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Due to mounting security concerns in healthcare in the 5G era, the U.S. Food and Drug Administration (FDA) has changed the way it views cybersecurity in regards to premarket submissions for medical devices.

In October 2014, the FDA released the first version of its Premarket Cybersecurity Guidance. This early version conveyed the FDA’s heightened interest in ensuring secure medical devices do no patient harm, but was unclear about exactly what steps needed to be taken in order to meet the FDA’s expectations.

But now that FDA guidance for better securing medical devices is quite clear to assist industry by identifying issues related to cybersecurity that manufacturers should address in the design and development of their medical devices as well as in preparing premarket submissions for those devices.

Current FDA cybersecurity premarket guidelines for medical devices address a wide range of digital security topics including:

  • Preventing unauthorized use
  • Designing trustworthy devices
  • Maintaining confidentiality of data
  • Attack detection capabilities
  • Software configuration management
  • Incident management

The need for effective cybersecurity to assure medical device functionality and safety has become more important with the increasing use of wireless, internet- and network- connected devices, and the frequent electronic exchange of medical device-related health information.

In addition, cybersecurity threats to the healthcare sector have become more frequent, more severe, and more clinically impactful.

There have already been numerous cybersecurity incidents that have rendered medical devices and hospital networks inoperable, disrupting the delivery of patient care across healthcare facilities in the U.S. and globally. Such cyberattacks and exploits can delay diagnoses and/or treatment and may lead to patient harm.

Want to learn more? Tonex offers FDA Cybersecurity Premarket Workshop, a 2-day course that introduces participants to Premarket Submissions for Management of Cybersecurity in Medical Devices.

You will learn about the need for effective cybersecurity and how to ensure medical device functionality and safety along with wireless, Internet- and network- connected devices, portable media (e.g., USB or CD), and the frequent electronic exchange of medical device-related health information.

For more information, questions, comments, contact us.

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