Abstract
Abstract Point-of-care testing (POCT) has been an essential service in hospitals for many years with a main focus on reliability, classical laboratory quality criteria and easy handling. Hospital information technology (IT) security regulations, however, have not yet been adapted to the specificities of POCT. Following the POCT Symposium in Munich, the “1st Round Table POCT-IT-Security Meeting” held in October 2019 in Cologne addressed these issues and managed to establish first consensus results in the essential fields of user, data and update management, as well as network connections and user-friendliness. First practical steps include optimizing the user management by connection to a directory service and definition of access control (including emergency authorization). Patient data economy on analyzers in combination with data and data transmission encryption as well as technically secure communication protocols are relevant steps in the fields of data management and network connections. An update management needs to be contractually defined for remote services and generally includes testing in a protocol-based scenario. Providing an organizational structure for POCT-IT security is a necessary prerequisite, as are continuous training and awareness for this topic with a strong focus on usability.
Highlights
Point-of-care testing (POCT) has been an essential service in hospitals for many years with a main focus on reliability, classical laboratory quality criteria and easy handling
“Health care” is one of three subbranches within this field and industry-specific security standards (B3S) for health care in hospitals have been created by the German Hospital Society (DKG) as an orientation guide for implementation of the requirements stated in the BSIG, taking the Kritische Infrastrukturen (KRITIS) protection requirements’ availability, integrity, authenticity and confidentiality into consideration
The POCT devices require access control, which should consist of a user ID in combination with a passcode
Summary
Abstract: Point-of-care testing (POCT) has been an essential service in hospitals for many years with a main focus on reliability, classical laboratory quality criteria and easy handling. Extensive remote maintenance from the clinic as well as from external suppliers (e.g. the device manufacturer) is standard This process must be controlled and documented; this includes the proper day-to-day functioning of the system and the documentation of system failures with the consecutive corrective actions [5]. “Health care” is one of three subbranches within this field (the others being “Pharmaceuticals and vaccines” and “Laboratories”) and industry-specific security standards (B3S) for health care in hospitals have been created by the German Hospital Society (DKG) as an orientation guide for implementation of the requirements stated in the BSIG, taking the KRITIS protection requirements’ availability, integrity, authenticity and confidentiality into consideration. Five areas of interest were consensually identified during “The 1st Round Table POCT-IT-Security Meeting”: (1) user management, (2) data management, (3) update management, (4) network connections and (5) user-friendliness
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