MC10 BioStamp nPoint - Hazardous Situations

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BioStamp nPoint User Manual
Sensor to Mobile Communication
Data stored on the patch’s on-board memory is secured through a
proprietary bit packing and memory block allocation scheme.
Communication to the patch is only enabled through custom-built
mobile applications. All MC10 applications require an authorized user
login using valid credentials. During operation, each patch is uniquely
assigned to a subject, in a specied conguration mode which includes
the sensor modality and body location. Patch to mobile and mobile
to patch communication is secured through a custom cmd-ctrl-data
protocol and compression algorithm that runs across the Bluetooth LE
protocol packets.
Mobile to MC10 Cloud Communication
Application data is encrypted (256-bit AES) and stored on the local
SQLite database on the mobile.
Upon network connectivity, data is transmitted between the mobile and
cloud using HTTPS protocols, which requires authentication with valid
credentials. This encrypted connection protects the privacy and
integrity of the exchanged data.
All cloud API interactions are logged with the following attributes:
• Authenticated user taking the action
• Source IP address of user
• Time of interaction
• Resources viewed or action taken
MC10’s cloud network and systems are protected with standard security
practices (rewalls, VPC, access restrictions, and automated
conguration management). Access to the data is restricted at multiple
levels and is protected by MC10’s Access Control Lists (ACLs) framework.
ACLs restrict resource availability to approved users and groups. Each
user belongs to at least one group and is assigned one or more roles
within their respective group. Roles dene which resources and what
actions are available to a user in a given group.
Hazardous Situations
Potential hazardous situations resulting from a failure of the IT-NETWORK to
provide the characteristics required to meet the purpose of the PEMS
connection to the IT-NETWORK:
• Investigator Portal, Investigator App, and/or Link App cannot connect to
public internet;