The potential of Biomedical Big Data (BBD) coupled with the big strive for open science opens up regulatory and ethical challenges for the development of EU health research. Due to the increasing importance of the exploitation of data in health domain (for example – but not only – in the case of a pandemic) and to exploit the full potential of health data, the establishment of the European Health Data Space is being discussed and the notion of Open Science and Data-sharing acquires new dimensions.

While looking at what the brave new world might look like, we will explore how to frame research in this changing landscape that requires a greater exploitation of medical records, the extensive sharing of research datasets, and the introduction of new technologies such as Artificial Intelligence (AI). These concepts challenge our existing ethical and regulatory frameworks based on individual rights and new concepts emerge to frame a new bioethical paradigm based on the balance between individual rights and public value. Issues to be revised include FAIR access, control, privacy, transparency, security, accountability and justice. Coupled with a focus on the development of safe spaces to use data for health, in this e-course, we present hands on experiences and potential solutions.

This e-course, framed around lectures and exercise based on a real-life case study, offers basis to analyze, categorize and address key ethical considerations of data sharing and usage in the era of Open Science in the Life Sciences & Health domain. By taking the course, you will develop understanding on how to assess the use of Biomedical Big Data in the context of the ethical implications that inevitably follow it, and how to leverage ethical consideration in decision making. Participation in this course will foster your transversal skills and equip you with cutting edge knowledge on big data relevant to your study, research or internships.

The expertise of the speakers covers a broad spectrum of research and application interests from bioethics, health policy and social studies of medicine, to cutting-edge genomics, analysis of large heterogeneous high-throughput data-sets and usage related to Open Science for biomedicine.