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Draft Standard for Health informatics -- Point-of-care medical device communication -- Part 20401: Application profile -Common networking services
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P11073-20401™/D1.2
Draft Standard for Health informatics -Point-of-care medical device
communication -- Part 20401:
Application profile -- Common
networking services
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Draft Standard for Health informatics -- Point-of-care medical device communication -- Part 20401: Application profile -Common networking services
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Draft Standard for Health informatics -- Point-of-care medical device communication -- Part 20401: Application profile -Common networking services
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Participants
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At the time this draft standard was completed, the Upper Layers Working Group had the following
membership:
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Jan Wittenber, Chair
<Vice-chair Name>, Vice Chair
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Participant1
Participant2
Participant3
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Participant4
Participant5
Participant6
Participant7
Participant8
Participant9
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The following members of the <individual/entity> balloting committee voted on this standard. Balloters
may have voted for approval, disapproval, or abstention.
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[To be supplied by IEEE]
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Balloter1
Balloter2
Balloter3
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When the IEEE-SA Standards Board approved this standard on <Date Approved>, it had the following
membership:
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[To be supplied by IEEE]
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Balloter4
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Balloter6
Balloter7
Balloter8
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<Name>, Chair
<Name>, Vice Chair
<Name>, Past Chair
<Name>, Secretary
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SBMember1
SBMember2
SBMember3
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SBMember4
SBMember5
SBMember6
SBMember7
SBMember8
SBMember9
*Member Emeritus
Also included are the following nonvoting IEEE-SA Standards Board liaisons:
<Name>, DOE Representative
<Name>, NIST Representative
<Name>
IEEE Standards Program Manager, Document Development
<Name>
IEEE Standards Program Manager, Technical Program Development
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P11073-20401/D1.2, November 2013
Draft Standard for Health informatics -- Point-of-care medical device communication -- Part 20401: Application profile -Common networking services
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Introduction
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This introduction is not part of P11073-20401/D1.2, Draft Standard for Health informatics -- Point-of-care medical
device communication -- Part 20401: Application profile -- Common networking services.
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5
Within the framework of IEEE 11073 standards, this standard defines a common, transport neutral set of
networking services that enable plug and play interoperability of medical devices.
vii
Copyright © 2013 IEEE. All rights reserved.
This is an unapproved IEEE Standards Draft, subject to change.
P11073-20401/D1.2, November 2013
Draft Standard for Health informatics -- Point-of-care medical device communication -- Part 20401: Application profile -Common networking services
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Contents
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1. Overview .................................................................................................................................................... 1
1.1 Scope ................................................................................................................................................... 1
1.2 Purpose ................................................................................................................................................ 1
5
2. Normative references .................................................................................................................................. 2
6
3. Definitions .................................................................................................................................................. 2
7
4. Common networking services .................................................................................................................... 2
8
5. Topological profiles.................................................................................................................................... 2
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10
6. Service profiles ........................................................................................................................................... 3
6.1 Overview ............................................................................................................................................. 3
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7. Transport profiles ....................................................................................................................................... 3
7.1 Networking technology profiles .......................................................................................................... 3
7.2 Transport independent system layer .................................................................................................... 4
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15
8. Physical layer ............................................................................................................................................. 5
8.1 Physical / link layer 802.3 ................................................................................................................... 5
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9. Provisioning services .................................................................................................................................. 5
9.1 DHCP service ...................................................................................................................................... 6
9.1.1 General ......................................................................................................................................... 6
9.1.2 Autonet address selection ............................................................................................................. 7
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10. Discovery services .................................................................................................................................... 7
10.1 DNS mDNS service ........................................................................................................................... 7
10.2 DNS discovery in domain .................................................................................................................. 8
10.3 mDNS name selection and publication .............................................................................................. 9
10.4 mDNS service discovery ..................................................................................................................10
10.5 DNS service URL format .................................................................................................................10
10.6 Resource types ..................................................................................................................................10
10.7 State chart .........................................................................................................................................11
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11. Connectivity services ...............................................................................................................................11
11.1 Overview ..........................................................................................................................................11
11.2 TCP/IP and UDP/IP v4 .....................................................................................................................11
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12. Quality of service (QoS) ..........................................................................................................................12
12.1 QoS requirements .............................................................................................................................12
12.2 Preferred technologies ......................................................................................................................12
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13. Security services ......................................................................................................................................13
