Integration of Heterogeneous Data & Evidence Towards Regulatory & HTA Acceptance (D6.4)

IDERHA is a European public-private partnership launched in April 2023. This pioneering project aims to create an open platform designed to enable connectivity, access, sharing, use and reuse of digital health data to maximize their value for patient care and medical research. In addition, IDERHA's policy recommendations will enhance regulatory and HTA decision making, facilitating access to digital health innovations for patients and health care professionals.

This report is Deliverable 6.4 in the project. It updates and extends an earlier deliverable, D6.1, and is the final deliverable from Task 6.2. It presents the main areas of potential policy and strategy (including European Regulations) that can influence the IDERHA secondary data reuse landscape. The most important areas have been elaborated on by invited project experts to explain the policy instrument(s), how each might impact IDERHA, and how IDERHA should respond.