Security and privacy features of the product.
We aim to protect your data and patients through the design and maintenance of our products. As a result of our
security- and privacy-by-design approach to product development, we have implemented the following non-
exhaustive security controls in the iTero Element Family of products.
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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
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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
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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
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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
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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
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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
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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
iTero Element 5D and iTero Element 5D Plus imaging systems User manual
© 2022 Align Technology, Inc. All rights reserved.
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