Digital health is revolutionizing the approach to healthcare, particularly in the context of healthy aging1. Through innovative technologies such as wearable devices, mobile apps, and telemedicine platforms, digital health empowers individuals to monitor and manage their health proactively2. This means easier access to medical consultations, real-time health monitoring, and personalised fitness programs, enabling elderly people to maintain their well-being and independence3. Furthermore, digital health tools facilitate the seamless sharing of health data between patients and healthcare providers, fostering more personalised and efficient healthcare solutions tailored to the specific needs of aging populations4. As a result, healthy aging is no longer just about adding years to life but ensuring those added years are lived in good health and vitality, thanks to the transformative potential of digital health technologies. However, the efficacy, cost-effectiveness, and scalability of eHealth interventions must be tested before large-scale adoption. In this framework, large-scale pilots (LSPs) are key as a last step in the implementation strategy towards real-world adoption of such technologies.
In this remit, the European Horizon 2020 project GATEKEEPER (GK) (https://www.gatekeeper-project.eu/) aims to connect healthcare providers, businesses, entrepreneurs, older citizens, and the communities in which they live, to create an open and trust-based arena to combine user ideas, technologies, needs, and processes, to ensure a healthier independent life for aging populations5. As a result, GATEKEEPER has created an open-source, European, standard-based, interoperable, and secure framework available to all developers, for the creation of combined digital solutions for personalised early detection and interventions that cover the entire care cycle for elderly citizens. The system envisaged by GATEKEEPER is broader in scope than other eHealth solutions: instead of focusing on one disease or condition, it tries to meet the heterogeneous health needs of the elderly. In this context, and with the aim of validating the project’s technical developments in real scenarios, GATEKEEPER is an LSP project organised into 8 Pilot sites in Europe (Aragon, Basque Country, Cyprus, Greece, Poland, Puglia, Saxony, and the UK [Milton Keynes and Bangor]). Up to 30 implementation trials tackling 9 reference use cases (RUCs) are being conducted (see Table 1). However, the added value of GATEKEEPER lies not only in its many implementation trials but in their pooling via a federated approach, aiming at demonstrating the effectiveness and the cost-effectiveness of Key Enabling Technologies (KETs) such as AI, big data, and Internet of Things (IoT) for the prevention of adverse events and the management of health in later life. In order to get the gears going, looking into obtaining several ethical approvals was essential (see Table 1).
In fact, a project such as GATEKEEPER, which includes the use of KETs for people and, in particular, on patients suffering from pathologies of different complexity and the use of their data, requires attention to a multitude of ethical questions. The ever-increasing use of Internet of Things (IoT) and Artificial Intelligence (AI) in healthcare itself is deeply intertwined with numerous ethical challenges concerning the interrelations between “things”/machines and humans. Specifically, the use of ICT (including IoT) in applications for personal assistance presents several challenges6. These include the complexity and pervasiveness of the technology that users find difficult to understand, significant privacy and confidentiality concerns, difficulties in ensuring the security of personal data, the absence of a trusted framework for data protection, and a lack of transparency in data collection and processing7.
As can be seen from above, and as confirmed by a literature review on the subject8, a frequent theme in the debate on ethics, AI, and IoT, relates to privacy, and, more prominently, to the issues regarding personal data sharing and protection9. It has been argued that one key feature of the use of digital devices is the passive and continuous collection of information10, which makes it difficult for the users to feel in complete control of the sharing and use of their data11.
Ethical aspects of interrelations between humans and technology are even more relevant when it comes to the application of AI and IoT in the field of health and the medical sector. Health-related data necessarily touch upon the user’s identity and the most intimate sphere of their private life. Due to the sensitivity of the data12 and the potential consequences for the users, human control over algorithms and decision-making systems is paramount for these applications. This is further highlighted in the European Health Data Space Regulation13, the ambitious initiative held by the European Union aimed at improving the healthcare sector by facilitating the secure and efficient exchange of health data across member states.
Currently, although a unified legal ethical framework of reference for AI applications is still missing, there are many different regulatory efforts to address these ethical aspects, such as The Ethics Guidelines for Trustworthy Artificial Intelligence, published by the High-level Expert Group on AI, in April 201914. Another important document in this field is the EU AI Act, which is expected to reach its final adoption by the end of 2024.
To safely navigate this “uncharted” territory, since its beginning, the GATEKEEPER project has established some overarching ethical principles. The list of guiding principles was informed by the principalist approach to medical ethics15 and the Organization for Economic Cooperation and Development (OECD)’s Privacy Framework16. These principles are listed below, with a comment on their relation to the four principles embedded in the Ethics Guidelines for Trustworthy AI, namely (1) Respect for human autonomy, (2) Prevention of harm, (3) Fairness, and (4) Explicability:
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A.
Collect the minimum required data and ensure that data processing protocols are transparent and accountable (principles 2 and 4);
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B.
Support the ethical capabilities of human beings such as agency, awareness and reflexivity (requiring transparency on how data are collected and distributed) (principles 1 and 4);
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C.
Create and maintain trust and confidentiality between users and providers (all 4 principles);
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D.
Embed inclusiveness in design (principle 3);
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E.
Facilitate public health actions and user engagement related to IoT for health (principles 1, 3 and 4).
Nevertheless, in an LSP Project, apart from the overarching ethical principles guidelines (see also Supplementary Note 1), each pilot should refer to their respective ethical committee and follow their own ethical procedure. As such, the Ethical approval procedure is an integral part of the research process as it aims to protect both researchers and participants. Participants should be provided with enough details to make informed, autonomous decisions17. Therefore, while respecting shared principles, within GATEKEEPER each pilot has followed the procedures requested by their local Ethical Committees for submitting their ethical approvals, preparing the required documentation following the official forms and the languages locally requested.
During the preparation of the pilot application, a multiformity of ethical application procedures and documents to be submitted to different Local Ethical Review Boards (LERBs) different for each pilot and sometimes for each RUC emerged, resulting in a jeopardised situation, which revealed a complexity of the procedural mechanism that it seemed appropriate to rethink starting from a unified perspective18. In fact, it was noted that even if the framework of existing principles is very well-structured and satisfying, there is a lack of tools that can concretely, and in a harmonized way, guide the application of such principles in the management of a LSP research project.
For all the reasons anticipated, this manuscript provides an overview of the ethical management strategy implemented in the GATEKEEPER project and the proposed idea of building a common European ethical legal framework that could serve as a model for supporting and guiding the management of LSP research projects in the future.