Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 236: Advocating for Accessible Diagnoses with Sydney Severance of Operation Upright
Federal Court Strikes Down FDA Rule on LDTs - Thought Leaders in Health Law®
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 233: Prioritizing Women’s Health Through Innovation with Lindsey Calcutt of Incora Health
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 228: Designing & Manufacturing Auto-Injectors with Kimberlee Steele of SHL Medical
Building a Business at the Intersection of Neurodata and Innovation With Rob Cooley
AGG Talks: Cross-Border Business Podcast - Episode 26: U.S. Enforcement Trends Targeting Foreign Pharmaceutical and Medical Device Manufacturers
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 209: North Carolina’s Life Sciences Industry with Laura Gunter of NCLifeSci
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 208: Extended Reality Technology and the ThinkReality Headset with Mattney Beck of Lenovo
AI in the Operating Room: Liability Issues for Device Makers — The Good Bot Podcast
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 201: SHL Medical’s Investment in the Carolinas with Kimberlee Steele of SHL Medical
The FDA's Response to AI Medical Innovation — The Good Bot Podcast
Meet Meaghan Luster: Patent Litigation Associate at Wolf Greenfield
FDA Releases Laboratory-Developed Tests Final Rule – Thought Leaders in Health Law
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 177: Brain Health and Research with Dr. Fridriksson, Neuroscientist, Professor, & Vice President of Research at the Universit
Transparency and the Open Payments Program
Medical Device Legal News with Sam Bernstein: Episode 19
Medical Device Legal News with Sam Bernstein: Episode 18
Medical Device Legal News with Sam Bernstein: Episode 17
Health + Tech - Improving Cancer Care With Digital Health Tools
Medical Device Legal News with Sam Bernstein: Episode 14
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
With the first half of 2025 in the rearview mirror, the government’s continued focus on False Claims Act (FCA) enforcement shows no signs of slowing. In fact, the Department of Justice recently announced the results of a...more
- 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
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
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
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
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
President Ronald Reagan famously quipped, "I think you all know that I've always felt that the nine most terrifying words in the English language are: I'm from the Government, and I'm here to help."1 At an Oct. 23-24, 2024,...more
As healthcare technology continues to evolve, so does the need for robust compliance strategies to safeguard patient information and ensure the integrity of medical devices. In a joint September 19, 2024 presentation, the...more
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
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
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
...Innovation in connected medical devices is critical to advances in health care outcomes, user experience, and reducing costs. These exciting technologies also can be challenging when it comes to navigating the complex...more
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
The World Health Organization ("WHO") published key principles for regulating artificial intelligence (AI) for health on 19 October 2023. The document, titled ‘Regulatory Considerations on Artificial Intelligence for Health’...more
On September 27, 2023, FDA finalized its guidance entitled “Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions” (the “2023 Final Guidance”). The Final Guidance replaces...more
The U.S. Food and Drug Administration (FDA) has finalized its guidance on “Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions,” which advises medical device manufacturers on...more
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
Artificial intelligence promises to transform the way we live and work and its impact will undoubtedly stretch to every business sector across the globe. This next generation of technology brings exciting possibilities and...more
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
(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
Medtech companies are evolving rapidly as more and more of them develop products that collect and leverage substantial patient and provider data. Companies that once only developed hardware-based solutions for...more
Editor’s Note: We are excited to announce that this article is the first of a series addressing Software as a Medical Device and the issues that plague digital health companies, investors, clinicians and other organizations...more
In recent years, products liability law has been significantly impacted by advancements in technology, particularly with the rise of artificial intelligence (AI) and automation. As more companies adopt these technologies to...more
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