Difference between revisions of "ISO and JIC projects"

Revision as of 14:56, 17 November 2010

see current list from Project Insight

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	NWIP 2009-5-27 passed
NWIP 16527 (N796) - Personal Health Record System Functional Model, Release 1 (PHRS FM) Description	WG 8	PI 660, Electronic Health Records WG Gary Dickinson	NWIP vote ends 2010-10-07 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 Engagement (i.e. HL7 for comments only ballot, ISO Committee Draft and working draft in CEN) Enquiry = DIS (ISO), ENQ (CEN) MRB (HL7) Ballot Approval = FDIS (ISO), Final Vote (FV) (CEN), ANSI approval (HL7 ) ballot. ISO Vote, HL7 ballot link (when applicable)
IS 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, Julie Evans or Ed Tripp	Passed CD ballot 2010-05-10, pending DIS
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, reballot 2010-07-15 to 2010-09-13, HL7 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, 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)	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 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, 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
- 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	Published 2009; R2 in Preliminary status
TS 28379 Common Glossary for ISO/TC 215 Deliverables: Standards Knowledge Management Tool (SKMT) Web Site	WG 3	JIC lead=ISO TC215, Joint Project	PI 495, Vocabulary WG Heather Grain - Heather@ lginformatics.com	withdrawn from active work program as of October 2010.
ISO/TS/NWIP# 28379 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;

