September 12, 2019

FDA Meeting Sparks Debate on Cybersecurity Risks in Medical Devices

On September 10, 2019, the FDA's Patient Engagement Advisory Committee met to discuss cybersecurity risks in medical devices. As Internet connectivity becomes the norm, hacking of medical devices has become an area of increasing concern. The FDA established the Patient Engagement Advisory Committee to give a voice to patients and to ensure that they are included as part of the FDA's deliberations on complex issues involving regulation and use of medical devices. The FDA prepared questions and talking points prior to the meeting. During the meeting, the FDA noted that it isn't aware of any patient deaths or injuries resulting from cybersecurity gaps with medical devices.