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 Despite these efforts, key challenges remain, including outdated systems and ‘legacy devices’, while future device security may be influenced by artificial intelligence technologies and evolving threats.

Edelson Lechtzin LLP Is Investigating Claims On Behalf Of Oracle Health Customers Whose Data May Have Been Compromised
National class action law firm Edelson Lechtzin LLP is investigating data privacy violations at Oracle Health. In February 2025, Oracle Health discovered a security breach