Abstract
The focus of this chapter is to provide a review of and general guidance for specifying conformance in data exchange standards. The guidance is grouped into three notions.
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Definition of conformance keywords
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Conformance clauses
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Specification of conformance requirements
These three notions should be included, or at least referenced, in all standards documents. Consistent and unambiguous specification of requirements is vital to the development of implementations and test suites. Well-defined standards and the accompanying conformance test tools lead to better implementations.
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Notes
- 1.
We use the generic term “normative statement” to describe explicitly written requirements. Forthcoming is a discussion on synonymous terms.
- 2.
A Conformance Clause is sometimes referred to as a Conformance Statement in various standards.
- 3.
This is not to say that the definitions are to be altered, only that all parts of RFC 2119 need not be included. For example, a specification may choose to use only the verbs SHALL, SHALL NOT, SHOULD, SHOULD NOT, and MAY.
- 4.
Chapter 7 presents a methodology for specifying and documenting these agreements.
- 5.
This example is taken from HL7 v2.x; EI is the Entity Identifier data type and in this instance is a reference to the 3rd component (Universal ID) is made.
- 6.
Although not indicated here, a precise definition (or reference to) of what constitutes “an ISO-compliant OID” is necessary.
- 7.
As mentioned earlier, different terms are used in various standards. Sometimes (at a high-level) conformance statement is used by an implementer to “make a statement” or “claim” about their implementation.
- 8.
This is good practice.
- 9.
Most of the standards do not provide such an assessment. Sometimes it can be extracted from explanations given in the standard (but, if not given explicitly, it is difficult to enforce the same interpretation of requirements among implementers).
- 10.
As can be seen with the introduction of the various standards in Chap. 4, they are on a different maturity level of how deep the conformance constructs are explicitly defined.
- 11.
Analysis of the background of these two conformance concepts reveals that they are similar and in some views identical; there is disagreement among authors and implementers, which results in unnecessary confusion.
- 12.
In other words, supported by the application.
- 13.
Additional text is provided in the standard that describes the concept being conveyed by the element. Moreover, the implied requirement for the application is to support the concept of Administrative Gender (as a pre-condition), which is typically agnostic to the interface specification.
- 14.
We assume that the value set specification indicates these requirements. Unfortunately, too often seen in practice value set specifications in implementation guides are underspecified and/or ambiguous.
- 15.
As described earlier, normative statements are referred to as predicate constraints, conformance statements, and by other terms.
- 16.
This example assumes the component delimiter is fixed to the constant value ‘^’ which in HL7 v2 standards may be changed by implementers at run time to a different character.
- 17.
Referred to as a conformance statement in HL7 V2.x.
- 18.
An example of a condition that is implied is “RE” usage in HL7 v2.x.
- 19.
Such extensions (options) can be documented as profile components as described in Chap. 7.
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Oemig, F., Snelick, R. (2016). Principles of Specifying Conformance. In: Healthcare Interoperability Standards Compliance Handbook. Springer, Cham. https://doi.org/10.1007/978-3-319-44839-8_6
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