The promotion of data sharing in pharmacoepidemiology

This article addresses the role of pharmacoepidemiology in patient safety and the crucial role of data sharing in ensuring that such activities occur. Against the backdrop of proposed reforms of European data protection legislation, it considers whether the current legislative landscape adequately facilitates this essential data sharing. It is argued that rather than maximising and promoting the benefits of such activities by facilitating data sharing, current and proposed legislative landscapes hamper these vital activities. The article posits that current and proposed data protection approaches to pharmacoepidemiology — and more broadly, re-uses of data — should be reoriented towards enabling these important safety enhancing activities. Two potential solutions are offered: 1) a dedicated working party on data reuse for health research and 2) the introduction of new, dedicated legislation

Remaining rooted whilst branching out: an investigation of rules and principles in decision-making

Against the backdrop of health research regulation, this work engages in an exploration of, and offers suggestions towards, how the decision maker can negotiate the complex path of the difficult decision. It is argued that whilst rules and principles are heavily relied upon in order to determine what to do, this reliance takes place without adequate reflection of the different ways in which we seek to rely upon these decision-making aids. What is most often the topic of analysis is the content which rules and principles carry rather than consideration of the different functions which each can fulfil or their (un)suitability in helping the decision maker. Before we consider which principles or rules should inform our decisions, we need to understand why we are using rules and principles. It follows that in order to understand why we might use rules and principles, we must understand how rules and principles can actually help us to reach decisions. Through the development and refinement of a conceptual tree, this thesis sheds light on the how and the why, in order to help decision makers determine the which. Through the metaphor of a continuum, additional insights are offered on the interrelationships that might co-exist between rules and principles. This thesis begins by offering an analysis of pre-existing understandings of rules and principles from legal theory and bioethics literatures. Additionally, I consider the implications of principle-centric and rule-centric approaches to decision-making. Through the overarching metaphor of a tree, a conceptualisation of best practice instantiations, which represent a helpful middle-ground between rules and principles is also offered. This can provide significant practical support to the decision maker in navigating the path of the difficult decision

Delivering Proportionate Governance in the Era of eHealth:Making Linkage and Privacy Work Together

This article advances a principled proportionate governance model (PPGM) that overcomes key impediments to using health records for research. Despite increasing initiatives for maximising benefits of data linkage, significant challenges remain, including a culture of caution around data sharing and linkage, failure to make use of flexibilities within the law and failure to incorporate intelligent iterative design. The article identifies key issues for consideration and posits a flexible and accessible governance model that provides a robust and efficient means of paying due regard to both privacy and the public interests in research. We argue that proportionate governance based on clear guiding principles accurately gauges risks associated with data uses and assigns safeguards accordingly. This requires a clear articulation of roles and responsibilities at all levels of decision-making and effective training for researchers and data custodians. Accordingly, the PPGM encourages and supports defensible judgements about data linkage in the public interest