ISO/TS TECHNICAL SPECIFICATION 20405 First edition 2018-05 Health informatics Framework of event data and reporting definitions for the safety of health software Informatique de santé - Cadre des données relatives aux événements et de compte-rendu des définitions pour la sécurité des logiciels de santé Reference number IS0/TS 20405:2018(E) International Organization for Standardization ee=Shenzhen Institute of Standards and Technology 9972181 @ IS0 2018 IS0/TS 20405:2018(E) COPYRIGHTPROTECTEDDOCUMENT @ IS0 2018 All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior 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 CP 401 : Ch. de Blandonnet 8 CH-1214 Vernier, Geneva Phone: +41 22 749 01 11 Fax: +41 22 749 09 47 Email: copyright@iso.org Website: www.iso.org Published in Switzerland Inteationaibr Drganization for Standardization Licensee-Shenzhen nstute of Standards andecS.e- All rights reserved rious National Standards Bodies Not for Resale, 2018/8/23 07:06:48 No reproduction or networking permitted without license from IHS IS0/TS 20405:2018(E) Contents Page Foreword ..iv Introduction. ..V 1 Scope. 2 Normative references 3 Terms and definitions 4 Principles, data concepts and process model 2 4.1 General .2 4.2 Principles .3 4.2.1 General. 3 4.2.2 Proactivity .3 4.2.3 Objectivity 3 4.2.4 Accountability .3 4.2.5 Transparency 3 4.2.6 Preparedness .3 4.2.7 Comprehensiveness 4 4.3 Data concepts. 4 4.3.1 General. ..4 4.3.2 Accuracy .4 4.3.3 Timeliness. ..4 4.3.4 Comparability .4 4.3.5 Usability. .4 4.3.6 Relevance. 5 4.4 Process model. .5 4.4.1 General .5 4.4.2 Recording .5 4.4.3 Analysing .5 4.4.4 Reporting. ..5 5 Patient safety data elements .6 5.1 General .6 5.2 Event information. .6 5.2.1 General. 5.2.2 Event identification 6 5.2.3 Event date and time. .6 5.2.4 Reportdate .6 5.2.5 Event reporter information ..6 5.2.6 Event supplementary information .7 5.3 Event categorization. .7 5.4 Event classification. 5.4.1 General. .7 5.4.2 Information input/output errors .8 Annex A (informative) Information on various health software surveillance systems. ..13 Bibliography ..15 Intenatonal Oganization S2-All rights reserved iii Not for Resale, 2018/8/23 07:06:48