AAMI Wireless Strategy Task Force Discuss FDA Cybersecurity Guidance

Recently the Association for the Advancement of Medical Instrumentation (AAMI) quoted Laird's Jay White, Product Manager of the Connectivity Solutions Business Unit, in an article regarding the FDA's latest cybersecurity recommendations for medical device manufacturers. Titled, "Draft Cybersecurity Guidance Draws Mixed Reviews", the article highlights the FDA's recommendations on how manufacturers should manage cybersecurity vulnerabilities after their medical device is on the market. Cybersecurity threats in healthcare are a growing concern. In the FDA's latest draft guidance, they encourage manufacturers to not only incorporate controls in a product to help prevent security risks, but to also address any security concerns during maintenance throughout the product's entire lifecycle.

While some would say that the FDA's recommendations are proactive, others question whether or not stricter regulations should be in place. AAMI quoted Laird's Jay White, among other wireless experts, who says, "Cybersecurity is a hot topic. It’s interesting that the Institute for Critical Infrastructure found the FDA’s cybersecurity recommendations inadequate but were quick to recognize that regulatory frameworks are difficult to develop and enforce. While cybersecurity regulations may be necessary to ensure a standardized level of security, regulatory bodies must be nimble enough to adopt and enforce the latest security practices." Read the full article for details on the FDA’s cybersecurity recommendations as well as what other wireless experts have to say about them.