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Manufacturers › Healthcare › Cyber Attacks

Bradley Arant Boult Cummings LLP

Balancing Act: Industry Concerns Over CISA’s Proposed Cyber Incident Reporting Rule

Bradley Arant Boult Cummings LLP on

As discussed in our previous blog post, the Cybersecurity and Infrastructure Security Agency (CISA) is proposing a significant new rule to bolster the nation’s cyber defenses through mandatory incident reporting. While...more

Foley & Lardner LLP

Recommendations for Managing Cybersecurity Threats in the Manufacturing Sector

Foley & Lardner LLP on

In the hyper-connected era of smart manufacturing, accelerated by “Industry 4.0,” the manufacturing sector is undergoing a digital revolution. By leveraging technologies such as advanced automation, artificial intelligence,...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

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FDA’s New Draft Guidance on Cybersecurity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 In April of this year, the Agency released the latest draft guidance addressing cybersecurity in the medical device...more

Baker Donelson

FDA Recommends that Manufacturers Seeking Medical Device Approval Submit Cyber Security Plans

Baker Donelson on

Last week, the FDA took steps to address a quietly growing concern regarding cyber security and medical devices. Specifically, the agency issued Draft Guidance requiring the submission of cyber security materials as part of...more

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