December 18, 2008

Version 1.0

HITSP Remote Monitoring Interoperability Specification

Submitted to:

Healthcare Information Technology Standards Panel

Submitted by:

Consumer Perspective Technical Committee

Document Change History

Version Number	Description of Change	Name of Author	Date Published
	Template Updated to V2.4	Project Team	July 31, 2008
0.0.1	Review Copy	Consumer Perspective Technical Committee	September 26, 2008
0.0.2	Review Copy	Consumer Perspective Technical Committee	December 10, 2008
1.0	Released for Implementation	Consumer 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. 7

1.2.1 List of Constructs. 7

1.3 Copyright Permissions. 10

1.4 Reference Documents. 10

2.0 Interoperability Requirements. 11

2.1 Use Case Synopsis. 11

2.2 Use Case Requirements. 12

2.2.1 Mapping of Use Case Actions to Information Exchange Requirements. 13

2.2.2 Data and Information Exchange Requirements. 13

2.2.3 Identification of Business Actors, and Scenarios. 17

2.2.4 High-Level Business Sequence Diagram.. 19

3.0 Design. 22

3.1 Scope of Design. 22

3.1.1 Assumptions. 24

3.1.2 Constraints. 24

3.1.3 Pre-conditions. 25

3.1.4 Post-conditions. 25

3.1.5 Process Triggers. 25

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. 31

3.2.4 Construct Dependencies. 37

3.2.5 Additional Constraints on Required Constructs. 37

4.0 Standards Selection. 38

4.1 Standards. 39

4.1.1 Regulatory Guidance. 39

4.1.2 Selected Standards. 39

4.1.3 Informative Reference Standards. 44

4.2 Gaps Where There Are No Standards. 47

4.3 Standard Overlaps. 51

4.3.1 Strategy for HITSP/IS77 and Completing IER39 (HITSP/T73) 51

5.0 Technical Implementation. 53

5.1 Conformance Criteria. 53

5.2 Conformance Scoping, Subsetting and Options. 53

5.3 Test Methods. 53

6.0 Appendix. 54

6.1 Description of Standards. 54

6.2 Use Case to Information Exchange and Data Requirements. 64

6.3 Use Case Sequence Diagrams. 69

6.4 Mapping of Constructs to Information Exchange and Data Requirements. 72

7.0 Change History. 74

7.1 December 10, 2008. 74

7.2 December 18, 2008. 74

Figures and Tables

Figure 1-1 Interoperability Specification Document Map. 7

Figure 2-1 Business System Interfaces. 20

Figure 2-2 Component Data Flow Diagram Legend. 21

Figure 2-3 Remote Monitoring Component Data Flow Diagram.. 21

Figure 3-1 Detailed Sequence Diagram for Scenario 1. 30

Figure 3-2 Detailed Sequence Diagram for Scenario 2. 31

Figure 6-1 Evaluate Patient and Order Remote Monitoring. 69

Figure 6-2 Setup and Receive Remote Monitoring Summary. 70

Figure 6-3 Evaluate/Manage Patient, and Modify Treatment Plan & Communicate with Patient 70

Figure 6-4 Initiate Remote Monitoring and Coordinate with Patient 71

Figure 6-5 Receive Remote Monitoring Data, and Utilize Device to Obtain Measurements. 71

Figure 6-6 Receive Remote Monitoring Data, and Patient Modifies Meds, Dosage, Activities, Diet, etc. 72

Table 1-1 List of Constructs. 8

Table 1-2 Reference Documents. 10

Table 2-1 Data Element and Information Requirements. 13

Table 2-2 Information Exchange Requirements (IER) 17

Table 2-3 Business Actors. 18

Table 3-1 Scoping Clarifications. 22

Table 3-2 Assumptions. 24

Table 3-3 Constraints. 24

Table 3-4 Pre-conditions. 25

Table 3-5 Post-conditions. 25

Table 3-6 Process Triggers. 26

Table 3-7 Technical Actor Role Descriptions. 28

Table 3-8 Business-Technical Actor Mapping to Transaction and/or Content 32

Table 3-9 Implementation Conditions/Constraints. 36

Table 3-10 Construct Dependencies. 37

Table 3-11 Additional Constraints on Required Constructs. 37

Table 4-1 Regulatory and Guidance Standards. 39

Table 4-2 Selected Standards Linked to HITSP Constructs. 40

Table 4-3 Informative Reference Standards. 44

Table 4-4 Use Case Events and Associated Gaps. 48

Table 4-5 Remote Monitoring Roadmap. 49

Table 4-6 Use Case Requirements and Associated Standards Overlaps. 51

Table 4-7 Selected Nomenclature Standards for HITSP/T73. 52

Table 6-1 Description of Standards. 54

Table 6-2 Mapping of Use Case Actions to Information Exchange Requirements: Remote Monitoring: 7.1 Clinician 1. Communication of Remote Monitoring Information to EHR or PHR. 64

Table 6-3 Mapping of Use Case Actions to Information Exchange Requirements: Remote Monitoring: 7.2 Care Coordinator 1. Communication of Remote Monitoring Information to EHR or PHR. 65

Table 6-4 Mapping of Use Case Actions to Information Exchange Requirements: Remote Monitoring: 7.3 Patient 1. Communication of Remote Monitoring Information to EHR or PHR. 67

Table 6-5 Mapping of Requirements to HITSP Constructs. 72