Difference between revisions of "ISO and JIC projects"

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back to [[Main_Page]]
 
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See the main [http://www.hl7.org/implement/standards/index.cfm?ref=nav standards page] at HL7.org for ISO approved HL7 Standards
  
 
;Link to [http://hl7projects.hl7.nscee.edu/tracker/download.php/52/313/332/719/Form4.doc Form4], to be used if one wishes to submit an HL7 document to ISO for ballot.
 
;Link to [http://hl7projects.hl7.nscee.edu/tracker/download.php/52/313/332/719/Form4.doc Form4], to be used if one wishes to submit an HL7 document to ISO for ballot.
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|valign="top" | DIS 2008-09-24 passed, awaiting FDIS ballot
 
|valign="top" | DIS 2008-09-24 passed, awaiting FDIS ballot
  
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|valign="top" | IS 27932 - Health Informatics: Clinical Document Architecture, Release 2 (CDA R2)<br/> [http://www.hl7.org/special/Committees/projman/searchableProjectIndex.cfm?action=edit&ProjectNumber=482 Description]
 
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|valign="top" | WG 2 
 
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|valign="top" | [http://www.hl7.org/special/Committees/projman/searchableProjectIndex.cfm?action=edit&ProjectNumber=482 PI 482], [http://www.hl7.org/Special/committees/structure/index.cfm Structured Documents WG],<br/>Ed Hammond, Woody Beeler
 
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|valign="top" | DIS 2008-06-10 passed; published 2009-11-24
 
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|valign="top" | IS 27931 - Health Informatics: HL7 Messaging Standard Version 2.5 'An Application Protocol for Electronic Data Exchange in Healthcare Environments' <br/> [http://www.hl7.org/special/Committees/projman/searchableProjectIndex.cfm?action=edit&ProjectNumber=481 Description]
 
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|valign="top" | WG 2 
 
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|valign="top" |[http://www.hl7.org/special/Committees/projman/searchableProjectIndex.cfm?action=edit&ProjectNumber=481 PI 481], [http://www.hl7.org/Special/committees/publishing/index.cfm Publishing WG] <br/> Ed Hammond
 
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|valign="top" | DIS 2008-06-10 passed 100%, published 2009-06-17
 
  
 
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|valign="top" | ISO/NWIP 27952 - Health Informatics: HL7 Structured Product Labeling Standard (SPL)<br/>  
 
|valign="top" | ISO/NWIP 27952 - Health Informatics: HL7 Structured Product Labeling Standard (SPL)<br/>  
 
|valign="top" | WG 6  
 
|valign="top" | WG 6  
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|valign="top" | [http://wiki.hl7.org/index.php?title=Annotated_ECG Project Wiki], [http://www.hl7.org/Special/committees/RCRIM/index.cfm RCRIM WG] (Regulated Clinical Research Information Management)<br/> Beeler/ Hammond
 
|valign="top" | [http://wiki.hl7.org/index.php?title=Annotated_ECG Project Wiki], [http://www.hl7.org/Special/committees/RCRIM/index.cfm RCRIM WG] (Regulated Clinical Research Information Management)<br/> Beeler/ Hammond
 
|valign="top" | NWIP 2006-09-08 failed
 
|valign="top" | NWIP 2006-09-08 failed
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|valign="top" | IS 27953 - Health Informatics:Pharmacovigilance - Structure and Data Elements for (HL7 V3) Individual Case Safety Report (ICSR)
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|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 27953-2: 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
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|valign="top" | [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" | 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" | '''2''' - Enquiry
 
|valign="top" | '''2''' - Enquiry
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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] ISO ballot September 2009 failed,m pending second DIS ballot
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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, HL7 reballot 2010-07-15 to 2010-09-13, ISO reballoting FDIS 2010-08-14 to 2010-09-13 - see [http://www.hl7.org/documentcenter/ballots/2010SEP/announcements/Formation%20of%20Ballot%20Groups%20for%20HL7%20JIC%20Pharmacovigilance%20Ballot%20for%20August%202010.pdf announcement]
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|valign="top" | '''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)<br/>'''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)<br/>'''NWIP 11240 IDMP 693:''' Health informatics - Identification of Medicinal Products - Data elements and structures to uniquely identify Units of Measurement (aka IDMP UOM)<br/> '''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)<br/>'''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)
 
|valign="top" | '''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)<br/>'''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)<br/>'''NWIP 11240 IDMP 693:''' Health informatics - Identification of Medicinal Products - Data elements and structures to uniquely identify Units of Measurement (aka IDMP UOM)<br/> '''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)<br/>'''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)

Revision as of 15:31, 15 July 2010

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 21090 - Health informatics - Harmonized Data Types for Information Interchange
Description 		WG 2 PI 484, MnM WG,
Grahame Grieve 		DIS 2008-09-24 passed, awaiting FDIS ballot


IS 13449 - Health Informatics: Clinical Genomics Pedigree Topic
Description 		WG 2 PI 479, Clinical Genomics WG
Ed Hammond, Jill Kaufman 		NWIP 2009-5-27 passed


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)
IS 27953 - Health Informatics:Pharmacovigilance - Structure and Data Elements for (HL7 V3) Individual Case Safety Report (ICSR)
  • ISO/DIS 27953-1: Health Informatics – Pharmacovigilance – Individual Case Safety Report, Part 1: the framework for adverse event reporting.
  • ISO/DIS 27953-2: 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 		2 - Enquiry

