FDA holds cybersecurity of medical devices workshop

30 Jan 2019

The US Food and Drugs Administration (FDA) held a public workshop dealing with cybersecurity in medical devices. The purpose of the workshop was to discuss the newly released draft guidance ‘Content of Premarket Submissions for Management of Cybersecurity in Medical Devices’, especially the topic of cybersecurity bill of materials (CBOM). The guidance details recommendations such as: limiting data access only to reliable users and devices, improving security measures for data access, and securing data integrity and confidentiality. The public can comment on the guidance until 18 March 2019.

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Cybersecurity is among the main concerns of governments, Internet users, technical and business communities. Cyberthreats and cyberattacks are on the increase, and so is the extent of the financial loss. 

Yet, when the Internet was first invented, security was not a concern for the inventors. In fact, the Internet was originally designed for use by a closed circle of (mainly) academics. Communication among its users was open.

Cybersecurity came into sharper focus with the Internet expansion beyond the circle of the Internet pioneers. The Internet reiterated the old truism that technology can be both enabling and threatening. What can be used to the advantage of society can also be used to its disadvantage.

The Internet of Things (IoT) includes a wide range of Internet-connected devices, from highly digitalised cars, home appliances (e.g. fridges), and smart watches, to digitalised clothes that can monitor health. IoT devices are often connected in wide-systems, typically described as 'smart houses' or 'smart cities'.


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