Disambiguating the health-standards acronym soup
Health informatics has produced an unusual number of overlapping standards bodies, standards, and projects whose names only make sense if you already know the history. That is not a sign of rigour - it is a 25-year symptom of nobody owning convergence. This page exists so that reading one openEHR Discourse thread does not require a decade of institutional memory.
It is deliberately reference-grade: short definitions, who owns each thing,
how they relate, and a primary source for each. Where anarchie already has
a longer treatment of a topic, this page links out rather than repeating it.
Where this came from
Prompted directly by a real openEHR Discourse thread from 2025, a good illustration of just how much institutional history (TC251, 13606, CEN, FHIR, CIMI, ADL2, JIC membership, OMOP) can be packed into one conversation among people who have been close to these standards for decades. Reading it cold needs more context than the thread itself supplies - this page is that context.
Who governs what
Three kinds of organisation get conflated constantly: formal standards bodies (can publish an ISO/CEN number, cannot force anyone to implement it), a technical specification community (publishes a spec, no legal standing), and a non-profit alliance (convenes people, publishes nothing normative itself).
| Name | What it actually is | Publishes | Binding on anyone? |
|---|---|---|---|
| ISO/TC 215 | The ISO technical committee for health informatics | ISO standards (13606, 13940, …) | No - ISO standards are voluntary unless a regulator or contract cites them |
| CEN/TC 251 | The European standards committee for health informatics | EN (European Norm) standards, often adopted in parallel with ISO/TC 215's | No, with the same caveat |
| HL7 (and HL7 Europe) | An international standards-development organisation | HL7v2, HL7v3/CDA, FHIR | No, until a jurisdiction mandates it |
| openEHR Foundation | A non-profit that stewards the openEHR specifications | The openEHR RM, AOM/ADL, AQL, ITS-REST specs | No, same caveat |
| JIC (Joint Initiative Council) | A coordination body between the above (ISO, CEN, HL7, openEHR, IHE, GS1, SNOMED International, DICOM and others) | Nothing itself - it coordinates who works on what, to reduce duplicate effort | No |
| ESHIA | A Brussels AISBL (non-profit), founded Sept 2025 by 18 partners including CEN/TC 251, HL7 Europe, IHE-Europe | Nothing normative - it hosts the EEHRxF "Standards & Policy Hub" and helps adoption | No |
| European Commission / EHDS | An EU institution and its regulation | A binding EU Regulation (in force Mar 2025) | Yes - the only entity on this table that can actually force anything |
The one-line version: everything above the EHDS row is voluntary technical work. EHDS is law. A standard only becomes practically unavoidable when a regulation like EHDS points at it - which is exactly why so much of the Discourse thread is people trying to work out whether ISO 13606 is still relevant now that EHDS exists and points mostly at FHIR instead.
openEHR became a JIC member relatively recently, which is part of why some of these threads read as "wait, are we even talking to each other?" - the coordination body itself is newer than most of the standards it coordinates.
The reference-model family tree
These are the actual information models - the thing that says what a clinical record looks like structurally. This is where openEHR, 13606, CIMI, RIM, and FHIR actually relate to each other, as opposed to who's in which committee.
flowchart TD
EN13606["EN13606<br/>(CEN, Dipak Kalra et al., 1990s-2000s)"]
RM1["openEHR RM + AOM/ADL1<br/>(mid-2000s-)"]
RIM["HL7 v3 / RIM<br/>(1990s-2000s)"]
ISO13606_2["EN/ISO 13606-2<br/>archetype model<br/>(openEHR AOM donated as an informative annexe)"]
CIMI["CIMI<br/>(2013-2018)<br/>one shared clinical model<br/>under v2/v3/CDA/FHIR alike"]
FHIR["FHIR Resource/profile model<br/>(2014-)"]
AOM2["openEHR RM/AOM2<br/>continues independently"]
ISO13606_2019["ISO 13606-2:2019<br/>incorporates AOM 2.0.6"]
EN13606 --> ISO13606_2
RM1 -- "openEHR donated its AOM/ADL" --> ISO13606_2
RM1 --> CIMI
RIM --> CIMI
CIMI -- "stalled as a separate deliverable;<br/>modelling work absorbed into" --> FHIR
RM1 --> AOM2
AOM2 -- "revised into" --> ISO13606_2019
- openEHR's Reference Model (RM) and Archetype Object Model
(AOM)/ADL are openEHR's own, developed from the mid-2000s. ADL2/AOM2 is
the current generation;
anarchiereads ADL 1.4-era OPT XML and lowers it into a native form - see specs/serialisation-formats.md. - ISO 13606 is a five-part standard. Part 1 is a reference model of its own (not identical to openEHR's RM - they diverged). Part 2 is where openEHR's actual AOM was donated as an informative annexe - the current edition, ISO 13606-2:2019, incorporates AOM 2.0.6. This is the detail that confused the Discourse thread's own participants: 13606-2 isn't "like openEHR", a chunk of it is openEHR, frozen at a 2018-era AOM2 snapshot that hasn't tracked ADL2's subsequent 2.1.0+ revisions.