13.1 IPSec .................................................................................................................................................13
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14. Conformance ...........................................................................................................................................13
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Annex A Clinical xcenarios - ENV 13735 Annex E 2.1 ...............................................................................14
A.1 Emergency situation – one of the main scenarios is alarm (2.1.1) .....................................................14
viii
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A.2 Normal patient nursing condition in ICU, non-emergency situations (2.2) .......................................14
A.3 Data logger ( 3.1) ...............................................................................................................................14
A.4 Patient alarm monitoring (3.3) ...........................................................................................................14
A.5 Remote control (3.4) ..........................................................................................................................14
A.6 Patient viewing interoperability (3.5) ................................................................................................14
A.7 Patient monitoring interoperability (3.6) ...........................................................................................15
A.8 Maintenance and configuration support (3.8) ....................................................................................15
A.9 Intrabed symmetric data exchange between DCC and BCC (4.1) interbed symmetric data exchange
over an "Interbed Network“ (4.2) .............................................................................................................15
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Annex B TISL Specifications ........................................................................................................................16
14.1 Provisioning TISL primitives ...........................................................................................................16
14.2 Discovery TISL primitives ...............................................................................................................18
14.3 Security TISL primitives ..................................................................................................................19
14
Annex C (informative) Data distribution service (DDS) usage .....................................................................20
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Annex D (informative) Bibliography ............................................................................................................21
ix
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P11073-20401/D1.2, November 2013
Draft Standard for Health informatics -- Point-of-care medical device communication -- Part 20401: Application profile -Common networking services
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Draft Standard for Health informatics -Point-of-care medical device
communication -- Part 20401:
Application profile -- Common
networking services
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IMPORTANT NOTICE: IEEE Standards documents are not intended to ensure safety, security, health,
or environmental protection, or ensure against interference with or from other devices or networks.
Implementers of IEEE Standards documents are responsible for determining and complying with all
appropriate safety, security, environmental, health, and interference protection practices and all
applicable laws and regulations.
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This IEEE document is made available for use subject to important notices and legal disclaimers.
These notices and disclaimers appear in all publications containing this document and may
be found under the heading “Important Notice” or “Important Notices and Disclaimers
Concerning IEEE Documents.” They can also be obtained on request from IEEE or viewed at
http://standards.ieee.org/IPR/disclaimers.html.
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1. Overview
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1.1 Scope
18
19
Within the framework of IEEE 11073 standards, this standard defines a common, transport neutral set of
networking services that enable plug and play interoperability of medical devices.
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This standard does not address quality of service over radio frequency (RF) wireless network connections.
21
1.2 Purpose
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There are many different networking technologies that may be used to achieve medical device connectivity;
however, there is no commonly agreed upon set of services and protocol profiles defined for medical
device communication. As a result, achieving any level of interoperability using networked medical devices
requires significant effort and resources.
1
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P11073-20401/D1.2, November 2013
Draft Standard for Health informatics -- Point-of-care medical device communication -- Part 20401: Application profile -Common networking services
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2
RF network quality of service may be addressed in subsequent revisions of this standard; however,
addressing it at this stage is too challenging given the state of the underlying technology.
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2. Normative references
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The following referenced documents are indispensable for the application of this document (i.e., they must
be understood and used, so each referenced document is cited in text and its relationship to this document is
explained). For dated references, only the edition cited applies. For undated references, the latest edition of
the referenced document (including any amendments or corrigenda) applies.
8
3. Definitions
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For the purposes of this document, the following terms and definitions apply. The IEEE Standards
Dictionary Online should be consulted for terms not defined in this clause. 1
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<CNS>
<TISL>
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4. Common networking services
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[NOTE: This section provides an overview of the entire topic of CNS and lays the foundation for the
subsequent sections.]
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5. Topological profiles
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18
Figure 1 — Topological profiles
1
IEEE Standards Dictionary Online subscription is available at:
http://www.ieee.org/portal/innovate/products/standard/standards_dictionary.html.
2
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This is an unapproved IEEE Standards Draft, subject to change.
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6. Service profiles
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3
[NOTE: This section lays the foundation for specific types of service sets that are dealt with more detail in
subsequent sections and annexes.]
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6.1 Overview
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6
Figure 2 Clinical use contexts and service profiles
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7. Transport profiles
8
7.1 Networking technology profiles
9
The Transport Independent System Layer (TISL) provides a standard interface for the upper layers.
3
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P11073-20401/D1.2, November 2013
Draft Standard for Health informatics -- Point-of-care medical device communication -- Part 20401: Application profile -Common networking services
IP Support Services
Location
services
LDAP
Net.
capacity
service
11073
“upper layers”
SNMP
IrLMP
current
Interface to ‘upper
layers” - TISL
RTP/SCTP
SCTP
short term
RF
ether
class drv
RF
short term
IP
profile
possible
future
point to point links
ZigBee
USB
802.16
BlueTooth
10/100/
1000BT
GPRS
EDGE
1xRTT
4G /LTE
RF
Wi-Max
802.11
Cellular Data
802.3
Wi-Fi
PHDC
ethernet
BlueTooth
USB
MDP
RS-232
1
11073 assoc
service
IP
IrLAP
2
3
UDP
NAT
NTP
Presence
services
TCP
TinyTP
Radius
802.1x
11073 config
service
DNS
IR
DHCP
MICS
WMTS
possible
future
IP centric links
Figure 3 —TISL interface for the upper layers
The technologies that may be used for transport-level functions are listed in Table 1.
4
Table 1 Technologies that can be used for CNS (Initial Scope)
Components
Layer
Technology
Interface
Physical/Link
802.3
Connectivity
Transport/Network
UDP/IP v4 and TCP/IP v4
Security
Network
IPSec over UDP, IPSec over TCP, None
Quality Of Service
Application
RTP over UDP, RSVP
Discovery
Application
mDNS, DNS
Provisioning
Application
DHCP, Statically provisioned
5
7.2 Transport independent system layer
6
The Transport Independent System Layer (TISL) provides:
7

