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)

Overview

• Introduction

• ISO TC215 WG6– Requirements for electronic prescriptions

• IHE Pharmacy– Methodology and Profiles

• Conclusion

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Introduction

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HL7IHE

Overview of the state of Art on ePrescription standards and profiles:

ISO TC215 WG6: ePrescription Niels Speksnijder IHE Pharmacy profiles Jürgen Brandstätter

A Conceptual FrameworkTo Implementation Guidelines

Objective

4

ISO/CEN

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ISO TC215 WG6 “Pharmacy”

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Health Informatics – Requirements for electronic prescriptions

ISO/TC 215/WG 6 17523

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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

• 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

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• 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

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• 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

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• 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

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• 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?

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• 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

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IHE Pharmacy

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What is IHE?

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Use cases typically require„combinations“ of standards

- but how to compose?

eHealth Projects

IHTSDO

IETFIETF

Standards

What is IHE?

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Profiling and TestingeHealth Projects

IHTSDO

IETFIETF

Standards

Products Projects

IHE methodology

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Use Case

Identify available standards

Products declare

IHE

Easy to integrate products

RFPs with IHE reqs

Liaisons

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ISO TC 215 WG6 „Pharmacy“ / CEN TC 251Global recognition

HL7 PharmacyBase Standards

IHE PharmacyProfiling Layer

Friendly collaboration

Liaisons

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ISO TC 215 WG6 / CENGlobal recognition

HL7 Pharmacy Base Standards

IHE PharmacyProfiling Layer

Contributions

User/Vendor Input

ISO Standards

Liaisons

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ISO TC215 WG6 / CENGlobal recognition

HL7 PharmacyBase Standards

IHE PharmacyProfiling LayerProjects

High-level

TechnicalProfiles

(Use Cases)HL7 StandardsHL7 Standards

ISO Standards

• Profiles– Workflow

• Community Medication Prescription and Dispense– Content

• Prescription• Dispensation

• Whitepapers– Medication Management - Concepts and Definitions

• Joint work item with ISO/HL7

IHE Pharmacy

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Synced

1) Concept derived from epSOS2) Worked in sync with epSOS3) Further elaborated in IHE

• 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

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Conclusion

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• 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

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Thank you for your attention!