Complying with Section 524B for Connected Medical Devices

It’s a sign of our hyper-connected times - every widespread virus attack, every corporate hack, and every government security breach gets widespread media attention. And rightly so. The privacy, reputation, financial, even emotional risks are known, even feared. For many, they just want their data, their money, their privacy, their systems, to ‘just work’, which includes being secure.

Corporate and government IT instantiate processes and systems to build walls and moats around access to treasured digital assets. Consumer devices add their own technologies, and by now we’re all used to the frequent over-the-air (OTA) updates to our smartphones.

As we scan the landscape of vulnerabilities, connected medical devices are another vector for malicious action. Here the stakes are raised to affecting physical well-being, potentially even life or death should a product offer a bad actor an attack vector to exploit for gain.

So, the US government has enacted regulations to protect the cybersecurity of new or updated connected medical devices, in the hopes of closing these attack vectors before (more) damage can be done. These regulations apply new requirements to not only US device manufacturers, but also to all manufacturers selling devices into the US market.

Wind River is offering two webinars to help medical device manufacturers make sense of these new regulations and formulate strategies for how to comply so that pre-market approvals aren’t held up. The first, Navigating Section 524B: What You Need to Know About Ensuring Cybersecurity in Medical Devices, will be held on August 24 at 8:00am Pacific Time. The second, Open Source Strategies for 524B Success, will follow on September 21, also at 8:00am Pacific Time. You can conveniently register for both at the same time.

Complying with new regulations can open risk to product development efforts. Join our two webinars for a roadmap through the maze.

About the author

Tim Fahey is a Senior Product Marketing Line Manager at Wind River