Hugh Harvey MD, FRCR

Hugh Harvey trained as a radiologist, becoming an NHS consultant at GSTT. After his training, he undertook a post-graduate research degree at the Institute of Cancer Research, where he worked on early computer vision and image data processing models, and caught the AI bug.

Harvey worked for a year at Babylon Health, gaining the first-ever CE mark for an AI-powered chatbot. He then joined Kheiron Medical as Clinical Director, where we became the first radiology AI startup to get a Class II CE mark for deep-learning-assisted mammography screening. These experiences, combined with his clinical background, led him into the world of medical device regulation.

Harvey was invited by the Secretary of State for Health to act as a lead on the seminal Topol Review, looking at how the NHS could harness the power of AI across healthcare. He has also acted as an editor at Nature: Digital Medicine and sat on various committees at the Royal College of Radiologists, British Institute of Radiology, and the MHRA. He continues to publish academically while managing the team at Hardian full-time.

Harvey founded Hardian in 2018 and, since then, has helped over 100 companies globally get their SaMD and AIaMD to market, providing clinical and regulatory excellence. Hardian also conducts health economic modelling, IP management, and market access strategy, making us the only UK full-stack consultancy for software medical devices.