Best practices and challenges in executing large scale pilots for eHealth deployment and managing innovation: the GATEKEEPER experience

The large-scale deployment of digital health solutions requires robust operational frameworks capable of coordinating heterogeneous settings, diverse stakeholders, and complex technical infrastructures. However, actionable guidance for executing federated, multinational eHealth pilots remains limited in the implementation literature. Methods: Using a mixed-methods approach, including iterative focus groups, co-creation sessions, and a Delphi study, we developed and refined a practice-derived management framework over four years within the GATEKEEPER project (EU Horizon 2020, Grant Agreement No. 857223). The study involved a federation of four European large-scale pilots. A panel of 23 experts ranked 45 best practices across six operational domains: Engagement, Intervention, Monitoring and Control, Planning, Recruitment, and Other. Results: The resulting framework integrates a structured definition of operative key performance indicators, standardised reporting and analysis tools, and a Business Intelligence dashboard to support real-time monitoring and decision-making across the preparation, deployment, and running phases of large-scale pilots. Among the ranked best practices, usability testing, user-centred digital tool design, and active recruitment strategies emerged as top priorities across pilot sites. Discussion: This management framework addresses a critical gap in implementation science by offering actionable, consensus-validated guidance for coordinating large, distributed, multi-site digital health deployments. The GATEKEEPER experience demonstrates how structured operational governance and shared performance monitoring can support the execution of complex eHealth pilots, with insights that may inform future large-scale initiatives seeking sustainable and patient-centred digital health integration.