Uniform interface to upper layers
8

Support for following services:
9
o
Discovery of services
10
o
Connectivity
11
o
Provisioning
12
o
Security
4
Copyright © 2013 IEEE. All rights reserved.
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P11073-20401/D1.2, November 2013
Draft Standard for Health informatics -- Point-of-care medical device communication -- Part 20401: Application profile -Common networking services
o
1
Quality Of Service (QoS)
2
8. Physical layer
3
8.1 Physical / link layer 802.3
4

Will be used as specified in IEEE 11073-30400
5

MAC/PHY specified in 11073-30400
6
9. Provisioning services
7

Apart from IP address
8

Following options will be implemented
9
o
Domain Name Server Option. Code = 6
10
o
Subnet Mask Option. Code=1
11
o
Time Server Option. Code=4
12
o
Others?
5
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P11073-20401/D1.2, November 2013
Draft Standard for Health informatics -- Point-of-care medical device communication -- Part 20401: Application profile -Common networking services
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9.1 DHCP service
2
9.1.1 General
Medical Device (DHCP Client)
DHCP Server (not selected)
DHCP Server (selected)
Begins Initialization
DHCPDISCOVER
DHCPDISCOVER
Determines Configuration
Determines Configuration
DHCPOFFER
DHCPOFFER
Collects replies
Selects configuration
DHCPREQUEST
DHCPREQUEST
DHCPACK
Commits Configuration
Initialization complete
Graceful shutdown
DHCPRELEASE
Discards Lease
3
4
DHCP Server can be used to provision IP Address and other artifacts
Figure 4 —DHCP service
6
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P11073-20401/D1.2, November 2013
Draft Standard for Health informatics -- Point-of-care medical device communication -- Part 20401: Application profile -Common networking services
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9.1.2 Autonet address selection
Medical Device (DHCP Client)
Begins Initialization
Pick random address in 169.* scope
Is address available?
No Response
Self assign selected address
2
Figure 5 —Autonet address selection
3
4
10. Discovery services
5

Plug and Play scenarios need provisioning in order to successfully associate with the peer
6

Can be used to discover services on a medical network
7

Examples:
8
9
o
An Agent starts up and tries to find Manager on local sub-network with some additional
information to connect
10
11
o
Manager needs to find one of the IHE applications on the enterprise network to send
PCD01 message
12
10.1 DNS mDNS service
13

Can be done using multicast DNS for local subnet and unicast DNS for enterprise scope
14

Has two parts to it:
15
o
Resource Description
7
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2
o
Resource Discovery
10.2 DNS discovery in domain
Medical Device (DNS Client)
DNS Server
DNS Standard Query(SRV)
DNS Standard Query Response (SRV)
DNS Standard Query(A/AAAA)
DNS Standard Query Response (A/AAAA)
3
4
Figure 6 — DNS discovery in domain
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10.3 mDNS name selection and publication
Medical Device (mDNS Client)
Use configured name
bed2floor1unit4._11073PocAgent._udp.local.
Is address available?
No Response
Start Service with configured Name
on udp port XXXX
Register SRV record with
bed2floor1unit4._11073PocAgent._udp.local.
Now available
bed2floor1unit4._11073PocAgent._udp.local.
2
3
Figure 7 — mDNS name selection and publication
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10.4 mDNS service discovery
2
3
4
5
Figure 8 — mDNS service discovery
10.5 DNS service URL format

