Work Packages

WP1 Ethics Requirements

This work package sets out the ‘ethics requirements’ that the project must comply with. Law and ethics are closely connected, in the sense that both disciplines look into fundamental human values that are either enshrined in binding legal texts and other self-regulatory instruments (e.g. codes of conduct) or –to an extent– reflected in social norms shaping human behaviour accordingly. In this respect and considering the scope of RETENTION, the ethical and legal aspects associated to the design and use of AI (e.g. human oversight, decision making, protection of personal data), will be integral part of the project foundations.

WP1 Ethics Requirements

This work package sets out the ‘ethics requirements’ that the project must comply with. Law and ethics are closely connected, in the sense that both disciplines look into fundamental human values that are either enshrined in binding legal texts and other self-regulatory instruments (e.g. codes of conduct) or –to an extent– reflected in social norms shaping human behaviour accordingly. In this respect and considering the scope of RETENTION, the ethical and legal aspects associated to the design and use of AI (e.g. human oversight, decision making, protection of personal data), will be integral part of the project foundations.

WP2 Project Management

WP 2 Project Management This work package coordinates all technical, clinical, innovation and administrative project activities and ensures the compliance with the Grant Agreement, the Consortium Agreement, the Description of Action and Quality Plan. It also sets the overall strategic plans, facilitates communication and interactions within the consortium, establishes a smooth collaboration and a common understanding among the teams, enforces mechanisms to timely identify risks and deviations, takes corrective measures and facilitates the management of the innovation processes related to the project outcomes. Finally it produces reports on project progress and ensures the effective use of resources for realising project activities.

WP3 RETENTION Clinical and System Requirements & Platform Design

Within WP3 the involved technical and clinical partners will gather and analyse all the user requirements, from different stakeholders, useful for the design of the RETENTION solution; The Work package will also define and analyse the system requirements of the envisioned integrated solution while identifying and provide critical updates in terms of available tools and technologies, arising in the period between proposal submission and project’s initiation; The main milestone is the design of the architecture and features’ specification of the solution.

WP3 RETENTION Clinical and System Requirements & Platform Design

Within WP3 the involved technical and clinical partners will gather and analyse all the user requirements, from different stakeholders, useful for the design of the RETENTION solution; The Work package will also define and analyse the system requirements of the envisioned integrated solution while identifying and provide critical updates in terms of available tools and technologies, arising in the period between proposal submission and project’s initiation; The main milestone is the design of the architecture and features’ specification of the solution.

WP4 Retention Data Management

The activities envisaged in WP4 include the design and development of the data modelling and data management capabilities of the RETENTION platform, including the definition of the models, based on the specifications of the platform architecture, and deployment of the data repositories. Furthermore, it includes the deployment of the computing infrastructure needed to support the models’ computational requirements, by enabling the exchange of the globally anonymised data, the collection, storage and processing of the heterogeneous aggregated data, generated during the platform’s operation.

Retention Implementation Guide

WP5 Analytics & Decision-making for Personalised Management & Interventions

WP5 mission is to provide the models and components enabling the platform’s analytics and decision support features. The starting point is the provision of the data analytics models’ specifications and the tool support for the creation and editing of those models, followed by the development of verification capabilities (processes and associated components) for the models learned by applying ML techniques to generate disease insights which are transparent, explainable and trustworthy. The models will be then deployed in the RETENTION platform’s decision & policy support capabilities for the benefit of clinical experts as well as public health experts that will be able to access all the necessary information to continuously improve HF patient management, to enhance the relevance of results from controlled clinical trials targeting HF and to refine protocols, regulations and public health.

WP5 Analytics & Decision-making for Personalised Management & Interventions

WP5 mission is to provide the models and components enabling the platform’s analytics and decision support features. The starting point is the provision of the data analytics models’ specifications and the tool support for the creation and editing of those models, followed by the development of verification capabilities (processes and associated components) for the models learned by applying ML techniques to generate disease insights which are transparent, explainable and trustworthy. The models will be then deployed in the RETENTION platform’s decision & policy support capabilities for the benefit of clinical experts as well as public health experts that will be able to access all the necessary information to continuously improve HF patient management, to enhance the relevance of results from controlled clinical trials targeting HF and to refine protocols, regulations and public health.

WP6 Enabling Technologies & Secure, Privacy-aware by Design Data Handling

WP6 aims at designing and developing the RETENTION Mobile Application & Gateway and visualisation dashboards. The Edge Mobile Application will be the main module for end-users to interact with the RETENTION platform and the Edge Gateway will allow the seamless integration of the deployed smart monitoring devices, e.g. smart consumer and medical devices. The visualization features and services will allow clinical experts to monitor their patients, the interventions delivered, alerts being raised and other aspects of the local operation of the platform. WP6 activities will specifically focus on the provision of security and privacy-by-design approach by following comprehensive security and privacy risk assessment, and integration of the mechanisms and processes needed to guarantee the security of all RETENTION assets.

