ISO INTERNATIONAL STANDARD 16527 First edition 2023-10 Health informatics HL7 Personal Health Record Svstem Functional Model, Release 2 (PHR-S FM) Informatique de santé - Modele fonctionnel d'un systeme de dossier de santé personnel, version 2 (PHR-S FM) Reference number IS0 16527:2023(E) ISO @ IS0 2023 IS0 16527:2023(E) COPYRIGHTPROTECTED DOCUMENT IS02023 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 40i : Ch. de Blandonnet 8 CH-1214Vernier, Geneva Phone: +4122 749 0111 Email: [email protected] Website: www.iso.org Published in Switzerland ii @ IS0 2023 - All rights reserved IS0 16527:2023(E) Contents Page Foreword Introduction.... 0.1 Notes to Readers.. .vili 0.2 Changes from Previous Release . .vili 0.3 ...ili 0.3.1 Personal Health Record (PHR) Versus a Personal Health Record System (PHR-S).. 0.3.2 Designation of Sections.... ix 1 Scope... 1.1 PHR-S Functional Model Scope.. 2 Normative References.... 3 Terms and Definitions.. 4 The Functional Model.... 4.1 Overview and Definition ... 4.2 PHR-S Functional Outline.... 4.2.1 TheFunctionsandTheirUse.. 4.2.2 Personal Health Section Functions.. 4.2.3 Personal Health Support Section Functions.... 4.2.4 Record Infrastructure Section and Trust Infrastructure Section Functions .... 4.3 Common Major Concepts Across the Model.... 4.3.1 Consistency in the Conformance Criteria... 4.3.2 4.3.3 Functionality versus Implementation... 4.3.4 Relevant Standards ... 4.3.5 Consents, Authorizations, and Preferences. 4.3.6 Scope of Downstream Uses of PHR data..... 4.4 Type of Profiles..... 5 Conformance Clause.. 5.1 Introduction (Reference). 5.2 Scope and Field of Application (Normative)..... 5.3 Concepts (Normative) .... 5.3.1 Functional Profiles. 5.3.2 Conformance Model (Normative). 5.3.3 Profile Traceability (Normative).... 5.4 Normative Language (Normative)... 5.5 Conformance Criteria (Normative)... 5.5.1 Introduction.... 5.5.2 Criteria in the Functional Profile.... 5.5.3 "Dependent SHALL' Criteria .... 5.5.4 Referencing Other Criteria or Functions 5.6 PHR-S FM Structure and Extensibility (Normative) .... 5.6.1 HierarchicalStructure... 5.6.2 Naming Convention..... 5.6.3 Priorities 14 5.6.4 Extensibility. 5.7 Functional Profile Conformance (Normative).... 5.7.1 Introduction... 14 5.7.2 Rules for Domain Functional Profiles . 5.7.3 Rules for Creating New Functions in Functional Profiles. 6 5.7.4 Rules for Derived Functional Profiles. 17 5.7.5 Conformance Statement... 5.7.6 Rules for Companion Functional Profiles... 18 5.8 Use Cases and Samples (Reference) ... 19 5.8.1 Functional Profile Use Cases.................. 5.8.2 Sample Domain Functional Profile Conformance Clauses. 20 5.9 Interpreting and Applying Conditional SHALL' (Reference)... 21 @ IS0 2023 - All rights reserved iii IS0 16527:2023(E) 5.9.1 Construction of Conformance Criteria Using the Conditional 'SHALL' Overview.. 21 5.9.2 5.9.3 Rationale for ‘Dependent SHALL 22 5.9.4 How to Apply the ‘Dependent SHALL' .22 6 Glossary.. .24 6.1 Preface (Reference) .24 6.2 Introduction (Normative) ...24 6.3 Overview (Reference).. .24 6.4 The Action-Verb Structure (Normative). .24 6.4.1 Secure (System) Hierarchy ... .24 6.4.2 Data Management Hierarchy 6.4.3 How Action-Verbs are defined.. .26 6.4.4 Deprecated Action-Verbs.. .32 6.5 Guidelines for Use (Reference) ... .35 6.5.1 6.5.2 Constructing Rigorous Conformance Criteria... ..36 7 PHR System Conformance Claim via Self-Attestation.. ...37 8 Glossary Supplement: Record Lifecycle Events and Descriptions (Normative) ... 8.1 Record Lifecycle Events (See RI.1.1)..... .37 Annex A (Normative) Fu