Prof Aisling McMahon (Maynooth University) and Dr Ciara Staunton (Independent Legal Consultant) have published a chapter entitled ‘Managing access to health data for research and innovation in the EU: Is a better regulatory approach possible?’ in a recently published edited collection entitled Confidentiality, Privacy, and Data Protection in Biomedicine: International Concepts and Issues (Routledge, 2024) edited by Prof Ted Dove (Maynooth University). This collection features contributions from leading scholars of health law, and offers insightful reflections on a range of health privacy law issues such as confidentiality, privacy, and data protection, as well as comparative analysis of how a range of jurisdictions address challenges posed by the evolving biomedical environment.
This co-authored chapter reflects on the competing rights and interests of the differing stakeholders involved in the use of health data for health research purposes. It argues that regulatory frameworks need to account for and engage with these competing motivations and interests and must ensure that benefits arising are accessible to stakeholders in an equitable manner. The authors set out some of these competing interests before considering the GDPR and possible role of the EHDS for the governance of data in the health research context given these considerations. Part of the chapter also engages with the role of intellectual property rights in the health data context, and how such rights may impact provisions around secondary use of data as proposed within the EHDS. The chapter concludes by reflecting on the limits of both regulations, with proposals for reframing of the system from one primarily focused on individual risk to a system that considers both the individual and collective risks and benefits at stake.
An open access version of this chapter is available here
For full details on the edited collection, see: here
The discussion of intellectual property rights in the chapter is based on research conducted as part of the ERC funded PatentsInHumans Project. That research is funded by the European Union (ERC, PatentsInHumans, Project No. 101042147). Views and opinions expressed are however those of the authors only and do not necessarily reflect those of the European Union or the European Research Council Executive Agency. Neither the European Union nor the granting authority can be held responsible for them.