Affiliate Governance of Localised FHIR Artefacts
FHIR® (Fast Healthcare Interoperability Resources) is the latest standard produced by Health Level Seven International (HL7®), the world’s largest developer of standards for the interoperability of health information, with members in over 55 countries and official affiliate organizations in 35 of them.
Since its initial DSTU release back in 2012, FHIR has matured beyond a draft standard to Release 3 (R3) released in March 2017 . While this does not contain any ‘normative’ content (resources with FHIR Maturity Model Level 6), it is anticipated that much of the R3 specification will become normative, with minimal breaking changes in Release 4, currently planned for late 2018. Consequently, after a 5 year period in which experimental implementations of FHIR have been encouraged, a significant number of HL7 Affiliates have expressed the view that R3 marks a ‘line in the sand’ where the effective governance of the localization of FHIR artifacts should begin.
These localizations are manifestations of the ability of users to both extend and constrain the core FHIR specification. However, while HL7 promotes FHIR as a standard that makes interoperability both easier and cheaper to achieve, it is acknowledged that the unregulated proliferation of localized artifacts will have a counter-productive effect on the ability for data to be passed between systems with no loss of meaning.
These concerns have been raised by the conformance WG when included into this impressive work force requiring to make conformance statements a mandatory part of FHIR. This led to the fact that the FHIR methodology is used to fulfill this request and that FHIR resources are used for that purpose.
In the meantime HL7NZ, and other affiliates, at HL7 International Council meetings in 2017 and, in return, prescriptive advice has been received from the FHIR Foundation Board. Consequently, several affiliates, such as HL7 Netherlands have already created governance processes, either independently or in conjunction with other national standards bodies.
San Antonio WGM: January 2017
The following issues, relating to "self-germinating” FHIR projects, were raised at the International Council meeting with responses delivered from a representative of the Board of the FHIR Foundation at the subsequent Affiliate Chairs' Meeting...
- URLs domain names: FHIR and HL7 are both internationally-registered trademarks and, as such, cannot be used in domain names registered by non-HL7 organizations. While it is considered too late to ‘police’ the use of ‘HL7’ in domain names, they would like affiliates to resolve or report any violations relating to the unauthorized use of ‘FHIR’. The FHIR Foundation already owns the fhir.hl7.org domain and issues sub-domains, with country extensions, to affiliates – e.g. fhir.hl7.org.nz which is already in use as the HL7NZ FHIR Web Service endpoint.
- Trademark Policy: Affiliates are requested to publish the FHIR Trademark Policy on their Web Sites.
- Extensions & identifiers: These should be designed from an initial viewpoint that they are no necessarily localizations – i.e. there is an overarching need to constrain similarities.
- Profiles & Implementation Guides:Similar to extensions & identifiers, noting the option of using the HL7 FHIR registry.
- Balloting Process: Must satisfy the relevant Affiliate Agreement - e.g.
“Localisations of HL7 standards, within New Zealand, published as “HL7 New Zealand Localisation (HL7 Standard)”, must be balloted at a General Meeting and affirmed by more than 60% of the combined “yes” and “no” votes following attempts to resolve all issues raised by negative voters."
- Validation and Compliance Testing: FHIR Director to advise. The availability of cloud-based testing services, notably AEGIS.net Touchstone  and Crucible  was noted.
- Education & Individual certification / Education: FHIR Exams, based on R3 will be available later in 2017.
A general consensus was reached that, from an Affiliate governance perspective, the upcoming R3 release would represent a "line in the sand".
Madrid WGM: May 2017
The following update was provided to the International Council by the FHIR Management Group...
- Certification will be introduced – 2 levels – Proficiency certificate – details to be finalized this week and hope to be available by next WGM and FHIR Professional Credential – much harder, need to have participated in Connectathon and implementations – hope to be introduced by the end of this year.
- Release 3 (STU) has been published and Release 4 is now being worked on. Some of the content in Release 4 will be normative. Current timelines – draft ballot in Dec/Jan; mixed normative – April ballot – published by end of 2018.
- The Community is asking for stability.
- Implementation Guides – there is a publishing tool and infrastructure. Several countries are publishing guides using this tooling.
- Registries – registry.fhir.org – for profile discovery and sharing – still being worked on – not ETA yet.
- US Implementation Guides are being published at hl7.fhir.org/us.
- Any affiliate can publish on the HL7 website – regardless of whether they have been balloted at HL7 International or not. There will be processes established but need to be defined.
- Intent that the technical resources will be shared through registry.fhir.org.
- FHIR Registry project – a process project understanding how the pieces fit together. First draft will be US Centric.
HL7 The Netherlands  presented an HL7 FHIR-NL Validation - Organisation and Process diagram at the International Poster Session and this was used as the basis for further discussions at the Affiliate Chairs' Meeting.... [BERT...]
HL7 The Netherlands, HL7 New Zealand, HL7 Norway