Podcast Overview
<p>The show where digital health leaders stop hand-waving, start evidence-building, and reveal how extraordinary claims become extraordinary results. <br /><br />Each episode I’ll be joined by someone who’s had their ideas tested in the fire of peer review, regulators, and the real world.</p>
Language
🇺🇲
Publishing Since
2/17/2026
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Recent Episodes
May 7, 2026
Regulation Is Not the Enemy of Speed Tauseef Mehrali on Building Safety Culture at 400 million Users
<p>Paul Wicks sits down with Dr. Tauseef Mehrali , GP, former VP of Medical Safety at Ada Health, and now VP of Regulatory Science at Flo Health, the world's largest femtech platform, for a deeply practical conversation about what it actually takes to build safety and regulatory rigour into digital health products at scale.<br /><br />Flo has over 400 million downloads and nearly 80 million monthly active users. When something goes wrong at that scale, the harm is invisible, insidious and potentially enormous. Tauseef's job is to make sure it doesn't.<br />In this conversation they cover:<br /><br />🛑 Why he turned down a job after reading their company bible, and why culture is a safety signal<br />🌡️ The Ada orange flag system: how to detect harm before it becomes a crisis<br />📱 Introducing medical device regulation into a 400M-user consumer app without breaking it<br />⚖️ Intended use vs actualised use vs off-label use, the grey zone nobody talks about in femtech<br />🏰 The regulatory moat and the drawbridge: why one without the other is worthless<br />📋 The single most important thing a founder can do on day one (it's not what you think)<br /><br />Plus: what book should be on the shelf instead of Blitzscaling, and why Tauseef might just have to write it himself.<br /><br />🎙️ Host: Paul Wicks | ProofStack Health<br />🏢 Guest: Dr. Tauseef Mehrali, VP Regulatory Science, Flo Health<br />🔗 Connect with Tauseef on LinkedIn<br />🔗 Learn more: <a rel="noopener noreferrer nofollow" href="https://www.proofstackhealth.com" target="_blank">https://www.proofstackhealth.com</a><br />📬 Subscribe to Proof Points for evidence frameworks built for digital health teams<br /><a rel="noopener noreferrer nofollow" href="https://proofpoints.proofstack.health" target="_blank">https://proofpoints.proofstack.health</a></p>
April 15, 2026
Hugh Harvey on Radiology AI Startups, Regulation, Evidence & the Only Way to Win in Health Tech
<p>In 2015 Geoffrey Hinton said radiologists would lose their jobs to AI within five years. It's 2026 and we're still short of radiologists. Dr. Hugh Harvey has a few thoughts on that.<br /><br />Paul Wicks sits down with Hugh, radiologist, ex-Babylon Health, Europe's first CE-marked deep learning mammography device, and now regulatory consultant to over 150 medical device companies, for a masterclass on why most healthcare AI companies fail, and what the ones that survive actually do differently.<br /><br />In this conversation they cover:<br />🏥 Why AI didn't replace radiologists, and what that really tells us about healthcare AI<br />📋 How software gets classified as a medical device (and why start-ups always try to game it)<br />🚩 "Class one washing": the shortcut that makes your product less useful AND gets you caught<br />🤖 AI-generated fake regulatory documentation — it's happening and it's worse than you think<br />💰 The health economics gap: why regulatory clearance is just the entry ticket, not the prize<br />⚠️ Digital thalidomide: why a small error rate at scale is an entirely different category of harm<br />🏆 What the companies that actually make it do from day one<br />Plus: why there's no such thing as vibe-coding your way through medical device regulation.<br /><br />🎙️ Host: Paul Wicks | ProofStack Health<br />🏢 Guest: Dr. Hugh Harvey, Regulatory Consultant, Hardian Health<br />🔗 Hardian Summit — April 29th, BMA House, London: <a rel="noopener noreferrer nofollow" href="https://www.hardianhealth.com/" target="_blank">visit Hardian's website for tickets</a><br />🔗 Learn more: <a rel="noopener noreferrer nofollow" href="https://www.proofstackhealth.com" target="_blank">https://www.proofstackhealth.com</a><br />📬 Subscribe to<a rel="noopener noreferrer nofollow" href="https://proofpoints.proofstack.health/" target="_blank"> Proof Points for evidence frameworks built for digital health teams</a><br /><br /><br /><a rel="noopener noreferrer nofollow" href="https://www.youtube.com/watch?v=9IvZ1Gx4Szs" target="_blank">00:00</a> — Introduction: The Magic Trick That Doesn't Work at Home<br /><a rel="noopener noreferrer nofollow" href="https://www.youtube.com/watch?v=9IvZ1Gx4Szs&t=120s" target="_blank">02:00</a> — Why