0.1.1                       Table of Contents


 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 
                  6.1.6     Quality of service strategy 
                          General overview  
                          Reliability and latency 
                          Reliability vector 
                          Latency vector 
                          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
                          TAN/PAN/LAN component - general
                          TAN/PAN/LAN component – communication capabilities 
                          TAN/PAN/LAN component – device information 
                          TAN/PAN/LAN component – unsupported service component
                          TAN/PAN/LAN component – quality of service 
                          TAN/PAN/LAN component - regulatory settings 
                          Regulatory / certification information 
                          Nomenclature codes 
                          TAN/PAN/LAN component – user identification 
                  7.2.3     Devices 
                          Pulse oximeter 
                          Pulse oximeter – general requirements 
                          PM-store objects for the pulse oximeter 
                          PM-Store Object Attributes 
                          Basic 1-3 lead ECG  
                          PM-store objects for the Basic 1-3 lead ECG  
                          PM-Store object attributes 
                          Heart-rate sensor 
                          PM-store objects for the heart-rate sensor 
                          PM-Store object attributes 
                          Blood pressure monitor 
                          Glucose Meter 
                          INR meter 
                          Body composition analyzer 
                          Peak flow monitor 
                          Cardiovascular fitness 
                          Cardiovascular step counter 
                          Strength fitness 
                          Activity hub 
                          Fall sensor 
                          Motion sensor 
                          Enuresis sensor 
                          Contact closure sensor 
                          Switch sensor 
                          Dosage sensor 
                          Water sensor 
                          Smoke sensor 
                          Property exit sensor 
                          Temperature sensor 
                          Usage sensor 
                          PERS sensor 
                          CO sensor 
                          Gas sensor 
                          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 
                          Device to AHD linkage 
                          User experience 
                  8.2.2     NFC transport
                          Personal health device communication 
                          Multi-function devices 
                          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 
                          Device to AHD linkage 
                  9.2.2     Wireless PAN transport
                          Bluetooth health device profile 
                          Discovery and pairing 
                          Bluetooth discoverable mode 
                          Notifying the user 
                          Quality of service 
                          Secure simple pairing debug mode 
                  9.2.3     Low-power (LP) wireless PAN transport
                          Bluetooth low energy and profiles 
                          Device discovery, pairing and service discovery 
                          User notification 
                          OEM requirements 
                          Date and time requirements 
                          Certification and regulatory aspects 
                  9.2.4     Wired PAN transport - USB  
                          USB general requirements 
                          Map to ISO/IEEE 11073-20601 
                          Sending metadata via USB PHDC  
                          Quality of service 
                          Multi-function devices 
                          Data rates 
                  9.2.5     PAN data/messaging layer 
                          PAN wired/wireless sensor component – communication capabilities 
                          PAN wired/wireless sensor component multi-function devices 
                  9.2.6     Low-power wireless PAN devices 
                          Blood pressure monitor 
                          Heart-rate sensor 
                          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 
                          ZigBee health care profile 
                          Quality of service 
                          Multiple connections 
                  10.2.2     Sensor-LAN data/messaging layer 
                          Sensor-LAN component one-to-many connectivity 
                          Dominant association 
                          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 
                          Data payload 
                          Message exchange framework 
       11.2     WAN protocol (informative) 
                  11.2.1     Data payload 
                  11.2.2     Message exchange framework 
                  11.2.3     Security 
                          Secure point-to-point communication 
                          Entity identity assertion 
                          Consent management
                          Consent enforcement
                          Identification and cross referencing 
       11.3     Implementation guidance (informative) 
                  11.3.1     AHD conceptual model
                          Overview of operation 
                  11.3.2     Sample service description 
                          Device observation consumer WSDL  
                          Device observation consumer XSD  
                  11.3.3     Messaging examples 
                          Communicate PCD data 
                          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  
                          Chosen standards and profiles 
                  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 
                          Requirements for direct communications via XDR  
                          Requirements for indirect communications via XDM   
                  12.2.3     Messaging guidelines 
                          Messaging guidelines for direct communications via XDR  
                          Messaging guidelines for indirect communications via XDM   
                          Messaging guidelines applicable to both direct and indirect communications    
                  12.2.4     Data guidelines 
                          Data guidelines for devices related to medication delivery 
                  12.2.5     Security guidelines 
                          Security guidelines for direct communications via XDR  
                          Security guidelines for indirect communications via XDM   
                          Security guidelines for integrity, data origin authentication and non-repudiation    
                  12.2.6     Consent management guidelines 
                          Security guidelines for consent management
                  12.2.7     Consent enforcement design guidelines 
                          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