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Governance 24 Apr 2023

This talk consists of six videos:

2.1   What AI governance entails - Dr Christina Malamateniou

AI is increasingly being used in medical Imaging. AI governance is vital for AI implementation into medical imaging and radiotherapy. It is vital to engage with AI governance for a safe and effective use of AI innovation, to maximise workflow efficiency, patient benefits and staff satisfaction. It is also vital to engage in AI education to ensure seamless AI integration into clinical practice and minimisation of any risks.

This presentation will discuss the definition of AI governance, what it entails and delve into each of its constituents, their benefits and challenges and offer future suggestions to support the medical imaging workforce.

2.2 Medical device regulation and standards: (a) CE Mark/ UKCA/FDA - Dr Shahriar Islam (b) Post-market - Dr Lizzie Barclay (c) Case study - Dr Camille Vidal GEHC

(a)   Health care is the most regulated market in the world to ensure patient safety. In 2021 the Medical Device Directive (MDD) was replaced to the MDR. In this talk we look at why regulation is needed in radiology AI, what is required to regulate appropriately, and the long-term impact of MDR.

(b)   Post market surveillance of AI as a medical device is an evolving area of regulation, in terms of what’s mandated and what’s considered best practice.

This session is intended to provide adopters of AI technologies with an introduction to post market surveillance and useful resources for staying up to date as the regulations and guidelines evolve.

(c)   In this presentation, we provide a brief overview of the current regulatory framework for Medical Imaging Devices containing AI functionality. We provide an example of evidence produced by Medical Device Manufacturer to demonstrate the safety and performance of a Computer Aided Triage device.

2.3 Evaluation and validation: case examples? Annalise - Dr Gerald Lip, Dr Struan Wilkie

(a)   Dr Lip will be speaking about a evaluation and validation of AI as part of the AI Education essentials series. He will review concepts on AI drift, a review of current regulations and responsibility. He will detail current and proposed methods of post market surveillance detailing feedback and monitoring routes. He will use his experience with AI in breast screening as a use case study on real life feedback and monitoring of an algorithm. He will also look at application of QI methodologies to AI.

(b)   Evaluation and validation of AI in healthcare is vital for governance if users are to have confidence in the AI solution being used. There are a number of components to evaluation and validation which which initially begins with the AI developer. As AI becomes more common place, local validation of an AI product is needed to ensure the performance of AI in healthcare is maintained in the real-world use case. Achieving this needs clear guidelines and workflow integration as well as time.

2.4 Guidelines: explainable AI - Dr Catherine Jones

Explainable AI serves to engender trust and improved performance in the underlying AI model, through attempts to understand the model processes in producing outputs. This talk outlines the reasons for improving transparency of AI models, the reasons and the risks of making AI explainable, and the limitations of current methods for explaining the performance of AI models in radiology.

2.5 Ethics, liability and ownership - Prof Dr med Matthias Goyen GEHC

The use of AI in healthcare is rapidly growing, with the potential to greatly improve patient outcomes, reduce costs, and increase efficiency. However, as with any new technology, there are also ethical and legal considerations that must be considered. The lecture discusses that by ensuring that AI algorithms are unbiased, that data privacy is protected, that liability is clearly defined, and that ownership is established, we can ensure that AI is used in a responsible and ethical manner.

2.6 AI Safety - Dr Anjum Ahmed

3 CPD credits

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Duration:3 hour 10 mins

Speaker info

Prof. Dr. med. Mathias Goyen

Prof. Dr. med. Mathias Goyen is the Chief Medical Officer EMEA for GE HealthCare. Mathias is responsible for leading GE HealthCare’s medical, clinical and evidence generation strategies for product modalities in Europe, the Middle East & Africa. Together with his team he provides leadership in healthcare economics and outcomes research and comparative effectiveness research to develop customer value propositions for new and existing products Mathias began his career as a diagnostic Radiologist working at Essen and Hamburg/Germany. He was appointed Professor of Diagnostic Radiology at the University of Hamburg/Germany in 2010. Mathias holds a medical degree (MD) from the University of Bochum, Germany. He has been secretary general of the German Chinese Society of Medicine, Berlin, from 2005 - 2019.

Dr Gerald Lip

Dr Gerald Lip is the Clinical Director for breast screening in the North East of Scotland and the Principal Investigator of the GEMINI prospective evaluation of mammography artificial intelligence supported by the NHS National Strategy for AI in Health and Social Care. He has recently completed a 4-year retrospective research project in the same topic with the Industrial Centre for Artificial Intelligence and Digital Diagnostics in Scotland. Dr Lip has recently been awarded a two-year Innovation Fellowship by the Chief Scientists Office of Scotland to lead innovation adoption in the NHS. Dr Lip is the vice chair of the British Society of Breast Radiology and sits on the UK Royal College of Radiology Informatics committee, on the Advisory Board of the Centre for Doctoral Training for Biomedical AI in Edinburgh University and is a scientific advisor to the National Covid Chest Imaging Database. Dr Lip is active in research, education and training publishing on work with radiology trainees in AI, opinions on the member of the public and professional colleagues on AI and also sits on the British Institute of Radiology AI special interest group leading on education. A graduate of Trinity College Medicine, along with his medical degree he also qualified with an Msc. in Health Informatics and completed his radiology training in Aberdeen. He is an honorary senior clinical lecturer in the University of Aberdeen. Dr Lip has published and spoken on topics nationally and internationally such as patient engagement, innovation in breast imaging techniques, quality assurance and safety and monitoring in AI.

Dr Chrstina Malamateniou

Christina is the Director of the postgraduate programme of radiography at City, University of London and a Visiting Professor of Radiography at HESAV University in Switzerland. She is a widely published researcher in medical imaging, with more than £3.25 million in research grants in her name as PI and Co-I and an enthusiastic educator. Her area of research revolves around AI adoption and education in radiography, person centred care and supporting the workforce in its recovery after the Covid19 pandemic. Christina is also the chair of the AI advisory group of the SCoR and the new Chair of research for the EFRS from April 2023-2025. She is an associate editor with JMIRS. Christina believes in leading from the heart and in the power (and fun) of collaborative work.