ISO and JIC projects

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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 = Data Interchange PI 484, MnM WG,
Grahame Grieve 		DIS 2008-09-24 passed
IS 27951 - Health Informatics: Common Terminology Services Release 1 (CTS R1)
Description 		WG 3 = Semantic Content PI 483, Vocabulary WG,
Christopher Chute, Harold Solbrig 		DIS 2008-09-22 passed
IS 27932 - Health Informatics: Clinical Document Architecture, Release 2 (CDA R2)
Description 		WG 2 = Data Interchange PI 482, Structured Documents WG,
Ed Hammond, Woody Beeler 		DIS 2008-06-10 passed
IS 27931 - Health Informatics: HL7 Messaging Standard Version 2.5 'An Application Protocol for Electronic Data Exchange in Healthcare Environments'
Description 		ISO WG 2 = Data Interchange PI 481, Publishing WG
Ed Hammond 		DIS 2008-06-10 passed 100%
prEN ISO 10781 - EHR Systems Functional Model, Release 1 (EHR-S FM R1)
Description 		WG 8: Business Requirements For Electronic Health Records PI 480, EHR WG
Don Mon, Don.Mon@ ahima.org 		DIS (2nd) 2009-04-19 passed
IS 13449 - Health Informatics: Clinical Genomics Pedigree Topic
Description 		ISO WG 2 = Data Interchange PI 479, Clinical Genomics WG
Ed Hammond, Jill Kaufman 		NWIP 2009-5-27 passed
IS 27953 - Health Informatics: Pharmacovigilance - Structure and Data Elements for (HL7 V3) Individual Case Safety Report (ICSR)
Description 		WG 6 = Pharmacy & Medicines Business PI 227, Patient Safety WG
Lise Stevens - Lise.Stevens@ fda.hhs.gov 		NWIP 2 2007-08-22 passed

DIS 2009-05-18 failed

ISO/NWIP 27952 - Health Informatics: HL7 Structured Product Labeling Standard (SPL)
 WG 6 = Pharmacy & Medicines Business SPL Project Wiki, RCRIM WG
Beeler/ Hammond 		NWIP 2006-09-08 failed
ISO/NWIP #27954 Health Informatics: Electronic Submission of Stability Data (HL7 Product Stability Data Standard ) WG 6 = Pharmacy & Medicines Business PI 275, Drug Stability Reporting Project Wiki, RCRIM WG
Beeler/ Hammond 		NWIP 2006-09-08 failed
ISO/NWIP #27933 Health Informatics: Annotated ECG for Clinical Trial Submission (HL7 Annotated ECG Waveform Data Standards ) WG 6 = Pharmacy & Medicines Business Project Wiki, RCRIM WG (Regulated Clinical Research Information Management)
Beeler/ Hammond 		NWIP 2006-09-08 failed

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:
  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. ISO Vote, HL7 ballot link (when applicable)
IS 27953 - Health Informatics:Pharmacovigilance - Structure and Data Elements for (HL7 V3) Individual Case Safety Report (ICSR) WG 6= Pharmacy & Medicines Business JIC lead=HL7, New Joint Project PI 227, Patient Safety WG
Lise Stevens - Lise.Stevens@ fda.hhs.gov 		NWIP 2 2007-08-22 passed

DIS 2009-05-18 failed
HL7 TSC Approved 2008-03-04, see TSC Issue # 355

Medical Product and Device Listing

HL7 Templates Registry Business Requirements Analysis n/a JIC lead=n/a PI 473,Templates WG,
Mark Shafarman - mark.shafarman@ earthlink.net 		Target date June 2009
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 = Semantic Content JIC lead=ISO TC215, Joint Project PI 495, TSC Tracker 984, Vocabulary WG
Heather Grain - Heather@ lginformatics.com 		NWIP 2006-09-13 passed
Principles and Guidelines of Vocabulary Maintenance
(Vocab Maintenance Best Practices) 		WG 3 = Semantic Content JIC lead=n/a, PI 499, Vocabulary WG
Beverly Knight (bknight@ infoway-inforoute.ca) 		Target December 2009
Provide comments and suggestions on the clinical use of the IDMP terminologies. TS ? , WG 6 = Pharmacy & Medicines Business Garry Cruickshank (g.cruickshank@ sympatico.ca), coordinate with ISO TS215 WG6 Tim Buxton PI 501, Pharmacy WG
IDMP Data Elements and Structures (Substances) -
Health Informatics – Identification of Medicinal Products – Data elements and structures to uniquely identify and describe substances and specified substances 		TS 11238 (N691) , WG 6 = Pharmacy & Medicines Business
Pharmacy WG 		ISO lead, see Form 4, joint adoption

