Health data has become the focal point of discussions on data infrastructure and governance. Large-scale initiatives in the UK and the EU are currently set to enable the sharing of individuals’ and communities’ health data, with regulation. England’s National Data Opt-Out, implemented in 2018, was set to allow patients to opt out of their patient information used for research and planning. The EHDS proposed regulation, issued in 2021, promises data portability, enhanced data control and patient access rights. However, while the EHDS Regulation might be seen as an opportunity for advancing legitimate mechanisms to regulate health data sharing, some aspects might not adhere to these promises. Criticisms emerge, starting from the (lack of) evidence of its usefulness and feasibility, patients’ consent and medical confidentiality.
In this view, the panel seeks to formulate questions from a patient’s rights perspective with a critical eye on the EU’s narratives encouraging an automated-driven healthcare system. We will explore concepts such as data automation in healthcare and what that means for rights and protections for people at individual and collective levels (including the lived experience of people in communities that have been oppressed historically). To do so, we will review the experience of England and the EHDS. A focus will be applied to the issue of opt-in/out, with regard to the UK National Data Opt-Out policy, the possible technical solutions, and how these could be of relevance in the European context.
We will review the experience of England in relation to its National Data Opt-Out policy, where individuals can opt-out of their data being used beyond their direct care in some circumstances, and how learning can be applied to a European context.
We will then consider the latest developments of the European Health Data Space, including the recent debates and votes in the European Parliament.
Moderator:
- Elisabetta Biasin – Doctoral Researcher, KU Leuven Centre for IT & IP Law
Speakers:
- Elisa Leila Elhadj – Doctoral Researcher, Life Sciences & Society Lab, KU Leuven
- Nicola Hamilton – Head, Understanding Patient Data
- Benoit Marchal – Founder and Director of PicAps Association
- Francesco Vogelezang – Policy Advisor, European Parliament