July 8, 2009

Version 1.3

HITSP Manage Consent Directives Transaction Package

HITSP/TP30

Healthcare Information Technology Standards Panel (HITSP) logo

Submitted to:

Healthcare Information Technology Standards Panel

Submitted by:

Security, Privacy and Infrastructure Domain Technical Committee
(Formerly Security and Privacy Technical Committee)

Document Change History

Version Number	Description of Change	Name of Author	Date Published
1.0	Review Copy	Security and Privacy Technical Committee	July 20, 2007
1.0.1	Review Copy	Security and Privacy Technical Committee	October 5, 2007
1.1	Released for Implementation	Security and Privacy Technical Committee	October 15, 2007
1.1.1	Review Copy	Security, Privacy and Infrastructure Domain Technical Committee	August 20, 2008
1.2	Released for Implementation	Security, Privacy and Infrastructure Domain Technical Committee	August 27, 2008
	Template V2.5	Project Team	June 30, 2009
1.2.1	Review Copy	Security, Privacy and Infrastructure Domain Technical Committee	June 30, 2009
1.3	Released for Implementation	Security, Privacy and Infrastructure Domain Technical Committee	July 8, 2009

Table of Contents

1.0 Introduction . 5

1.1 Overview . 5

1.2 Copyright Permissions . 5

1.3 Reference Documents . 6

1.4 Conformance . 6

1.4.1 Conformance Criteria . 6

1.4.2 Conformance Scoping, Subsetting and Options . 6

2.0 Transaction Definition . 7

2.1 Context Overview . 7

2.1.1 HITSP Document Management and Exchange Specifications that Address the AHIC USe Cases 7

2.1.1.1 BPPC Implemented with HITSP/TP13 Manage Sharing of Documents . 8

2.1.1.2 BPPC Implemented with HITSP/T31 Document Reliable Interchange . 9

2.1.1.3 BPPC Implemented with HITSP/T33 Transfer of Documents on Media . 9

2.1.2 Transaction Package Constraints . 9

2.1.3 Interfaces . 10

2.1.3.1 Consenter (Consumer/Patient) Role and Interactions . 10

2.1.3.2 IIHI Requester Role and Interactions . 11

2.1.4 Interface Interactions . 11

2.1.4.1 Capture Consent Directive Transaction . 12

2.1.4.1.1 Example Scenario: Create Consent Directive . 13

2.1.4.1.2 Example Scenario: Update an Existing Consent Directive . 14

2.1.4.2 Request Consent Directive Transaction . 15

2.1.5 Pre-conditions . 17

2.1.5.1 Process Triggers . 17

2.1.6 Post-conditions . 17

2.1.6.1 Required Output 17

2.1.7 Data Flows . 17

2.2 List of Constructs . 18

2.2.1 Construct Dependencies . 18

2.2.2 Additional Constraints on Required Constructs . 18

2.3 Standards . 19

2.3.1 Regulatory Guidance . 19

2.3.2 Selected Standards . 19

2.3.3 Informative Reference Standards . 20

3.0 Appendix . 21

3.1 Consent Directives Concepts . 21

4.0 Change History . 23

4.1 October 5, 2007 . 23

4.2 October 15, 2007 . 23

4.3 July 11, 2008 . 23

4.4 August 20, 2008 . 23

4.5 August 27, 2008 . 24

4.6 June 30, 2009 . 24

4.7 July 8, 2009 . 24

Figures and Tables

Figure 2-1 Example of Content Creator for Consents GUI 11

Figure 2-2 Manage Consent Directive High Level Sequence Diagram .. 12

Figure 2-3 Capture Consent Directive . 13

Figure 2-4 Request Consent Directive . 15

Figure 2-5 XDR Interchange: Provide & Register Document Set with Consent Directive . 16

Figure 2-6 HITSP/T33 Transfer of Document on Media Transaction . 16

Figure 3-1 Consent Directives Concepts . 22

Table 1-1 Reference Documents . 6

Table 2-1 Transaction Package Constraints . 9

Table 2-2 Interfaces . 10

Table 2-3 Pre-conditions . 17

Table 2-4 Process Triggers . 17

Table 2-5 Post-conditions . 17

Table 2-6 Required Outputs . 17

Table 2-7 List of Constructs . 18

Table 2-8 Construct Dependencies . 18

Table 2-9 Additional Constraints on Required Constructs . 18

Table 2-10 Regulatory Guidance . 19

Table 2-11 Selected Standards . 19

Table 2-12 Informative Reference Standards . 20