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0
Introduction xxiv
0.1
Organization xxiv
0.2
Guideline releases and versioning xxv
0.2.1
Scope of the CDG 2013 xxv
0.3
White papers xxvi
0.3.1
Implementation guidelines for cellular modems embedded into medical
devices xxvi
0.3.2
Recommendations for USB PHDC device driver interoperability xxvi
0.4
Certification programme xxvii
1
Scope
2
References
3
Definitions
3.1
Terms defined elsewhere
3.2
Terms defined in this Recommendation
4
Abbreviations and Acronyms
5
Conventions
5.1
Guideline terminology and conventions
5.1.1
Guideline compliance classifiers
5.1.2
Guideline font usage conventions
5.1.3
Design guidelines format
6
System overview
6.1
E2E system architecture
6.1.1
Devices, components and interfaces
6.1.2
Design guideline types
6.1.3
Reference device classes and system topology
6.1.4
Reference, certified and logo-ed device classes
6.1.5
Compatibility
6.1.5.1 Definitions
6.1.5.2 Philosophy
6.1.6
Quality of service strategy
6.1.6.1 General overview
6.1.6.2 Reliability and latency
6.1.6.3 Reliability vector
6.1.6.4 Latency vector
6.1.6.5 Reliability.Latency pairs
6.1.7
E2E security
7
Common TAN/PAN/LAN interface design guidelines
7.1
Architecture
7.1.1
Introduction
7.1.2
Overview
7.1.3
Common data/messaging layer and selected standards
7.2
Common data/messaging layer guidelines
7.2.1
Applicable interfaces
7.2.2
Exchange protocol
7.2.2.1 TAN/PAN/LAN component - general
7.2.2.2 TAN/PAN/LAN component –
communication capabilities
7.2.2.3 TAN/PAN/LAN component –
device information
7.2.2.4 TAN/PAN/LAN component – unsupported service component
7.2.2.5 TAN/PAN/LAN component –
quality of service
7.2.2.6 TAN/PAN/LAN component -
regulatory settings
7.2.2.6.1 Regulatory / certification
information
7.2.2.6.2 Conformance
7.2.2.6.3 Nomenclature codes
7.2.2.7 TAN/PAN/LAN component – user identification
7.2.3
Devices
7.2.3.1 Pulse oximeter
7.2.3.1.1 Pulse oximeter – general
requirements
7.2.3.1.2 PM-store objects for the
pulse oximeter
7.2.3.1.3 PM-Store Object Attributes
7.2.3.2 Basic 1-3 lead ECG
7.2.3.2.1 PM-store objects for the
Basic 1-3 lead ECG
7.2.3.2.2 PM-Store object attributes
7.2.3.3 Heart-rate sensor
7.2.3.3.1 PM-store objects for the
heart-rate sensor
7.2.3.3.2 PM-Store object attributes
7.2.3.4 Blood pressure monitor
7.2.3.5 Thermometer
7.2.3.6 Weighing-scales
7.2.3.7 Glucose Meter
7.2.3.8 INR meter
7.2.3.9 Body composition analyzer
7.2.3.10 Peak flow monitor
7.2.3.11 Cardiovascular fitness
7.2.3.12 Cardiovascular step counter
7.2.3.13 Strength fitness
7.2.3.14 Activity hub
7.2.3.15 Fall sensor
7.2.3.16 Motion sensor
7.2.3.17 Enuresis sensor
7.2.3.18 Contact closure sensor
7.2.3.19 Switch sensor
7.2.3.20 Dosage sensor
7.2.3.21 Water sensor
7.2.3.22 Smoke sensor
7.2.3.23 Property exit sensor
7.2.3.24 Temperature sensor
7.2.3.25 Usage sensor
7.2.3.26 PERS sensor
7.2.3.27 CO sensor
7.2.3.28 Gas sensor
7.2.3.29 Adherence monitor
8
TAN interface design guidelines
8.1
TAN-IF architecture (informative)
8.1.1
Overview
8.1.2
Transport protocols and selected standards
8.1.3
Exchange protocols and selected standards
8.1.4
Certified device classes
8.1.5
Device communication styles
8.1.6
TAN-IF security
8.2
Device and interface guidelines
8.2.1
TAN device guidelines
8.2.1.1 Device to AHD linkage
8.2.1.2 User experience
8.2.2
NFC transport
8.2.2.1 Personal health device
communication
8.2.2.2 Multi-function devices
8.2.2.3 Quality of service
9
PAN interface design guidelines
9.1
PAN-IF architecture (informative)
