Key ethical challenges in the European Medical Information Framework

The European Medical Information Framework (EMIF) project, funded through the IMI programme (Innovative Medicines Initiative Joint Undertaking under Grant Agreement No. 115372), has designed and implemented a federated platform to connect health data from a variety of sources across Europe, to facilitate large scale clinical and life sciences research. It enables approved users to analyse securely multiple, diverse, data via a single portal, thereby mediating research opportunities across a large quantity of research data. EMIF developed a code of practice (ECoP) to ensure the privacy protection of data subjects, protect the interests of data sharing parties, comply with legislation and various organisational policies on data protection, uphold best practices in the protection of personal privacy and information governance, and eventually promote these best practices more widely. EMIF convened an Ethics Advisory Board (EAB), to provide feedback on its approach, platform, and the EcoP. The most important challenges the ECoP team faced were: how to define, control and monitor the purposes (kinds of research) for which federated health data are used; the kinds of organisation that should be permitted to conduct permitted research; and how to monitor this. This manuscript explores those issues, offering the combined insights of the EAB and EMIF core ECoP team. For some issues, a consensus on how to approach them is proposed. For other issues, a singular approach may be premature but the challenges are summarised to help the community to debate the topic further. Arguably, the issues and their analyses have application beyond EMIF, to many research infrastructures connected to health data sources

Managing the Ethical Dimensions of Brain-Computer Interfaces in eHealth: An SDLC-based Approach

A growing range of brain-computer interface (BCI) technologies is being employed for purposes of therapy and human augmentation. While much thought has been given to the ethical implications of such technologies at the ‘macro’ level of social policy and ‘micro’ level of individual users, little attention has been given to the unique ethical issues that arise during the process of incorporating BCIs into eHealth ecosystems. In this text a conceptual framework is developed that enables the operators of eHealth ecosystems to manage the ethical components of such processes in a more comprehensive and systematic way than has previously been possible. The framework’s first axis defines five ethical dimensions that must be successfully addressed by eHealth ecosystems: 1) beneficence; 2) consent; 3) privacy; 4) equity; and 5) liability. The second axis describes five stages of the systems development life cycle (SDLC) process whereby new technology is incorporated into an eHealth ecosystem: 1) analysis and planning; 2) design, development, and acquisition; 3) integration and activation; 4) operation and maintenance; and 5) disposal. Known ethical issues relating to the deployment of BCIs are mapped onto this matrix in order to demonstrate how it can be employed by the managers of eHealth ecosystems as a tool for fulfilling ethical requirements established by regulatory standards or stakeholders’ expectations. Beyond its immediate application in the case of BCIs, we suggest that this framework may also be utilized beneficially when incorporating other innovative forms of information and communications technology (ICT) into eHealth ecosystems

Managing the Ethical Dimensions of Brain-Computer Interfaces in eHealth: An SDLC-based Approach

A growing range of brain-computer interface (BCI) technologies is being employed for purposes of therapy and human augmentation. While much thought has been given to the ethical implications of such technologies at the ‘macro’ level of social policy and ‘micro’ level of individual users, little attention has been given to the unique ethical issues that arise during the process of incorporating BCIs into eHealth ecosystems. In this text a conceptual framework is developed that enables the operators of eHealth ecosystems to manage the ethical components of such processes in a more comprehensive and systematic way than has previously been possible. The framework’s first axis defines five ethical dimensions that must be successfully addressed by eHealth ecosystems: 1) beneficence; 2) consent; 3) privacy; 4) equity; and 5) liability. The second axis describes five stages of the systems development life cycle (SDLC) process whereby new technology is incorporated into an eHealth ecosystem: 1) analysis and planning; 2) design, development, and acquisition; 3) integration and activation; 4) operation and maintenance; and 5) disposal. Known ethical issues relating to the deployment of BCIs are mapped onto this matrix in order to demonstrate how it can be employed by the managers of eHealth ecosystems as a tool for fulfilling ethical requirements established by regulatory standards or stakeholders’ expectations. Beyond its immediate application in the case of BCIs, we suggest that this framework may also be utilized beneficially when incorporating other innovative forms of information and communications technology (ICT) into eHealth ecosystems

