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The following checklist can be used as a template for performing an Implementation Guide review – it guides the overall process for the review.

This slide deck gives details for reviewing FHIR IGs: 2019-09 FHIR IG Review.pptx

To use this checklist, copy the content to a Word Document for each IG Review.

Step #1: Orientation / Conceptual

  • Is the purpose of the IG clearly explained?
  • Have roles and use cases been defined?
  • Does the IG have the appropriate dependencies? Is it reinventing existing content?
  • Do the artifacts fit appropriately into the defined scope? 
  • Check stated Realm
  • Check kind of IG – what expectations arise?

Step #2: Orientation / Technical

  • Read note to balloters (if present)
  • Check history notes
  • Check qa.html

Step #3: Orientation / Approach

  • Check kinds of exchanges
  • APIs
  • Document
  • Messaging (o Check messaging protocol)
  • Make list of kinds of information exchanged
  • Check consistent with realm core expectations
  • Make list of actors described in system
  • Characterize as Producer | Consumer | Repository

Step #4: Capability Statement

  • Check resources exposed. For each resource
    • Check Interactions
    • Check Search Parameters
    • Modifiers 
    • Chaining
    • Combinations
  • Conformance expectations clear
  • Check System Profile
  • Check Use case Profiles
  • Check Global Profiles

Step #5: Profiles

Check resources/profiles exposed. For each resource

  • Check Text Summary – human to human
  • Check Differential as summary (consistent with text summary?)
  • Check what other related profiles exist in other IGs
  • For each element in the differential:
    • Check definitions – changed? Needs to be changed?
    • Check any mappings added
    • Check cardinality - elements should be 0..0 only if the inclusion of that element would be an error
    • Check must support (and check it’s meaning is defined)
    • Check Terminology Binding – extensible and preferred binding pose challenges for searching
  • For each sliced element (including extensions), assure the generic short and definition have been replaced with real definitions
  • Any orphan profiles?

Step #6: Extensions

Any extensions? For each extension:

  • Is there a standard extension that could be used?
  • Has the context of use been set (associating the extension with the type of resource it can be used with)
  • If a simple extension, has the data type of the value been appropriately constrained? Has the extension's extension been set to 0..0?
  • Has the short and definition of the extension been set? (These are appear in the profile, so they are important)

Step #7: Value Sets / Code Systems

  • Check Copyright (externally sourced content)
  • Check Versioning
  • For code systems: something that needed to be defined?

Step #8: Examples

  • Check that all examples validate against profiles
  • Check that examples have all information required for the use case
  • Where there are slices, examples should populate every slice. Check that the QA report to see if the slices were uniquely distinguishable.

Step #9: Specific Requirements

  • For each:
    • Defined / described?
    • Requirements described?
    • Do you agree?
  • Security
  • Error Handling
    • Specifying correct behaviour for operational failures
    • Mechanisms for handling erroneous data
  • Audit / Provenance
  • Consent / Privacy
  • Test Cases / Conformance testing support
  • Safety Issues (check)


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3 Comments

  1. This guide and checklist is great.  IMO As I was reviewing the fhir implementation guides out there, I saw variation in how information was presented.  They did not have the same look and feel.  I also felt that the executive summary/high level use cases which the guide is about were not always covered well and in an obvious frontpage-like place.  I think guides need to be readable and have consistent look and feel.  I was trying to find a guide to use as a gold standard but couldn't find one.  Interested in recommendations.  Anyway, I think its important that guide clearly explain in a consistent upfront place  the main objective of this guide (with an end user focus - whose who would benefit from its implementation) and what business use cases it is trying to solve. Consistency is important - for example - there isn't a clear place to find an overview of the guide.  Also its important that everyone does diff and snapshot and examples the same way and fill all those out.

  2. I agree with VIrginia - having the same lay-out for the FHIR IGs is important to help folks in reading them - there are a lot of guides out there and getting the infromation about what the IG is for up front lets the reader decide if they need to read all of it, or if it isn't of importance to them at the moment = giving a clear WHAT and WHY in the intro page / executive summary is most helpful here, but also having the same organization makes reading them easier.