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Healthcare › Food and Drug Administration (FDA) › Vulnerability Assessments

Orrick, Herrington & Sutcliffe LLP

Medical Devices, Cybersecurity & The False Claims Act: What are the Key Takeaways from the Illumina - DOJ Settlement?

Orrick, Herrington & Sutcliffe LLP on

Illumina, Inc., a publicly-traded biotechnology company, agreed to a $9.8 million settlement with the U.S. Department of Justice (DOJ) in response to alleged violations of the False Claims Act (FCA). DOJ alleged that Illumina...more

Ankura

Is Your DNA Safe? DNA Sequencing Machines Found to Contain Critical Vulnerabilities

Ankura on

Key Points: Illumina DNA sequencing machines are vulnerable to exploitation. Both the Cybersecurity and Infrastructure Security Agency (CISA) and the Food and Drug Administration (FDA) have published advisories urging all...more

Nelson Mullins Riley & Scarborough LLP

FDA Issues Implementation Guidance on Cybersecurity Requirements for Medical Device Premarket Submissions

Nelson Mullins Riley & Scarborough LLP on

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 Guidance outlines the implementation of...more

Buchalter

From Heart Monitors to Hack Monitors: Medical Device Cybersecurity

Buchalter on

ALERT: Recent guidance from the Food and Drug Administration (“FDA”) clarifies a procedural issue for premarket submissions related to cybersecurity of medical devices and emphasizes the importance of collaboration between...more

Gardner Law

FDA’s New Draft Guidance on Cybersecurity

Gardner Law on

The FDA has been continuing to work on protecting medical devices from the threats of cybersecurity. In April of this year, the Agency released the latest draft guidance addressing cybersecurity in the medical device...more

Skadden, Arps, Slate, Meagher & Flom LLP

Privacy & Cybersecurity Update - October 2019

Skadden, Arps, Slate, Meagher & Flom LLP on

In this month's edition of our Privacy & Cybersecurity Update, we examine the California attorney general's draft regulations on the California Consumer Privacy Act, the CJEU's clarified rulings on the use of cookies, the...more

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