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Data Privacy Data Protection Food and Drug Administration (FDA)

Akin Gump Strauss Hauer & Feld LLP

Security Requirements and Compliance Obligations in DOJ's Final Rule on Data Transactions

The Department of Justice’s (DOJ) final rule implements President Biden’s Executive Order 14117 of February 28, 2024, on “Preventing Access to Americans’ Bulk Sensitive Personal Data and United States Government-Related Data...more

Polsinelli

CISA and FDA Sound Alarm on Backdoor Cybersecurity Threat with Patient Monitoring Devices

Polsinelli on

Last week, the U.S. Cybersecurity and Infrastructure Security Agency (“CISA”) and the U.S. Food and Drug Administration (“FDA”) released warnings about an embedded function they found in the firmware of the Contec CMS8000,...more

Polsinelli

Generative Artificial Intelligence Leveraged to Deliver Healthcare - Legal Risks and Issues

Polsinelli on

With daily media reports citing to the explosion of interest in Artificial Intelligence (“AI”), AI start-ups have attracted a huge capital influx. During the last fiscal quarter of 2024 ending on December 31st, investors...more

Nelson Mullins Riley & Scarborough LLP

Bipartisan House Task Force Report Outlines Key Areas of AI Focus for Health Care

As the New Year begins, questions surrounding how recent election results will impact technology regulation across industries loom large. It’s hardly a bold prediction that artificial intelligence (“AI”) and the regulation...more

Brownstein Hyatt Farber Schreck

Bipartisan AI Task Force Report Sets the Stage for Health Care AI Action in 2025

The House Task Force on Artificial Intelligence (AI) released a comprehensive 253-page report providing a roadmap for Congress as it develops policies to regulate and optimize the use of this rapidly advancing technology. The...more

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

Jackson Lewis P.C.

Cybersecurity Awareness Month: FDA Guidance on Cybersecurity in Medical Devices

Jackson Lewis P.C. on

Cyber incidents are on the rise with no signs of slowing down, particularly in the healthcare industry. To combat this trend, on September 27, 2023, the U.S. Food and Drug Administration (FDA) released guidance on...more

Knobbe Martens

FDA Updates Cybersecurity Guidance

Knobbe Martens on

(May 30, 2023) Going forward, medical device approval will require the device maker to provide cybersecurity information to the FDA. Congress made this change by adding Section 524B to the Federal Food, Drug, and Cosmetic...more

McDermott+

McDermottPlus Check-Up: May 19, 2023

McDermott+ on

The House and Senate were both in session this week, with significant healthcare activity at the committee level. The House Ways & Means Committee met to discuss healthcare price transparency, and the Ways & Means Health...more

Skadden, Arps, Slate, Meagher & Flom LLP

Privacy & Cybersecurity Update - April 2023

In this month’s Privacy & Cybersecurity Update, we look at Washington state’s passage of the first-ever state-level health data privacy law and the finalized California Consumer Privacy Act regulations. We also examine a...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, Volume 3, Issue 16

CHIPS and Science Act Will Lower Costs, Create Jobs, Strengthen Supply Chains, and Counter China "Spurred by the passage of the CHIPS and Science Act of 2022, companies have announced nearly $50 billion in additional...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, Volume 3, Issue 14

Is the U.S. Finally Getting a Comprehensive Cybersecurity and Data Protection Law? What You Need to Know About the Proposed American Data Privacy and Protection Act - In the beginning of the 2000s, as a result of the...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...

Hogan Lovells on

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

Spilman Thomas & Battle, PLLC

Decoded: Technology Law Insights, Volume 3, Issue 5

The Cryptocurrency Revolution and President Biden's Formal Recognition - Out of the ashes of the 2008 financial crisis, Bitcoin sprang up like an insurgency, targeting both the unbridled activity of large financial...more

Goodwin

Five Emerging Concerns for the Health Care Industry as AI & Telehealth Converge

Goodwin on

The use of telehealth continues to grow rapidly across the U.S. Given legislative proposals and the Centers for Medicare & Medicaid Services efforts to expand access to telehealth, we can only anticipate that remotely...more

Morgan Lewis - Up & Atom

Cybersecurity and the NRC: A Primer for Radioactive Materials Licensees

As is clear from recent news reports, cybersecurity hacks and breaches have been trending upward for some time, and there has been a noticeable uptick over the last several months—including in the energy industry. ...more

Arnall Golden Gregory LLP

I Wish I Knew What I Know Now: Conversations with AGG on FDA Issues - Data Privacy Issues Life Sciences Companies May Encounter

In this episode, AGG’s Food & Drug team leader, Alan G. Minsk, and co-chair of AGG's Data Privacy practice, Kevin L. Coy, discuss U.S. and international privacy and data security law issues life sciences companies may...more

Health Care Compliance Association (HCCA)

[Event] March Research Compliance Academy - March 9th - 12th, San Diego, CA

HCCA's Health Care Research Compliance Academy is a three-and-a-half-day intensive training program focuses on compliance issues related solely to research. Its faculty is made up of experts in the field. With a wide range of...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

Robinson+Cole Data Privacy + Security Insider

Cybersecurity Risks in Medical Devices Discussed at Recent FDA Meeting

The Patient Engagement Advisory Committee to the Food and Drug Association (FDA) met recently to discuss cybersecurity in medical devices. Medical devices are increasingly connected to the internet, hospital networks, and...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

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