Governance, risk & compliance

ANSI/AAMI SW96 Medical Device Security Risk Management 2023

The American National Standard for security risk management of medical devices, published November 2023, together with AAMI TIR57:2016/(R)2023, the technical information report it builds on.

It extends ISO 14971 safety risk management to security risk rather than replacing it, and the distinction is the reason it exists: safety risk is estimated from the probability of harm, and security risk cannot be, because an attacker is not a random process. SW96 uses exploitability instead.

The practical consequence is that a manufacturer keeps the security risk file linked to the safety risk file without merging them, and both FDA and Health Canada expect to see a named security risk management method. This standard is that method.

Assessment tiers & levels Lavawall supports

Lavawall assesses ANSI/AAMI SW96 Medical Device Security Risk Management at every level below, so you can start where you are and step up as your program matures.

How Lavawall® helps you get to ANSI/AAMI SW96 Medical Device Security Risk Management compliance

Most of ANSI/AAMI SW96 Medical Device Security Risk Management comes down to technical controls you have to run and prove: keeping systems patched, hardening configuration, detecting breaches early, backing up what matters, controlling access, and keeping evidence that all of it actually happened. Lavawall® runs those controls across Windows, macOS, Linux, and Microsoft 365 / Google Workspace from one console, maps them to ANSI/AAMI SW96 Medical Device Security Risk Management, and tracks your posture continuously instead of once a year at audit time.

• Assess your current state against ANSI/AAMI SW96 Medical Device Security Risk Management in the Lavawall GRC module, with the questionnaire and control set built in.
• Remediate the gaps with the same platform — automated patching, configuration fixes, backups, and access review — not a separate project.
• Evidence everything with timestamped, exportable records auditors, insurers, and clients accept.

Related

Lavawall® supports ANSI/AAMI SW96 Medical Device Security Risk Management as part of a built-in catalogue of compliance frameworks. Framework requirements are summarized for planning purposes; always confirm the current official text before certifying.