@@ Line 31: / Line 31: @@
 ·         Withdrawn then give date
 -->
-|-
-|valign="top" | IS 21090 - Health informatics - Harmonized Data Types for Information Interchange<br/> [http://www.hl7.org/special/Committees/projman/searchableProjectIndex.cfm?action=edit&ProjectNumber=484 Description]
-|valign="top" | WG 2
-|valign="top" |[http://www.hl7.org/special/Committees/projman/searchableProjectIndex.cfm?action=edit&ProjectNumber=484 PI 484], [http://www.hl7.org/Special/committees/mnm/index.cfm MnM WG],<br/>Grahame Grieve
-|valign="top" | DIS 2008-09-24 passed, awaiting FDIS ballot
 |-
@@ Line 53: / Line 46: @@
-|-
-<!--
-|valign="top" | ISO/NWIP 27952 - Health Informatics: HL7 Structured Product Labeling Standard (SPL)<br/>
-|valign="top" | WG 6
-|valign="top" |[http://wiki.hl7.org/index.php?title=Structured_Product_Labeling SPL Project Wiki], [http://www.hl7.org/Special/committees/RCRIM/index.cfm RCRIM WG] <br/> Beeler/ Hammond
-|valign="top" | NWIP 2006-09-08 failed
-|-
-|valign="top" | ISO/NWIP #27954 Health Informatics: Electronic Submission of Stability Data (HL7 Product Stability Data Standard )
-|valign="top" | WG 6
-|valign="top" | [http://www.hl7.org/special/Committees/projman/searchableProjectIndex.cfm?action=edit&ProjectNumber=275 PI 275], [http://wiki.hl7.org/index.php?title=Drug_Stability_Reporting Drug Stability Reporting Project Wiki], [http://www.hl7.org/Special/committees/RCRIM/index.cfm RCRIM WG] <br/>Beeler/ Hammond
-|valign="top" | NWIP 2006-09-08 failed
 |-
-|valign="top" | ISO/NWIP #27933 Health Informatics: Annotated ECG for Clinical Trial Submission (HL7 Annotated ECG Waveform Data Standards )
-|valign="top" | WG 6
-|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
--->
 |}
@@ Line 96: / Line 68: @@
 #Approval = FDIS (ISO), Final Vote (FV) (CEN), ANSI approval (HL7 ) ballot. ISO Vote, HL7 ballot link (when applicable)
 <!--COMMENT: (1) Engagement (equals HL7’s for comments only ballot. Committee draft in ISO 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.  It would be good if we could, as noted under the ISO section above, list the dates for these ballots.  The ISO and CEN ballot dates are always the same; HL7 ballots occur in final 30-days of ISO/CEN ballots.-->
 |-
+|valign="top" | IS 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" | JIC lead=CDISC, JIC Shepherd: Becky Kush
+|[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
+|valign="top" | Passed CD ballot 2010-05-10, pending DIS
+|-
 |valign="top" | '''IS 27953 - Health Informatics:Pharmacovigilance - Structure and Data Elements for (HL7 V3) Individual Case Safety Report (ICSR)'''<br/>
 *ISO/DIS 27953-1: Health Informatics – Pharmacovigilance – Individual Case Safety Report, Part 1: the framework for adverse event reporting.
@@ Line 110: / Line 92: @@
 |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" | WG 6
-|valign="top" | ISO/TC 215 <br/>WG 6, see [[JIC_projects_IDMP]]
+|valign="top" | ISO/TC 215 <br/>WG 6, see [[JIC_projects_IDMP]], Lead: Ian Shepherd
-<!--COMMENT [http://hl7projects.hl7.nscee.edu/frs/download.php/645/ISO_Form4_NWIP_Ingredients_11238.doc 11238 Form 4,] <br/>[http://hl7projects.hl7.nscee.edu/frs/download.php/646/ISO_Form4_NWIP_PhD-RA-CVs_11239.doc 11239 Form4,]<br/> [http://hl7projects.hl7.nscee.edu/frs/download.php/647/ISO_Form4_NWIP_UM_11240.doc 11240 Form4,] <br/>[http://hl7projects.hl7.nscee.edu/frs/download.php/648/ISO_Form4_NWIP_MPID_11615.doc 11615 Form4,]<br/> [http://hl7projects.hl7.nscee.edu/frs/download.php/649/ISO_Form4_NWIP_PhPID-CVs_11616.doc 11616 Form4] -->
 <br/>- Joint Adoption
 |valign="top" |
@@ Line 119: / Line 100: @@
 |valign="top" | '''1''' - Engagement
 * 11238, 11239, 11240, 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
+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
-<!--* see[http://hl7projects.hl7.nscee.edu/frs/shownotes.php?release_id=515 11238 documents],  -->
-*HL7 Unique Ballot Id: ISO_SPL_SUBSTID _R1_O1_2009AUG
-<!--*see[http://hl7projects.hl7.nscee.edu/frs/shownotes.php?release_id=516 11239 documents], -->
-* HL7 Unique Ballot Id: ISO_SPL_DOSEFORMS_R1_O1_2009AUG
-<!--*see [http://hl7projects.hl7.nscee.edu/frs/shownotes.php?release_id=517 11240 documents],-->
-* HL7 Unique Ballot Id: ISO_SPL_UNITSMEASURE _R1_O1_2009AUG
-<!--*[http://hl7projects.hl7.nscee.edu/frs/shownotes.php?release_id=518 11615 documents], -->
-* 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
-<!--*[http://hl7projects.hl7.nscee.edu/frs/shownotes.php?release_id=519 11616 documents]-->
-* HL7 Unique Ballot Id: ISO_SPL_PHPID _R1_O1_2009AUG
-<!--COMMENT:|-
-|valign="top" | HL7 Templates Registry Business Requirements Analysis
-|valign="top" | n/a
-|valign="top" | JIC lead=n/a
-|[http://www.hl7.org/special/Committees/projman/searchableProjectIndex.cfm?action=edit&ProjectNumber=473 PI 473],[http://www.hl7.org/Special/committees/template/index.cfm Templates WG], <br/> Mark Shafarman - mark.shafarman@ earthlink.net
-|valign="top" | Target date June 2009
--->
 |-
-|valign="top" | ISO/TS/NWIP# 28379 Health Informatics:Common Glossary for TC215 <br/> Deliverables: Glossary and Document Register User Guide and Standards Knowledge Management Tool (SKMT) Web Site
+|valign="top" | Clinical Trials Registry<br/> AKA Clinical Trials Registry and Results (CTRR)
-|valign="top" |WG 3
+|valign="top" | WG
-|valign="top" | JIC lead=ISO TC215, Joint Project
+|JIC Lead=HL7 (CDISC), Scott Getzin, 2009-04-29
