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by Joel_Mckay
749 days ago
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In general, up here the 3 relevant ISO certifications (around $45k to $80k each) that apply to e-record and diagnostic systems are required, or software cannot be legally purchased by the health authority. For many reasons, the e-record system software was written in partnership between a large telecom and Microsoft. slicer.org has their detailed story why "3D Slicer is NOT FDA approved", and its unfortunate given the transient nature of volumetric imaging data formats. My point was this area is a mine-field of regulation. Generally, the above rules trip the instant a doctor uses something to diagnose or communicate patient data. Notably, the same software is deployed across provinces and states... but will obviously have different certification requirements in each locale. Some people seem to get really rude over the most mundane details. =3 |
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