December 18, 2008

Version 1.0

HITSP Personalized Healthcare Interoperability Specification

Submitted to:

Healthcare Information Technology Standards Panel

Submitted by:

Provider Perspective Technical Committee
(Formerly Care Delivery Technical Committee)

Document Change History

Version Number	Description of Change	Name of Author	Date Published
	Template V2.4	Project Team	July 31, 2008
0.0.1	Review Copy	Provider Perspective Technical Committee	September 26, 2008
0.0.2	Review Copy	Provider Perspective Technical Committee	December 10, 2008
1.0	Released for Implementation	Provider Perspective Technical Committee	December 18, 2008

Table of Contents

1.0 Introduction. 6

1.1 Interoperability Specification Overview. 6

1.2 Interoperability Specification Document Map. 6

1.2.1 List of Constructs. 7

1.3 Copyright Permissions. 10

1.4 Reference Documents. 10

2.0 Requirements. 12

2.1 Use Case Synopsis. 12

2.2 Use Case Requirements. 12

2.2.1 Mapping of Use Case Actions to Information Exchange Requirements. 14

2.2.2 Data and Information Exchange Requirements. 14

2.2.3 Identification of Business Actors, Mapped to Requirements. 16

2.2.4 High-Level Diagrams. 22

3.0 Design. 25

3.1 Scope of Design. 25

3.1.1 Assumptions. 25

3.1.2 Constraints. 25

3.1.3 Pre-conditions. 25

3.1.4 Post-conditions. 26

3.1.5 Process Triggers. 26

3.2 Detailed Design. 26

3.2.1 Technical Actor Role Descriptions. 27

3.2.2 Construct Requirements. 29

3.2.3 Mapping of Business Actors to Technical Actors and Constructs with Optionality. 35

3.2.4 Construct Dependencies. 44

3.2.5 Additional Constraints on Required Constructs. 45

4.0 Standards Selection. 46

4.1 Standards. 47

4.1.1 Regulatory and Guidance Standards. 47

4.1.2 Selected Standards. 47

4.1.3 Informative Reference Standards. 52

4.2 Gaps Where There Are No Standards. 52

4.3 Standard Overlaps. 53

5.0 Conformance. 55

5.1 Conformance Criteria. 55

5.2 Conformance Scoping, Subsetting and Options. 55

5.3 Test Methods. 55

6.0 Appendix. 57

6.1 Description of Standards. 57

6.2 Use Case to Information Exchange and Data Requirements. 66

6.3 Use Case Sequence Diagrams. 72

6.4 Mapping of Constructs to Information Exchange and Data Requirements. 79

7.0 Document Updates. 94

7.1 December 10, 2008. 94

7.1.1 Updates from Public Comment 94

7.1.2 Global Changes. 94

7.2 December 18, 2008. 95

Figures and Tables

Figure 1-1 Interoperability Specification Document Map. 7

Figure 2-1 Legend for Component Diagrams. 22

Figure 2-2 Scenario 1: Clinical Assessment Component Data Flow Diagram.. 23

Figure 2-3 Scenario 2: Testing, Reporting and Clinical Management Component Data Flow Diagram.. 24

Figure 3-1 Clinical Assessment Scenario 7.1.1. 30

Figure 3-2 Clinical Assessment Scenario 7.1.2 and 7.1.3. 31

Figure 3-3 Clinical Assessment Scenario 7.3.1 and 7.3.2. 31

Figure 3-4 Genetic Testing, Reporting, and Clinical Management Scenario 8.1.1. 32

Figure 3-5 Genetic Testing, Reporting, and Clinical Management Scenario 8.1.3. 33

Figure 3-6 Genetic Testing, Reporting, and Clinical Management Scenario 8.2.1 and 8.2.3. 34

Figure 3-7 Genetic Testing, Reporting, and Clinical Management Scenario 8.2.4 and 8.2.5. 34

Figure 3-8 Genetic Testing, Reporting, and Clinical Management Scenario 8.3.1. 35

Figure 6-1 Construct Personal and Family Health History & Pedigree (event 7.1.1) 72

Figure 6-2 Evaluate Reference Data and Order Tests (events 7.1.2, 7.1.3) 73

Figure 6-3 Share and Receive Family Health History and Pedigree (events 7.3.1, 7.3.2) 74

Figure 6-4 Receive Results and Perform Interpretation (events 8.1.1, 8.1.2) 75

Figure 6-5 Provide Results to Patient (event 8.1.3) 76

Figure 6-6 Receive Genetic Test Order & Prepare for Test (events 8.2.1, 8.2.2 and 8.2.3) 77

Figure 6-7 Send Lab Result and Answer Questions (events 8.2.4, 8.2.5) 78

Figure 6-8 Receive Results and Interpretation (event 8.3.1) 79

Table 1-1 List of Constructs. 8

Table 1-2 Reference Documents. 11

Table 2-1 Data Element and Information Requirements (DR) 14

Table 2-2 Information Exchange Requirements (IER) 15

Table 2-3 Business Actors. 17

Table 3-1 Assumptions. 25

Table 3-2 Constraints. 25

Table 3-3 Pre-conditions. 26

Table 3-4 Post-conditions. 26

Table 3-5 Process Triggers. 26

Table 3-6 Technical Actor Role Descriptions. 27

Table 3-7 Business-Technical Actor Mapping to Transactions and/or Content 36

Table 3-8 Implementation Conditions/Constraints. 44

Table 3-9 Construct Dependencies. 45

Table 3-10 Additional Constraints on Required Constructs. 45

Table 4-1 Regulatory and Guidance Standards. 47

Table 4-2 Selected Standards Linked to HITSP Constructs. 48

Table 4-3 Informative Reference Standards. 52

Table 4-4 Use Case Requirements and Associated Standards Gaps. 53

Table 4-5 Use Case Requirements and Associated Standard Overlaps. 54

Table 6-1 Description of Standards. 57

Table 6-2 Mapping of Use Case Actions to Information Exchange Requirements. 67

Table 6-3 Mapping of Requirements to HITSP Constructs. 79

Table 6-4 Mapping of HITSP Constructs to Requirements. 84