CERGAS Seminar "Striking the balance between regulation, value assessment and reimbursement of Digital Medical Devices: evidence from CERGAS research"

Digital Medical Devices (DMDs), encompassing digital health technologies meeting the definition of medical devices, offer promising avenues to revolutionize healthcare delivery. However, their regulation, value assessment and reimbursement are characterized by distinctive challenges and opportunities. After offering an overview of the research activities that our group is conducting in this arena, the seminar will present the findings from a recently concluded work aimed to evaluate the potential of DMD-based interventions in improving self-management in prevalent noncommunicable diseases like diabetes, with a particular focus on intervention characteristics that significantly impact glycemic control.

 

Based on a systematic review with meta-analysis and meta-regression of 57 RCTs, our results confirm the potential of patient-facing mobile apps in diabetes self-management. Specifically, our analyses reveal a statistically significant reduction in HbA1c levels (change in mean difference = -0.36, 95% CI=-0.46, -0.26, p<0.001) associated with the use of patient-facing mobile apps compared to control groups. Moreover, our study sheds lights on specific intervention characteristics, such as “self-monitoring of behaviour” as a behaviour change technique and “taking medication” as a target behavior, associated with improved metabolic outcomes. Nevertheless, we emphasize the necessity for ongoing progress in behavioural theories and methodological advancements in study designs to further enhance the quality of evidence and adequately inform decision-making processes concerning DMDs.

 

Francesco Petracca is a Lecturer of the Government, Health & Not for Profit Knowledge Group at SDA Bocconi School of Management and a member of CERGAS (Centre for research on health and social care management) Bocconi.

His research activities focus on digital technologies in the health care sector, with a specific focus on Digital Medical Devices (DMDs), their regulation, evaluation methodologies and impact on chronic disease management. Other areas of interest include: institutional and organizational arrangements in the Italian National Health Service; community and primary care; disease management models.

He earned an MSc in Economics and Management of Public Administration and International Institutions from Università Bocconi.