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Developing Novel AI-based Internet of Medical Things: What is the Added Value of the Data Act and the EHDS Proposal?

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Quoi:
Panel
Quand:
12:00 PM, Lundi 10 Juin 2024 (30 minutes)
Pauses:
Lunch Break at Scuola Grande di San Rocco (Track IV)   12:30 PM à 02:00 PM (1 heure 30 minutes)
Où:
Thème:
Scientific Track
Mot-clé:
Research and Innovation
After the most acute phase of the Covid-19 pandemic has passed, it is clear that the healthcare system will increasingly exploit the advantages of Internet of Things technologies: distance-vitals-monitoring and telemedicine are just two of the concrete applications, rehabilitation through exoskeletons or exergames are the next great barrier shattered in the field of home healthcare. Despite these perspectives, challenges remain for potential innovators of new medical IoT devices as more and more regulatory instruments will be applicable to them, beyond the General Data Protection Regulation (GDPR) and the Medical Devices Regulation (MDR) already in force. 

This paper will investigate what is likely to happen when manufacturers would like to develop novel AI-based IoT in the medical sector and have them trained, tested or validated through the data already collected by other manufacturers of IoT. This secondary use of data is now feasible according to the rules provided by the recently adopted Data Act, but new avenues may also emerge in the framework of the proposed European Health Data Space. Against the basic qualification of IoT-generated data as health data, according to the GDPR definition, and the qualification of IoT as medical devices, pursuant to the MDR; the contribution will analyze what are the choices for manufacturers of new IoT devices or software to lawfully process health data. The comparison will highlight that different paths may emerge and depending on the manufacturer's objectives of novel IoT health-data sharing options may be more or less convenient. 

Prof Federica Casarosa

Conférencier.ère

Prof Francesca Gennari

Conférencier.ère

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