On September 10, 2019 the FDA will hold a meeting of the Patient Engagement Advisory Committee. The committee provides advice to the FDA on complex issues relating to medical devices, the regulation of devices, and their use by patients. During the meeting the committee will discuss and make recommendations on the topic “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 health care and increase the ability of health care providers to treat patients. These same features may also increase cybersecurity risk. Ensuring these devices continue to provide benefit requires timely and effective communication to medical device users about evolving cybersecurity risks. The recommendations provided will address which factors the FDA and medical device industry should consider when communicating cybersecurity risks to patients and to the public.
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