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My understanding is that one of the biggest challenges (expenses) for these systems is getting them certified. If I recall correctly, reusing an Operating Syste
by cbhl 14y ago
My understanding is that one of the biggest challenges (expenses) for these systems is getting them certified. If I recall correctly, reusing an Operating System that has already been used in certified products helps make the various certification bodies more convinced that the software involved will function "correctly".
I think the other issue here is liability -- if the manufacturer provides a "security update" and subsequently causes an error which kills a patient, it's the manufacturer's fault. Whereas if there's malware on the device, then it's the hospital's fault for not keeping the device clean.
Plus, there's a great deal of vendor lock-in in the medical devices industry, so I wouldn't expect to see hospitals suddenly adding devices from $NEW_VENDOR which bothers to spend the extra money to write security updates and spend millions getting them recertified.
- SchwarzerHund 14y agoThis is incorrect. All COTS in a medical device is considered SOUP (Software Of Unknown Pedigree). All COTS must be validated for its intended use regardless of the supplier and a risk analysis must be performed for the use of the COTS. The device manufacturer is held liable for defects, not the supplier.