Difference between revisions of "ISO and JIC projects"

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|valign="top" | ISO/HL7 NP 13972 - Detailed Clinical Models<br/> [http://www.hl7.org/special/Committees/projman/searchableProjectIndex.cfm?action=edit&ProjectNumber=320 Description]
 
|valign="top" | ISO/HL7 NP 13972 - Detailed Clinical Models<br/> [http://www.hl7.org/special/Committees/projman/searchableProjectIndex.cfm?action=edit&ProjectNumber=320 Description]
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|valign="top" |  WG 8
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|valign="top" |  WG  
 
|valign="top" | [http://www.hl7.org/special/Committees/projman/searchableProjectIndex.cfm?action=edit&ProjectNumber=320 PI 320], <br/>[http://www.hl7.org/Special/committees/patientcare/index.cfm Patient Care WG]<br/>William Goossen
 
|valign="top" | [http://www.hl7.org/special/Committees/projman/searchableProjectIndex.cfm?action=edit&ProjectNumber=320 PI 320], <br/>[http://www.hl7.org/Special/committees/patientcare/index.cfm Patient Care WG]<br/>William Goossen
 
|valign="top" | ISO stage 30.20=Committee Draft study/ballot initiated  
 
|valign="top" | ISO stage 30.20=Committee Draft study/ballot initiated  
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|-
  
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|valign="top" | ISO21090:2011 - Data Types<br/> [http://www.hl7.org/special/Committees/projman/searchableProjectIndex.cfm?action=edit&ProjectNumber=484 Description]
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|valign="top" |  WG
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|valign="top" | [http://www.hl7.org/special/Committees/projman/searchableProjectIndex.cfm?action=edit&ProjectNumber=484 PI 484], <br/>[http://www.hl7.org/Special/committees/xml/index.cfm ITS WG]<br/>Grahame Grieve
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|valign="top" | ISO stage status 60.60=International Standard Published
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|-
 
|-
  
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|valign="top" | '''IS 14199:''' HI: The BRIDG domain analysis model for protocol-driven biomedical research <br/> AKA: Biomedical Research Information Domain Group (BRIDG) Model
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|valign="top" | '''ISO/CD 14199:''' HI: The BRIDG domain analysis model for protocol-driven biomedical research <br/> AKA: Biomedical Research Information Domain Group (BRIDG) Model
 
|valign="top" | WG 2  
 
|valign="top" | WG 2  
 
|valign="top" | JIC lead=CDISC, JIC Shepherd: Becky Kush
 
|valign="top" | JIC lead=CDISC, JIC Shepherd: Becky Kush
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|[http://www.hl7.org/special/Committees/projman/searchableProjectIndex.cfm?action=edit&ProjectNumber=538 PI 538],[http://www.hl7.org/Special/committees/rcrim/index.cfm RCRIM WG], <br/> Julie Evans or Ed Tripp
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|[http://www.hl7.org/special/Committees/projman/searchableProjectIndex.cfm?action=edit&ProjectNumber=538 PI 538],[http://www.hl7.org/Special/committees/rcrim/index.cfm RCRIM WG], <br/> Becky Kush, Julie Evans or Ed Tripp
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|valign="top" | Passed CD ballot 2010-05-10, pending DIS
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|valign="top" | ISO status 30.99=Committee Draft approved for registration as DIS
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|-
 
|-
 
|valign="top" | '''IS 27953 - Health Informatics:Pharmacovigilance - Structure and Data Elements for (HL7 V3) Individual Case Safety Report (ICSR)'''<br/>
 
|valign="top" | '''IS 27953 - Health Informatics:Pharmacovigilance - Structure and Data Elements for (HL7 V3) Individual Case Safety Report (ICSR)'''<br/>
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*ISO/DIS 27953-1: Health Informatics – Pharmacovigilance – Individual Case Safety Report, Part 1: the framework for adverse event reporting.  
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*ISO/DIS 27953-1:2011 Health Informatics – Pharmacovigilance – Individual Case Safety Report, Part 1: the framework for adverse event reporting.  
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*ISO/DIS 27953-2: Health Informatics – Pharmacovigilance – Individual Case Safety Report, Part 2: Human pharmaceutical reporting requirements for ICSR.
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*ISO/DIS 27953-2:2011  Health Informatics – Pharmacovigilance – Individual Case Safety Report, Part 2: Human pharmaceutical reporting requirements for ICSR.
 
