eHGI Workshop, 11 th March 2014

1. eHGI Workshop, 11 th March 2014 Towards"Guidelines supporting the Member States in developing the interoperability of ePrescriptions”Standards Development and Profiling Organisations' Contribution 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 ePrescription workshop

3. Introduction ePrescription workshop

4. Objective ISO/CEN IHE HL7 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 ePrescription workshop 4

5. ISO TC215 WG6 “Pharmacy” ePrescription workshop

6. Health Informatics – Requirements for electronic prescriptions ISO/TC 215/ WG 6 17523 ePrescription workshop

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. Scope ISO/TC215 WG6 • 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. ePrescription workshop

9. Background - ePrescription • 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 ePrescription workshop

10. Scope - ePrescription • 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 ePrescription workshop

11. Contacts and meetings • 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 ePrescription workshop

12. Where do we stand now? • 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 ePrescription workshop

13. Ongoing projects • 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 ePrescription workshop

14. IHE Pharmacy ePrescription workshop

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

16. IETF IHTSDO What is IHE? eHealth Projects Standards Profiling and Testing ePrescription workshop

17. Testing at Connectathons Profile Development Identify available standards Use Case Easy to integrate products IHE methodology Products Projects Products declare IHE RFPs with IHE reqs ePrescription workshop

18. Liaisons ISO TC 215 WG6 „Pharmacy“ / CEN TC 251 Global recognition Friendlycollaboration IHE Pharmacy Profiling Layer HL7 Pharmacy Base Standards ePrescription workshop

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

20. Liaisons Projects ISO TC215 WG6 / CEN Global recognition High-level ISO Standards IHE Pharmacy Profiling Layer HL7 Pharmacy Base Standards Profiles (UseCases) Technical HL7 Standards ePrescription workshop

21. IHE Pharmacy • Profiles • Workflow • Community Medication Prescription and Dispense • Content • Prescription • Dispensation • Whitepapers • Medication Management - Concepts and Definitions • Joint work item with ISO/HL7 Synced • ConceptderivedfromepSOS • Worked in syncwithepSOS • Further elaborated in IHE ePrescription workshop

22. IHE Pharmacy • 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) • … ePrescription workshop

23. Conclusion ePrescription workshop

24. Conclusion • ISO • Global recognitionandauthority • High-level requirementsofePrescriptions • Dispensation nexttocome • IHE • The people in themiddlecreatethebridgebetweentheoryandimplementation (= Standards and Projects) • Practical Workflow and Content profilestoePrescription/eDispensation • In syncwithepSOS • 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 ePrescription workshop

25. Thank you for your attention!