1. What is ISO in medical informatics about? Christian Hay, Convener TC 215, WG 6 «pharmacy and medicines business» 12 September 2013

2. © 2014 GS1 Scope TC 215: Health Informatics Standardization in the field of information for health, and Health Information and Communications Technology (ICT) to promote interoperability between independent systems, to enable compatibility and consistency for health information and data, as well as to reduce duplication of effort and redundancies The domain of ICT for health includes but is not limited to: Healthcare delivery; Disease prevention and wellness promotion; Public health and surveillance; Clinical research related to health service.

3. © 2014 GS1 TC 215 structure NMB: National Mirror Body: IPQ - Instituto Português da Qualidade, Rua António Gião, 2 - PT-2829-513 Caparica IPQ has an “observer” status

4. © 2014 GS1 TC 215 structure Liaison: e.g. CEN TC 251, DICOM, GS1, HL7, IHE, IHTSDO (SNOMED)

5. © 2014 GS1 TC 215 structure WG1: Architecture, Frameworks and Models WG2: Systems and Device Interoperability WG3: Semantic content WG4: Security, Safety, and Privacy

6. © 2014 GS1 TC 215 structure WG6 : Pharmacy and medicines business JWG1 : Informatics of Traditional Chinese medicine JWG7: Application of risk management to IT networks incorporating medical devices

7. © 2014 GS1 An example of WG 6 delivery

8. © 2014 GS1 ISO IDMP – Identification of Medicinal Products Substance Dose Form Strength Substance Dose Form Strength Substance Dose Form Strength Substance Dose Form Strength Regulated Medicinal Product Pharmaceutical Product Substance Pharmaceutical Dose Form Units of measurement Standard Terminology EN ISO 11615 EN ISO 11616 EN ISO 11238 EN ISO 11240 EN ISO 11239 8 All these EN ISO standards have been jointly developed with HL7 and are currently in implementation by US FDA, European Medicines Agency and other regulators

9. © 2014 GS1 Contact 9 Christian Hay GS1 Global Office Sr Consultant Healthcare Convenor ISO TC 215, WG 6 Tel +41 21 825 32 19 Mob+41 76 369 10 54 christian.hay@gs1.org