TT Electronics Blog

Cybersecurity and the U.S. Medical Manufacturers' Role

Posted by Katelyn M. DeVan on Jul 24, 2018 9:00:00 AM

An emerging trend in the U.S. MedTech Industry is the increasing attention to cybersecurity. Through the continuous establishment of regulations, more and more is expected of U.S. medical manufacturers with regard to the security of medical devices, data, and information technology that ultimately affect patient safety. In order to meet these expectations, medical manufacturers turn to the U.S. Food and Drug Administration for guidelines. It is through voluntary measures such as the benefit-risk framework that U.S. medical manufacturers can detect what level of cybersecurity risks are present in the medical devices, thus communicate these to end-users. ANSI UL 2900-2-1, for example, is a recently recognized consensus standard that provides a framework for developers and medical manufacturers to assess cybersecurity risk, thus improving the safety of the devices.

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Topics: Cybersecurity, medical device manufacturing, FDA, Medical Industry, global electronics manufacturing