Why Radiology AI Platforms Need Regulatory Approvals: Dr Hugh Harvey from Hardian Health Explains!

In Episode 20 of Unboxing AI by CARPL.ai, Dhruv Sahai, COO of CARPL.ai, speaks with Dr. Hugh Harvey (Managing Director, Hardian Health), where he reveals how he changed from practicing clinical radiology to being one of the sought in health technology regulatory affairs – globally. According to Dr. Hugh Harvey who was once employed by Babylon Health where he took a team, turned around, and shared the regulatory world, this is how he came to be the most prominent person who can explain the measures of the medical devices in the market.

He elaborates more about how the FDA works and the European systems and how he relates that to healthcare AI forward innovation from those systems. He also tackles contemporary topics with relevance such as why it is difficult to have strict legal provisions regarding the prescription use of intelligent systems and technologies, the importance of post-marketing studies, and the use of models in medicine – any models, particularly large foundational ones.

The episode highlights key points in the discussion:

1. Dr. Hugh’s journey from practicing radiology to expertise in health tech regulatory affairs.

2. A comparison of FDA and CE regulatory pathways – the 510k clearances and CE mark in high risk.

3. AI in medicine – where are the boundaries, how do you resolve things like model drift and safety?

4. Technology and regulatory approval of AI nowadays – it’s not all about shall we say easy models, how about language models and big vision systems?

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