Periodic Reporting for period 1 - HumanITcare (Revolutionizing remote care of chronic disease patients – an interoperable and smart monitoring platform)
Période du rapport: 2022-07-01 au 2023-06-30
We cater to the great need for remote patient monitoring with the HumanITcare platform, an AI-based monitoring platform that enables the remote collection and processing of real-world data from patients with chronic diseases, including heart failure, to provide better patient care and reduce the cost of care. The uniqueness of the solution lies in its flexibility and scalability, which have enabled its implementation in cardiology, pneumology, oncology, mental health and diabetes, thus providing immediate medical insight into any chronic condition. HumanITcare promotes patient adherence and empowerment, addresses digital and health literacy, and improves clinical outcomes while optimizing resources. It is autoscalable, as it is cloud-based, and is in constant development, either optimizing the platform for a better product-market fit or developing AI algorithms to optimize the smart alarm system.
The main objectives of the project are to improve the remote patient monitoring platform, from optimizing the architecture, API and usability, to developing the AI-based smart alarm system in heart failure. With that, clinical studies are promoted and regulatory steps are planned to certify the platform. Finally, the last objective is to commercialize the improved platform, fostering scaling of the business.
As for the clinical studies, we are conducting the two first clinical studies to improve the platform and gather the evidence to seek for CE mark Class IIa MDR. A first validation study of the HumanITcare platform at the national level, and a second clinical study to create the huge dataset for developing the AI layer and thus optimizing the smart alarm system.
An important achievement is having secured a Notified Body to certify our platform in 2024 with the new MDR framework, and we are working preparing the required documentation and evidence.
For this, it is crucial to create the network of EU hospitals to participate in the clinical studies promoted. Success is guaranteed by contacting relevant stakeholders and clinical advisors, and closing collaboration agreements during and after the studies.