WP1 – Governance, Sustainability & Capabilities

The observatory business architecture outlines the initial design of the national and umbrella observatories, together with the principles behind that design. The business architecture covers organizational matters and is complementary to the technical architecture for the observatory network.

The six components of the business architecture include: the mission statement and governance principles; the legal structure for the formation of the observatories and the network of observatories; a summary of the first version of the data management plan; the organizational characteristics of the observatories; and an outline of the approach for the observatories to be sustained beyond the IMI funding period.

Read or download H2O_D1.1 Observatory business architecture

This document is the first version of the Data Management Plan Deliverable 1.1 of the IMI H2O project. This version (v1.0) of the DMP will focus primarily on intended developments in the first half of the project, up to and including the setting up of the European and National Observatories as legal entities, though it will note developments that are expected to occur in the rest of the project or developments that are anticipated for entities that continue after the project is complete. Possible issues with this later work will be noted, but not necessarily explored in depth.

Read or download H2O_D1.2 Data Management Plan

H2O is a strategic partnership between the public and private sectors to create a robust data governance and infrastructure model to collect and incorporate patient outcomes at scale into healthcare decision making at an individual and population level. It aims to support better health outcomes by creating and implementing an unprecedented, standardised data governance and infrastructure system across Europe to incorporate patients’ experiences and preferences in decisions affecting their health care. The public and private sectors have partnered to launch the H2O project to deliver a positive impact across the health care ecosystem by enhancing health research prospects, promoting the development of new treatments that reflect outcomes reported by patients and sustaining more efficient healthcare systems.

The aim of deliverable D1.3 – Bylaws of the Patient Advisory Boards – is to lay the foundation of patient involvement in H2O project, set the terms of reference and recommend principles for the selection and engagement of patients and patient representatives in the three disease-specific Patient Advisory Boards (PABs). Furthermore, this deliverable will present the most important operational and governing sides of the three boards within the disease-specific work packages, propose potential activities and timelines, and finally, highlight good practices for patient co-creation across all relevant aspects of the H2O project’s activities.

Read or download H2O_D1.3 Bylaws of the Patient Advisory Boards

Deliverable 1.4 describes the set of Key Performance Indicators (KPIs) and success metrics that meet the H2O project’s mission and ambition. Measuring and monitoring these KPIs will be responsible for ensuring that the project, its implementation and deployment and the outcomes evidence generated are of a high and trustworthy quality.

We defined a set of KPIs, in collaboration with all work packages (WPs), for monitoring the progress and success per WP and for the project as a whole to ensure sustainability (linking this deliverable closely with the work done in WP6 which focuses on implementation and sustainability). Some of the KPIs directly refer to deliverables specified in the Grant Agreement. It should prioritise the success metrics, according to the governing principals and taking into account the project’s mission.

Read or download H2O_D1.4 KPIs and success metrics

This document describes the Information Governance Framework for the H2O project, including the establishment of the Health Outcomes Observatories. ‘Information Governance’ is considered to be a broad term covering data protection, confidentiality and ethics as well as high-level elements of information security, which are required when considering the appropriate processing of healthcare data for public benefit.

The document describes a number of instruments which will be needed as part of this ‘framework’ as well as how these are linked to other project deliverables. It builds on the earlier deliverable, D1.2 Data Management Plan v1.

Read or download H2O_D1.5 H2O information governance and ethics framework

WP2 – Technical Infrastructure and Interoperability

The main aim of Work Package 2 (WP2) of H2O is the design and implementation of the technical architecture of the H2O project, to support data management according to the project vision. This document reports on our assessment of the local and national situation regarding data protection, access to and integration of outcomes data from existing clinical records in the participating hospitals and the TOC, which will pilot the solutions developed and drive the adoption of H2O throughout Europe.

Read or download H2O_D2.1 Assessment of the Local and National Situation

The main aim of Work Package 2 (WP2) of H2O is the design and implementation of the technical architecture of the H2O project, to support data management according to the project vision. This document serves to capture the current planning status, to communicate it within the consortium and with the public and to coordinate it with the parties involved.

Read or download H2O_D2.2 Architecture Blueprint

WP6 – Observatory Management – Communications & Analysis

The scope of this deliverable is to describe an overarching operational plan for the four National Observatories (NO). The overarching operational plan for the NOs contains a general description of the main actions required for the deployment and operational functioning. This deliverable describes on a high level the necessary capabilities and the main tasks that the national observatories will implement.

Read or download H2O_D6.1 Operational Plan National Observatories

This deliverable describes the operational plan for the Pan-European Umbrella H2O Observatory (EUO).

The EUO will coordinate the H2O effort at the European level and ensures standardization as well as interoperability across NOs. More specifically, the EUO will be able to conduct multi-country analysis of this outcomes’ data across several jurisdictions through federated access to the data from the NOs and serve as a common repository for reports, analytical tools and educative materials to make it available to the respective stakeholders of the health eco-system.

