Devices

Meeting Transcript on Cybersecurity Patient Messaging

FDA has made available a transcript of a 9/10 Patient Engagement Advisory Committee that recommended the agency develop standards for device companies to use when communicating any cybersecurity concerns to patients. Panel members recommended that the format for cybersecurity messages to patients should include e-mails, Web postings, social media and webinars. “There should be a high standard of outreach to all patients regardless of the challenges with reaching them since connectivity will be increasing with time and those populations in rural or internet sparse areas will become increasingly vulnerable to cybersecurity threats,” the transcript said.

The panel also recommended that FDA evaluate the standards that the Department of Transportation and other transportation agencies use to “hold high standards for manufacturers across their supply chains and the FDA should consider some of the mandates the transportations agencies use to communicate risks to their passengers,” according to an agency summary.

Overall, the committee agreed that there is not a blanket approach that would work for all patients. They did, however, recommend three strategic elements that FDA and industry should consider when communicating cybersecurity risks to patients when the probability of exploitation is not known: 1) explain unknown factors; 2) discuss any concerns addressed and factored in well in advance of the preapproval process; and 3) a balanced discussion between risk and benefits, highlighting the benefits especially if it is a lifesaving device.

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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