This project is supported by the Innovative Health Initiative Joint Undertaking (IHI), under Grant Agreement No. 101194778. The UJ receives support from the European Union’s Horizon Europe research and innovation program and COCIS, EFPIA, Europa Bio, MedTech Europe, and Vaccines Europe.

Project duration: 54 months

Total budget: €19,16 millions

Coordinator of the project: Università Campus Bio-Medico di Roma (UCBM)

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No.	Legal Name	Short Name	Logo
1	Università Campus Bio-Medico di Roma	UCBM
2	Medtronic Iberica SA	MDT-IB
3	Active Ageing Association	ACTIVAGE
4	Philips Medical Systems Nederlands BV	PMSN
5	Philips Medical Systems Technologies LTD	PMST
6	Samsung Electronics (UK) Limited	SAMSUNG
7	DEDALUS Italia S.P.A.	DEDALUS
8	Medtronic France	MDT-FR
9	Astrazeneca Farmaceutica Spain, S.A.	AZ
10	BRIDG OU	BRD
11	PredictBY Research and Consulting S.L.	PBY
12	Happy Mondays Communication SL	HMC
13	Ethniko Kentro Erevnas Kai Technologikis Anaptyxis	CERTH
14	Fundacion para la Investigacion Biosanitaria de Andalucia Oriental – Alejandro Otero	FIBAO
15	Servicio Madrileño de Salud	SERMAS
16	Outcomes’10 SL	O10
17	Centre Hospitalier Universitaire de Rennes	CHU
18	Centro Nacional de InvestigacionesCardiovasculares Carlos III	CNIC
19	Universitatsklinikum Bonn	UKB
20	Universitair Medisch Centrum Utrecht	UMCU
21	WAVY Assistant B.V.	WAVY
22	Fondazione Policlinico Universitario Campus Bio-Medico	FPUCBM
23	Human Factor & Innovation SRL Start-Up	HFI
24	Fondazione Policlinico Universitario Agostino Gemelli IRCCS	FPG
25	Institut Catala de la Salut	ICS-HUB
26	UDG Alliance	UDGA

HEALTHCARE PROVIDERS:

1. CHU RENNES (CHU)
2. CENTRO NACIONAL DE INVESTIGACIONES CARDIOVASCULARES CARLOS III (F.S.P) (CNIC)
3. UNIVERSITATSKLINIKUM BONN (UKB)
4. UNIVERSITAIR MEDISCH CENTRUM UTRECHT (UMCU)
5. FONDAZIONE POLICLINICO UNIVERSITARIO CAMPUS BIO-MEDICO (FPUCBM)
6. FONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS (FPG)
7. FUNDACION PARA LA INVESTIGACION BIOSANITARIA DE ANDALUCIA ORIENTAL-ALEJANDRO OTERO (FIBAO)
8. SERVICIO MADRILENO DE SALUD (SERMAS)
9. INSITUT CATALA DE LA SALUT (ICS-HUB)

ENTERPRISE PARTNERS:

1. MEDTRONIC IBERICA SA (MDT-IB)
2. MEDTRONIC FRANCE (MDT-FR)
3. PHILIPS MEDICAL SYSTEMS NEDERLANDS BV (PMSN)
4. PHILIPS MEDICAL SYSTEMS TECHNOLOGIES LTD (PMST)
5. SAMSUNG ELECTRONICS (UK) LIMITED (SAMSUNG)
6. DEDALUS ITALIA S.P.A. (DEDALUS)
7. ASTRAZENECA FARMACEUTICA SPAIN, S.A. (AZ)

SMALL AND MEDIUM ENTERPRISE PARTNERS:

1. BRIDG OU (BRD)
2. PREDICTBY RESEARCH AND CONSULTING S.L. (PBY)
3. HAPPY MONDAYS COMMUNICATION SL (HMC)
4. UDG ALLIANCE (UDGA)
5. OUTCOMES’10 SL (O10)
6. WAVY ASSISTANT B.V. (WAVY)
7. HUMAN FACTOR & INNOVATION SRL START-UP (HFI)
8. ACTIVE AGEING ASSOCIATION (ACTIVAGE)

RESEARCH INSTITUTIONS:

1. UNIVERSITÀ CAMPUS BIO-MEDICO DI ROMA (UCBM)
2. ETHNIKO KENTRO EREVNAS KAI TECHNOLOGIKIS ANAPTYXIS (CERTH)

Aim of the Project

GRACE Project (IHI) aims to transform the healthcare ecosystem by providing essential knowledge and innovative public-private partnership for reorganizing healthcare services with embedded innovative technologies and tools, helping to identify and overcome barriers and gaps that are now hindering cardiovascular diseases (CVD) management, ensuring a seamless continuum of care and optimized care pathways. GRACE will focus on an end-to-end clinical pathway CVD, considering a holistic view of the patient and optimizing healthcare services leveraging on advanced technological solutions. This project will enable early and personalized interventions, fostering coordination of multidiscipline healthcare teams, triggering more intense and person-specific management using innovative technologies, AI and digital solutions for early detection of red flags, promoting patient empowerment, while comprehensively containing CVD risk factors and burden.

