S
snoopy2017
Hi everyone,
In a risk analysis, how can we tie security breach (e.g. losing confidentiality of patient information) to ISO 14971? What is the severity level of harm for loss of confidentiality of information in a mobile app? I would think we should do that exploitability analysis first as per FDA's 2016 guidance on cybersecurity. Has anyone had first hand experience doing this analysis tied to 14971? If so, could you provide some guidance or a sample template of this type of a security risk analysis? Thank you. I would appreciate any reply.
In a risk analysis, how can we tie security breach (e.g. losing confidentiality of patient information) to ISO 14971? What is the severity level of harm for loss of confidentiality of information in a mobile app? I would think we should do that exploitability analysis first as per FDA's 2016 guidance on cybersecurity. Has anyone had first hand experience doing this analysis tied to 14971? If so, could you provide some guidance or a sample template of this type of a security risk analysis? Thank you. I would appreciate any reply.