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Session 1: Regulation essentials

Time

Session details

09:45

Welcome address 
Chair to be announced

09:50

EU AI Act - when to start panicking? 
Mr Leon Doorn, Independent Medical Device Quality, Regulatory and Information Security Consultant, Qair.io, Amsterdam, The Netherlands

10:10

Coming to America - FDA tips and tricks 
Dr Hugh Harvey, Managing Director, Hardian Health, UK

10:30

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

10:50

Panel discussion, featuring: Mr Leon Doorn, Dr Hugh Harvey and Mr Dominic Cushnan

11:10

Closing remarks 
Chair to be announced

11:15

Session ends

Programme subject to change

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Speakers

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

    Read more - Stream 3, Session 1: Coming to America - FDA tips and tricks

    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
  • Mr Dominic Cushnan

    Read more - Stream 2, Session 4 Chair: AI in clinical leadership

    Read more - Stream 3, Session 1: UK Information Governance

    Dominic is fascinated by digital disruption, namely, how digital can be used to streamline and automate healthcare and the services provided, that means staff are supported to provide better care for patients. Any large-scale transformational changes need spread and adoption. This involves taking people on a journey as systems are changed but more importantly making them part of the decisions for change. Helping people become partners in their own health well being by using apps and other digital technologies in order for the prevention and management of their own health.

    Dominic wants to facilitate digital innovation by bringing all the relevant people around the table, including digital experts as well as managers, staff and service users. This is so they can understand digital trends, the benefits of technology and the limitations, which is imperative when planning for change and how a range of connecting and converging digital health technologies are challenging existing service models.

    As part of the digital transformation of health services, Dominic is interested in looking at "the uberisation of healthcare". What do projects like Google Deepmind and IBM Watson, Chatbot AI’s, Internet of Things etc have to offer for the underlying opportunity to rethink public health?

    Read more

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