GATEKEEPER’s Strategy for the Multinational Large-Scale Piloting of an eHealth Platform: Tutorial on How to Identify Relevant Settings and Use Cases

Abstract

Background The World Health Organization’s strategy toward healthy aging fosters person-centered integrated care sustained by eHealth systems. However, there is a need for standardized frameworks or platforms accommodating and interconnecting multiple of these systems while ensuring secure, relevant, fair, trust-based data sharing and use. The H2020 project GATEKEEPER aims to implement and test an open-source, European, standard-based, interoperable, and secure framework serving broad populations of aging citizens with heterogeneous health needs. Objective We aim to describe the rationale for the selection of an optimal group of settings for the multinational large-scale piloting of the GATEKEEPER platform. Methods The selection of implementation sites and reference use cases (RUCs) was based on the adoption of a double stratification pyramid reflecting the overall health of target populations and the intensity of proposed interventions; the identification of a principles guiding implementation site selection; and the elaboration of guidelines for RUC selection, ensuring clinical relevance and scientific excellence while covering the whole spectrum of citizen complexities and intervention intensities. Results Seven European countries were selected, covering Europe’s geographical and socioeconomic heterogeneity: Cyprus, Germany, Greece, Italy, Poland, Spain, and the United Kingdom. These were complemented by the following 3 Asian pilots: Hong Kong, Singapore, and Taiwan. Implementation sites consisted of local ecosystems, including health care organizations and partners from industry, civil society, academia, and government, prioritizing the highly rated European Innovation Partnership on Active and Healthy Aging reference sites. RUCs covered the whole spectrum of chronic diseases, citizen complexities, and intervention intensities while privileging clinical relevance and scientific rigor. These included lifestyle-related early detection and interventions, using artificial intelligence–based digital coaches to promote healthy lifestyle and delay the onset or worsening of chronic diseases in healthy citizens; chronic obstructive pulmonary disease and heart failure decompensations management, proposing integrated care management based on advanced wearable monitoring and machine learning (ML) to predict decompensations; management of glycemic status in diabetes mellitus, based on beat to beat monitoring and short-term ML-based prediction of glycemic dynamics; treatment decision support systems for Parkinson disease, continuously monitoring motor and nonmotor complications to trigger enhanced treatment strategies; primary and secondary stroke prevention, using a coaching app and educational simulations with virtual and augmented reality; management of multimorbid older patients or patients with cancer, exploring novel chronic care models based on digital coaching, and advanced monitoring and ML; high blood pressure management, with ML-based predictions based on different intensities of monitoring through self-managed apps; and COVID-19 management, with integrated management tools limiting physical contact among actors. Conclusions This paper provides a methodology for selecting adequate settings for the large-scale piloting of eHealth frameworks and exemplifies with the decisions taken in GATEKEEPER the current views of the WHO and European Commission while moving forward toward a European Data Space.

Digital Remote Monitoring Using an mHealth Solution for Survivors of Cancer: Protocol for a Pilot Observational Study

“…This study is one of the many being developed within the scope of the GK project, all of which share the underlying aim of improving the quality of life of the aging population and people living with chronic conditions. However, this is 1 of the only 2 GK studies focused on cancer, with a study in Cyprus focusing on palliative care for the end of life [ 13 ]. As such, this is the only pilot in the GK large-scale pilot that addresses the challenges of long-term monitoring of cancer symptoms.…”

“…The intuition is that apps and devices would bring critical contextual and behavioral information that, combined with medical data and knowledge, would lead to a breakthrough in AI for health care. For instance, ongoing investigations within the GK project involve the development of risk prediction algorithms for mental health and cognitive impairment and digital coaching to mitigate loneliness-related risks [ 13 ]. These breakthroughs are the result of this new approach and the data sets collected as part of the project.…”

“…The large-scale pilot aims to develop and test a novel approach to the evaluation of digital innovation in health care. The proposed approach can be described as an integrative analysis of cost-benefits, combining the local evaluation of the wide range of approaches and solutions at the reference sites with 10 main health care themes [ 13 ]. Pilots within the GK project evaluate, monitor, or treat the most prevalent, chronic, noncommunicable conditions according to the World Health Organization, including cardiovascular, metabolic, and respiratory diseases, whereas this pilot study focuses on cancer [ 14 ].…”

“…In preparation for the proposed study, a new mHealth solution for survivors of cancer was co-designed. This solution was initially tested in a small-scale study focused on the use of a wearable mHealth app before further expansion within the context of GK [ 13 ].…”

Towards a common European ethical and legal framework for conducting clinical research: the GATEKEEPER experience

“…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 populations 5 . 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.…”