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Food and Drug Administration (FDA) Compliance Artificial Intelligence

Gardner Law

What the DOJ Looks For: Key Insights into Evaluating Your Compliance Program

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The Department of Justice's Criminal Division recently released an updated version of its Evaluation of Corporate Compliance Programs document (the "Guidance" or “ECCP”). This Guidance is designed to be a resource for...more

Benesch

Pulse on AI + Healthcare: An Introduction to Healthcare AI Innovation in an Evolving Regulatory Landscape

Benesch on

The expansion of artificial intelligence (“AI”) applications in healthcare (“Healthcare AI”) has made recent headlines, from the transformation of clinical diagnostics with increased accuracy, to use of personalized medicine...more

Mintz - Health Care Viewpoints

Colorado AI Systems Regulation: What Health Care Deployers and Developers Need to Know

As the first state law to regulate the results of Artificial Intelligence System (AI System) use, Colorado’s SB24-205, “Concerning Consumer Protections in Interactions with Artificial Intelligence Systems” (the Act), has...more

Arnall Golden Gregory LLP

Welcome to the Machine: FDA Issues White Paper on AI and Medical Products

For music aficionados, many would agree that the rock band, Pink Floyd, was ahead of its time. “Welcome to the Machine,” from the 1975 album Wish You Were Here, was one of those transformative songs for one of this Bulletin’s...more

Dechert LLP

Dechert Re:Torts - Issue 14

Dechert LLP on

A Prescription for Liability: Michigan Repeals Flagship Drug Immunity Law - Michigan’s recent repeal of immunity provisions under its Product Liability Act has potentially significant implications for pharmaceutical...more

Holland & Knight LLP

Key Value-Based Care Developments to Watch in 2024

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The goal of value-based care (VBC) is to promote better care for individual patients and improved health outcomes for communities at reduced costs. This is an important and admirable purpose as many VBC stakeholders attempt...more

Sheppard Mullin Richter & Hampton LLP

2024 Top-of-Mind Issues for Life Sciences Companies

As we reflect on 2023 and make predictions for 2024, it is remarkable the number of significant events occurring this past year that will be impactful for the activities of the life sciences industry going forward. Although...more

Gardner Law

[Hybrid Event] MASTERING TOMORROW'S HEALTHCARE TECH: A CUTTING-EDGE APPROACH TO REGULATORY, COMPLIANCE, AND PRIVACY DEMANDS -...

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FDA law firm Gardner Law and EU-based Fieldfisher discuss regulatory, compliance, and privacy matters relevant to high-tech healthcare products. - - Harnessing AI and Connected Devices in Medical Innovation in an...more

ArentFox Schiff

Legal Implications of AI in the Life Sciences Industry

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Artificial intelligence (AI) is rapidly transforming the life sciences industry, with significant advancements in various areas. These innovations bring new legal challenges related to intellectual property, data protection,...more

Goodwin

Top IP, FDA, and Compliance Issues for Medtech Companies Transitioning to Data-Enabled Product Solutions

Goodwin on

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

Foley & Lardner LLP

Top Legal Issues Facing the Manufacturing Sector in 2022

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As the global economy faces the third year of the pandemic, manufacturers are no longer focused on figuring out when things will return to “normal.” Instead, they are applying lessons learned from the past few years to become...more

Foley & Lardner LLP

CPSC Takes First Step to Expand Enforcement

Foley & Lardner LLP on

On March 1, 2021, the Consumer Product Safety Commission (CPSC) signaled its intent to increase enforcement of its product safety regimen by seeking to more than double its current $135 million budget via a public letter from...more

Health Care Compliance Association (HCCA)

[Virtual Event] 2021 Research Compliance Conference - June 14th - 16th, 9:00 am - 5:00 pm CDT

Attend HCCA’s annual Research Compliance Conference to receive the latest insights and guidance on emerging research compliance risks and solutions. This virtual event, held June 14 – 16, will be live and interactive. Learn...more

Lowenstein Sandler LLP

A Look Ahead: US FDA And Medical Device Regulations In 2021

Lowenstein Sandler LLP on

The pandemic year of 2020 presented FDA with many enormous challenges, including how to use emergency authorizations to approve diagnostic tests, personal protective equipment, and therapies, how to conduct remote...more

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