Prof. Mahsa Shabani1
1Ghent University
In the recent years importance of secondary uses of health data for clinical, research and policy making purposes has been further stressed in view of the availability of health-related data collected in traditional and non-traditional settings. Processing health data as sensitive type of personal data however requires adopting adequate legal and ethical protections, to ensure that rights of the data subjects have been respected, while responsible access to data has been facilitated. In this presentation we investigate how responsible uses of health data for research purposes under the three pillars of lawfulness, transparency, and fairness has been promoted by the relevant data protection regulations. The current data protection regulatory framework in the European Union, namely the EU General Data Protection Regulation (GDPR) has set important rules regarding explicit consent (Art 9) and informational rights of the data subjects (Art 13 &14) which are essential in respecting the aforementioned principles. However, the implementation of the GDPR in various member states in the previous years has shown that the sufficiency and adequacy of the current legal protections when there is a plan for secondary uses of data are far from certain. In addition, introduction of a new health-specific legislative proposal namely European Health Data Space has raised new questions about the legal basis for secondary uses of health data and the responsibilities of the data controllers regarding transparency. We will discuss how these new rules will interplay with the existing data protection rules and how they will impact health research.
Biography:
Mahsa Shabani is an assistant professor in health privacy law. She is also a co-coordinator for interfaculty Metamedical platform in Ghent University. Her research interest is on privacy, data sharing, ELSI genomics and research ethics.