|valign="top" | WG 6  
 
|valign="top" | WG 6  
 
|valign="top" | JIC lead=HL7, see [http://hl7projects.hl7.nscee.edu/tracker/download.php/52/313/355/441/ICSR_R3_ProjectScope.docProject Scope Statement], New Joint Project
 
|valign="top" | JIC lead=HL7, see [http://hl7projects.hl7.nscee.edu/tracker/download.php/52/313/355/441/ICSR_R3_ProjectScope.docProject Scope Statement], New Joint Project
 
|valign="top" | HL7 Individual Case Safety Report Release 3 (JIC Ballot Project) [http://www.hl7.org/special/Committees/projman/searchableProjectIndex.cfm?action=edit&ProjectNumber=227 PI 227], [http://www.hl7.org/Special/committees/patientsafety/index.cfm Patient Safety WG]<br/> Lise Stevens - Lise.Stevens@ fda.hhs.gov
 
|valign="top" | HL7 Individual Case Safety Report Release 3 (JIC Ballot Project) [http://www.hl7.org/special/Committees/projman/searchableProjectIndex.cfm?action=edit&ProjectNumber=227 PI 227], [http://www.hl7.org/Special/committees/patientsafety/index.cfm Patient Safety WG]<br/> Lise Stevens - Lise.Stevens@ fda.hhs.gov
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|valign="top" | '''2''' - Enquiry
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|valign="top" | '''3''' - Approval; ISO status 60.60=International Standard Published
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DIS 2009-05-18 passed <br/>HL7 [http://hl7projects.hl7.nscee.edu/tracker/index.php?func=detail&aid=355&group_id=52&atid=313 TSC Issue # 355] first ISO ballot September 2009, reballot 2010-07-15 to 2010-09-13, HL7 reballoting FDIS 2010-08-14 to 2010-09-13 - see [http://www.hl7.org/documentcenter/ballots/2010SEP/announcements/Announcement%20of%20HL7%20JIC%20Pharmacovigilance%20Ballot%20for%20August%202010.pdf announcement]
 
  
 
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* Sponsoring Work Group: [http://www.hl7.org/Special/committees/medication/index.cfm Pharmacy WG]
 
* Sponsoring Work Group: [http://www.hl7.org/Special/committees/medication/index.cfm Pharmacy WG]
 
* Contact: <br/>11238: Garry Cruickshank (g.cruickshank@ sympatico.ca) <br/> 11239: Julie James (julie@blue-wave.co.uk)<br/> 11240: Beverly Knight (bknight@infoway-inforoute.ca) <br/> 11615: Gary Meyer (Gary.Meyer2@CareFusion.com)<br/>11616: Nicolas Canu (nicolas.canu@phast.fr)
 
* Contact: <br/>11238: Garry Cruickshank (g.cruickshank@ sympatico.ca) <br/> 11239: Julie James (julie@blue-wave.co.uk)<br/> 11240: Beverly Knight (bknight@infoway-inforoute.ca) <br/> 11615: Gary Meyer (Gary.Meyer2@CareFusion.com)<br/>11616: Nicolas Canu (nicolas.canu@phast.fr)
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|valign="top" | '''1''' - Engagement
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|valign="top" | '''3''' - Approval
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* 11238, 11239, 11240, 11615, 11616 Passed ISO NWIP/CD ballot August 2009<br/>
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* 11238, 11239, 11240, ISO status status 50.00=FDIS approved for publication):
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* 11615, 11616 Passed ISO NWIP/CD ballot August 2009<br/>
 
Awaiting NWIP ballot TC 215/CEN in parallel, July 12-Aug 12; passed HL7 comments-only ballot 20090812 <br/> ''Informative note:'' Action items include Formal request to withdraw IS#27952 HL7 Structured Product Labeling from ISO work program
 
