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FDA Patient Engagement Advisory Committee

09/10/19     Gaithersburg, MD

This will me a public meeting of the Patient Engagement Advisory Committee on medical device cybersecurity.

The general function of the Committee is to provide advice to the Commissioner, or designee, on complex issues relating to medical devices, the regulation of devices, and their use by patients.  

“Cybersecurity in Medical Devices:  Communication That Empowers Patients”

Medical devices are increasingly connected to the internet, hospital networks, and other medical devices to provide features that improve healthcare and increase the ability of healthcare providers to treat patients.  These same features may also increase cybersecurity risks.  Preserving the benefit of these devices requires continuous vigilance as well as timely and effective communication to medical device users about evolving cybersecurity risks.  The recommendations provided by the committee will address which factors should be considered by FDA and industry when communicating cybersecurity risks to patients and to the public, including but not limited to the content, phrasing, the methods used to disseminate the message and the timing of that communication.  The recommendations will also address concerns patients have about changes to their devices to reduce cybersecurity risks as well as the role of other stakeholders such as healthcare providers in communicating cybersecurity risks to patients.