General Service URL format
o
6
<Instance> . <Service> . <Domain>
7

_tcp – used when TCP is the underlying protocol
8

_udp – used for everything else
9
10

Example, _11073PoCAgent._udp.example.com – 11073 agent services that
don’t use TCP in the domain example.com
o
11
12

13
14
15
Instance name is a user friendly name consisting of up to 63 Net-Unicode [RFC5198]
characters.
Example, bed2Floor1Unit4._11073PoCAgent._tcp.example.com
10.6 Resource types

Device Resource Types
16
o
_11073PoCAgent
17
o
_11073PoCManager
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
More?
2

Additional information in TXT record
3
o
Data-proto-id=“20101”,”20202”
4
o
More?
5
10.7 State chart
Events/States
Uninitialized
Initialized
Initialize discovery service,
Change state to Initialized
TISL_discovery_init
TISL_discovery_enum_providers
Return all providers
TISL_discovery_init_provider
Initialize provider, return
provider handle
TISL_discovery_register_service_notification
Register Notification
Handler
TISL_discovery_start
Start Discovery, change state
to discovery started
Cancel discovery in
progress, change
state to initialized
TISL_discovery_cancel
TISL_discovery_setDiscoverable
Advertise service
discoverability
TISL_discovery_resetDiscoverable
Don’t respond to service
discovery requests
TISL_discovery_uninit
Uninitialize service
Uninitialize service and
and change state to
change state to uninitialized uninitialized
Empty fields in the table mean that the event does not cause any actions or state changes.
6
11. Connectivity services
7
11.1 Overview
8
11.2 TCP/IP and UDP/IP v4
9
Discovery Started

TCP or UDP can be used to establish communication between agent and manager
11
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Advertise service
discoverability
Don’t respond to
service discovery
requests
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2
3

IP address and port needed for manager or agent service can be obtained using DNS or mDNS
mechanism
12. Quality of service (QoS)
4

Reliability
5

Latency
6

Priority
7

Bandwidth
8
12.1 QoS requirements
9
NOTE: table copied from 11073-00101:2008.
10
Table 1 —QoS requirements
11
12
13
12.2 Preferred technologies

RTP over UDP
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1
2

4
TCP/IP
o
3

RTP provides a reliability layer over UDP
Guaranteed delivery
RSVP for bandwidth reservation
5
o
6
13. Security services
7
13.1 IPSec
All hops in the network have to participate to reserve bandwidth
8

