Devices

Communicating Cybersecurity Best Practices

FDA has released a document entitled “Best Practices for Communicating Cybersecurity Vulnerabilities to Patients.” The document is intended to provides helpful information and elements for industry stakeholders, federal partners, and other interested stakeholders to consider when developing a cybersecurity communication strategy. It was developed based on comments submitted to the agency under a 10/2020 discussion paper under the same title. These elements include:

· interpretability;
· discussing risks and benefits;
· acknowledging and explaining the unknown;
· information availability and findability
· communication material structure; and
· outreach and distribution vehicles.

The document says that when developing safety communications, messages should be written in clear and plain language consistent with the audience’s need to receive and understand the messages conveyed. “Several factors, such as timeliness, relevance, simplicity, and readability for diverse audiences, are key for patients and caregivers to read and understand the safety communications,” it says. Another key element is timeliness. “Early access to serious cybersecurity vulnerability information may provide assurance to patients and empower them to take early action to avoid any potentially harmful consequences to their health,” it says.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome