No Password Required: CEO of HACKERverse.ai, Disruptor of Cybersecurity Sales and Most Other Things
Investment Opportunities in Italy's Tech Market
The SaaS Tacks – The Ins and Outs of Negotiating SaaS Contracts
Law School Toolbox Podcast Episode 430: The Paxton AI Founders Talk About Their AI Legal Assistant
CMO Series EP100 - Celebrating 100 episodes and exploring the future of professional services marketing
Medical Device Legal News with Sam Bernstein: Episode 10
PODCAST: Williams Mullen's Trending Now: An IP Podcast - Paralegal Insights: A Collaborative Trademark Practice, Series 3
JONES DAY PRESENTS®: Enhancing Trade Secret Protection in Remote Work Environments
Investigative Power: Utilizing Self Service Solutions for Internal Investigations?
Podcast: Unpacking FDA's Final Clinical Decision Support Guidance - Diagnosing Health Care
Software Escrow: An enterprise resiliency tool every legal department should have in their toolbox (with Don Dennis Jr.)
ASG LegalTech CEO Soumya Nettimi Talks Covid, Racial Injustice and The Future of Legal Payments: On Record PR
E8: Interview with Cookiebot CEO on Technical Solutions to GDPR Readiness
New Revenue Recognition Standard-Part III, Shaking Up the Software Industry?
Unfair and Unbalanced-Episode 19
FCPA Compliance Report-Episode 286-Use of Technology in Supply Chain Risk Management
Compiling Successful IP Solutions for Software Developers
Drafting Software Patents In A Post-Alice World
Polsinelli Podcasts - Hear How the SCOTUS Ruling May Impact Patent-Eligible Subject Matter for Software
IP|Trend: New Era in Protection of Software by Intellectual Property Law?
Despite continued macroeconomic headwinds and a cautious investment climate, Mintz’s Venture Capital and Emerging Companies practice remained highly active throughout 2024 and into the first half of 2025. Our team advised on...more
For the past decade, controversy regarding the laws of patent eligibility has created uncertainty in the minds of inventors and investors, especially in the biotechnology, medical diagnostics, and software industries adjacent...more
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
Last week, the U.S. Food and Drug Administration (FDA) issued two significant draft guidance documents concerning the use of artificial intelligence (AI) in medical devices and in drug and biological product development....more
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
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
Last week, the U.S. Food and Drug Administration (FDA) finalized guidance on the types of information that should be included in a Predetermined Change Control Plan (PCCP) as part of a marketing submission for an artificial...more
On December 4, 2024, the U.S. Food and Drug Administration (“FDA”) released its final guidance for industry on predetermined change control plans (“PCCPs”) for devices that utilize artificial intelligence-enabled software...more
For decades, FDA’s Center for Devices and Radiological Health (CDRH) has been recognizing standards that can be referenced in premarket medical device submissions....more
Investment in artificial intelligence (AI) is rising fast. The International Data Corporation projects global spending on AI R&D will reach $632 billion by 2028, more than twice the expected total for 2024....more
Even before the Biden administration issued a landmark executive order on October 30, 2023, establishing new standards for artificial intelligence (AI) safety and security, the US Food and Drug Administration (FDA) had been...more
regulators. The U.S. Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) regulates medical devices, including software-as-a-medical-device (SaMD). Several years ago, the FDA upgraded its...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
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
Software is increasingly used as a medical device, transforming the healthcare industry with the goal of improving patient outcomes. However, developing software as a medical device involves navigating complex and evolving...more
Introduction - Hardly a day goes by when we don’t see some media report of health care providers experimenting with machine learning, and more recently with generative AI, in the context of patient care. The allure is...more
If there is one thing that everyone can agree on, it is that health is an important factor in life. In 2021, over 3 million people died in the United States with heart disease and cancer topping the list....more
The U.S. Food and Drug Administration (“FDA” or the “Agency”) has issued a final report discussing the results of its Software Precertification Pilot Program (the “Pilot Program”). Importantly, the September 26, 2022 report...more
Part 1 of this article discussed the background and purpose of the EU In Vitro Diagnostic Regulation (EU) 2017/746 (IVDR), the definition of in vitro diagnostic medical devices (IVDs), the risk-based classification system,...more
In vitro diagnostic medical devices (IVDs), hence devices used for medical tests on samples such as blood or tissue that have been taken from the human body, have become the center of attention in the public eye during the...more
The International Electrotechnical Commission (IEC) and the International Organization for Standards (ISO) recently published a cybersecurity standard that has received limited press but may have a significant impact on...more
FDA is actively monitoring the use of AI and machine learning (ML) software in medical devices and clinical developments, and has taken a number of first steps in building out a regulatory framework. In 2021, FDA published...more
What This Means for the FDA and the Industry - The COVID-19 pandemic has spurred the development of digital health products utilizing artificial intelligence (AI) and machine learning (ML). When the pandemic passes, there...more
When negotiating a digital health collaboration agreement between a tech company and a life sciences company, whether for the development of artificial intelligence or other software, the provision of data hosting and...more
After having dealt with the issue when software may be considered a medical device according to its intended purpose (in part 2) and the implications of the new risk classification regime (in part 3), in this part 4 of our...more