AGFA DR 800 User Manual page 281

• Medical devices shall be on an isolated network segment that restricts
communication of the medical devices to the systems that are required for
the device to function.
• Internal firewalls shall be put in place to improve upon network
segmentation and to further restrict communications of medical devices to
the systems (internal and external) that they need to interact with.
• Medical device configurations shall be backed up in a secure separate
device.
• Security controls shall be put in place to ensure that physical access to
medical devices is limited only to authorized individuals and that physical
theft of the device is prohibited.
• An incident response plan detailing responsibilities and how to react and
recover from incidents, shall be in place. Staff involved in the incident
response plan shall be trained to respond appropriately and effectively.
• A formal user provisioning and de-provisioning process shall be
implemented to enable the appropriate management of access rights to
medical devices.
• Users shall be assigned unique accounts to medical devices.
• User access rights to medical devices shall be reviewed for appropriateness
and corrected as needed, at regular intervals not exceeding once a year.
DR 800 | Product Information | 281
0392C EN 20210309 1049