ISO TC215 WG7 Health Informatics - Devices

							ISO TC215 WG7
Health Informatics - Devices
2010.05.10 – 13, Rio de Janeiro, Brazil

Convenor: Todd Cooper
Vice Convenor: Thomas Norgall
Secretary: Patty Krantz
        Health Informatics - Devices


Meeting Overview – Monday Q2
     Introductions, Schedule & Agenda Review
     Remembrances
     ISO/IEC JWG7 80001 Status Update
     ISO CS / “11073” Issues
     Patient Safety & Quality Report
     11073 Lower Layers Update
     General Status Updates

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        Health Informatics - Devices
Meeting Overview – Tuesday Q1
   MFER Update
         Current Ballot Results
         11073-9yyzz Series?
         Next Projects
     General Work Programme Review
     WG7 Leadership Status Review
     2010/11 Meeting Review
     New Business …
         Urinalysis PHD Proposal (Kwak)
   Resolution Drafting
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      Health Informatics - Devices


Meeting Overview – WG Coordination
   Monday Q3 w/ WG4 @ WG7: 80001
   Monday Q3 w/ PS&Q @ Liberdade
   Monday Q3 w/ WG1 @ WG1: DCM (general)
   Monday Q4 w/ WG2-b @ WG2: Telemedicine
   Tuesday Q4 w/ WG1/8/3 @ WG1:
                            Alerts in Records
   …

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 Health Informatics - Devices




Joe Morrisey
     1962 - 2010
      TC215 WG7 - 2010.05 - Rio de Janeiro   5
            Health Informatics - Devices
                                                        Single set of
 IHE Patient        ISO                                 Internationally
Care Devices     TC215 WG7                              Harmonized
                                                        Medical Device
                                                        Informatics &
                                                          Interoperability
Other                                                   Standards
Standards


   IEEE        CEN                             HL7            IHT SDO
 EMBS 11073 TC251 WGIV                       DEV WG          (SNOMED)

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       ISO/IEC JWG7 - 80001




 Passed CDV/DIS Ballot 2010.01.08
 Final DIS ballot scheduled for 2010.07
 Publication target @ 2010.11
 Rio Resolution: Accept FDIS from IEC SC62A
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            ISO/IEC JWG7 - 80001
Additional 80001 guidance …
          Guidance for HDOs
          Step-by-step risk management with examples
          Guidance for wireless networking
          Guidance for specifying security requirements
          …

1. 3 of 4 Durham Preliminary WI’s have mature drafts
2. All (4) planning final round of informal draft reviews
3. Submit NWIPs for all (4) late 2010.09 pending
   successful 80001-1 FDIS ballot
4. TR ballots / publication completion ~ mid-2011
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       Health Informatics - Devices
ISO/IEEE 11073 – ISO CS Issues
   Issue Summary:
       Document Renaming (FDIS!)
         • Changed PHD doc names
         • No noticed / consensus beforehand
         • Renaming inconsistent w/ IEEE & 11073
       Document Renumbering
         • Numbering part of published ISO & IEEE Stds
         • Long history of “-xyyzz” in ISO & IEEE
         • Previously harmonized from x.y.z to xyyzz!
         • Extensive cross-referencing w/ other standards
           and specifications (incl. Continua spec’s)
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      Health Informatics - Devices
ISO/IEEE 11073 – ISO CS Issues
   Issue Summary:
        PSDO Agreement & “fastrack” Processing
           • Previous process facilitated joint development
             and timely consensus formation
           • New process … inhibits
        Document types supported: IS only?!
        Mixed document types in a single series not
         allowed
   NOTE: Issues created by ISO CS …
   WG7 Feedback to ISO CS / Resolutions

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