The aim of the project was to define and implement a sustainable model for the scientific and technical cooperation on Health Technology Assessment.

IDERHA aims to build a scalable platform for an integration or linkage of diverse real world data at scale to support healthcare professionals, patients and researchers with new capabilities to improve patients’ outcomes. The aim is to do that by achieving better treatment and disease management, enabling personalized care, bolstering research innovation based on the development of common standards and practices.

The project is funded by Innovative Health Initiative (IHI).

The initiative will be led by the Fraunhofer Institute for Translational Medicine and Pharmacology ITMP and Johnson & Johnson Medical GmbH, part of Johnson & Johnson MedTech, in a consortium of 33 academic, clinical, medtech, pharmaceutical, and IT partners, as well as patient advocacy organizations and public authorities.

This innovative European public-private partnership addresses health data access, integration, and analysis challenges to maximise patient care and medical research.

IDERHA is part of the Europe Beating Cancer Plan and is in alignment with the implementation of the European Health Data Space (EHDS).

DEFACTUMS role in IDERHA

DEFACTUM is co-leading work package 6, focusing on making recommendations to accelerate policy development in the digitisation of health data, research methods, and health care innovations. The policy recommendations will focus on data access and sharing for research and regulatory HTA acceptance. The proposed approach aims to align stakeholders and address policy gaps for better use of health data research. Additionally, DEFACTUM is part of establishing a leadership council called the Integrated Data Access Governance Council (IDAGC). The IDAGC will be formed to prioritise work packages and ensure timely and high-quality deliverables. The IDAGC, co-chaired by the Danish Medicines Agency and ECPC, and consists of around 12 senior leaders and experts representing various stakeholder groups.

Some of the key lessons we bring to future projects are:

• How important it is to collaborate across borders, stakeholders and public/private sectors if data access and sharing shall succeed in a secure and democratic way
• Data access and sharing is very complex and not just a matter of technical solutions. It shapes and influence the very foundation of our society