What the module explicitly does not do
It does not bill on its own. Every item is confirmed by an authorised person before invoicing; without that confirmation no item comes into being.
It asserts nothing that is not in the record. Justification text is built exclusively from evidenced facts. Where the documentation is silent, a gap notice is produced rather than a sentence.
It makes no diagnoses and proposes no treatment. What it contributes to coding is called a coding proposal and treated as one. No assessment of patients takes place.
It transmits nothing. Nothing goes to insurers, patients or a billing office without the hospital's release; in the statutory data-exchange area we prepare and check the data, and transmission stays with the hospital information system.
None of the modules described here falls under Rule 11 of the EU Medical Device Regulation. We structure, check and evidence documentation. The regulatory qualification is documented before any function is developed; where a planned function departs from it, it is re-qualified before it is built.