CF2

Conformance clause

This section references the requirements, criteria, or conditions to be satisfied in order that a product (tangible) or a service may claim conformance to this guide, and how other artifacts may claim compliance with it. (Note: The concept of conformance and compliance are used coherently with the HL7 Service-Aware Interoperability Framework: Canonical Definition Specification, Release 2 [HL7 Service-Aware Interoperability Framework: Canonical Definition Specification, Release 2 <a href="http://www.hl7.org/implement/standards/product_brief.cfm?product_id=3" rel="noopener noreferrer nofollow">http://www.hl7.org/implement/standards/product_brief.cfm?product_id=3</a>].

The fulfilment of these clauses indirectly assures that a product that is the subject of a “conformity assessment” satisfies the business or the design requirements this specification complies to. It should, however, be clear that compliance with the specified business or design requirements, for example with the EN ISO 17269 IPS, does not imply that the compliant implementations are technically interoperable.

A “conformity assessment” is a process that assesses that any proposition that is true in a given specification is also true in the service or product that implements it. In most real-world cases conformance testing objects are used to technically validate the products. These objects provide a great help in the validation of the instances, even if they are most often not sufficient to guarantee the functional/ semantic conformity: many real-life examples can be made about instances that are technically valid, but not clinically meaningful or correct.

The "rules" and processes for refining the standard through constraint and extension, including which standard artifacts are subject to constraint or extension; the definition of constraint and localization profiles; the criteria for establishing a conformance statement; and the principles guiding who may define extensions to the standards and under what circumstances they apply to the CDA standards are defined in §1.3 CDA Conformance of the CDA and detailed in the HL7 V3 Refinement, Constraint and Localization section (see the CDA R2 Standard [<a href="https://www.hl7.org/implement/standards/product_brief.cfm?product_id=7" rel="noopener noreferrer nofollow">CDA R2 Standard</a>]).

This guide does not provide additional requirements regarding the Recipient and the Originator Responsibilities.

The formal representation used in this implementation guide for expressing the conformance statement is described in chapter "How to read the table view for templates" of this guide and makes use of a tabular representation that may include also computable or textual constraints. The template rules are formalized using the computable format defined by the HL7 Templates Standard: Specification and Use of Reusable Information Constraint Templates, Release 1 [HL7 Templates Standard: Specification and Use of Reusable Information Constraint Templates, Release 1 <a href="http://www.hl7.org/implement/standards/product_brief.cfm?product_id=377" rel="noopener noreferrer nofollow" >http://www.hl7.org/implement/standards/product_brief.cfm?product_id=377</a>] in order to facilitate also the automatic generation of consistent testing and validation capabilities.

The HL7 Templates Standard: "Specification and Use of Reusable Information Constraint Templates, Release 1" defines also how derived templates may relate to the templates defined in this guide for example:

• Specialization: “A specialized template is a narrower, more explicit, more constrained template based on a “parent” template.

• Adaptation: “The adapted template is “based on” the original template which means it can be an extension or a specialization (restriction) of the original template design.”

• Equivalency: “two templates have the same purpose and the same design; however, their governance and/or metadata and/or details of their design may be different.”

Based on this the following way to use this guide may be considered :

• IPS as a document: the conformance is asserted at the document level. All the rules defined by this guide, or by a specialized IPS document level template, are fulfilled. Implementers may take advantage of the template openness to better support specific cases - “extended” parts, however, may not be interoperable among them.

• IPS as a library: the conformance is asserted at the section or the entry level. The templates are used as a library to build, for example, new cross-border documents. For example the immunization section may be used to build an electronic implementation of the WHO yellow card for vaccinations; or the IPS section templates are used to communicate to the country of affiliation minimal and non-exhaustive information about the encounter in which the Patient Summary has been used (cross-border encounter report ). Implementers may take advantage of the template openness to better support specific cases - "extended” parts, however, may not be interoperable among them.

• IPS as a reference: the implementation is conformant with templates that are an adaptation of or equivalent to those defined by this guide. In this case some of the rules defined by this guide are not fulfilled and the conformance cannot be asserted. However, differences may be limited and the effort required to achieve the harmonization may not be not large. Typical examples are templates in which alternatives vocabularies are used.

Jurisdictions may also decide to impose the closure of the template in order to limit the implementation optionality.

This should be carefully evaluated in terms of the flexibility of the solution.