FDA Proposes New Cybersecurity Submission Standards For Devices
This article was originally published in The Gray Sheet
The agency issued a draft guidance and safety communication last week in response to a recent emergence of cybersecurity breaches occurring in wirelessly connected medical devices in hospitals.
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The vulnerability of wireless medical technology to theft of intellectual property, regulatory violations, and loss of proprietary information assets should prompt medtech companies to make security measures a top priority.
Chinese hackers recently broke into Community Health Systems’ IT system and stole patient data. Although they did not take device data in this instance, the hackers might have been after that, experts suggest, highlighting vulnerabilities for industry.
CDRH’s emergency preparedness director spelled out the device center’s cybersecurity efforts during a recent webinar. The efforts go beyond guidance and regulations and include proactive steps to tackle the challenge, including weekly meetings with the Department of Homeland Security, she said.