Hi,
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"??
Wolf
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"??
Wolf