IEEE 11073-20601-2022

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IEEE/ISO International Standard–Health informatics–Device interoperability–Part 20601: Personal health device communication–Application profile –Optimized exchange protocol (Published)

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IEEE	2022

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Description

Adoption Standard – Active. Within the context of the ISO/IEEE 11073 family of standards for device communication, a common framework for making an abstract model of personal health data available in transport-independent transfer syntax required to establish logical connections between systems and to provide presentation capabilities and services needed to perform communication tasks is described in this standard. The protocol is optimized to personal health usage requirements and leverages commonly used methods and tools wherever possible.

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PDF Pages	PDF Title
4	Blank Page
7	Notice and Disclaimer of Liability Concerning the Use of IEEE Standards Documents
8	Translations Official statements Comments on standards Laws and regulations Copyrights
9	Photocopies Updating of IEEE Standards documents Errata Patents
17	1. Overview 1.1 Scope 1.2 Purpose 1.3 Context
21	1.4 Word usage 2. Normative references
22	3. Definitions, acronyms, and abbreviations 3.1 Definitions
23	3.2 Acronyms and abbreviations
24	4. Guiding principles a) Personal health agents typically have very limited computing capabilities. b) Personal health agents typically have a fixed configuration, and they are used with a single manager device. c) Personal health agents are frequently battery powered, mobile devices, using a wireless communication link. Therefore, energy efficiency of the protocol is an important aspect. d) Personal health agents are often not permanently active. For example, a weighing scale may provide data only once or twice a day. An efficient connection procedure is needed for minimum overhead for such devices. e) Personal health managers tend to have more processing power, memory, and storage space so the protocol intentionally places more load on the managers. f) Personal health agents and managers convey information that could be useful to clinical professionals. As such, the quality of the data may be considered to have clinical merit even if acquired in a personal health or remote monitoring environment.
25	5. Introduction to IEEE 11073 personal health devices 5.1 General 5.2 Domain information model (DIM) 5.3 Service model
26	5.4 Communication model 5.5 Compliance with other standards 5.6 Security 6. Personal health device DIM 6.1 General
27	6.2 Nomenclature usage
28	6.3 Personal health object class definitions 6.3.1 General
31	6.3.2 MDS class 6.3.2.1 General 6.3.2.2 MDS class identification 6.3.2.3 MDS class attributes
36	6.3.2.4 MDS object methods
37	6.3.2.5 MDS object events
38	6.3.2.6 Other MDS services 6.3.2.6.1 GET service 6.3.2.6.2 SET service 6.3.3 Metric class 6.3.3.1 General
39	6.3.3.2 Metric class identification 6.3.3.3 Metric class attributes
44	6.3.3.4 Metric object methods 6.3.3.5 Metric object events 6.3.3.6 Other metric services 6.3.4 Numeric class 6.3.4.1 General 6.3.4.2 Numeric class identification
45	6.3.4.3 Numeric class attributes
47	6.3.4.4 Numeric object methods 6.3.4.5 Numeric object events 6.3.4.6 Other numeric services
48	6.3.5 RT-SA class 6.3.5.1 General 6.3.5.2 RT-SA class identification 6.3.5.3 RT-SA class attributes
50	6.3.5.4 RT-SA object methods 6.3.5.5 RT-SA object events 6.3.5.6 Other RT-SA services 6.3.6 Enumeration class 6.3.6.1 General 6.3.6.2 Enumeration class identification 6.3.6.3 Enumeration class attributes
52	6.3.6.4 Enumeration object methods 6.3.6.5 Enumeration object events 6.3.6.6 Other enumeration services
53	6.3.7 PM-store class 6.3.7.1 General 6.3.7.2 PM-store class identification 6.3.7.3 PM-store class attributes
55	6.3.7.4 PM-store object methods
58	6.3.7.5 PM-store object events 6.3.7.6 Other PM-store services 6.3.7.6.1 GET service 6.3.7.6.2 SET service
59	6.3.8 PM-segment class 6.3.8.1 General 6.3.8.2 PM-segment class identification 6.3.8.3 PM-segment class attributes
63	6.3.8.4 PM-segment object methods 6.3.8.5 PM-segment object events 6.3.8.6 Other PM-segment services 6.3.9 Scanner classes 6.3.9.1 General
64	6.3.9.2 Conceptual model
65	6.3.9.3 Scanner class 6.3.9.3.1 General 6.3.9.3.2 Scanner class identification
66	6.3.9.3.3 Scanner class attributes
67	6.3.9.3.4 Scanner object methods 6.3.9.3.5 Scanner object events 6.3.9.3.6 Other scanner services
68	6.3.9.4 CfgScanner class 6.3.9.4.1 General 6.3.9.4.2 Configurable scanner class identification 6.3.9.4.3 Configurable scanner class attributes
