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BS EN ISO/IEEE 11073-20601:2022:2023 Edition

BS EN ISO/IEEE 11073-20601:2022:2023 Edition

$215.11

Health informatics. Device interoperability – Personal health device communication. Application profile. Optimized exchange protocol

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BSI 2023 288
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Within the context of the ISO/IEEE 11073 personal health device standard family, this document defines an optimized exchange protocol and modeling techniques to be used by implementers of personal health devices to create interoperability between device types and vendors. This document establishes a common framework for 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. The protocol is optimized to personal health usage requirements and leverages commonly used methods and tools wherever possible.

PDF Catalog

PDF Pages PDF Title
2 undefined
4 European foreword
Endorsement notice
6 Blank Page
9 Notice and Disclaimer of Liability Concerning the Use of IEEE Standards Documents
10 Translations
Official statements
Comments on standards
Laws and regulations
Copyrights
11 Photocopies
Updating of IEEE Standards documents
Errata
Patents
19 1. Overview
1.1 Scope
1.2 Purpose
1.3 Context
23 1.4 Word usage
2. Normative references
24 3. Definitions, acronyms, and abbreviations
3.1 Definitions
25 3.2 Acronyms and abbreviations
26 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.
27 5. Introduction to IEEE 11073 personal health devices
5.1 General
5.2 Domain information model (DIM)
5.3 Service model
28 5.4 Communication model
5.5 Compliance with other standards
5.6 Security
6. Personal health device DIM
6.1 General
29 6.2 Nomenclature usage
30 6.3 Personal health object class definitions
6.3.1 General
33 6.3.2 MDS class
6.3.2.1 General
6.3.2.2 MDS class identification
6.3.2.3 MDS class attributes
38 6.3.2.4 MDS object methods
39 6.3.2.5 MDS object events
40 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
41 6.3.3.2 Metric class identification
6.3.3.3 Metric class attributes
46 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
47 6.3.4.3 Numeric class attributes
49 6.3.4.4 Numeric object methods
6.3.4.5 Numeric object events
6.3.4.6 Other numeric services
50 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
52 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
54 6.3.6.4 Enumeration object methods
6.3.6.5 Enumeration object events
6.3.6.6 Other enumeration services
55 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
57 6.3.7.4 PM-store object methods
60 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
61 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
65 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
66 6.3.9.2 Conceptual model
67 6.3.9.3 Scanner class
6.3.9.3.1 General
6.3.9.3.2 Scanner class identification
68 6.3.9.3.3 Scanner class attributes
69 6.3.9.3.4 Scanner object methods
6.3.9.3.5 Scanner object events
6.3.9.3.6 Other scanner services
70 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
73 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
74 6.3.9.5.5 Episodic configurable scanner object events
6.3.9.5.6 Other episodic configurable scanner services
75 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
76 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
78 6.3.10.3 PHD DM Status object methods
79 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
81 6.3.11.4 Schedule-store object methods
82 6.3.11.5 Schedule-store object events
83 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
84 6.3.12.3 Schedule-segment class attributes
89 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
90 7.2 Association service
7.3 Object access services
91 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
92 7.4.3.4 Device specializations
93 7.4.3.5 Profiles
7.4.3.5.1 General
7.4.3.5.2 DIM constraints
94 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
95 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
96 7.4.5 Variable, fixed, and grouped format event reports
98 7.4.6 Single-person and multiple-person event reports
7.4.7 Temporarily stored measurements
99 8. Communication model
8.1 General
8.2 System context
100 8.3 Communications characteristics
8.3.1 General
102 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.
103 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
106 8.4.2 Manager state machine
107 8.4.3 Timeout variables
109 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
110 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
111 8.7.2 Entry conditions
8.7.3 Normal procedures
112 8.7.3.1 Agent procedure
8.7.3.1.1 General
113 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
115 8.7.3.3 Manager procedure
8.7.4 Exit conditions
116 8.7.5 Error conditions
8.7.6 Test association
117 8.8 Configuring procedure
8.8.1 General
8.8.2 Entry conditions
8.8.3 Normal procedures
120 8.8.4 Exit conditions
121 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
122 8.9.3.3 Measurement data transfer
8.9.3.3.1 General
8.9.3.3.2 Agent-initiated measurement data transmission
123 8.9.3.3.3 Manager-initiated data request
124 8.9.3.3.4 Scan report number management
125 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…
126 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 …
127 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…
129 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…
130 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…
