News & Analysis as of September 24, 2024

Cybersecurity › Final Guidance

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Follow this channel for advisories on one of the biggest threats to businesses today. Read a morning brief of fresh guidance and commentary by leading lawyers on security, privacy, risk management, global regulations, data protection, leaks, hacking, cyber insurance, compliance, HIPAA, and every other aspect of cybersecurity of import to corporate readers right now. less -

Federal Regulators Unveil Revised Final Guidance for Healthcare Cybersecurity and HIPAA Compliance

Ogletree, Deakins, Nash, Smoak & Stewart,... on 2/26/2024

On February 14, 2024, the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) and the National Institute of Standards and Technology (NIST) published a new, final version of their guidance for...more

Dechert Re:Torts - Key Developments in Product Liability and Mass Torts - Issue 10

Dechert LLP on 10/31/2023

Senators Focus Attention on Litigation Funding’s Opacity - Building on the momentum we previously noted related to litigation funding, on September 14, Senator John Kennedy introduced the Protecting Our Courts from Foreign...more

FDA Finalizes Premarket Cybersecurity Guidance for Medical Devices

King & Spalding on 10/11/2023

On September 27, 2023, FDA finalized its guidance entitled “Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions” (the “2023 Final Guidance”). The Final Guidance replaces...more

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

Hogan Lovells on 6/22/2022

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

And So It Begins: House Energy and Commerce Leaders Unveil FDA User Fees Legislative Package

King & Spalding on 5/11/2022

On May 4, 2022, House Energy and Commerce (“E&C”) Committee leaders unveiled the legislative package to reauthorize the U.S. Food and Drug Administration (“FDA” or the “Agency”) user fee agreements (the “House Draft”)...more

NIST Finalizes Guidance on Security and Privacy Control Baselines – SP 800-53B

Sheppard Mullin Richter & Hampton LLP on 11/9/2020

NIST has now finalized its guidance providing important information on selecting both security and privacy control baselines for the Federal Government. The guidance is available here: Special Publication 800-53B, Control...more

Bridging the Week - August 2019

Katten Muchin Rosenman LLP on 8/6/2019

Both the Commodity Futures Trading Commission and the Chicago Mercantile Exchange brought and settled charges against a CFTC-registered floor broker, claiming he engaged in spoofing trading activity on the CME. The two...more

DOD and Other Agencies Seek to Enhance Contractors’ Cyber and Supply Chain Security

Akin Gump Strauss Hauer & Feld LLP on 12/20/2018

The Department of Defense (DOD) and its component services and agencies are taking several independent steps to assess and enhance their cyber and supply chain security that will directly or indirectly affect DOD contractors...more

Working Together: FDA Releases Final Guidance on Interoperability

Hogan Lovells on 10/3/2017

On September 6, 2017, the Food and Drug Administration (FDA or the Agency) released its final guidance document, Design Considerations and Pre-Market Submission Recommendations for Interoperable Medical Devices (Final...more

Cybersecurity Disclosures: A How-To Guide

BCLP on 5/2/2017

In October of 2011, the U.S. Securities and Exchange Commission (“SEC”) issued guidance regarding a public company’s obligations to disclose cybersecurity risks and cyber incidents (the “Cybersecurity Disclosure Guidance”)....more

FDA Issues Final Guidance on Postmarket Cybersecurity

Morgan Lewis on 1/10/2017

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

ALERT: NIST Issues Final Guidance on Federal Contractor Cybersecurity Standards for Controlled Unclassified Information

Sheppard Mullin Richter & Hampton LLP on 6/24/2015

On June 19, 2015, the National Institute of Standards and Technology (NIST) published the final version of guidance for federal agencies to ensure sensitive information remains confidential when stored outside of federal...more

New FDA Cybersecurity Guidance for Medical Device Manufacturers

Parker Poe Adams & Bernstein LLP on 11/20/2014

Last month, the U.S. Food and Drug Administration issued its final guidance, “Content of Premarket Submissions for Management of Cybersecurity in Medical Devices.” Those guidelines make non-binding recommendations on the...more

FDA Releases Final Cybersecurity Guidance for Medical Devices

Polsinelli on 10/29/2014

Overview and General Principles - On October 2, 2014, the Food and Drug Administration (“FDA”) finalized guidance describing the FDA’s position on cybersecurity standards for medical devices. The guidance discusses...more

Medical Devices and Cybersecurity Risks - DHS investigates at-risk devices

King & Spalding on 10/27/2014

On October 2, 2014, the U.S. Food and Drug Administration (FDA) issued its final guidance on cybersecurity for medical device manufacturers, titled “Content of Premarket Submissions for Management of Cybersecurity in Medical...more

A Different Kind of “Virus”: FDA Follows NIST Framework in Cybersecurity Guidance for Medical Devices

Mintz - Privacy & Cybersecurity Viewpoints on 10/9/2014

In past posts we’ve taken a close look at the Framework for Improving Critical Infrastructure Cybersecurity put forth by the National Institute of Standards and Technology (NIST), exploring its wide-ranging implications for...more

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