GRACE Project is formed by 4 interdisciplinary activities:

1. Six Use Cases (UCs): the project will run 6 pilots in different European areas, covering 4 specific target cardiovascular diseases [coronary artery disease (CAD), structural heart disease (SHD), heart failure (HF), arrythmias] targeting the general population, elderly and patients with comorbidities.
2. Six advanced functionalities for CVD management: advanced patient monitoring and management (remotely and in-hospital) function; early detection and diagnosis of red flags and health trajectory deviations; optimization of the clinical workflow; co-pilot for personalized treatment definition; knowledge discovery function via patient digital twins; functions for increasing and monitor users engagement and satisfaction.
3. Continuum of care models, approaches and tools: the technology and the deployment procedures will consider critical aspects related to the Continuum of Care (CoC), that this project proposes as a set of 4 pathways as early detection, accurate diagnosis, effective treatment and long-term management. The model will also consider the specific clinical settings and the required coordination activities in order to grant a smooth, efficient and cost- effective collaboration between primary care, ambulatory and secondary care.
4. Assessment framework: it considers 3 main aspects. 1) the clinical workflow and the early interventions; 2) the allocated resources and health care coordination teams; 3) the patient empowerment and self-management strategies. These dimensions will be used to define specific indicators, methodologies and Key Performance Indicators (KPIs) to provide feedback on the evaluated technology, policy recommendations and best practices for the implementation of the CoC in the clinical practice, considering dimensions such as clinical need, overall solution, patient safety, clinical effectiveness, cost and economics, ethical analysis, patient and social aspects and legal analysis proposed by EUneHTA. GRACE will overcome standard HTA methods including also environmental KPIs into the assessment, integrating life-cycle assessment tools and health economics’ ones

1. USE CASE 1: EARLY AF DETECTION AND REMOTE FOLLOW-UP AFTER ABLATION PROCEDURE FOR DETECTION OF POTENTIAL AF RECURRENCE

Leader: Medtronic Iberica SA

UC1 Initial Team: Hospital Universitario Clinico San Cecilio, Samsung UK

Aim: transform the management of AF through an innovative, integrative, and personalised care pathway, from early detection to post-procedure monitoring and ongoing care, shifting the paradigm from reactive to proactive healthcare. The focus is on leveraging advanced digital technologies and patient-centric solutions to improve patient outcomes, optimize resource utilisation, and streamline care delivery. This UC also focuses on strengthening patient engagement through educational programs. Additionally, it will enable large-scale screening of at-risk populations, addressing current gaps in AF diagnosis and follow-up.

Lead Technologies:

• Get Ready: is a digital platform for remote patient monitoring and care plan management, enhancing early detection and post-ablation follow-up in AF.
• Kardia Mobile 6L device is an advanced ECG monitoring device that provides comprehensive and accurate ECG readings. When integrated with the Get Ready platform, it allows for continuous and remote monitoring of patients’ heart rhythms.
• Samsung watch: measures ECG, vital signs, location, and physical activities, further enriching the patient’s health profile available to healthcare providers. By providing real-time data to healthcare providers, it facilitates timely interventions and ensures that any recurrence of AF post-ablation is promptly identified and managed.

2. USE CASE 2: EARLY DETECTION OF POST-TAVI COMPLICATIONS IN PATIENTS WITH HISTORY OF CANCER WITH OR WITHOUT PRIOR CHEST RADIATION 

Leader: Medtronic Iberica SA

UC2 Initial Team: Hospital Universitario La Paz

Aim: improve the management of AS in patients with history of cancer from early identification of complications to post-treatment follow-up and ongoing care, shifting the paradigm from traditional face-to-face care to a combined remote follow-up model. The focus is on leveraging advanced digital technologies, Business Process Management (BPM) tools, and patient-centric solutions to improve patient outcomes, optimize resource utilization, and streamline care delivery. Utilizing the Get Ready platform, alongside interoperable wearables, this solution facilitates early detection of severe AS, ensures effective monitoring, and tailored treatment plans. This proactive approach aims to prevent patients from reaching advanced stages of the diseases or complications, thereby reducing the severity of complications and optimizing clinical outcomes. The solution is expected to empower patients to take an active role in their health management

