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FHIR Artifact Governance Process

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This page describes the governance process associated with FHIR resources, implementation guides and individual profiles.

Resource approval process

The creation of resources is managed by HL7 International and is managed by the [FHIR Management Group]. At present, resources can *only* be defined by HL7 International. Affiliate or project-specific resources are non-conformant and will not be supported by reference implementations, test servers and other tooling.

Each resource must fall under the oversight of a single HL7 work group (though other work groups may provide requirements and be involved in discussions and approving changes). That work group must have an active Project Scope Statement (PSS) that covers performing resource design and maintenance. (Draft PSSs working their way through the approval process are also acceptable.)

Each resource is expected to have a Resource Proposal that defines the intended scope of the resource, provides justification for the resource's existence and that describes relationships to other resources. In some cases, the resource may evolve (renamed/spit/merge/etc.) after this point. These changes are vetted by the FMG but are not necessarily reflected in the resource proposals. A resource cannot progress past the "draft" (FMM0) state until the FMG approves the resource proposal.

In some cases, the FMG may encourage the development and evolution of a draft resource and potentially even the balloting and publication of a resource prior to approving the resource proposal. This may occur when the FMG wants a better sense of what the resource will look like, how it will compare to other resources and/or to allow multiple resources with similar scope to evolve somewhat prior to finalizing the decision about whether a resource is justified and is appropriately bounded. Explicit FMG approval is required for a resource to be included in a non-draft ballot or publication if the associated resource proposal has not yet been approved.

Temporary resources may also be created and included in ballots to allow work groups to gain feedback on design alternatives. Typically alternate views of a single resource will not be retained when an official publication is produced.

Search criteria, operations, value sets and code systems associated with a resource are considered to be covered by the resource's proposal.

The FMG must also approve a resource proceeding to "normative" ballot. This approval process includes a verification that all necessary FHIR maturity metric and quality requirements have been met, as well as a comfort level that there are no major outstanding issues that need to be resolved prior to the resource being "locked down". In some cases, approval may be granted with "exceptions" where small portions of the resource might be excluded from normative status. Approval must be sought to lift these exceptions in subsequent ballot.

Implementation Guide Approval Process

The approval process for implementation guides only applies to implementation guides produced by HL7 work groups and balloted through HL7 processes. These processes do not apply to implementation guides published by external organizations or implementation groups outside the HL7 balloting process.

Implementation guides subject to this process must have an FMG-approved Implementation Guide Proposal. These proposals allow the FMG to verify the scope of the IG and to ensure scope is clear and does not overlap any other HL7-published guides.

As with resources, the FMG may permit balloting and/or publication prior to approving an implementation guide proposal. FMG approval must be received prior to elevating an implementation guide to trial use or normative status.

Profile Approval Process

When a work group wishes to publish profiles as part of the FHIR core specification rather than as part of an implementation guide, they must prepare a profile proposal. These proposals are reviewed by the FMG to confirm that they don't overlap with other HL7-published IGs and that the content is appropriate to publish as part of the core specification rather than as part of an independent implementation guide.

Profiles may *only* be published by HL7 work groups outside of an implementation guide if they are part of the core specification because HL7 balloting only occurs on the core specification and implementation guides, not individual profiles.

Similar to resource proposals, the FMG may occasionally permit the balloting and perhaps publication of "draft" profiles whose proposals have not yet been approved if they feel additional time, information or feedback are required prior to making a final determination.