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Real-world-data enabled assessment
for health regulatory decision-making

Centre for Health, Law & Emerging Technologies, University of Oxford

The Centre for Health, Law and Emerging Technologies (HeLEX) was established within the University of Oxford in October 2009 and has been part of the Faculty of Law since August 2019. The Centre uses an interdisciplinary approach, incorporating methods of investigation and analysis from legal scholarship and the social sciences, with a commitment to public and patient engagement and outreach. Our aim is to support societally responsible innovation that engages with and responds to the needs and concerns of multiple stakeholders, meets its legal obligations, and gives due consideration to the public interest and the needs of future generations.

Role within REALM

HeLEX brings expertise in analysis of ELSI issues of AI systems in healthcare as part of work package two. The contribution is linked to the analysis of ethical and societal challenges in design, development, and implementation of software in healthcare, and to the analysis of European and national legislative and regulatory frameworks on data processing in relation to secondary processing of personal data for the purpose of scientific research and the use of synthetic data as an alternative to real-world data. HeLEX also leads on the research task of societal impact via public workshops. The combined outputs of work package two feed into and inform work packages three to six 3-6 through the research task ‘integration of ethical and legal analyses into the design processes of technological tools’.

Main contacts

Photo of Dr Michael Morrison
Dr Michael Morrison

Senior Researcher in Social Science