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FDA Announces Efforts to Strengthen Medical Devices Against Cybersecurity Threats

This week, FDA Commissioner Scott Gottlieb, MD, released a statement on multiple efforts the agency is taking to strengthen its cybersecurity program for medical devices. First, Dr. Gottlieb announced the launch of the “Medical Device Cybersecurity: Regional Incident Preparedness and Response Playbook” that provides health organizations a framework for integrated preparedness and response to cybersecurity threats. Additionally, the FDA issued two memoranda of understanding (MOUs) that will create groups of industry experts charged with gathering, analyzing, and disseminating information about cyber threats. The goal of the MOUs is to share information about cybersecurity vulnerabilities that may impact the safety of medical devices.

As a reminder, the ASCRS•ASOA Health Information Technology Committee has developed resources to assist practices in protecting themselves against cybersecurity threats. If you need additional information, please contact Jillian Winans, regulatory affairs specialist, at jwinans@ascrs.org or 703-591-2220.