GS1 Healthcare Roadmap January 2015

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: Rules for HC GTIN Allocation AIDC Application Standard Phase 1 (covering 90% of healthcare products) HC AIDC Small Instrument Marking HC GLN Implementation Guide & Registry Strategy Recommendations HC AIDC Implementation Guideline AIDC for Blood Derivatives Guideline National Healthcare Reimbursement Number Application Identifier Patient & Caregiver ID Solution Multiple Bar Codes (initial work complete) Level below the Each Completed (continued): Patient and Caregiver ID in ISO GTIN Non-reuse HC AIDC Updates Custom, Configurable Trade Items Clarifications on HRI, DPM application HC Kit ID HC Software ID Next steps: AIDC-GDSN Terminology Alignment (moved to GO project)

Roadmap to Global Standards AIDC Application Standards for Healthcare 2013 2014 2015 2016 Patient & Caregiver ID in ISO Level Below The Each/Unit Dose AIDC HC Updates & Clarifications Ratified standard or work finalised Work near closure Work in progress or planned Version – January 2015

Global Traceability Standards 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: Global Traceability Standard for Healthcare (GTSH) GTSH Implementation Guide (GTSH IG) Training for Member Organisations Pilot Global Traceability Conformance (GTC) Audit in two hospitals Gap analysis against GS1 System of Standards: Visibility Standards and eCom Standards Work Requests (2:WR 12-126 12-127) for Event Based Traceability Standards Approved & in GSMP Next steps: Progress Event Based Traceability work through GSMP to enhance EPCIS/Visibility standards to enable Chain of Custody/Chain of Ownership (CoC/CoO (aka Pedigree)) and Product Identifier Authentication (PIA) Use Cases GTC for Healthcare (2015/16) GTSH & GTSH IG V2 (2016) Training for Member Organisations (ongoing)

Roadmap to Global Standards Global Traceability Standards for Healthcare 2013 2014 2015 2016 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 Version – January 2015

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: GDSN Implementation guide for Healthcare UDI database gap analysis completed. Work Request entered to add missing attributes Latex attributes Use Case document Release 1 completed New GDSN attributes added to support the FDA GUDID Medicine Dispensing Use Case GDSN guide for UDI database GDSN Global Implementation work group for Medical Devices GDSN Use Cases with the Medical Device implementation requirements for multiple countries Next steps: Launch GDSN Pharma and Pharmacy implementation work group Complete GDSN Use Cases for Pharma and Pharmacy Develop a training program for MOs and Data Pools based on the GDSN Use Cases Develop a guidance paper for Classification in healthcare

Roadmap to Global Standards GDSN, Classification & GLN Service 2013 2014 2015 2016 COMPLETED Healthcare GDSN Extension Trade Item Implementation Guide Use Cases V1 9 Use Cases for GDSN Medicine Dispensing UC GDSN Guide for UDI Databases Medical Devices: GDSN Global Implementation Analysis Pharma and Pharmacy GDSN Global Implementation Data Synchronisation Develop MO / DP Training Program based on Use Cases, including recommended implementation attributes UDI Database and GDSN education as part of the overall GS1 UDI Education Project Classification Survey HIG MOs to better understand current Classification usage Develop Guidance Paper for Countries with no national Classification standard GLN Service GLN Service Launch Launch of the GLN Service (see separate roadmap in this presentation) Ratified standard or work finalised Work near closure Work in progress or planned Version – January 2015

Roadmap to Global Standards GLN Service Deployment 2013 2014 2015 2016 GSMP WG Requirements, GLN Reg. Framework, MO team formed; Developed and Approved Functional Requirements, Aligned on Technical Design, Functional Requirements Document, Business Model, Summary Use Cases Development October Launch GO Hosted Registries June Launch GS1 Global Index Piloting & Enhancements Initial Pilot Q4 CY 2012 for learning’s Develop technology for the Data Quality Framework & Conformance program Launch the Data Quality Framework & Conformance Program Define Data Quality Framework & Conformance Program Launched Interest Group MO training & awareness to help drive adoption of Service Adoption Develop Engagement Kit, including Use Cases Ratified standard or work finalised Work near closure Work in progress or planned Version – January 2015

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 Scope: Completed: Gap-analysis of existing national/regional EANCOM® and GS1 XML guidelines Next steps: Development of the Healthcare 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) Development of Global eCom Guidelines

Roadmap to Global Standards GS1 eCom in Healthcare 2013 2014 2015 2016 Project Initiation Team Formation As-is Gap Analysis HIM Development Order to Cash GSMP Consignment GSMP Master Data GSMP Invoice GSMP HER Development Order, Order Rsp, Despatch Advice GSMP Receiving Advice, Inventory, Sales GSMP Master Data (eCom & GDSN) GSMP Invoice, Remittance GSMP Ratified standard or work finalised Work near closure Work in progress or planned Version – January 2015