1. When Supply Chain meets Care Delivery: Background on GS1 and HL7 Ulrike Kreysa Director Healthcare, GS1 Global Office

2. © 2008 GS1 GS1 is a not-for-profit organisation dedicated to the design and implementation of global standards to improve the efficiency and visibility of supply chains globally and across sectors 108 member organisations Over 30 years of experience Neutral platform for all supply chain stakeholders Over a million companies doing business across 150 countries Over 6 billion transactions a day based on GS1 Standards The role of GS1

3. © 2008 GS1 108 Member Organisations - 150 Countries served Countries with a GS1 Member Organisation Countries served on a direct basis from GS1 Global Office (Brussels) GS1 Around the World

4. © 2008 GS1 GS1 System of Standards 4 Global reach An integrated approach Standardised identification keys Products, locations, assets, … Standardised data carriers Bar codes & RFID Standardised sharing of static data Data on products & locations Standardised sharing of dynamic data Event data Standardised electronic communication Open standards Proven standards

5. © 2008 GS1 GS1 System of Standards

6. © 2008 GS1 GS1 Identification Keys 6 Item identifier = Logistics unit identifier = Location identifier = And more … GTIN SSCC GLN Global Trade Item Number Serial Shipping Container Code Global Location Number  Unique  Non-significant  International  Secure  Foundational

7. © 2008 GS1 GTIN - Global Trade Item Number 7 Manufacturer Distributor, wholesaler, GPO, … Point-of-care Healthcare provider Assigns GTIN GTIN allows unambiguous product identification at every step GTIN enables traceability ‘from production to patient’

8. © 2008 GS1 Scope: Data Data – a few examples: Global Trade Item Number (GTIN) Expiry Date Batch / Lot Serial Number ( 21)123

9. © 2008 GS1 Pharma / Vaccine / Nutritional Medical devices Retail Non-retail Scope: All healthcare products

10. © 2008 GS1 GS1 data carriers 10

11. © 2008 GS1 GS1 eCom Purchase orders, despatch advices, invoices, … GS1 eCom standards provide clear guidelines for creating electronic versions of many business documents, enabling trading partners to smoothly exchange information electronically. 11

12. © 2008 GS1 GS1 GDSN 12

13. © 2008 GS1 13

14. © 2008 GS1 GS1 Standards in Retail 14 Supplier Retailer Consumer

15. © 2008 GS1 GS1 Standards in Healthcare 15 Supplier Distributor Wholesaler GPO Healthcare provider Patient

16. © 2008 GS1 GS1 Standards in Healthcare 16 Supplier Distributor Wholesaler GPO Healthcare provider Patient Regulator

17. © 2008 GS1 Interoperability in Healthcare 17 Interoperability standard HL7 Manufacturer Pharmacy Physician Hospital EHR Payer

18. © 2008 GS1 Interoperability standards and GS1 Standards in Healthcare 18 Interoperability standards HL7 Manufacturer Pharmacy Physician Hospital EHR Payer GDSN EPCIS

19. © 2008 GS1 19

20. © 2008 GS1 GS1 – HL7 (1) Development of ISO Standard« Individual Case Safety Report » [ICSR] Adopt a global standard for the communication of adverse events between the user community and the regulators, as well as between regulators GTIN’s and their attributes proposed as product ID in the communication process

21. © 2008 GS1 GS1 – HL7 (2) “Common Product Model” [CPM] A full domain providing a fundamental structure for entities across health informatics Currently evolving to capture requirements from major ISO Standards development GS1 product hierarchy and the attributes proposed as product ID (including lot #, serial #, expiry date, etc.) in the CPM

22. © 2008 GS1 Final thoughts Every clinical decision is also a procurement decision e.g., bedside scanning needs a unique identification number, which is best assigned by the manufacturer From the GS1 “numbering plate”, links can be created to any other information that is needed We need to seamlessly integrate the supply chain into the clinical chain 22

23. © 2008 GS1 Conclusion 23

24. Contact Details Ulrike Kreysa GS1 Global Office Brussels T + 32 2 788 78 37 E ulrike.kreysa@gs1.orgulrike.kreysa@gs1.org W www.gs1.org/healthcarewww.gs1.org/healthcare