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Cybersecurity › 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 -
Holland & Knight LLP

Holland & Knight Health Dose: July 15, 2025

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The U.S. House of Representatives returns from a district work period. The U.S. Senate is expected to consider the $9.4 billion rescissions package that passed the House last month. If not passed by July 18, 2025, the...more

Clark Hill PLC

The Learned Concierge - July 2025, Vol. 21

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The Learned Concierge - Welcome to your monthly legal insights on the trends impacting the Retail, Hospitality, and Food & Beverage Industries. Cybersecurity & Privacy - The Monthly Rundown of All Things Cyber, Privacy,...more

Hogan Lovells

FDA finalizes cyber device “select updates” guidance, potentially affecting substantial equivalence findings for 510(k)s

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The U.S. Food and Drug Administration (FDA) recently finalized its March 2024 select updates to its guidance "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions” (“Premarket...more

Blank Rome LLP

[Webinar] 180 Days of the Trump Administration—Quick Hits on Executive Orders, Actions, and Policies - July 17th - August 13th,...

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Blank Rome presents a new summer webinar series where our interdisciplinary team will unpack the most pressing legal, regulatory, and policy developments from the Trump Administration’s first 180 days. Each session offers...more

Gardner Law

FDA Finalizes Cybersecurity Premarket Guidance: What It Means for Medical Device Makers

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The FDA has finalized its guidance on cybersecurity for medical device premarket submissions, providing additional insight into the agency’s expectations for how manufacturers integrate cybersecurity risk management into...more

Clark Hill PLC

The Learned Concierge - May 2025, Vol. 19

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Welcome to your monthly legal insights on the trends impacting the Retail, Hospitality, and Food & Beverage Industries. Alcohol Law - New Colorado Law Limits Grocery Stores’ Ability to Sell Hard Alcohol - Michael...more

Morgan Lewis

Key Messaging from ‘Aging Technology, Emerging Threats: Examining Cybersecurity Vulnerabilities in Legacy Medical Devices’

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On April 1, 2025, the subcommittee on Oversight and Investigations of the House Committee on Energy and Commerce held a hearing on cybersecurity vulnerabilities in legacy medical devices. The hearing was largely a...more

Clark Hill PLC

The Learned Concierge - March 2025, Vol. 17

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The Learned Concierge - Welcome to your monthly legal insights on the trends impacting the Retail, Hospitality, and Food & Beverage Industries....more

Gardner Law

AI Regulation and Legal Trends in the U.S and Abroad

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The Evolving Role of AI/ML in Healthcare - The use of artificial intelligence/machine learning (AI/ML) in healthcare is evolving rapidly and introducing new challenges. Not only are medical devices using AI for diagnostics,...more

Spilman Thomas & Battle, PLLC

Decoded - Technology Law Insights, V 6, Issue 2, February 2025

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Welcome to our second issue of 2025 of Decoded - our technology law insights e-newsletter. For those of you with an interest in the Corporate Transparency Act, Brienne Marco and Joe Unger report that the recent injunction...more

Akin Gump Strauss Hauer & Feld LLP

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

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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

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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

Clark Hill PLC

The Learned Concierge - February 2025, Vol. 16

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The Learned Concierge - Welcome to your monthly legal insights on the trends impacting the Retail, Hospitality, and Food & Beverage Industries....more

Polsinelli

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

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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

Arnall Golden Gregory LLP

Healthcare Authority Newsletter - January 2025 #4

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News Briefs - 80 Percent of Health Organizations Hit with Cyberattack - More than 80 percent of healthcare organizations detected a cyberattack on their technology infrastructure within the past year, according to a survey by...more

Morrison & Foerster LLP

2024 Healthcare Fraud Enforcement Year in Review

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In 2024, as in years past, healthcare fraud enforcement by the U.S. Department of Justice (DOJ) was substantial. Federal actions under the False Claims Act (FCA) alone resulted in $1.67 billion in settlements and judgments...more

Sheppard Mullin Richter & Hampton LLP

FDA Dumps Trio of Device-Related Guidances Prior to Administration Change

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Among the wave of guidance documents issued by the U.S. Food and Drug Administration (“FDA” or the “Agency”) in the first week of 2025 were three notable draft guidance documents pertaining to medical devices (together, the...more

Knobbe Martens

FDA Issues Draft Guidance for the Use of Artificial Intelligence (AI) in Medical Devices and Drug Development

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The Food and Drug Administration (FDA) has recently issued two draft guidance documents aimed at providing recommendations for the use of AI in medical devices and drug and biological product development.These guidance...more

MoFo Life Sciences

FDA Draft Guidance on Artificial Intelligence-Enabled Device Software Functions

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This post is part of MoFo’s 2025 Intersection of AI and Life Sciences blog series. In this blog series, we explore how artificial intelligence is revolutionizing research, innovation, and patient care in the life sciences....more

Skadden, Arps, Slate, Meagher & Flom LLP

Drug Pricing and Health Care Fraud Remain Key Issues

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Key Points - - It remains to be seen what priorities Robert F. Kennedy Jr. and Marty Makary might set if confirmed as HHS secretary and FDA commissioner, respectively. - The Trump administration will likely focus on drug...more

DLA Piper

FDA Issues Artificial Intelligence-Enabled Device Software Functions Draft Guidance

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The US Food and Drug Administration (FDA) recently issued its draft guidance, Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations on January 7, 2025....more

Hogan Lovells

New guidance on AI-enabled device software functions clarifies information FDA expects in marketing applications

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On January 7, 2024, the U.S. Food and Drug Administration (FDA) published the draft guidance “Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations,” which...more

Arnall Golden Gregory LLP

Healthcare Authority Newsletter - January 2025 #1

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News Briefs - Number of Official Physician Union Drives Soared Over Two Years - While fewer than 10 percent of U.S. physicians are unionized, the number of official union drives among private-sector doctors have skyrocketed...more

King & Spalding

FDA Releases Draft Guidance on Submission Recommendations for AI-Enabled Device Software Functions

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On January 7, 2025, FDA published a draft guidance titled “Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations.” The draft guidance was long-anticipated; it...more

Sheppard Mullin Richter & Hampton LLP

Healthy AI: 2024 Year in Review

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On October 30, 2023, President Biden signed Executive Order 14110, laying the groundwork for the ethical and secure deployment of AI across industries, including healthcare. This comprehensive directive outlines policy goals...more

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