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Medical Devices › Healthcare › 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

Butler Snow LLP

Cybersecurity: What Businesses Need to Know

Butler Snow LLP on

Cybersecurity is a top concern for all industries, particularly for the pharmaceutical and medical device industries. These industries hold some of the most sensitive data and highly valuable technology, making them prime...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

Robinson+Cole Data Privacy + Security Insider

FBI Issues Notice to Health Industry Highlighting Risks of Unpatched Medical Devices

Robinson+Cole Data Privacy + Security Insider on

The FBI issued a Private Industry Notification targeted to the health care sector on September 12, 2022, warning that it has “identified an increasing number of vulnerabilities posed by unpatched medical devices that run on...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FDA’s New Draft Guidance on Cybersecurity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 In April of this year, the Agency released the latest draft guidance addressing cybersecurity in the medical device...more

Robinson+Cole Data Privacy + Security Insider

Health Care IoT Devices Pose Risk to Patient Care

Robinson+Cole Data Privacy + Security Insider on

As if health care entities don’t have enough to worry about  during this chaotic and difficult time in the pandemic, a new report released by Cynerio, entitled “The State of IoMT Device Security 2022,” provides a list of...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

Robinson & Cole LLP

Data Privacy + Cybersecurity Insider - February 2019 #4

Robinson & Cole LLP on

In an effort to phase out what many in the security world believe are threats to the cybersecurity posture of governmental agencies and private entities alike, John Quinn, the Chief Information Officer of the State of...more

Robinson+Cole Data Privacy + Security Insider

Privacy Tip #148 – Medtronic MyCareLink Heart Monitors Vulnerabilities Identified

Robinson+Cole Data Privacy + Security Insider on

Wearable technology and medical devices have vulnerabilities just like anything else that is digital. ICS-CERT recently issued an advisory about vulnerabilities in Medtronic’s MyCareLink patient heart monitors. ...more

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