The US Congress implemented stricter medical device cybersecurity regulations last year to prioritize safety amid growing cyberattack incidents. The new requirements incorporated into the Federal Food, Drug, and Cosmetic Act define a “cyber device” and outline stricter cybersecurity requirements for device makers. Simultaneously, the FDA issued a final premarket guidance for manufacturers. Despite these efforts, key challenges remain, including outdated systems and ‘legacy devices’, while future device security may be influenced by artificial intelligence technologies and evolving threats.
Commission wants health-dedicated centre in EU cybersecurity agency
The EU Commission has proposed an action plan to protect the healthcare sector from cyber threats, including setting up a cybersecurity centre within the EU’s
