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Daily Compliance News: April 22, 2025, The Upping Your Game Edition
Transparency of artificial intelligence (AI) systems in healthcare is quickly becoming a central concern for regulators due to potential impacts on patient safety, healthcare quality, bias mitigation, and public trust. To...more
On March 22, 2025, Gardner Law, PLLC proudly co-hosted a thought-provoking continuing legal education (CLE) event with the Mitchell Hamline School of Law Health Law Institute, titled “AI in Healthcare: Adapting to...more
Effective May 1, 2025, the Section 1557 regulations require covered healthcare providers to take reasonable steps by May 1, 2025, to identify and mitigate the risk of discrimination when they use AI and other emergency...more
Welcome to our third issue of 2025 of Decoded - our technology law insights e-newsletter. We hope you enjoy this issue and thank you for reading. SEC may Reverse Proposed Cryptocurrency Custody Rule and Ohio House...more
This past week, the Trump administration put its first major stamp on the Medicare Advantage (MA) program. The Centers for Medicare & Medicaid Services (CMS) released two final regulatory documents related to MA: - The...more
In a development for state-level AI policy, Virginia Governor Glenn Youngkin has vetoed the "High-Risk Artificial Intelligence Developer and Deployer Act" (HB 2094). The bill, which narrowly passed both chambers of the...more
Cyber incidents such as the 2024 event involving Change Healthcare, which compromised the personal information of over 100 million people, highlight the evolving nature of cyber threats – increasingly becoming risk management...more
Artificial intelligence (AI) is transforming the medical technology (“medtech”) and healthcare industries through the integration of advanced AI agents. Unlike traditional AI systems that perform discrete, predefined tasks,...more
Virginia has become the first state in 2025 to pass comprehensive artificial intelligence regulation, with lawmakers approving the "High-Risk Artificial Intelligence Developer and Deployer Act" (HB 2094). The legislation,...more
While AI has many people uptight, Aescape has developed technology to help you relax – AI robotic massage. Aescape touts that it combines the timeless art of massage with robotics and artificial intelligence to deliver an...more
The Evolving Role of AI/ML in Healthcare - The use of artificial intelligence/machine learning (AI/ML) in healthcare is evolving rapidly and introducing new challenges. Not only are medical devices using AI for diagnostics,...more
Welcome to our second issue of 2025 of Decoded - our technology law insights e-newsletter. For those of you with an interest in the Corporate Transparency Act, Brienne Marco and Joe Unger report that the recent injunction...more
Early in the new year, the US Food and Drug Administration (FDA) released two anticipated draft guidance documents focused on artificial intelligence (AI): Artificial Intelligence-Enabled Device Software Functions: Lifecycle...more
Keypoint: Virginia becomes the second legislature – after Colorado – to pass an algorithmic discrimination bill – although the bill still needs to get through the state’s Republican governor to become law. On February 20,...more
The veterinary industry has experienced significant transformations over the past few years, particularly in the realm of mergers and acquisitions (M&A). As we look at the state of the market in 2025, it is crucial to analyze...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
In January, the U.S. Food and Drug Administration (FDA) issued its first guidance on the use of artificial intelligence (AI) models in drug development and in regulatory submissions titled, “Considerations for the Use of...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
With daily media reports citing to the explosion of interest in Artificial Intelligence (“AI”), AI start-ups have attracted a huge capital influx. During the last fiscal quarter of 2024 ending on December 31st, investors...more
The European Union Artificial Intelligence Act (AI Act) entered into force on 1 August 2024. The AI Act establishes a risk-based approach to AI, prohibiting certain practices that are deemed unacceptable, such as social...more
California sets the pace for all sorts of trends in the world – so perhaps compliance officers should take note of two recent advisories the state’s attorney general published on artificial intelligence. They capture a lot...more
What is your favorite part about practicing healthcare law at McDermott? I am grateful to be part of a health and life sciences team that is truly world-class. Our group is intentional about collaboration and innovation....more
In the waning days of the Biden administration, the FDA released a flood of new guidance documents and other agency actions, including several important items related to digital health. On January 7, FDA published two new...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
On May 6, 2024, OCR published the final rule interpreting and implementing Section 1557 at 45 C.F.R. § 92 (the Final Rule). The Final Rule regulates the use of patient care decision support tools, including AI algorithms for...more