December 18, 2008

Version 2.0

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

Submitted to:

Healthcare Information Technology Standards Panel

Submitted to:

Consumer Perspective Technical Committee
(Formerly Consumer Empowerment Technical Committee)

Document Change History

Version Number	Description of Change	Name of Author	Date Published
0.0.1	Review Copy	Consumer Empowerment Technical Committee	September 18, 2007
0.0.2	Review Copy	Consumer Empowerment Technical Committee	December 5, 2007
1.0	Released for Implementation	Consumer Empowerment Technical Committee	December 13, 2007
	Template Updated to V2.4	Project Team	July 31, 2008
1.0.1	Review Copy	Consumer Perspective Technical Committee	August 20, 2008
1.1.3	Review Copy	Consumer Perspective Technical Committee	December 10, 2008
2.0	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. 9

1.2.1 List of Constructs. 10

1.3 Copyright Permissions. 12

1.4 Reference Documents. 12

2.0 REQUIREMENTS. 14

2.1 Use Case Synopsis. 14

2.2 Use Case Requirements. 15

2.2.1 Mapping of Use Case Requirements to Information Exchange Requirements. 17

2.2.2 Data and Information exchange Requirements. 18

2.2.3 Identification of Business Actors, Interactions and Scenarios. 22

2.2.4 High-Level UML Interaction (Business Sequence) Diagram.. 27

3.0 DESIGN. 30

3.1 Scope of Design. 30

3.1.1 Assumptions. 31

3.1.2 Constraints. 32

3.1.3 Pre-conditions. 32

3.1.4 Post-conditions. 34

3.1.5 Process Triggers. 34

3.2 Detailed Design. 35

3.2.1 Technical Actors Role Descriptions. 35

3.2.2 Construct Requirements. 37

3.2.2.1 Summary Document Using HL7 Continuity of Care Document (CCD) Component 38

3.2.2.2 Lab Report Document 39

3.2.2.3 Unstructured Document Component 39

3.2.2.4 Transfer of Consumer Health Information from an Existing PHR System to another PHR System Scenario Actor Interactions. 40

3.2.2.4.1 Transactions Description. 41

3.2.2.5 Healthcare Professional Provides Patient with an Extract of Current Health Record on Portable Media for Import into PHR Scenario Actor Interactions. 41

3.2.2.5.1 Transaction Description. 42

3.2.2.6 Consumer Creates an Extract from its PHR, and Makes it Available on Portable Media to Healthcare Professionals of its choice. 43

3.2.2.6.1 Transaction Description. 43

3.2.3 Mapping of Business Actors to Technical Actors and Constructs with Optionality. 44

3.2.3.1 C32 Creator-Registration Subset 49

3.2.3.2 C32 Creator-Registration-Coded Subset 50

3.2.3.3 C32 Creator-Medication and Immunization History Subset 50

3.2.3.4 C32 Creator-Medication and Immunization History-Coded Subset 50

3.2.3.5 C32 Creator-Conditions and Allergy Subset 50

3.2.3.6 C32 Creator-Conditions and Allergy-Coded Subset 51

3.2.3.7 C32 Creator-Laboratory Section Subset 51

3.2.3.8 C32 Creator-Laboratory Section-Coded Subset 52

3.2.3.9 Consumer-Document Display Subset 52

3.2.3.10 Consumer-Document Import Subset 52

3.2.3.11 C32 Consumer-Registration Discrete Data Import Subset 52

3.2.3.12 C32 Consumer-Medication and Immunization History Discrete Data Import Subset 52

3.2.3.13 C32 Consumer-Conditions and Allergy Discrete Data Import Subset 52

3.2.3.14 C32 Consumer-Laboratory Discrete Data Import Subset 53

3.2.3.15 C37 Consumer-Lab Report Discrete Data Import Subset 53

3.2.4 Construct Dependencies. 53

3.2.5 Additional Constraints on Required Constructs. 53

4.0 STANDARDS SELECTION. 54

4.1 Standards. 55

4.1.1 Regulatory Guidance. 55

4.1.2 Selected Standards. 56

4.1.3 Informative Reference Standards. 59

4.2 Gaps Where There Are No Standards. 63

4.3 Standard Overlaps. 66

5.0 Conformance. 68

5.1 Conformance Criteria. 68

5.2 Conformance Scoping, Subsetting and Options. 68

5.3 Test Methods. 69

6.0 APPENDIX. 70

6.1 Description of Standards. 70

6.2 Use Case to Information Exchange and Data Requirements. 76

6.3 Use Case Sequence Diagrams. 89

6.4 Mapping of Constructs to Information Exchange and Data Requirements. 96

7.0 Change History. 98

7.1 December 5, 2007. 98

7.2 December 13, 2007. 99

7.3 August 20, 2008. 99

7.4 December 10, 2008. 99

7.5 December 18, 2008. 100

Figures and Tables

Figure 1.2-1 Interoperability Specification Document Map. 10

Figure 2.2.4-1 Legend for Component Diagrams. 28

Figure 2.2.4-2 Component Data Flow Diagram.. 29

Figure 3.2.2.4-1 Transfer of Consumer Health Information from one PHR System to another PHR System on Media 40

