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?
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
In late September 2023, the U.S. Food and Drug Administration (FDA) released a draft guidance on “Regulatory Considerations for Prescription Drug Use-Related Software.”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Food and Drug Administration (FDA) provided an expansive definition of “promotional labeling” in its recently issued draft guidance document on Regulatory Considerations...more
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
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
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
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
On Monday, the FDA published the draft guidance, “Type V DMFs for CDER-Led Combination Products Using Device Constituent Parts With Electronics or Software,” which could facilitate drug manufacturers’ ability to integrate...more
On January 7, 2019, FDA Commissioner Scott Gottlieb announced significant updates to the FDA’s pilot Software Pre-Certification Program, sometimes referred to more broadly as a Digital Health Pre-Certification Program...more
From insulin pumps and pacemakers to defibrillators, medical devices increasingly rely on wireless and internet connectivity for efficient operations. Unfortunately, these interconnections also leave devices vulnerable to an...more
This is the third installment of our year-in-review series covering major developments at FDA. While the previous two installments, pertain to FDA actions on drugs and biologics, this post will address developments related...more
The FDA recently published two draft guidance documents to clarify which types of medical software, based on their functionality, are no longer considered medical devices as a result of the changes imposed under section 3060...more
Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s Washington, DC...more
In This Issue: - Move over Big Pharma: Health care is not the only industry susceptible to False Claims Act scrutiny - Third Circuit affirms dismissal of False Claims Act suit, citing contract ambiguity ...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