Towards Guidelines supporting the Member States in developing

Towards "Guidelines supporting the Member States in developing the interoperability of e. Prescriptions” Standards Development and Profiling Organisations' Contribution Jürgen Brandstätter (IHE Pharmacy) Niels Speksnijder (CEN/ISO TC 215) Shirin Golyardi (CEN/ISO TC 215) Karima Bourquard (IHE-Europe) e. HGI Workshop, 11 th March 2014

Overview • Introduction • ISO TC 215 WG 6 – Requirements for electronic prescriptions • IHE Pharmacy – Methodology and Profiles • Conclusion 11/03/2014 e. Prescription workshop 2

Introduction 11/03/2014 e. Prescription workshop 3

Objective Overview of the state of Art on e. Prescription standards and profiles: ISO TC 215 WG 6: e. Prescription Niels Speksnijder ISO/ CEN IHE Pharmacy profiles Jürgen Brandstätter A Conceptual Framework To Implementation Guidelines 11/03/2014 e. Prescription workshop IHE HL 7 4

ISO TC 215 WG 6 “Pharmacy” 11/03/2014 e. Prescription workshop 5

Health Informatics – Requirements for electronic prescriptions ISO/TC 215/ WG 6 17523 11/03/2014 e. Prescription workshop 6

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

Scope ISO/TC 215 WG 6 • 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. 11/03/2014 e. Prescription workshop 8

Background - e. Prescription • 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 11/03/2014 e. Prescription workshop 9

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

Contacts and meetings • • Karl Stroetmann – Empirica Jürgen Brandstätter – IHE Fredrik Linden – ep. SOS Christian Hay – GS 1 • IHE, ISO, HL 7 Pharmacy SIG joint meeting – June 2013 – Emphasis on scope, boundaries and common ground • Follow up meeting June 2014 11/03/2014 e. Prescription workshop 11

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 11/03/2014 e. Prescription workshop 12

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 11/03/2014 e. Prescription workshop 13

IHE Pharmacy 11/03/2014 e. Prescription workshop 14

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

What is IHE? Standards Profiling and Testing e. Health Projects IETF IHTSDO 11/03/2014 e. Prescription workshop 16

IHE methodology Products Profile Development Projects Testing at Connectathons Products declare IHE Identify available standards RFPs with IHE reqs Use Case Easy to integrate products 11/03/2014 e. Prescription workshop 17

Liaisons ISO TC 215 WG 6 „Pharmacy“ / CEN TC 251 Global recognition IHE Pharmacy Profiling Layer Friendly collaboration HL 7 Pharmacy Base Standards 11/03/2014 e. Prescription workshop 18

Liaisons ISO TC 215 WG 6 / CEN ISO Standards Global recognition IHE Pharmacy Profiling Layer Inpu r o nd t r/Ve e s U Contributions HL 7 Pharmacy Base Standards 11/03/2014 e. Prescription workshop 19

Liaisons High-level Projects ISO TC 215 WG 6 / CEN ISO Standards Global recognition IHE Pharmacy Profiling Layer Technical Profiles (Use Cases) HL 7 S tanda rds HL 7 Pharmacy Base Standards 11/03/2014 e. Prescription workshop 20

IHE Pharmacy • Profiles – Workflow • Community Medication Prescription and Dispense – Content • Prescription • Dispensation • Whitepapers Synced 1) Concept derived from ep. SOS 2) Worked in sync with ep. SOS 3) Further elaborated in IHE – Medication Management - Concepts and Definitions • Joint work item with ISO/HL 7 11/03/2014 e. Prescription workshop 21

IHE Pharmacy • Prescription / Dispensation profiles – Content structure derived from HL 7 – Mature set of data, requirements practice approved – Minimum data requirements incorporated – Leveraged by … • • 11/03/2014 ep. SOS Austria Italy / Veneto region (Dispensation only) … e. Prescription workshop 22

Conclusion 11/03/2014 e. Prescription workshop 23

Conclusion • ISO – Global recognition and authority – High-level requirements of e. Prescriptions • 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 e. Prescription/e. Dispensation – In sync with ep. SOS • 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, HL 7, IHE, HL 7, CDISC and others 11/03/2014 e. Prescription workshop 24

Thank you for your attention!