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Life Sciences › Cybersecurity › Manufacturers

Akin Gump Strauss Hauer & Feld LLP

Three Questions with Sedgwick’s Jeremy Schutz

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In this edition of Three Questions, health care & life sciences partner Nate Brown spoke with Jeremy Schutz, director of business development, recall & remediation at Sedgwick, to explore key strategies that pharmaceutical...more

Troutman Pepper Locke

New FDA Guidance on AI and Medical Products

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n March 15, the U.S. Food and Drug Administration (FDA) published a paper titled “Artificial Intelligence and Medical Products: How CBER, CDER, CDRH, and OCP are Working Together.” This paper describes the FDA’s strategy for...more

Skadden, Arps, Slate, Meagher & Flom LLP

The Informed Board - Winter 2024

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The oversight obligations of boards continue to expand. Recent enforcement actions and new laws in areas such as cybersecurity, artificial intelligence and supply chains create new challenges for boards, as we explain in this...more

Spilman Thomas & Battle, PLLC

Decoded: Technology Law Insights - V 4, Issue 10, December 2023

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Revisiting…Are Automakers Making Sufficient Efforts to Protect Customer Data? As a follow-up to our previous article and webinar, “Are Automakers Making Sufficient Efforts to Protect Customer Data?", we are addressing the...more

McGuireWoods LLP

FDA Publishes New Guidance on Cybersecurity in Medical Devices

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In response to a growing number of cyberattacks in the healthcare and life sciences industries, on Sept. 27, 2023, the U.S. Food and Drug Administration (FDA) released updated guidance regarding cybersecurity safety...more

Nelson Mullins Riley & Scarborough LLP

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

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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FDA’s New Draft Guidance on Cybersecurity

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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

Hogan Lovells

FDA spells out electromagnetic compatibility info needed in medical device premarket submissions

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The U.S. Food and Drug Administration (FDA) recently issued the final guidance, “Electromagnetic Compatibility (EMC) of Medical Devices: Guidance for Industry and Food and Drug Administration Staff,” which details the...more

MoFo Life Sciences

EU: In Vitro Diagnostic Regulation Entered Into Force (Part 3 Of 3)

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Part 1 of this article discussed the background and purpose of the EU In Vitro Diagnostic Regulation (EU) 2017/746 (IVDR), the definition of in vitro diagnostic medical devices (IVDs), the risk-based classification system,...more

Proskauer - Life Sciences

U.S. Medical Device Manufacturers Should Take Note of New European Medical Device Regulations

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The European Union has been a leader in recent years when it comes to regulatory reform intended to protect individuals’ privacy, safety, and health. As Europe leads the way, regulators in the United States often follow suit...more

Hogan Lovells

IoT in the EU: Lessons from COVID-19, and next steps for liability and regulation

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The IoT sector has exploded over the past few years, and, even taking into account the globally inhibitive effects of COVID-19, this growth shows few long-term signs of abating. The buoyant, fast-paced IoT industry was the...more

Hogan Lovells

Harmonizing cybersecurity for medical devices: International collaboration moves forward

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On 1 October 2019 the International Medical Device Regulators Forum (IMDRF) Medical Device Cybersecurity Working Group released a draft document titled "Principles and Practices for Medical Device Cybersecurity" (IMDRF...more

Baker Donelson

FDA Issues Cybersecurity Alert to Health Care Providers and Device Manufacturers

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The U.S. Food and Drug Administration took the unprecedented step this week of issuing an alert to health care providers and device manufacturers about potentially serious security flaws that may allow hackers to remotely...more

Morgan Lewis

FDA Devices Center Issues Multiple Guidances in the Obama Administration’s Final Months

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A flurry of regulatory activity preceded the transition in administration on January 20. Anticipating that the new administration would impose a regulatory slowdown, the Food and Drug Administration’s (FDA’s or the...more

Morgan Lewis

FDA Issues Final Guidance on Postmarket Cybersecurity

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Agency establishes a risk-based framework for assessment of postmarket cybersecurity risks for medical devices. On December 28, 2016, FDA issued a final guidance titled “Postmarket Management of Cybersecurity in Medical...more

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