are hierarchical - each code is assigned a level. In this scheme, some codes are under other codes, and imply that the code they are under also applies
SourceThe source of the definition of the code (when the value set draws in codes defined elsewhere)
CodeThe code (used as the code in the resource instance)
DisplayThe display (used in the display element of a Coding). If there is no display, implementers should not simply display the code, but map the concept into their application
DefinitionAn explanation of the meaning of the concept
CommentsAdditional notes about how to use the code