13 iTero Element product security whitepaper
This whitepaper applies to the iTero® Element™ optical impression system series. Depending on the version
of the product you have procured, there may be differences in the features of the product. In addition, as this
artifact was created at a point-in-time, changes may have occurred in Align Technology’s product security
practices to address evolution and maturation in the product security ecosystem.
We understand the life sciences and healthcare industry and are addressing security across
the organization.
The threat of cyber-attacks to life sciences and healthcare products is
constantly evolving. With this in mind, we proactively established a
product security program that is focused on minimizing the security risk
associated with our products, enabling us to be vigilant when facing
emerging threats and to continuously improve our products.
We recognized the importance of incorporating security and privacy
considerations by design and throughout our product lifecycle. To
accomplish this, we established a cross-functional product security
team, including representatives from engineering/software
development, security, legal/privacy, information technology, and
quality.
We identify security risks using robust risk management processes.
Align Technology is committed to addressing and minimizing security and privacy risks in the products that we
design, develop, and maintain. We conduct in-depth assessments of our products so that we can implement
appropriate risk mitigation measures at the outset of product development. Based on the risk level of the
product, as well as the functionality of the product, the below methodology is applied.
Product Security Risk Assessment (PSRA): Align
Technology conducted a PSRA on the iTero® Element™
optical impression system series. The assessment
methodology included planning and information gathering,
identifying applicable product profiles, developing a
component register, performing a controls analysis,
identifying vulnerabilities, calculating the risk rating of the
vulnerability, identifying appropriated mitigating controls,
and calculating the residual risk rating. Security and privacy
risks considered as part of the assessment leverage industry
leading practice security risk frameworks including, but not
limited to, NIST 800-53, NIST CSF, UL 2900-2-1, ISO
80001, and the FDA’s Content of Premarket Submissions for
Management of Cybersecurity in Medical Devices.
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