MDS2 (Medical Device) MLDP: MLDP Malware detection and protection: disclose anti-malware support, its limits, compensating controls, allow-listing and host intrusion detection

Discloses the device's ability to prevent, detect and remove malware: whether it can host executable software (MLDP-1); whether it supports anti-malware software or another mechanism, with any constraints on purchase, installation or configuration noted (MLDP-2), including whether anti-malware is included by default (2.1) or as an option (2.2), whether the documentation lets the owner or operator install or update it (2.3), whether the owner or operator can reconfigure it independently (2.4), whether detections are notified in the user interface or otherwise (2.5), whether only manufacturer-authorised people may repair the system after a detection (2.6), whether malware notifications are written to a log (2.7), and whether there are restrictions on anti-malware purchase, installation, configuration or scheduling (2.8); where anti-malware cannot be installed, whether other compensating controls are in place or available (MLDP-3); whether application allow-listing restricts the software and services allowed to run (MLDP-4); and whether a host-based intrusion detection or prevention system is used (MLDP-5), configurable by the customer (5.1) or installable by the customer (5.2).