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Insights from The Identity Jedi for shoring up healthcare's cybersecurity defenses

Ransomware and killware cyberattacks can pose lethal threats to hospitals and critical infrastructure. ....

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FDA Issues Implementation Guidance on Cybersecurity Requirements for Medical Device Premarket Submissions | Nelson Mullins Riley & Scarborough LLP

The U.S. Food and Drug Administration (FDA or the Agency) has issued guidance concerning cybersecurity requirements for certain medical device premarket submissions (the Guidance). The. ....

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FDA Releases Cybersecurity Policy for Medical Devices

FDA published guidance on cybersecurity requirements for certain device premarket submissions outlining implementation of new Section 524B of Federal Food, Drug, and Cosmetic Act FDCA. Manufacturers must meet cybersecurity requirements. ....

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FDA To Require Demonstration of Cybersecurity Safeguards for Pre-Market Submissions of Certain Medical Devices | Sheppard Mullin Richter & Hampton LLP

On March 29, 2023, and March 30, 2023, the U.S. Food & Drug Administration (“FDA”) issued a series of FAQs and a guidance document clarifying the agency’s intended implementation of the. ....

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Cybersecurity Safeguards for Pre Market Medical Devices FDA

Guidance documents from FDA clarifying agency implementation of Consolidated Appropriations Act that amended Section 524B of the Food Drug and Cosmetics Act to require the demonstration of cybersecurity safeguards in pre market submissions for certain medical devices. ....

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