News & Analysis as of August 14, 2025

Food and Drug Administration (FDA)

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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... 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 -

DOJ Announces First FCA Settlement with Medical Device Company for Cybersecurity Violations

Morgan Lewis - As Prescribed on 8/13/2025

The US Department of Justice’s settlement with Illumina, Inc. is a first-of-its-kind involving alleged cybersecurity deficiencies causing violations of the False Claims Act (FCA) based on FDA quality standards. The...more

DOJ Settlement With Medical Technology Company Signals Expanding Cybersecurity FCA Risk for Life Sciences Companies

Skadden, Arps, Slate, Meagher & Flom LLP on 8/8/2025

- What is new: DOJ announced a $9.8 million FCA settlement with Illumina Inc. to resolve claims arising out of alleged cybersecurity deficiencies in DNA sequencing systems Illumina sold to government agencies. - Why it...more

At the Crossroads: Illumina Settlement Reflects the Intersection of Cybersecurity and Healthcare Law

Paul Hastings LLP on 8/8/2025

On July 31, the U.S. Department of Justice (DOJ) announced a settlement in United States ex rel. Lenore v. Illumina, Inc, the first case in which underlying cybersecurity issues formed the basis of a settlement under the...more

DOJ Secures First of Its Kind Cybersecurity False Claims Act Settlement

White & Case LLP on 8/6/2025

On July 30, 2025, the U.S. Department of Justice (DOJ) announced that biotechnology company Illumina Inc. agreed to pay $9.8 million plus interest to resolve allegations of misrepresenting compliance with federal...more

Why Every Manufacturer Needs a Robust Information Security Program

Gardner Law on 7/31/2025

Drug and device manufacturers are increasingly targeted by cyber threats that can compromise patient safety, intellectual property, and other critical data and systems, while also facing new regulatory demands. As regulators...more

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

Hogan Lovells on 7/7/2025

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

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

Gardner Law on 7/2/2025

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

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

Morgan Lewis on 4/10/2025

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

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

Gardner Law on 2/28/2025

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

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

Spilman Thomas & Battle, PLLC on 2/27/2025

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

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

Polsinelli on 2/13/2025

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

Healthcare Authority Newsletter - January 2025 #4

Arnall Golden Gregory LLP on 2/3/2025

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

2024 Healthcare Fraud Enforcement Year in Review

Morrison & Foerster LLP on 1/28/2025

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

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

Sheppard Mullin Richter & Hampton LLP on 1/28/2025

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

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

Knobbe Martens on 1/23/2025

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

FDA Draft Guidance on Artificial Intelligence-Enabled Device Software Functions

MoFo Life Sciences on 1/22/2025

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

Drug Pricing and Health Care Fraud Remain Key Issues

Skadden, Arps, Slate, Meagher & Flom LLP on 1/21/2025

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

FDA Issues Artificial Intelligence-Enabled Device Software Functions Draft Guidance

DLA Piper on 1/16/2025

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

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

Hogan Lovells on 1/15/2025

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

Healthcare Authority Newsletter - January 2025 #1

Arnall Golden Gregory LLP on 1/13/2025

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

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

King & Spalding on 1/13/2025

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

FDA Issues Draft Guidance on AI-Enabled Medical Devices

Orrick, Herrington & Sutcliffe LLP on 1/8/2025

The FDA has shared draft guidance on the design and development of AI-enabled medical devices and marketing submissions for those devices. The Importance of Engaging Early Sponsors of AI-enabled devices should engage with the...more

Healthcare Authority Newsletter - December 2024 #2

Arnall Golden Gregory LLP on 12/20/2024

News Briefs - Congress Taking on Healthcare Policies Set to Expire - Congress has begun discussions on important healthcare policies set to expire on December 31....more

AI in Drug Discovery: 2025 Outlook

Foley & Lardner LLP on 12/19/2024

Looking forward to the 2025 prediction season, a survey of the emerging AI-powered drug discovery landscape has been making the rounds—and with good reason. The survey, summarized by Stanford’s Chris Bradbury, is likely the...more

Three Questions with Sedgwick’s Jeremy Schutz

Akin Gump Strauss Hauer & Feld LLP on 12/4/2024

In this edition of Three Questions, health care & life sciences partner Nate Brown spoke with Jeremy Schutz, director of business development, recall & remediation at Sedgwick, to explore key strategies that pharmaceutical...more

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