HL7 Clinical Document Architecture (CDA) Release Two (R2) Implementation Guide: Privacy Consent Directives

General Information

Technologies must be operated and maintained in accordance with Federal and Department security and privacy policies and guidelines. More information on the proper use of the TRM can be found on the TRM Proper Use Tab/Section.

Website:	Go to site
Description:	This is a structured document specification to exchange signed Consent Directives. This specification will make use of the concepts identified in the Composite Privacy Consent Directive - Domain Analysis Model - and the CDA R2 specification. This implementation guide is not only intended to provide a computable representation of a consent directive but the resulting structured documents could be used to generate enforceable assertions or rules (e.g. Security Assertion Markup Language (SAML), eXtensible Access Control Markup Language (XACML). This project is intended to support the management of consent directives and policies. CDA R2 supports the multiple representations of a Consent Directive as a narrative, signed document (wet signature), and computable statements/entries using standard-based terminology. This IG enhances Integrating the Health Enterprise (IHE) BPPC (Basic Patient Privacy Consent) to include support for granular consent preferences and embedded alternative representations of consent.
Technology/Standard Usage Requirements:	Users must ensure their use of this technology/standard is consistent with VA policies and standards, including, but not limited to, VA Handbooks 6102 and 6500; VA Directives 6004, 6513, and 6517; and National Institute of Standards and Technology (NIST) standards, including Federal Information Processing Standards (FIPS). Users must ensure sensitive data is properly protected in compliance with all VA regulations. Prior to use of this technology, users should check with their supervisor, Information Security Officer (ISO), Facility Chief Information Officer (CIO), or local Office of Information and Technology (OI&T) representative to ensure that all actions are consistent with current VA policies and procedures prior to implementation.
Section 508 Information:
Decision:	View Decisions

Decision Source:	TRM Mgmt Group
Decision Process:	One-VA TRM v19.4
Decision Date:	04/26/2019 at 10:47:24 UTC
Aliases:	"HL7 IG for CDAR2: Consent Directives, Release 1", Privacy Consent, Authorization to Disclose
Introduced By:	TRM Request
Standards Body:	HL7

Vendor Release Information

The Vendor Release table provides the known releases for the TRM Industry Standard, obtained from the vendor (or from the release source).

Version	Release Date	Vendor End of Life Date	Vendor Desupport Date
1	01/01/2017

Current Decision Matrix (04/11/2019)

Users must ensure their use of this technology/standard is consistent with VA policies and standards, including, but not limited to, VA Handbooks 6102 and 6500; VA Directives 6004, 6513, and 6517; and National Institute of Standards and Technology (NIST) standards, including Federal Information Processing Standards (FIPS). Users must ensure sensitive data is properly protected in compliance with all VA regulations. Prior to use of this technology, users should check with their supervisor, Information Security Officer (ISO), Facility Chief Information Officer (CIO), or local Office of Information and Technology (OI&T) representative to ensure that all actions are consistent with current VA policies and procedures prior to implementation.

The VA Decision Matrix displays the current and future VA IT position regarding different releases of a TRM entry. These decisions are based upon the best information available as of the most current date. The consumer of this information has the responsibility to consult the organizations responsible for the desktop, testing, and/or production environments to ensure that the target version of the technology will be supported. Any major.minor version that is not listed in the VA Decision Matrix is considered unapproved for use.

Legend:

White	Approved: The technology/standard has been approved for use.
Yellow	Approved w/Constraints: The technology/standard can be used within the specified constraints located below the decision matrix in the footnote[1] and on the General tab.
Gray	Unapproved: This technology or standard can be used only if a POA&M review is conducted and signed by the Authorizing Official Designated Representative (AODR) as designated by the Authorizing Official (AO) or designee and based upon a recommendation from the POA&M Compliance Enforcement, has been granted to the project team or organization that wishes to use the technology.
Orange	Divest: VA has decided to divest itself on the use of the technology/standard. As a result, all projects currently utilizing the technology/standard must plan to eliminate their use of the technology/standard. Additional information on when the entry is projected to become unapproved may be found on the Decision tab for the specific entry.
Black	Prohibited: The technology/standard is not (currently) permitted to be used under any circumstances.
Blue	Planning/Evaluation Constraint:The period of time this technology is currently being evaluated, reviewed, and tested in controlled environments. Use of this technology is strictly controlled and not available for use within the general population. If a customer would like to use this technology, please work with your local or Regional OI&T office and contact the appropriate evaluation office displayed in the notes below the decision matrix. The Local or Regional OI&T office should submit an inquiry to the TRM if they require further assistance or if the evaluating office is not listed in the notes below.

Release/Version Information:

VA decisions for specific versions may include a ‘.x’ wildcard, which denotes a decision that pertains to a range of multiple versions.

For example, a technology approved with a decision for 7.x would cover any version of 7.(Anything) - 7.(Anything). However, a 7.4.x decision would cover any version of 7.4.(Anything), but would not cover any version of 7.5.x or 7.6.x on the TRM.

VA decisions for specific versions may include ‘+’ symbols; which denotes that the decision for the version specified also includes versions greater than what is specified but is not to exceed or affect previous decimal places.

For example, a technology approved with a decision for 12.6.4+ would cover any version that is greater than 12.6.4, but would not exceed the .6 decimal ie: 12.6.401 is ok, 12.6.5 is ok, 12.6.9 is ok, however 12.7.0 or 13.0 is not.

Release	Q1	Q2	Q3	Q4	Q1	Q2	Q3	Q4	Q1	Q2	Q3	Q4
<Past	CY2023				CY2024				CY2025				Future>
1	Approved	Approved	Approved	Approved	Approved	Approved	Approved	Approved	Approved	Approved	Approved	Approved

References

The following reference(s) are associated with this entry:
Type	Name	Source	Description
There are no references identified for this entry.

Standard Components

Note: This list may not be complete. No component, listed or unlisted, may be used outside of the technology in which it is released. The usage decision for a component is found in the Decision and Decision Constraints.
Source	Name	Description
No components have been identified for this entry.

VA Categories View the VA Categorization Framework

Domain Area	Category	Customer Guidance	Category Locked By ELT Date
Health Care Standard	Health Care Standards

Technologies/Standards Relationships

Implemented By/Verified With:

No technologies have been identified with this standard.

Comparable Standards:

No comparable entries have been identified.

Associated Standards:

No standards have been associated with this standard.

General Analysis

Adoption Benefits

Creates a CDA representation of privacy consents (e.g. authorization to disclose health information, consent for research)
Enables the exchange of computable consents across EHRs
Supports Data Use and Reciprocal Support Agreement (DURSA) opt-in and other opt-in consent agreements
Enhances IHE BPPC (Basic Patient Privacy Consent) based on the HL7-approved Domain Analysis Model
Supports the display of consents to end-users based on existing CDA infrastructure and applications

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VA Technical Reference Model v 24.7

General Information

Vendor Release Information

Current Decision Matrix (04/11/2019)

References

Standard Components

VA Categories View the VA Categorization Framework

Technologies/Standards Relationships

Implemented By/Verified With:

Comparable Standards:

Associated Standards:

General Analysis

Adoption Benefits

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VA Technical Reference Model v 24.7

General Information

Vendor Release Information

Current Decision Matrix (04/11/2019)

References

Standard Components

VA Categories View the VA Categorization Framework

Technologies/Standards Relationships

Implemented By/Verified With:

Comparable Standards:

Associated Standards:

General Analysis

Adoption Benefits

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