Navigating AI Regulation in Healthcare | Dr Hugh Harvey

In this insightful interview, Future Medicine AI speaks with Dr. Hugh Harvey, a distinguished figure at the intersection of healthcare, AI, and regulatory compliance. As the founder and leader of Hardian Health, Dr. Harvey has established himself as a key player in helping healthcare technology companies navigate the complex landscape of bringing AI solutions to market.

Dr. Harvey’s journey from practicing radiologist to regulatory expert offers a unique perspective on the challenges and opportunities in healthcare AI. His company, Hardian Health, serves as a crucial bridge between innovative healthcare technology and market implementation, offering comprehensive services including clinical evidence generation, regulatory compliance, health economic modeling, and market access strategy.

Throughout this conversation, Dr. Harvey shares valuable insights on several critical aspects of AI in healthcare:

• The intricate process of regulatory approval for AI medical devices
• The distinct challenges posed by different types of AI systems, from deterministic deep learning models to emerging generative AI
• The complexities of implementing AI solutions within healthcare systems like the NHS
• The future trajectory of AI in healthcare and its potential impact

This discussion arrives at a pivotal moment in healthcare technology, as the industry grapples with rapid technological advancement while maintaining essential safety and efficacy standards. Dr. Harvey’s expertise illuminates the path forward for companies and healthcare providers looking to harness AI’s potential while ensuring patient safety and regulatory compliance.

In sharing his experiences and insights, Dr. Harvey provides a comprehensive overview of the current state of AI medical device regulation and offers valuable guidance for organizations navigating this evolving landscape.