Periodic Reporting for period 2 - HumanITcare (Revolutionizing remote care of chronic disease patients – an interoperable and smart monitoring platform)
Reporting period: 2023-07-01 to 2025-06-30
Chronic heart failure (CHF) represents a major clinical and economic challenge in Europe, affecting millions and costing the EU an estimated €196 billion annually, with over €100 billion in direct healthcare expenditures. A critical gap exists in the ability of healthcare professionals to monitor patients remotely and make data-driven decisions in real time. This leads to two extremes: high-risk patients are often missed, resulting in preventable hospitalizations and deaths, while low-risk patients are overtreated, consuming unnecessary resources.
The Vitalera project aims to transform chronic disease management by enhancing an AI-powered, interoperable remote patient monitoring (RPM) platform capable of capturing and processing real-world data from patients with CHF and other chronic conditions. The project will optimize the platform’s architecture and usability, develop an AI-based smart alarm system for early clinical intervention, and advance regulatory pathways toward CE certification. The integration of social sciences and humanities is essential to the project’s approach, ensuring that issues such as digital literacy, health equity, patient empowerment, and ethical AI are fully addressed to maximize adoption and inclusivity.
By supporting earlier interventions, improving clinical decision-making, and optimizing resource allocation, the platform is expected to reduce hospitalizations, improve outcomes, and save up to hundreds of euros per patient annually. The project contributes to Europe’s broader digital health strategy, supports sustainable healthcare delivery, and aligns with efforts to enhance chronic disease management in aging populations. Ultimately, Vitalera sets the foundation for a scalable, evidence-based, and patient-centered model of care across Europe.
The Vitalera project aims to transform chronic disease management by enhancing an AI-powered, interoperable remote patient monitoring (RPM) platform capable of capturing and processing real-world data from patients with CHF and other chronic conditions. The project will optimize the platform’s architecture and usability, develop an AI-based smart alarm system for early clinical intervention, and advance regulatory pathways toward CE certification. The integration of social sciences and humanities is essential to the project’s approach, ensuring that issues such as digital literacy, health equity, patient empowerment, and ethical AI are fully addressed to maximize adoption and inclusivity.
By supporting earlier interventions, improving clinical decision-making, and optimizing resource allocation, the platform is expected to reduce hospitalizations, improve outcomes, and save up to hundreds of euros per patient annually. The project contributes to Europe’s broader digital health strategy, supports sustainable healthcare delivery, and aligns with efforts to enhance chronic disease management in aging populations. Ultimately, Vitalera sets the foundation for a scalable, evidence-based, and patient-centered model of care across Europe.
During the project, key technical and scientific activities were completed to develop and validate the vitalera platform for remote patient monitoring. The platform was optimized through real-world feedback, leading to improvements in the alert system—shifting from static thresholds to customizable, time-based, and patient-specific alerts. Additional upgrades were identified, including UX improvement, adherence alerts and condition-based triggers.
Two clinical studies were conducted. The VAL-HIC interventional trial validated the platform’s safety and functionality, supporting its MDR Class IIa certification process. The DHEART observational study gathered data from patients in Spanish and Romanian hospitals, showing a 47% improvement in quality of life and 23% improvement in self-care behavior, while generating valuable datasets for AI development.
The platform met high usability standards (SUS 69.8 for patients, 80.8 for clinicians) and no major safety issues were reported. MDR and ISO13485 documentation was submitted to the notified body, and CAPAs are being addressed.
Vitalera achieved ISO/IEC 27001:2022 certifications and is finalizing ENS High alignment. As a result, the platform is now clinically validated, secure, and ready for MDR certification and international scale-up.
Two clinical studies were conducted. The VAL-HIC interventional trial validated the platform’s safety and functionality, supporting its MDR Class IIa certification process. The DHEART observational study gathered data from patients in Spanish and Romanian hospitals, showing a 47% improvement in quality of life and 23% improvement in self-care behavior, while generating valuable datasets for AI development.
The platform met high usability standards (SUS 69.8 for patients, 80.8 for clinicians) and no major safety issues were reported. MDR and ISO13485 documentation was submitted to the notified body, and CAPAs are being addressed.
Vitalera achieved ISO/IEC 27001:2022 certifications and is finalizing ENS High alignment. As a result, the platform is now clinically validated, secure, and ready for MDR certification and international scale-up.
The project led to the successful clinical validation and technical optimization of the vitalera platform, establishing it as a robust and reliable solution for remote patient monitoring (RPM). Clinical studies demonstrated the platform’s positive impact on patient outcomes, with a 47% improvement in quality of life and a 23% increase in self-care behavior. Usability scores were also high among both patients and healthcare professionals, confirming the platform’s practicality and user acceptance in real-world clinical settings.
In parallel, the first AI algorithms were developed using the high-quality data gathered during these clinical trials. These initial models—focused on functionalities such as patient prioritization and smart alarm management—show promising results. This foundational work sets the stage for advanced AI integration, although further clinical validation will be required, particularly in the context of heart failure and future therapeutic areas.
To ensure further uptake and long-term success, the following key needs have been identified:
- Finalization of the MDR CE Class IIa certification and continuous alignment with regulatory updates.
- Progressive deployment of AI-powered features to enhance clinical decision-making and scalability (e.g. intelligent alerts, patient overviews).
- Expansion into international markets via national approval pathways (e.g. ANVISA in Brazil, INFRAMED, FDA Q-submission in the US).
- Ongoing clinical research and pilot deployments to validate performance across different healthcare systems and disease areas.
- Commercial partnerships and access to financing to support market entry and sustained growth.
- Continued IPR strategy and support, especially around AI-driven clinical functionalities and multi-parameter alert logic.
These achievements and future steps collectively position vitalera for broad adoption and impactful integration into digital health ecosystems across Europe and beyond.
In parallel, the first AI algorithms were developed using the high-quality data gathered during these clinical trials. These initial models—focused on functionalities such as patient prioritization and smart alarm management—show promising results. This foundational work sets the stage for advanced AI integration, although further clinical validation will be required, particularly in the context of heart failure and future therapeutic areas.
To ensure further uptake and long-term success, the following key needs have been identified:
- Finalization of the MDR CE Class IIa certification and continuous alignment with regulatory updates.
- Progressive deployment of AI-powered features to enhance clinical decision-making and scalability (e.g. intelligent alerts, patient overviews).
- Expansion into international markets via national approval pathways (e.g. ANVISA in Brazil, INFRAMED, FDA Q-submission in the US).
- Ongoing clinical research and pilot deployments to validate performance across different healthcare systems and disease areas.
- Commercial partnerships and access to financing to support market entry and sustained growth.
- Continued IPR strategy and support, especially around AI-driven clinical functionalities and multi-parameter alert logic.
These achievements and future steps collectively position vitalera for broad adoption and impactful integration into digital health ecosystems across Europe and beyond.