Tag Archives: Medical Devices

FDA revamps cybersecurity guidance for marketed medical devices

The Food and Drug Administration (FDA) published a draft update to its premarket cybersecurity guidance for device makers on October 18, 2018. The expanded draft guidance includes recommendations on tiered classification of cybersecurity risk, trustworthiness, cybersecurity bill materials, and device cybersecurity labeling that are specific enough to be helpful to manufacturers while at the same … Continue Reading

FDA Releases Guidance on Cybersecurity and Medical Devices

The FDA represents the latest federal agency to show a focus on cybersecurity issues with the release December 28 of new guidance. While the prospect of network-enabled medical devices increasingly offers the promise of improved care and patient treatment, evolving technology and new-found connectivity present emerging security considerations as well. The Food and Drug Administration … Continue Reading

A Checklist for In-House Counsel: Cyber Security for Medical Devices

Medical device companies and manufactures of other connected devices need to be attentive to the ever-increasing risk of a cybersecurity breach affecting their own devices and the hospitals and other health care organizations where their devices are connected. Taking these challenges into consideration, the FDA has issued several guidance documents concerning cybersecurity for medical devices.  … Continue Reading
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