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UL 2800-1-2019 pdf free download
UL 2800-1-2019 pdf free download.Medical Device Interoperability.
h) The INTEROPERABLE MEDICAL SYSTEM RBAC policies are consistent with the responsibility policies of the ORGANIZATION associated with the DEPLOYMENT CONTEXT OF USE.
184.108.40.206 Item Id, AUTHENTICATION, and AUTHORIZATION
220.127.116.11.1 The following INTEROPERABLE MEDICAL SYSTEM-level risk concerns shall be considered in INTEROPERABLE ITEM RISK MANAGEMENT.
a) The specific INTEROPERABLE fltM responsible for particular actions that gives rise to PATIENT harm or uncontrolled information DISCLOSURE cannot be IDENTiFIED during or after the action (e.g., inappropriate or malicious);
NOTE The Organization associated with the DEPLOYMENT CONTEXT OF USE cannot then to take corrective action in the form ol. e.g. notifying correct manUfacturers, or revoking specific device access privileges.
b) UNAuTHENTiCATED ITEMS, (e. g., any medical or consumer electronic component (nonINTEROPERABLE ITEM)) may. lacking appropriate physical access controls, be attached by anyone. and thereby gain access to the INTEROPERA8LE MEDICAL SYSTEM and daim any IDENTITY, leading to actions (e.g.. inappropriate or malicious) that give rise to PATIENT harm or uncontrolled information
c) UNAUThORIZED commands or UNAUTHORIZED data access or manipulation may, lacking appropriate physical access controls, allow INTEROPERABLE ITEMS to issue commands (e. g., inappropriate or malicious either through INTEROPERABLE ITEM malfunction, malicious action, or problematic integration) outside of their intended purpose and responsibilities within a particular INTEROPERABLE MEDICAL SYSTEM configuration, that give rise to PATIENT harm, or access data outside of their intended purpose and responsibilities within a particular INTEROPERABLE MEDICAL SYSTEM configuration, leading to uncontrolled information DISCLOSURE;
d) Data (e. g., physician orders or PATIENT notes), metadata (e. g., timestamps. attesting to the freshness of information), and/or commands (e. g., direct device commands to start, stop, or change treatment parameters), whose INTEGRITY and AUTHENTICITY has not been verified (and therefore are of unknown PROVENANCE), may be inappropriate or missing as a result of random or malicious corruption, omission, or commission, and give rise to immediate (commands, orders) or delayed (PATIENT notes, metadata) PATIENT harm or uncontrolled information DISCLOSURE.
e) Access control policies which lack manual override capability (e.g. during emergency scenarios) may prevent individual INTEROPERABLE ITEMS from being included in the INTEROPERABLE MEDICAL SYSTEM, preventing timely action to prevent PATIENT harm; and
f) Insufficiently strict access control policies, i.e., overly permissive AUThORIZATION policies, may allow inappropriate INTEROPERABLE ITEMS to act beyond the scope of necessity for PATIENT treatment, leading to actions (e.g., inappropriate or malicious) that give rise to PATIENT harm or uncontrolled information DISCLOSURE.UL 2800-1-2019 pdf free download.
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