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Cybersecurity › National Institute of Standards and Technology › Food and Drug Administration (FDA)

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... more +
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 -
Akin Gump Strauss Hauer & Feld LLP

Akin Intelligence - June 2024

Akin Gump Strauss Hauer & Feld LLP on

Welcome to the June edition of Akin Intelligence. This month, the General Services Administration (GSA) launched its first AI-focused cohort of Presidential Innovation Fellows (PIF), bringing together experts from across the...more

Goodwin

A Look Ahead in Life Sciences: What We Are Tracking in Q2 2024 and Beyond

Goodwin on

As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving...more

Wiley Rein LLP

FCC Continues Push to Establish IoT Cyber Trust Mark Program

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On February 22, 2024, the Federal Communications Commission (FCC or “Commission”) released a Public Draft of a Report and Order that, if adopted, would establish a voluntary labeling program for Internet of Things (IoT)...more

Ankura

FDA Authorized to Establish New Cybersecurity Standards for Medical Devices: What it Means for Industry

Ankura on

On December 29, 2022, President Biden signed a new statute that will significantly impact medical device cybersecurity regulation. Section 3305 of the Consolidated Appropriations Act of 2023 (“Section 3305”) authorizes the...more

Sheppard Mullin Richter & Hampton LLP

HHS Releases Cybersecurity Guide

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The US Department of Health and Human Services recently updated its guide to help the private and public healthcare sectors develop cybersecurity protocols that address NIST’s Framework for Improving Critical Infrastructure...more

Clark Hill PLC

Window on Washington – Vol. 6, Issue 39

Clark Hill PLC on

Outlook for This Week in the Nation’s Capital - Congress.  Congress is in recess to campaign for the upcoming midterms. Senate Majority Whip Dick Durbin (D-IL) on Wednesday said the Senate will focus on judicial nominations...more

Health Care Compliance Association (HCCA)

[Event] Research Compliance Conference - June 8th - 10th, Anaheim, CA

Health Care Compliance Association (HCCA) on

Hear about the latest in research compliance - Do you want to learn… - How to prepare for upcoming changes in Medicaid? - Ways to build and maintain a better research compliance work plan for your program? - How...more

Arnall Golden Gregory LLP

Renewed Focus on Cybersecurity May Have Significant Impacts on Previously Shielded Healthcare Companies

Arnall Golden Gregory LLP on

On May 12, President Biden signed an executive order on improving the nation’s cybersecurity (the “Executive Order”). The Executive Order identified six broad initiatives for the improvement of security within federal...more

Spilman Thomas & Battle, PLLC

Decoded: Technology Law Insights - Issue 11, December 2020

Spilman Thomas & Battle, PLLC on

Brexit Effects on Trademarks Beginning January 1 - Trademark owners with registrations in EU where the UK is designated should soon receive notification for treatment of registrations and applications following the Brexit...more

Jones Day

Jones Day Global Privacy & Cybersecurity Update | Vol. 24

Jones Day on

UNITED STATES - Regulatory—Policy, Best Practices, and Standards - FTC Submits Comment on the Preliminary Draft for the NIST Privacy Framework - On October 24, 2019, the Federal Trade Commission ("FTC") announced that...more

Jones Day

Jones Day Global Privacy & Cybersecurity Update | Vol. 23

Jones Day on

UNITED STATES - Regulatory—Policy, Best Practices, and Standards - NIST Produces Roadmap for Improving Critical Infrastructure Cybersecurity Version 1.1 - On April 25, the National Institute of Standards and Technology...more

Holland & Knight LLP

Impact of the New Health Industry Cybersecurity Practices: 2019 Outlook

Holland & Knight LLP on

• The U.S. Department of Health and Human Services on Dec. 28, 2018, announced the release of the "Health Industry Cybersecurity Practices: Managing Threats and Protecting Patients" that provides a "Call to Action" to make...more

Sheppard Mullin Richter & Hampton LLP

FDA Issues New Draft Cybersecurity Guidance for Medical Devices

Sheppard Mullin Richter & Hampton LLP on

The Food & Drug Administration has recently released for comment a draft expansion of guidance regarding Content of Premarket Submissions for Management of Cybersecurity in Medical Devices. Although the FDA issued existing...more

Jones Day

Global Privacy & Cybersecurity Update Vol. 15

Jones Day on

UNITED STATES - Regulatory—Policy, Best Practices, and Standards - FTC Comments on Improvements to IoT Device Security - On June 19, the Federal Trade Commission ("FTC") submitted comments to a working group organized by the...more

Locke Lord LLP

After the Fact: FDA’s Guidance on Postmarket Management of Cybersecurity in Medical Devices

Locke Lord LLP on

The Food and Drug Administration (FDA) recently issued nonbinding guidance focusing on the software vulnerabilities of networked medical devices that are already on the market. The guidance focuses on the importance of...more

Locke Lord LLP

Privacy & Cybersecurity Newsletter

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New York’s Cybersecurity Requirements for DFS Licensees: A New Item at the Top of the To Do List - With a compliance date a few months away, licensees of the New York Department of Financial Services (DFS) must start...more

BakerHostetler

FDA Issues Guidance on Cybersecurity Issues for Postmarket Medical Devices

BakerHostetler on

On January 22, 2016, the Food and Drug Administration (FDA) issued draft guidance on cybersecurity risks associated with medical devices, and addressed steps that device manufacturers should take to mitigate such risks. The...more

Morrison & Foerster LLP

FDA Embraces Internet of Things: New Draft Guidance on Postmarket Cybersecurity for Medical Devices

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The FDA’s recently issued draft guidance on “Postmarket Management of Cybersecurity in Medical Devices” seeks to address some of the increasing concerns that medical device providers, regulators, and consumers have about...more

Cooley LLP

Blog: FDA Issues Draft Guidance on Medical Device Cybersecurity

Cooley LLP on

Recently, the U.S. Food and Drug Administration (FDA) published draft guidance entitled “Postmarket Management of Cybersecurity in Medical Devices” (the Guidance) that sets forth ways in which medical device manufacturers...more

Epstein Becker & Green

FDA Recommends Medical Device Manufacturers Implement a Comprehensive Cybersecurity Risk Management Program in Accordance with...

Epstein Becker & Green on

Medical devices increasingly contain software or connect to networks that may leave the devices vulnerable to cyber-attacks. The U.S. Food and Drug Administration (“FDA”) has recognized the potential risks that these...more

King & Spalding

FDA Issues Draft Guidance Governing Postmarket Cybersecurity Risk Management Standards

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On January 15, 2016, the U.S. Food and Drug Administration (FDA) announced in a Press Release that it would issue draft guidance on January 22 outlining “steps medical device manufacturers should take to continually address...more

Robinson+Cole Data Privacy + Security Insider

FDA issues guidance on cybersecurity risk management for medical devices

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Friday (January 22, 2016), the Food and Drug Administration (FDA) published draft guidance for medical device makers on the importance of including cybersecurity measures in approved products. Further, the guidance highlights...more

Sheppard Mullin Richter & Hampton LLP

Government Forces Awaken: The Rise of Cyber Regulators in 2016

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As the sun sets on 2015, but before it rises again in the New Year, we predict that, in the realm of cyber and data security, 2016 will become known as the “Rise of the Regulators.” Regulators across numerous industries and...more

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