Beyond Research Ethics: Dialogues in Neuro-ICT Research

open access articleThe increasing use of information and communication technologies (ICTs) to help facilitate neuroscience adds a new level of complexity to the question of how ethical issues of such research can be identified and addressed. Current research ethics practice, based on ethics reviews by institutional review boards (IRB) and underpinned by ethical principlism, has been widely criticized. In this article, we develop an alternative way of approaching ethics in neuro-ICT research, based on discourse ethics, which implements Responsible Research and Innovation (RRI) through dialogues. We draw on our work in Ethics Support, using the Human Brain Project (HBP) as empirical evidence of the viability of this approach

Science and Technology Governance and Ethics - A Global Perspective from Europe, India and China

This book analyzes the possibilities for effective global governance of science in Europe, India and China. Authors from the three regions join forces to explore how ethical concerns over new technologies can be incorporated into global science and technology policies. The first chapter introduces the topic, offering a global perspective on embedding ethics in science and technology policy. Chapter Two compares the institutionalization of ethical debates in science, technology and innovation policy in three important regions: Europe, India and China. The third chapter explores public perceptions of science and technology in these same three regions. Chapter Four discusses public engagement in the governance of science and technology, and Chapter Five reviews science and technology governance and European values. The sixth chapter describes and analyzes values demonstrated in the constitution of the People’s Republic of China. Chapter Seven describes emerging evidence from India on the uses of science and technology for socio-economic development, and the quest for inclusive growth. In Chapter Eight, the authors propose a comparative framework for studying global ethics in science and technology. The following three chapters offer case studies and analysis of three emerging industries in India, China and Europe: new food technologies, nanotechnology and synthetic biology. Chapter 12 gathers all these threads for a comprehensive discussion on incorporating ethics into science and technology policy. The analysis is undertaken against the backdrop of different value systems and varying levels of public perception of risks and benefits. The book introduces a common analytical framework for the comparative discussion of ethics at the international level. The authors offer policy recommendations for effective collaboration among the three regions, to promote responsible governance in science and technology and a common analytical perspective in ethics

Human Resources for Health Migration: global policy responses, initiatives, and emerging issues

This report identifies and maps contemporary global policy responses to, and initiatives on, international HRH migration, with particular reference to low‐income source countries. It reports on a systematic review and analysis of the responses and initiatives of twelve multilateral organisations and global fora: European Union; Global Forum on Migration and Development; Global Health Workforce Alliance; International Labour Organization; International Organization for Migration; Organisation for Economic Cooperation and Development; Pan‐American Health Organization; UN Global Migration Group; UN High‐Level Dialogue on Migration and Development; World Bank; World Health Organization; and the World Trade Organization. The report documents how these global policy actors are presently engaging with the HRH migration field through their activities, initiatives and policy responses. It situates this engagement within global policy initiatives spanning health, migration and development. In addition to reviewing and mapping current initiatives and policy responses and their outcomes, the report identifies emerging issues, upcoming promising initiatives and global policy scenarios

Designing the Health-related Internet of Things: Ethical Principles and Guidelines

The conjunction of wireless computing, ubiquitous Internet access, and the miniaturisation of sensors have opened the door for technological applications that can monitor health and well-being outside of formal healthcare systems. The health-related Internet of Things (H-IoT) increasingly plays a key role in health management by providing real-time tele-monitoring of patients, testing of treatments, actuation of medical devices, and fitness and well-being monitoring. Given its numerous applications and proposed benefits, adoption by medical and social care institutions and consumers may be rapid. However, a host of ethical concerns are also raised that must be addressed. The inherent sensitivity of health-related data being generated and latent risks of Internet-enabled devices pose serious challenges. Users, already in a vulnerable position as patients, face a seemingly impossible task to retain control over their data due to the scale, scope and complexity of systems that create, aggregate, and analyse personal health data. In response, the H-IoT must be designed to be technologically robust and scientifically reliable, while also remaining ethically responsible, trustworthy, and respectful of user rights and interests. To assist developers of the H-IoT, this paper describes nine principles and nine guidelines for ethical design of H-IoT devices and data protocols