9.1.1
Overview
9.1.2
Transport protocols and selected standards
9.1.3
Exchange protocols and selected standards
9.1.4
Certified device classes
9.1.5
Device communication styles
9.1.6
PAN-IF security
9.2
Device and interface guidelines
9.2.1
PAN device guidelines
9.2.1.1 Overview
9.2.1.2 Device to AHD linkage
9.2.2
Wireless PAN transport
9.2.2.1 Bluetooth health device
profile
9.2.2.2 Discovery and pairing
9.2.2.3 Bluetooth discoverable mode
9.2.2.4 Notifying the user
9.2.2.5 Quality of service
9.2.2.6 Secure simple pairing debug
mode
9.2.3
Low-power (LP) wireless PAN transport
9.2.3.1 Bluetooth low energy and
profiles
9.2.3.2 Device discovery, pairing and
service discovery
9.2.3.3 User notification
9.2.3.4 Authentication
9.2.3.5 OEM requirements
9.2.3.6 Date and time requirements
9.2.3.7 Certification and regulatory
aspects
9.2.3.8 Transcoding
9.2.4
Wired PAN transport - USB
9.2.4.1 USB general requirements
9.2.4.2 Map to ISO/IEEE 11073-20601
9.2.4.3 Sending metadata via USB PHDC
9.2.4.4 Quality of service
9.2.4.5 Multi-function devices
9.2.4.6 Connectors
9.2.4.7 Data rates
9.2.5
PAN data/messaging layer
9.2.5.1 PAN wired/wireless sensor
component – communication capabilities
9.2.5.2 PAN wired/wireless sensor
component multi-function devices
9.2.6
Low-power wireless PAN devices
9.2.6.1 Blood pressure monitor
9.2.6.2 Thermometer
9.2.6.3 Heart-rate sensor
9.2.6.4 Glucose meter
10
Sensor-LAN interface design guidelines
10.1
Architecture (informative)
10.1.1 Introduction
10.1.2 Scope
10.1.3 Overview
10.1.4 Transport protocol and selected standards
10.1.5 Data exchange protocol and selected
standards
10.1.6 Certified device classes
10.2
Device and interface guidelines
10.2.1 Sensor-LAN transport layer
10.2.1.1 ZigBee health care profile
10.2.1.2 Quality of service
10.2.1.3 Multiple connections
10.2.2 Sensor-LAN data/messaging layer
10.2.2.1 Sensor-LAN component
one-to-many connectivity
10.2.2.1.1 Dominant association
10.2.2.1.2 Time-stamping
10.2.2.1.3 Timeout management
11
WAN interface design guidelines
11.1
Architecture (informative)
11.1.1 Introduction
11.1.2 Scope
11.1.3 Chosen standards and profiles
11.1.3.1 Data payload
11.1.3.2 Message exchange framework
11.2
WAN protocol (informative)
11.2.1 Data payload
11.2.2 Message exchange framework
11.2.3 Security
11.2.3.1 Secure point-to-point
communication
11.2.3.2 Auditing
11.2.3.3 Entity identity assertion
11.2.3.4 Consent management
11.2.3.5 Consent enforcement
11.2.3.6 Identification and cross referencing
11.2.3.7 Reliability
11.3
Implementation guidance (informative)
11.3.1 AHD conceptual model
11.3.1.1 Overview of operation
11.3.2 Sample service description
11.3.2.1 Device observation consumer
WSDL
11.3.2.2 Device observation consumer
XSD
11.3.3 Messaging examples
11.3.3.1 Communicate PCD data
11.3.3.2 Communicate PCD data response
11.4
Certified device classes
11.5
Design guidelines
11.5.1 Introduction
11.5.2 Message exchange framework guidelines
11.5.3 Data guidelines
11.5.4 Security guidelines
12
HRN interface design guidelines
12.1
Architecture
12.1.1 Overview
12.1.1.1 Scope
12.1.1.2 Chosen standards and profiles
12.1.1.3 Topology
12.1.2 Messaging infrastructure and transport
standards
12.1.3 Messaging and selected standards
12.1.4 Data and selected standards
12.1.5 Security
12.1.6 Transport security
12.1.7 Document-level integrity, data origin
authentication and non-repudiation
12.1.8 Consent management
12.1.9 Consent enforcement
12.1.10 Certified device classes
12.2
