New FDA regulations require medical device vendors to enhance security features and address vulnerabilities, aiming to reduce the risk of compromised devices reaching consumers.

FDA Cyber Mandates for Medical Devices Goes Into Effect

New regulations from the Food and Drug Administration (FDA) require vendors of medical devices, such as pacemakers and insulin pumps, to enhance their security features. The regulations aim to prevent hacking into these devices by mandating vendors to address vulnerabilities, create a software bill of materials, and have a plan to address vulnerabilities after the products have been sold. The FDA can refuse to accept devices that do not meet cybersecurity guidelines, potentially leading to delayed market entry or recalls for companies. The Biden administration is pushing for greater cybersecurity responsibility from manufacturers, with the FDA's regulations being a part of that effort. The rules also require vendors to monitor and address cybersecurity vulnerabilities of already approved devices and patch any bugs that pose uncontrolled risks. The regulations come at a time when the healthcare industry is facing an increasing number of ransomware attacks. Some experts argue that the FDA should be more aggressive in policing the industry's cybersecurity. Medical device makers are in the midst of a digital transformation but need to prioritize proactive cybersecurity defenses.

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