71	6.3.9.4.4 Configurable scanner object methods 6.3.9.4.5 Configurable scanner object events 6.3.9.4.6 Other configurable scanner services 6.3.9.5 EpiCfgScanner class 6.3.9.5.1 General 6.3.9.5.2 Episodic configurable scanner class identification 6.3.9.5.3 Episodic configurable scanner class attributes 6.3.9.5.4 Episodic configurable scanner object methods
72	6.3.9.5.5 Episodic configurable scanner object events 6.3.9.5.6 Other episodic configurable scanner services
73	6.3.9.6 PeriCfgScanner class 6.3.9.6.1 General 6.3.9.6.2 Periodic configurable scanner object identification 6.3.9.6.3 Periodic configurable scanner object attributes 6.3.9.6.4 Periodic configurable scanner object methods
74	6.3.9.6.5 Periodic configurable scanner object events 6.3.9.6.6 Other periodic configurable scanner services 6.3.10 PHD DM Status object 6.3.10.1 General 6.3.10.2 PHD DM Status object attributes
76	6.3.10.3 PHD DM Status object methods
77	6.3.10.4 PHD DM Status object events 6.3.10.5 Other PHD DM Status services 6.3.11 Schedule-store class 6.3.11.1 General 6.3.11.2 Schedule-store class identification 6.3.11.3 Schedule-store class attributes
79	6.3.11.4 Schedule-store object methods
80	6.3.11.5 Schedule-store object events
81	6.3.11.6 Other Schedule-store services 6.3.11.6.1 GET service 6.3.11.6.2 SET service 6.3.12 Schedule-segment class 6.3.12.1 General 6.3.12.2 Schedule-segment class identification
82	6.3.12.3 Schedule-segment class attributes
87	6.3.12.4 Schedule-segment object methods 6.3.12.5 Schedule-segment object events 6.3.12.6 Other schedule-segment object services 6.4 Information model extensibility rules 7. Personal health device service model 7.1 General
88	7.2 Association service 7.3 Object access services
89	7.4 Specific application of object access EVENT REPORT services for personal health devices 7.4.1 General 7.4.2 Confirmed and unconfirmed event reports 7.4.3 Configuration event report 7.4.3.1 General 7.4.3.2 Agent device configuration 7.4.3.3 Configuration event report
90	7.4.3.4 Device specializations
91	7.4.3.5 Profiles 7.4.3.5.1 General 7.4.3.5.2 DIM constraints
92	7.4.3.5.3 Service model constraints 7.4.3.5.4 Communication model constraints 7.4.3.6 Types of configuration 7.4.3.6.1 Standard configuration
93	7.4.3.6.2 Extended configuration a) The same Dev-Configuration-Id shall not be used by an agent for subsequent associations to identify a different device configuration. b) An agent should use the same value for Dev-Configuration-Id in future Association Requests with the manager to denote the same configuration of the device. 7.4.4 Agent- and manager-initiated measurement data transmission
94	7.4.5 Variable, fixed, and grouped format event reports
96	7.4.6 Single-person and multiple-person event reports 7.4.7 Temporarily stored measurements
97	8. Communication model 8.1 General 8.2 System context
98	8.3 Communications characteristics 8.3.1 General
100	8.3.2 Common communications characteristics a) An APDU may be processed in any manner (e.g., part by part as the APDU arrives or as a complete buffered APDU in memory), but the APDU shall be processed so that its effects are as an atomic transaction. b) APDUs may be segmented and reassembled during transport, or they may be sent as a complete unit. c) APDUs, in the agent-to-manager direction, shall be no larger than 63K (64 512) bytes in size. Specific device specializations, profiles, or implementations may evaluate the messages exchanged to determine a specific implementation size for a manage… d) APDUs, in the manager-to-agent direction, shall be no larger than 8K (8192) bytes in size. Specific device specializations, profiles, or implementations may evaluate the messages exchanged to determine a specific implementation size for an agent re… e) The overall length of the APDU shall be passed to and from the communications layers as metadata. f) The communications layer shall indicate the overall length of the APDU to its peer communications layer. 8.3.3 Reliable communications characteristics a) APDUs shall be received in the order they are sent. b) APDUs shall be free of detectable errors. c) APDUs shall not be duplicated. d) APDUs shall not be missing. e) APDUs are generally sent in an expeditious manner, but may be delayed due to retries. f) The communications layers should provide a mechanism to indicate to the application layer when a complete APDU has been received. g) The communications layers shall provide a mechanism to indicate to the application layer when a connection path between an agent and a manager is established. h) The communications layers should provide a mechanism to indicate to the application layer when a connection is terminated or disconnected. i) The communications layers shall provide a mechanism to indicate to the application layer when it is unable to send an APDU. j) Flow control between the sending and receiving application shall be supported for complete APDUs. The lower layers may implement flow control for smaller subsets of the APDU.
