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Artificial intelligence (AI) is already indispensable in the healthcare and life sciences sector. Intelligent medical devices promise nothing less than a revolution in the art of healing. With its legislative projects on AI...more
A large health system implements an Artificial Intelligence (AI)-powered clinical decision support tool that promises to ensure “complete and accurate” diagnosis documentation. Within six months, the system’s Medicare...more
Already highly regulated with a risk-based approach at their core, AI-powered medical devices and in vitro diagnostic medical devices face new regulatory constraints stemming from the EU AI Act, a horizontal legal instrument...more
Our 2025 Life Sciences and Health Care Horizons edition is now live! Explore the latest global insights from the U.S., Asia-Pacific, Europe, Latin America, and the Middle East on the key issues and emerging trends shaping the...more
Innovation in life sciences isn’t just about scientific breakthroughs—it’s about making the right business decisions. Whether a company is developing AI-driven diagnostics, biotech therapies, connected medical devices, or...more
In recent weeks, the FDA has faced significant cuts, including the layoffs of probationary employees. These employees, many of whom had been hired to fill roles left by retirees or to bolster the agency’s staffing during the...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
The Food and Drug Administration (FDA) has recently released two draft guidance documents (Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations and...more
In 2024, the FDA issued two significant guidance documents on Predetermined Change Control Plans (PCCPs), formalizing a regulatory framework that allows medical device manufacturers to implement certain pre-approved...more
Artificial intelligence already is positively affecting health, according to Mark Gardner, MBA, Esq., Founder and Managing Partner, Gardner Law, which represents clients subject to Food and Drug Administration regulations. ...more
President Ronald Reagan famously quipped, "I think you all know that I've always felt that the nine most terrifying words in the English language are: I'm from the Government, and I'm here to help."1 At an Oct. 23-24, 2024,...more
Artificial intelligence (AI) has the power to revolutionize health care. In oncology, there are now opportunities to apply AI to support diagnostics, predictive analytics, and administrative functions. This hot topic was...more
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
On May 21, 2024, the European Union finalized the adoption of the groundbreaking EU Artificial Intelligence Act, a comprehensive and sector-agnostic legislation that extends globally. This 420-page Act aims to regulate the...more
Laws/Regulations directly regulating AI (the “AI Regulations”) - Currently, there are no specific laws, statutory rules, or regulations in Switzerland that directly regulate AI. AI in Switzerland is currently subject to...more
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
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
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
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
Health care companies are increasingly using artificial intelligence (AI) to create innovations, set prices, and compete with rivals. At the same time, federal and state antitrust enforcers are finding new ways to apply...more
ACI is excited to welcome you back in-person to the 14th Advanced Forum on FCPA & Anti-Corruption for the Life Sciences Industry, taking place on July 21–22, 2022 in Boston! Legal and compliance professionals from...more
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
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