The Healthtech Podcast #399 Dr Hugh Harvey: What Does the Future of Medical AI Regulation Look Like?
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May 7, 2025 Dr. Hugh Harvey is the Managing Director of Hardian Health, specializing in software and AI medical devices. He discusses the intricate landscape of medical AI regulation, stressing the importance of achieving Class 3 approvals amidst challenging market dynamics. Transparency in marketing and product claims is key, especially for mental health solutions. Dr. Harvey also highlights the need for ethical practices in healthcare technology. By improving regulatory processes, he envisions a future where both innovation and patient safety can thrive.
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Class 3 Is The Road To Autonomous AI
- Hugh Harvey says Class 3 enables fully autonomous, high-risk clinical functions.
- Class 3 approvals are the path to replacing human decision-making in medicine.
Barriers To Class 3 Scale
- Hugh Harvey identifies technical, clinical and economic barriers to Class 3.
- He warns clinical trials and evidence generation make Class 3 costly and slow.
Big Tech Will Mirror Pharma In Health
- Hugh Harvey predicts big tech will build pharma-like clinical and regulatory teams.
- These firms will partner with hospitals and run large trials to scale AI.