Security Risk Assessment for Medical Devices

ANSI/AAMI SW96:2023, “Standard for medical device security—Security risk management for device Manufacturers” has been recognized by FDA as a recommended standard for security risk management. FDA has stated that the standard “provides direction to sponsors on how to consider and address cybersecurity risks in device design and development.”¹

Note: In this article, security and cybersecurity are meant to be interchangeable terms as defined in ANSI/AAMI SW96:2023.²

At a high level, ANSI/AAMI SW96:2023 defines the security risk management process as follows:

Continue to Article