131 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 …
133 8.9.4 Exit conditions
134 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
135 8.9.5.5 Confirmed Set
8.9.5.6 Special timeouts
136 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
137 8.11 Message encoding
8.12 Time coordination
8.12.1 General
8.12.2 Absolute time
8.12.2.1 General
138 8.12.2.2 Comparable time
139 8.12.3 Base time with offset
8.12.4 Relative time
140 8.12.5 High-resolution relative time
141 9. Conformance model
9.1 Applicability
9.2 Conformance specification
142 9.3 Implementation conformance statements (ICSs)
9.4 General conformance
9.4.1 General ICS
144 9.4.2 Minimum requirements ICS
145 9.4.3 Service support ICS
146 9.5 Device additions/extensions ICS
9.5.1 General additions/extensions ICS
147 9.5.2 Personal health device DIM object and class (POC) ICS
9.5.3 POC attribute ICS
148 9.5.4 POC behavior ICS
9.5.5 POC notification ICS
149 9.5.6 POC nomenclature ICS
150 Annex A (normative) ASN.1 definitions
A.1 General
A.2 Common data types
A.2.1 Integer and bit string data types
151 A.2.2 Identification data type
152 A.2.3 Handle data type
A.2.4 Instance number data type
A.2.5 Type ID data type
153 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
154 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
155 A.2.13 Absolute time data type
A.2.14 Base time with offset data type
A.2.15 Operational state data type
156 A.3 Attribute data types
A.3.1 MDS attributes
158 A.3.2 Metric attributes
A.3.3 Numeric attributes
A.3.4 RT-SA attributes
160 A.3.5 Enumeration attributes
162 A.3.6 Scanner attributes
163 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
164 A.4 ACTION-method-related data types
166 A.5 Message-related data types
A.6 Other
A.7 Personal health device protocol frame
167 A.8 Association protocol definitions
170 A.9 Presentation protocol definitions
A.10 Data protocol definitions
A.10.1 General
171 A.10.2 Data protocol frame
173 A.10.3 EVENT REPORT service
A.10.4 GET service
174 A.10.5 SET service
175 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
178 A.11.3 Metric-related data types
179 A.11.4 Scanner-related data types
A.11.5 MDS services
183 A.11.6 Scanner services
A.11.7 Numeric-related data types
184 A.11.8 PM-store and PM-segment related data types
187 A.11.9 Schedule store and schedule-segment related data types
191 Annex B (informative) Scale and range specification example
B.1 General
B.2 Thermometer example
193 Annex C (informative) The PM-store concept
C.1 General
194 C.2 Persistent metric (PM) store object hierarchy
C.2.1 General
195 C.2.2 PM-store object
C.2.3 PM-segment object
196 C.2.4 PM-segment entry (within the fixed-segment-data)
197 C.2.5 PM-segment entry element
198 Annex D (informative) Transport profile types
D.1 General
D.2 Type 1
199 D.3 Type 2
D.4 Type 3
D.4.1 General
D.4.2 Type 3a
200 D.4.3 Type 3b
D.4.4 Type 3c
D.5 Summary
201 Annex E (normative) State tables
E.1 General
E.2 Events
203 E.3 Agent state table
212 E.4 Manager state table
221 Annex F (normative) Medical device encoding rules (MDER)
F.1 General
F.2 Supported ASN.1 syntax
222 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….
224 F.4 Encodings
F.4.1 General
F.4.2 INTEGER
225 F.4.3 BIT STRING
226 F.4.4 OCTET STRING
227 F.4.5 SEQUENCE
F.4.6 SEQUENCE OF
228 F.4.7 CHOICE
229 F.4.8 ANY DEFINED BY and instance-of
230 F.5 Floating point numbers
F.6 Floating point data structure—FLOAT-Type
231 F.7 Short floating point data structure—SFLOAT-Type
232 F.8 Expression of precision of floating point numbers
233 Annex G (informative) Encoded data type definitions
255 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
256 H.2.2 Configuration information exchange
H.2.2.1 Remote operation invoke event report configuration
257 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
258 H.2.3.3 Get response with all MDS attributes
259 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
260 H.2.4.3 Remote operation invoke confirmed action data request
H.2.4.4 Remote operation response confirmed action data request
261 H.3 Pulse oximeter
H.3.1 General
H.3.2 Initial conditions
262 H.3.3 Every 10th message
H.4 PM-store and PM-segment transactions
H.4.1 General
263 H.4.2 Configuration message
264 H.4.3 Manager invokes Get-Segment-Info ACTION
265 H.4.4 Agent responds to Get-Segment-Info with SegmentInfoList
266 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
267 H.4.8 Manager confirms reception of first block
H.4.9 Agent sends second block of PM-segment measurements
268 H.4.10 Manager confirms reception of second block
H.4.11 Agent sends last block of PM-segment measurements
269 H.4.12 Manager confirms reception of last block
H.4.13 Manager clears the PM-segment
270 H.4.14 Agent deletes segment and responds to manager
271 Annex I (normative) Nomenclature codes
278 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
279 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
280 J.4.6 Communication infrastructure codes
J.4.6.1 MDC_DEV_SPEC_PROFILE
J.4.6.2 MDC_TIME_SYNC
281 Annex K (informative) The schedule-store concept
K.1 General
282 K.2 Schedule-store object hierarchy
K.2.1 General
K.2.2 Schedule-store object
283 K.2.3 Schedule-segment object
284 K.2.4 Schedule-segment entry (within the fixed segment data)
K.2.5 Schedule-segment entry element
285 Annex L (informative) Revision history
286 Annex M (informative) Bibliography

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