Awaiting NWIP ballot TC 215/CEN in parallel, July 12-Aug 12; passed HL7 comments-only ballot 20090812 <br/> ''Informative note:'' Action items include Formal request to withdraw IS#27952 HL7 Structured Product Labeling from ISO work program
  
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|valign="top" | WG   
 
|valign="top" | WG   
 
|JIC Lead=HL7 (CDISC), Scott Getzin, 2009-04-29
 
|JIC Lead=HL7 (CDISC), Scott Getzin, 2009-04-29
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|valign="top" |[http://www.hl7.org/special/Committees/projman/searchableProjectIndex.cfm?action=edit&ProjectNumber=372 PI 372], [http://www.hl7.org/Special/committees/rcrim/index.cfm RCRIM WG],<br/>Ed Helton, Tracy Beck
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|valign="top" |[http://www.hl7.org/special/Committees/projman/searchableProjectIndex.cfm?action=edit&ProjectNumber=372 PI 372], [http://www.hl7.org/Special/committees/rcrim/index.cfm RCRIM WG],<br/> Becky Kush, Ed Helton, Tracy Beck
 
|valign="top" | TBD
 
|valign="top" | TBD
  

Revision as of 19:39, 19 December 2011

see current list from Project Insight

back to Main_Page

See the main standards page at HL7.org for ISO approved HL7 Standards

Link to Form4, to be used if one wishes to submit an HL7 document to ISO for ballot.

ISO Work Groups

WG1 – Data Structure
WG2 – Messaging & Communication (Data Interchange)
WG3 – Health Concept Representation (Semantic Content)
WG4 – Security
WG5 – Health Cards
WG6 – Pharmacy and Medication
WG7 – Devices
WG8 – Business Requirements for Electronic Health Records

ISO TC 215 Health Informatics Projects

ISO Designation / Name, link to Description ISO WG: HL7 information:
Corresponding HL7 document, Responsible HL7 Work Group, and HL7 Project Manager 		Status, ISO Vote, HL7 ballot link
IS 13449 - Health Informatics: Clinical Genomics Pedigree Topic
Description 		WG 2 PI 479, Clinical Genomics WG
Ed Hammond, Jill Kaufman 		ISO stage 40.60= Close of DIS voting
ANSI/HL7 normative standard 2007
IS 16527 (N796) - Personal Health Record System Functional Model, Release 1 (PHRS FM)
Description 		WG 8 PI 660,
Electronic Health Records WG
Gary Dickinson 		ISO stage 10.99=New project approved by ISO; NWIP vote 2010-10-07 passed, pending DIS ballot after reconciliation of many pages of comments;
ISO/HL7 NP 13972 - Detailed Clinical Models
Description 		WG PI 320,
Patient Care WG
William Goossen 		ISO stage 30.20=Committee Draft study/ballot initiated
ISO21090:2011 - Data Types
Description 		WG PI 484,
ITS WG
Grahame Grieve 		ISO stage status 60.60=International Standard Published


JIC Ballot process information

JIC Projects

ISO Designation/ Name ISO WG JIC lead SDO,
Project Type:
  • Joint Adoption (no standards development required of HL7)
  • New Joint Project
 HL7 Project Insight ID, HL7 WG
HL7 liaison 		Status:
See information on the JIC ballot process
  1. Engagement (i.e. HL7 for comments only ballot, ISO Committee Draft and working draft in CEN)
  2. Enquiry = DIS (ISO), ENQ (CEN) MRB (HL7) Ballot
  3. Approval = FDIS (ISO), Final Vote (FV) (CEN), ANSI approval (HL7 ) ballot. ISO Vote, HL7 ballot link (when applicable)


