On 13 October 2022, Filippo Tomasello, FF2020’s Regulations Manager and Senior Partner at EuroUSC Italia and Sara De Silvestri, Biomedical Engineer at Ospedale San Raffaele (Hospital San Raffaele) and part of the FF2020 team in Milan, held presentations at Dronitaly in Bologna. Dronitaly is one of the top Italian events about civil drones, where professionals and potential customers can debate the most important elements of the drone industry. Joining Filippo from EuroUSC Italia were Marilea Laviola, Dissemination Consultant, and Pasquale Junior Capasso, Safety and Compliance Engineer.
The conference was opened by Enrico Di Palma, president of ENAC (Italian Civil Aviation Authority), with contributions from Riccardo Delise, Programme Manager of UAS at ENAC, as well as Cristiano Baldoni, Chief of Business Systems Integration of D-flight (Italy’s leading Unmanned Traffic Management (UTM) provider).
The Integration of Drones into Airspace
During his speech, Filippo Tomasello explored the possibility of seeing drones from the perspective of a digital ecosystem with related requirements and interactions. From this broader perspective, not only the implementation of technology but also a clear regulatory framework (e.g. role of the geozone managers, liability, etc.) and societal acceptance would be essential components to integrate drones in U-space. Additionally, he highlighted the importance of considering that vertiports, drones, Unmanned Aircraft Systems (UAS) operators and UTM services exchange digital data in real-time, in some cases, without any human intervention. This means that the digital ecosystem brings UAS and Urban Air Mobility (UAM) towards the Internet of Things (IoT; the so-called fourth Industrial revolution).
For the ecosystem to be safe, secure, efficient and sustainable, and considering all societal concerns, Filippo Tomasello stressed the need to focus on legal requirements and industry standards supporting the rules. Because organisations are key actors in the ecosystem, even standards on organisations would apply. A performance-based approach to aviation regulation implies that authorities accept those standards as possible Means of Compliance (MoC). Therefore, beyond the famous 9001, the International Organization for Standardization (ISO) has already adopted a few standards on organisations: e.g. 5015-2 on vertiport operators, 21383-3 on UAS operators, and 23629-12 on UTM service providers. Since conformity with ISO or CEN standards (from the European Committee for Standardisation) may be verified through ‘Notified Bodies’, these frameworks would also enable risk-based regulation, looking at the total system. EuroUSC’s SAMWISE is one of the candidate services to be certified based on this new wave of ISO standards.
The Opportunities and Limitations of the Transport of Biomedical Goods via Drones
Sara De Silvestri presented Ospedale San Raffaele’s Center for Advanced Technologies in Health and Wellbeing, the technological research unit that coordinates the activities of the FF2020 living lab in Milan. The unit aims to design, develop and experiment with innovative services to improve quality of life. The introduction of these new services is based on the hospital’s perfect environment, which also provides the opportunity to observe the interactions with a high number of hospital visitors.
Sara also presented the designed use cases at Ospedale San Raffaele as part of the Flying Forward 2020 living labs demonstrations, which aim to increase the robustness and efficiency of the hospital’s logistics for transporting biomedical goods. Because biomedical goods can be classified as ‘dangerous goods’ by international standards, there are instructions for aerial transport. However, the instructions are currently not specific for drone transport, which prevents a shared consensus on the applicability of those standards for this transport modality. For this reason, Sara highlighted the urgency for standards that cover this topic, focusing on the safety of third parties and on medical logistics to ensure that the quality of the transported material is preserved.
EuroUSC Italia and Ospedale San Raffaele Developments
EuroUSC Italia has developed SAMWISE, the first risk assessment tool based on EASA’s SORA methodology for safe UAM operations and is currently developing training material for the FF2020 project.
Ospedale San Raffaele leads the FF2020 living lab in Milan and is currently preparing the drone demonstrations, which will be held in the first quarter of 2023. The demonstrations include autonomous monitoring and predictive intervention of critical infrastructures at a hospital and precision logistic services for air transport of critical medical and pharmaceutical material.