iTero Element 5D Plus - Page 196

l Data-at-rest is encrypted: The scanners store Personally Identifiable Information (PII) in an encrypted database
using AES-256 and intraoral scan images in an encrypted folder using Microsoft Encrypting File System (EFS).
These encryption technologies help to prevent an attacker from capturing patient information stored on the
scanner.
Applicable to iTero Element, iTero Element 2, iTero Element Flex, iTero Element 5D, and iTero Element 5D Laptop Configuration,
iTero Element 2 Plus, iTero Element 5D Plus, iTero Element 5D Plus Lite
l Data-in-transit is encrypted: PII and intraoral scan images that are backed up to Align servers is transmitted
over transport layer security (TLS) 1.2 encryption using trusted certificates. This helps to prevent an attacker from
capturing patient information while in transit.
Applicable to iTero Element, iTero Element 2, iTero Element Flex, iTero Element 5D, and iTero Element 5D Laptop Configuration,
iTero Element 2 Plus, iTero Element 5D Plus, iTero Element 5D Plus Lite
l Anti-malware protections are in place: The scanners come with pre-installed Trend Micro anti-virus software
that checks for malicious files on the system. The anti-virus software definitions are updated frequently and scans
are scheduled to run daily on the devices.
Applicable to iTero Element, iTero Element 2, iTero Element 5D, iTero Element 2 Plus, iTero Element 5D Plus, iTero Element 5D Plus
Lite
l Remote maintenance is not possible without permission: The devices use TeamViewer for establishing a
remote session. The TeamViewer software requires a User ID and password that must be supplied from the
customer to the Align service personnel before the connection can take place.
Applicable to iTero Element, iTero Element 2, iTero Element Flex, iTero Element 5D, and iTero Element 5D Laptop Configuration,
iTero Element 2 Plus, iTero Element 5D Plus, iTero Element 5D Plus Lite
l Changes to the operating system and software are restricted: The scanners implement a kiosk mode that
prevents the user from making any unwanted changes to the operating system and software components.
Applicable to iTero Element, iTero Element 2, iTero Element 5D, iTero Element 2 Plus, iTero Element 5D Plus, iTero Element 5D Plus
Lite
l User access management controls are enforced: A user account and password is required to utilize the
scanners. This helps protect access to the scanner and protects against unauthorized use.
Applicable to iTero Element, iTero Element 2, iTero Element Flex, iTero Element 5D, and iTero Element 5D Laptop Configuration,
iTero Element 2 Plus, iTero Element 5D Plus, iTero Element 5D Plus Lite
l Segregation of duties is applied: The scanners offer the ability to register multiple user accounts with different
roles to one scanner. There are roles for Doctor, Assistant, and Support Technician. This helps ensure the ability
to track activities performed by individual users better protecting the device.
Applicable to iTero Element, iTero Element 2, iTero Element Flex, iTero Element 5D, and iTero Element 5D Laptop Configuration,
iTero Element 2 Plus, iTero Element 5D Plus, iTero Element 5D Plus Lite
Security and privacy responsibilities of the customer.
As part of our assessments, we have identified risks that are dependent on how the product is used. The securing of
the products we provide to our customers is a shared responsibility among all stakeholders. Based on the
assessment conducted on the iTero® Element™ optical impression system series, we expect that you will take the
following security steps to protect the product:
l Physically secure the product and its operating environment: It is the customer’s responsibility to protect the
physical security of the product and operate it in a secure manner. For the iTero® Element™ Flex system, control
and monitor physical access to the platform hosting the application through the use of mechanisms such as
security cameras and security badges. In addition, shut down physical ports of network equipment that is not in
use to prevent unauthorized access to the application.
Applicable to iTero Element, iTero Element 2, iTero Element Flex, iTero Element 5D, and iTero Element 5D Laptop Configuration,
iTero Element 2 Plus, iTero Element 5D Plus, iTero Element 5D Plus Lite
iTero Element® 5D Plus User manual
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