ISO/CD 14199: HI: The BRIDG domain analysis model for protocol-driven biomedical research
AKA: Biomedical Research Information Domain Group (BRIDG) Model 		WG 2 JIC lead=CDISC, JIC Shepherd: Becky Kush PI 538,RCRIM WG,
Becky Kush, Julie Evans or Ed Tripp 		ISO status 30.99=Committee Draft approved for registration as DIS
IS 27953 - Health Informatics:Pharmacovigilance - Structure and Data Elements for (HL7 V3) Individual Case Safety Report (ICSR)
  • ISO/DIS 27953-1:2011 Health Informatics – Pharmacovigilance – Individual Case Safety Report, Part 1: the framework for adverse event reporting.
  • ISO/DIS 27953-2:2011 Health Informatics – Pharmacovigilance – Individual Case Safety Report, Part 2: Human pharmaceutical reporting requirements for ICSR.
 WG 6 JIC lead=HL7, see Scope Statement, New Joint Project HL7 Individual Case Safety Report Release 3 (JIC Ballot Project) PI 227, Patient Safety WG
Lise Stevens - Lise.Stevens@ fda.hhs.gov 		3 - Approval; ISO status 60.60=International Standard Published
ISO TS 11238 - Health Informatics – Identification of Medicinal Products – Data elements and structures to uniquely identify and describe substances and specified substances (aka IDMP Substances)
NWIP 11239 IDMP 692: Health informatics - Identification of Medicinal Products - Data elements and structures to uniquely identify pharmaceutical dose forms, units of presentation and routes of administration (aka IDMP Dose/Unit/Route)
NWIP 11240 IDMP 693: Health informatics - Identification of Medicinal Products - Data elements and structures to uniquely identify Units of Measurement (aka IDMP UOM)
NWIP 11615 IDMP 694: Health informatics – Identification of Medicinal Products - Data elements and structures to uniquely identify medicinal products (MPIDs) for the exchange of regulated medicinal product information aka Medical Product and Device Listing, or IDMP (MPIDs)
NWIP 11616 IDMP 693: Health informatics – Identification of Medicinal Products - Data elements and structures to uniquely identify and exchange pharmaceutical products (PhPIDs) (aka IDMP PhPIDs) 		WG 6 ISO/TC 215
WG 6, see JIC_projects_IDMP, Lead: Ian Shepherd


- Joint Adoption

  • JIC tracking at PI 501
  • Sponsoring Work Group: Pharmacy WG
  • Contact:
    11238: Garry Cruickshank (g.cruickshank@ sympatico.ca)
    11239: Julie James (julie@blue-wave.co.uk)
    11240: Beverly Knight (bknight@infoway-inforoute.ca)
    11615: Gary Meyer (Gary.Meyer2@CareFusion.com)
    11616: Nicolas Canu (nicolas.canu@phast.fr)
 3 - Approval
  • 11238, 11239, 11240, ISO status status 50.00=FDIS approved for publication):
  • 11615, 11616 Passed ISO NWIP/CD ballot August 2009

Awaiting NWIP ballot TC 215/CEN in parallel, July 12-Aug 12; passed HL7 comments-only ballot 20090812
Informative note: Action items include Formal request to withdraw IS#27952 HL7 Structured Product Labeling from ISO work program

Clinical Trials Registry
AKA Clinical Trials Registry and Results (CTRR) 		WG JIC Lead=HL7 (CDISC), Scott Getzin, 2009-04-29 PI 372, RCRIM WG,
Becky Kush, Ed Helton, Tracy Beck 		TBD
IS 21090 - Health informatics - Harmonized Data Types for Information Interchange
Description 		WG 2 JIC Lead=ISO/TC215, Lead Tom Marley PI 484, MnM WG,
Grahame Grieve 		DIS 2008-09-24 passed, awaiting FDIS ballot
ISO/HL7 10781:2009- Electronic Health Record System Functional Model, Release 1 (EHRS FM)
Description 		WG 8 JIC lead=ISO TC215, 2009-10-20 PI 480,
Electronic Health Records WG
Gary Dickinson 		R1 Published 2009; EHR-S FM R1.1 ISO/HL7 10781:2009 stage 90.92 not yet published by HL7 under project ID 276; EHR-S FM R2.0 is not yet approved as project by HL7 nor on the ISO work schedule
- Automatic Identification and Data Capture (AIDC) standard patient ID and Care Giver ID WG JIC lead=GS1, Christian Hay 2010-05-11 TBD 1 - Engagement;


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