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
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
In Dealmaker’s Digest, read the top 10 latest developments in global transactions. We offer insights into M&A activity across industries and borders. U.S. outbound deal value jumped to over $80 billion in July; the highest...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
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
Despite the summer doldrums, cartel enforcers around the world had several notable enforcement actions and, perhaps more importantly, signaled a busy fall and winter. In the United States, the Department of Justice’s...more
The Learned Concierge - Welcome to your monthly legal insights on the trends impacting the Retail, Hospitality, and Food & Beverage Industries....more
Generative AI (GenAI) surged to the forefront of corporate agendas and public policy debates last year, promising to boost productivity and innovation. What’s in store for AI in 2024?...more
In late September 2023, the U.S. Food and Drug Administration (FDA) released a draft guidance on “Regulatory Considerations for Prescription Drug Use-Related Software.” This guidance expands on (and was developed in response...more
After remaining silent on the topic for decades, the Food and Drug Administration (FDA) provided an expansive definition of “promotional labeling” in its recently issued draft guidance document on Regulatory Considerations...more
Encouraged by the relative strength of the dollar and improving financing conditions, US bidders are snapping up European assets - Transatlantic M&A was enjoying record-high activity before the war in Ukraine sparked...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
Summer 2023- Whistleblower Watch is a comprehensive source for all False Claims Act (FCA) news and information. Every quarter, Cozen O’Connor will provide in-house counsel and compliance professionals with a summary of the...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
Life sciences industry has regulatory compliance at the center of all its operations, so maintaining the integrity of data has always been a pressing need for this industry globally. Regulators such as the United States Food...more
Wilson Sonsini Goodrich & Rosati’s 2021 Technology and Life Sciences IPO Report presents analysis related to 179 initial public offerings and 6 direct listings completed by U.S.-based technology and life sciences companies...more
1. BIS Eliminates Reporting Requirements for Certain Encryption Items Effective March 29, 2021, BIS eliminated or reduced reporting requirements for certain encryption items. For encryption source code and beta test...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
The new classification rules for software-based medical devices (“SaMDs”) and personalised medical devices introduced by the Therapeutic Goods Legislation Amendment (2019 Measures No.1) Regulations 2019 commences this week,...more
At the beginning of February, the US Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) appointed Professor Kevin Fu as the first ever Acting Director of Medical Device Cybersecurity. Fu’s...more
On October 16, the U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) announced the list of priority guidance documents that CDRH intends to publish this fiscal year (FY-2021)....more
Less than a year after United States Attorney Christina E. Nolan warned electronic health records (“EHR”) companies in a DOJ press release that they “should consider themselves on notice” following a $57.25 million FCA...more
In the DOJ’s first-ever criminal action against an electronic health records vendor, San Francisco-based Practice Fusion Inc. agreed to pay $145 million to resolve allegations that it received kickbacks from pharmaceutical...more
The EU Medical Device Regulation goes into application on 26 May 2020, with the In Vitro Diagnostic Medical Device Regulation set to follow on 26 May 2022. These new Regulations bring sweeping changes to the market clearance...more