Activity 3 – Health Technology Assessment

The activities of A3 are aimed at supporting various stakeholders involved in measuring and evaluating the net benefits of robotic solutions and allied technologies in rehabilitation processes, including advanced scenario such as tele-rehabilitation, compared to standard care. Evaluating the real value of robotic rehabilitation is a crucial first step towards achieving full acceptance, reimbursement, and widespread use of these innovative solutions to transform current rehabilitation and assistive models in Italy and beyond. A3 focuses on assessing the impact of robotic solutions considering the organizational and economic specifics of outpatient, inpatient, and at-home rehabilitation processes. Various dimensions – in a Health Technology Assessment (HTA) perspective -, such as clinical effectiveness, organizational and economic impact, accessibility, usability, quality of life measures and overall patient experience, are highlighted in systematic comparative analysis between robotic and standard care procedures. These comparative analyses will be conducted integrating the dimensions of A3 into the design of clinical studies and the analysis of their outcomes. These methodologies will be applied both to technologies already in or close to the market (Health Technology Assessment - HTA) and to technologies still with low TRL (early Health Technology Assessment - eHTA), reapectively in sinergy with Mission 2 and Mission 3. Moreover, A3 aims to comprehensively investigate the innovation ecosystems surrounding robotic rehabilitation technologies at a macro (environmental barriers and facilitators affecting the integration of robotic rehabilitation into healthcare systems, including regulations, infrastructures, and institutions), meso (networks and open innovation practices between business and knowledge ecosystems to advance robotic rehabilitation integration), micro level (technology acceptance barriers at a behavioral level through), in order to suggest strategies and actions able to favour the development, adoption and use of rehab robotic solutions.

Activity 4 – Legal, ethics and policy acceleration

The A4 team is dedicated to the legal and ethical implications of the Fit4MedRob projects. Its research activities are dedicated to the mapping of the existing legal and policy frameworks investing the EU legislation and its implementations in the Italian legal order. Its fields of research span from the so-called  data laws which concern the project (such as the GDPR, the Data Act, the Data Governance Act, and the European Health Data Space Act) to the safety laws applicable (mainly the Medical Devices Regulation and the General Safety of Products Regulation) without losing focus on the latest developments concerning the AI Act regulation and on the upcoming directives concerning product liability and the AI non-contractual liability. The Activity 4 researchers’ main objective is not only to highlight the obstacles and gaps for the new generation of medical devices to be marketed in the EU but also to highlight solutions to the Fit4MedRob participants and to suggest relevant changes to the interested institutional actors in the future.