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Daily Compliance News: April 22, 2025, The Upping Your Game Edition
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
Investors are ramping up AI-related M&A to secure cutting-edge capabilities and market-beating returns, but high valuations and open-source disruption are forcing a rethink on deal strategy - Global M&A saw a year-on-year...more
In recent years, the rapid advancement of artificial intelligence (AI) and machine learning (ML) technologies has sparked a wave of innovation across various sectors, particularly in life sciences. ML technologies have...more
To help you stay on top of the latest news, our AI practice group has compiled a roundup of the developments we are following....more
Artificial intelligence (AI) has emerged as an influential technology, driving notable investments across various industries in recent years. In 2024, venture capital (VC) funding for AI companies reached record levels,...more
Private equity investors in health care and life sciences must navigate a complex and shifting landscape influenced by regulatory and policy changes and technological advancements. As private equity investments in the health...more
The life sciences industry has long been at the forefront of innovation, and 2025 promises to continue this trajectory with exciting developments in intellectual property (IP), licensing, and mergers and acquisitions (M&A)....more
FDA recently issued two draft guidance documents discussing: (1) the use of artificial intelligence (AI) to produce information to support a regulatory decision about a drug or biological product’s safety, effectiveness, or...more
On January 7, 2025, FDA published a draft guidance titled “Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations.” The draft guidance was long-anticipated; it...more
While generative artificial intelligence ("GenAI") has the potential to fundamentally change health care, it presents unique risks and complexities that challenge the U.S. Food and Drug Administration's ("FDA" or "Agency")...more
In 2025, Republicans will hold the majority in both chambers of Congress, and the incoming Trump Administration will preside over the executive branch. For healthcare issues at the intersection of access and equity, this...more
Life science companies will have to grapple with unique questions in complying with the European Artificial Intelligence Act, including the scope of the law’s research exemption and the use of AI in personalized medicine and...more
One year ago, on October 30, 2023, President Joe Biden signed an executive order laying the groundwork both for how federal agencies should responsibly incorporate artificial intelligence (AI) within their workflows and how...more
Welcome to Vital Signs, a curated compilation of the latest legal and regulatory developments in digital health. Our lead article reports on recent developments in the U.S. Food and Drug Administration's ("FDA") regulatory...more
GenAI, or Generative AI, has seen a surge in patenting activity with China leading the way in filing patent applications for this technology. The landscape analysis by WIPO reveals Tencent, Ping An Insurance Group, and Baidu...more
Between 2014-2023, China has filed more patent applications (38,000) covering Generative AI (GenAI) technology than another other country, six times more than second place United States, as reported by the World Intellectual...more
Join Troutman Pepper Partner Brett Mason for a podcast series analyzing the intersection of artificial intelligence (AI), health care, and the law. In this installment, Brett is joined by Partner Judy O'Grady and Associate...more
The European Union (EU) is leading the global charge with AI regulations. U.S. companies are not beyond their regulatory reach, however, and should be preparing their AI risk mitigation efforts accordingly....more
On this episode, Heather and Lauren welcome Shannon Frazier, the Executive Director of Human Resources for Lenovo North America, a Fortune 500 company and the world’s leading PC maker. They discuss how Lenovo’s products...more
The healthcare and life sciences ecosystem is witnessing significant growth in the Middle East as the GCC continues to seek economic diversification. The United Arab Emirates (UAE) and Kingdom of Saudi Arabia (KSA) are...more
Both the EU and Germany are taking significant steps to accelerate digitalization in the health sector and facilitate the exchange and use of health data for research and innovation purposes. They aim to improve...more
On March 15, the United States Food & Drug Administration published a white paper entitled “Artificial Intelligence & Medical Products: How CBER, CDER, CDRH, and OCP are Working Together.” FDA announced the paper by sharing a...more
The U.S. Senate and the U.S. House of Representatives are both considering legislation that could have a serious impact on the ability of U.S. biotechnology, drug, and medical device companies to do business with...more
We have been writing about software as a medical device (SaMD) for years, tracking the Food and Drug Administration's (FDA) efforts to keep up with the fast-paced development of digital technology, such as launching the...more
Artificial Intelligence (AI), specifically generative AI technologies, hold significant promise for improving the healthcare industry by streamlining clinical operations, freeing service providers from mundane tasks, and...more