Learning healthcare systems, where healthcare and research are closely connected, hold promise for addressing knowledge gaps that traditional clinical studies struggle to fill. But despite their potential, few of these systems are currently operational. Due to the resources needed, their implementation often falls to specific projects. To support stakeholders in this endeavour, researchers from the ConcePTION project have developed an ethics framework for transitioning to operational learning healthcare systems, detailed in their recent publication in Learning Health Systems.
Building a learning healthcare system is complex, involving aspects of big data research, public health, and healthcare system transformation. Researchers have merged existing ethics frameworks from these domains to tackle this complexity, identified commonalities, and applied insights from the ConcePTION project.
To effectively implement such systems, a robust ethics framework is essential. The authors propose four key ethical requirements: ensuring public benefit and a favourable risk-benefit balance, promoting equity and justice, engaging stakeholders, and ensuring sustainability.
Marieke Hollestelle, bioethicist at the University Medical Center Utrecht, one of the authors, explains how “Through these ethical requirements, we aim to encourage projects, networks, and organisations to make decisions that foster continuous learning while ensuring ethical practices. While ConcePTION’s framework aims to leverage real-world healthcare data to address gaps in medicine safety for pregnant and breastfeeding women specifically, it provides valuable guidance for developing operational learning healthcare systems across various healthcare domains.”
By Anna Holm Bodin
Hollestelle M, van der Graaf R, Sturkenboom MCJM, van Delden JJM, An ethics framework for the transition to an operational learning healthcare system, Learning Health Systems, 14 March 2024, DOI: 10.1002/lrh2.10414