MedTechLabel WP2 T2.2 Information Model Guide, published by HL7 Europe. This guide is not an authorized publication; it is the continuous build for version 0.4.15 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
Taxonomy + Abstract Model
In order to get a better understanding how the identified items
are organized a taxonomy has been created that consists of the following axes:
Basics: items that are directly mentioned to form requirements
object: bigger items that can stand alone and should be modeled as a class
data element: smaller items that are taken as attributes of objects/classes
data type: specific data types for certain items (to be applied on data elements)
data format: requirements for the representation of specific items
property: elements that are probably to be taken as properties of medical devices
Supporting: additional concepts to help organizing the identified items
codesystem and codes: coded information for certain items that belong to a codesystem
value set: subset of the codesystem to be used
text: some requirements are asking for explicit texts
ontology: what is needed for creating an ontology
relationship: for specifying the relation between the artefacts (from basics)
procedure: actions to be executed with or upon objects
out of scope: what is definitely out of scope for creating an information model
actor: item that may operate as an actor on a procedure
That results in the following abstract model that will be behind the information model:
Notes:
In principle all items (from basics) should be derived from an abstract artefact concept so that the relationship can be used to link two items (as source and target) together. However, this would pollute this short diagram.