HITSP Consumer Empowerment and Access to Clinical Information via Networks Interoperability Specification

December 18, 2008

Version 4.0

HITSP Consumer Empowerment and Access to Clinical Information via Networks Interoperability Specification

HITSP/IS03

Healthcare Information Technology Standards Panel (HITSP) logo

Submitted to:

Healthcare Information Technology Standards Panel

Submitted by:

Consumer Perspective Technical Committee
(Formerly Consumer Empowerment Technical Committee)

Document Change History

Version Number	Description of Change	Name of Author	Date Published
1.0	Final Draft	Consumer Empowerment Technical Committee	September 7, 2006
1.1	Ready for Public Comment	Consumer Empowerment Technical Committee	September 12, 2006
1.2	Ready for Implementation Testing	Consumer Empowerment Technical Committee	October 20, 2006
2.0	Released for Implementation	Consumer Empowerment Technical Committee	May 11, 2007
2.0.1	Review Copy	Consumer Empowerment Technical Committee	September 18, 2007
2.0.2	Review Copy	Consumer Empowerment Technical Committee	December 5, 2007
3.0	Released for Implementation	Consumer Empowerment Technical Committee	December 13, 2007
	Template Update to V2.4	Project Team	July 31, 2008
3.0.1	Review Copy	Consumer Perspective Technical Committee	August 20, 2008
3.1	Released for Implementation	Consumer Perspective Technical Committee	August 28, 2008
3.1.1	Review Copy	Consumer Perspective Technical Committee	September 26, 2008
3.1.2	Review Copy	Consumer Perspective Technical Committee	December 10, 2008
4.0	Released for Implementation	Consumer Perspective Technical Committee	December 18, 2008

Table of Contents

1.0 Introduction. 7

1.1 Interoperability Specification Overview. 7

1.2 Interoperability Specification Document Map. 8

1.2.1 List of Constructs. 9

1.3 Copyright Permissions. 11

1.4 Reference Documents. 11

2.0 Requirements. 13

2.1 Use Case Synopsis. 13

2.2 Use Case Requirements. 14

2.2.1 Mapping of Use Case Actions to Information Exchange Requirements. 15

2.2.2 Data and Information Exchange Requirements. 16

2.2.3 Identification of Business Actors, Mapped to Requirements. 19

2.2.4 High-Level Diagrams. 25

3.1 Scope of Design. 27

3.1.1 Assumptions. 27

3.1.2 Constraints. 28

3.1.3 Pre-conditions. 28

3.1.4 Post-conditions. 30

3.1.5 Process Triggers. 30

3.2 Detailed Design. 30

3.2.1 Technical Actors Role Descriptions. 31

3.2.2 Construct Requirements. 33

3.2.3 Mapping of Business Actors to Technical Actors and Constructs with Optionality. 46

3.2.4 Construct Dependencies. 56

3.2.5 Additional Constraints on Required Constructs. 57

4.0 Standards Selection. 58

4.1 Standards. 59

4.1.1 Regulatory Guidance. 59

4.1.2 Selected Standards. 59

4.1.3 Informative Reference Standards. 62

4.2 Gaps Where There Are No Standards. 65

4.3 Standard Overlaps. 69

5.0 Conformance. 70

5.1 Conformance Criteria. 70

5.2 Conformance Scoping, Subsetting and Options. 70

5.3 Test Methods. 70

6.0 Appendix. 71

6.1 Description of Standards. 71

6.2 Use Case to Information Exchange and Data Requirements. 77

6.3 Use Case Sequence Diagrams. 87

6.4 Mapping of Constructs to Information Exchange and Data Requirements. 95

7.0 Document Updates. 98

7.1 May 11, 2007. 98

7.2 September 18, 2007. 98

7.3 December 5, 2007. 98

7.4 December 13, 2007. 99

7.5 August 20, 2008. 99

7.6 August 27, 2008. 100

7.7 December 10, 2008. 100

7.8 December 18, 2008. 100

Figures and Tables

Figure 1-1 Interoperability Specification Construct Roadmap. 9

Figure 2-1 Legend for Component Diagrams. 25

Figure 2-2 Consumer Access to Clinical Information Component Data Flow Diagram.. 26

Figure 3-1 Customer Creates Accounts to Host Registration and Medication History. 36

