What You Need to Know: ANSI/AAMI SW96:2023 — Medical Device Security

Managing risk around a medical device’s entire life cycle has become increasingly complex. Many devices use third-party components, which is especially true for devices that require a network to operate. This increased need for connectivity, along with other emerging threats, is putting security at the forefront of medical device industry standards.

With device vulnerability increasing, new standards aim to keep up with emerging threats. As a result, ANSI/AAMI SW96:2023 was created to help protect against threats, understand risk, and guide manufacturers in taking the most appropriate actions to enhance security. However, because the standard is relatively new, many device manufacturers are still finalizing the interpretation on how this impacts their organizational processes. If you’re still working to get familiar with the standard, we’ve created a complete guide to make the task easier.

Download this guide to learn more about:

  • Understanding the security risk management process
  • The six sections of security risk management
  • How ANSI/AAMI SW96:2023 relates to other medical device standards