101	8.3.4 Best-effort communications characteristics a) An APDU may not be delivered in the order in which it was sent. It is possible for the communication channel itself, independent of the operation of a personal health device transmitter, to misorder packets. b) An APDU may be lost or duplicated. c) APDUs may arrive at a rate that causes buffer exhaustion at the receiver. 8.4 State machines 8.4.1 Agent state machine
104	8.4.2 Manager state machine
105	8.4.3 Timeout variables
107	8.5 Connected procedure 8.5.1 General 8.5.2 Entry conditions 8.5.3 Normal procedures 8.5.4 Exit conditions 8.5.5 Error conditions 8.6 Unassociated procedure 8.6.1 General
108	8.6.2 Entry conditions 8.6.3 Normal procedures 8.6.4 Exit conditions 8.6.5 Error conditions 8.7 Associating procedure 8.7.1 General
109	8.7.2 Entry conditions 8.7.3 Normal procedures
110	8.7.3.1 Agent procedure 8.7.3.1.1 General
111	8.7.3.1.2 Data-exchange protocol—defined by this standard 8.7.3.1.3 Data-exchange protocol—defined by the manufacturer 8.7.3.2 Association response
113	8.7.3.3 Manager procedure 8.7.4 Exit conditions
114	8.7.5 Error conditions 8.7.6 Test association
115	8.8 Configuring procedure 8.8.1 General 8.8.2 Entry conditions 8.8.3 Normal procedures
118	8.8.4 Exit conditions
119	8.8.5 Error conditions 8.9 Operating procedure 8.9.1 General 8.9.2 Entry conditions 8.9.3 Normal procedures 8.9.3.1 General 8.9.3.2 MDS object attributes
120	8.9.3.3 Measurement data transfer 8.9.3.3.1 General 8.9.3.3.2 Agent-initiated measurement data transmission
121	8.9.3.3.3 Manager-initiated data request
122	8.9.3.3.4 Scan report number management
123	8.9.3.4 Persistently stored metric data transfer 8.9.3.4.1 General 8.9.3.4.2 Persistently stored metric data transmission a) Retrieving the PM-store attributes. When the agent and manager are in the Operating state, the manager can inspect the configuration negotiated with the agent to determine the number of PM-store objects in the agent. The manager may query each PM-s…
124	b) Retrieving the ID list of PM-segments. The manager retrieves information on the segments in a PM-store by sending an ACTION.Get-Segment-Id-List command to the specific PM-store (see Figure 19). The agent responds to the ACTION.Get-Segment-Id-List c… c) Retrieving the PM-segment information. The manager retrieves information on the segments in a PM-store by sending an ACTION.Get-Segment-Info command to the specific PM-store (see Figure 20) with a request to return information from all segments, a …
125	d) Transferring PM-segment content. The manager retrieves specific PM-segments by using the Trig-Segment-Data-Xfer ACTION method to initiate the data transfer (see Figure 21). In the first step, the manager sends the ACTION method to the agent with th…
127	e) Clear a PM-segment. The agent may support PM-segment clearing. The manager determines whether the agent supports any of the clearing functions by inspecting the pmsc-clear-segm-all-sup, pmsc-clear-segm-by-list-sup, and pmsc-clear-segm-by-time-sup f…
128	8.9.3.5 Schedule-stored information retrieval 8.9.3.5.1 General 8.9.3.5.2 Schedule-stored information retrieval a) Retrieving the schedule-store attributes. When the agent and manager are in the Operating state, the manager can inspect the configuration negotiated with the agent to determine the number of schedule-store objects in the agent. The manager may que…
129	b) Retrieving the ID list of schedule-segments. The manager retrieves information on the segments in a schedule-store by sending an ACTION.Get-Schedule-Segment-Id-List command to the specific schedule-store. The agent responds to the ACTION.Get-Schedu… c) Retrieving the schedule-segment information. The manager retrieves information on the segments in a schedule-store by sending an ACTION.Get-Schedule-Segment-Info command to the specific schedule-store (see Figure 24) with a request to return inform… d) If the manager invokes the Get-Schedule-Segment-Info method but the agent does not support the specified choice, then the agent shall respond with a roer DataApdu with a RoerErrorValue of “unsupported-choice”. e) Transfer schedule-segment content. The manager retrieves specific schedule-segments by using the Trig-Schedule-Segment-Data-Xfer ACTION method to initiate the data transfer (see Figure 25). In the first step, the manager sends the ACTION method to …
