Artificial intelligence (AI) may hold the key to improving healthcare systems, contributing greater efficacy and supporting the analysis and use of Big Data for healthcare benefit. The European Medicines Agency (EMA), together with the Heads of Medicines Agencies (HMA), founded a Big Data Taskforce in 2017, identifying some of the challenges and opportunities posed by Big Data in medicines regulation. One of the main recommendations arising from the Taskforce was to "Strengthen the Network ability in AI", to enable healthcare systems and professionals to realise the potential of AI and Big Data in health.
On 19 and 20 April, the EMA and HMA hosted a joint workshop on AI in medicines regulation, aiming to inform public stakeholders on the use of AI in medicine, and to hear the views of experts on the AI actions in the Big Data Taskforce. On the first day of the workshop, which was opened by Emer Cooke, the Executive Director of the EMA, we heard how AI is helping to improve the lives of patients by increasing the accuracy of diagnostics, identifying individuals who are most likely to benefit from precision cancer therapeutics (and those who may experience severe side-effects), and how AI can tease out hidden patterns from healthcare records of millions of patients. Presentations on these topics were delivered by several experts in the field of AI and healthcare, including Andre Dekker of Maastricht University, Peter Rijnbeek of Erasmus UMC, and Atul Butte of UCSF in California.
Next, representatives from the World Health Organisation, pharmaceutical industry and several regulatory authorities (including the EMA and FDA) presented their perspectives on the application of AI in medicines and medicines regulation, identifying some of the key regulatory challenges facing AI. A strong emphasis was placed on the integral role played by AI in rapidly-evolving health ecosystems, from the use of digital technologies (e.g. smart watches and sensors), to the use of real world data for evidence generation, and the development of innovative clinical trial designs.
Day 2 of the workshop was primarily focused on policy. The EMA Strategy for digital transformation was presented by Jesper Kjaer of the DKMA (Danish Medicines Authority), and the Big Data Taskforce and ICMRA recommendations were presented by Gianmario Candore (EMA) and Agnes Saint-Raymond (EMA). In the final discussion section, representatives from a broad range of stakeholder groups (inspectors, researchers, consumers, patients, healthcare professionals and industry) presented their views on the Big Data Taskforce recommendations, highlighting the recommendations they felt were of highest importance. A majority felt that creating a framework for assessment and regulation of AI algorithms was of particular importance, with many also highlighting the value of obtaining multi-stakeholder input on AI developments, to ensure transparency and promote human-centric AI designs.