Radiologists Still Have Jobs in 2026 (And What That Tells Us About All of Healthcare AI)<br /><a rel="noopener noreferrer nofollow" href="https://www.youtube.com/watch?v=9IvZ1Gx4Szs&t=480s" target="_blank">08:00</a> — From Babylon Health to Europe's First CE-Marked Deep Learning Device: Hugh's Journey<br /><a rel="noopener noreferrer nofollow" href="https://www.youtube.com/watch?v=9IvZ1Gx4Szs&t=960s" target="_blank">16:00</a> — How Software Gets Regulated as a Medical Device (Explained Simply)<br /><a rel="noopener noreferrer nofollow" href="https://www.youtube.com/watch?v=9IvZ1Gx4Szs&t=1560s" target="_blank">26:00</a> — Class One Washing: The Shortcut That Backfires<br /><a rel="noopener noreferrer nofollow" href="https://www.youtube.com/watch?v=9IvZ1Gx4Szs&t=2160s" target="_blank">36:00</a> — AI-Generated Fake Regulatory Documentation: A Growing Real Problem<br /><a rel="noopener noreferrer nofollow" href="https://www.youtube.com/watch?v=9IvZ1Gx4Szs&t=2520s" target="_blank">42:00</a> — The Health Economics Gap: Why Regulatory Clearance Is Just the Entry Ticket<br />45:00 — Digital Thalidomide: Why Scale Changes Everything About Harm</p>
March 31, 2026
Can a Chatbot Really Care? Woebot's Founder on Therapeutic Bonds, CBT, and What LLMs Still Can't Do
<p>Before mental health chatbots were a trend, Dr. Ali Darcy was already running randomised controlled trials on one.<br /><br />In 2016, she and her collaborators at Stanford conducted what is widely regarded as the first ever formal RCT of a conversational AI for mental health. <br /><br />The paper has since been cited over 2,000 times. Her creation, Woebot, became one of the most studied and recognised digital mental health tools in the world.<br /></p><p>In this episode of Prove It, host Paul Wicks sits down with Ali for a wide-ranging, deeply honest conversation about what the science of AI mental health actually shows, and what it doesn't. <br /><br />They cover the engagement crisis in digital CBT, why humour is a legitimate and underused therapeutic tool, the surprising finding that users form a meaningful bond with a fictional robot character, and the critical question the field still hasn't answered: what exactly is the active ingredient of the human therapist?<br /></p><p>They also dig into the limits of large language models in mental health, why doubling NLP accuracy didn't improve outcomes, why "rushing in to help" is therapy's number one failure mode, and why role clarity may be the most important safety issue in AI mental health right now.<br /></p><p>This is a conversation between two researchers who refuse to hand-wave. If you care about digital mental health done right, this one is for your library.<br /></p><p>Topics covered:</p><ul><li>The 2016 Stanford RCT: design choices that still hold up nearly a decade later</li><li>Engagement as the primary unsolved problem in mental health tech</li><li>The therapeutic alliance paper: 37,000 users, 200x larger than the entire existing literature</li><li>What Woebot got right by being transparently fictional rather than pretending to be human</li><li>Why LLMs can generate profound-sounding insights that users forget within 24 hours</li><li>The Goldilocks zone of evidence: how much is enough, and when does more actually hurt you?</li><li>Role confusion as a safety crisis: why being a companion and a therapist is clinically dangerous<br /><br />🎙️ Host: Paul Wicks | ProofStack Health<br />🏢 Guest: Dr. Ali Darcy, Founder, Woebot Health<br />🔗 Learn more: <a rel="noopener noreferrer nofollow" href="http://www.proofstack.health" target="_blank">www.proofstack.health</a><br />📬 Subscribe to Proof Points, A biweekly newsletter on evidence that makes digital health work <a rel="noopener noreferrer nofollow" href="http://proofpoints.proofstack.health" target="_blank">proofpoints.proofstack.health</a></li></ul>
6 total episodes available
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- What is Prove It?
<p>The show where digital health leaders stop hand-waving, start evidence-building, and reveal how extraordinary claims become extraordinary results. <br /><br />Each episode I’ll be joined by someone who’s had their ideas tested in the fire of peer review, regulators, and the real world.</p> - How often does this podcast release new episodes?
This podcast updates daily.
- Where can I listen to this podcast?
This podcast is available on 4 platforms including Apple Podcasts, Spotify, and more. You can also use the RSS feed directly.
- Does this podcast accept guests?
Yes, this podcast regularly features guests.
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