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Type:
Change Request
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Resolution: Not Persuasive with Modification
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Priority:
Medium
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FHIR Core (FHIR)
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DSTU2
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Community-Based Care and Privacy
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Consent
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6.4.4
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Kathleen Connor/John Moehrke: 4-0-0
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Correction
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Compatible, substantive
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DSTU2
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
- is voted on by
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BALLOT-2852 Negative - Greg Staudenmaier : 2018-Sep-FHIR R1
- Balloted