What the FDA Wants in Security Architecture Views for Devices

What are the four security architecture views that the FDA prioritizes, and how do they impact your device's design?

This episode explores the FDA-defined security architecture views essential for medical device cybersecurity. Christian and Trevor break down the four views - global system, updatability/patchability, multi-patient harm, and secure use cases - with real-world examples and practical advice.

Key points:

(5:25) The Global System View

• Companion apps and cloud infrastructure must be part of the device scope.

• Many device manufacturers overlook update infrastructure in this view.

• Distinguishing in-scope versus out-of-scope components is a common challenge.

(12:52) Updatability and Patchability

• Secure update procedures must cover the entire lifecycle.

• FDA wants manufacturers to consider both infrastructure and delivery integrity.

• A weak development environment can compromise update trustworthiness.

(18:21) Multi-Patient Harm Scenarios

• Risk is based on the scope and scale of potential compromise.

• Even small devices can cause large-scale issues depending on their connectivity.

(23:09) Secure Use Case Views and Closing Advice

• Every device function should have a corresponding security consideration.

• Functional requirements can guide secure use case documentation.