Design guidelines
12.2.1 Introduction
12.2.2 Messaging infrastructure and transport
guidelines
12.2.2.1 Requirements for direct
communications via XDR
12.2.2.2 Requirements for indirect
communications via XDM
12.2.3 Messaging guidelines
12.2.3.1 Messaging guidelines for
direct communications via XDR
12.2.3.2 Messaging guidelines for
indirect communications via XDM
12.2.3.3 Messaging guidelines
applicable to both direct and indirect communications
12.2.4 Data guidelines
12.2.4.1 Data guidelines for devices
related to medication delivery
12.2.5 Security guidelines
12.2.5.1 Security guidelines for
direct communications via XDR
12.2.5.2 Security guidelines for
indirect communications via XDM
12.2.5.3 Security guidelines for
integrity, data origin authentication and non-repudiation
12.2.6 Consent management guidelines
12.2.6.1 Security guidelines for
consent management
12.2.7 Consent enforcement design guidelines
12.2.7.1 Security guidelines for
consent enforcement
Annex A Continua design guidelines change and maintenance control
procedure
Appendix I Additional Bluetooth BR/EDR Information
I.1
Bluetooth terminology
I.2
Bluetooth pairing methods
I.3
Bluetooth legacy pairing procedures
I.4
Supporting Bluetooth OEM subsystems and components
I.5
Quality of service bins for Bluetooth
Appendix II Additional ZigBee information
II.1
ZigBee networking
II.2
ZigBee pairing process/service discovery types
II.3
ZigBee security
Appendix III Messaging implementation and technology
III.1
Overview
III.2
XDR and XDM metadata
III.3 Document
source SOAP request/response messages
III.3.1 SOAP request message
III.3.2 SOAP response message
Appendix IV Security Recommendations
Appendix V ISO/IEEE 11073-10101 to SNOMED CT and UCUM
V.1
Observation types mapping to SNOMED CT
V.2
Events and attributes types mapping to SNOMED CT
V.3
Events and attributes not mapped to SNOMED CT
V.4
ISO/IEEE 11073-10101 Unit elements mapping to UCUM
Appendix VI IHE PCD-01 background
VI.1
Introduction
VI.1.1 Device enterprise communications (DEC)
VI.2
Core concepts
VI.2.1 Object hierarchy notation
VI.2.2 Nomenclature
VI.2.3 HL7 messages
VI.2.4 Segment scope
VI.2.5 Multiple devices
Appendix VII Mapping from IEEE 11073-20601 to the Continua WAN
VII.1
Base algorithm
VII.1.1 Observations
VII.1.1.1 Atomization
VII.1.1.2 Hierarchy assignment/grouping
VII.1.2 Message construction
VII.1.2.1 MSH
VII.1.2.2 PID
VII.1.2.3 OBR
VII.1.2.4 OBX
VII.2 Observation
result message examples
VII.2.1 Blood Pressure Example
VII.2.2 Weighing-scales example
VII.3
ISO/IEEE 11073-20601 Object/Attribute usage
VII.3.1 MDS
VII.3.2 Time-stamping and time synchronization
VII.3.2.1 Synchronization protocols
VII.3.2.2 Absolute or base offset time stamp accuracy
VII.3.2.3 Time synchronization example
VII.3.3 Metric
VII.3.3.1 Measurement status
VII.3.3.2 Metric relationships and grouping
VII.3.4 Numeric (subclass of Metric)
VII.3.5 RT-SA (subclass of Metric)
VII.3.6 Enumeration (subclass of Metric)
VII.3.7 PM-Store
VII.3.8 PM-Segment
VII.3.9 Scanner
VII.3.10 Configurable scanner (abstract subclass of Scanner)
VII.3.11 Episodic configurable scanner (subclass of Configurable scanner)
VII.3.12 Periodic configurable scanner (subclass of Configurable scanner)
Appendix VIII Mapping from the IEEE 11073-104xx device specializations
to the Continua WAN
VIII.1
AHD
VIII.1.1 Modelling
VIII.1.2 Transformations
VIII.1.3 Containment tree
VIII.1.4 OBX encoding
VIII.1.5 Example PCD-01 message including AHD
VIII.2
MDS object
VIII.2.1 Modelling