131	8.9.4 Exit conditions
132	8.9.5 Error conditions 8.9.5.1 General 8.9.5.2 Confirmed Action 8.9.5.3 Confirmed Event Report 8.9.5.4 Get
133	8.9.5.5 Confirmed Set 8.9.5.6 Special timeouts
134	8.10 Disassociating procedure 8.10.1 General 8.10.2 Entry conditions 8.10.3 Normal procedures 8.10.4 Exit conditions 8.10.5 Error conditions
135	8.11 Message encoding 8.12 Time coordination 8.12.1 General 8.12.2 Absolute time 8.12.2.1 General
136	8.12.2.2 Comparable time
137	8.12.3 Base time with offset 8.12.4 Relative time
138	8.12.5 High-resolution relative time
139	9. Conformance model 9.1 Applicability 9.2 Conformance specification
140	9.3 Implementation conformance statements (ICSs) 9.4 General conformance 9.4.1 General ICS
142	9.4.2 Minimum requirements ICS
143	9.4.3 Service support ICS
144	9.5 Device additions/extensions ICS 9.5.1 General additions/extensions ICS
145	9.5.2 Personal health device DIM object and class (POC) ICS 9.5.3 POC attribute ICS
146	9.5.4 POC behavior ICS 9.5.5 POC notification ICS
147	9.5.6 POC nomenclature ICS
148	Annex A (normative) ASN.1 definitions A.1 General A.2 Common data types A.2.1 Integer and bit string data types
149	A.2.2 Identification data type
150	A.2.3 Handle data type A.2.4 Instance number data type A.2.5 Type ID data type
151	A.2.6 Attribute value assertion (AVA) data type A.2.7 Attribute list data type A.2.8 Attribute ID list data type A.2.9 Floating point type (FLOAT-Type) data type
152	A.2.10 Short floating point type (SFLOAT-Type) data type A.2.11 Relative time data type A.2.12 High-resolution relative time data type
153	A.2.13 Absolute time data type A.2.14 Base time with offset data type A.2.15 Operational state data type
154	A.3 Attribute data types A.3.1 MDS attributes
156	A.3.2 Metric attributes A.3.3 Numeric attributes A.3.4 RT-SA attributes
158	A.3.5 Enumeration attributes
160	A.3.6 Scanner attributes
161	A.3.7 Configurable scanner attributes A.3.8 Episodic configurable scanner attributes A.3.9 Periodic configurable scanner attributes A.3.10 PM-store and PM-segment attributes A.3.11 PHD DM Status attributes
162	A.4 ACTION-method-related data types
164	A.5 Message-related data types A.6 Other A.7 Personal health device protocol frame
165	A.8 Association protocol definitions
168	A.9 Presentation protocol definitions A.10 Data protocol definitions A.10.1 General
169	A.10.2 Data protocol frame
171	A.10.3 EVENT REPORT service A.10.4 GET service
172	A.10.5 SET service
173	A.10.6 ACTION service A.11 Data types for new object attributes and object services A.11.1 General data types A.11.2 MDS-related data types
176	A.11.3 Metric-related data types
177	A.11.4 Scanner-related data types A.11.5 MDS services
181	A.11.6 Scanner services A.11.7 Numeric-related data types
182	A.11.8 PM-store and PM-segment related data types
185	A.11.9 Schedule store and schedule-segment related data types
189	Annex B (informative) Scale and range specification example B.1 General B.2 Thermometer example
191	Annex C (informative) The PM-store concept C.1 General
192	C.2 Persistent metric (PM) store object hierarchy C.2.1 General
193	C.2.2 PM-store object C.2.3 PM-segment object
194	C.2.4 PM-segment entry (within the fixed-segment-data)
195	C.2.5 PM-segment entry element
196	Annex D (informative) Transport profile types D.1 General D.2 Type 1
197	D.3 Type 2 D.4 Type 3 D.4.1 General D.4.2 Type 3a
198	D.4.3 Type 3b D.4.4 Type 3c D.5 Summary
199	Annex E (normative) State tables E.1 General E.2 Events
201	E.3 Agent state table
210	E.4 Manager state table
219	Annex F (normative) Medical device encoding rules (MDER) F.1 General F.2 Supported ASN.1 syntax
220	F.3 Byte order 1) Representation in diagrams uses the NBO format shown in Figure F.1. 2) No alignment is used in MDER. In other words, additional bytes are not added to byte strings, e.g., to obtain lengths that are divisible by two or four. However, variable-length data items, i.e., strings, should have an even length for performance … 3) MDAP communicants are restricted to using the NBO (big-endian) convention. 4) The association protocol shall use ISO MDER to provide for universal interoperability during negotiation of MDER conventions. All other PDUs exchanged in the life cycle of device-host communication will be based in MDER, e.g., CMIP* and ROSE* PDUs….
