Operational Blueprint For Regulatory Compliance In IDERHA AI Developments (D5.4)

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 deliverable describes the operational blueprint for trustworthy AI development and AI act compliance for IDERHA’s platform and the activities that the partners have been performing to develop it. This work has been a cross-Consortium effort that has focused on the advent of new regulations around Artificial Intelligence (AI) and an evolution in trustworthiness expectations around the use of AI in health care provision and individual self-care.