Lead Technologies:

• The technologies of UC1 will be tailored to AS patient needs and horizontally supported by the innovative BPM processes design and execution, focusing on improvements of each business process of healthcare facilities

3. USE CASE 3: AUGMENTED CARDIAC SURGICAL PATHWAY

 Leader: Medtronic France

UC3 Initial Team: CHU Rennes

Aim: transform cardiac surgery by implementing a tailored Enhanced Recovery After Surgery (ERAS) protocol, improving outcomes, recovery, and resource efficiency. Despite past challenges, pioneering centers have shown ERAS reduces ICU stays, complications, and hospital length of stay. The ACUT model promotes a multidisciplinary, patient-centered approach, standardizing care, enhancing patient education, and leveraging digital tools for remote monitoring. Key aspects include early coordination of home care nurses, prehabilitation programs, and innovative technologies like VR to reduce anxiety and improve adherence. This approach optimizes care, enhances patient empowerment, and accelerates recovery.

Lead Technologies:

• RDS: is a connected patch designed to monitor patients’ condition at home for seven consecutive days. It continuously tracks vital signs and health parameters, providing real-time data to healthcare professionals and enables early detection of potential complications and timely interventions, ensuring patient safety and improving post-operative care.
• Get Ready: also used in UC1 and UC2, is crucial for managing and monitoring patients throughout their recovery journey. It allows healthcare providers to create personalised care plans, schedule follow-up appointments, and track patient progress remotely. By facilitating seamless communication between patients and care teams, Get Ready ensures adherence to post-operative instructions and enhances overall patient engagement.
• DEEPSEN: uses VR glasses and personalised care pathway movies to prepare patients for their surgery and recovery process. By offering virtual consultations and preconditioning sessions, DEEPSEN helps reduce anxiety and improve patient understanding of care journey. This contributes to patient empowerment and adherence to care plan.
• Cortex: is an intermediation and orchestration platform integrating technologies and data sources to streamline care coordination. It manages the flow of information between systems, ensuring that relevant data is available to professionals in real time, enhancing decision-making, improves workflow efficiency, and adoption of standardised protocols.

4. USE CASE 4: ADVANCING CARDIAC MRI TOWARDS FULLY AUTOMATED QUANTITATIVE DIAGNOSIS OF ISCHEMIA WITH NO OBSTRUCTIVE CORONARY ARTERIES (INOCA) AND PATIENT-CENTRIC CARE

Leader: Philips Medical Systems Nederlands BV

UC4 Initial Team: Universitatsklinikum Bonn, Universitair Medisch Centrum Utrecht, Centro Nacional De Investigaciones Cardiovasculares Carlos III (F.S.P), WAVY Assistant B.V., SAMSUNG Electronics (UK) Limited

Aim: to establish a transformative approach in cardiac Magnetic Resonance Imaging (CMR) for diagnosing and managing INOCA, and ultimately improve CMR accuracy, efficiency, and patient accessibility

Lead Technologies:

• Ambient Experience: focuses on personalized patient guidance before and during MRI exams, aiming to improve patient preparation just before the exam and enhance the guidance provided in the MRI bore. The objectives aim to enhance preparation just before the exam and improve the current guidance in the MRI bore.
• SmartHeart: automates the cardiac planning of the most relevant cardiac views, such as short axis, long axis, and valve planes, based on a single automatic 3D scan sequence. This automated process aims to streamline cardiac imaging by providing essential views efficiently and accurately.
• Quantitative Myocardial Perfusion: creates a dedicated MRI pulse sequence to measure arterial input function and myocardial perfusion. Aim: develop an MRI sequence that captures quantitative data on myocardial perfusion, providing valuable insights into cardiac function and health.
• CMR Post-processing: integrate post-processing capabilities directly into the MRI scanner, allowing quantitative cardiac perfusion maps to be visible immediately while the patient is still on the MR table. This real-time post-processing will enhance the efficiency of cardiac assessments and provide immediate results for clinical decision-making.
• Wavy Health-app: uses Samsung wearables combined with deep tech to learn about the causes for cardiac stress in INOCA patients, providing them with improved ways to manage their symptoms.

