MedTechLabel WP2 T1.1 Information Model Guide, published by HL7 Europe. This guide is not an authorized publication; it is the continuous build for version 0.4.3 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/hl7-eu/medtechlabel-wp2-im/ and changes regularly. See the Directory of published versions

Terms

An important aspect is the understanding what conformance vs. compliance means. Those two are a commonly misunderstood or misinterpreted. In the following two major different ways of interpreting them are presented:

Legislation vs. Standard

This perspective considers from where a requirement is derived:

Taking a legal requirement, as provided from a jurisdiction, that is treated as a compliance issue. On the other hand, if a requirement is taken from a standard it is taken as conformant.

Document vs. Implementation

Another way of looking at it is as follows:

The derivation from a standard creates a more constraint document that represents a profile on the basis of this standard. This derivation is declared as conformant if the rules are followed. An implementation based on that derived specification is then taken as compliant, aka of behavior.