Figure 3-2 Consumer Visits Healthcare Provider and Provides Registration and Medication History Information 38

Figure 3-3 Authorized Healthcare Provider Views Registration and Medication History. 40

Figure 3-4 RHIO/HIE Functionality Assumed by PHR Service Provider 42

Figure 3-5 Payer assumes RHIO/HIE functionality and PHR Service Provider 43

Figure 3-6 RHIO/HIE is Only Registry, No Central Repository. 44

Figure 3-7 EHR System or Health Plan Assumes RHIO/HIE Functionality. 45

Figure 3-8 Intermediary between Health Plans and PHR Service Provider 46

Figure 6-1 Scenario 1: Consumer Creates Account to Host and Access Registration Summary and Clinical Information High-Level Business Sequence Diagram - Part A. 88

Figure 6-2 Scenario 1: Consumer Creates Account to Host and Access Registration Summary and Clinical Information High-Level Business Sequence Diagram - Part B. 89

Figure 6-3 Scenario 1: Consumer Creates Account to Host and Access Registration Summary and Clinical Information High-Level Business Sequence Diagram - Part C. 90

Figure 6-4 Scenario 1: Consumer Creates Account to Host and Access Registration Summary and Clinical Information High-Level Business Sequence Diagram - Part D.. 91

Figure 6-5 Scenario 2: Consumer Visits Healthcare Provider and Provides Registration Summary Information and Clinical Information High-Level Business Sequence Diagram Part A. 92

Figure 6-6 Scenario 2: Consumer Visits Healthcare Provider and Provides Registration Summary Information and Clinical Information High-Level Business Sequence Diagram Part B. 93

Figure 6-7 Scenario 3: Authorized Healthcare Provider Reviews Registration Summary and Other Clinical Information High-Level Business Sequence Diagram Part A. 94

Figure 6-8 Scenario 3: Authorized Healthcare Provider Reviews Registration Summary and Other Clinical Information High-Level Business Sequence Diagram Part B. 95

Table 1-1 List of Constructs. 9

Table 1-2 Reference Documents. 11

Table 2-1 Table and Information Requirements Matrix. 16

Table 2-2 Information Exchange Requirements (IER) 19

Table 2-3 Business Actors. 21

Table 3-1 Scoping. 27

Table 3-2 Assumptions. 28

Table 3-3 Constraints. 28

Table 3-4 Pre-conditions. 29

Table 3-5 Post-conditions. 30

Table 3-6 Process Triggers. 30

Table 3-7 Technical Actor Role Descriptions. 31

Table 3-8 HITSP/C32 Content Modules in this IS. 34

Table 3-9 Business-Technical Actor Mapping to Transaction and/or Content 47

Table 3-10 Implementation Conditions/Constraints. 53

Table 3-11 Creator Registration Subset Content Modules. 53

Table 3-12 Creator Medication and Immunization History Subset Content Modules. 54

Table 3-13 Creator Conditions and Allergy Subset Content Modules. 54

Table 3-14 Creator Laboratory Subset Content Modules. 55

Table 3-15 Construct Dependencies. 56

Table 3-16 Additional Constraints on Required Constructs. 57

Table 4-1 Regulatory Guidance. 59

Table 4-2 Selected Standards Linked to HITSP Constructs. 59

Table 4-3 Informative Reference Standards. 62

Table 4-4 Use Case Events and Associated Gaps. 66

Table 4-5 Use Case Requirements and Associated Standard Overlaps. 69

Table 6-1 Description of Standards. 71

Table 6-2 Mapping of Use Case Actions to Information Exchange Requirements Consumer Empowerment Use Case Scenario 1. 77

Table 6-3 Mapping of Use Case Actions to Information Exchange Requirements - Consumer Empowerment Use Case Scenario 2. 81

Table 6-4 Mapping of Use Case Actions to Information Exchange Requirements - Consumer Empowerment Use Case Scenario 3. 84

Table 6-5 Mapping of Use Case Actions to Information Exchange Requirements Consumer Access to Clinical Information Use Case Scenario 2. 86

Table 6-6 Mapping of Use Case Actions to Information Exchange Requirements Consumer Access to Clinical Information Use Case Scenario 3. 87

Table 6-7 Mapping of HITSP Constructs to Requirements. 96