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What Happens When AI in Medical Devices Make Mistakes?
MedTech manufacturers and developers, what happens if your AI-powered medical device makes a terrible, life-threatening mistake?
This episode explores what happens when artificial intelligence in medical devices goes wrong. Christian Espinosa and Trevor Slattery break down the real-world consequences of AI failure, using a tragic mental health chatbot case to highlight the stakes of inadequate oversight. They also examine the EU AI Act, new MDCG guidance, and the ethical, regulatory, and cybersecurity challenges facing innovators in the high-risk medical AI space.
Key points:
(03:02) The EU AI Act and how it intersects with the MDR and IVDR.
(03:55) A real case study involving a suicidal patient and an AI mental health chatbot.
(06:07) How general-purpose AI tools differ from regulated medical AI.
(09:57) Why threat modeling should apply to AI systems.
(12:16) Ethical decision-making in autonomous systems using self-driving car analogies.
(14:02) The Medical Device Coordination Group’s guidance on aligning the AI Act with EU medical device regulations.
(17:10) Shared accountability across regulators, manufacturers, and users for AI oversight.
(18:35) The U.S. still treats AI as a “Wild West” compared to the EU’s stricter approach.
(22:42) Regulators aren’t asking if your AI works—they’re asking how it fails.
The Med Device Cyber Podcast is brought to you by Blue Goat Cyber, cybersecurity professionals specializing in providing elite cyber solutions for medical devices. Learn more about securing your product and business from cyber-criminals by visiting https://bluegoatcyber.com
If you’re interested in our services or partnering with us, schedule a Discovery Session: https://meetings.hubspot.com/blue-goat-cyber/discovery-session
Christian Espinosa is the CEO and founder of Blue Goat Cyber. Trevor Slattery is the Chief Technology Officer / Director of MedTech Cybersecurity at Blue Goat Cyber.
Christian Espinosa on LinkedIn: https://www.linkedin.com/in/christianespinosa/
Trevor Slattery on LinkedIn: https://www.linkedin.com/in/trevor-slattery-34852b1a9
Blue Goat Cyber on LinkedIn: https://www.linkedin.com/company/blue-goat-cyber/
Blue Goat Cyber on Instagram: https://www.instagram.com/bluegoatcyber/
Blue Goat Cyber on Facebook: https://www.facebook.com/bluegoatcyber/
Blue Goat Cyber on YouTube: https://www.youtube.com/@BlueGoatCyber
Feedback? Questions? Contact: https://bluegoatcyber.com/contact/
Learn more about Christian Espinosa, buy his books, or invite him to speak on your stage: https://christianespinosa.com/
Christian Espinosa on YouTube: http://www.youtube.com/@ChristianEspinosaOfficial
The Med Device Cyber Podcast is your essential resource for medical device cybersecurity. Each episode we dive into the latest threats, solutions, and best practices to protect modern healthcare technology. Whether you're a provider, a manufacturer, or a cybersecurity professional, gain the knowledge to safeguard patient safety by subscribing to the Med Device Cyber Podcast.
Subscribe via Spotify: https://open.spotify.com/show/5ol62ROdF6mBfwOFqKFHmh
Subscribe via Apple Podcasts: https://apple.co/483OJ9I
Subscribe via YouTube: https://www.youtube.com/@BlueGoatCyber/?sub_confirmation=1
This episode was produced by Story On Media: https://www.storyon.co/
View all episodes
By Blue Goat CyberMedTech manufacturers and developers, what happens if your AI-powered medical device makes a terrible, life-threatening mistake?
This episode explores what happens when artificial intelligence in medical devices goes wrong. Christian Espinosa and Trevor Slattery break down the real-world consequences of AI failure, using a tragic mental health chatbot case to highlight the stakes of inadequate oversight. They also examine the EU AI Act, new MDCG guidance, and the ethical, regulatory, and cybersecurity challenges facing innovators in the high-risk medical AI space.
Key points:
(03:02) The EU AI Act and how it intersects with the MDR and IVDR.
(03:55) A real case study involving a suicidal patient and an AI mental health chatbot.
(06:07) How general-purpose AI tools differ from regulated medical AI.
(09:57) Why threat modeling should apply to AI systems.
(12:16) Ethical decision-making in autonomous systems using self-driving car analogies.
(14:02) The Medical Device Coordination Group’s guidance on aligning the AI Act with EU medical device regulations.
(17:10) Shared accountability across regulators, manufacturers, and users for AI oversight.
(18:35) The U.S. still treats AI as a “Wild West” compared to the EU’s stricter approach.
(22:42) Regulators aren’t asking if your AI works—they’re asking how it fails.
The Med Device Cyber Podcast is brought to you by Blue Goat Cyber, cybersecurity professionals specializing in providing elite cyber solutions for medical devices. Learn more about securing your product and business from cyber-criminals by visiting https://bluegoatcyber.com
If you’re interested in our services or partnering with us, schedule a Discovery Session: https://meetings.hubspot.com/blue-goat-cyber/discovery-session
Christian Espinosa is the CEO and founder of Blue Goat Cyber. Trevor Slattery is the Chief Technology Officer / Director of MedTech Cybersecurity at Blue Goat Cyber.
Christian Espinosa on LinkedIn: https://www.linkedin.com/in/christianespinosa/
Trevor Slattery on LinkedIn: https://www.linkedin.com/in/trevor-slattery-34852b1a9
Blue Goat Cyber on LinkedIn: https://www.linkedin.com/company/blue-goat-cyber/
Blue Goat Cyber on Instagram: https://www.instagram.com/bluegoatcyber/
Blue Goat Cyber on Facebook: https://www.facebook.com/bluegoatcyber/
Blue Goat Cyber on YouTube: https://www.youtube.com/@BlueGoatCyber
Feedback? Questions? Contact: https://bluegoatcyber.com/contact/
Learn more about Christian Espinosa, buy his books, or invite him to speak on your stage: https://christianespinosa.com/
Christian Espinosa on YouTube: http://www.youtube.com/@ChristianEspinosaOfficial
The Med Device Cyber Podcast is your essential resource for medical device cybersecurity. Each episode we dive into the latest threats, solutions, and best practices to protect modern healthcare technology. Whether you're a provider, a manufacturer, or a cybersecurity professional, gain the knowledge to safeguard patient safety by subscribing to the Med Device Cyber Podcast.
Subscribe via Spotify: https://open.spotify.com/show/5ol62ROdF6mBfwOFqKFHmh
Subscribe via Apple Podcasts: https://apple.co/483OJ9I
Subscribe via YouTube: https://www.youtube.com/@BlueGoatCyber/?sub_confirmation=1
This episode was produced by Story On Media: https://www.storyon.co/