Trusted End-to-End Information Flows (Jira PSS-2702)

ISO 21089:2018 (Health Informatics - Trusted End-to-End Information Flows) is currently an ISO Normative Technical Specification. In 2004, ISO 21089 first introduced a standards based approach to managing electronic health record entries throughout their lifespan, including record lifecycle events (RLEs) occurring within that lifespan. ISO and HL7 Standards incorporating RLEs:

ISO/HL7 10781:2023 - Electronic Health Record System Functional Model Release 2.1

EHR-S FM - Normative Requirements Standard

ISO/HL7 16527:2023 - Personal Health Record System Functional Model Release 2

PHR-S FM - Normative Requirements Standard

HL7 FHIR R5 Record Lifecycle Event Implementation Guide (2023)

RLE IG - Informative Implementable Standard

On the ISO side, ISO 21089 just completed a Systematic Review (SR). Of the ISO National Member Bodies, 37 ISO TC215 Participating Members and 2 ISO TC215 Observing Members responded to the SR. The vote was 14 to confirm, 5 to revise, 18 abstaining and none voting to withdraw the specification. There are 47 SR comments to be reviewed and dispositioned.

Separately, at the ISO TC215 Toronto meeting on 22 October 2025, WG2 agreed to make revision of ISO 21089 a joint project with HL7 under auspices of the ISO/HL7 Cooperation Agreement and promote it from a normative Technical Specification (TS) to a full normative International Standard (IS). The WG2 vote was affirmed by the full ISO TC215 in Plenary session on 23 October 2025.

The introduction of this PSS is to formalize revision of this TS>IS as a formal project on the HL7 side. The HL7 EHR WG will be the designated project lead.