ISO/TS 21089:2018

Health informatics — Trusted end-to-end information flows

ISO/TS 21089:2018 describes trusted end-to-end flow for health information and health data/record management. Health data is originated and retained, typically as discrete record entries within a trusted electronic health record (EHR), personal health record (PHR) or other system/device. Health data can include clinical genomics information. Health record entries have a lifespan (period of time managed by one or more systems) and within that lifespan, various lifecycle events starting with "originate/retain". Subsequent record lifecycle events may include "update", "attest", "disclose", "transmit", "receive", "access/view" and more. A record entry instance is managed ? over its lifespan ? by the source system. If record entry content is exchanged, this instance may also be managed intact by one or more downstream systems. Consistent, trusted management of record entry instances is the objective of this document, continuously and consistently whether the instance is at rest or in motion, before/during/after each lifecycle event, across one or more systems.

Informatique de santé — Flux d'informations "trusted end-to-end"

General Information

• Status: Published
• Publication Date: 08-Apr-2018
• ICS: 35.240.80 - IT applications in health care technology
• Technical Committee: ISO/TC 215 - Health informatics
• Drafting Committee: ISO/TC 215/WG 2 - Systems and Device Interoperability
• Current Stage: 9020 - International Standard under periodical review
• Start Date: 15-Jan-2025
• Due Date: 15-Jan-2025
• Completion Date: 15-Jan-2025

Relations

• Revises: ISO/TR 21089:2004 - Health informatics — Trusted end-to-end information flows
• Effective Date: 05-Jul-2014

Standards Content (Sample)

TECHNICAL ISO/TS
SPECIFICATION 21089
First edition
2018-04
Health informatics — Trusted end-to-
end information flows
Informatique de santé — Flux d'informations "trusted end-to-end"
Reference number
©
ISO 2018
© ISO 2018
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ii © ISO 2018 – All rights reserved

Contents Page
Foreword .v
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Abbreviated terms .25
5 Truth, trust, end-to-end information flows and foundations of interoperability.27
6 Trust characteristics in end-to-end information flow .28
7 The trust constituency .29
8 Principles and objectives .32
8.1 Ensured trust .32
8.2 Trust constituency .32
8.3 Health record rights .33
8.4 Health record obligations .33
8.5 Health record composition .34
8.6 Human and business agents and their accountable actions .34
8.7 Software and device agents and their accountable actions.34
8.8 Scope of accountability .34
8.9 Provenance .35
8.10 Authentication .35
8.11 Auditability .36
8.12 Chain of trust .36
8.13 Faithfulness, permanence, persistence and indelibility .36
8.14 Data definition, data registry .36
8.15 Data integrity .36
8.16 Completeness .36
9 Downstream/upstream information flow perspectives .37
9.1 Downstream information flow perspective — Subject of care .37
9.2 Downstream information flow perspective — Accountable agent(s) for health
record content .38
9.3 Upstream perspective — Accountable agent(s) for health record access/view .39
10 Agents, actions and corresponding persistent record entries .39
10.1 Agent takes action .39
10.2 Agent documents action taken .40
10.3 Agent stewards the record entry .40
11 Key contexts for action instances and record entry instances .41
11.1 Identity Context .41
11.2 Accountability Context .41
11.3 Data Integrity Context.41
11.4 Clinical Context .41
11.5 Administrative/operational context.42
12 Roles and relationships (examples) .42
12.1 Subject of care and provider relationships .42
12.2 Health services .42
12.3 Health record relationships .42
12.4 Individuals, organizations and business unit relationships .43
12.5 Inter-healthcare professional relationships .43
13 Record lifecycle events and CRUD (create, read, update, delete) .44
14 Key lifecycle events in trusted end-to-end information flows .46
15 Record lifecycle events and action instances .47
15.1 Initial instance .47
15.1.1 Initial action instance .47
15.1.2 Record lifecycle event — Originate/retain record entry instance(s) .48
15.2 Subsequent instance .50
15.2.1 Subsequent action instance .50
15.2.2 Record lifecycle event — Amend (update) record entry instance(s) .50
15.3 Record lifecycle event — Transform/translate .51
15.4 Record lifecycle event — Attest .52
15.5 Record lifecycle event — Access/view .53
15.6 Record lifecycle event — Report (output).54
15.7 Record lifecycle event — Disclose .54
15.8 Record lifecycle event — Transmit .54
15.9 Record lifecycle event — Receive/retain .56
15.10 Record lifecycle event — De-identify (anonymize) .57
15.11 Record lifecycle event — Pseudonymize .58
15.12 Record lifecycle event — Re-identify .60
15.13 Record lifecycle event — Extract .61
15.14 Record lifecycle event — Archive .62
15.15 Record lifecycle event — Restore (from archive) .63
15.16 Record lifecycle event — Destroy/delete.64
15.17 Record lifecycle event — Deprecate .65
15.18 Record lifecycle event — Reactivate (from delete or deprecate) .66
15.19 Record lifecycle event — Merge .67
15.20 Record lifecycle event — Unmerge .68
15.21 Record lifecycle event — Link .69
15.22 Record lifecycle event — Unlink .69
15.23 Record lifecycle event — Add legal hold .70
15.24 Record lifecycle event — Remove legal hold .71
15.25 Record lifecycle event — Verify .
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