IP Goes Pop! S6 Ep #3 The (Copy)Right Tool for the Job- The Copyright Tool Kit
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
Illumina, Inc., a publicly-traded biotechnology company, agreed to a $9.8 million settlement with the U.S. Department of Justice (DOJ) in response to alleged violations of the False Claims Act (FCA). DOJ alleged that Illumina...more
The Food and Drug Administration (FDA) issued final guidance Monday that explains how medical device manufacturers can use a Predetermined Change Control Plan (PCCP) to update AI-enabled device software functions (AI-DSFs)...more
The US Food and Drug Administration (FDA) recently issued its draft guidance, Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations on January 7, 2025....more
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
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
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
The use of artificial intelligence (AI) in healthcare has been growing rapidly in recent years, and AI-enabled medical devices are playing a larger role in patient care. Such devices may use machine learning algorithms to...more
The U.S. Food and Drug Administration (FDA) recently issued a final guidance document clarifying how the agency intends to regulate clinical decision support (CDS) software. How has this document caused confusion for...more
Clinical decision support (CDS) software has been recognized — including by government agencies — as having significant potential to increase quality of care and enhance health outcomes, and companies across the health care...more
The convergence of wearable technology and artificial intelligence systems that can analyze data in real time to optimize health care delivery is generating a new wave of products that raise novel regulatory, business, and...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
A spurt of letters from California Attorney General Rob Bonta to leaders of hospitals and other health care facilities sent on August 31, 2022 signaled the kickoff of a government probe into bias in health care algorithms...more
On April 2, 2019, the U.S. Food and Drug Administration (“FDA” or “Agency”) proposed a new regulatory framework to address the development and marketing of artificial intelligence and machine learning-based software as a...more
Investors are increasingly interested in companies with technologies that will be subject to U.S. Food and Drug Administration (FDA) regulation. Until recently, some investors shied away from companies targeting the...more
Companies that develop software that functions as a medical device should be aware that the Food and Drug Administration (FDA) has issued draft guidance that, once finalized, will classify the endless variety of Software as a...more
New Technology = New Threats - With new technology comes new security concerns. But when that new technology is in the medical field, the cybersecurity vulnerabilities can be particularly devastating. The...more
I am often called upon to address the nature of how regulatory controls may apply to the organization of healthcare companies in their ability to create, deliver, and capture value (their ‘business models’). While no...more