IEEE 11073-10419-2023

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IEEE Standard for Health informatics–Device interoperability Part 10419: Personal Health Device Communication–Device Specialization–Insulin Pump (Approved Draft)

Published By	Publication Date	Number of Pages
IEEE	2023	121

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Description

Revision Standard – Active. Within the context of the ISO/IEEE 11073 family of standards for device communication, a normative definition of communication between personal telehealth insulin pump devices and compute engines (e.g., cell phones, personal computers, personal health appliances, set top boxes) in a manner that enables plug-and-play interoperability, is established in this standard. Appropriate portions of existing standards including ISO/IEEE 11073 terminology, information models, application profile standards, and transport standards are leveraged. The use of specific term codes, formats, and behaviors in telehealth environments restricting optionality in base frameworks in favor of interoperability are specified. A common core of communication functionality for personal telehealth insulin pump devices is defined.

PDF Catalog

PDF Pages	PDF Title
1	IEEE Std 11073-10419™-2023 Front Cover
2	Title page
4	Important Notices and Disclaimers Concerning IEEE Standards Documents Notice and Disclaimer of Liability Concerning the Use of IEEE Standards Documents
5	Translations Official statements Comments on standards Laws and regulations
6	Data privacy Copyrights Photocopies Updating of IEEE Standards documents Errata
7	Patents IMPORTANT NOTICE
8	Participants
11	Introduction
12	Contents
14	1. Overview 1.1 Scope 1.2 Purpose
15	1.3 Word usage 1.4 Context
16	2. Normative references 3. Definitions, acronyms, and abbreviations 3.1 Definitions
18	3.2 Acronyms and abbreviations
19	4. Introduction to ISO/IEEE 11073 personal health devices 4.1 General 4.2 Introduction to ISO/IEEE 11073-20601 modeling constructs 4.2.1 General 4.2.2 Domain information model 4.2.3 Service model
20	4.2.4 Communication model 4.2.5 Implementing the models 4.3 Compliance with other standards 5. Insulin pump device concepts and modalities 5.1 General
21	5.2 Device types
22	5.3 Collected data 5.3.1 General 5.3.2 Current bolus setting
23	5.3.3 Pending bolus delay 5.3.4 Bolus delivered
24	5.3.5 Basal rate schedule setting 5.3.6 Basal profile setting
25	5.3.7 Current basal rate setting 5.3.8 Basal delivered
26	5.3.9 Insulin on board 5.3.10 Insulin reservoir remaining
27	5.3.11 Insulin concentration 5.3.12 Insulin to carbohydrate ratio profile settings 5.3.13 Insulin sensitivity factor profile settings 5.3.14 Timer 5.3.15 Operational status
28	5.3.16 PHD DM status 5.3.17 Insulin pump status 5.4 Stored data 5.5 Scheduled data 6. Insulin pump domain information model 6.1 Overview 6.2 Object instance diagram
30	6.3 Types of configuration 6.3.1 General 6.3.2 Standard configuration
31	6.3.3 Extended configuration 6.4 Profiles 6.4.1 General 6.5 Medical device system object 6.5.1 Medical device system object attributes
32	6.5.2 Medical device system object methods
33	6.5.3 Medical device system object events
35	6.5.4 Other medical device system services 6.5.4.1 GET service 6.5.4.2 SET service 6.6 Numeric objects 6.6.1 General 6.6.2 Current bolus setting
37	6.6.3 Pending bolus delay
39	6.6.4 Bolus delivered
42	6.6.5 Current basal rate setting
44	6.6.6 Basal delivered
46	6.6.7 Basal rate schedule setting
47	6.6.8 Insulin to carbohydrate ratio schedule setting
48	6.6.9 Insulin sensitivity factor schedule setting 6.6.10 Insulin reservoir remaining
49	6.6.11 Insulin concentration
50	6.6.12 Timer
51	6.6.12.1 Lifetime Timer
52	6.6.12.2 Warranty Timer 6.6.12.3 Loaner Timer
53	6.6.12.4 Reservoir Timer 6.6.13 Insulin on Board
55	6.6.14 Insulin delivered
56	6.7 Real-time sample array objects 6.8 Enumeration objects 6.8.1 General 6.8.2 Operational status
