1. Where ever possible HL7 artifacts that reference coded content should use externally managed, established, curated concepts made available as a versioned code system (or can be a subset of said code system) that is
    1. Follows good vocabulary practices as defined by HL7 e.g.
      1. Have definitions for each concept and the relationships it uses
      2. Uses meaningless identifiers
      3. Manages synonymy
    2. Under the curation of an established organization that is committed to maintaining the code system content, i.e. a terminology authority (see also ISO/TR 12309:2009 Health informatics -- Guidelines for terminology development organizations) and particularly
      1. Either provide, or work with HL7 to establish an identifier for the code system
      2. Provide a current human contact for the content and a link to a source for the content
    3. Has established processes for content improvement
    4. Has straightforward licensing requirements
    5. Provides easy access to the code system content, either directly or through shared terminology services, including having the current version available to support publishing and maintenance of those published artifacts
    6. Is well established for use to describe the concepts in question (i.e. well established for use in the context of the concept domain)
    7. If alternatives are available, code systems that have low or no cost for use are preferable
  2. Any publication or draft HL7 specification or implementation guide that references an external code system in any way must:
    1. Clearly identify the external content governed by IP restrictions beyond those of HL7
    2. Provide a web-link to the licensing information for the content and/or provide a short description of the requirements
    3. Reference the code system version when the artifact is published, and whether the version for use is important for the artifact
    4. If translations are involved, provide information as to the ownership of the translations
    5. Include, at minimum the following statement, prominently placed (e.g., black box warnings at the begining of Structured Product Labels in the United States) :
      "This HL7 specification contains and references intellectual property owned by third parties ("Third Party IP").  Implementers and testers of this specification SHALL abide by the license requirements for each terminology content artifact utilized within a functioning implementation. Terminology licenses SHALL be obtained from the Third Party IP owner for each code system and/or other specified artifact used. It is the sole responsibility of each organization deploying or testing this specification to ensure their implementations comply with licensing requirements of each Third Party IP."
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3 Comments

  1. Lloyd McKenzie

    Consider adding a guideline that prohibits the mandating of terminologies that are not free-for use in the jurisdiction(s) in which the specification is intended for use.  (You could still reference such terminologies, so long as they weren't mandatory for use.)

  2. Julie James

    The HTA does not feel that it can prohibit mandating the use of terminologies that are not free-for-use, not least because this is a jurisdictional issue.  The HTA advises, as above, that specification developers are mindful of the consequences of using terminologies that are not free-for-use, especially for those things that are to be used in a number of different jurisdictions. 

    1. Lloyd McKenzie

      Ok.  It's certainly FMG policy for all international-scope specifications and that's a policy that would probably make sense to be consistent across product families.