The ICE System shall provide the capability and mechanism for the 6.2.14 CR_0000000015 Data validation clinician to validate the physiological data and device data coming in from various sources. The ICE System shall not allow the clinician to interact with the ICE System until s/he is For audit purposes, we authenticated and need to ensure that only appropriate people view Unauthorized authorized, unless it 6.2.15 CR_0000000016 patient information or access is an emergency change settings. We need situation or the new to be able to track who is clinician identifies using the system. himself or herself. [Compound requirement - needs to be decomposed The ICE system shall configure the system such that during clinical operation it shall not To ensure safe operation of allow unauthorized or all the devices running Device non-user-initiated 6.2.18 CR_0000000019 interrupt (system-initiated) JMG - excellent comments diagnostic tests on the on complex issue. medical device that interrupt the regular use of the device, and allow only Biom The ICE system shall be capable of receiving For audit purposes (Root messages from connected Cause Analysis) - analysis devices indicating when would reveal if a particular User-selectable their settings are changed, setting has been changed 6.2.19 CR_0000000020 settings along with the old and by the clinician or new setting values, and, within the where possible, the device. May be used for identity of the clinician remote control. making the change. Any device that fails a The ICE system shall Power-On-Set-Test provide a mechanism to accept the (POST) that could (POST) results 6.2.20 CR_0000000021 have serious (POST) (pass/fail) from each consequences on device upon start-up. If patient care, shall not the device is already be used in the clinical turned on or ICE is
6.2.14 CR_0000000015 Data validation The ICE System shall provide the capability and mechanism for the clinician to validate the physiological data and device data coming in from various sources. 6.2.15 CR_0000000016 Unauthorized access The ICE System shall not allow the clinician to interact with the ICE System until s/he is authenticated and authorized, unless it is an emergency situation or the new clinician identifies himself or herself. [Compound requirement - needs to be decomposed For audit purposes, we need to ensure that only appropriate people view patient information or change settings. We need to be able to track who is using the system. 6.2.18 CR_0000000019 Device interrupt The ICE system shall configure the system such that during clinical operation it shall not allow unauthorized or non-user-initiated (system-initiated) diagnostic tests on the medical device that interrupt the regular use of the device, and allow only Biom To ensure safe operation of all the devices running JMG - excellent comments on complex issue. 6.2.19 CR_0000000020 User-selectable settings The ICE system shall be capable of receiving messages from connected devices indicating when their settings are changed, along with the old and new setting values, and, where possible, the identity of the clinician making the change. For audit purposes (Root Cause Analysis) - analysis would reveal if a particular setting has been changed by the clinician or within the device. May be used for remote control. 6.2.20 CR_0000000021 (POST) The ICE system shall provide a mechanism to accept the (POST) results (pass/fail) from each device upon start-up. If the device is already turned on or ICE is Any device that fails a Power-On-Set-Test (POST) that could have serious consequences on patient care, shall not be used in the clinical
ICE-PCA-MSIS-Mock-Vendor-Submission-v0.11.docx