5. USE CASE 5: INNOVATIVE MODEL BASED ON THE INTEGRATION OF DIGITIZED CLINICAL GUIDELINES AND ML MODELS TO IMPROVE THE HEART FAILURE CARE PATHWAY

Leader: DEDALUS ITALIA S.P.A.,

UC5 Initial Team: SAMSUNG Electronics (UK) Limited, Medtronic Iberica SA, Medtronic France, Astrazeneca Farmaceutica Spain, S.A., Fondazione Policlinico Universitario Campus Bio-Medico, Università Campus Bio-Medico, Ospedale Umberto I.

Aim: to optimize HF care delivery through AI, digital technologies, and evidence-based decision support. To improve care coordination and patient empowerment.

Lead Technologies:

• Clinical Knowledge Platform: facilitates the digitalisation and integration of clinical guidelines into the EMR. By embedding these guidelines directly into the EHR, healthcare professionals can access up-to-date, evidence-based protocols during clinical practice, ensuring consistent and high-quality patient care. It serves as a centralised repository for patient data, enhancing the efficiency and accuracy of clinical documentation and care coordination.
• Clinical Guidelines Copilot (CGC): a module that integrates clinical guidelines with predictions from explainable AI models, including machine ML and SHAP (Shapley Additive Explanations) techniques. This integration provides clinicians with tailored, data-driven decision support, combining the best practices from clinical guidelines with predictive insights from advanced analytics.
• Connected Care Solution: manages the enrolment, evaluation of clinical and healthcare needs, planning of individual care plans, and follow-up of patients at the territorial level. It supports continuity of care by ensuring that patient management is coordinated across different healthcare settings, from primary care to specialised tertiary care

6. USE CASE 6: HOLISTIC END-TO-END HEALTHCARE PATHWAY FOR INDIVIDUALS AT RISK OF HEART DISEASE FOR PATIENTS LIVING WITH AF, CAD, AND HF

Leader: Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Department of Cardiovascular Science.

UC5 Initial Team: SAMSUNG Electronics (UK) Limited, DEDALUS ITALIA S.P.A., ASL Rome.

Aim: To establish an integrated, AI-driven, patient-centric cardiovascular care model. Covers primary prevention to acute & chronic care for AF, CAD, and HF. Shifts from reactive to preventative healthcare using precision medicine. 

Lead Technologies:

• Genome-wide SNP genotyping and copy number variation analysis: utilising microarray processing of SNPs along with publicly available imputation algorithms, generates Polygenic Risk Scores (PRS) for assessing genetic predispositions to AF, CAD, and HF, facilitating early prevention strategies tailored to individual genetic profiles. 
• Bioinformatics Integrated Platform: a comprehensive information system for real-time monitoring of patients’ health, supporting multidisciplinary teams in both in-patient and out-patient care settings.
• Holistic Health Records (HHRs): aggregate individualised data from various sources, including Electronic Health Records (EHRs), genomic data, exposome data, real-world data (RWD), and specific personal information such as age, ethnicity, lifestyle, and fitness. The data is coded in HL7 FHIR format to ensure interoperability with other health systems, offering a comprehensive and continuous view of a patient’s health status.
• Advanced Monitoring Systems: employ wearable devices, sensors, and remote monitoring technologies to continuously track vital signs, physiological parameters, and activity levels in real-time. They provide clinicians with timely and objective data, facilitating early detection of health changes and enabling proactive, personalised management strategies. Technologies like cMRI and CT angiography support accurate diagnosis, treatment planning, and monitoring of cardiovascular conditions.
• Sensor-Based Diagnostics: leverage novel sensor technologies to detect biomarkers or physiological signals associated with cardiovascular health, including POC testing devices, biosensors, and mobile health applications that enable convenient and rapid assessment of risk factors or disease markers, providing actionable insights for both patients and providers.

The GRACE Project will span across 9 highly interlinked Work Packages (WPs):

• WP1: Project coordination, IPR and Data Management.

Leader: Università Campus Bio-Medico (UCBM).

Objectives: WP1 ensures smooth coordination and timely execution of GRACE project activities by continuously monitoring

progress (administrative, technical, and financial), taking corrective actions, and aligning work with project plans, resources, timing and ethical enforcement. This involves facilitating collaboration among participants, ensuring resource distribution to address problems and risks, and maintaining effective communication with stakeholders, including the European Commission.

• WP2: User-Centric Approach and Patient Empowerment

Leader: Bridg OU (BRD)

Objectives: WP2 includes analysing state-of-the-art empowerment techniques across the continuum of care involves engaging patients and stakeholders through co-design and living lab activities to develop effective patient empowerment strategies for at-risk populations. These efforts focus on enhancing patient empowerment during diagnostics, ensuring that individuals are actively involved in their care process and decision-making.

