Background

The amount of health-related data collected within the public health sector, but also in the course of activities of daily living, is exponentially growing. The increasing availability of ever larger amounts of data and new technical possibilities for their processing open up opportunities for a healthcare system that systematically and quickly transfers findings from research into health practice and practical findings into research. Such a learning health system promises significant improvements in terms of the quality and efficiency of trans-sectoral health care.  However, it also raises important legal, social, and ethical questions. Apart from the need to meet strict data protection requirements, a learning health system faces significant challenges in terms of protecting essential ethical principles such as autonomy, privacy, solidarity and equity in health care.

Questions and Objectives

The project is divided into an ethical and a legal subproject, and essentially addresses the following issues: Which implications and consequences arise within a learning health system with regard to generally recognized ethical principles relevant in digitization, in medical practice and research? Which conflicts of values or principles do typically occur? How can they be resolved or at least balanced in the sense of a multi-level approach to ethical governance?

These questions will be tackled with reference to considerations and approaches from thematically related ethical and legal discourses. Existing directives, guidelines, regulations and laws will be analyzed and evaluated with regard to their normative implications for the further development of a learning health system. In this context, the experience already gained in other countries with a digitized health care system will also be made fruitful.

The aim of the research project is to develop and make available an ethically and legally sound multi-level model of ethical governance for a learning health system for political decision-makers and health care actors.