Our Beyond Regulation theme seeks to understand and develop responsible and responsive regulatory approaches to healthcare and medical practice. Theme Summary Law and regulation are sometimes perceived as placing barriers along the route from science to health. For instance, they "obstruct" research or by create unnecessary boundaries between different jurisdictions or sectors of research. Regulation is often framed as stifling innovation and the law is often criticised for failing to keep up with the fast pace at which technologies continue to develop. Many legal instruments and regulatory mechanisms are considered to be out of touch, or far removed from the settings in which they are meant to be applied or ignorant of the consequences they can have for different individuals. Our Beyond Regulation theme explores the different functions, features and forms that regulation can take across a variety of biomedical contexts and seeks to understand how we can build more responsible and responsive regulatory approaches. Our core research questions include: How do we develop regulatory approaches that can make sure we enable important advancements whilst preventing undesirable developments? How can we ensure that the regulatory landscapes that biomedical actors must work within accurately reflect biomedical practice in reality? How can we ensure that legal frameworks are constructed in ways that reflect the lived experiences of patients, publics and other key stakeholders and their often competing interests? Engagement & Outputs Trustworthy Autonomous Systems Nayha Sethi (co-I) and Louise Heatherall (PDRF) are currently undertaking a UKRI-funded Trustworthy Autonomous Systems project called ‘Making Systems Answer: Dialogical Design as a Bridge for Responsibility Gaps in Trustworthy Autonomous Systems. This project explores how to make autonomous systems like AI more trustworthy across health, finance and public sector contexts. Specifically, the project seeks to understand what responsible regulation of Autonomous Systems looks like. It asks: How can we ensure robust oversight of such technologies whilst maintaining flexibility and context-sensitivity? How do we embed stakeholder perspectives into our regulatory approaches? Making Systems Answer Interdisciplinarity in Health Research Regulation Although we normally associate the regulation of healthcare with legal rules and case law, it does of course implicate a much broader sphere of considerations that draw on many different disciplines including philosophy, social sciences and many more. Colleagues from across CBSS have contributed to the first ever interdisciplinary handbook exploring key issues concerning health research at both local and international levels in the Cambridge Handbook on Health Research Regulation (co-editors include Sethi and Ganguli-Mitra). Shifting Boundaries within and across Regulation and Health A unifying theme across Beyond Regulation is the emphasis placed on identifying and interrogating ever-shifting boundaries across regulatory landscapes and asking what the implications might be for both regulation and health. This includes Ruby Reed-Berendt’s work on When Borders Change: Public Health, Trade and the Role of Law in the UK and Ireland. This project aims to understand the shifting boundaries of the post-Brexit relationship between public health, trade and the law in the UK and Ireland, including North-South relations on the island of Ireland. Theme lead Nayha Sethi Sarah Chan Researchers and partners Louise Hatherall Elaina Gauthier-Mamaril Esther Gonzalez Hernando Ruby Reed-Berendt This article was published on 2024-09-24