• WP3: Care Coordination and Process optimization

 Leader: Medtronic Iberica SA (MDT-IB)

Objectives: WP3 aims to establish care coordination and process optimization guidelines and KPIs, enhance in-hospital coordination, develop effective hospitalization and discharge strategies, and improve integration between community and secondary care.

• WP4: Early Interventions and Proactive Healthcare Response

 Leader: DEDALUS ITALIA S.P.A.

Objectives: This work package focuses on integrating existing frameworks and knowledge sources to create innovative strategies, and predictive models for early interventions and proactive healthcare responses. By integrating advanced diagnostic techniques, remote monitoring systems, predictive modelling, and genetic profiling, early detection and management of conditions like AF, CAD, and HF will be enhanced, ultimately improving patient outcomes and reducing the burden on healthcare systems.

• WP5: Continuum of Care Reference Model and Tools

Leader: PredictBY Research and Consulting SL (PBY)

Objectives: The objectives of WP5 encompass conducting a systematic analysis of the continuum of care, defining KPIs to assess its effectiveness, developing an economic impact assessment framework, identifying gaps and barriers within the continuum of care, establishing data collection procedures from use cases, and creating benchmarking tools along with a marketplace for solutions.

• WP6: Pilot Set-up and Deployment

Leader: PHILIPS Medical Systems Nederlands BV (PMSN)

Objectives: WP6 includes setting up the main components of the GRACE framework and defining pilot requirements and setting up necessary technology infrastructure, implementing and monitoring use cases (UC1-UC6), and developing guidelines for service industrialization and scale-up to ensure the successful deployment and integration of the pilot initiatives.

• WP7: Clinical Validation and Adoption Measures

Leader: Università Campus Bio-Medico (UCBM)

Objectives: WP7 involves defining medical requirements for validation, developing study protocols for both medical and Continuum of Care (CoC) studies, measuring clinical adoption and user experience, and creating training materials. Additionally, this work package aims to conduct clinical studies for each use case (UC1-UC6) of WP6 to validate the efficacy, the impact on the healthcare system and the user’s experience of the developed solutions within real clinical settings.

• WP8: Business Model Development and Marketplace

Leader: SAMSUNG Electronics (UK) Limited

Objectives: WP8 aims to bridge the gap between research and implementation by developing robust business models and exploitation routes for GRACE solutions. This includes conducting market analysis, developing sustainable business strategies, defining requirements for integrating with marketplace platforms such as ActivAge, and deploying the platform to facilitate dissemination, adoption, and commercialization of solutions.

• WP9: Communication, Policy Advocacy, and Knowledge Sharing

 Leader: Happy Mondays Communication SL (HMC)

Objectives: WP9 ensures widespread dissemination, communication, and advocacy efforts to promote the GRACE project’s objectives and outcomes among stakeholders and the public. This work package aims to raise awareness, establish a stakeholders’ community, analyze regulatory frameworks, and advocate for supportive policies to facilitate adoption of GRACE solutions.

• Outcome 1: Healthcare systems and patients benefit from the development of integrated solutions for improving critical aspects in the overall care pathway (primary, ambulatory and hospital care) for heart disease.
• Outcome 2: Healthcare systems and patients will benefit from development or optimisation of innovative technologies leading to personalised, patient-centric solutions for the early detection, diagnosis or treatment of heart disease.
• Outcome 3: Patients benefit from proposed strategies tailored to their needs for improved outcomes in heart disease.
• Outcome 4: Healthcare professionals benefit from the deployment of solutions for improved diagnostic procedures, referral programs or clinical workflows as well as targeted training for relevant clinical staff where appropriate.

• Impact 1: Patients benefit from personalised patient-centred healthcare from early detection to treatment, and improved patient outcomes and experience due to advanced detection, diagnostic, decision-making and disease management throughout the continuum of care
• Impact 2: Healthcare professionals benefit from novel diagnostic procedures and optimised clinical workflows, which lead to improved clinical outcomes for heart disease
• Impact 3: Healthcare systems benefit from organisational solutions and an efficient transition through the different stages along the whole continuum of the care pathway for heart disease.
• Impact 4: Companies develop and offer advanced, robust and scalable solutions that leverage innovative technologies, tools and services allowing for integration with other existing workflows to effectively and efficiently support healthcare professionals and health systems in achieving their goals.
• Impact 5: Healthcare professionals benefit from the enhancement of existing clinical management guidelines and the development of new ones as appropriate