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
This page is intended to analyse and document the underlying framework
so that it can be stored in a database to fully align consistency:
Data Model
The framework focuses on the requirement and the evidence to where it is found.
Therefore, a standard/specification links to a set of individual (globally defined) requirements
by adding an evidence to where it is found in combination with the statement.
The details of how a requirement can reference a digital label elements require further examination
whether a generic representation is possible or requires different specialisations!?
Alternative Framework
As a result from initial tests the following framework is proposed:
source type: "internationl standard" vs. "European standard" can be derived
from issuing organisation; should be "standard" only
requirements: given that requirements are the binding between the source and
a digital label element this list is even longer than the one for the elements
evidence: this is the reference to a section/paragraph in the standard where a requirement occurs.
identifying requirements and reusing it seems to be reasonable approach in order not to get too many entries.
copying relevent paragraphs from the standard in order to quote the requirement
seems to be reasonable but it appears that due to the nature of how standards are written
is an inappropriate way forward because it will be hard to identify to where a requirements should be bound to.
Requirements for the Framework
editable
cooperation between different contributors
versioning: tracking changes
Process
Following a first draft for a process to collect the requirements and to populate a database
as well as feeding the information model:
Open Topics
The following topics need to addressed:
cooperatively populate database
several contributors can work on content in parallel