WP7 Platform Integration and Testing

Within WP7 all the tools and components developed in the R&D work packages are integrated in a stable and user friendly solution. Test cases and unit tests will be developed, driven by the platform requirement specifications and the architecture model. The integrated and tested version of the solution will provide the basis for evaluating the effectiveness of the RETENTION project approach in a clinical trial phase. For such a purpose, an end-user guide for installing, deploying and using the RETENTION solution and its components (edge, clinical backend and cloud instances) will be released within this Work package. The target user groups include doctors, supporting medical staff, data scientists, and end users.

WP7 Platform Integration and Testing

Within WP7 all the tools and components developed in the R&D work packages are integrated in a stable and user friendly solution. Test cases and unit tests will be developed, driven by the platform requirement specifications and the architecture model. The integrated and tested version of the solution will provide the basis for evaluating the effectiveness of the RETENTION project approach in a clinical trial phase. For such a purpose, an end-user guide for installing, deploying and using the RETENTION solution and its components (edge, clinical backend and cloud instances) will be released within this Work package. The target user groups include doctors, supporting medical staff, data scientists, and end users.

WP8 RETENTION Clinical Trials and Validation

WP8 establishes the project experimental and validation ground with end-users, such as patients and clinicians. After obtaining the approval from the ethical committees and authorities in the relevant EU countries hosting clinical trials, the activities will focus on the definition of the clinical trial protocol to be followed in all the validation activities. Moreover, it will define the criteria for the evaluation of the RETENTION solution, finalizing the targeted outcome measures for the different types of evaluation, extending and refining the KPIs identified in the project plan. The planned activities involve all the preparatory steps paving the way for the clinical trials such as the preparatory steps (equipment procurement, pre-recruitment, screening), the setup (platform setup, user recruitment), the clinical trials organization (including monitoring and support) and the evaluation activities, in the context of the involved clinical environments. Furthermore a cross-EU trial analysis and an overall assessment of the RETENTION solution from a technical/technological perspective, will cope with all non-clinical aspects and the pertinent KPIs identified in the project.

WP9 Dissemination, Exploitation, Standardisation & Sustainability

WP9 team plans to pursue a multi-facetted plan intended to communicate and disseminate the project and its results, aiming to reach to and engage the healthcare community, as well as the broader research, expert communities and the general public. Dissemination activities in RETENTION will be tailored to and aim at peers, scientific communities, technology experts and providers familiar with the areas related to the RETENTION platform and its individual features, and the medical experts treating patients suffering from HF and associated comorbidities. Communication activities, conversely, will aim at non-specialists and address wider groups, e.g. the general public, people working in the greater healthcare sector but who are not necessarily medical experts, National and European Authorities, municipalities, distribution chains, media & advertising. Exploitation and Sustainability activities will be performed to facilitate the market penetration of the RETENTION platform and it will foster the outreach and interactions between platform and service providers and end-users.

WP9 Dissemination, Exploitation, Standardisation & Sustainability

WP9 team plans to pursue a multi-facetted plan intended to communicate and disseminate the project and its results, aiming to reach to and engage the healthcare community, as well as the broader research, expert communities and the general public. Dissemination activities in RETENTION will be tailored to and aim at peers, scientific communities, technology experts and providers familiar with the areas related to the RETENTION platform and its individual features, and the medical experts treating patients suffering from HF and associated comorbidities. Communication activities, conversely, will aim at non-specialists and address wider groups, e.g. the general public, people working in the greater healthcare sector but who are not necessarily medical experts, National and European Authorities, municipalities, distribution chains, media & advertising. Exploitation and Sustainability activities will be performed to facilitate the market penetration of the RETENTION platform and it will foster the outreach and interactions between platform and service providers and end-users.

WP10 Ethics Management

aims to oversee compliance with the regulatory framework set by the ethics requirements of RETENTION. Considering the project’s scenarios, especially regarding the envisioned clinical trials, ethics and privacy considerations arising in its context require constant monitoring and analysis. WP10 ensures that all steps regarding ethics assurance procedures are taken appropriately and in a timely manner. Additionally, it ensures that all data processing in the project is compliant with existing legal and ethical rules deriving from national and EU legislation and guidelines, as well as from international soft-law instruments. To demonstrate compliance with the project’s ethics requirements, respective reports will be issued at M18, M36 and M48 of RETENTION.