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Stream 3: Governance and regulation

Hear about the latest developments on policy/regulation, validation, managing risk, post-market surveillance, health economics and what the future holds.

Leads - Dr Hugh Harvey and Professor Rowena Johnson 

Session 1: Regulation essentials

Updates on UK medical device regulations, international regulatory recognition, upcoming AI standards and the EU AI Act.

Chair: Professor Erika Denton, SRO - Greener NHS Lead, NHS England, UK

 

Time

Talk Title

Speaker

09:45

Welcome

Professor  Erika Denton, NHS England, UK

09:50

EU AI Act - when to start panicking?

Mr. Leon Doorn, MedQAIR, The Netherlands

10:10

Coming to America - FDA tips and tricks

Dr. Hugh Harvey, Hardian Health, UK

10:30

UK IG governance

Mr. Dominic Cushnan, NHS England, UK

11:15

Close

Programme subject to change

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Speakers

Professor Erika Denton

SRO – Greener NHS Lead
NHS England, UK
Professor Erika Denton

Mr Leon Doorn

Independent Medical Device Quality, Regulatory and Information Security Consultant
Qair.io, Amsterdam, The Netherlands
Mr Leon Doorn

Dr Hugh Harvey

Managing Director
Hardian Health, UK
Dr Hugh Harvey
  • Dr Hugh Harvey

    Dr Harvey is an ex-NHS consultant radiologist and academic, trained at the Institute of Cancer Research, twice awarded ICR Science Writer of the Year.

    He is a prior member of the RCRs informatics and AI committees, a lifetime Fellow of the Royal College of Radiologists and is an honorary fellow of the British Institute of Radiology. He also holds an honorary academic position at the University of Birmingham. He acted as co-chair to the UK Topol Health Technology Review for Health Education England, and is an advisor to the Medicines & Healthcare products Regulatory Agency.

    After leaving NHS medicine and academia he worked at Babylon Health where he gained world-first regulatory approval for an AI-enabled chatbot, and then became medical director at Kheron Medical gaining EU-first CE marking for a Class IIb breast cancer screening AI software. He is globally regarded as a top clinical regulatory expert for software and AI devices.

    Managing Director at Hardian Health since 2018, he has built a specialist global consultancy focussed on software as a medical device regulatory, clinical, health economics, market strategy and intellectual property services.

    Read more

Mr Dominic Cushnan

Director of AI, Imaging and Deployment
NHS England, UK
Mr Dominic Cushnan

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