A learning health system (LHS) seeks to establish a closer connection between clinical care and research and establishes new responsibilities for healthcare providers as well as patients. A new set of technological approaches in medication adherence monitoring can potentially yield valuable data within an LHS, and raises the question of the scope and limitations of patients’ responsibilities to use them. We argue here that, in principle, it is plausible to suggest that patients have a prima facie obligation to use novel (...) adherence monitors. However, the strength of the obligations depends considerably on the extent to which data that adherence monitors generate are, in fact, used to further the goals of LHSs. The way in which data ownership is structured in the USA poses a considerable challenge here, while the European Union framework offers a more promising alternative. (shrink)

BackgroundThis manuscript presents a framework to guide the identification and assessment of ethical opportunities and challenges associated with electronic patient records (EPR). The framework is intended to support designers, software engineers, health service managers, and end-users to realise a responsible, robust and reliable EPR-enabled healthcare system that delivers safe, quality assured, value conscious care.MethodsDevelopment of the EPR applied ethics framework was preceded by a scoping review which mapped the literature related to the ethics of EPR technology. The underlying assumption behind (...) the framework presented in this manuscript is that ethical values can inform all stages of the EPR-lifecycle from design, through development, implementation, and practical application.ResultsThe framework is divided into two parts: context and core functions. The first part ‘context’ entails clarifying: the purpose(s) within which the EPR exists or will exist; the interested parties and their relationships; and the regulatory, codes of professional conduct and organisational policy frame of reference. Understanding the context is required before addressing the second part of the framework which focuses on EPR ‘core functions’ of data collection, data access, and digitally-enabled healthcare.ConclusionsThe primary objective of the EPR Applied Ethics Framework is to help identify and create value and benefits rather than to merely prevent risks. It should therefore be used to steer an EPR project to success rather than be seen as a set of inhibitory rules. The framework is adaptable to a wide range of EPR categories and can cater for new and evolving EPR-enabled healthcare priorities. It is therefore an iterative tool that should be revisited as new EPR-related state-of-affairs, capabilities or activities emerge. (shrink)

BackgroundElectronic patient record (EPR) technology is a key enabler for improvements to healthcare service and management. To ensure these improvements and the means to achieve them are socially and ethically desirable, careful consideration of the ethical implications of EPRs is indicated. The purpose of this scoping review was to map the literature related to the ethics of EPR technology. The literature review was conducted to catalogue the prevalent ethical terms, to describe the associated ethical challenges and opportunities, and to identify (...) the actors involved. By doing so, it aimed to support the future development of ethics guidance in the EPR domain.MethodsTo identify journal articles debating the ethics of EPRs, Scopus, Web of Science, and PubMed academic databases were queried and yielded 123 eligible articles. The following inclusion criteria were applied: articles need to be in the English language; present normative arguments and not solely empirical research; include an abstract for software analysis; and discuss EPR technology.ResultsThe medical specialty, type of information captured and stored in EPRs, their use and functionality varied widely across the included articles. Ethical terms extracted were categorised into clusters ‘privacy’, ‘autonomy’, ‘risk/benefit’, ‘human relationships’, and ‘responsibility’. The literature shows that EPR-related ethical concerns can have both positive and negative implications, and that a wide variety of actors with rights and/or responsibilities regarding the safe and ethical adoption of the technology are involved.ConclusionsWhile there is considerable consensus in the literature regarding EPR-related ethical principles, some of the associated challenges and opportunities remain underdiscussed. For example, much of the debate is presented in a manner more in keeping with a traditional model of healthcare and fails to take account of the multidimensional ensemble of factors at play in the EPR era and the consequent need to redefine/modify ethical norms to align with a digitally-enabled health service. Similarly, the academic discussion focuses predominantly on bioethical values. However, approaches from digital ethics may also be helpful to identify and deliberate about current and emerging EPR-related ethical concerns. (shrink)