ISO 14155 - Electronic clinical data systems - Definition


Quite Involved in Discussions

I wonder if someone has an idea about the definition of ISO 14155' "electronic clinical data systems", chapter 6.8.3:

If I get print-outs of (anonymized) patient records and do some statistical calculation with the data for either a scientific publication or for the clinical evaluation of a device - is this data processing already what ISO 14155 calls an "electronic clinical data system"??

:confused: Wolf
Top Bottom