58	6.8.3 PHD DM status
60	6.8.4 Insulin pump status
62	6.9 PM-store objects 6.9.1 General
63	6.9.2 Persistent store model
64	6.9.3 Metric results PM-store object attributes
65	6.9.4 PM-store object methods 6.9.4.1 Clear-Segments
66	6.9.5 PM-store object events 6.9.6 PM-store object services 6.9.6.1 GET service 6.9.6.2 SET service 6.9.7 PM-segment objects
67	6.10 Schedule-store objects 6.10.1 General 6.10.2 Schedule-store model
68	6.10.3 Basal profile settings schedule-store object attributes
70	6.10.4 Insulin to carbohydrate ratio profile settings schedule-store object attributes
72	6.10.5 Insulin sensitivity factor profiles schedule-store object attributes
74	6.10.6 Schedule-store object methods
75	6.10.7 Schedule-store object events 6.10.8 Schedule-store object services
76	6.10.8.1 GET service 6.10.8.2 SET service 6.10.9 Schedule-segment objects
77	6.11 Scanner objects 6.12 Class extension objects 6.13 Insulin pump information model extensibility rules 7. Insulin pump service model 7.1 General 7.2 Object access services
79	7.3 Object access event report services
80	8. Insulin pump communication model 8.1 Overview 8.2 Communications characteristics 8.3 Association procedure 8.3.1 General
81	8.3.2 Agent procedure—association request
85	9. Test associations 9.1 Behavior with standard configuration 9.2 Behavior with extended configurations 10. Conformance 10.1 Applicability
86	10.2 Conformance specification 10.3 Levels of conformance 10.3.1 General 10.3.2 Conformance level 1: base conformance 10.3.3 Conformance level 2: extended nomenclature (ASN.1 and/or IEEE 11073-10101 )
87	10.4 Implementation conformance statements 10.4.1 General format 10.4.2 General implementation conformance statement
89	10.4.3 DIM MOC implementation conformance statement 10.4.4 MOC attribute ICS
90	10.4.5 MOC notification implementation conformance statement
91	10.4.6 MOC nomenclature implementation conformance statement
92	Annex A (informative) Bibliography
93	Annex B (normative) Any additional ASN.1 definitions B.1 Device status and insulin pump status bit mapping
94	Annex C (normative) Allocation of identifiers C.1 General C.2 Definitions of terms and codes
97	C.3 Systematic derivations of terms and codes
105	Annex D (informative) Message sequence examples
107	Annex E (informative) Protocol data unit examples E.1 General E.2 Association information exchange E.2.1 General E.2.2 Extended configuration E.2.2.1 General E.2.2.2 Association request
108	E.2.2.3 Association response E.2.3 Previously known extended configuration E.2.3.1 General E.2.3.2 Association request
109	E.2.3.3 Association response E.2.4 Standard configuration E.2.4.1 General E.2.4.2 Association request
110	E.2.4.3 Association response E.3 Configuration information exchange E.3.1 General
111	E.3.2 Extended configuration E.3.2.1 General E.3.2.2 Remote operation invoke event report configuration
113	E.3.2.3 Remote operation response event report configuration
114	E.3.3 Known configuration E.3.3.1 General E.3.3.2 Remote operation invoke event report configuration E.3.3.3 Remote operation response event report configuration E.3.4 Standard configuration E.3.4.1 General E.3.4.2 Remote operation invoke event report configuration
115	E.3.4.3 Remote operation response event report configuration E.4 GET MDS attributes service E.4.1.1 General E.4.1.2 Get all MDS attributes request E.4.1.3 Get response with all MDS attributes
116	E.5 Data reporting E.5.1 Unconfirmed measurement data transmission
117	E.6 Disassociation E.6.1 Association release request E.6.2 Association release response
118	Annex F (informative) Revision history
121	Back Cover

Additional information

Standard Title	IEEE Standard for Health informatics–Device interoperability Part 10419: Personal Health Device Communication–Device Specialization–Insulin Pump (Approved Draft)
Published Code	IEEE
Publication Date	2023
Pages Count	121

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