DIS 2009-05-18 passed
HL7 TSC Issue # 355 first ISO ballot September 2009, HL7 reballot 2010-07-15 to 2010-09-13, ISO reballoting FDIS 2010-08-14 to 2010-09-13 - see announcement

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


- 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)
 1 - Engagement
  • 11238, 11239, 11240, 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

  • HL7 Unique Ballot Id: ISO_SPL_SUBSTID _R1_O1_2009AUG
  • HL7 Unique Ballot Id: ISO_SPL_DOSEFORMS_R1_O1_2009AUG
  • HL7 Unique Ballot Id: ISO_SPL_UNITSMEASURE _R1_O1_2009AUG
  • HL7 Unique Ballot Id: ISO_SPL_MPID _R1_O1_2009AUG. Informative note: Action items include Formal request to withdraw IS#27952 HL7 Structured Product Labeling from ISO work program
  • HL7 Unique Ballot Id: ISO_SPL_PHPID _R1_O1_2009AUG
ISO/TS/NWIP# 28379 Health Informatics:Common Glossary for TC215
Deliverables: Glossary and Document Register User Guide and Standards Knowledge Management Tool (SKMT) Web Site 		WG 3 JIC lead=ISO TC215, Joint Project PI 495, TSC Tracker 984, Vocabulary WG
Heather Grain - Heather@ lginformatics.com 		1 - Engagement; NWIP 2006-09-13 passed

ISO Projects of Interest

Name/Description ISO Designation, ISO WG, or HL7 WG

Health informatics – Document Registry Framework /
The Document Registry Framework for transmitting, storing and utilizing documents in clinical and personalized health environments is quite broad in its applicability to realize the goal of sharing health related documents spanning health domains such as Laboratory, Cardiology, Eye Care, etc and the many areas of personalized health. This Web Services based Registry Framework includes a document registry and associated repository to allow the sharing of any form of health documents including HL7 CDA.

ISO DTS 27790
IST_35_09_0026

Health informatics—Personal health device communication
Part 10408: Device specialization— Thermometer

IEEE Std 11073-10408 (TM)-2008
ISO/TC215/SC WG 7 N684, N697

Health informatics—Personal health device communication

Part 10415: Device specialization— Weighing scale

IEEE Std 11073-10415 (TM)-2008
ISO/TC215/SC WG 7 N685, N698

Health informatics—Personal health device communication

Part 10471: Device specialization— Independent living activity hub

IEEE Std 11073-10471 (TM)-2008
ISO/TC215/SC WG 7 N686, N699
Health informatics—Personal health device communication

Part 20601: Application profile— Optimized Exchange Protocol

IEEE Std 11073-20601 (TM)-2008
ISO/TC215/SC WG 7 N687, N700
Health informatics—Personal health device communication

Part 10404: Device specialization — Pulse oximeter

IEEE Std 11073-10404 (TM)-2008
ISO/TC215/SC WG 7 N707, N716
Health informatics—Personal health device communication

Part 10407: Device specialization — Blood pressure monitor

IEEE Std 11073-10407 (TM)-2008
ISO/TC215/SC WG 7 N708, N717
Health informatics—Personal health device communication

Part 10417: Device specialization – Glucose meter

IEEE Std 11073-10417 (TM)-2008
ISO/TC215/SC WG 7 N709, N718
Health informatics—Classification of purposes for processing personal health information IST_35_09_0114
WG 4 N702
ISO/NWIP 21549-8 Health informatics - Patient healthcard data -
Part 8: Links 		09/30160536 DC - prEN ISO 21549-8:2009
ISO/TC 215/SC WG5 N498 N526
Draft BS EN ISO 21091 Health informatics - Directory services for security, communications and identification of professionals and patients;
(Revision of ISO/TS 21091:2005) 		08/30194076 DC
IST_35_09_0266 (related to Entity Identification Service Functional Model ?)
Health informatics – System of concepts to support continuity of care – Part 2: Health care process and workflow CEN/TC 251 N09-011, prEN 13940-2:2009.2
IST_35_09_0039
ISO/DIS 18308 Health informatics — Requirements for an electronic health record architecture 08/30194011 DC - ISO/DIS 18308
Quality Requirements and Methodology for Detailed Clinical Models CEN/TC 251 N09-020 -
IST_35_09_0071
Electronic health record (EHR) communication -
  • Part 1: Reference model (ISO WG 1) TR 13606-1, EN 13606-1:2007
  • Part 2 - Archetype Interchange Specifications (ISO WG 1) TR 13606-2, EN 13606-2:2007
  • Part 3 - Archetypes and Term List Interchange Specifications (ISO WG 1) TR 13606-3
  • Part 4: Security (ISO WG 4) TR 13606-4, EN 13606-4:2007
  • Part 5 - Interface Specification (ISO WG 1) TR 13606-4
ISO/TC 215 WG 8N706 – Health Informatics: Personal Health Records - Definition, scope, context and global variations of use ISO/TC 215 WG 8N706 - IST_35_09_0107
ISO/DTS 19218-1 – Medical devices - Hierarchal Coding Structure for Adverse Events - Part 1: Event Type Codes ISO/TC 210 WG 3
ISO/TC 215 WG 8, N721 – eHealth Enterprise Architecture for emerging and developing countries - Part 2: Business Requirements ISO/TC 215 WG 8, N721
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