Posts Tagged cybersecurity

OIG: FDA Should Address Postmarket Cybersecurity Risk to Medical Devices

The Food and Drug Administration’s policies and procedures were insufficient for handling postmarket medical device cybersecurity events, and the agency has not adequately tested its ability to respond to emergencies resulting from cybersecurity events in medical devices, according to a Department of Health

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HHS Opens Cybersecurity Coordination Center

The US Department of Health and Human Services this week opened a Health Sector Cybersecurity Coordination Center (HC3) at its headquarters in Washington, D.C., which will coordinate activities across the sector and report to the US Department of Homeland Security threats, profiles and preventive strategies.

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FDA Issues Draft Guidance on Cybersecurity for Medical Device Industry

The Food and Drug Administration today issued draft guidance that provides recommendations to the medical device industry on cybersecurity considerations for device design, labeling and documentation that the FDA recommends be included in premarket submissions for medical devices with cybersecurity risk. The guidance builds on the

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Conference Oct. 25-26 on Strategies to Improve Healthcare Cybersecurity

The InfraGard Cyber Health Working Group, a partnership between the FBI and information technology professionals in the health sector, will host a conference Oct. 25-26 in Charlotte on strategies and tactics to improve healthcare cybersecurity. Conference registration is open to working group members and non-members,

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FDA Announces Actions to Strengthen Medical Device Cybersecurity

The Food and Drug Administration has released a framework to help hospitals and other health care providers plan for and respond to cybersecurity incidents involving medical devices. Developed by MITRE Corp., the “playbook” includes steps such as developing a medical device inventory and conducting training

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