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Data Breach Data Privacy Food and Drug Administration (FDA)

Spilman Thomas & Battle, PLLC

Decoded - Technology Law Insights, V 5, Issue 7, August 2024

Welcome to our seventh 2024 issue of Decoded - our technology law insights e-newsletter. We have a few events we want to pass along to those interested in technology, but also other areas of law and business. ...more

Ankura

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

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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

Gardner Law

[Hybrid Event] Navigating the M&A Waters of FDA-Regulated Companies - May 18th, Spring Park, MN

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Join Gardner Law and colleagues live from Lord Fletcher's on Lake Minnetonka, Minnesota for a complimentary CLE event. Hear from a panel of experts on compliance, data breaches, FDA regulations, privacy, and more....more

Orrick, Herrington & Sutcliffe LLP

Global Authorities Ramp Up Medical Device Cybersecurity Expectations: What Medical Device Companies Need to Know

The last year has seen a multijurisdictional regulatory push for increased cybersecurity standards for medical devices. The new approaches, issued by regulatory authorities in the United States (U.S.), the United Kingdom (UK)...more

Spilman Thomas & Battle, PLLC

Decoded - Technology Law Insights, Issue 15, 2022

Data Privacy, Abortion Limits Set to Collide Post-Roe "Even before the June 24 ruling in Dobbs v. Jackson Women’s Health Organization, privacy advocates, concerned that data on women seeking abortions could be used to target...more

Spilman Thomas & Battle, PLLC

Decoded: Technology Law Insights - Issue 10, 2022

House Subcommittee Debates Device Remanufacturing Definition, Sends User-Fees Bill to Next Stage "Proponents of the remanufacturing bill are looking to better distinguish between medical device remanufacturing, and...more

Skadden, Arps, Slate, Meagher & Flom LLP

Privacy & Cybersecurity Update - April 2022

In this month’s Privacy & Cybersecurity Update, we examine the FTC chair’s comments suggesting a potential shift in its approach to data privacy regulation, the European Data Protection Board’s request for comment on its...more

Hogan Lovells

FDA updates “cybersecurity in medical devices” guidance, seeks industry input - Draft guidance addresses quality system...

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The U.S. Food and Drug Administration (FDA) issued updated draft guidance, “Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions,” which aims to help industry take a more...more

Spilman Thomas & Battle, PLLC

Decoded - Technology Law Insights, Volume 3, Issue 6

Massachusetts-Based Background Check Company Creative Services Faces Multiple Lawsuits Over Data Breach - "'CSI determined that certain files dating from November 2018 to November 2021 may have been copied from their...more

Sheppard Mullin Richter & Hampton LLP

Eye On Privacy: 2021 Year in Review

Just as we thought 2022 was going to be significantly different than 2021, December 2021 and January 2022 events have thrown us for another (pandemic) loop. We anticipate that some of the privacy and cybersecurity...more

Spilman Thomas & Battle, PLLC

Decoded: Technology Law Insights - Issue 3, August 2020

The Editors' Note - Welcome to the third issue of Decoded, Spilman's e-newsletter focusing on technology law, including data security, privacy standards, financing technologies, and digital-based means of conducting...more

Jones Day

Jones Day Global Privacy & Cybersecurity Update | Vol. 24

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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

Cozen O'Connor

The State AG Report Weekly Update August 2019 #3

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Charities- 4 Attorneys General Settle with Military Charity Over Alleged Deceptive Practices- Four AGs, led by Virginia AG Mark Herring, reached a settlement with Hearts 2 Heroes Inc., d/b/a Active Duty Support Services...more

Cozen O'Connor

The State AG Report Weekly Update June 2019 #2

Cozen O'Connor on

Antitrust- 10 Attorneys General Sue to Enjoin Merger of Major Wireless Phone Companies- 10 AGs, led by New York AG Letitia James and California AG Xavier Becerra, filed a lawsuit to enjoin T-Mobile US, Inc. and its parent...more

Holland & Knight LLP

Impact of the New Health Industry Cybersecurity Practices: 2019 Outlook

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• 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

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

King & Spalding

FDA Proposes Updates To Premarket Cybersecurity Guidance For Medical Devices

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The U.S. Food and Drug Administration (“FDA”) released updated draft guidelines on how medical device manufacturers should protect against data breaches and viruses prior to marketing their products. The new draft, once...more

Holland & Knight LLP

FDA, DHS Increase Coordination Over Medical Device Cybersecurity Risks to Patient Safety

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The U.S. Food and Drug Administration (FDA) is moving aggressively in the month of October to continue to raise concerns about cybersecurity risks to medical devices, with three recent updates. The FDA just released new draft...more

Akin Gump Strauss Hauer & Feld LLP

What's New In Washington - September 2018

Following a truncated August recess, the House and the Senate returned to Washington after Labor Day with a full plate of legislative items to address prior to the end of the fiscal year on September 30. That list includes...more

K&L Gates LLP

K&L Gates Triage: Artificial Intelligence in Health Care

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Artificial Intelligence (AI) systems, including the use of algorithms and computer software to analyze complex data and perform certain decision making functions without direct human involvement, are rapidly developing in...more

Akin Gump Strauss Hauer & Feld LLP

Trump Administration: 2017 Recap and 2018 Outlook

On January 20, 2017, businessman Donald J. Trump was sworn in as the 45th President of the United States following a contentious and unconventional 2016 presidential election. Republicans also successfully maintained control...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

Arnall Golden Gregory LLP

Six Ways for Data-Driven Medical Device Companies to Implement Effective Privacy and Security Measures

The increasing amounts of health information being generated, stored and collected have heightened the special risks medical device manufacturers have long faced. In addition to the nexus to patient health and safety, if a...more

Robinson+Cole Data Privacy + Security Insider

FDA issues first medical device hacking alert

Reportedly for the first time ever, the FDA recently issued a declaration that hospitals should not use a medical device manufactured by Hospira Inc. because of security flaws that could allow hackers to penetrate hospital...more

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