The Italian lawyer Silvia Stefanelli, an expert in health law, with particular expertise in the field of medical devices and data protection (among others), suggests that following the GDPR that came into force in 2018, the European Legislative framework has a renewed focus on the safety of devices before, requiring the demonstration of clinical benefits for patients. These requirements have led to an increase in the need to process data, most of which is collected through clinical investigation, post-marketing surveillance and PMCF (Post Market Clinical Follow UP).
Basically, data collection has become one of the cornerstones of the system. Therefore, knowledge of the GDPR and how data is treated becomes increasingly central to structuring new processes within any company. Compared to the American system, the GDPR regulates the subject of data protection in a very advanced way, whilst America has a strong principle of individual data protection, it has a milder discipline on data processing.