Regulatory science to support translational development of patient-centred health technologies

Expected Outcome:This topic aims at supporting activities that are enabling or contributing to one or several expected impacts of destination “Maintaining an innovative, sustainable, and competitive EU health industry”. To that end, proposals under this topic should aim to deliver results that are directed at, tailored towards and contributing to several of the following expected outcomes:Policymakers and regulators will get accelerated access to improved evidence driven methodologies to evaluate the impact and efficiency of novel health technologies, facilitating decision-making for their use in humans and uptake in clinical practice.Patients and the health systems will benefit from the more targeted and efficient uptake of safe and effective health innovations in clinical practice, supporting more personalised approaches and improved care and public health. Scope:The development, uptake and impact of health technologies typically results from a long product development process that is based on a 'life cycle approach' which typically involves several iterations of defined stages, i.e. from development, assessment to post-market surveillance and post-market clinical follow-up.While health technologies are governed by comprehensive legal frameworks aiming to ensure that health technologies are safe and effective, the regulatory science underlying these legal frameworks needs to be updated. This concerns inter alia i) more precise delineation of specific requirements (e.g. closing existing gaps concerning sufficiency of clinical evidence) and ii) the consideration of novel biomedical approaches, data and digital solutions (e.g. artificial intelligence - AI, virtual human twin, new approach methodologies as well as methods that cut through these domains) which model and predict relevant biological parameters and exploit relevant end-points and novel (bio)markers for clinical diagnostic and prognostic predictions. Such update of the regulatory science of health technolo