VIII.2.2 Transformations
VIII.2.3 Containment tree
VIII.2.4 OBX encoding
VIII.2.5 Examples
VIII.3
10404 pulse oximeter
VIII.3.1 Modelling
VIII.3.2 Transformations
VIII.3.3 Containment tree
VIII.3.4 OBX encoding
VIII.3.5 Examples
VIII.4
10407 blood pressure monitor
VIII.4.1 Modelling
VIII.4.2 Transformations
VIII.4.3 Containment tree
VIII.4.4 OBX encoding
VIII.4.5 Examples
VIII.5
10408 thermometer
VIII.5.1 Modelling
VIII.5.2 Transformations
VIII.5.3 Containment tree
VIII.5.4 OBX encoding
VIII.5.5 Examples
VIII.6
10415 weighing-scales
VIII.6.1 Modelling
VIII.6.2 Transformations
VIII.6.3 Containment tree
VIII.6.4 OBX encoding
VIII.6.5 Examples
VIII.7
10417 glucose meter
VIII.7.1 Modelling
VIII.7.2 Transformations
VIII.7.3 Containment tree
VIII.7.4 OBX encoding
VIII.7.5 Examples
VIII.8
10418 INR meter
VIII.8.1 Modelling
VIII.8.2 Transformations
VIII.8.3 Containment tree
VIII.8.4 OBX encoding
VIII.8.5 Examples
VIII.9
10441 cardiovascular fitness and activity monitor
VIII.9.1 Modelling
VIII.9.2 Transformations
VIII.9.3 Containment tree
VIII.9.4 OBX encoding
VIII.9.5 Examples
VIII.10
10442 strength fitness equipment
VIII.10.1 Modelling
VIII.10.2 Transformations
VIII.10.3 Containment
tree
VIII.10.4 OBX encoding
VIII.10.5 Examples
VIII.11
10471 independent living activity hub
VIII.11.1 Modelling
VIII.11.2 Transformations
VIII.11.3 Containment
tree
VIII.11.4 OBX encoding
VIII.11.5 Examples
VIII.12
10472 adherence monitor
VIII.12.1 Modelling
VIII.12.2 Transformations
VIII.12.3 Containment
tree
VIII.12.4 OBX encoding
VIII.12.5 Examples
VIII.13
10421 peak expiratory flow monitor
VIII.13.1 Modelling
VIII.13.2 Transformations
VIII.13.3 Containment
tree
VIII.13.4 OBX encoding
VIII.13.5 Examples
VIII.14
10420 body composition analyser
VIII.14.1 Modelling
VIII.14.2 Transformations
VIII.14.3 Containment
tree
VIII.14.4 OBX encoding
VIII.14.5 Examples
VIII.15
10406 basic 1-3 lead ECG
VIII.15.1 Modelling
VIII.15.2 Transformations
VIII.15.3 Containment
tree
VIII.15.4 OBX encoding
VIII.15.5 Examples
Appendix IX HL7 v2.6 messaging information
IX.1
HL7 unsolicited observation result
IX.1.1 MSH
IX.1.2 PID
IX.1.3 OBR
IX.1.4 OBX
IX.1.5 PV1
IX.1.6 NTE
IX.1.7 TQ1
IX.1.8 MSA
IX.1.9 ERR
IX.1.9.1 HL7 v2.6 error tables
IX.2
HL7 Data types – observations
IX.2.1 CWE
IX.2.1.1 Examples
IX.2.2 DTM
IX.2.2.1 Example
IX.2.3 NM
IX.2.3.1 Examples
IX.2.4 ST
IX.2.4.1 Example
IX.2.5 NA - numeric array
IX.2.5.1 Example 1: vector of 8 numbers
IX.2.5.2 Example 2: 3 x 3 array of numbers
IX.2.5.3 Example 3: 5 x 4 array of numbers with the values in positions
(1,1), (2,2), (2,3), (3,3), (3,4), (4,1), (4,2), (4,3), and (4,4) not present
IX.2.6 XAD
IX.2.6.1 Examples
IX.2.7 XPN
IX.2.7.1 Examples
IX.3
HL7 data types – Other
IX.3.1 CX
IX.3.1.1 Examples
IX.3.2 EI
IX.3.2.1 Examples
IX.3.3 ID - coded value for HL7 defined tables
IX.3.4 IS - coded value for user-defined tables
IX.3.5 SI - sequence ID
IX.3.6 SN - structured numeric
IX.3.6.1 Comparator (ST)
IX.3.6.2 Num1 (NM)
IX.3.6.3 Separator/Suffix (ST)
IX.3.6.4 Num2 (NM)
IX.3.7 XTN
IX.3.7.1 Examples
IX.4
HL7 control characters
IX.5
Examples of the consent enforcement at the WAN-IF
Appendix X Mapping from the Continua WAN to the HL7 Personal Health
Monitoring Report object model (Informative)
X.1
Introduction
X.2
Base mapping strategy
X.3
Device information
X.4
Observation information
X.5
Device information
X.6
Observation information
Appendix XI Recommendation for use of generic USB drivers
Bibliography
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