Confidentiality

For devices, confidentiality usually concerns patient data. A breach may not hurt the patient physically, but it still needs to be part of security risk management.

the property of data, information, or system structures to be accessible only to authorized persons and entities and are processed at authorized times and in the authorized manner, thereby helping ensure data and system security. Confidentiality provides the assurance that no unauthorized users (i.e., only trusted users) have access to the data, information, or system structures.

FDA guidance: Cybersecurity in Medical Devices: Quality Management System Considerations and Content of Premarket Submissions (February 2026), Appendix 5, Terminology