GS1 Healthcare Roadmap

Version 27 November 2013

 AIDC Application Standards
Objective: develop global standards for the automatic identification and
data capture for Healthcare products at all packaging levels
Scope:
• Healthcare products - from finished goods at manufacture to the end of treatment
at the Healthcare provider
Completed: Next steps:
• Rules for HC GTIN Allocation • Patient and Caregiver ID in ISO (in process)
• AIDC Application Standard Phase 1 (covering • AIDC App Standards Phase 2 – Work items:
90% of healthcare products) •HC AIDC Updates - (e.g. Custom, Configurable &
• HC AIDC Small Instrument Marking Software Trade Items) & Clarifications (e.g GTIN Re-
• HC GLN Implementation Guide & Registry use, HRI, DPM application…)
Strategy Recommendations • GTIN Non-reuse (near complete)
• HC Kit ID (in process)
• HC AIDC Implementation Guideline • HC Software ID (in process)
• AIDC for Blood Derivatives Guideline • Solution for EIFU (Electronic Instructions for Use) / EPI
• National Healthcare Reimbursement Number (Electronic Package Inserts) (Removed from AIDC list –
Application Identifier Moved to Public Policy / Marketing)
• Patient & Caregiver ID Solution • AIDC-GDSN Terminology Alignment (next priority)
• Multiple Bar Codes (initial work complete)
• Level below the Each
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© 2013 GS1
 Roadmap to Global Standards
AIDC Application Standards for Healthcare
2012 2013 2014
COMPLETED
U
 AIDC Application
Standards Ph #1
 GTIN Alloc Rules
 Med Instrum. ID
 Implementation
Guidelines - AIDC,
GLN, Plasma Deriv.
 GS1 Patient &
Caregiver ID
 AI for NHRN

Patient & Caregiver ID in ISO

Level Below The Each/Unit Dose

AIDC HC Updates & Clarifications

AIDC-GDSN Term.
Alignment (Start TBD)

Ratified standard or work finalised Work near closure Work in progress or planned
3
© 2013 GS1 Version - 27 November 2013
 Global Traceability

Objective:
Develop a suite of global standards (process and technical standards)
that enable GS1’s Vision for Traceability in Healthcare
Scope:
• Pharmaceuticals and medical devices
• From point of production to point of use
Completed: Next steps:
• Global Traceability Standard for • Progress approved Work Requests (WR 12-126
Healthcare (GTSH) 12-127; part 11-213) through GSMP to enhance
• GTSH Implementation Guide Visibility/eCom standards, based on gap analysis,
• Training for Member Organisations to enable Chain of Custody/Chain of Ownership
(CoC/CoO (aka Pedigree)) and Product Identifier
• Pilot Global Traceability Conformance Authentication (PIA) Use Cases
(GTC) Audit in a hospital
• GTSH & GTSH IG V2 (2014/15)
• Gap analysis against GS1 System of
Standards: Visibility Standards and eCom • GTC for Healthcare (2015/16)
Standards •Training for Member Organisations (ongoing)
• Work Requests (2) Approval & in GSMP 4
© 2013 GS1
 Roadmap to Global Standards
Global Traceability Standards for Healthcare
2012 2013 2014
GTSH
V.1

Traceability in Healthcare II (TH-II) Project

Visibility Standards – Gap analysis

eCom Standards – Gap analysis

Traceability models-
Stakeholder Survey
and Analysis

Work Requests: MSWG EPCIS V1.1. & CBV

MSWG Event Based Traceability (EBT): Security Standard, Conformance Tests & Prototype

MSWG (EBT): BRs for Checking Services Tests

MSWG (EBT): System Choreograph Standard

MSWG (EBT): Checking Services Standard

2014/15
GTSH &
GTSH IG V2
2015/2016
Global
Traceability
Conformance
Checklist

Ratified standard or work finalised Work near closure Work in progress or planned
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© 2013 GS1 Version - 27 November 2013
 Global Data Synchronisation &
Product Classification
Objective: Develop a global adoption and implementation program to
leverage the GDSN and data quality to provide accurate product data across
the global healthcare value chain.
Completed: Next steps:
• GDSN Healthcare Extension • Develop UDI Database implementation guide
• Global GDSN pilot and phase 2 • To be jointly developed with GS1 US, to be completed
after FDA finalizes the UDID implementation guide
Implementation report
• Launch the GDSN Global Implementation project
• Global Product Classification (GPC) codes
for Healthcare • Develop a training program for MOs and Data Pools
based on the GDSN Use Cases
• GDSN Implementation guide for Healthcare
• Develop GS1 Healthcare position paper on
• UDI database gap analysis completed. Work
Classification
Request entered to add missing attributes
• Re-engage Leighton Hansel and David Turner
• Latex attributes
as industry Subject Matter Experts and
• Use Case document Release 1 completed determine course of action
• New GDSN attributes added to support the • Launch an adoption program for the GLN Service in
FDA GUDID healthcare
• Medicine Dispensing Use Case

© 2013 GS1
 Roadmap to Global Standards
Data Synchronisation, Classification and GLN Service
2013 2014 2015
COMPLETED
 Healthcare Launch GDSN Global Implementation and Expansion Project
Daya Synchronisation

GDSN
Nov.
Extension
 Trade Item Country GDSN Implementation Data Requirements Database (PP)
Implementatio
n Guide
 Use Cases V1 UDI Database and GDSN Training as part of the overall GS1 UDI
Complete
 9 Use Cases Education Project
for GDSN GDSN / UDID
Guide

Develop and Launch MO / DP Training Program for Use Cases and

Complete Medicine Dispensing Use Case
Implementation of GDSN in Healthcare, Including guidance from the
Global Implementation and Expansion Project
Classification

Survey HIG Develop

MOs to better Guidance Paper
Launch understand for Countries
Nov. current with no national
Classification Classification
usage standard
Service

Launch
GLN

GLN Registries Framework Q1 2014 Launch GLN Service & Adoption Program

Ratified standard or work finalised Work near closure Work in progress or planned
7
© 2013 GS1 Version – 27 November 2013
 eCom Harmonisation in Healthcare
Objective: Develop a framework to align GS1 eCom standards so they can
be used throughout the Global Healthcare supply chain from supplier to
logistic end-user
Current: Next steps:
Gap-analysis of existing national/regional 1. Development of the Healthcare
EANCOM® and GS1 XML guidelines Interoperability Model (HIM) according to
the agreed priority:
Prio I: Purchase Order, Purchase Order
Response, Despatch advice
Prio II: Master Data (both eCom and GDSN)
Prio III: Invoice
Prio IV: Receiving Advice, Inventory Report (for
Consignment processes)
2. Development of Global eCom Guidelines

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© 2013 GS1
 Roadmap to Harmonised Standards
GS1 eCom in Healthcare
2013 Current Phase 2014 Future Phases 2015 2016
Project Initiation

Team Formation

As-is Gap
Analysis

HIM Development

Supply Chain Process Model Supply Chain Process Guide

Master Data Model Master Data Guide

Invoice Process Model Invoice Process Guide

Consignment Process Model Consignment Process Guide

Ratified standard or work finalised Work near closure Work in progress or planned
9
© 2013 GS1 Version – 27 November 2013
Contact Details
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T + 32 2 788 78 00
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