Figure 3.2.2.5-1 Healthcare Professional Provides Patient with Extract of Current Health Record on Portable Media for Import into PHR. 42

Figure 3.2.2.6-1 Consumer Creates an Extract from its PHR, and makes it available on Portable Media to Healthcare Professionals. 43

Figure 6.3-1 Scenario 1: Consumer Creates Account to Host and Access Registration Summary and Clinical Information High-Level UML Business Sequence Diagram - Part A. 90

Figure 6.3-2 Scenario 1: Consumer Creates Account to Host and Access Registration Summary and Clinical Information High-Level UML Business Sequence Diagram - Part B. 91

Figure 6.3-3 Scenario 1: Consumer Creates Account to Host and Access Registration Summary and Clinical Information High-Level UML Business Sequence Diagram - Part C. 92

Figure 6.3-4 Scenario 1: Consumer Creates Account to Host and Access Registration Summary and Clinical Information High-Level UML Business Sequence Diagram - Part D.. 93

Figure 6.3-5 Scenario 2: Consumer Visits Healthcare Provider and Provides Registration Summary Information and Clinical Information High-Level UML Business Sequence. 94

Figure 6.3-6 Scenario 3: Authorized Healthcare Provider Reviews Registration Summary and Other Clinical Information 95

Table 1.2.1-1 List of Constructs. 10

Table 1.4-1 Reference Documents. 12

Table 2.2.2-1 Table and Information Requirements Matrix. 18

Table 2.2.2-2 Information Exchange Requirements (IER) 21

Table 2.2.3-1 Business Actors. 22

Table 3.1-1 Scoping. 30

Table 3.1.1-1 Assumptions. 31

Table 3.1.2-1 Constraints. 32

Table 3.1.3-1 Pre-conditions. 33

Table 3.1.5-1 Post-conditions. 34

Table 3.1.4-1 Process Triggers. 35

Table 3.2.1-1 Technical Actor Role Descriptions. 36

Table 3.2.2.1-1 HITSP/C32 Content Modules in this Interoperability Specification. 38

Table 3.2.3-1 Business-Technical Actor Mapping to Transaction and/or Content 45

Table 3.2.3-2 Implementation Conditions/Constraints. 49

Table 3.2.3.1-1 Creator Registration Subset Content Modules. 49

Table 3.2.3.3-1 Creator Medication and Immunization History Subset Content Modules. 50

Table 3.2.3.5-1 Creator Conditions and Allergy Subset Content Modules. 51

Table 3.2.3.7-1 Creator Laboratory Subset Content Modules. 51

Table 3.2.4-1 Construct Dependencies. 53

Table 3.2.5-1 Additional Constraints on Required Constructs. 53

Table 4.1.1-1 Regulatory Guidance. 55

Table 4.1.2-1 Selected Standards Linked to HITSP Constructs. 56

Table 4.1.3-1 Informative Reference Standards. 59

Table 4.2-1 Use Case Events and Associated Gaps. 64

Table 4.3-1 Use Case Requirements and Associated Standard Overlaps. 67

Table 6.1-1 Descriptions of Standards. 70

Table 6.2-1 Mapping of Use Case Actions to Information Exchange Requirements: Consumer Empowerment and Consumer Access to Clinical Information Use Cases Scenario 1 - Consumer Creates Account to Host and Access Registration Summary and Clinical Information. 76

Table 6.2-2 Mapping of Use Case Actions to Information Exchange Requirements: Consumer Empowerment Scenario 2: Consumer Visits Healthcare Provider and Provides Registration Summary Information and Clinical Information 81

Table 6.2-3 Mapping of Use Case Actions to Information Exchange Requirements: Consumer Empowerment Scenario 3: Authorized Healthcare Provider Reviews Registration Summary and Other Clinical Information. 85

Table 6.2-4 Mapping of Use Case Actions to Information Exchange Requirements: Consumer Access Use Case Scenario 2: Provider Lists and Permissions. 87

Table 6.2-5 Mapping of Use Case Actions to Information Exchange Requirements: Consumer Access Use Case Scenario 3: Transfer of PHR Information. 88

Table 6.4-1 Mapping of Requirements to HITSP Constructs. 96