TNO joins the iCARE4CVD consortium for personalised cardiovascular care

Personalised care pathways needed

Cardiovascular disease is highly prevalent worldwide with enormous socioeconomic impact. It still is the most common cause of death, despite significant advances in therapy. Due to population ageing and unhealthy lifestyle, the number of Europeans suffering from CVD currently exceeds 85 million and is still on the rise. This underscores the critical need for better care pathways to reduce the impact of CVD.

To improve patient outcomes, iCARE4CVD aims to improve four aspects of current care:

1. Early diagnosis and classification into clinically meaningful subgroups
2. Risk stratification defining urgency for intervention
3. Prediction of individual treatment response
4. Inclusion of outcomes based on patient perspectives

Digital biomarkers

The team at TNO will lead a working group on the development and validation of meaningful digital biomarkers within the consortium, bring in expertise on federated data management, and coordinate a work package on regulatory, legal, and policy aspects. Digital biomarkers, as an add-on to other biomarker types, facilitate continuous, non-invasive, monitoring in daily life. With the working group of partners providing expertise, data, and devices, we will identify and validate beyond state-of-the-art digital biomarkers that the four iCARE4CVD aims. With a specific focus on digital biomarkers, TNO will support the development of the federated data management solution that ensures standardised, and privacy-preserving development and utilisation of biomarkers in cardiovascular disease.

Regulatory, legal, and policy aspects

The iCARE4CVD project touches upon multiple existing and upcoming regulations like the European Health Data Space (EHDS), the Medical Device Regulation (MDR) the AI Act and the biomarkers qualification pathway. One can imagine the interaction between these regulatory pathways and guidelines is complex. Pulling together the knowledge and expertise within the consortium, TNO will co-lead a working package that develops a strategy for biomarker and medical AI development that facilitates safe, ethical, and successful adoption and implementation of the iCARE4CVD medical tools

iCARE4CVD has been granted €22 million in funding from the Innovative Health Initiative (IHI) - a joint undertaking of the European Commission and the European life science industry. The project officially kicked off its activities across Europe in October 2023 and will run until 31 March 2028.