1. Towards "Guidelines supporting the Member States in developing the interoperability of ePrescriptions” Standards Development and Profiling Organisations' Contribution eHGI Workshop, 11 th March 2014 Jürgen Brandstätter (IHE Pharmacy) Niels Speksnijder (CEN/ISO TC215) Shirin Golyardi (CEN/ISO TC215) Karima Bourquard (IHE-Europe)

2. Overview Introduction ISO TC215 WG6 – Requirements for electronic prescriptions IHE Pharmacy – Methodology and Profiles Conclusion 11/03/2014ePrescription workshop2

3. Introduction 11/03/2014ePrescription workshop3

4. HL7 IHE Overview of the state of Art on ePrescription standards and profiles: ISO TC215 WG6: ePrescription Niels Speksnijder IHE Pharmacy profiles Jürgen Brandstätter A Conceptual Framework To Implementation Guidelines Objective 4 ISO/ CEN ePrescription workshop411/03/2014

5. ISO TC215 WG6 “Pharmacy” 11/03/2014ePrescription workshop5

6. Health Informatics – Requirements for electronic prescriptions ISO/TC 215/ WG 6 17523 11/03/2014ePrescription workshop6

7. CEN-ISO connection CEN/TC 251 – Health informatics ISO/TC 215 – Health informatics – WG 6 Pharmacy and medicines business CEN experts join together efforts with ISO Vienna Agreement between CEN and ISO to avoid duplication of (potentially conflicting) standards

8. Standardization related to the application of information and communication technology in the domain of pharmacy and medication, including standardization to improve patient safety and the efficiency and interoperability of information systems used in researching, developing, regulating, supplying, using and monitoring pharmaceutical products. Scope ISO/TC215 WG6 11/03/2014ePrescription workshop8

9. May 2011 (Kuopia, Finland) decision to revise ENV 13607 (pre-standard from 2000) Health informatics - Messages for the exchange of information on medicine prescriptions NP Ballot passed October 2011 Background - ePrescription 11/03/2014ePrescription workshop9

10. Specifies general principles for ePrescription and content that facilitates exchange and processing of ePrescription Annex: ‘core’ and ‘optional’ elements of ePrescriptions Out of scope: other messages and how ePrescriptions are exchanged/made available Out of scope: dispense information Scope - ePrescription 11/03/2014ePrescription workshop10

11. Karl Stroetmann – Empirica Jürgen Brandstätter – IHE Fredrik Linden – epSOS Christian Hay – GS1 IHE, ISO, HL7 Pharmacy SIG joint meeting – June 2013 – Emphasis on scope, boundaries and common ground Follow up meeting June 2014 Contacts and meetings 11/03/2014ePrescription workshop11

12. CD Ballot passed October 2013 (Sydney, Australia) – Processing and answering comments – Input from (international) experts – Input from the recently delivered Empirica report May 2014 Karuizawa, Japan meeting to approve DIS ballot to start – Processing last comments Publication December 2014 Where do we stand now? 11/03/2014ePrescription workshop12

13. Health Informatics – Requirements for Medicinal Product Dictionaries Health Informatics – Requirements for a record of the Dispense of a Medicinal Product Health informatics — Data elements and structures for identification of extemporeanous and magistral (compound) pharmaceutical preparations without marketing authorisation Ongoing projects 11/03/2014ePrescription workshop13

14. IHE Pharmacy 11/03/2014ePrescription workshop14

15. What is IHE? 11/03/2014ePrescription workshop15 Use cases typically require „combinations“ of standards - but how to compose? eHealth Projects IHTSDO IETF Standards

16. What is IHE? 11/03/2014ePrescription workshop16 Profiling and Testing eHealth Projects IHTSDO IETF Standards

17. ProductsProjects IHE methodology 11/03/2014ePrescription workshop17 Use Case Identify available standards Products declare IHE Easy to integrate products RFPs with IHE reqs

18. Liaisons 11/03/2014ePrescription workshop18 ISO TC 215 WG6 „Pharmacy“ / CEN TC 251 Global recognition ISO TC 215 WG6 „Pharmacy“ / CEN TC 251 Global recognition HL7 Pharmacy Base Standards HL7 Pharmacy Base Standards IHE Pharmacy Profiling Layer Friendly collaboration

19. Liaisons 11/03/2014ePrescription workshop19 ISO TC 215 WG6 / CEN Global recognition ISO TC 215 WG6 / CEN Global recognition HL7 Pharmacy Base Standards HL7 Pharmacy Base Standards IHE Pharmacy Profiling Layer Contributions User/Vendor Input ISO Standards

20. Liaisons 11/03/2014ePrescription workshop20 ISO TC215 WG6 / CEN Global recognition ISO TC215 WG6 / CEN Global recognition HL7 Pharmacy Base Standards HL7 Pharmacy Base Standards IHE Pharmacy Profiling Layer Projects High-level Technical Profiles (Use Cases) HL7 Standards ISO Standards

21. Profiles – Workflow Community Medication Prescription and Dispense – Content Prescription Dispensation Whitepapers – Medication Management - Concepts and Definitions Joint work item with ISO/HL7 IHE Pharmacy 11/03/2014ePrescription workshop21 Synced 1)Concept derived from epSOS 2)Worked in sync with epSOS 3)Further elaborated in IHE

22. Prescription / Dispensation profiles – Content structure derived from HL7 – Mature set of data, requirements practice approved – Minimum data requirements incorporated – Leveraged by … epSOS Austria Italy / Veneto region (Dispensation only) … IHE Pharmacy 11/03/2014ePrescription workshop22

23. Conclusion 11/03/2014ePrescription workshop23

24. ISO – Global recognition and authority – High-level requirements of ePrescriptions Dispensation next to come IHE – The people in the middle create the bridge between theory and implementation (= Standards and Projects) – Practical Workflow and Content profiles to ePrescription/eDispensation – In sync with epSOS SDOs united – Cooperation between the SDO's is essential for standards users so overlap between standards is avoided – This is the objective of the Joint Initiative Council (JIC) – Members: ISO, CEN, HL7, IHE, HL7, CDISC and others Conclusion 11/03/2014ePrescription workshop24

25. Thank you for your attention!