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Regulation & Policy: AI in Medicine podcast episodes
Regulators and governments on AI in health: FDA, EMA, MHRA, the EU AI Act, WHO and national strategies.
- Why Faster AI Submissions Mean Slower Approvals: IQVIA on Regulatory Velocity9 October 2026 · 17 minMedTech and Pharma companies are using AI to speed up regulatory submissions, but many are finding that faster output is actually leading to more rejections. This episode unpacks a 2026 white paper from IQVIA detailing…
- The 44-Point Plan: How the UK is Rewriting the Rules for Healthcare AI7 October 2026 · 19 minThe UK government has officially accepted all 44 recommendations from the National Commission into the Regulation of AI in Healthcare. In this episode, Maya and Sam unpack the MHRA's extensive response, detailing the…
- Digital Measures in Trials: Unpacking the FDA's New Framework7 October 2026 · 17 minThe FDA recently released a framework detailing how to use digital health technologies and AI to capture clinical trial outcomes. We explore the critical differences between verification, analytical validation, and…
- Regulators Build an AI Arsenal: Unpacking the EMA 2025 Observatory Report6 October 2026 · 18 minThe European Medicines Agency has released its 2025 AI Observatory report, revealing how regulators are deploying 61 internal AI use cases to evaluate pharmaceutical submissions. Maya and Sam dive deep into the…
- Who Holds the Bag When Medical AI Fails? The UK's New Blueprint6 October 2026 · 18 minThe UK Government has released a sweeping blueprint for the future regulation of AI in healthcare, aimed at moving away from static, one-off approvals. Listeners will learn how new concepts like Predetermined Change…
- Will AI Redefine Burn Triage? Unpacking the FDA's DeepView AI De Novo Order6 October 2026 · 18 minThe FDA has granted De Novo classification to Spectral MD's DeepView AI System, a software that predicts burn wound healing. Maya and Sam unpack the device's indications, the strict special controls required, and what…
- Inside the MHRA AI Airlock: Testing the Boundaries of Medical Software6 October 2026 · 20 minWe unpack the MHRA's AI Airlock Sandbox Phase 2 Programme Report to explore how the UK regulator is pressure-testing rules for adaptive algorithms. From generative AI drifting out of scope to algorithms outperforming…
- AI moving medicine to your wrist - top 3 movers and shakers1 December 2025 · 5 minThis report provides an exhaustive analysis of this transition, forecasting the technological, clinical, and commercial trajectory of the sector over the next three years (2025–2028). It posits that the integration of…
- Shaping Tomorrow's Healthcare: Canada’s AI Apps for 20252 September 2025 · 25 minWhat AI is being used right now in healthcare in Canada? What should health systems stay vigilant for as AI reshapes care? In this episode, we explore Canada’s “2025 Watch List: Artificial Intelligence in Health Care.”…
- AI in Clinical Trials: How to Govern the Future of Research2 September 2025 · 17 minAI is reshaping clinical trials—but current oversight mechanisms aren't prepared. In this episode, we unpack a newly released framework from the MRCT Center that helps IRBs and researchers navigate AI’s ethical…
- Governing GenAI in Healthcare: Regulating LLMs in Clinical Settings24 July 2025 · 19 minGenAI is reshaping medical workflows—but our regulatory tools aren't ready. In this episode, we explore: Why lifecycle-based regulation fails with generative models How regulatory sandboxes and adaptive policies can…
- Generative AI for Health: A WEF Look at the Future of Personalized Care5 July 2025 · 23 minThe World Economic Forum ranks Generative AI for Health as one of the Top 10 Emerging Technologies of 2024 . But what does that really mean for hospitals, clinicians, and patient outcomes? In this episode, we unpack…
- Revolutionizing Clinical Trials with AI: Lessons from Latin America5 July 2025 · 13 min🚨 New Episode: Revolutionizing Clinical Trials with AI – Lessons from Latin America In this episode, we unpack the AI-Driven Clinical Trial Playbook —a bold roadmap for how MedTech innovators can cut costs…
- The Future of Global Healthcare Depends on Shared Data1 June 2025 · 18 minWhat if no single country could fix healthcare alone? In this week’s podcast, we explore the World Economic Forum’s 2025 white paper on building a Global Health Network Economy — one grounded in trusted, secure data…
- WEF - The Future of AI-Enabled Health 202524 May 2025 · 21 minIn this episode, we explore a powerful new white paper from the World Economic Forum and Boston Consulting Group that outlines how AI could reshape global healthcare. But the future isn’t just about technology—it’s…
- Can We Trust AI in Healthcare? Unpacking the National AI Code of Conduct16 May 2025 · 13 minIn this episode, we delve into the National Academy of Medicine's draft AI Code of Conduct, exploring its implications for healthcare. We discuss the proposed principles and commitments designed to ensure the ethical…
- Is AI in Medicine Crossing the Line? Ethics, Laws, and What Comes Next?28 March 2025 · 14 minAI is revolutionizing medicine—but are we thinking deeply enough about what happens when it goes wrong? In this episode, we break down a landmark paper that explores the ethical and legal minefields of using AI in…
- The WHO on AI in Pharma: Power, Profit, and Global Risk27 February 2025 · 19 minThis World Health Organization (WHO) report explores the potential benefits and risks of using artificial intelligence (AI) in the creation and distribution of pharmaceuticals. It examines how AI is currently being…
- Who Gets Sued When a Robot Surgeon Fails? AI, Law, and Medical Liability in the U.S.27 February 2025 · 14 minThe University of Miami Business Law Review article, "The AI-Robotic Prescription: Legal Liability When an Autonomous AI Robot is Your Medical Provider", addresses the increasing use of autonomous AI robots in…
- Who’s Responsible When AI Fails in Europe? Robotics, Medicine, and Liability Across the EU27 February 2025 · 14 minThe intersection of robotics and artificial intelligence (AI) in healthcare within the framework of European regulations, focusing specifically on medical malpractice. It highlights the transformative potential of…
- The evolution of AI in Healthcare - a conversation15 February 2025 · 16 minThis Congressional Research Service report, dated December 30, 2024, offers a wide view of artificial intelligence use in healthcare. It details AI techniques, like machine learning and natural language processing, and…
- AI-Enabled Medical Device Software Functions: FDA Guidance15 February 2025 · 22 minThis FDA guidance offers recommendations for manufacturers regarding marketing submissions for medical devices incorporating artificial intelligence (AI). It outlines a total product lifecycle (TPLC) approach…
- AI in Medical Devices - Regulations and Clinical evidence, a conversation15 February 2025 · 15 minThis document offers a review of the landscape surrounding the use of artificial intelligence (AI) in medical devices, highlighting the definitions, recommendations, and regulations shaping its implementation. It…
- OECD report AI and the Health Workforce - a conversation25 January 2025 · 15 minThis OECD report examines medical associations' perspectives on integrating artificial intelligence (AI) into healthcare. The study, conducted through a survey and interviews, explores both the potential benefits of AI…
- Ai in Healthcare Management - Ethics, Regulation and Efficiency - a conversation25 January 2025 · 19 minExplore the transformative potential of artificial intelligence (AI) in healthcare. These studies examine AI's impact on operational efficiency, focusing on improved resource allocation, predictive analytics, and…
- Data Security Challenges in AI-Enabled Medical Devices - a conversation3 December 2024 · 33 mincheckout this popular paper as a hosted conversation Summary This research paper examines data security challenges in AI-enabled medical device software. The authors explore various threats, including data breaches…