Medtech Insight

Experts: New Cybersecurity Standard Goes Beyond What US And Other Regulators Require

11 Feb 2022

A recently published international cybersecurity standard goes beyond what regulators currently require of medtech manufacturers, say attorneys at King and Spalding. If adopted by the US FDA and others, it could add significant burden on medical software developers.

Businessman hand points to the word ISO with check tick icon — • Source: Alamy

International standards organizations have adopted a new cybersecurity standard for medical devices that goes beyond just looking at a product’s risk level as required by the US Food and Drug Administration, say attorneys at King and Spalding.

In a 8 February blog post, King and Spalding attorneys Eric Henry, Lisa Dwyer and Jessica Ringel wrote that...