The main results after 36 months are:
The Platform: an instrument for health care providers to create standardized health data sets from real world data, enabling public-private collaboration with medtech SME and industries, to create AI solutions.
The GK AI Solutions: AI algorithms and models for health and wellbeing monitoring, early risk detection, assessment and intervention, and Integrated Plug&Play services.
The GK Data Cloud: a secure- open-source infrastructure for data federation and advanced big data services, models, and analytics.
The GK Impact: Through the open innovation approach, composed of open calls, twinning and ecosystem co-creation mechanisms, GATEKEEPER has created a Community of Interest (CoI) composed of 240 entities validating the GATEKEEPER business cases, organized in Platform business, AI services business and Data business, all of them under the new forthcoming regulation of the European Health Data Space (EHDS): GATEKEEPER is providing a secure and protected environment for primary and secondary use of health data, to be tested with the CoI through living lab approach for regulatory training.
As of month 36 the platform is now fully deployed and executed in all 11 regional healthcare systems and has been validated by the winners of the first open call. The platform is now being adopted by the 7 winners of the second open call. The platform, will be further tested in the remaining period,from a business perspective, by the CoI early adopters.
The execution of the pilot is successful as well because all of them are running, the ethical committees have approved all the studies, the recruitments are now increasing in all the sites and in some cases finalized. All the agreements in relation to the sharing, controlling, processing of the data are in place, constituting an important innovation of the project also in view of the forthcoming regulation on the EHDS. However, the structural delays that the COVID19 pandemic has brought to the healthcare systems in the pilot sites (shortage of personnel, impossibility of involving healthcare personnel in pilot studies, priority from ethical committees in approving other activities in their institutions, impossibility of organizing physical meetings and interviews with patients) prevented them to produce the originally planned amount of data and number of patients. For this reason, an extension of 12 months has been agreed by the consortium, discussed several times with the project officer in 2022 and included in the forthcoming amendment. There is clear commitment and believe from the consortium in reaching all the expected objectives from a qualitative and quantitative standpoint. Interestingly, the problem of getting the due date on time for the generation of the AI services. GATEKEEPER has now put in place a complete pipeline for the generation of AI service, compliant with the EHDS and integrated with the GATEKEEPER platform and with the federated data spaces from each pilot. Also, the AI task force has produced a synthetic data generators to start working with the synthetic data and progressively integrate the data provided by pilots when they are available. The work done by the AI taskforce has also fuelled with ideas, challenges, and requirements the activities done by the business cluster, turning GATEKEEPER in a potential reference implementation of the EHDS for the management of chronic diseases.In a nutshell, GATEKEEPER has produced the following outcomes and inputs:
-Reference Use Cases defined around 9 medical conditions, 83 recommendations, 65 risks & mitigation strategies, involving more than 6000 subjects already
-Mappings of Measures Interventions, Big Data & Key Enabling Technologies (KET): 67 KETs identified and 33 User Stories
-GATEKEEPER AI/ML Strategy defined, through 8 Pilots’ AI/ML Modelling Requirements and a catalogue of 24 AI services with clinical and technical details
-24 Clinical studies approved by Ethical Committees and Ethical Assessments
-An additional Reference Use Case on COVID-19: the project has developed a COVID-19 survey integrated into the GK data federation, with about 1500 responders (data will be analysed)
-8 ex-ante impact assessments to show cost-benefit of the GK digital services put in place in the 8 European regional healthcare systems