222	F.4 Encodings F.4.1 General F.4.2 INTEGER
223	F.4.3 BIT STRING
224	F.4.4 OCTET STRING
225	F.4.5 SEQUENCE F.4.6 SEQUENCE OF
226	F.4.7 CHOICE
227	F.4.8 ANY DEFINED BY and instance-of
228	F.5 Floating point numbers F.6 Floating point data structure—FLOAT-Type
229	F.7 Short floating point data structure—SFLOAT-Type
230	F.8 Expression of precision of floating point numbers
231	Annex G (informative) Encoded data type definitions
253	Annex H (informative) Examples H.1 General H.2 Weighing scale H.2.1 Association H.2.1.1 Association request H.2.1.2 Association response
254	H.2.2 Configuration information exchange H.2.2.1 Remote operation invoke event report configuration
255	H.2.2.2 Remote operation response event report configuration H.2.3 GET MDS attributes service H.2.3.1 General H.2.3.2 Get all MDS attributes request
256	H.2.3.3 Get response with all MDS attributes
257	H.2.4 Data reporting H.2.4.1 Agent-initiated measurement data transmission H.2.4.2 Response to agent-initiated measurement data transmission
258	H.2.4.3 Remote operation invoke confirmed action data request H.2.4.4 Remote operation response confirmed action data request
259	H.3 Pulse oximeter H.3.1 General H.3.2 Initial conditions
260	H.3.3 Every 10th message H.4 PM-store and PM-segment transactions H.4.1 General
261	H.4.2 Configuration message
262	H.4.3 Manager invokes Get-Segment-Info ACTION
263	H.4.4 Agent responds to Get-Segment-Info with SegmentInfoList
264	H.4.5 Manager initiates transfer with Trig-SegmData-Xfer ACTION requesting segment 1 data H.4.6 Agent responds to Trig-Seg-Data-Transfer H.4.7 Agent sends first block of PM-segment measurements via Segment-Data-Event reports
265	H.4.8 Manager confirms reception of first block H.4.9 Agent sends second block of PM-segment measurements
266	H.4.10 Manager confirms reception of second block H.4.11 Agent sends last block of PM-segment measurements
267	H.4.12 Manager confirms reception of last block H.4.13 Manager clears the PM-segment
268	H.4.14 Agent deletes segment and responds to manager
269	Annex I (normative) Nomenclature codes
276	Annex J (informative) Derivation and modification history J.1 General J.2 ASN.1 structures J.3 Medical device encoding rules (MDER) J.4 Nomenclature codes J.4.1 General
277	J.4.2 Partition codes J.4.3 Object infrastructure codes J.4.3.1 MDC_MOC J.4.3.2 MDC_ATTR J.4.3.3 MDC_ACT J.4.3.4 MDC_NOTI J.4.3.5 MDC_RET_CODE J.4.4 Medical supervisory control and data acquisition J.4.5 Dimension codes
278	J.4.6 Communication infrastructure codes J.4.6.1 MDC_DEV_SPEC_PROFILE J.4.6.2 MDC_TIME_SYNC
279	Annex K (informative) The schedule-store concept K.1 General
280	K.2 Schedule-store object hierarchy K.2.1 General K.2.2 Schedule-store object
281	K.2.3 Schedule-segment object
282	K.2.4 Schedule-segment entry (within the fixed segment data) K.2.5 Schedule-segment entry element
283	Annex L (informative) Revision history
284	Annex M (informative) Bibliography

Additional information

Standard Title	IEEE/ISO International Standard–Health informatics–Device interoperability–Part 20601: Personal health device communication–Application profile –Optimized exchange protocol (Published)
Published Code	IEEE
Publication Date	2022

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