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.
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Abbreviated terms
5 Truth, trust, end-to-end information flows and foundations of interoperability
6 Trust characteristics in end-to-end information flow
7 The trust constituency
8 Principles and objectives
8.1 Ensured trust
8.2 Trust constituency
8.3 Health record rights
8.4 Health record obligations
8.5 Health record composition
8.6 Human and business agents and their accountable actions
8.7 Software and device agents and their accountable actions
8.8 Scope of accountability
8.9 Provenance
8.10 Authentication
8.11 Auditability
8.12 Chain of trust
8.13 Faithfulness, permanence, persistence and indelibility
8.14 Data definition, data registry
8.15 Data integrity
8.16 Completeness
9 Downstream/upstream information flow perspectives
9.1 Downstream information flow perspective — Subject of care
9.2 Downstream information flow perspective — Accountable agent(s) for health record content
9.3 Upstream perspective — Accountable agent(s) for health record access/view
10 Agents, actions and corresponding persistent record entries
10.1 Agent takes action
10.2 Agent documents action taken
10.3 Agent stewards the record entry
11 Key contexts for action instances and record entry instances
11.1 Identity Context
11.2 Accountability Context
11.3 Data Integrity Context
11.4 Clinical Context
11.5 Administrative/operational context
12 Roles and relationships (examples)
12.1 Subject of care and provider relationships
12.2 Health services
12.3 Health record relationships
12.4 Individuals, organizations and business unit relationships
12.5 Inter-healthcare professional relationships
13 Record lifecycle events and CRUD (create, read, update, delete)
14 Key lifecycle events in trusted end-to-end information flows
15 Record lifecycle events and action instances
15.1 Initial instance
15.1.1 Initial action instance
15.1.2 Record lifecycle event — Originate/retain record entry instance(s)
15.2 Subsequent instance
15.2.1 Subsequent action instance
15.2.2 Record lifecycle event — Amend (update) record entry instance(s)
15.3 Record lifecycle event — Transform/translate
15.4 Record lifecycle event — Attest
15.5 Record lifecycle event — Access/view
15.6 Record lifecycle event — Report (output)
15.7 Record lifecycle event — Disclose
15.8 Record lifecycle event — Transmit
15.9 Record lifecycle event — Receive/retain
15.10 Record lifecycle event — De-identify (anonymize)
15.11 Record lifecycle event — Pseudonymize
15.12 Record lifecycle event — Re-identify
15.13 Record lifecycle event — Extract
15.14 Record lifecycle event — Archive
15.15 Record lifecycle event — Restore (from archive)
15.16 Record lifecycle event — Destroy/delete
15.17 Record lifecycle event — Deprecate
15.18 Record lifecycle event — Reactivate (from delete or deprecate)
15.19 Record lifecycle event — Merge
15.20 Record lifecycle event — Unmerge
15.21 Record lifecycle event — Link
15.22 Record lifecycle event — Unlink
15.23 Record lifecycle event — Add legal hold
15.24 Record lifecycle event — Remove legal hold
15.25 Record lifecycle event — Verify
15.26 Record lifecycle event — Encrypt
15.27 Record lifecycle event — Decrypt
Annex A (informative) HL7 Fast Health Interoperable Resources (FHIR)
Annex B (informative) Lifecycle metadata captured in FHIR resources
Annex C (informative) Sample lifecycle event sequence with FHIR resources
Annex D (informative) Lifecycle Event Sequence — Point of Origination to Point of Access (Example)
Bibliography
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Abbreviated terms
5 Truth, trust, end-to-end information flows and foundations of interoperability
6 Trust characteristics in end-to-end information flow
7 The trust constituency
8 Principles and objectives
8.1 Ensured trust
8.2 Trust constituency
8.3 Health record rights
8.4 Health record obligations
8.5 Health record composition
8.6 Human and business agents and their accountable actions
8.7 Software and device agents and their accountable actions
8.8 Scope of accountability
8.9 Provenance
8.10 Authentication
8.11 Auditability
8.12 Chain of trust
8.13 Faithfulness, permanence, persistence and indelibility
8.14 Data definition, data registry
8.15 Data integrity
8.16 Completeness
9 Downstream/upstream information flow perspectives
9.1 Downstream information flow perspective — Subject of care
9.2 Downstream information flow perspective — Accountable agent(s) for health record content
9.3 Upstream perspective — Accountable agent(s) for health record access/view
10 Agents, actions and corresponding persistent record entries
10.1 Agent takes action
10.2 Agent documents action taken
10.3 Agent stewards the record entry
11 Key contexts for action instances and record entry instances
11.1 Identity Context
11.2 Accountability Context
11.3 Data Integrity Context
11.4 Clinical Context
11.5 Administrative/operational context
12 Roles and relationships (examples)
12.1 Subject of care and provider relationships
12.2 Health services
12.3 Health record relationships
12.4 Individuals, organizations and business unit relationships
12.5 Inter-healthcare professional relationships
13 Record lifecycle events and CRUD (create, read, update, delete)
14 Key lifecycle events in trusted end-to-end information flows
15 Record lifecycle events and action instances
15.1 Initial instance
15.1.1 Initial action instance
15.1.2 Record lifecycle event — Originate/retain record entry instance(s)
15.2 Subsequent instance
15.2.1 Subsequent action instance
15.2.2 Record lifecycle event — Amend (update) record entry instance(s)
15.3 Record lifecycle event — Transform/translate
15.4 Record lifecycle event — Attest
15.5 Record lifecycle event — Access/view
15.6 Record lifecycle event — Report (output)
15.7 Record lifecycle event — Disclose
15.8 Record lifecycle event — Transmit
15.9 Record lifecycle event — Receive/retain
15.10 Record lifecycle event — De-identify (anonymize)
15.11 Record lifecycle event — Pseudonymize
15.12 Record lifecycle event — Re-identify
15.13 Record lifecycle event — Extract
15.14 Record lifecycle event — Archive
15.15 Record lifecycle event — Restore (from archive)
15.16 Record lifecycle event — Destroy/delete
15.17 Record lifecycle event — Deprecate
15.18 Record lifecycle event — Reactivate (from delete or deprecate)
15.19 Record lifecycle event — Merge
15.20 Record lifecycle event — Unmerge
15.21 Record lifecycle event — Link
15.22 Record lifecycle event — Unlink
15.23 Record lifecycle event — Add legal hold
15.24 Record lifecycle event — Remove legal hold
15.25 Record lifecycle event — Verify
15.26 Record lifecycle event — Encrypt
15.27 Record lifecycle event — Decrypt
Annex A (informative) HL7 Fast Health Interoperable Resources (FHIR)
Annex B (informative) Lifecycle metadata captured in FHIR resources
Annex C (informative) Sample lifecycle event sequence with FHIR resources
Annex D (informative) Lifecycle Event Sequence — Point of Origination to Point of Access (Example)
Bibliography