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Substantive Change

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Definition of Substantive Change (approved 2017-08-23):

  • Any change that meets the ANSI substantive change definition (see below) is to be considered an HL7 substantive change. Examples of HL7 substantive changes are: altering the information content of an instance, the circumstances under which it would be sent, or the interpretation of its content.
    • For Normative ballots: Any substantive change shall necessitate a subsequent normative ballot of the content, allowing the consensus group [§02.04.04] to respond, reaffirm, or change their vote due to the substantive change.


  • ANSI Definition of Substantive Change: A substantive change in a proposed American National Standard is one that directly and materially affects the use of the standard. Examples of substantive changes are below:
    • “Shall” to “should” or “should” to “shall”;
    • Addition, deletion or revision of requirements, regardless of the number of changes;
    • Addition of mandatory compliance with referenced standards.
    • Adding an optional field.