CNS will provide mechanisms to allow for secure connection
9

Technologies such as IPSec can be used for end to end security.
10
14. Conformance
11
NOTE: This section will detail the conformance model and associated tables.
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Annex A Clinical xcenarios - ENV 13735 Annex E 2.1
2
A.1 Emergency situation – one of the main scenarios is alarm (2.1.1)
3
4
5
Plug and Play - the device communication must start immediately after device connection without any
further user intervention. That implies e.g. automatic device recognition, identification, and initialization of
communication.
6
7
Safety and reliability of communication and network - connection of a new device must not influence the
communication of other devices connected earlier unique device identification.
8
A.2 Normal patient nursing condition in ICU, non-emergency situations (2.2)
9
Same conditions as A.1 above.
10
A.3 Data logger ( 3.1)
11
12
Graphic parameter data volumes can require high bandwidth ‘Loose’ device time stamp synchronization, in
the order of 0.01 second, is required.
13
14
Latency of data between amplifier output and display on screen must be less than 0.2 seconds to be
invisible to the user.
15
A.4 Patient alarm monitoring (3.3)
16
17
The communication of alarm related information must be expedited, in order to be processed prior to other
data, and must be reliable.
18
19
Display device must be able to detect when a Data Agent is removed. Ideally it should be able to
distinguish between an intentional disconnection and unintentional disconnection.
20
The latency of occurrence for alarm and signaling to user must be less than 0.25 seconds.
21
A.5 Remote control (3.4)
22
23
24
25
26
In a remote control system, the communication must fulfill a higher level of reliability, because of a higher
risk for the patient. This includes the needs for comprehensive message validation, data verification,
message retries, and notification of communication system failures. This implies the need for system
management functionality. A mechanism to send control data to the Data Agent and acknowledge receipt is
required. In some cases manual control of the device should be precluded.
27
A.6 Patient viewing interoperability (3.5)
28
29
There must be some level of control such that a remote user (for example, outside the care unit) cannot
change the settings established by a nurse at the bedside.
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2
Harmonization of communication methods for RF telemetry systems would be required in order to support
interoperable telemetry systems.
3
Bandwidth management may become a significant issue.
4
5
The issue of managing multiple associations between a Data Agent and multiple Data Loggers or Data
Display needs attention.
6
A.7 Patient monitoring interoperability (3.6)
7
Communication over different hospital LANs and maybe even on the Internet.
8
Ordering of physiological data is important.
9
10
Latency from Data Agent to Remote Monitoring Device must be controlled and specified. Generally, this
should be less than one second to be acceptable.
11
A.8 Maintenance and configuration support (3.8)
12
Physical connect/disconnect sensing for devices.
13
System management protocol.
14
15
A.9 Intrabed symmetric data exchange between DCC and BCC (4.1) interbed
symmetric data exchange over an "Interbed Network“ (4.2)
16
Symmetry in communication between device (DCC) and BCC.
17
18
Symmetry in data propagation in through the BCC, from the device (DCC) through BCC to the Application
System and back.
19
Propagation of a remote device containment tree to the receiver (DCC).
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Annex B TISL Specifications
2
14.1 Provisioning TISL primitives
3
Provision TISL primitives
Name
4
5
Description
TISL_provisioning_init
Initialize provisioning services
TISL_provisioning_enum_providers
Enumerate available provisioning providers
TISL_provisioning_set_provider
Set current provider
TISL_provisioning_add_item
Add provisioning item given the code
TISL_provisioning_remove_item
Remove provisioning item given the code
TISL_provisioning_get_item
Get item value given code
TISL_provisioning_auto_start
Start automatic provisioning using current provider.
TISL_provisioning_uninit
Uninitialize provisioning services
Table 2 Provisioning TISL primitives
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Provisioning services (TISL state chart) is shown below.
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Events/States
Uninitialized
Initialized
Discovery Started
Initialize discovery
service, Change state to
Initialized
TISL_discovery_init
TISL_discovery_enum_providers
Return all providers
TISL_discovery_iunit_provider
Initialize provider, return
provider handle
TISL_discovery_register_service_
notification
Register Notification Handler
TISL_discovery_start
Start Discovery, change state
to discovery started
Cancel discovery in
progress, change state to
initialized
TISL_discovery_cancel
TISL_discovery_setDiscoverable
Advertise service
discoverability
Advertise service
discoverability
TISL_discovery_resetDiscoverabl
e
Don’t respond to service
discovery requests
Don’t respond to service
discovery requests
TISL_discovery_uninit
Uninitialize service and
change state to uninitialized
Uninitialize service and
change state to uninitialized
Empty fields in the table mean that the event does not cause any actions or state changes.
1
2
Table 3 Provisioning TISL state chart
14.2 Discovery TISL primitives
Table 4 — Discovery TISL primitives
3
Name
Description
TISL_discovery_init
Initializes discovery services
TISL_discovery_enum_providers
Enumerates available discovery service providers
TISL_discovery_init_provider
Initializes provider for use
TISL_discovery_register_service_notification
Sets callback for service discovery
TISL_discovery_start
Start discovery
TISL_discovery_cancel
Cancel discovery in progress
18
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TISL_discovery_setDiscoverable
Set current device as discoverable for zero-touch mode
TISL_discovery_resetDiscoverable
Cancel current device as discoverable for zero-touch mode
TISL_discovery_uninit
Uninitialize discovery services
14.3 Security TISL primitives
Table 5 — Security TISL primitives
2
Name
Description
TISL_security_init
Initialize security services
TISL_security_enum_providers
Enumerate security providers
TISL_security_set_provider
Set current security provider
TISL_security_uninit
Uninitialize security services
3
19
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Annex C
2
(informative)
3
Data distribution service (DDS) usage
4
This section will provide profiling of DDS within the context of CNS.
20
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Annex D
2
(informative)
3
Bibliography
4
5
6
Bibliographical references are resources that provide additional or helpful material but do not need to be
understood or used to implement this standard. Reference to these resources is made for informational use
only.
21
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