4 ms·
Software that merely displays data is not typically a medical device, as long as it doesn’t transform or otherwise alter the data.
by et2o 6y ago
Software that merely displays data is not typically a medical device, as long as it doesn’t transform or otherwise alter the data.
- fhsm 6y agoUS only knowledge but in the US... This is (possibly depending on use) a biomedical device. These are regulated such that we pull separate cat5/6 and put up chain link in network closets. The Cisco switch in one side of that fence just vanilla corporate IT with email, EHR, Netflix etc; the same switch on the other side and all the stuff connected to it - from the bedside monitor out through the central alarm station - is a medical device. That isolation is the presumption referenced in the recent GE vulnerability [0] and the challenges of getting bio med chocolate in the corporate (ehr) peanut butter presents significant challenges [1]. [0] https://www.fda.gov/medical-devices/safety-communications/cybersecurity-vulnerabilities-certain-ge-healthcare-clinical-information-central-stations-and https://www.fda.gov/medical-devices/safety-communications/cy... [1] https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/detail.cfm?standard__identification_no=36409 https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandar...