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
How to forward the information between the different work packages?
In other words, how to cooperate and transfer information between WPs?
Information Gathering
Ideally, the information should be collected as follows thus transforming the details from requirements
and standards into a fine-grained list of artefacts for the library:
But presumably, it has to be done in separated steps:
initiate artefact library of data elements for MD labels.
extract
create information model
create profiles for use cases, eg. "sterile devices"
create profiles for data subsets, eg. "information provided by manufacturer"
verify model against profiles
…
The idea is to reduce the amount of work by providing the details for specific data subsets,
for example "information provided by manufacturer".
Requirement Gathering
from Legislation
The following information is collected for legal requirements:
Req ID: individual identifier for each requirement
Pillar: device labelling, packaging, batteries, ecodesign, health data
Regulatory requirement: statement for requirement
Source of provision: where does the requirement come from?
Regulatory artefact: digital label element/item (precoordinated list, to be considered for the information model)
Applicable scope
Regulatory status: conditional, future, mandatory, not applicable, proposed, voluntary
Required information
Current provision
Modality: digital, hybrid, physical, n/a (grouping in the information model)
Device dimension (helps for creating the model)
Applies from
Obligated actor
Ethical flag
Notes
The columns being relevant for the information model are marked in bold.
from Standards
Ideally, the requirements extracted from standards will provide exactly the same
details as from legislation.
Clause / section
Source Element
Conformity Verb
Relates To
Cardinality
Target Element
for Information Models
The following aspects and details are necessary to create an information model:
The requirements taken from the legislation sheet require a dedicated
mapping into the artefacts because they are captured in a different precoordination:
Standards to Digital Label Elements
The requirements taken from the different standards are very similar
to what is needed for information modelling.
The list needs further verification whether the artefacts exist
and are provided in the same granularity:
