News & Analysis as of June 3, 2025

Cybersecurity › Food and Drug Administration (FDA) › Life Sciences

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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 -

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issued by the U.S. Food and Drug Administration (“FDA” or the “Agency”) in the first week of 2025 were three notable draft guidance documents pertaining to medical devices (together, the...more

FDA Issues Draft Guidance for the Use of Artificial Intelligence (AI) in Medical Devices and Drug Development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The Food and Drug Administration (FDA) has recently issued two draft guidance documents aimed at providing recommendations for the use of AI in medical devices and drug and biological product development.These guidance...more

FDA Draft Guidance on Artificial Intelligence-Enabled Device Software Functions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

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On January 7, 2024, the U.S. Food and Drug Administration (FDA) published the draft guidance “Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations,” which...more

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

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

In This Month’s E-News: November 2024

Health Care Compliance Association (HCCA) on 11/4/2024

On the heels of a $7.6 million payment by Cleveland Clinic to settle allegations of False Claims Act (FCA) violations and unallowable sharing of passwords, Michael Lauer, NIH deputy director for extramural research, penned a...more

Vital Signs: Digital Health Law Update | Spring 2024

Jones Day on 7/22/2024

Welcome to Vital Signs, a curated compilation of the latest legal and regulatory developments in digital health. Our lead article reports on recent developments in the U.S. Food and Drug Administration's ("FDA") regulatory...more

New FDA Guidance on AI and Medical Products

Troutman Pepper Locke on 4/12/2024

n March 15, the U.S. Food and Drug Administration (FDA) published a paper titled “Artificial Intelligence and Medical Products: How CBER, CDER, CDRH, and OCP are Working Together.” This paper describes the FDA’s strategy for...more

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

Goodwin on 4/1/2024

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

The Nucleus: Life Sciences Enforcement and Regulatory Updates - March 2024

Skadden, Arps, Slate, Meagher & Flom LLP on 3/25/2024

Circuit Split Widens Over AKS-Based FCA Causation Element - The Anti-Kickback Statute (AKS) continues to form the basis of hundreds of millions of dollars of annual recoveries for the government under the federal False...more

FDA Needs a New Approach to AI/ML-Enabled Medical Devices

Mintz - Health Care Viewpoints on 3/13/2024

We have been writing about software as a medical device (SaMD) for years, tracking the Food and Drug Administration's (FDA) efforts to keep up with the fast-paced development of digital technology, such as launching the...more

Decoded - Technology Law Insights, V 5, Issue 2, March 2024

Spilman Thomas & Battle, PLLC on 3/8/2024

HHS Cybersecurity Performance Goals and the Healthcare Industry - The healthcare industry is a major target for cyberattacks because of all of the personal information collected from patients. Recognizing that the healthcare...more

In This Month’s E-News: February 2024

Health Care Compliance Association (HCCA) on 1/30/2024

The Food and Drug Administration (FDA) is seeking strategies from Jeffrey W. Taub, M.D., to prevent future violations of human subject regulations the agency said were documented during site visits in September and October...more

2024 Regulatory, Compliance, and Enforcement Predictions for Life Sciences Companies

Morrison & Foerster LLP on 1/10/2024

The year 2023 was a busy one for regulatory, compliance, and enforcement developments in the healthcare and life sciences industries, and 2024 promises to be even busier. We tapped MoFo’s Life Sciences + Healthcare Compliance...more

President Biden's AI EO: Key Takeaways for Health Care & Life Sciences

Akin Gump Strauss Hauer & Feld LLP on 11/13/2023

Key Points - President Biden’s eagerly-awaited executive order (EO) on artificial intelligence (AI) tasks the Department of Health & Human Services (HHS) with promoting responsible AI innovation, development and use,...more

The Nucleus: Life Sciences Enforcement and Regulatory Updates

Skadden, Arps, Slate, Meagher & Flom LLP on 11/3/2023

In this issue of our newsletter on developments impacting the life sciences industry, we examine topics including how the increased DOJ and FDA focus on cybersecurity issues could lead to new theories of False Claims Act...more

FDA Publishes New Guidance on Cybersecurity in Medical Devices

McGuireWoods LLP on 10/3/2023

In response to a growing number of cyberattacks in the healthcare and life sciences industries, on Sept. 27, 2023, the U.S. Food and Drug Administration (FDA) released updated guidance regarding cybersecurity safety...more

Hot Topics in Health Care July 2023

Burr & Forman on 7/27/2023

Progress of Pre-Submissions for Medical Devices Now Trackable Through CDRH Portal - Medical device manufacturers must submit applications for certain classes of medical devices for approval by the Food and Drug...more

FDA Issues Implementation Guidance on Cybersecurity Requirements for Medical Device Premarket Submissions

Nelson Mullins Riley & Scarborough LLP on 4/18/2023

The U.S. Food and Drug Administration (FDA or the Agency) has issued guidance concerning cybersecurity requirements for certain medical device premarket submissions (the Guidance). The Guidance outlines the implementation of...more

FDA Publishes Implementation Policy Regarding Cybersecurity Requirements for Medical Device Premarket Submissions

Nelson Mullins Riley & Scarborough LLP on 4/17/2023

The U.S. Food and Drug Administration (FDA or the Agency) published guidance regarding cybersecurity requirements for certain device premarket submissions (the Guidance). The Guidance outlines the implementation of new...more

Software and Digital Health Policies Issued by FDA

Akin Gump Strauss Hauer & Feld LLP on 4/6/2023

Multiple policy documents relating to software and digital health have been issued by the U.S. Food and Drug Administration (FDA). The documents offer: a framework for the use of digital health tools in the context of drug...more

Prevent A Clinical Trial From Turning Into A Criminal Trial

MoFo Life Sciences on 11/16/2022

On November 2, 2022, Stacy Cline Amin, former Chief Counsel of the U.S. Food and Drug Administration (FDA) and Deputy General Counsel of the Department of Health and Human Services (HHS), moderated the panel “Compliance and...more

FDA’s New Draft Guidance on Cybersecurity

Gardner Law on 8/17/2022

The FDA has been continuing to work on protecting medical devices from the threats of cybersecurity. In April of this year, the Agency released the latest draft guidance addressing cybersecurity in the medical device...more

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