ISO/TS TECHNICAL SPECIFICATION 19256 First edition 2016-06-01 Health informatics Requirements for medicinal product dictionary systems for health care Informatique de santé - Exigences pour les systemes de dictionnaires de produits médicaux pour les soins de santé Reference number ISO/TS 19256:2016(E) ISO International Organization for Standardization ee=ZHEJIANG INST OF STANDARDIZATION C1 5956617 @IS02016 No reproduction or networking permitted without license from IHS IS0/TS 19256:2016(E) COPYRIGHT PROTECTED DOCUMENT IS0 2016, Published in Switzerland All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form written permission. Permission can be requested from either Iso at the address below or Iso's member body in the country of the requester. ISO copyright office Ch. de Blandonnet 8 . CP 401 CH-1214 Vernier, Geneva, Switzerland Tel. +41 22 749 01 11 Fax +41 22 749 09 47 [email protected] www.iso.org Licensee-ZHEJIANG INST.OF STANDARDIZoISQ6 -All rights reserved Not for Resale, 2016/7/20 07:53:23 networking permited without license from IHS IS0/TS 19256:2016(E) Contents Page Foreword ..V Introduction. ...vi 1 Scope. 2 Normative references 3 Terms and definitions ..2 4 Abbreviated terms .9 5 Boundary between MPD-systems and IDMP, ancillary information to build an MPD- system and local implementation. 9 5.1 Boundary between MPD-systems and IDMP .9 5.2 Boundary between MPD-systems and ancillary information to build an MPD-system. 9 5.3 Boundary between MPD-systems and local implementation, .9 5.4 Content of the MPD-systems in terms of product coverage. .10 5.5 Definition of Medicinal Product Dictionary MPD-systems 10 5.6 Benefits of the Technical Specification. ..10 5.7 Target users for the Technical Specification. ..10 6 Positioning of Medicinal Product Dictionary Systems for Healthcare .11 6.1 Base materials for MPD-systems.. ..11 6.1.1 Relation with ISO IDMP standards. .. 12 6.1.2 Relation with health/clinical/pharmacy information systems, decision support, EHR and dose instructions. ..13 6.1.3 Relation with EHR-S FM. ..14 6.2 Use cases for requirements for an MPD-system ..14 6.2.1 Prescribing use case... ..15 6.2.2 Dispensing use case.. ..15 6.2.3 Administration use case ..15 6.2.4 Recording medication history use case. .15 6.2.5 Reconcilingmedicationlistusecase .. 15 6.2.6 Ordering and supply chain (logistics) use case .. 16 6.2.7 Analysis, statistics, and pharmacoepidemiology use case. ..16 6.2.8 Electronic data exchange of medicinal product information between healthcare systems and/or related systems, i.e. reporting use case. ..16 6.2.9 Reimbursement use case ..16 6.2.10 Clinical research use case. ..16 6.2.11 Tracking and tracing for patient and public safety use case.. ..17 6.2.12 Pharmacovigilance use case. ..17 6.2.13 Patient safety through linking personal data with the decision support system on medicinal products use case. .18 6.2.14 Migration use case. ..18 The Functional Requirements for MPD-systems ..18 > 7.1 Introduction ..18 7.2 Goal of an MPD system. ..19 7.3 Normative content .19 7.3.1 Content of regulated medicinal products .19 7.3.2 Prescription. 23 7.3.3 Dispensing. 23 7.3.4 Administration. 24 7.3.5 Recording and reconciliation .24 7.3.6 Order and supply chain and logistics 25 7.3.7 Analysis, statistics, pharmacoepidemiology, and clinical research ..25 7.3.8 Ensuring patient safety through linking personal data with the decision support system on medicinal products... ..27 7.3.9 Interaction with reimbursement systems ..27 ntemaionalganzation@6All rights reserved ii Licensee=ZHEJIANG INST OF STANDARDIZATION C1 5956617 ed without license from IHS Not for Resale, 2016/7/20 07:53:23 No reproduction or networking pe