-|valign="top" | [http://www.hl7.org/special/Committees/projman/searchableProjectIndex.cfm?action=edit&ProjectNumber=495 PI 495], [http://hl7projects.hl7.nscee.edu/tracker/index.php?func=detail&aid=984&group_id=52&atid=313 TSC Tracker 984], [http://www.hl7.org/Special/committees/Vocab/index.cfm Vocabulary WG]<br/> Heather Grain - Heather@ lginformatics.com
+|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
-|valign="top" | '''1''' - Engagement; NWIP 2006-09-13 passed
+|valign="top" | TBD
 |-
-<!-- paperwork not filed for this project, not a JIC project per Bev Knight 2010May
+|valign="top" | IS 21090 - Health informatics - Harmonized Data Types for Information Interchange<br/> [http://www.hl7.org/special/Committees/projman/searchableProjectIndex.cfm?action=edit&ProjectNumber=484 Description]
-|ISO/NWIP/TR #12310 Health informatics - Principles and guidelines for the measurement of conformance in the implementation of terminological systems
+|valign="top" | WG 2
-|WG3
+|JIC Lead=ISO/TC215, Lead Tom Marley
-|JIC lead= ISO TC 215 WG 3
+|valign="top" |[http://www.hl7.org/special/Committees/projman/searchableProjectIndex.cfm?action=edit&ProjectNumber=484 PI 484], [http://www.hl7.org/Special/committees/mnm/index.cfm MnM WG],<br/>Grahame Grieve
-|[http://www.hl7.org/special/Committees/projman/searchableProjectIndex.cfm?action=edit&ProjectNumber=496 PI 496], [http://www.hl7.org/Special/committees/Vocab/index.cfm Vocabulary WG]<br/>Beverly Knight (bknight@ infoway-inforoute.ca)
+|valign="top" | DIS 2008-09-24 passed, awaiting FDIS ballot
-|valign="top" |  '''1''' - Engagement; NWIP 2008-06-16 passed
--->
-|}
-===ISO Projects of Interest===
+|-
-{| border="1" cellpadding="2" cellspacing="0"
+|valign="top" | - Electronic Health Record System Functional Model, Release 1 (EHRS FM)<br/> [http://www.hl7.org/special/Committees/projman/searchableProjectIndex.cfm?action=edit&ProjectNumber=480 Description]
+|valign="top" |  WG 8
+|valign="top" | JIC lead=ISO TC215, 2009-10-20
+|valign="top" | [http://www.hl7.org/special/Committees/projman/searchableProjectIndex.cfm?action=edit&ProjectNumber=480 PI 480], <br/>[http://www.hl7.org/Special/committees/ehr/index.cfm Electronic Health Records WG]<br/>Gary Dickinson
+|valign="top" | Published 2009; R2 in Preliminary status
 |-
-!width=65%|Name/Description
+|valign="top" | TS 28379 Common Glossary for ISO/TC 215 <br/> Deliverables:  Standards Knowledge Management Tool (SKMT) Web Site
-!width=35%|ISO Designation, ISO WG, or HL7 WG
+|valign="top" |WG 3
+|valign="top" | JIC lead=ISO TC215, Joint Project
+|valign="top" | [http://www.hl7.org/special/Committees/projman/searchableProjectIndex.cfm?action=edit&ProjectNumber=495 PI 495], [http://www.hl7.org/Special/committees/Vocab/index.cfm Vocabulary WG]<br/> Heather Grain - Heather@ lginformatics.com
+|valign="top" | ''withdrawn from active work program'' as of October 2010.
 |-
-|
-Health informatics – Document Registry Framework /<br/>
+|valign="top" | ISO/TS/NWIP# 28379 Automatic Identification and Data Capture (AIDC)  standard patient ID and Care Giver ID
-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.
+|valign="top" |WG
-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.
+|valign="top" | JIC lead=GS1, Christian Hay 2010-05-11
-|
+|valign="top" | TBD
-ISO DTS 27790 <br/>IST_35_09_0026
+|valign="top" | '''1''' - Engagement;
-|
-|-
-|
-Health informatics—Personal health device communication <br/>
-Part 10408: Device specialization— Thermometer
-|
-IEEE Std 11073-10408 (TM)-2008 <br/>ISO/TC215/SC WG 7 N684, N697
-|
-|-
-|Health informatics—Personal health device communication <br/>
-Part 10415: Device specialization— Weighing scale
-|
-IEEE Std 11073-10415 (TM)-2008 <br/>ISO/TC215/SC WG 7 N685, N698
-|-
-|Health informatics—Personal health device communication <br/>
-Part 10471: Device specialization— Independent living activity hub
-|IEEE Std 11073-10471 (TM)-2008 <br/>ISO/TC215/SC WG 7 N686, N699
-|-
-|Health informatics—Personal health device communication<br/>
-Part 20601: Application profile— Optimized Exchange Protocol
-|IEEE Std 11073-20601 (TM)-2008 <br/>ISO/TC215/SC WG 7 N687, N700
-|-
-|Health informatics—Personal health device communication<br/>
-Part 10404: Device specialization — Pulse oximeter
-|IEEE Std 11073-10404 (TM)-2008 <br/>ISO/TC215/SC WG 7 N707, N716
-|-
-|Health informatics—Personal health device communication<br/>
-Part 10407: Device specialization — Blood pressure monitor
-|IEEE Std 11073-10407 (TM)-2008 <br/>ISO/TC215/SC WG 7 N708, N717
-|-
-|Health informatics—Personal health device communication<br/>
-Part 10417: Device specialization – Glucose meter
-|IEEE Std 11073-10417 (TM)-2008 <br/>ISO/TC215/SC WG 7 N709, N718
-|-
-|Health informatics—Classification of purposes for processing personal health information
-|IST_35_09_0114<br/>WG 4 N702
-|-
-|ISO/NWIP 21549-8 Health informatics - Patient healthcard data - <br/> Part 8: Links
-|09/30160536 DC - prEN ISO 21549-8:2009 <br/>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; <br/>(Revision of ISO/TS 21091:2005)
-|08/30194076 DC <br/>IST_35_09_0266 (related to [[TSC_Product_List_SFM#Product_Brief_-_Entity_Identification_Service_Functional_Model_.28EIS_SFM.29 | 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 <br/>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 - <br/>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
 |}

Difference between revisions of "ISO and JIC projects"

Revision as of 14:56, 17 November 2010

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ISO TC 215 Health Informatics Projects

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