- CIMI (Clinical Information Modeling Initiative, ~2013-2018) tried to be a single detailed clinical model underneath HL7 v2/v3/CDA and the then-emerging FHIR, deliberately modelled on openEHR's archetype approach. It never shipped as an adopted cross-standard backbone; its modelling work diffused into FHIR's own resource/profile process instead.
- HL7v3 / RIM (the Reference Information Model) was HL7's own attempt at one formal backbone, in the 1990s-2000s. It is widely regarded in the community as too complex to implement consistently - clinical meaning got encoded combinatorially into mood codes and act-class vocabularies baked into the one model, rather than factored out the way openEHR's archetypes do. FHIR was HL7's deliberate reaction against RIM's complexity - simpler resources, pragmatic profiling, REST instead of a message-based architecture.
Where openEHR and FHIR actually sit relative to each other
Not competitors at the same layer - this is the most common confusion in the thread and everywhere else this topic comes up.
| openEHR | FHIR | |
|---|---|---|
| Primary job | System of record: long-term storage, versioning, rich clinical modelling | Exchange: a wire format and API for moving defined datasets between systems |
| Granularity | Maximal - an archetype tries to capture everything that could ever be said about a concept | Use-case-sized - a Bundle/Resource captures what one exchange scenario needs |
| Lifecycle | Decades; a Composition version is permanent | Produced at exchange time; often not persisted as-is |
The dominant real-world pattern, and the one anarchie is built around, is
openEHR behind, FHIR in front: an openEHR CDR holds the durable record,
and FHIR resources are projected from it at the exchange boundary when data
needs to leave. See
specs/regulatory-context.md
for how anarchie positions itself against the EU's EHDS/EEHRxF regulation
specifically, which is the concrete current instance of this pattern.
OMOP - a different axis entirely
OMOP (Observational Medical Outcomes Partnership Common Data Model) is
not a clinical exchange or record standard at all - it is an
analytical schema, maintained by OHDSI, designed for running the same
observational-research study across many databases without rewriting the
query each time. It sits downstream of a system of record, not beside it:
data gets mapped into OMOP for research, the same way it might get
projected into FHIR for exchange. anarchie's own roadmap treats it the
same way - an analytics projection, never a replacement for the openEHR
store (see the OMOP item in
specs/roadmap.md).
A worked example: tracing one real sentence
From the thread (post 29, Thomas Beale, lightly reformatted):
"The current version of 13606-2 (contains openEHR AOM 2.0.6) though is potentially of remaining political value, but again, recent JIC membership may mean that even this no longer matters."
Decoded with the table above:
- "13606-2 ... contains openEHR AOM 2.0.6" - ISO 13606 Part 2, the archetype-model part, is substantially openEHR's own AOM, frozen at the 2018-era 2.0.6 release.
- "political value" - not technical value. Nobody is proposing to implement 13606-2; its only remaining use is as leverage in conversations with regulators or suppliers who recognise an ISO number but not "openEHR".
- "recent JIC membership may mean ... this no longer matters" - now that openEHR sits at the same coordination table (JIC) as ISO/CEN/HL7 directly, the political need for a 2019-vintage ISO-badged proxy for openEHR is weaker: openEHR can make its own case in the room.
That one sentence required the whole governance table, the whole reference- model tree, and the EHDS-is-law distinction to parse. That is the problem this page exists to solve.
Primary sources, by acronym
- TC215 / TC251: ISO/TC 215 · CEN/TC 251
- ISO 13606: ISO 13606-1:2019 overview (parts 2-5 are separate ISO numbers under the same family)
- EHDS: European Commission - European Health Data Space (binding Regulation, in force 26 March 2025) - full detail in specs/regulatory-context.md
- CIMI: historical - see the HL7 CIMI overview for the project's own archived account of what it attempted and why it wound down as a separate deliverable
- AOM 2.0.6 / ADL2: openEHR Architecture Overview specifications
- JIC: Joint Initiative Council on SDO Global Health Informatics Standardization
- OMOP: OHDSI - OMOP Common Data Model
- FHIR: HL7 FHIR specification
- The thread this page is based on: ISO 13606 revision? - openEHR Discourse, 2025