To achieve its mission, the EUO will strive to ensure harmonization and standardization of outcomes data, the patient reported outcomes (PROs) and patient reported outcome measures (PROMs) used in clinical care within the NO community with the clear intent to adopt a common standardised language for patients and HCPs and to pave the way towards value based health care. Furthermore, it will promote wide-scale adoption of outcomes, and the value of outcomes data for a diversity of purposes, such as health care decision, health policy, drug development or digital health innovation. Eventually, it will offer outcomes related products and services. Finally, the EUO will be a catalyst for the future growth of the network of NOs.

Read or download H2O_D6.3 Operational Plan for the Pan-European Observatory

This deliverable outlines the potential multipurpose value of the H2O National Observatory (NO). The purpose of this document is to make an inventory of use cases, in order to show what value the NOs could bring. For example; how the H2O NO might create value for patients, healthcare providers, private sector and to the society. This will lead to examples to show the range of practical implications and promote their adoption. We aim to do this in two ways; 1) by choosing existing use cases that have a strong basis and longer existence with a broader patient population in a country, 2) by making assumptions and placing questions that are still unanswered on a disease population level. The latter exercise will be continued after submitting the deliverable. In order to compare the use cases in the different countries, identify strong assets in knowledge and geographic coverage and eventual gaps, we will follow up the developments in the countries on the use cases with a working group from this deliverable’s group. It will take more time to analyse all use cases and create insights which questions have been answered and which ones still needs effort to answer.

Read or download H2O_ D6.4 Repository of use cases of the Observatories

This document presents the plan and initial concepts for the H2O sustainability roadmap. Sustainability is vital for the H2O Observatory network and needs careful planning because of the innovative nature of the ecosystem it is creating. This innovation focuses on providing the capability for multiple stakeholders to gain insights relating to health outcomes that can inform decision-making across a broad scale ranging from individual patients through to multinational policy-setting organisations like the WHO and OECD, spanning direct care to individuals, care planning and optimisation, public health and health strategy, research and health technology innovation.

This document presents an initial qualitative analysis of “demand” side and “supply” side perspectives and explains how each of these will be investigated in more detail in the coming months. The sustainability plan will progressively shift from qualitative interview and survey style intelligence gathering to quantitative business modelling in which projected costs and projected revenues will be quantified. At the same time, as the delineation of activities across the national and EU level observatories, in compliance to the Data Governance Act (DGA), will become more and solid, this will allow for precision in the business modelling and the respective cost and revenue calculations.

This deliverable is therefore the start of a process which will continue throughout the project duration and be periodically reported in later deliverables.

Read or download H2O_ D6.12 H2O exploitation and sustainability strategy

WP7 – Scientific Coordination & Project Management

The deliverable D7.1 Project Handbook describes the management and administrative procedures and principles that will ensure efficient execution of the H2O project and thus contribute to the production of high-quality project results. As the project evolves further over the next 60 months, the handbook will be updated after its submission on a quarterly basis to ensure that the information is coherent with the development of the project.

The main objective of the Handbook is to provide an understandable and short reference ‘manual’ that describes the management structure, tasks, decision-making processes, responsibilities and procedures on all levels of the project execution. All the information and general principles in the Handbook were taken from the Grant Agreement, the Description of Action and the Consortium Agreement provisions, but it also draws from best practice, IMI2 rules and accepted project management standards.

Read or download H2O_D7.1 Project Handbook

Crucial to the project’s success and its future sustainability is the ability to communicate to external key stakeholders, H2O’s vision, objectives, expected impacts and important operational aspects regarding the Observatories. To ensure that all relevant target groups are properly engaged, and key messages properly conveyed in a timely manner and through the right channels and tools, a communication strategy needs to be formulated and a plan outlined. The present document lays down H2O’s overall communication policy to achieve maximum efficacy and instill the transformational nature of this project and its value for health care.

All in all, this report will provide a harmonized approach and shared strategy for all partners, whilst outlining a communication plan. This will reflect the communication objectives, roles and responsibilities, target audiences, and activities and tools to support their implementation in a timely basis and in line with the project’s budget. An initial set of communication materials which is already being developed, will also be described.

Read or download H2O_D7.2 Project communication plan and initial tool set

Peer-reviewed publications and presentations on conferences are essential to establish credibility and show thought leadership in the scientific community. The deliverable D7.3 Scientific Publication Plan outlines the Health Outcomes Observatory (H2O) project’s planned efforts to support and promote scientific publications and presentations at conferences. It details current and anticipated research activities at the time of submission (M12; September 2021) and their associated dissemination through publication and/or presentation. This document will be updated and supplemented as needed with specific publication tactical plans over the duration of the project.

The main objective of this document is to provide a guideline and reference for the scientific dissemination of H2O’s results. It complements the efforts of the Work Packages and the project deliverables, ensuring that project results are disseminated to their fullest potential.

Read or download H2O_D7.3 Scientific Publication Plan