Garry Cruickshank (g.cruickshank@ sympatico.ca)

See ISO Form4, Awaiting NWIP ballot TC 215/CEN in parallel, and July 12-Aug 12 HL7 comments-only ballot
IDMP Data Elements and Structures (Dose/Unit/Route) -
Health informatics - Identification of Medicinal Products - Data elements and structures to uniquely identify pharmaceutical dose forms, units of presentation and routes of administration 		TS 11239 (N692), WG 6 = Pharmacy & Medicines Business
Pharmacy WG 		JIC project, see wiki page Garry Cruickshank (g.cruickshank@ sympatico.ca) See ISO Form4, Awaiting NWIP ballot TC 215/CEN in parallel, and July 12-Aug 12 HL7 comments-only ballot
IDMP Data Elements and Structures (UOM) -
Health informatics - Identification of Medicinal Products - Data elements and structures to uniquely identify Units of Measurement 		TS 11240 (N693) , WG 6 = Pharmacy & Medicines Business
Pharmacy WG 		JIC project, see wiki page Garry Cruickshank (g.cruickshank@ sympatico.ca) See ISO Form4, Awaiting NWIP ballot TC 215/CEN in parallel, and July 12-Aug 12 HL7 comments-only ballot
IDMP Data Elements and Structures (MPIDs) -
Health informatics – Identification of Medicinal Products - Data elements and structures to uniquely identify medicinal products (MPIDs) for the exchange of regulated medicinal product information 		TS 11615 (N694) , WG 6 = Pharmacy & Medicines Business
Pharmacy WG 		HL7 lead, JIC project, see Form4
  • PI 506
  • Sponsoring Work Group: Pharmacy WG
  • Contact: Garry Cruickshank (g.cruickshank@ sympatico.ca)
 TSC approved 2008-02-08 see Issue # 357
See ISO Form4, Awaiting NWIP ballot TC 215/CEN in parallel, and July 12-Aug 12 HL7 comments-only ballot
IDMP Data Elements and Structures (PhPIDs) -
Health informatics – Identification of Medicinal Products - Data elements and structures to uniquely identify and exchange pharmaceutical products (PhPIDs) 		TS 11616 (N695) , WG 6 = Pharmacy & Medicines Business
Pharmacy WG 		JIC project, see wiki page Garry Cruickshank (g.cruickshank@ sympatico.ca) See ISO Form4, Awaiting NWIP ballot TC 215/CEN in parallel, and July 12-Aug 12 HL7 comments-only ballot

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
IST_35_09_0059

Health informatics—Personal health device communication

Part 10415: Device specialization— Weighing scale

IEEE Std 11073-10415 (TM)-2008
IST_35_09_0060

Health informatics—Personal health device communication

Part 10471: Device specialization— Independent living activity hub

IEEE Std 11073-10471 (TM)-2008
IST_35_09_0061
Health informatics—Personal health device communication

Part 20601: Application profile— Optimized Exchange Protocol

IEEE Std 11073-20601 (TM)-2008
IST_35_09_0062
Health informatics—Personal health device communication

Part 10404: Device specialization — Pulse oximeter

IEEE Std 11073-10404 (TM)-2008
IST_35_09_0111
Health informatics—Personal health device communication

Part 10407: Device specialization — Blood pressure monitor

IEEE Std 11073-10407 (TM)-2008
IST_35_09_0112
Health informatics—Personal health device communication

Part 10417: Device specialization – Glucose meter

IEEE Std 11073-10417 (TM)-2008
IST_35_09_0113
Draft BS EN ISO 21549-8 Health informatics - Patient healthcard data -
Part 8: Links 		09/30160536 DC - prEN ISO 21549-8:2009
IST_35_09_0082
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
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