Affiliate Governance of Localised FHIR Artefacts

Introduction

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 [1]. While this does not contain any ‘normative’ content (resources with FHIR Maturity Model Level 6), it is anticipated that limited portions of the R3 specification will become normative in Release 4 (R4), 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.

Recent Activity

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[2] 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’. Notes:
  • HL7 owns the "FHIR" trademark, and polices it's use. Non-Hl7 organizations can use "FHIR" to refer to the HL7 standard or activities, but must seek written permission from HL7 to use "fhir" to describe their own activities (including domain names)
  • many organizations have sought and gained such approval (it is granted if it is clear that they are *using* FHIR rather than making their own version of it). Please check with the FHIR product director before contacting local organizations as part of the policing process
  • Affiliate themselves do not need permission to use "HL7" or "FHIR" in their work (including domain names)
  • The FHIR Foundation owns the fhir.org domain and may issues sub-domains, with country extensions, to affiliates – e.g. nz.fhir.org. However most affiliates use something like fhir.hl7.org.nz which is issued under their own authority.

• Trademark Policy: Affiliates are requested to publish the FHIR Trademark Policy[3] 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[4].

• 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 [5] and Crucible [6] 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.

Special topic Madrid WGM: Governance model for country specific validation of HL7 FHIR profiles

Bert Kabbes, chair of HL7 The Netherlands [7] presented the "HL7 FHIR-NL Validation Organisation and Process Model" at the International Poster Session and the International Affiliates Meeting. This model has been developed to ensure countrywide standardization of FHIR profiles in the Netherlands (most probably relevant to other Affiliates) by validation, central publication and quality mark. Thus to avoid duplicate/overlapping profiles, inconsistent profiles, dispersed publication of profiles by developers as well as to provide a quality mark to users. The organization as described is operational in The Netherlands as of January 1, 2017. The presented model may well function as a model approach for other Affiliates, since all Affiliates are facing the same challenges related with open source resources and softeware like FHIR - the need to standardize HL7 profiles on a national level; to ensure to the market which profiles are consistent and meet local requirements; and to create a single publication source of validated FHIR profiles.

San Diego WGM: Sept 2017

Affiliate Updates...

• HL7 Australia: Summary of an updated supplied by Brett Esler on Zulip..."currently running FHIR localisation content through a minuted committee approval process we have 3 'working groups' Patient Administration, Orders and Observations and Medications - there are open community meetings, no membership check. This does not have a lot of formal governance at this stage; more of a general committee approval process for content to be worked on and included in IG publications...We are expecting that there will be balloting with full AU membership at some stage but there are no firm plans for this."
• HL7 France: Announced a 5 stage process developed by Interop’Santé for the production of FHIR Profiles...1. Use case inventory; 2. Identify needs for constraints, value sets, extensions; 3. Check profiles & extensions already available; 4. Build (or adopt) ValueSet resources and Profiles (Forge); 5. Publish on a FHIR Server (to be chosen)
• HL7 Germany: Simone Heckmann, via Zulip..."we're going to have a call for comments for our German national profiles soon. Our process in a nutshell: we're hosting our Profiles on Simplifier with an underlying GitHub. Any comments we get (either directly submitted into GitHub or via ExcelSheet) are documented as GitHub-issues. We discuss our issues on Zulip and we are planning to do the voting on Zulip, too. For this purpose, we will announce all issues that are ready for voting over a mailing list, to alert people who are not regularly active on Zulip. When the votes are in, we document the result in the issue and update the profile on Simplifier according to the resolution." Simone adds..."we're not balloting on zulip, just voting on ballot reconciliation items. We are not planning on enforcing HL7 membership to join the discussion or the voting."
• HL7 The Netherlands: Rene Spronk announced, via Zulip that, at the upcoming FHIR DevDays in Amsterdam, he'll be presenting a session on 'FHIR profiling Governance'..."how does a country and/or large scale project create/ballot a set of profiles and/or a FHIR implementation guide ? What's the process behind this, how is consensus achieved, how is it made sure that the (clinical?) stakeholders agree with the content of the profiles?"
• HL7 New Zealand: A joint process has been agreed with the Health Information Standards Organisation (HISO) and this is awaiting formal ratification. Candidate NZ Naming System Identifiers have been posted on an HL7NZ Collaboration Site and discussed on the NZ Zulip Stream.
• HL7 Norway: Single national process for development of FHIR profiles in collaboration with Nasjonal IKT.
• HL7 UK: National profiles produced by INTEROPen and NHS Digital, some of the later have been balloted by the Affiliate but with limited response.

The Road Ahead : Create a Generic International Affiliate HL7 FHIR Localisation Validation Model

Following to the discussions at the Madrid meeting, it was concluded that the Governance & Validation Model as presented is in fact a generic model, which can be adopted by any Affiliate and be adjusted to local views. It was also agreed that some aspects of the model should be equally defined and equally applied by all Affiliates, in order to create a solid, transparent and organization-wide approach. It was also clear that the establishment of validation criteria was an essential pre-requisite. Subsequently, HL7 Netherlands has submitted the following artefacts for consideration...

FORM A - HL7 THE NETHERLANDS: FHIR GOVERANCE BOARD: Required information/materials for validation requests[8]

FORM B - HL7 THE NETHERLANDS: VALIDATION & PUBLICATION TEAM: Validation criteria & checks [9]

Version 1, dated September 9, 2017 was presented at the Affiliate Meeting in San Diego on September 14, 2017.

References :

- The presented HL7 FHIR-NL Governance and Validation Model can be downloaded via at : [10]

- The article by Bert Kabbes of HL7 The Netherlands which describes all aspects of background, organizational set-up, validation criteria, publication as well as benefits for key players etc. in more detail can be downloaded at : [11] This article has been published aso in HL7 Europe News - Nr 07 - May 2017

Participating affiliates

HL7 Australia, HL7 France, HL7 Germany HL7 The Netherlands, HL7 New Zealand, HL7 Norway, HL7 UK

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