Table 2.

Safety of the artificial pancreas system

Topic	Safety aspects	Mitigation measures
Combining the components	Reliability and security wireless communication	Integration of devices; Evaluate functionality and safety of wireless communication and take appropriate measures
	Cybersecurity	Specify requirements regarding cryptography, secure and authorized communication, and integrity protection of software and data
	Low batteries	Minimize power consumption to enable battery life of at least multiple days; Use of widely available batteries or charger; Appropriate use of electronic components with high power consumption and storage of essential data
	Reliability operating system and software	Dedicated operating system and software; Modular software design; Safety processor
Alarms	Alarm fatigue	Restricted number of alarms: only alarms that require action from the patient
	No response to alarm	Multiple ways of giving alarms; Evaluate adequacy alarms
User	Low acceptance by patients	Involve user and psychosocial impact in design; Weather-, play-, sport-proof system
	Difficulties in use	Intuitive user-interface that indicates component status and required actions; User manual and training with focus on required actions