Medical device manufacturers must implement cyber security in the design of their products and submit a plan to the FDA for every new product application. This requirement, set by the Food and Drug Omnibus Reform Act of 2022, includes developing a risk-based vulnerability management system and following steps to avoid cyber attacks and data breaches. The grace period for compliance ends on October 1, 2023. Failure to adhere can lead to legal action under the Federal Food, Drug, and Cosmetic Act.
EU launches plan to combat cyber threats to hospitals
Luxembourg’s hospitals are unprepared for cyber threats, as are many across Europe. Threats include ransomware and hacks that can impact patient care. The European Commission
